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Proenkephalin A 119–159 (penKid) Leads the Way in Predicting Graft Outcomes for Kidney Transplant Recipients

Tue, 28 Oct 2025 11:06:06 GMT

• PenKid surpasses serum creatinine on Day 1 post-transplant in detecting delayed graft function (DGF), with an AUROC of 0.87 versus 0.56 for creatinine.

• PenKid differentiates slow graft function (SGF) from DGF up to 8 days earlier than current methods, supporting more timely clinical decisions.

• PenKid levels remain unaffected by kidney replacement therapy (KRT), allowing for more accurate assessment of kidney function.

• Independent validation in transplant cohort from Australia confirms performance and broad applicability.

Hennigsdorf/Berlin, Germany, July 1, 2025 - Diagnostic company SphingoTec GmbH (“SphingoTec”) announces a landmark study (1) published in Transplant International, led by Heidelberg University Hospital in Germany in collaboration with researchers from Sydney, Australia, which identifies Proenkephalin A 119-159 (penKid) as a reliable biomarker for early and precise assessment of graft function trajectories following kidney transplantation. The research demonstrates that PenKid not only identifies patients at risk for DGF significantly earlier than traditional markers but also distinguishes between slow and delayed graft function with remarkable accuracy, offering clinicians a valuable new tool for patient management.

The study prospectively evaluated 159 consecutive kidney transplant recipients at Heidelberg University Hospital and validated findings in an independent cohort from Sydney. PenKid consistently outperformed serum creatinine (SCr) in predicting graft function trajectories, particularly in the critical early post-transplant period. Notably, PenKid’s ability to remain unaffected by KRT—a treatment for severe kidney dysfunction—further sets it apart from SCr, which can be influenced by non-renal factors and KRT itself, thereby enhancing the reliability of graft function assessment.

Multivariate analysis confirmed PenKid as the strongest independent predictor of both short-term graft function and 30-day outcomes, underscoring its clinical utility for early risk stratification. The biomarker’s superior granularity allows for nuanced classification of DGF severity, supporting more informed decisions regarding the initiation of dialysis or biopsy and offering potential for individualized patient care.

With these findings, penKid steps forward as a practical addition to the transplant clinician’s toolkit, promising to sharpen decision-making for optimal outcomes. Its adoption could help transplant teams act with greater confidence and precision, ultimately strengthening the standard of care in kidney transplantation.

References

1. Benning L et al. (2025) Proenkephalin A 119-159 in Kidney Transplantation: A Novel Biomarker for Superior Tracking of Graft Function Trajectories. Transpl. Int. 38:14366. doi: 10.3389/ti.2025.14366

About SphingoTec

SphingoTec GmbH ("SphingoTec"; Hennigsdorf near Berlin, Germany) is a biomarker company focusing on the out-licensing of innovative critical care solutions for diagnosing, predicting, and monitoring acute medical conditions. SphingoTec develops its biomarkers to the commercial stage and partners with IVD companies to make them available on different IVD platforms. SphingoTec's proprietary biomarker portfolio includes Proenkephalin A 119-159 (penKid), a biomarker for the assessment of kidney function in critical diseases, commercially available on diagnostic platforms AFIAS and Nexus IB10 and bioactive Adrenomedullin 1-52 (bio-ADM), a biomarker for the assessment of endothelial function in conditions like sepsis. Discover more on www.sphingotec.com

Contact :

Ruxandra Lenz

Marketing and Communication

SphingoTec GmbH

Phone +49-3302-20565-0

Email: press@sphingotec.com

Boditech Med and SphingoTec Announce Launch of AFIAS penKid® Assay for Kidney Function Diagnostics

Tue, 28 Oct 2025 11:03:11 GMT

• Boditech Med and SphingoTec announce the launch of the AFIAS sphingotest® penKid® assay, a diagnostic tool designed to aid in kidney function assessment for critically ill patients.

• The IVDR-marked assay provides quantitative measurements of Proenkephalin A 119-159 (penKid), supporting clinical decision-making in acute and critical care.

• This launch follows a licensing agreement granting Boditech the rights to develop and commercialize penKid-based assays, as well as a market development agreement between the two companies.

Gangwon-do, Republic of Korea, and Hennigsdorf/Berlin, Germany, May 6, 2025 - Boditech Med Inc. (“Boditech”) and SphingoTec GmbH (“SphingoTec”) today announced the commercial launch of the AFIAS sphingotest® penKid® assay. The assay is designed to provide clinicians with a tool for assessing kidney function in critically ill patients by measuring Proenkephalin A 119-159 (penKid), a biomarker that reflects real-time kidney function independently of inflammation or comorbidities.

The AFIAS sphingotest® penKid® assay is IVDR-marked for its intended use as an automated fluorescence immunoassay for the in vitro diagnostic quantitative determination of Proenkephalin A 119-159 in human whole blood/plasma, serving as an aid in the diagnosis of acute kidney injury (AKI) in adult patients with sepsis or septic shock. It provides additional information to support clinical decision-making in managing critically ill patients at risk of acute kidney injury (AKI). This launch is the result of a strategic collaboration between Boditech and SphingoTec, including a licensing agreement granting Boditech the rights to develop and commercialize penKid-based assays on its diagnostic platforms, as well as a market development agreement aimed at accelerating global commercialization efforts.

Eui-Yul Choi, CEO of Boditech Med, commented: “We are proud to introduce the AFIAS sphingotest® penKid® assay to clinicians worldwide. This launch reflects our commitment to delivering innovative diagnostic solutions that address critical needs in healthcare. Our collaboration with SphingoTec has been instrumental in bringing this important tool to market.”

Deborah Bergmann, CEO of SphingoTec, added: “The launch of AFIAS sphingotest® penKid® demonstrates how partnerships can drive innovation and improve access to advanced diagnostics. By combining our biomarker expertise with Boditech’s diagnostic capabilities, we are reaching a new chapter in our collaboration. We are streamlining our processes to support the business of our license partners and further expand our global reach. This enables us to provide clinicians with essential tools to enhance patient care.”

Scientific insights on penKid

PenKid is a biomarker that enables real-time assessment of kidney function (1). Unlike traditional markers such as serum creatinine, penKid levels are not influenced by inflammation or other confounding factors like age or sex (1,2,3). Studies have shown that penKid allows earlier detection of acute kidney injury (AKI), predicting changes in serum creatinine up to 48 hours before conventional diagnostic criteria are met (1,3). This early detection capability is particularly valuable in critically ill patients, including those with sepsis or septic shock (1,3,4). Additionally, penKid has shown potential for monitoring renal recovery under dialysis and could help predict successful weaning from renal replacement therapy (5,6).

References

1. Hollinger A, et.al. Proenkephalin A 119-159 (Penkid) Is an Early Biomarker of Septic Acute Kidney Injury: The Kidney in Sepsis and Septic Shock (Kid-SSS) Study. Kidney Int Rep. 2018 Aug 22;3(6):1424-1433. doi: 10.1016/j.ekir.2018.08.006.

2. Beunders et al. Assessing GFR With Proenkephalin, Kidney International Reports, 2023, DOI: https://doi.org/10.1016/j.ekir.2023.08.006

3. Caironi et al., Circulating proenkephalin, acute kidney injury, and its improvement in patients with severe sepsis or shock. Clin Chem (2018) DOI:10.1373/clinchem.2018.288068

4. Moledina DG. Penkid: A Novel Biomarker of Reduced GFR in Sepsis. Kidney Int Rep. 2018 Nov 15;4(1):17-19. doi: 10.1016/j.ekir.2018.11.002.

5. von Groote T et al. Proenkephalin A 119–159 predicts early and successful liberation from renal replacement therapy in critically ill patients with acute kidney injury: a post hoc analysis of the ELAIN trial. Crit Care 26, 333 (2022). doi.org/10.1186/s13054-022-04217-4

6. von Groote T, et al. Evaluation of Proenkephalin A 119-159 for liberation from renal replacement therapy: an external, multicenter pilot study in critically ill patients with acute kidney injury. Crit Care. 2023 Jul 10;27(1):276. doi: 10.1186/s13054-023-04556-w.

About Boditech

Boditech Med (based in Chuncheon, Gangwon-do, Republic of Korea) is a leading company in the field of point-of-care diagnostics, which has accumulated 25 years of business expertise in the field. The company has more than 80 types of in vitro diagnostic products that detect biomarkers related to infectious diseases, diabetes, cardiovascular diseases, cancer, and hormone-related diseases with its immunofluorescence lateral flow technology, quantitative immunofluorescence technology and spectrophotometric technology. And the list continues to grow with new high-value-added products. With its instrument platform installed in more than 120 countries, the company also has a stable revenue model. The company is currently strengthening its value as a global company by expanding its manufacturing bases in the US, China, India, and Indonesia.

About SphingoTec

SphingoTec GmbH ("SphingoTec"; Hennigsdorf near Berlin, Germany) is a diagnostic company focusing on the out-licensing of innovative critical care biomarkers for diagnosing, predicting, and monitoring acute medical conditions. SphingoTec develops its biomarkers to the commercial stage and partners with IVD companies to make them available on different IVD platforms. SphingoTec's proprietary biomarker portfolio includes Proenkephalin A 119-159 (penKid), a biomarker for the assessment of kidney function in critical diseases, commercially available on diagnostic platforms AFIAS and Nexus IB10 and bioactive Adrenomedullin 1-52 (bio-ADM), a biomarker for the assessment of endothelial function in conditions like sepsis. Discover more on www.sphingotec.com

Contact:

Ruxandra Lenz

Head of Marketing and Communication

SphingoTec GmbH

Phone +49-3302-20565-0

Email: press@sphingotec.com

Beyond Creatinine: First Real-World Evidence Highlights Proenkephalin A 119–159 (penKid) as a Valuable Kidney Function Biomarker

Tue, 28 Oct 2025 10:59:47 GMT

• Real-World Implementation: Proenkephalin A 119–159 (penKid) has been successfully integrated into daily practice in intensive care unit (ICU), demonstrating its effectiveness in assessing kidney function and predicting acute kidney injury (AKI) in over 4,000 patients.

• Superior Dynamics: PenKid augments traditional markers by detecting rapid changes in kidney function, particularly beneficial in critically ill patients where timely information is crucial.

• Clinical Impact: PenKid proved valuable in identifying high-risk patients at ICU admission, especially those with a normal serum creatinine. Additionally, penKid provided valuable insights into kidney function during renal replacement therapy (RRT).

• International Recognition: Beyond its use in reference hospitals in Germany, international experts, including those at the Mayo Clinic, acknowledge the added value of penKid on top of standard care.

Hennigsdorf/Berlin, Germany, April 16, 2025 - Diagnostic company SphingoTec GmbH (“SphingoTec”) announces the publication of real-world data on the effectiveness of Proenkephalin A 119–159 (penKid) in improving kidney function assessment in intensive care units (ICUs) (1). This study confirms penKid's value in identifying high-risk patients at admission and supporting the management of renal replacement therapy (1). The published data complement a recent review from the Mayo Clinic that highlights penKid's potential as a new method to measure renal function beyond creatinine (2).

Acute kidney injury (AKI) is a significant challenge in intensive care units (ICUs), affecting up to half of all patients and leading to increased morbidity and mortality (1). Traditional markers like serum creatinine have limitations, as they may not detect kidney dysfunction until significant damage has occurred. A recent study from the University Hospital Aachen marks the first publication based on real-world data from over 4,000 patients, reporting the outcome implementation of penKid in daily practice.

Study Overview

During a two-year period, the University Hospital Aachen, Germany implemented penKid in their ICU (1). The study analyzed almost 18,000 penKid measurements from 4,169 patients, including the use of a penKid-GFR formula to estimate glomerular filtration rate (GFR). PenKid outperformed traditional markers in assessing kidney function and remained dynamic under RRT, supporting clinical decision-making in critical care.

Key Findings

The data show that penKid allows for a significantly better assessment of renal dysfunction upon admission, particularly in identifying patients at risk of developing severe AKI. In patients with normal serum creatinine levels at admission, penKid and its GFR formula outperformed traditional methods in predicting AKI within 24 and 48 hours.

As penKid is effectively removed by RRT, as demonstrated by studies such as Lorenzin et al. (3), persistently elevated levels during RRT may indicate ongoing renal dysfunction, while declining levels could signal renal recovery. This dynamic nature of penKid – even during ongoing RRT - can support decisions that may optimize RRT duration and reduce associated risks.

Clinical Significance

Prof. Dr. Gernot Marx, the Director of the Clinic for Operative Intensive Care and Intermediate Care at Uniklinik RWTH Aachen highlights, "After using penKid in clinical settings for five years, I see significant value in specific use cases due to its swift dynamics, addressing creatinine blind spots. The published data confirms our clinical observations and paves the way for bringing innovation into daily practice." Early detection of compromised renal function could allow for timely interventions, reducing the risk of emergency RRT and improving the chance for full renal recovery. In RRT scenarios, penKid could help de-escalate treatments and prevent unnecessary RRT, potentially reducing ICU stays.

Recent Review

The critical care community is seeking tools for improving kidney health assessment, as indicated by a recent review published by researchers from the Mayo Clinic (2). This review highlights penKid's ability in detecting rapid GFR changes and predicting AKI, particularly in critically ill patients. PenKid's strong correlation with measured GFR makes it a valuable tool, enabling more accurate and timely assessments of kidney function. The Mayo Clinic review also notes that penKid's ability to predict major adverse kidney events, such as worsening renal function and the need for RRT, aligns with its potential to provide valuable prognostic information in clinical settings.

References

1. Martin, L. et al. Implementation and One-Year Evaluation of Proenkephalin A in Critical Care. Int. J. Mol. Sci. 2025, 26, 2602. https://doi.org/10.3390/ijms26062602

2. Sheikh MS, Kashani KB. Beyond creatinine: New methods to measure renal function? Eur J Intern Med. 2025 Jan 31:S0953-6205(25)00025-1. doi: 10.1016/j.ejim.2025.01.015.

3. Lorenzin, A. et al. Human Proenkephalin A 119-159 (penKid) in Extracorporeal Therapies: Ex vivo Sieving Coefficient, Diffusive Clearance, and Hemoadsorption Kinetics. Blood Purif. 2024, 53, 773–780. doi: 10.1159/000540061.

About SphingoTec

Contact:

Ruxandra Lenz

Head of Marketing and Communication

SphingoTec GmbH

Phone +49-3302-20565-0

Email: press@sphingotec.com

Assessing Post-Cardiac Surgery Kidney Recovery Through PenKid's Emerging Role in Renal Replacement Therapy Decisions

Tue, 28 Oct 2025 10:55:44 GMT

• Proenkephalin A 119-159 (penKid) demonstrates potential as a predictor for successful discontinuation of continuous renal replacement therapy (CRRT) in cardiac surgery patients.

• Study reveals significant differences in penKid levels between patients successfully and unsuccessfully liberated from CRRT.

• Findings suggest penKid could be a valuable tool in guiding CRRT liberation decisions.

Hennigsdorf/Berlin, Germany, January 9, 2025 - Diagnostic company SphingoTec GmbH ("SphingoTec") announces results from the first prospective study, conducted at the Medical University of Vienna, demonstrating penKid as a discriminatory biomarker for successful liberation from CRRT in cardiac surgery patients with acute kidney injury (AKI) (1).

AKI remains a significant challenge in hospitals and is not limited to emergency cases, affecting a substantial number of up to 40% of elective cardiac surgery patients (2,3). When prolonged or further complicated, the use of CRRT might become necessary, which is one of the most resource-intensive interventions. Determining the optimal time to discontinue CRRT has been a persistent clinical challenge. The research, led by Ap. Prof. PD DDr. Martin Bernardi and colleagues, provides new insights into the utility of this biomarker.

Key Findings

The study revealed that patients successfully liberated from CRRT had significantly lower penKid levels compared to those unsuccessfully liberated (1). This distinction was particularly notable at the time of CRRT liberation. "Our findings suggest that penKid could be a valuable tool in supporting clinical decisions regarding CRRT discontinuation," stated Prof. Bernardi. "Additionally, this biomarker shows potential in identifying patients who are likely to maintain kidney function after CRRT is stopped."

Supporting evidence comes from post-hoc analyses of the RICH (5) and ELAIN (6) trials, which consistently demonstrate penKid's capability to predict kidney function recovery under renal replacement therapy and successful treatment liberation.

Bridging Gaps in AKI Management

As the critical care community continues to optimize AKI management protocols in cardiac surgery patients and beyond, penKid stands out as a promising biomarker that could refine current acute dialysis management strategies, particularly in determining optimal timing for CRRT discontinuation. For more information, Prof. Bernardi will be discussing these findings and their implications in an upcoming webinar titled "Practice-Oriented Management of Acute Dialysis in Cardiac Surgery Patients: Strategies and Challenges in Clinical Practice."

References:

1. Tichy J, et.al. Prediction of Successful Liberation from Continuous Renal Replacement Therapy Using a Novel Biomarker in Patients with Acute Kidney Injury after Cardiac Surgery-An Observational Trial. Int J Mol Sci. 2024 Oct 10;25(20):10873. doi: 10.3390/ijms252010873.

2. Grams, M.E. et. al. Acute Kidney Injury after Major Surgery: A Retrospective Analysis of Veterans Health Administration Data. Am. J. Kidney Dis. 2016, 67, 872–880.

3. Wang, Y. et al. Cardiac surgery-associated acute kidney injury: Risk factors, pathophysiology and treatment. Nat. Rev. Nephrol. 2017, 13, 697–711.

4. Lorenzin A, et al. Human Proenkephalin A 119-159 (penKid) in Extracorporeal Therapies: Ex vivo Sieving Coefficient, Diffusive Clearance, and Hemoadsorption Kinetics. Blood Purif. 2024;53(10):773-780. doi: 10.1159/000540061.

6. (3) von Groote T, et al. Evaluation of Proenkephalin A 119-159 for liberation from renal replacement therapy: an external, multicenter pilot study in critically ill patients with acute kidney injury. Crit Care. 2023 Jul 10;27(1):276. doi: 10.1186/s13054-023-04556-w.

About SphingoTec

Contact:

Ruxandra Lenz

Head of Marketing and Communication

SphingoTec GmbH

Phone +49-3302-20565-0

Email: press@sphingotec.com

Beckman Coulter and SphingoTec Partner to Improve Kidney Health Assessment in Critical Care

Tue, 28 Oct 2025 10:51:26 GMT

• Alliance marks first penKid licensing agreement for high throughput immunoassay.

• Partnership leverages SphingoTec's proficiency in acute kidney injury testing, and Beckman Coulter’s extensive, globally installed Access Family of immunoassay analyzers.

HENNIGSDORF/BERLIN, GERMANY — October 9, 2024: Diagnostic company SphingoTec GmbH (“SphingoTec”) today announced a new partnership with Beckman Coulter Diagnostics Inc. (“Beckman Coulter”). Through this collaboration, the companies will bring an assay for SphingoTec’s innovative kidney function biomarker, Proenkephalin 119-159 (penKid), to Beckman Coulter’s extensive test menu for use on the Access Family of Immunoassay Analyzers. This alliance marks the first central laboratory license for a penKid assay and aims to significantly enhance the diagnostic capabilities for acute kidney injury (AKI) globally, by leveraging Beckman Coulter’s global installed base of instruments.

PenKid is a real-time biomarker in plasma designed to address critical gaps in the standard diagnostic practices for AKI, particularly in critical care environments. Specifically, scientific evidence shows that, unlike current methods, a penKid assay offers early detection of kidney function decline, unaffected by inflammation, potentially enabling earlier intervention and improved patient outcomes (1,2,3). The incidence of AKI is increasing in both hospital and community settings; it is estimated that more than 13 million people are affected by AKI annually worldwide (4, 5).

Under the terms of the agreement, Beckman Coulter will develop and validate a fully automated diagnostic test for penKid, leveraging SphingoTec’s IVD certified assay. This assay has already been implemented as a routine test in the first university hospitals. This collaborative effort will facilitate high-throughput availability of penKid assays in central laboratories, supporting critical care physicians with the ability for timely and precise kidney health assessment.

“Acute kidney injury exerts a profound impact on patients globally, complicates acute and chronic illnesses frequently resulting in poor outcomes, and rivals many other critical diseases in its severity and consequences,” said Kevin O’Reilly, President, at Beckman Coulter Diagnostics. “The published evidence for penKid testing combined with SphingoTec’s scientific expertise provides an exciting opportunity to improve kidney health management. Working with SphingoTec, our goal is to expand access to and improve workflow from this important kidney health innovation underscoring our commitment to enhancing patient care worldwide.”

Deborah Bergmann, Managing Director and CEO of SphingoTec, emphasized, “The development of a penKid-based assay for use on Beckman Coulter’s globally installed immunoassay platforms represents a significant step toward realizing our vision of transforming diagnostic innovation into tangible patient benefits. This partnership accelerates our mission to deliver precise, actionable insights to clinicians worldwide, ultimately improving outcomes for patients suffering from acute kidney injury.”

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References:

(1) Beunders et al. Assessing GFR With Proenkephalin, Kidney International Reports, 2023, DOI: https://doi.org/10.1016/j.ekir.2023.08.006

(2) Caironi et al., Circulating proenkephalin, acute kidney injury, and its improvement in patients with severe sepsis or shock. Clin Chem (2018) https://doi.org/10.1373/clinchem.2018.288068

(3) Lin, LC., et al. Proenkephalin as a biomarker correlates with acute kidney injury: a systematic review with meta-analysis and trial sequential analysis. Crit Care 27, 481 (2023). https://doi.org/10.1186/s13054-023-04747-5

(4) Mehta RL et al. International Society of Nephrology’s 0by25 initiative for acute kidney injury (zero preventable deaths by 2025): a human rights case for nephrology. Lancet. 2015 Jun 27;385(9987):2616–43. http://dx.doi.org/10.1016/S0140-6736(15)60126-X

(5) Susantitaphong P et al. World incidence of AKI: a meta-analysis. Clin J Am Soc Nephrol. 2013 Sep;8(9):1482–93. http://dx.doi.org/10.2215/CJN.00710113

About SphingoTec

SphingoTec GmbH ("SphingoTec"; Hennigsdorf near Berlin, Germany) is a commercial-stage diagnostic company focusing on innovative critical care biomarkers for diagnosing, predicting, and monitoring acute medical conditions. SphingoTec’s innovative markers are made available on different IVD platforms. SphingoTec's proprietary biomarker portfolio includes Proenkephalin A 119-159 (penKid), a biomarker for the assessment of kidney function in critical diseases, and bioactive Adrenomedullin 1-52 (bio-ADM), a biomarker for the assessment of endothelial function in conditions like sepsis. Discover more on www.sphingotec.com

Contact:

Ruxandra Lenz

Head of Marketing and Communication

SphingoTec GmbH

Phone +49-3302-20565-0

Email: ruxandra.lenz@sphingotec.com

SphingoTec Closes €5M Series C to Accelerate Market Development and Financial Growth with Innovative Biomarkers

Tue, 28 Oct 2025 10:47:31 GMT

• SphingoTec GmbH has successfully secured funding to drive its global expansion, including the US market, through strategic collaborations.

• The investment round is led by Think.Health Ventures, with support from existing investors. Think.Health Ventures will add significant value to SphingoTec through its expertise in diagnostics and its extensive network in clinics and laboratories.

• The raised capital will be pivotal in advancing the out-licensing and commercialization of SphingoTec’s innovative biomarkers for critical care, aiming to significantly improve patient management and outcomes.

• The funding underscores SphingoTec’s dedication to pioneering advancements in critical care patient management.

Hennigsdorf/Berlin, Germany, August 8, 2024 - Diagnostics company SphingoTec GmbH (“SphingoTec”) announces the successful closing of a Series C financing round. The raised capital will allow the company to reach profitability through sustained and strategic commercialization of its products. This includes supporting market development, out-licensing activities, and close collaboration with licensees. SphingoTec aims for global expansion, including entry into the US market.

The lead investor, Think.Health Ventures, specializes in healthcare ventures that focus on innovations and business models in digital healthcare, medical technologies, and health service providers. Think.Health Ventures will provide support to the SphingoTec management team through its extensive network in clinics and laboratories. Additionally, SphingoTec has secured support from existing investors, which include Brandenburg Kapital, HBM Healthcare Investments, NRW.BANK, and Wellington Partners.

Dr. Florian Kainzinger, Managing Partner and Founder of Think.Health Ventures, commented, "We are pleased to support SphingoTec at this exciting stage of the company's development. With its developed and commercialized lead product penKid, SphingoTec is well-positioned for global expansion through out-licensing to key players in the diagnostic industry."

SphingoTec develops and markets in vitro diagnostic (IVD) solutions for novel and proprietary blood-based protein biomarkers. The company focuses on translational medicine, bringing innovations to frontline healthcare by discovering biomarkers, developing IVD assays, and making them available on different diagnostic platforms. The biomarker portfolio includes Proenkephalin A 119-159 (penKid), a biomarker for the assessment of kidney function, and bioactive Adrenomedullin 1-52 (bio-ADM), a biomarker for the assessment of endothelial function. PenKid has been out-licensed and commercialized and is currently used in routine measurements in university hospitals to improve patient management. To achieve broad market adoption of its first-in-class biomarkers, SphingoTec partners with global IVD companies. The portfolio is available for licensing to companies seeking to enhance their immunoassay portfolios and develop biomarker-based diagnostics for clinical use on high-throughput and near-patient testing platforms.

Deborah Bergmann, Managing Director and CEO, stated, "There is a substantial demand for more advancements in critical care diagnostics. Our scientifically and clinically validated innovations have the potential to improve the management of critically ill patients. With this investment, we will focus on further out-licensing our biomarkers to translate scientific advancements into routine clinical practice, ultimately supporting clinicians in improving patient outcomes."

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About SphingoTec

About penKid

Proenkephalin A 119-159 (penKid) is a blood-based biomarker for assessing kidney function in acute and critical conditions. The biomarker offers a blood-based alternative for the complex and time-consuming in vivo measurement of true glomerular filtration rate (GFR). PenKid is independent of common comorbidities (e.g., hypertension and diabetes) and the frequently occurring inflammation in critically ill patients. Rising penKid blood levels predict acute kidney injury earlier than today’s standard of care, and decreasing penKid blood levels indicate the improvement of kidney function, even under dialysis.

About bio-ADM

Bioactive Adrenomedullin 1-52 (bio-ADM) is a dynamic blood biomarker for the real-time assessment of endothelial function. The endothelium contributes to blood pressure and separates blood from the surrounding tissue. Elevated bio-ADM blood levels predict both blood pressure drop, resulting in shock and leaky blood vessels, leading to edema formation. Early identification of an imbalance in endothelial function allows for the prediction of vasopressor demand in critically ill patients and aids in the identification of residual congestion in acute heart failure patients.

Media contact:

Ruxandra Lenz

Head of Marketing and Communication

SphingoTec GmbH

Neuendorfstr. 15 A

16761 Hennigsdorf

Tel. +49-3302-20565-0

Advancing Kidney Care With Solidified Evidence – SphingoTec Presents PenKid at AKI & CRRT Course in Vicenza

Tue, 28 Oct 2025 10:44:52 GMT

• SphingoTec and Boditech jointly introduced the kidney function biomarker Proenkephalin A 119-159 (penKid) at the 42nd AKI & CRRT course in Vicenza, highlighting its upcoming integration with the AFIAS platform.

• PenKid is a real-time kidney function biomarker that addresses the standard acute kidney injury (AKI) diagnostic gaps.

• During a scientific session on AKI biomarkers, penKid was presented as a biomarker for risk prediction and early identification of AKI, with performance data that could support clinical routine implementation for effective AKI management.

Hennigsdorf/Berlin, Germany, June 18, 2024 - Diagnostics company SphingoTec GmbH (“SphingoTec”) introduced together with Boditech Med Inc. (Boditech) at the 42nd AKI & CRRT Course in Vicenza the innovative kidney function biomarker penKid developed by SphingoTec and licensed to Boditech. They highlighted the benefits of penKid on the AFIAS platform, emphasizing its promise in enhancing kidney function assessment. With the AFIAS penKid® test, the companies will focus on market development, engaging with healthcare professionals, and ensuring a successful product rollout starting in Europe.

The current standard of care diagnosis for AKI is to use serum creatinine and urine output, which are both lagging indicators. Many clinical studies point to the delay in AKI identification and its impact on mortality. PenKid is a functional biomarker that overcomes the shortcomings in the standard AKI diagnosis of critically ill patients by assessing kidney function in real time without being influenced by inflammation. A new penKid-based formula for estimating the glomerular filtration rate (eGFR) has been developed, outperforming widely used conventional equations based on creatinine alone (1). In previous studies, penKid has shown the potential to support increased clinical vigilance by risk prediction and identifying sub-clinical AKI, with changes in penKid levels pointing to worsening or recovery of kidney function (2).

Prof. Lui Forni, (Professor and Consultant in intensive care at Royal Surrey County Hospital NHS Foundation Trust and the School of Medicine, University of Surrey) introduced penKid to the international audience during the session “Update on biomarkers". In addition to the well-established scientific evidence on penKid as a kidney function biomarker for critical care settings, the presentation also included the results of a decentralized analysis that consolidates evidence from 11 independent studies and nearly 4,000 patients (3). Beyond unified and compelling evidence of penKid’s clinical performance, the systematic meta-analysis explores the role of penKid in identifying patients at high risk for AKI. Incorporating penKid into patient care could enable more intensive surveillance and personalized and early prevention efforts, including optimizing hemodynamic stability and prudent use of nephrotoxic agents.

Prof. Lui Forni emphasizes the potential for penKid to serve as an alternative to serum creatinine in critical care: “While creatinine is the mainstay for monitoring kidney function in chronic kidney disease, its limitations in the acute setting call for better solutions. It's time to embrace novel diagnostics in our day-to-day practice.”

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References:

(1) Beunders et al. Assessing GFR With Proenkephalin, Kidney International Reports, 2023, DOI: https://doi.org/10.1016/j.ekir.2023.08.006

(2) Caironi et al., Circulating proenkephalin, acute kidney injury, and its improvement in patients with severe sepsis or shock. Clin Chem (2018) DOI:10.1373/clinchem.2018.288068

About SphingoTec

About penKid

Media contact:

Ruxandra Lenz

Head of Marketing and Communication

SphingoTec GmbH

Neuendorfstr. 15 A

16761 Hennigsdorf

Tel. +49-3302-20565-0

SphingoTec Announces Management Changes

Tue, 28 Oct 2025 10:42:42 GMT

Hennigsdorf/Berlin, Germany, March 26, 2024 – Diagnostic company SphingoTec announces a significant change in its management team. Joerg Menten, Managing Director and CEO, leaves the company to enter into retirement. Dr. Angelo Moesslang, Managing Director and CFO, leaves SphingoTec after the completion of a 3-year term. SphingoTec is pleased to announce the following appointments to its management team, mainly selected from the internal ranks:

• Deborah Bergmann as Managing Director and Chief Executive Officer (CEO)

• Dr. Florian Uhle as Managing Director and Chief Medical Officer (CMO)

• Nicole Witzmann as Chief Financial Officer (CFO)

Dr. Gerald Moeller, Chairman of the Advisory Board at SphingoTec, said, "On behalf of the Advisory Board, I would like to thank Joerg Menten and Dr. Angelo Moesslang for successfully leading the company during the past years in a challenging external environment, preparing SphingoTec for entering into first commercial agreements, and streamlining the company's complex portfolio. This will allow their successors to focus on the key value drivers going forward. Furthermore, I congratulate Deborah Bergmann, Dr. Florian Uhle, and Nicole Witzmann on their appointments. Their hands-on experience in our global industry will help grow our company to become a key provider of diagnostic innovations in critical care.

The long-term and multi-faceted past management roles of Deborah Bergmann within the company offer an experienced and dynamic leader. Dr. Florian Uhle is completing the team with his deep understanding of critical care settings and experience in translating science into clinical routine practice, and Nicole Witzmann with her successful track record in ensuring financing structure, fundraising, and allocation of funds for successfully achieving relevant milestones. I look forward to dynamic and focused actions with the new management team."

Deborah Bergmann, CEO of SphingoTec, stated, "With gratitude to the outgoing management team for their dedicated leadership, I am honored by this appointment and committed to building upon their foundation. Together with the team, we will expand the global reach of our biomarker innovations, focusing on enhancing patient care and addressing unmet clinical needs. Our collective effort aims to reshape diagnostic standards in critical care while focusing on further licensing agreements and assisting current partners and pharma cooperations. Additionally, we are committed to supporting existing customers as routine users, particularly university hospitals, and strengthening the scientific and clinical evidence around our diagnostic tests."

Deborah Bergmann appointed as Managing Director and CEO:

Deborah Bergmann brings a wealth of experience and a deep understanding of SphingoTec's mission. With a Master's degree in Biochemistry from the University of Potsdam, Ms. Bergmann has been an integral part of SphingoTec's journey from its inception. Her multifaceted contributions across research and development, marketing, sales, and business development have been instrumental in securing the company's first routine users, driving sales conversion of reference customers, and overseeing the out-licensing activities. Ms. Bergmann's leadership skills and international cooperation aptitude have facilitated the company's expansion into global markets, underscoring her commitment to advancing diagnostic standards in critical care.

Dr. Florian Uhle appointed as Managing Director and CMO:

Dr. Florian Uhle brings over 15 years of experience in healthcare. With a diploma in Biology from the Justus-Liebig University, a Master of Science in Clinical Research and Translational Medicine from the University of Leipzig, and a Ph.D. in Translational Critical Care from the Justus-Liebig University, Dr. Uhle has held several leadership roles within Inflammatix Inc. and the University Hospitals Heidelberg and Giessen. His expertise in diagnostic research activities and innovation-oriented initiatives, coupled with his extensive publication record in renowned scientific journals, positions him as a valuable leader to SphingoTec. Dr. Uhle is committed to bridging the gap between research and clinical practice, ensuring that SphingoTec's diagnostic innovations translate into tangible improvements in patient outcomes.

Nicole Witzmann joins SphingoTec as CFO:

Nicole Witzmann assumes the role of Chief Financial Officer, bringing over eight years of corporate finance experience in the healthcare industry. With a Master's degree in Business Communication from the University of Applied Sciences Berlin (HTW Berlin), Ms. Witzmann previously served as CFO at InfanDx. She was instrumental as Head of Finance at Adrenomed AG, ensuring financial oversight and fundraising. Her expertise aligns seamlessly with SphingoTec's strategic objectives: allocating financial resources, which aims to achieve tangible milestones, fostering shareholder value, and substantial advancements in patient care.

About SphingoTec

Media contact:

Ruxandra Lenz

Head of Marketing and Communication

SphingoTec GmbH

Neuendorfstr. 15 A

16761 Hennigsdorf

Tel. +49-3302-20565-0

New Formula Leverages Proenkephalin A 119-159 (penKid) for Improved GFR Estimation in Steady-State and Critically Ill Patients

Tue, 28 Oct 2025 10:33:27 GMT

• PenKid is a kidney function biomarker that correlates with gold standard GFR measurements in stable and acute kidney injury (AKI) patients.

• Based on penKid, a new formula was developed to estimate the GFR, outperforming widely used conventional equations based on creatinine alone.

• Scientists from Radboud University and Mayo Clinic developed and validated this formula in a large cohort of stable, as well as critically ill patients, laying the foundation for future increased clinical vigilance in kidney health assessment.

Hennigsdorf/Berlin, Germany, October 5, 2023 - Diagnostic company SphingoTec GmbH (“SphingoTec”) announces that a new, improved formula has been developed for estimating the GFR using its kidney function biomarker penKid (1). According to the data, penKid strongly correlates with the measured GFR (mGFR), while the penKid-based formula for estimating GFR performs better than routinely used equations.

In clinical practice, kidney dysfunction is monitored using creatinine-based estimates of GFR. Creatinine is recognized as a late and insensitive biomarker of GFR, with consensus guidelines emphasizing that a more timely and accurate estimation of GFR in AKI is a relevant unmet medical need (2,3,4).

Researchers from the Radboud University Medical Centre, Netherlands, and Mayo Clinic, USA, have included a cohort of over 1,300 patients in a data-driven approach for developing an equation to estimate the GFR using the kidney function biomarker penKid (1). According to the findings, this novel equation performs better in calculating eGFR compared to creatinine-based equations. The formula can be applied to a wide range of patients since the cohort used for its development and validation included a broad spectrum of patients, such as patients with established chronic kidney disease, and critically ill patients. The compelling data is further strengthened by the fact that gold-standard methods to determine the true mGFR were used in all patients, and penKid concentration was most strongly correlated with mGFR.

Prof. Peter Pickkers (Head of Research in Intensive Care Medicine at Radboud University Nijmegen Medical Centre) summarized, “The innovative biomarker penKid has previously demonstrated significant potential in increasing the clinical vigilance and supporting the management of AKI patients. The penKid-based formula will facilitate in future its implementation in the clinical routine since it translates penKid concentrations into a more accurate GFR estimation that can now be implemented by physicians worldwide.“

Dr. Florian Uhle, Medical Director at SphingoTec, added, “With this landmark research, the first formula using penKid has been successfully established in chronic and acute kidney impairment. Starting from this evidence base, we will focus on further validating this formula in critically ill patients and aiming to overcome the shortcomings of our current diagnostic standards in AKI management. We are looking forward to interacting closely with global healthcare providers in the future to drive this concept to clinical reality.”

References:

(1) Beunders et. al. Assessing GFR With Proenkephalin, Kidney International Reports, 2023, DOI: https://doi.org/10.1016/j.ekir.2023.08.006

(2) Chawla et al. Acute kidney disease and renal recovery: consensus report of the Acute Disease Quality Initiative (ADQI) 16 Workgroup. Nature Reviews Nephrology 2017; 13: 241-257.

(3) Ostermann et al. Report of the first AKI Round Table meeting: an initiative of the ESICM AKI Section. Intensive Care Med Exp 2019; 7: 69.

(4) Pickkers et al. The intensive care medicine agenda on acute kidney injury. Intensive care medicine 2017; 43: 1198-1209.

About SphingoTec

About penKid

Media contact:

Ruxandra Lenz

Head of Marketing and Communication

SphingoTec GmbH

Neuendorfstr. 15 A

16761 Hennigsdorf

Tel. +49-3302-20565-0

International Experts Highlight Demand for Diagnostic Innovations as PenKid's Research and Real-World Data Fuels Quest for Improved RRT Liberation Tools

Tue, 28 Oct 2025 10:32:01 GMT

• International experts recognize the need for diagnostic innovations to support more informed and standardized decisions for liberation from renal replacement therapy (RRT).

• A presentation during the 41st Vicenza Course on AKI-CRRT highlights the promising results of a real-world evaluation of kidney function under RRT with Proenkephalin A 119-159 (penKid).

• Recently published scientific data affirms that penKid remains informative under acute renal replacement therapy (RRT) and can identify patients for successful liberation.

Hennigsdorf/Berlin, Germany, September 6, 2023 – Diagnostic company SphingoTec has announced that a new study and real-world data on its kidney function biomarker penKid underline its potential to monitor kidney function during acute kidney injury (AKI) and RRT and to support liberation decisions from RRT. These findings are especially relevant in the context of a liberation failure rate of up to 50% (1), considering the lack of consensus guidelines, and tools to support clinical decision-making.

Experts advocate for improved tools in critical decision-making

RRT, a common practice in Intensive Care Units (ICUs), has long relied on clinical observations for stop decisions. However, the lack of a dependable biomarker poses challenges in accurately assessing when to discontinue RRT. Considering this, leading experts from the field have discussed in a recent advisory board the importance of identifying the right tools to improve the outcomes in AKI.

According to Claudio Ronco (Director of the International Renal Research Institute of Vicenza, Italy), "The future availability of a reliable biomarker to support stop decisions in RRT is crucial. It has the potential to minimize liberation failure rates and enhance patient care significantly." Lui Forni (Professor and Consultant in intensive care at Royal Surrey County Hospital NHS Foundation Trust and the School of Medicine, University of Surrey) highlights the ethical concerns surrounding unsuccessful liberation, stating, "When patients need to restart RRT after failed liberation, in many cases this will affect the overall patient outcome with an increase in mortality being seen. Therefore, it is imperative that we explore solutions that can help avoid such scenarios." The expert group supports the planning of a prospective study involving penKid as a potential tool to promote uniform treatment standards for RRT liberation.

Advancements in assessing kidney function under RRT

During the 41st Vicenza Course on AKI-CRRT, a presentation by Christian Nusshag (Senior Physician at the University Hospital Heidelberg, Germany) and titled “Real-world evaluation of residual kidney function under RRT - what’s new?” introduced the latest insights emerging from real-world data.

Dr. Nusshag highlighted, "In the realm of AKI, there is a recognized need for relevant biomarkers that can accurately assess kidney function, especially in the context of RRT. The data we generated with penKid during our real-world evaluation at University Hospital Heidelberg, allowed us to observe that penKid seems not to be affected by RRT procedure, as standard markers are. In this case, penKid may help to identify patients at high risk for liberation failure or patients with unnecessary prolongation of RRT, potentially supporting successful RRT liberation decisions in the future."

Recently published data support these real-world findings. The post-hoc analysis of the multicentric RICH trial show that penKid may be a competent biomarker to monitor the recovery of kidney function during continuous RRT (CRRT) and identify patients for liberation from CRRT (2). This aligns with data from the ELAIN trial, where penKid showed the potential to guide early and successful liberation of treatment (3).

Dr. Florian Uhle, Medical Director at SphingoTec comments, “PenKid’s ability to provide patient-specific insights for informed clinical decision-making opens exciting possibilities in monitoring kidney function in critically ill patients, as it mirrors the real-time glomerular filtration rate in non-stable settings. The potential of penKid in kidney health assessment opens new avenues for personalized medicine in AKI.”

References:

(1) Schiffl H, et al. Current Approach to Successful Liberation from Renal Replacement Therapy in Critically Ill Patients with Severe Acute Kidney Injury: The Quest for Biomarkers Continues. Mol Diagn Ther. 2021 Jan;25(1):1-8. doi: 10.1007/s40291-020-00498-z.

(2) von Groote T et al. Proenkephalin A 119–159 predicts early and successful liberation from renal replacement therapy in critically ill patients with acute kidney injury: a post hoc analysis of the ELAIN trial. Crit Care 26, 333 (2022). https://doi.org/10.1186/s13054-022-04217-4

(3) von Groote T, et al. Evaluation of Proenkephalin A 119-159 for liberation from renal replacement therapy: an external, multicenter pilot study in critically ill patients with acute kidney injury. Crit Care. 2023 Jul 10;27(1):276. doi: 10.1186/s13054-023-04556-w.

About SphingoTec

SphingoTec GmbH ("SphingoTec"; Hennigsdorf near Berlin, Germany) is a commercial-stage diagnostic company focusing on innovative critical care biomarkers for the diagnosis, prediction, and monitoring of acute medical conditions. SphingoTec’s innovative markers are made available on different IVD platforms. SphingoTec's proprietary biomarker portfolio includes Proenkephalin A 119-159 (penKid), a biomarker for the assessment of kidney function in critical diseases, and bioactive Adrenomedullin 1-52 (bio-ADM), a biomarker for the assessment of endothelial function in conditions like sepsis.

Media contact:

Ruxandra Lenz

Head of Marketing and Communication

SphingoTec GmbH

Neuendorfstr. 15 A

16761 Hennigsdorf

Tel. +49-3302-20565-0

Boditech Med and SphingoTec close Market Development Agreement to Boost Commercialization of Kidney Function Biomarker PenKid

Tue, 28 Oct 2025 10:29:41 GMT

• In 2022, Boditech Med and SphingoTec closed a global licensing agreement to develop and offer the Proenkephalin A 119-159 (penKid) test on Boditech's automated immunoassay systems.

• The current market development agreement aims at enhancing the commercialization of the upcoming assay for penKid and ultimately advancing AKI diagnostics.

Gangwon-do, Republic of Korea and Hennigsdorf/Berlin, Germany, August 31, 2023 - Boditech Med Inc. (“Boditech”) and SphingoTec GmbH (“SphingoTec”) today announced they have entered into a market development agreement (MDA), building on their previous licensing collaboration for the kidney function biomarker penKid. The MDA solidifies the partnership between Boditech and SphingoTec, aiming to support the successful commercialization of the assay for the biomarker penKid on the AFIAS platforms.

This strategic collaboration unites the expertise and resources of both companies to drive advancements in kidney health assessment, addressing the unmet needs in acute kidney injury (AKI) diagnosis. AKI is a life-threatening condition that affects 13 million patients worldwide (1), and existing diagnostic standards often fall short, particularly for non-stable patients (2). The biomarker penKid shows significant potential to address these unmet needs as it delivers information on kidney function earlier and more precisely than the currently used markers, even under renal replacement therapy (3,4).

Eui-Yul Choi, CEO, Boditech stated, “We are excited to soon introduce this innovative diagnostic biomarker to the market through our point-of-care platforms. To expedite market development, we have made the strategic decision to collaborate with SphingoTec, leveraging their know-how and experience in working alongside a global network of medical experts.”

SphingoTec's CEO, Jörg Menten, emphasized on the significance of the partnership saying “We are dedicated to expanding our collaboration and providing robust support for the commercialization of penKid. By combining expertise, resources, and a shared vision, both companies are committed to advance AKI diagnostics and improve the management of critically ill patients.”

References

(1) Ponce D, et al. Acute kidney injury: risk factors and management challenges in developing countries. Int J Nephrol Renovasc Dis. 2016 Aug 22;9:193-200. doi: 10.2147/IJNRD.S104209. PMID: 27578995; PMCID: PMC5001661

(2) Makris K, et al. Acute Kidney Injury: Diagnostic Approaches and Controversies. Clin Biochem Rev. 2016 Dec;37(4):153-175. PMID: 28167845; PMCID: PMC5242479.

(3) Hollinger A, et al. Proenkephalin A 119-159 (Penkid) Is an Early Biomarker of Septic Acute Kidney Injury: The Kidney in Sepsis and Septic Shock (Kid-SSS) Study. Kidney Int Rep. 2018 Aug 22;3(6):1424-1433. doi: 10.1016/j.ekir.2018.08.006.

(4) von Groote et al. Proenkephalin A 119–159 predicts early and successful liberation from renal replacement therapy in critically ill patients with acute kidney injury: a post hoc analysis of the ELAIN trial. Crit Care 26, 333 (2022). doi.org/10.1186/s13054-022-04217-4

About Boditech

About SphingoTec

About penKid

Proenkephalin A 119-159 (penKid) is a blood-based biomarker for assessing the kidney function in acute and critical conditions. The biomarker offers a blood-based alternative for the complex and time-consuming in vivo measurement of true glomerular filtration rate (GFR). PenKid is independent of common comorbidities (e.g. hypertension and diabetes) and the frequently occurring inflammation in critically ill patients. Rising penKid blood levels predict acute kidney injury earlier than today’s standard of care and decreasing penKid blood levels indicate the improvement of kidney function. Scientific evidence shows that penKid also reflects kidney function in children, representing a potential biomarker for pediatric AKI.

Press contact

Boditech Med Inc.

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Email: nds@boditech.co.kr

Phone: +821028451778

www.boditech.co.kr SphingoTec GmbH

Ruxandra Lenz

Email: press@sphingotec.de

Phone: +49-3302-20565-0

www.sphingotec.com

SphingoTec's Innovative IVD Product sphingotest® penKid® Receives First IVDR Certificate

Tue, 28 Oct 2025 10:25:14 GMT

• SphingoTec GmbH has received its IVDR certificate for its sphingotest® penKid® confirming the quality and compliance of this product with regulatory requirements.

• Sphingotest® penKid® aids in the diagnosis of acute kidney injury and meets rigorous safety standards to ensure the best possible outcomes for critically ill patients.

Hennigsdorf/Berlin, Germany, May 9, 2023 - Diagnostic company SphingoTec has been successfully re-certified according to ISO 13485 and received its first IVDR certificate for its IVD product sphingotest® penKid®. The certificates awarded by its Notified Body TÜV SÜD Product Service GmbH demonstrate the commitment of SphingoTec to meet the high-quality requirements of the ISO 13485 and the (EU) 2017/746 (IVDR).

The IVDR-compliant and CE IVD-released product sphingotest® penKid® is used as an aid in the diagnosis of kidney injury in patients with sepsis or septic shock and meets the regulatory requirements to ensure the safety of critically ill patients to the utmost extent possible.

Dr. Angelo Moesslang, Managing Director and CFO of SphingoTec commented, “Ensuring compliance in all aspects of our clinical biomarker validation processes is an absolute requirement for our company and our licensing partners. This includes robust quality management, setting up and maintaining technical documentation, continuous biomarker evaluation, and diligent manufacturing of products. By maintaining these quality standards, we are able to offer our partners valuable business opportunities and a strong competitive advantage in the marketplace.”

As a company committed to innovation in the field of diagnostic testing, SphingoTec plans to continue collaborating with official regulatory bodies in the future to certify further products and expand existing certifications. By building up on the success with sphingotest® penKid®, SphingoTec aims to lead the way in developing diagnostic tools that meet the highest standards of quality, safety, and regulatory compliance.

About SphingoTec

Media contact:

Ruxandra Lenz

Head of Marketing and Communication

SphingoTec GmbH

Neuendorfstr. 15 A

16761 Hennigsdorf

Tel. +49-3302-20565-0

ADQI Group Recognizes PenKid as Relevant Functional Biomarker for Sepsis-Associated Acute Kidney Injury

Tue, 28 Oct 2025 10:23:25 GMT

• The Acute Disease Quality Initiative (ADQI) has published a consensus statement that strongly recommends using innovative biomarkers to improve the management of sepsis-associated acute kidney injury (SA-AKI).

• According to the statement, the kidney function biomarker Proenkephalin A 119-159 (penKid) can detect subclinical AKI, enabling early risk prediction for upcoming AKI.

• Looking ahead, integrating clinical information including relevant biomarkers might support the identification of specific disease endotypes and organ-related tolerance mechanisms as a basis for future personalized therapies.

Hennigsdorf/Berlin, Germany, April 4, 2023 - Diagnostic company SphingoTec announces that in the consensus statement of the 28th ADQI workgroup, penKid is recognized as a relevant functional biomarker able to predict SA-AKI with high accuracy (1). Sepsis is a life-threatening disease that leads to organ dysfunction, accounting for up to 70% of all cases of AKI in critically ill patients (1). The current standard of care diagnostics for AKI has considerable limitations, therefore it is an urgent need to implement new biomarkers to enable better patient management.

According to the consensus statement, penKid can identify patients with sepsis who are at an increased risk of developing AKI and major adverse kidney events (1). The study cites previous research that demonstrates the ability of penKid to detect subclinical AKI, including multicentric studies that shows the incidence and outcome relevance of subclinical AKI in critically ill patients (2,3).

SA-AKI is a heterogeneous syndrome, with multiple mechanisms that contribute to its development. The recommendations also include the use of biomarkers and clinical information to identify distinct disease mechanisms and characteristics that can inform personalized treatment decisions in clinical practice. Furthermore, the same granular approach focused on early patient risk identification could also enable predictive enrichment in randomized trials of development-stage therapeutics.

Dr. Florian Uhle, Medical Director at SphingoTec commented “There are few options available for assessing the kidney function in the context of AKI, and the standard of care biomarkers have well-known limitations, especially in septic patients. PenKid offers additional insights that could help clinicians recognize subclinical AKI and take preventive measures before the true problem even occurs. Since the main therapy in AKI relies on the management of symptoms, there is also a high need to advance the drug development and use these tools to support the identification of the right patients with the highest benefit and no harm in clinical trials.”

Beyond the early detection of SA-AKI, previous scientific evidence shows that penKid has other applications that make it a versatile biomarker for kidney function assessment. PenKid correlates to the true glomerular filtration rate (true GFR), detects the presence and severity of AKI, identifies patients at high risk of unfavorable outcomes, and indicates renal recovery, even under dialysis (3,4).

###

References:

1. Zarbock, A. et al. Sepsis-associated acute kidney injury: consensus report of the 28th Acute Disease Quality Initiative workgroup. Nat Rev Nephrol (2023). https://doi.org/10.1038/s41581-023-00683-3

2. Depret, F. et al. Incidence and outcome of subclinical acute kidney injury using penKid in critically ill patients. Am. J. Respir. Crit. Care Med. 202, 822–829 (2020).

3. Hollinger, A. et al. Proenkephalin A 119-159 (Penkid) is an early biomarker of septic acute kidney injury: the kidney in sepsis and septic shock (Kid-SSS) study. Kidney Int. Rep. 3, 1424–1433 (2018).

4. von Groote T et al. Proenkephalin A 119–159 predicts early and successful liberation from renal replacement therapy in critically ill patients with acute kidney injury: a post hoc analysis of the ELAIN trial. Crit Care 26, 333 (2022)

About SphingoTec

Media contact:

Ruxandra Lenz

Head of Marketing and Communication

SphingoTec GmbH

Neuendorfstr. 15 A

16761 Hennigsdorf

Tel. +49-3302-20565-0

SphingoTec Appoints Dr. Florian Uhle as Medical Director

Tue, 28 Oct 2025 10:20:24 GMT

Hennigsdorf/Berlin, Germany, February 23, 2023 – Diagnostic company SphingoTec is pleased to announce the appointment of Dr. Florian Uhle as the company's new Medical Director. Dr. Uhle is a subject matter expert in translating innovations into routine clinical practice with a broad experience in both clinical and corporate settings.

Dr. Uhle brings a wealth of knowledge and experience to the role, having spent 15 years in healthcare. In his new position, he will work cross-functionally to perfect the clear applications of the company's innovative diagnostic biomarkers while focusing on expanding their use for added value in clinical practice. SphingoTec recognizes the importance of addressing unmet needs in critical care settings with clear applications that can improve decision-making and patient management while reducing healthcare cost.

Jörg Menten, Managing Director and CEO of SphingoTec, comments, "We are thrilled to welcome Dr. Uhle to our team as our new Medical Director. His experience in the medical field and passion for innovation make him the perfect candidate for this role. He will support our goal of increasing awareness and demand for our biomarker-based diagnostic innovations within the acute and critical care community."

Dr. Florian Uhle said, "I am excited to join SphingoTec and work with such a talented and innovative team. The company's diagnostic portfolio has the potential to meet the growing need for effective diagnostic tools in critical care settings. I am eager to apply my knowledge and expertise to help bring the company's biomarkers to the forefront of clinical practice and to work towards improving patient outcomes."

Before joining SphingoTec, Florian Uhle, Ph.D., was Director of Medical Affairs at Inflammatix Inc., a development-stage diagnostic company focusing on acute and critically ill patients. Prior to that, he held several leadership roles within the University Hospitals Heidelberg and Giessen, focusing on leading diagnostic research activities and innovation-oriented initiatives. He has a diploma in Biology from the Justus-Liebig University, a Master of Science from the University of Leipzig in Clinical Research and Translational Medicine, and a Ph.D. in Human Biology from the Justus-Liebig University. He completed the International Graduate School „Molecular Biology and Medicine of the Lung“ at the Universities of Giessen and Marburg Lung Center.

About SphingoTec

Media contact:

Ruxandra Lenz

Head of Marketing and Communication

SphingoTec GmbH

Neuendorfstr. 15 A

16761 Hennigsdorf

Tel. +49-3302-20565-0

Liberation from renal replacement therapy and early initiation to be supported by the kidney function biomarker Proenkephalin A 119-159 (penKid)

Tue, 28 Oct 2025 10:09:49 GMT

• PenKid identified as a promising kidney function biomarker to support future precision medicine approaches for RRT-dependent AKI.

• A post-hoc analysis of the ELAIN trial indicates that penKid could enable the assessment of kidney function under RRT and guide early and successful liberation of treatment.

• For the risk stratification of AKI patients, penKid may be a useful biomarker in identifying the need for timely RRT initiation.

Hennigsdorf, Germany, December 15, 2022 - The diagnostic company SphingoTec GmbH (SphingoTec) announces first data on the kidney function biomarker penKid as a promising tool in supporting early initiation and liberation from RRT (1). Although RRT remains a pivotal measure in treating AKI complications, it is also associated with significant risks and its duration should be restricted to a minimum. The current findings show that penKid has the potential to reveal unprecedented insights on the underlying kidney function prior and during ongoing RRT, facilitating an early and successful termination of treatment. This may support timely risk stratification and individualization of treatment pathways.

To allow kidney recovery in critically ill patients with AKI, RRT remains the key rescue therapy. However, no precise prediction tools are currently available to determine RRT liberation, although 5 - 13% of AKI patients have a high need for RRT (2,3). Due to scarcely available options, discontinuation of RRT relies on expert-based recommendations or clinical judgment based on controversial indications such as urine output. And yet, early discontinuation of RRT would not only be beneficial for the patient but also support the allocation of limited intensive care resources, thereby helping to reduce costs of unnecessarily long periods of RRT or unsuccessful termination with subsequent need for re-initiation of RRT (4).

The current analysis has demonstrated that penKid could be a competent marker to monitor kidney function during ongoing RRT (1). Low penKid values during RRT were associated with earlier and successful liberation from RRT, compared to the group presenting high penKid levels. As a consequence, penKid could support clinicians identify those patients with sufficient kidney recovery, suitable for RRT liberation. In addition, at the time point of AKI diagnosis, measuring penKid values could allow the identification of patients who may benefit from early RRT initiation. Supplementary data suggest that prompt intervention may result in shorter RRT duration.

The results of this study are complemented by previous scientific evidence showing that penKid mirrors real-time glomerular filtration rate (GFR) even in non-stable settings (5). Furthermore, penKid is unaffected by non-renal factors such as inflammation, common comorbidities, and gender (6,7,8), making it a suitable biomarker, especially for critically ill patients.

Deborah Bergmann, Director of Marketing and Sales at SphingoTec commented, “The implications of the current findings are of great significance for future individualized approaches in managing RRT-dependent AKI. For the first time, scientists identified a biomarker that has the potential to shed light on clinically hidden developments in patients undergoing RRT, a highly challenging stage. This may benefit patients’ health on short and long term, as well as support healthcare providers reduce costs and better assign resources.”

References:

1. von Groote T et al. Proenkephalin A 119–159 predicts early and successful liberation from renal replacement therapy in critically ill patients with acute kidney injury: a post hoc analysis of the ELAIN trial. Crit Care 26, 333 (2022). https://doi.org/10.1186/s13054-022-04217-4

2. Hoste EA, Bagshaw SM, Bellomo R, et al. Epidemiology of acute kidney injury in critically ill patients: the multinational AKI-EPI study. Intensive Care Med 2015;41:1411–23.

3. Uchino S, Kellum JA, Bellomo R, Doig GS, Morimatsu H, Morgera S, et al. Acute renal failure in critically ill patients: a multinational, multicenter study. JAMA. 2005;294:813–8.

4. Korkeila M, Ruokonen E, Takala J. Costs of care, long-term prognosis and quality of life in patients requiring renal replacement therapy during intensive care. Intensive Care Med. 2000;26:1824-1831.

5. Beunders R, van Groenendael R, Leijte G, Kox M, Pickkers P. Proenkephalin compared to conventional methods to assess kidney function in critically ill sepsis patients. Shock. 2020 Jan;1

6. Beunders et al. (2017), Proenkephalin (PENK) as a novel biomarker for kidney function, JALM, DOI: 10.1373/jalm.2017.023598

7. Caironi P, Latini R, Struck J, Hartmann O, Bergmann A, Bellato V, et al. Circulating proenkephalin, acute kidney injury, and its improvement in patients with severe sepsis or shock. Clin Chem. 2018;64((9)):1361–9.

8. Donato LJ, Meeusen JW, Lieske JC, Bergmann D, Sparwaßer A, Jaffe AS. Analytical performance of an immunoassay to measure proenkephalin. Clin Biochem. 2018 Aug;58:72–7.

About SphingoTec

SphingoTec GmbH ("SphingoTec"; Hennigsdorf near Berlin, Germany) is a commercial-stage diagnostic company focusing on innovative critical care biomarkers for the diagnosis, prediction and monitoring of acute medical conditions. Sphingotec’s innovative markers are made available on different IVD platforms. SphingoTec's proprietary biomarker portfolio includes bioactive Adrenomedullin 1-52 (bio-ADM), a biomarker for assessment of endothelial function in conditions like sepsis, and Proenkephalin A 119-159 (penKid), a biomarker for assessment of kidney function in critical diseases.

About penKid

Media contact:

Ruxandra Lenz

Head of Marketing and Communication

SphingoTec GmbH

Neuendorfstr. 15 A

16761 Hennigsdorf

Tel. +49-3302-20565-0

Boditech Med and SphingoTec close global licensing agreement for kidney function biomarker Proenkephalin A 119-159 (penKid)

Tue, 28 Oct 2025 10:06:50 GMT

• Worldwide licensing agreement signed to develop and offer penKid as test on Boditech’s fully automated immunoassay systems.

• The biomarker penKid adds diagnostic value and addresses current unmet needs in the management of patients suffering from acute kidney injury.

• PenKid’s availability on Boditech’s global network of analyzers will amplify the reach of penKid to the wider critical care community.

Gangwon-do, Republic of Korea and Hennigsdorf/Berlin, Germany, November 15, 2022 - Boditech Med Inc. (“Boditech”) and SphingoTec GmbH (“SphingoTec”) today announced they have entered into a non-exclusive royalty-bearing license agreement. Under the terms of this agreement, Boditech has obtained the rights to develop and commercialize clinical tests for the kidney function biomarker penKid on its renowned AFIAS and ichroma Point of Care platforms. Through this partnership, Boditech and SphingoTec will make the biomarker penKid available on Boditech’s worldwide installed base with the goal of improving the management of patients suffering from acute kidney injury (AKI).

AKI affects one in five hospitalized patients (1). The critical state is currently diagnosed by standard-of-care biomarkers when 50% of the kidney function is already lost (1). PenKid addresses these pitfalls, offering an earlier and more precise determination of kidney function in acute and critical care settings (2).

Eui-Yul Choi, CEO, Boditech Med said “Expanding our critical care portfolio with innovation in the field of acute diseases can, in the future, support our customers applying medical advancements and improve patient outcomes. After successfully evaluating the feasibility of penKid on our diagnostic solutions, we are looking forward to working with SphingoTec for the development and commercialization of the new test.”

Jörg Menten, CEO, SphingoTec said “Boditech is a leader in point of care diagnostics with a strong global footprint. The agreement entered into with Boditech marks a significant milestone in SphingoTec’s mission to provide early detection of acute kidney injury to the international acute and critical care community. Our scientific research shows the future potential of penKid to monitor kidney function in further clinical settings such as renal replacement therapy (3) and pediatric AKI management (4,5). We are excited to work with our new partner to bring these advancements to critical care physicians around the globe very soon.”

References:

1. Kellum, J.A. et al. Acute kidney injury. Nat Rev Dis Primers 7, 52 (2021). https://doi.org/10.1038/s41572-021-00284-z

2. Hollinger A, et al. Proenkephalin A 119-159 (Penkid) Is an Early Biomarker of Septic Acute Kidney Injury: The Kidney in Sepsis and Septic Shock (Kid-SSS) Study. Kidney Int Rep. 2018 Aug 22;3(6):1424-1433. doi: 10.1016/j.ekir.2018.08.006.

3. von Groote et al. Proenkephalin A 119–159 predicts early and successful liberation from renal replacement therapy in critically ill patients with acute kidney injury: a post hoc analysis of the ELAIN trial. Crit Care 26, 333 (2022). https://doi.org/10.1186/s13054-022-04217-4

4. Smeets NJL, et al. Proenkephalin A as a marker for glomerular filtration rate in critically ill children: validation against gold standard iohexol GFR measurements. Clin Chem Lab Med. 2022 Oct 27. doi: 10.1515/cclm-2022-0545.

5. Hartman et al (2020), Proenkephalin as a New Biomarker for Pediatric Acute Kidney Injury - Reference Values and Performance in Children Under One Year of Age, Clin Chem Lab Med, doi: 10.1515/cclm-2020-0381

About Boditech

Boditech Med (based in Chuncheon, Gangwon-do, Republic of Korea) is a leading company in the field of point-of-care diagnostics, which has accumulated more than 20 years of business expertise in the field. The company has more than 85 types of in vitro diagnostic products that detect biomarkers related to infectious diseases, diabetes, cardiovascular diseases, cancer, and hormone-related diseases with its immunofluorescence lateral flow technology, quantitative immunofluorescence technology and spectrophotometric technology. And the list continues to grow with new high-value-added products. With its instrument platform installed in more than 120 countries, the company also has a stable revenue model. The company is currently strengthening its value as a global company by expanding its manufacturing bases in the US, China, India, and Indonesia.

About SphingoTec

SphingoTec GmbH ("SphingoTec"; Hennigsdorf near Berlin, Germany) is a commercial-stage diagnostic company focusing on innovative critical care biomarker for the diagnosis, prediction and monitoring of acute medical conditions. Sphingotec’s innovative markers are made available on different IVD platforms. SphingoTec's proprietary biomarker portfolio includes bioactive Adrenomedullin 1-52 (bio-ADM), a biomarker for assessment of endothelial function in conditions like sepsis, and Proenkephalin A 119-159 (penKid), a biomarker for assessment of kidney function in critical diseases.

About penKid

Press contact

Boditech Med Inc.

Duk Seung Na

Email: nds@boditech.co.kr

Phone: +821028451778

www.boditech.co.kr SphingoTec GmbH

Ruxandra Lenz

Email: press@sphingotec.de

Phone: +49-3302-20565-0

www.sphingotec.com

Interdepartmental testing of the kidney function biomarker penKid in routine care at Heidelberg University Hospital and the Heidelberg Kidney Center

Tue, 28 Oct 2025 09:58:26 GMT

Acute kidney injury (AKI) is a complex syndrome, which results in a rapid loss of kidney function, affecting 1 in 5 patients (1) during hospitalization.
Four units at the University Hospital Heidelberg and Heidelberg Kidney Center implement Proenkephalin (penKid) in a pilot biomarker-based treatment approach to diagnose AKI faster and monitor it more accurately across departments.
PenKid is a proposed biomarker for real-time kidney function that potentially closes on the gaps of the standard diagnostic procedures.

Hennigsdorf, Germany, August 26, 2022 - The diagnostic company SphingoTec GmbH (SphingoTec) announces the introduction of novel biomarker penKid in the clinical routine management of patients on a test basis in a total of four units at the University Hospital Heidelberg (UKHD) and Heidelberg Kidney Center (NZH). This includes the normal, the intermediate care (IMC), the nephrology, and the intensive care units (ICU) of both clinics in Heidelberg. According to recent data, the new diagnostic tool provides a faster and more accurate assessment of kidney function than current practice and aims to improve the management of patients with AKI. The condition is associated with high morbidity and mortality, and is a frequent complication of severe diseases, such as sepsis.

The pilot implementation of penKid was started in cooperation with the Clinic for Anesthesiology at UKHD and the NZH with the long-term goal of improving the monitoring of patient’s kidney function. This routine use of penKid on a centralized level in the hospital drives innovation on multiple wards such as nephrology, ICU and IMC. The biomarker will be used on top of standard of care, in order to compare penKid with the existing standard diagnostics. Better and faster information assessment of kidney function helps detect AKI earlier, so that prompt action can be taken to protect renal function and improve patient prognosis.

Prof. Dr. med. Martin Zeier, Medical Director at NZH added, “After the first experience of penKid on the point of care analyzer from SphingoTec, we have decided to implement it in the central laboratory to apply the test in more patients at the same time. The goal is to investigate the added value compared to established renal function parameters in routine diagnostics. To date, our data suggest better and more direct information about kidney function, which may allow for more rapid action. Acute kidney injury is a serious condition that needs to be detected early and counteracted promptly. When the critically ill patients are undergoing renal replacement therapy, the decision to terminate the treatment is of high importance for the success of the therapy. With penKid we may achieve better insights that complement our current practices, and we have strong hopes that this will help us improve patient outcomes on short and long term.”

PenKid is a promising biomarker to determine kidney function. It has been studied in over 55,000 patients showing the potential to reflect kidney function in real-time (2,3). Data from the PredARRT-Sep-Trial enrolling patients hospitalized in the surgical ICU of UKHD showed that penKid is a kidney function biomarker with rapid kinetics. According to these findings shared with the scientific community during the AKI&CRRT 2021 conference in San Diego US (4), penKid especially indicates changes in kidney function more dynamically than established functional markers. For those patients in critical conditions who require dialysis, penKid seems to be an early indicator of the kidney function and a potential tool to monitor kidney function and recovery during dialysis.

Prof. Dr. med. Markus Weigand, Medical Director of the Clinic for Anesthesiology at UKHD commented “On the ICU we experience the extreme of human disease, and AKI remains a serious complication in critically ill patients. A biomarker alerting changes in the kidney function faster than the currently known standards and uninfluenced by inflammation, has a significant potential for improving patient management. The sooner we identify a patient with kidney dysfunction, the faster we can intervene with life-saving procedures.”

Dr. Andreas Bergmann, founder and CSO of SphingoTec added “Testing penKid in routine practice at University Hospital Heidelberg brings the scientific advancements directly to those needing them the most: the patients. AKI is usually diagnosed after symptoms manifest, with diagnostic tests that have limited ability to identify early the onset of the disease. The blind spots in diagnosing kidney dysfunction are well known to the medical community, therefore penKid is a functional biomarker that addresses a clear unmet need and provides actionable information on all stages of the disease evolution.”

References:

1. Wang HE, Muntner P, Chertow GM, Warnock DG. Acute kidney injury and mortality in hospitalized patients. Am J Nephrol. 2012;35(4):349-55. doi: 10.1159/000337487. Epub 2012 Apr 2. PMID: 22473149; PMCID: PMC3362180.

2. Beunders R et al. Proenkephalin Compared to Conventional Methods to Assess Kidney Function in Critically Ill Sepsis Patients. Shock. 2020;54(3):308-14.

3. Donato LJ et al. Analytical performance of an immunoassay to measure proenkephalin. Clin Biochem. 2018;58:72-7

4. https://www.crrtonline.com/conference/support/AKI&CRRT2021_Syllabus.pdf

About SphingoTec

SphingoTec GmbH ("SphingoTec"; Hennigsdorf near Berlin, Germany) develops and markets innovative in vitro diagnostic (IVD) tests for novel and proprietary biomarkers for the diagnosis, prediction and monitoring of acute medical conditions. SphingoTec's proprietary biomarker portfolio includes bioactive Adrenomedullin (bio-ADM), a unique biomarker for real-time assessment of endothelial function in conditions like sepsis or congestive heart failure, Proenkephalin (penKid), a unique biomarker for real-time assessment of kidney function, and Dipeptidyl Peptidase 3 (DPP3), a unique biomarker for cardiac depression. IVD tests for SphingoTec’s proprietary biomarkers are made available as sphingotest® microtiter plate tests as well as point-of-care tests on the Nexus IB10 immunoassay platform by SphingoTec’s subsidiary Nexus Dx Inc. (San Diego, CA, USA) alongside a broad menu of established and commonly used tests for acute and critical care.

Media contact:

Ulrike Glaubitz

Sr. Public relations specialist

SphingoTec GmbH

Neuendorfstr. 15 A

16761 Hennigsdorf

Tel. +49-3302-20565-0

press@sphingotec.com

www.sphingotec.com

Medical thought leaders in critical care aim to advance precision medicine using biomarker-based approaches

Tue, 28 Oct 2025 09:55:45 GMT

• Innovative biomarkers open new avenues for precision medicine approaches in treating acute and critical diseases that need differentiation of the underlying pathophysiology.

• Physicians from Europe, Canada, and the USA explore the role of biomarkers in the leap from a “one-fits-all”-treatment to a personalized approach based on the patient’s characteristics.

• International medical leaders discuss ways to successfully implement biomarkers penKid, bio-ADM and DPP3 from research into routine clinical practice.

Hennigsdorf, Germany, August 8, 2022 – The diagnostics company SphingoTec GmbH (SphingoTec), announces that, during the 4th Scientific Symposium held near Potsdam, Germany, international medical experts discussed the latest developments in diagnostic and therapeutic innovations for advancing precision medicine in critically ill patients. The approach encompasses organ-specific biomarkers working hand in hand with drug candidates and existing therapies to improve the management of diseases such as sepsis and septic shock, acute kidney injury, COVID-19, and cardiogenic shock. The successful transition of the biomarkers from research to clinical routine is an important step that was addressed by current routine users.

Biomarkers from research to clinical practice

Acute kidney injury (AKI) affects 1 in 3 ICU patients. Since the therapeutical options are limited, the focus lies in managing the symptoms and avoiding the progression of AKI. However, current diagnostics are too late and insensitive, thus resulting in a limited intervention window.

Prof. Peter Pickkers, Head of research in Intensive Care Medicine at Radboud University Nijmegen Medical Centre, explained “In AKI we need to bring the diagnostic clock before the current clinical clock to avoid further organ dysfunction. Proenkephalin A 119 - 159 (penKid) is a kidney function biomarker with more swift kinetics that strongly correlates with the actual glomerular filtration rate (GFR). It allows to detect a change in kidney function more than 24 hours earlier compared to the current diagnostic standard creatinine. We have confirmed these findings by developing a formula for estimating the GFR using penKid. After measuring penKid against complex and invasive reference diagnostics and comparing it to existing formulas for kidney function, we have seen a superior performance of the new penKid model.”

Notably, the biomarker penKid shows good kinetics in both adults and children (1,3). It is earlier than the current standard of care, and its property of not being influenced by muscle mass, inflammation and common comorbidities allows for monitoring the patient’s condition, especially in critical care (2, 3). Scientists and routine users of penKid highlighted the potential to predict AKI development and recovery, as well as the need for renal replacement therapy (RRT) (3), which are unique features for a kidney biomarker (4, 5).

Prof. Gernot Marx, Clinic Director of the University Hospital RWTH Aachen, comments: “We have made the first steps in translating scientific research into clinical practice. Measuring penKid in the morning routine required a change of our procedure and the alignment of all teams. Once established, we have seen immediate benefits in our daily practice that range from better risk stratification to early identification of worsening and improvement of renal function. The potential of this biomarker has not yet been fully exploited, therefore we are currently focused on better understanding the benefits for patients under RRT.”

Precision medicine relies on biomarkers for a targeted approach

Not only diagnosing but also treating patients correctly can be a major challenge, especially if the underlying mechanisms of a disease vary and require different therapies. This is the case, for example, with sepsis, a disease that encompasses a very heterogeneous group of patients, making the discovery of new therapies very challenging. The biomarkers bioactive adrenomedullin (bio-ADM) and dipeptidyl peptidase 3 (DPP3) distinguish between two independent etiologies of septic shock (6). This facilitates the identification of separate homogenous groups of shock patients with the respective pathological mechanisms.

Prof. Alexandre Mebazaa, Head of the Department of Anesthesia and Critical Care Medicine at Lariboisière, Paris stated “The biomarkers bio-ADM and DPP3 are biologically active. This means they can be both, biomarkers that point at different pathophysiologies of sepsis, but also biotargets for new drug candidates that modulate their activity, allowing specific treatment of respective disease mechanisms.”

Bio-ADM identifies patients with endothelial dysfunction causing vascular leakage, which escalates into shock and organ dysfunction. The medical experts discussed the latest findings on Adrecizumab, a new promising clinical late-stage drug candidate developed by Adrenomed AG, that targets endothelial barrier dysfunction (7, 8).

A separate disease mechanism, leading to hemodynamic instability and shock in sepsis, is the depletion of angiotensin II. DPP3, a biomarker that causes this depletion has been proposed to identify patients who may not be able to develop a positive treatment effect due to the different pathophysiology, thus excluding them from the respective clinical trials. Apart from the use of DPP3 as an enrichment tool for clinical trials, the modulation of DPP3 activity by the antibody Procizumab, a new drug candidate developed by 4TEEN4 Pharmaceuticals, has been discussed (9). Beyond sepsis and septic shock, the identified pathophysiologies could be of relevance in other distinct major mortality drivers such as COVID-19 (10) and cardiogenic shock (11).

Dr. Andreas Bergmann, the founder of the three companies SphingoTec, Adrenomed, and 4TEEN4, summarizes: “During the symposium, we have shared the same vision with prestigious representatives of the critical care community: bringing personalized medicine in critical care to the same level the colleagues in oncology have succeeded. At the core of this endeavor are biomarkers that guide clinical decision making and support the development of new therapies. Now SphingoTec’s biomarkers are well positioned for the adoption in clinical routine, laying a strong basis for "precision medicine".”

References:

1. Hartman et al, Proenkephalin as a New Biomarker for Pediatric Acute Kidney Injury – Reference Values and Performance in Children Under One Year of Age, Clin Chem Lab Med, 2020; doi: 10.1515/cclm-2020-0381.

2. Kim et al. Proenkephalin Predicts Organ Failure, Renal Replacement Therapy, and Mortality in Patients with Sepsis. Ann Lab Med. 2020;40(6):466-73

3. Caironi P, Latini R, Struck J, Hartmann O, Bergmann A, Bellato V, Ferraris S, Tognoni G, Pesenti A, Gattinoni L, Masson S; ALBIOS Study Investigators. Circulating Proenkephalin, Acute Kidney Injury, and Its Improvement in Patients with Severe Sepsis or Shock. Clin Chem. 2018 Sep;64(9):1361-1369.

4. Khorashadi M, Beunders R, Pickkers P, Legrand M: Proenkephalin: A New Biomarker for Glomerular Filtration Rate and Acute Kidney Injury. Nephron 2020;144:655-661. Doi: 10.1159/000509352

5. Hollinger et al, Proenkephalin A 119-159 (Penkid) Is an Early Biomarker of Septic Acute Kidney Injury: The Kidney in Sepsis and Septic Shock (Kid-SSS) Study, Kidney Int Rep, 2018; doi: 10.1016/j.ekir.2018.08.006

6. van Lier (2020), Promotion of vascular integrity in sepsis through modulation of bioactive adrenomedullin and dipeptidyl peptidase 3, J. Intern. Med., DOI: doi.org/10.1111/joim.13220

7. Laterre PF, et al. Safety and tolerability of non-neutralizing adrenomedullin antibody adrecizumab (HAM8101) in septic shock patients: the AdrenOSS-2 phase 2a biomarker-guided trial. Intensive Care Med. 2021 Nov;47(11):1284-1294. Doi: 10.1007/s00134-021-06537-5.

8. Geven et al, Effects of the Humanized Anti-Adrenomedullin Antibody Adrecizumab (HAM8101) on Vascular Barrier Function and Survival in Rodent Models of Systemic Inflammation and Sepsis. Shock. 2018 Dec;50(6):648-654. Doi: 10.1097/SHK.0000000000001102.

9. Deniau et al, Circulating dipeptidyl peptidase 3 is a myocardial depressant factor: dipeptidyl peptidase 3 inhibition rapidly and sustainably improves haemodynamics. Eur J Heart Fail, 2020; 22: 290-299. Doi: 10.1002/ejhf.1601

10. Clinicaltrials.gov/ct2/show/NCT05156671

11. Takagi K, Blet A, Levy B, Deniau B, Azibani F, Feliot E, Bergmann A, Santos K, Hartmann O, Gayat E, Mebazaa A, Kimmoun A. Circulating dipeptidyl peptidase 3 and alteration in haemodynamics in cardiogenic shock: results from the OptimaCC trial. Eur J Heart Fail. 2020 Feb;22(2):279-286.

About SphingoTec

SphingoTec GmbH ("SphingoTec"; Hennigsdorf near Berlin, Germany) develops and markets innovative in vitro diagnostic (IVD) tests for novel and proprietary biomarkers for the diagnosis, prediction, and monitoring of critical medical conditions. SphingoTec's proprietary biomarker portfolio includes bioactive Adrenomedullin (bio-ADM), a biomarker for real-time assessment of endothelial function in conditions like sepsis, and Proenkephalin (penKid), a biomarker for real-time assessment of kidney function. Dipeptidyl Peptidase 3 (DPP3) is a biomarker for cardiac depression, in-licensed from 4TEEN4 Pharmaceuticals GmbH (www.4teen4.de). IVD tests for SphingoTec’s biomarkers are made available as sphingotest® microtiter plate tests as well as point-of-care tests on the Nexus IB10 immunoassay platform by SphingoTec’s subsidiary Nexus Dx Inc. (San Diego, CA, USA). The Nexus IB10 portfolio is complemented by established and commonly used biomarker tests for acute and critical care such as PCT, Troponin, NT-proBNP, D-Dimer, TSH and others.

Media contact:

Dr. Ulrike Glaubitz

Senior Public Relations Specialist

SphingoTec GmbH

Neuendorfstr. 15 A

16761 Hennigsdorf

Tel. +49-3302-20565-113

Endothelial function biomarker bioactive Adrenomedullin (bio-ADM) enables triage of sepsis patients in the emergency department

Tue, 28 Oct 2025 09:54:00 GMT

• Bio-ADM is a biomarker for the assessment of endothelial dysfunction, a hallmark of sepsis, and has been widely studied in intensive care units (ICU)

• Clinical trial in the emergency department (ED) shows that bio-ADM is predictive of ICU admission and may be used for early stratification of unselected sepsis patients

• The published data show that high levels of bio-ADM are predicting the risk for multiple organ failure and mortality, while low levels are associated with ED discharge

Hennigsdorf, Germany, August 1, 2022 – The diagnostics company SphingoTec GmbH (SphingoTec) announces new findings that support the clinical value of the biomarker bio-ADM for triaging sepsis patients in ED, exceeding the prognostic performance of routine biomarkers. So far, the predictive potential of the innovative biomarker has been confirmed and used primarily in ICU. A new study, recently published, confirms its applicability in ED (1).

A severe infection can quickly progress to sepsis - a life-threatening situation. Unfortunately, sepsis is difficult to diagnose and treat because it has a high range of forms and intensities. However, successful treatment is primarily time-dependent (2): an early diagnosis can save lives! In ED, it is still difficult to identify sepsis patients early, and assigning the correct further treatment is thus challenging. Adrenomedullin, a hormone that has homeostatic and regulatory effects on various body systems (3,4), as well as playing a role in hemodynamic regulation, and is measurable via the biomarker bioactive Adrenomedullin (bio-ADM), may help to bridge this gap.

Biomarkers can provide information about the underlying causes of a disease and allow predictions about potential changes in patient condition in the next hours to days. Bio-ADM is an already known biomarker in intensive care units (5). Now, it has been tested in ED whether there was an association between bio-ADM and sepsis severity. Furthermore, it was examined whether bio-ADM would allow distinguishing between patients who could be discharged from ED from those who, for example, are at high risk for multiple organ failure due to sepsis and thus need to be transferred to the ICU.

Prof. Olle Melander, Professor and Senior Physician, Lund University and Skåne University Hospital in Sweden, explains: "The results of our study suggest that bio-ADM is potentially an important clinical biomarker in ED and could be used to allow early triage of sepsis patients. We demonstrated that bio-ADM allows a significantly better prediction of the sepsis severity than other biomarkers. Accordingly, high bio-ADM levels in ED are associated with mortality, as well as the development of severe multiple organ failure, while low levels indicate that patients may be discharged”.

Dr. Andreas Bergmann, founder, and CSO of SphingoTec adds: "In ED, triage is of enormous importance to provide patients with the right treatment. The study results indicate that previous experiences with the biomarker bio-ADM in ICU could be transferred to ED. The ability of bio-ADM to identify high-risk patients thus could help ED physicians to optimize their decision-making and patient management."

References:

1. Lundberg OHM, Rosenqvist M, Bronton K, Schulte J, Friberg H, Melander O (2022) Bioactive adrenomedullin in sepsis patients in the emergency department is associated with mortality, organ failure, and admission to intensive care. PLoS ONE 17(4): e0267497. https://doi.org/10.1371/journal.pone.0267497

2. World Health Organization Improving the prevention, diagnosis and clinical management of sepsis 2017, April 13. Available from: http://apps.who.int/gb/ebwha/pdf_files/WHA70/A70_13-en.pdf?ua=1

3. Kitamura K, Kangawa K, Kawamoto M, Ichiki Y, Nakamura S, Matsuo H, et al. Adrenomedullin: a novel hypotensive peptide isolated from human pheochromocytoma. Biochem Biophys Res Commun. 1993; 192(2):553–60. https://doi.org/10.1006/bbrc.1993.1451

4. Samson WK, Resch ZT, Murphy TC, Vargas TT, Schell DA. Adrenomedullin: Is There Physiological Relevance in the Pathology and Pharmacology? News Physiol Sci. 1999; 14:255–9, https://doi.org/10.1152/physiologyonline.1999.14.6.255

5. Lundberg OHM, Lengquist M, Spangfors M, Annborn M, Bergmann D, Schulte J, et al. Circulating bioactive adrenomedullin as a marker of sepsis, septic shock, and critical illness. Crit Care. 2020; 24 (1):636. https://doi.org/10.1186/s13054-020-03351-1

About SphingoTec

SphingoTec GmbH ("SphingoTec"; Hennigsdorf near Berlin, Germany) develops and markets innovative in vitro diagnostic (IVD) tests for novel and proprietary biomarkers for the diagnosis, prediction and monitoring of acute medical conditions. SphingoTec's proprietary biomarker portfolio includes bioactive Adrenomedullin (bio-ADM), a biomarker for real-time assessment of endothelial function in conditions like sepsis, and Proenkephalin (penKid), a biomarker for real-time assessment of kidney function. Dipeptidyl Peptidase 3 (DPP3), a biomarker for cardiac depression. IVD tests for SphingoTec’s biomarkers are made available as sphingotest® microtiter plate tests as well as point-of-care tests on the Nexus IB10 immunoassay platform by SphingoTec’s subsidiary Nexus Dx Inc. (San Diego, CA, USA). The Nexus IB10 portfolio is complemented by established and commonly used biomarker tests for acute and critical care such as PCT, Troponin, NT-proBNP, D-Dimer, TSH and others.

Media contact:

Dr. Ulrike Glaubitz

Senior Public Relations Specialist

SphingoTec GmbH

Neuendorfstr. 15 A

16761 Hennigsdorf

Tel. +49-3302-20565-113

SphingoTec appoints Jörg Menten as CEO to accelerate commercialization and global growth

Tue, 28 Oct 2025 09:52:23 GMT

• SphingoTec appoints Jörg Menten as Chief Executive Officer (CEO) as from July 1, 2022 to drive the commercialization and scale its diagnostic business.

• SphingoTec is a commercial-stage diagnostic company focusing on innovative critical care diagnostics made available on multiple IVD platforms.

• Founder Dr. Andreas Bergmann transitions his role as CEO to Chief Scientific Officer (CSO) to ensure scientific leadership of the company.

Hennigsdorf/Berlin, Germany, June 30, 2021 – Diagnostics company SphingoTec GmbH (“SphingoTec”) today announced that Jörg Menten was appointed CEO of SphingoTec effective of July 1, 2022. Jörg Menten, previously acting as Chief Commercial Officer of the company, will focus on successfully commercializing the biomarker-based diagnostics that address high unmet needs in critical care settings. Dr. Andreas Bergmann assumes the role of CSO within SphingoTec to further develop strategic innovations.

Jörg Menten is a highly skilled senior executive with a long-standing track record of leadership positions in the global healthcare industry. With an MBA from the University of Mannheim, he spent more than 13 years with Boehringer Mannheim in several roles contributing to its steep global growth in all care settings – patient monitoring, Point of Care, and Lab Diagnostics. As CFO of the Boehringer Mannheim Group, he had a significant role in its acquisition through Roche AG in 1998. Menten served as President International for Kinetic Concepts Inc. driving the global adoption of its wound-healing technology VAC® and its IPO on NYSE in 2004. Later, he served as CEO of Vanguard AG, Berlin, a European market leader in hospital services. In his position as President International for CeloNova Inc. he led the global commercialization of Embozene Tandem®, an innovative drug delivery system applied in Interventional Radiology settings for the treatment of liver cancer; acquired by Boston Scientific in 2015.

Jörg Menten commented on his appointment, “I am pleased to support SphingoTec in such an exciting time in its evolution. The products developed under the leadership of Dr. Andreas Bergmann have the potential to change the standard of care in diagnosing critically ill patients. Together with Dr. Angelo Moesslang, Chief Financial Officer, we have the clear mission of bringing innovations to the patients. I look forward to further scaling and accelerating SphingoTec’s growth.”

Gerald Möller, Chairman of the Advisory Board at SphingoTec, said, „On behalf of the Advisory board and all the employees, I would like to thank Dr. Andreas Bergmann for his restless dedication to discovering actionable Biomarkers in Critical Care. These are the basis for developing precision medicine from research to medical practice in a global business. The successful integration of our Nexus POC platform advanced SphingoTec to a diagnostic solution provider. With his future support as CSO, we can continue the innovation legacy at SphingoTec.

On behalf of the Advisory Board, I welcome Jörg Menten in his new capacity as CEO of SphingoTec. His tremendous experience in our global industry will help grow our company to become a key provider of diagnostic innovations in Critical Care. Dynamics and discipline will foster the company’s expansion. His experience as CCO of SphingoTec will help drive and accelerate growth and success. I look forward to a creative and exciting dialogue with Jörg and the Management Team.”

Dr. Andreas Bergmann explained, “SphingoTec has now reached a full commercial stage, and we have built a strong leadership team that can support scaling the business. As my personal goal lies in further developing medical innovations, I have decided to shift my focus at SphingoTec from the CEO role to the CSO position. With this change, I will be able to direct my resources on the further development and research of the products at SphingoTec and on developing precision medicine solutions.”

About SphingoTec

SphingoTec GmbH ("SphingoTec"; Hennigsdorf near Berlin, Germany) develops and markets innovative in vitro diagnostic (IVD) tests for novel and proprietary biomarkers for the diagnosis, prediction, and monitoring of critical medical conditions. SphingoTec's proprietary biomarker portfolio includes bioactive Adrenomedullin (bio-ADM), a biomarker for real-time assessment of endothelial function in conditions like sepsis, and Proenkephalin (penKid), a biomarker for real-time assessment of kidney function. Dipeptidyl Peptidase 3 (DPP3) is a biomarker for cardiac depression. IVD tests for SphingoTec’s biomarkers are made available as sphingotest® microtiter plate tests as well as point-of-care tests on the Nexus IB10 immunoassay platform by SphingoTec’s subsidiary Nexus Dx Inc. (San Diego, CA, USA). The Nexus IB10 portfolio is complemented by established and commonly used biomarker tests for acute and critical care such as PCT, Troponin, NT-proBNP, D-Dimer, TSH and others.

Media contact:

Dr. Ulrike Glaubitz

Senior Public Relations Specialist

SphingoTec GmbH

Neuendorfstr. 15 A

16761 Hennigsdorf

Tel. +49-3302-20565-113

Biomarker-guided trial led by University Hospital Hamburg-Eppendorf (UKE) opens new avenues for personalized medicine in COVID-19

Tue, 28 Oct 2025 09:51:09 GMT

• A multi-center study led by UKE is evaluating one of the first personalized approaches for moderate to severe COVID-19 patients

• The innovative biomarkers bio-ADM and DPP3 are guiding the enrollment of patients suffering from endothelial barrier dysfunction

• The biomarkers are measured with SphingoTec’s point of care tests for timely decision making.

Hennigsdorf/Berlin, Germany, April 11, 2022 - Diagnostics company SphingoTec GmbH (SphingoTec) announced the implementation of two critical care biomarkers to guide the application of a potential new drug candidate for the treatment of COVID-19 patients. The personalized approach will allow to distinguish between separate clinical pathways, requiring different treatment decisions.

This trial will implement the biomarker bioactive Adrenomedullin (bio-ADM) for early identification of endothelial dysfunction (1), which plays a central role in the pathophysiology of COVID-19 (2). The drug candidate Adrecizumab targets septic shock patients with high bio-ADM levels to restore the endothelial barrier function (3), and has already shown favorable outcomes in a case series of eight severe COVID-19 patients (4). At the same time, patients with high Dipeptidyl peptidase 3 (DPP3) levels will not be included in the trial. The biomarker DPP3 is indicating another underlying disease mechanism leading to cardiac depression and requiring different therapeutic options (5). Both critical care biomarkers are measured via SphingoTec’s rapid point of care platform Nexus IB10. For more information visit https://sphingotec.com/science/acute-care-pathways/covid-19 .

PD Dr. med. Mahir Karakas (Department of Intensive Care Medicine at UKE) said, “Not all COVID-19 patients have the same disease course and the pathology is very different. Therefore, we have to adapt the treatment to each individual patient. We will now use in a double blind randomized multicenter trial the biomarker bio-ADM and DPP3 which proved to be useful for patient enrichment in a phase II trial for treatment of septic shock.”

This is one of the first personalized, biomarker-guided trials in moderately to severely ill COVID-19 patients. The multicenter study led by UKE plans to enroll more than 200 patients for treatment with the new compound (6). Adrecizumab is provided by Adrenomed AG (www.adrenomed.com), and the critical care biomarkers are determined via SphingoTec’s rapid point of care platform Nexus IB10.

Dr. Andreas Bergmann, founder of SphingoTec and co-founder of Adrenomed stated: “The innovative biomarkers generate better insights into the pathophysiology of critically ill patients. This is translated into clear decisions that allow a better treatment guidance and ultimately reduce mortality. This study represents a leap from “one drug fits all” to a personalized approach in treating COVID-19.”

References:

(1) Simon T-P et al. Prognostic Value of Bioactive Adrenomedullin in Critically Ill Patients with COVID-19 in Germany: An Observational Cohort Study. Journal of Clinical Medicine. 2021, 10, 1667. doi.org/10.3390/jcm10081667

(2) Varga et al. Endothelial cell infection and endothelitis in COVID-19. The Lancet, 2020, DOI: https://doi.org/10.1016/S0140-6736(20)30937-5

(3) Laterre PF, et al. Safety and tolerability of non-neutralizing adrenomedullin antibody adrecizumab (HAM8101) in septic shock patients: the AdrenOSS-2 phase 2a biomarker-guided trial. Intensive Care Med. 2021 Nov;47(11):1284-1294. doi: 10.1007/s00134-021-06537-5.

(4) Karakas, M et al. Targeting Endothelial Dysfunction in Eight Extreme-Critically Ill Patients with COVID-19 Using the Anti-Adrenomedullin Antibody Adrecizumab (HAM8101). Biomolecules 2020, 10, 1171. https://doi.org/10.3390/biom10081171

(5) van Lier et al 2020, Promotion of vascular integrity in sepsis through modulation of bioactive adrenomedullin and dipeptidyl peptidase 3, J. Intern. Med., DOI: doi.org/10.1111/joim.13220

(6) https://clinicaltrials.gov/ct2/show/NCT05156671

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About SphingoTec

SphingoTec GmbH develops and markets innovative in vitro diagnostic (IVD) tests for novel and proprietary biomarkers for the diagnosis, prediction and monitoring of acute medical conditions. SphingoTec's proprietary biomarker portfolio includes bioactive Adrenomedullin (bio-ADM), a biomarker for real-time assessment of endothelial function in conditions like sepsis or COVID-19, Proenkephalin (penKid), a biomarker for real-time assessment of kidney function. Dipeptidyl Peptidase 3 (DPP3), a biomarker for cardiac depression was in-licensed from 4TEEN4 Pharmaceuticals GmbH (www.4teen4.de). IVD tests for SphingoTec’s proprietary biomarkers are made available as sphingotest® microtiter plate tests as well as point-of-care tests on the Nexus IB10 immunoassay platform by SphingoTec’s subsidiary Nexus Dx Inc. (San Diego, CA, USA). The Nexus IB10 portfolio is complemented by established and commonly used biomarker tests for acute and critical care such as PCT, Troponin, NT-proBNP, D-Dimer, TSH and others. Find out more www.sphingotec.com

Media contact:

Ruxandra Lenz

Sr. Manager Marketing and Communications

SphingoTec GmbH

Neuendorfstr. 15 A

16761 Hennigsdorf

Tel. +49-3302-20565-0

press@sphingotec.com

www.sphingotec.com

The Biomarkers bio-ADM and DPP3 Complement Post-Cardiac Surgery Diagnostics to Early Detect Organ Failure

Tue, 28 Oct 2025 09:49:08 GMT

• Post-surgical increase of endothelial function biomarker bioactive adrenomedullin (bio-ADM) concentrations predicts organ dysfunction.

• Bio-ADM may help identify patients with an increased risk of developing prolonged vasopressor dependence and prolonged ICU stay after cardiac surgery.

• Increased blood concentrations of cardiac depressant factor dipeptidyl peptidase 3 (DPP3) are related to the complexity and duration of the intervention.

Hennigsdorf, Germany, March 24, 2022 - The diagnostic company SphingoTec GmbH (SphingoTec) announces new evidence supporting the use of innovative biomarkers in the early identification of organ dysfunction and risk stratification of cardiac surgery patients (1). Despite many serious post-operative complications (2), there are currently limited tools available for the early identification of organ dysfunction in these patients (3,4).

Scientists from the Radboud University Medical Center have analyzed the predictive value of bio-ADM and DPP3 for short-term outcomes in a prospective study in cardiac surgery patients. Bio-ADM and DPP3 represent two distinct molecular pathways involved in the development of circulatory shock (5). Compromised hemodynamics after surgery triggers the release of the hormone bio-ADM, a key regulator of endothelial barrier function and vascular tone. The current data shows that bio-ADM at day two after ICU admission effectively differentiated between high-risk and low-risk patients for developing organ failure.

The study data also confirmed the independency of a second pathophysiological process, the release of DPP3 upon cell death. Surgery acts as an additional factor leading to an increase in DPP3 in the bloodstream, which is mainly related to tissue injury and the extent of the procedure. Therefore, elevated levels of DPP3 decrease shortly after the surgery. Not surgery-induced and persistently high concentration of DPP3 signals impaired tissue perfusion and high risk for organ failure (5).

Dr. Andreas Bergmann, founder and CEO of SphingoTec, added, “Cardiac surgery is often accompanied by postoperative complications. By using the innovative biomarkers, clinicians can improve the risk stratification provided by conventional risk scores and improve their patient management.”

References:

1. van Lier et al. The value of bioactive adrenomedullin and dipeptidyl peptidase 3 to predict short-term unfavourable outcomes after cardiac surgery: A prospective cohort study. Eur J Anaesthesiol. 2022 Apr 1;39(4):342-351. doi: 10.1097/EJA.0000000000001662.

2. Nearman et al. Perioperative complications of cardiac surgery and postoperative care. Crit Care Clin 2014; 30:527–555.

3. Paparella et al. Cardiopulmonary bypass induced inflammation: pathophysiology and treatment. An update. Eur J Cardiothorac Surg 2002; 21:232–244.

4. Laffey JG, Boylan JF, Cheng DC. The systemic inflammatory response to cardiac surgery: implications for the anesthesiologist. Anesthesiology 2002; 97:215–252

5. van Lier D, Kox M, Pickkers P. Promotion of vascular integrity in sepsis through modulation of bioactive adrenomedullin and dipeptidyl peptidase 3. J Intern Med 2020; 289:792–806.

About SphingoTec

SphingoTec GmbH ("SphingoTec"; Hennigsdorf near Berlin, Germany) develops and markets innovative in vitro diagnostic (IVD) tests for novel and proprietary biomarkers for the diagnosis, prediction and monitoring of acute medical conditions. SphingoTec's proprietary biomarker portfolio includes bioactive Adrenomedullin (bio-ADM), a biomarker for real-time assessment of endothelial function in conditions like sepsis, and Proenkephalin (penKid), a biomarker for real-time assessment of kidney function. Dipeptidyl Peptidase 3 (DPP3), a biomarker for cardiac depression. IVD tests for SphingoTec’s biomarkers are made available as sphingotest® microtiter plate tests as well as point-of-care tests on the Nexus IB10 immunoassay platform by SphingoTec’s subsidiary Nexus Dx Inc. (San Diego, CA, USA). The Nexus IB10 portfolio is complemented by established and commonly used biomarker tests for acute and critical care such as PCT, Troponin, NT-proBNP, D-Dimer, TSH, and others.

Media contact SphingoTec:

Ruxandra Lenz

Sr. Manager Marketing and Communications

SphingoTec GmbH

Neuendorfstr. 15 A

16761 Hennigsdorf

Tel. +49-3302-20565-0

SphingoTec and Rivaara Labs Close Exclusive Distribution Agreement for Point of Care Diagnostics in India

Tue, 28 Oct 2025 09:47:12 GMT

• The collaboration focuses on SphingoTec’s near patient diagnostic solution for critical care settings.
• Rivaara gains exclusive rights to market and distribute the Nexus IB10 platform and its rapid tests for innovative biomarkers and commonly used parameters in the Indian subcontinent.
• The Nexus IB10 technology is a “hand-held laboratory” providing fast and reliable diagnostics to support the management of critically ill patients.

Hennigsdorf, Germany and Mumbai, India, March 17, 2022 - The diagnostic company SphingoTec GmbH (SphingoTec) and Rivaara Labs Pvt Ltd. (Rivaara) today announced that they have entered into a multi-year distribution agreement for the commercialization of SphingoTec’s point of care diagnostic solutions in the Indian subcontinent. The Nexus IB10 analyzer and its portfolio of rapid tests allow convenient assessment of biomarkers relevant in critical care conditions such as sepsis, acute kidney injury, cardiogenic shock, acute heart failure, and myocardial infarction.

Under the terms of the agreement, Rivaara will have the exclusive right to market and distribute SphingoTec’s point of care tests for innovative biomarkers in the Indian subcontinent. This includes the biomarkers proenkephalin (penKid) for the assessment of kidney function (1), bioactive adrenomedullin (bio-ADM) for the assessment of endothelial function (2), and dipeptidyl peptidase 3 (DPP3) a biomarker for cardiac depression (3). The innovative markers are complemented by commonly used parameters such as procalcitonin, troponin, D-dimer, NT-proBNP, and TSH. The biomarkers are made available as rapid tests on the Nexus IB10 bedside technology, a fully automated immunoassay point-of-care instrument, which provides accurate test results within only 20 minutes from whole blood samples. The Nexus IB10 analyzer and its test portfolio can be flexibly deployed in a variety of point of care settings, including emergency departments, intensive care units, and laboratories.

Dr. Angelo Moesslang, Managing Director and Chief Financial Officer of SphingoTec, said, “This distribution agreement is an important step in making our near-patient diagnostics globally available. A point of care solution for acute and critical cases can enable healthcare organizations to maximize diagnostic resources and help clinicians make more informed decisions.”

Mr. Shyamakant Giri, Chief Executive Officer of Rivaara said, “Adding the point of care platform and its rapid tests to our portfolio is increasing the settings in which we facilitate integrated diagnostic testing in the patient-care pathway. Not only are we able to provide well established tests used on a daily basis, but we can also enable access to innovative biomarkers, which address unmet needs in disease areas such as acute kidney injury and sepsis.”

To discover more about the Nexus IB10 and SphingoTec’s portfolio of diagnostic solutions for acute and critical care, please visit www.sphingotec.com. For more information on the Rivaara Labs portfolio, please visit www.rivaaralabs.com

References:

1. Beunders et. al. Proenkephalin (PENK) as a Novel Biomarker for Kidney Function, The Journal of Applied Laboratory Medicine, Volume 2, Issue 3, 1 November 2017, Pages 400–412, doi: https://doi.org/10.1373/jalm.2017.023598

2. Geven et. al. Vascular Effects of Adrenomedullin and the Anti-Adrenomedullin Antibody Adrecizumab in Sepsis, SHOCK: August 2018 - Volume 50 - Issue 2 - p 132-140 doi: 10.1097/SHK.0000000000001103

3. Boorsma et. al. Dipeptidyl peptidase 3, a marker of the antagonist pathway of the renin-angiotensin-aldosterone system in patients with heart failure. Eur J Heart Fail. 2021 Jun;23(6):947-953. doi: 10.1002/ejhf.2158.

About SphingoTec

SphingoTec GmbH ("SphingoTec"; Hennigsdorf near Berlin, Germany) develops and markets innovative in vitro diagnostic (IVD) tests for novel and proprietary biomarkers for the diagnosis, prediction and monitoring of acute medical conditions. SphingoTec's proprietary biomarker portfolio includes bioactive Adrenomedullin (bio-ADM), a biomarker for real-time assessment of endothelial function in conditions like sepsis, and Proenkephalin (penKid), a biomarker for real-time assessment of kidney function. Dipeptidyl Peptidase 3 (DPP3), a biomarker for cardiac depression was in-licensed from 4TEEN4 Pharmaceuticals GmbH (www.4teen4.de). IVD tests for SphingoTec’s biomarkers are made available as sphingotest® microtiter plate tests as well as point-of-care tests on the Nexus IB10 immunoassay platform by SphingoTec’s subsidiary Nexus Dx Inc. (San Diego, CA, USA). The Nexus IB10 portfolio is complemented by established and commonly used biomarker tests for acute and critical care such as PCT, Troponin, NT-proBNP, D-Dimer, TSH and others.

About Rivaara Labs

Rivaara Labs Pvt Ltd. (“Rivaara”, Mumbai, India) is harnessing the power of Molecular diagnostics to bring disruptive, affordable, and innovative need-based diagnostic solutions to India. With an extensive range of test services, Rivaara offers sample-to-answer qualified solutions based on a broad portfolio of automated RT-PCR, IT connectivity, superior analysis, and LIMS interface with actionable clinical reports across infectious diseases, oncology, antibiotic resistance, pathogen detection, inherited disease testing and precision medicine. The solutions address a significant unmet medical need for timely, actionable information that addresses the challenges of the current standard of care for diagnosing and monitoring the diseases. The aim is to develop a strong network of specialized Molecular Diagnostics labs, market novel point of care solutions and build a best-in-class national reference lab. Apart from the investment in infrastructure, Rivaara also invests in highly inspired and motivated human capital within the organization.

Media contact SphingoTec:

Ruxandra Lenz

Sr. Manager Marketing and Communications

SphingoTec GmbH

Neuendorfstr. 15 A

16761 Hennigsdorf

Proenkephalin (penKid) sheds light on the diagnostic blind spots in assessing acute kidney injury in children

Tue, 28 Oct 2025 09:45:29 GMT

• For children burdened with life-threatening acute kidney injury (AKI) there are no reliable diagnostics to assist the management of pediatric AKI.

• The biomarker proenkephalin (penKid) sets a firm foundation in pediatric kidney assessment as it can identify fast and accurate pediatric AKI and its severity, overcoming current limitations.

Hennigsdorf, Germany, March 15, 2022 - The diagnostic company SphingoTec GmbH (SphingoTec) SphingoTec GmbH (SphingoTec) announces that its kidney function biomarker penKid is reliably identifying AKI in infants, offering a solution to the shortcomings in pediatric critical care. AKI is mostly diagnosed too late for successful intervention which leads to steep mortality rates and chronic kidney disease (1,2).

AKI is a life-threatening complication to every 1 in 3 children in intensive care - a shockingly high prevalence (1). The current routine measurements are not only biased by non-AKI related factors (3), but also identify with an unacceptable delay of 72 hours the impairment, when 50% of the kidney function is already lost (4).

PenKid is a blood-based biomarker that supports clinicians overcoming these limitations. High or increasing penKid concentrations accurately predict AKI and its severity in infants (5), offering an unprecedented alternative to managing pediatric AKI. PenKid is not influenced by non-renal factors making it easy to adopt in critical care (6,7). As a non-invasive biomarker, penKid provides unparalleled real-time and accurate information for the early recognition, severity, and recovery from AKI (8,9). Since AKI is a sudden and severe disease, this information can help vital interventions and improve recovery.

Dr. Andreas Bergmann, CEO of SphingoTec, commented: “AKI is a challenging setting in pediatric critical care with persisting unmet diagnostic needs. With clinical symptoms showing only shortly before kidney failure, it remains a blind spot and a silent threat on the pediatric wards. PenKid offers a solution for the early recognition of AKI in children which is a main condition for improving their prognosis.”

During the recent scientific sessions at AKI & CRRT 2022 in San Diego, CA, Prof. Peter Pickkers (Radboud University, Nijmegen) presented the data on penKid in pediatric AKI, alongside a new formula that translates penKid into a familiar scale for the clinical routine use initially in adults. Data from the researchers of Radboud University, The Netherlands, and Mayo Clinic, US confirms that the new formula is overcoming the limitations of the current clinical practice.

References:

1. Sutherland et al (2015) AKI in Hospitalized Children: Comparing the pRIFLE, AKIN, and KDIGO Definitions, Clin J Am Soc Nephrol, doi: 10.2215/CJN.01900214.

2. Kaddourah A, Basu RK, Bagshaw SM, Goldstein SL. Epidemiology of Acute Kidney Injury in Critically Ill Children and Young Adults. N Engl J Med 2017;376:11-20.

3. Jetton JG, Askenazi DJ. Update on acute kidney injury in the neonate. Curr Opin Pediatr 2012;24:191-6.

4. Bennett MR, Nehus E, Haffner C, Ma Q, Devarajan P. Pediatric reference ranges for acute kidney injury biomarkers. Pediatr Nephrol 2015;30:677-85.

6. Caironi et al. Circulating Proenkephalin, Acute Kidney Injury, and Its Improvement in Patients with Severe Sepsis or Shock. Clin Chem. 2018;64(9):1361-9.

7. Kim et al. Proenkephalin Predicts Organ Failure, Renal Replacement Therapy, and Mortality in Patients with Sepsis. Ann Lab Med. 2020;40(6):466-73

8. Marino et al (2015), Diagnostic and short-term prognostic utility of plasma proenkephalin (pro-ENK) for acute kidney injury in patients admitted with sepsis in the emergency department, J Nephrol, DOI 10.1007/s40620-014-0163-z

9. Hollinger et at (2018), Proenkephalin A 119-159 (Penkid) Is an Early Biomarker of Septic Acute Kidney Injury: The Kidney in Sepsis and Septic Shock (Kid-SSS) Study, Kidney Int Rep, DOI: 10.1016/j.ekir.2018.08.006

About SphingoTec

SphingoTec GmbH ("SphingoTec"; Hennigsdorf near Berlin, Germany) develops and markets innovative in vitro diagnostic (IVD) tests for novel and proprietary biomarkers for the diagnosis, prediction and monitoring of acute medical conditions. SphingoTec's proprietary biomarker portfolio includes bioactive Adrenomedullin (bio-ADM), a biomarker for real-time assessment of endothelial function in conditions like sepsis, and Proenkephalin (penKid), a biomarker for real-time assessment of kidney function. Dipeptidyl Peptidase 3 (DPP3), a biomarker for cardiac depression. IVD tests for SphingoTec’s biomarkers are made available as sphingotest® microtiter plate tests as well as point-of-care tests on the Nexus IB10 immunoassay platform by SphingoTec’s subsidiary Nexus Dx Inc. (San Diego, CA, USA). The Nexus IB10 portfolio is complemented by established and commonly used biomarker tests for acute and critical care such as PCT, Troponin, NT-proBNP, D-Dimer, TSH and others.

Media contact SphingoTec:

Ruxandra Lenz

Sr. Manager Marketing and Communications

SphingoTec GmbH

Neuendorfstr. 15 A

16761 Hennigsdorf

Tel. +49-3302-20565-0

SphingoTec Appoints Jörg Menten to Leadership Team as Chief Commercial Officer to Drive New Business Growth

Tue, 28 Oct 2025 09:43:39 GMT

SphingoTec expands leadership team to facilitate scaling of its fast-growing diagnostics business.
The company commercializes innovative biomarkers for critical care settings and makes them available on multiple IVD instrument platforms.
Jörg Menten will lead the company’s commercial efforts and drive expansion into global markets.

Hennigsdorf/Berlin, Germany, November 29, 2021 – Diagnostics company SphingoTec GmbH (“SphingoTec”) today announced the appointment of Jörg Menten as its Chief Commercial Officer. In this role, Menten will develop the global commercial strategy, oversee the expansion in diagnostic markets worldwide, strengthen existing customer relations and forge new partnerships with global IVD leaders and pharmaceutical companies.

“We are committed to bringing personalized medicine to critical care,” said Dr. Andreas Bergmann, Chief Executive Officer and founder of SphingoTec. “I welcome Mr. Menten on board. His wealth of experience in the healthcare industry provides SphingoTec with strong commercial leadership in accelerating the adoption of our novel biomarkers in the clinical routine. Our goal is to improve patient management with evidence-driven treatment decisions.”

SphingoTec focuses on discovering, developing, and commercializing novel, biomarker-based diagnostics for personalized medicine in critical care settings. The innovative diagnostic solutions are made available on the proprietary point of care platform Nexus IB10 and laboratory diagnostic platforms. SphingoTec’s bedside technology is complemented by a broad portfolio of standard parameters, making it an ideal addition to hospitals, laboratories, and other near-patient settings. Menten will lead the team to build new partnerships for the out-licensing of biomarkers to global diagnostics companies as well as drive companion diagnostics partnerships with the pharmaceutical industry.

Jörg Menten is a highly skilled senior executive with a long-standing track record of leadership positions in the global healthcare industry. With an MBA from the University of Mannheim, he spent more than 13 years with Boehringer Mannheim in several roles contributing to its steep global growth in all care settings – patient monitoring, Point of Care and Lab Diagnostics. As CFO of the Boehringer Mannheim Group, he had a significant role in its acquisition through Roche AG in 1998. Menten served as President International for Kinetic Concepts Inc. driving the global adoption of its wound healing technology VAC® and its IPO on NYSE in 2004. Later, he served as CEO of Vanguard AG, Berlin, a European market leader in hospital services and as President International for CeloNova Inc. leading the global commercialization of Embozene Tandem®, an innovative drug delivery system applied in Interventional Radiology settings for the treatment of liver cancer; acquired by Boston Scientific in 2015.

Jörg Menten commented, “SphingoTec has all assets in place for successful commercialization! SphingoTec’s biomarkers are covering main unmet medical needs in critical care: real-time kidney function assessment, real-time endothelial function assessment, cardiac depression, diagnosis of sepsis, diagnosis of acute heart failure, diagnosis of myocardial infarction, and diagnosis of lung embolism. I am excited to join this team and to lead the market development and commercialization of our biomarkers and POC platform.”

About SphingoTec

SphingoTec GmbH ("SphingoTec"; Hennigsdorf near Berlin, Germany) develops and markets innovative in vitro diagnostic (IVD) tests for novel and proprietary biomarkers for the diagnosis, prediction and monitoring of acute medical conditions. SphingoTec's proprietary biomarker portfolio includes bioactive Adrenomedullin (bio-ADM), a unique biomarker for real-time assessment of endothelial function in conditions like sepsis or congestive heart failure, Proenkephalin (penKid), a unique biomarker for real-time assessment of kidney function, and Dipeptidyl Peptidase 3 (DPP3), a unique biomarker for cardiac depression. IVD tests for SphingoTec’s proprietary biomarkers are made available as sphingotest® microtiterplate tests as well as point-of-care tests on the Nexus IB10 immunoassay platform by SphingoTec’s subsidiary Nexus Dx Inc. (San Diego, CA, USA). The Nexus IB10 portfolio is complemented by established and commonly used biomarker tests for acute and critical care such as PCT, Troponin, NT-proBNP, D-Dimer, TSH and others.

Media contact:

Ruxandra Lenz

Sr. Manager Marketing and Communications

SphingoTec GmbH

Neuendorfstr. 15 A

16761 Hennigsdorf

Tel. +49-3302-20565-0

press[at]sphingotec.com

www.sphingotec.com

SphingoTec’s innovative biomarkers to enable personalized medicine in septic organ failure

Tue, 28 Oct 2025 09:41:58 GMT

• Sepsis is a life-threatening medical emergency that quickly escalates into multiple organ failure.

• SphingoTec’s biomarkers for assessing organ function in real-time help guide clinical decision making by providing patient-specific information.

• Multiple presentations at the Weimar Sepsis Update in Weimar help push forward the science and practice of precision medicine with diagnosis and biomarker-guided therapy.

Hennigsdorf/Berlin, Germany, September 9, 2021 – Diagnostics company SphingoTec GmbH (“SphingoTec”) announces a series of presentations demonstrating the utility of its innovative biomarkers in sepsis, positively impacting diagnostic and treatment decisions for critically ill patients. The new data will be presented at the 10th Weimar Sepsis Update, Germany.

In the oral presentation on the “Properties of Proenkephalin in septic acute kidney injury”, Dr. med. Christian Nusshag presented the results of a prospective observational study and the performance of kidney function biomarker Proenkephalin (penKid). Measured on top of standard of care, penKid can reliably indicate changes in renal function more dynamically than serum creatinine and can also provide additional diagnostic information on renal function, even when the patient is under renal replacement therapy.

In addition to the research presentation, during a lunch symposium, new data will highlight the utility of the biomarkers in clinical routine as well as in biomarker-guided clinical trials in sepsis. In the presentation “Implementing new Biomarkers in Daily Practice: Proenkephalin and bioactive Adrenomedullin in sepsis”, Dr. med. Lukas Martin from the Uniklinik RWTH Aachen, shares the insights from the first hospital to have implemented the innovative biomarkers in clinical routine. The regular measurements of the biomarkers penKid and bio-ADM have supported clinicians to improve diagnosis, help earlier risk stratification and optimize the treatment of critically ill patients. Bioactive adrenomedullin (bio-ADM) is a dynamic biomarker delivering real-time information on the endothelial function, one of the most common causes of septic shock. Moreover, increased bio-ADM levels were used as inclusion criteria in the AdrenOSS-2 Phase II trial to identify patients with endothelial dysfunction. In the presentation “Biomarker-guided Approach for the Treatment of Septic Shock – Precision Medicine in the AdrenOSS-2”, Prof. Dr. med. Tobias Schürholz from the Uniklinik RWTH Aachen will show a closer look at the steps taken to achieve precision medicine in septic organ failure.

Dr. Andreas Bergmann, CEO and founder of SphingoTec said “it is clear that sepsis is not only characterized by a high incidence worldwide, but it is also diagnostically underserved. Our biomarkers provide actionable information on pathophysiological mechanisms in sepsis. By early identifying and monitoring the hallmarks of sepsis, such as endothelial dysfunction and kidney dysfunction, our biomarkers can provide patient-specific information, paving the way for personalized medicine in sepsis, and beyond.”

10th Weimar Sepsis Update

Oral presentation

• Properties of Proenkephalin in septic acute kidney injury. Speaker: Dr. Med. Christian Nusshag, University Hospital Heidelberg.

Session: WS2: European Group on Immunology of Sepsis (EGIS)

Lunch symposium: Precision Medicine in Septic Organ Failure

• Implementing new Biomarkers in Daily Practice: Proenkephalin and bioactive Adrenomedullin in sepsis. Speaker: Priv. Doz. Dr. Med. Lukas Martin, Uniklinik RWTH Aachen

• Biomarker-guided Approach for the Treatment of Septic Shock – Precision Medicine in the AdrenOSS-2. Speaker: Prof. Dr. Med. Tobias Schürholz, Uniklinik RWTH Aachen

About SphingoTec

SphingoTec GmbH ("SphingoTec"; Hennigsdorf near Berlin, Germany) develops and markets innovative in vitro diagnostic (IVD) tests for novel and proprietary biomarkers for the diagnosis, prediction and monitoring of acute medical conditions. SphingoTec's proprietary biomarker portfolio includes bioactive Adrenomedullin (bio-ADM), a unique biomarker for real-time assessment of endothelial function in conditions like sepsis or congestive heart failure, Proenkephalin (penKid), a unique biomarker for real-time assessment of kidney function, and Dipeptidyl Peptidase 3 (DPP3), a unique biomarker for cardiac depression. IVD tests for SphingoTec’s proprietary biomarkers are made available as sphingotest® microtiter plate tests as well as point-of-care tests on the Nexus IB10 immunoassay platform. SphingoTec’s subsidiary Nexus Dx Inc. (San Diego, CA, USA) produces the tests alongside a broad menu of established and commonly used tests for acute and critical care.

Ruxandra Lenz

Sr. Manager Marketing and Communications

SphingoTec GmbH

Neuendorfstr. 15 A

16761 Hennigsdorf

Tel. +49-3302-20565-0

press@sphingotec.com

www.sphingotec.com

New data on innovative biomarkers used to guide the clinical management of septic patients

Tue, 28 Oct 2025 09:39:51 GMT

Endothelial and kidney dysfunction are common complications in septic patients leading to organ failure and unfavorable outcomes.
The organ-specific biomarkers bio-ADM and penKid are used in clinical routine for monitoring the endothelium and respectively kidney function in intensive care units.
Prof. Dr. Gernot Marx of Uniklinik RWTH Aachen is presenting at ISICEM new evidence on how the use of biomarkers can support clinicians in the management of sepsis.

Aachen, Germany and Hennigsdorf/Berlin, Germany, August 31, 2021 – German University Hospital Uniklinik RWTH Aachen (“Uniklinik RWTH Aachen”) and diagnostics company SphingoTec GmbH (“SphingoTec”) announce today that novel data on the acute care biomarkers bioactive adrenomedullin (bio-ADM) and proenkephalin (penKid) will be presented at the 40th International Symposium on Intensive Care and Emergency Medicine (ISICEM) taking place in Brussels, Belgium on August 31 - September 3, 2021. Sepsis is a medical emergency in need of quick therapeutic decisions, although it often progresses undetected in its early stages and remains difficult to manage in the late stages. The organ specific biomarkers first introduced in the clinical routine at Uniklinik RWTH Aachen, Germany offer a new perspective on the disease pathology and facilitate a more timely and efficient treatment.

Prof. Dr. Gernot Marx, the Director of the Clinic for Operative Intensive Care and Intermediate Care at Uniklinik RWTH Aachen, one of the largest ICU wards in Europe, explains “Septic patients are at high risk of developing life-threatening complications. The use of biomarkers that can facilitate a faster and better diagnosis and monitoring of sepsis progression allows clinicians to provide the best available treatment. I am excited to share with the critical care community the latest insights on improving septic patients’ management with the help of innovative biomarkers.”

PenKid is a biomarker for the real-time assessment of kidney function. It is a blood-based solution for detecting true glomerular filtration rate (true GFR) in clinical routine testing and is independent from inflammation and comorbidities (1). PenKid has been proven to not only predict septic acute kidney injury earlier than today’s standard of care, but also to detect the presence and severity of the disease, identify patients at high risk of unfavorable outcomes and indicate the renal recovery (1,2).

Bio-ADM is a biomarker for the real-time assessment of endothelial function (3). The endothelium is the interior wall of the blood vessels that acts as a barrier separating the blood from its surroundings. Bio-ADM enables the assessment of endothelial function up to 48 hours before the symptoms become visible. High bio-ADM levels indicate severe hypotension, edema formation, need for immediate therapeutic interventions and for organ support. Being a dynamic biomarker, low or decreasing bio-ADM blood levels indicate improved outcomes (3,4).

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40th ISICEM Presentation:

Session: Sepsis Biomarkers

Title: “Endothelial and kidney function biomarkers to guide management”

Speaker: Dr. Gernot Marx, Uniklinik RWTH Aachen, Germany

Date & Time: September 1. at 5:15 p.m. CET

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References

(1) Khorashadi M, et al. Proenkephalin: A New Biomarker for Glomerular Filtration Rate and Acute Kidney Injury. Nephron. 2020;144(12):655-61 DOI: 10.1159/000509352

(2) Hollinger A, et al. Proenkephalin A 119-159 (Penkid) Is an Early Biomarker of Septic Acute Kidney Injury: The Kidney in Sepsis and Septic Shock (Kid-SSS) Study. Kidney Int Rep. 2018;3(6):1424-33. DOI: 10.1016/j.ekir.2018.08.006

(3) Geven C, et al. Vascular Effects of Adrenomedullin and the Anti-Adrenomedullin Antibody Adrecizumab in Sepsis. Shock. 2018 Aug;50(2):132-140. doi: 10.1097/SHK.0000000000001103.

(4) van Lier D, et al. Promotion of vascular integrity in sepsis through modulation of bioactive adrenomedullin and dipeptidyl peptidase 3. J Intern Med. 2021 Jun;289(6):792-806. doi: 10.1111/joim.13220.

Uniklinik RWTH Aachen

The Uniklinik RWTH Aachen is a supramaximal care provider that combines patient-oriented medicine and nursing, teaching and research at an international level. With 36 specialist clinics, 28 institutes and five interdisciplinary units, the University Hospital covers the entire medical spectrum. Excellently qualified teams of doctors, nurses and scientists are competently committed to the health of the patients. The bundling of patient care, research and teaching in one central building offers the best conditions for intensive interdisciplinary exchange and close clinical and scientific networking. Around 8.000 employees provide patient-oriented medicine and care according to recognized quality standards. With 1.400 beds, the University Hospital treats around 50.000 inpatient and 200.000 outpatient cases per year.

About SphingoTec

SphingoTec GmbH ("SphingoTec"; Hennigsdorf near Berlin, Germany) develops and markets innovative in vitro diagnostic (IVD) tests for novel and proprietary biomarkers for the diagnosis, prediction and monitoring of acute medical conditions. SphingoTec's proprietary biomarker portfolio includes bioactive Adrenomedullin (bio-ADM), a unique biomarker for real-time assessment of endothelial function in conditions like sepsis or congestive heart failure, Proenkephalin (penKid), a unique biomarker for real-time assessment of kidney function, and Dipeptidyl Peptidase 3 (DPP3), a unique biomarker for cardiac depression. IVD tests for SphingoTec’s proprietary biomarkers are made available as sphingotest® microtiter plate tests as well as point-of-care tests on the Nexus IB10 immunoassay platform. SphingoTec’s subsidiary Nexus Dx Inc. (San Diego, CA, USA) produces the tests alongside a broad menu of established and commonly used tests for acute and critical care.

Press contact

Dr. Mathias Brandstädter

Leitung Unternehmenskommunikation

Uniklinik RWTH Aachen

Pauwelsstraße 30

52074 Aachen

Telefon: 0241 80-89893

mbrandstaedter@ukaachen.de

www.ukaachen.de

Ruxandra Lenz

Sr. Manager Marketing and Communications

SphingoTec GmbH

Neuendorfstr. 15 A

16761 Hennigsdorf

Tel. +49-3302-20565-0

press@sphingotec.com

www.sphingotec.com

SphingoTec Appoints Dr. Gerald Möller as Chairman of the Advisory Board

Tue, 28 Oct 2025 09:36:23 GMT

Dr. Möller’s appointment will strengthen SphingoTec capacities to drive global expansion
SphingoTec develops biomarker tests for critical care settings and markets them on its point of care analyzer, Nexus IB10.

Hennigsdorf/Berlin, Germany, August 23, 2021 – Diagnostics company SphingoTec GmbH (“SphingoTec”) announces that Dr. Gerald Möller has joined the company’s advisory board as chairman of the board. With over 40 years of experience in diagnostics and life sciences, Dr. Möller will guide the company’s strategic expansion. SphingoTec is a fully integrated diagnostic company that develops innovative biomarkers for critical care settings and makes them available as rapid tests on its point of care analyzer.

Dr. Andreas Bergmann, CEO and founder of SphingoTec said, “We are very pleased to welcome Dr. Möller as chairman of our advisory board. Dr. Möller brings a wealth of knowledge and expertise accumulated throughout a distinguished international career. His perspective and experience will be an invaluable asset as we head into the next phase of our development.”

Dr. Möller takes over the chair of the advisory board from Dr. Ute Kilger who will continue leveraging her skills and experience as member of the advisory board. “I am confident that our combined experience in key areas will play a valuable role in guiding strategic decisions and broadening SphingoTec’s global footprint,” added Dr. Kilger.

Commenting on the appointment, Dr. Gerald Möller said, “I am excited about the opportunity to serve the company now as Chairman of the Advisory Board. The next phase of SphingoTec will be the dynamic commercialization of the innovative Biomarkers. This will include the market entry and expansion in the US and other key countries. I want to thank Dr. Kilger for her enthusiastic service as Chair of the Advisory Board over many years. Her profound insight in protecting our scientific discoveries laid the ground for what is now possible – building a global business. I am looking forward to working with Dr. Bergmann and Dr. Moesslang in making this happen.”

Previously, Dr. Möller spent 23 years at Boehringer Mannheim Group, where he held several senior management positions, including CEO of the worldwide operating Group. Following the company’s acquisition by Roche, Dr. Möller was named Head of Global Development and Strategic Marketing Pharmaceuticals, and a member of Roche’s Executive Committee. He has been an investment advisor at HBM Partners for 12 years and an active board member of many innovative life science companies such as Illumina Inc, B.R.A.H.M.S. AG, MTM Laboratories AG and Morphosys AG. From 2003 to 2016, Dr. Moeller served as Chairman of FIND (Foundation for Innovative New Diagnostics), a product development and implementation partnership financed by the Bill and Melinda Gates Foundation.

About SphingoTec

SphingoTec GmbH ("SphingoTec"; Hennigsdorf near Berlin, Germany) develops and markets innovative in vitro diagnostic (IVD) tests for novel and proprietary biomarkers for the diagnosis, prediction and monitoring of acute medical conditions. SphingoTec's proprietary biomarker portfolio includes bioactive Adrenomedullin (bio-ADM), a unique biomarker for real-time assessment of endothelial function in conditions like sepsis or congestive heart failure, Proenkephalin (penKid), a unique biomarker for real-time assessment of kidney function, and Dipeptidyl Peptidase 3 (DPP3), a unique biomarker for cardiac depression. IVD tests for SphingoTec’s proprietary biomarkers are made available as sphingotest® microtiter plate tests as well as point-of-care tests on the Nexus IB10 immunoassay platform. SphingoTec’s subsidiary Nexus Dx Inc. (San Diego, CA, USA) produces the tests alongside a broad menu of established and commonly used tests for acute and critical care.

Contact

Ruxandra Lenz

Sr. Manager Marketing and Communications

SphingoTec GmbH

Neuendorfstr. 15 A

16761 Hennigsdorf

Tel. +49-3302-20565-0

press[at]sphingotec.com

www.sphingotec.com

SphingoTec Expands Management Team and Appoints new CFO

Tue, 28 Oct 2025 09:35:05 GMT

Dr. Angelo Moesslang was named CFO and Managing Director of SphingoTec.
The company has developed innovative biomarkers for critical care settings and makes them available on their point of care platform, Nexus IB10.
The new senior leadership addition broadens SphingoTec’s core capabilities in response to the anticipated significant expansion of its activities.

Hennigsdorf/Berlin, Germany, June 10, 2021 – Diagnostics company SphingoTec GmbH (“SphingoTec”) announces the appointment of Dr. Angelo Moesslang as new chief financial officer (CFO) and managing director.

SphingoTec develops and markets innovative in vitro diagnostic solutions for novel biomarkers that support personalized medicine in critical care conditions. SphingoTec is a fully integrated diagnostics company: the innovative biomarkers are commercially available on the proprietary point of care platform Nexus IB10. Following a successful implementation of the biomarkers in clinical routine, the company is now oriented towards geographical expansion and commercial growth.

Dr. Angelo Moesslang commented, “I was drawn to SphingoTec’s vision and focus of translating the science of novel biomarkers into clinical routine. I am excited to join such an innovative young company, ideally positioned for growth. This new role will allow me to leverage my expertise, contribute to the commercialization effort and continue the initiatives of improving patient management in critical care with innovative diagnostic solutions.”

Dr. Moesslang has more than 20 years of global healthcare and finance leadership experience. Prior to joining SphingoTec he served as CEO of a US-based medical device startup and held various executive roles with the Fresenius Group in Europe, Asia, and the US, most recently CFO of Fresenius Medical Care North America.

Dr. Andreas Bergmann, CEO and founder of SphingoTec added, “With the international commercialization of our validated biomarkers and established point of care platform, we are now bringing diagnostic breakthroughs to critical care clinicians. We are excited to welcome Mr. Moesslang, whose entrepreneurial spirit and energy will bring strategic value to our next stage of business development. “

About SphingoTec

SphingoTec GmbH ("SphingoTec"; Hennigsdorf near Berlin, Germany) develops and markets innovative in vitro diagnostic (IVD) tests for novel and proprietary biomarkers for the diagnosis, prediction and monitoring of acute medical conditions. SphingoTec's proprietary biomarker portfolio includes bioactive Adrenomedullin (bio-ADM), a unique biomarker for real-time assessment of endothelial function in conditions like sepsis or congestive heart failure, Proenkephalin (penKid), a unique biomarker for real-time assessment of kidney function, and Dipeptidyl Peptidase 3 (DPP3), a unique biomarker for cardiac depression. IVD tests for SphingoTec’s proprietary biomarkers are made available as sphingotest® microtiter plate tests as well as point-of-care tests on the Nexus IB10 immunoassay platform. SphingoTec’s subsidiary Nexus Dx Inc. (San Diego, CA, USA) produces the tests alongside a broad menu of established and commonly used tests for acute and critical care.

Contact

Ruxandra Lenz

Sr. Manager Marketing and Communications

SphingoTec GmbH

Neuendorfstr. 15 A

16761 Hennigsdorf

Tel. +49-3302-20565-0

press[at]sphingotec.com

www.sphingotec.com

SphingoTec Accelerates Growth with Direct Sales

Tue, 28 Oct 2025 09:30:45 GMT

SphingoTec to expand the commercialization strategy by establishing a sales division and appointing new head of sales
Tailored diagnostic solutions for point of care use
Innovative proprietary biomarkers and standard parameters available on the fully automated Nexus IB10 platform

Hennigsdorf/Berlin, Germany, May 20, 2021 – Diagnostics company SphingoTec GmbH (“SphingoTec”) announces an expansion of its go-to-market strategy to scale its sales in Germany by creating a direct sales force for its integrated diagnostic solutions. SphingoTec will sell directly to healthcare providers its Nexus IB10 point of care platform together with a broad portfolio of assays. The rapid tests include commonly used parameters as well as innovative and proprietary biomarkers for critical care settings. The direct sales team will be complementing the already established distributor network and will drive commercialization going forward.

The Nexus IB10 platform provides an end-to-end solution for critical care settings that can perform up to three diagnostic parameters on one test disc in only 20 minutes using whole blood samples. The Nexus IB10 analyzer addresses a growing demand for rapid point of care testing in hospital departments, such as intensive care units, emergency rooms, and cath labs.

Nexus IB10 is complemented by SphingoTec’s novel biomarker portfolio and targets critical conditions such as sepsis, myocardial infarction, or heart failure. The innovative biomarkers include the kidney function biomarker Proenkephalin (penKid), the endothelial function biomarker bioactive Adrenomedullin (bio-ADM), and the cardiac depression biomarker Dipeptidyl Peptidase 3 (DPP3).

To drive growth in the German healthcare market, SphingoTec has appointed Steffen Hohmann to lead the direct sales efforts in Germany. Mr. Hohmann brings 30 years of successful leadership experience working with clinicians, important purchasing groups, and hospital chains. “I am excited to be part of the journey of bringing diagnostic innovation to clinical routine. I am looking forward to increasing the installed base of point of care solutions for improved patient care,” said Hohmann.

Dr. Andreas Bergmann, CEO and founder of SphingoTec, said, “Following a successful translation of our novel biomarkers from validation to clinical practice, we are now focusing on actively commercializing our diagnostic solutions. Direct access to our end-users is a key strategic initiative. It enables SphingoTec to serve the critical care community's needs better and help improve care for critically ill patients. We are delighted to have Steffen Hohmann on board to lead our sales initiatives in 2021 and beyond.”

About SphingoTec

SphingoTec GmbH ("SphingoTec"; Hennigsdorf near Berlin, Germany) develops and markets innovative in vitro diagnostic (IVD) tests for novel and proprietary biomarkers for the diagnosis, prediction and monitoring of acute medical conditions. SphingoTec's proprietary biomarker portfolio includes bioactive Adrenomedullin (bio-ADM), a unique biomarker for real-time assessment of endothelial function in conditions like sepsis or congestive heart failure, Proenkephalin (penKid), a unique biomarker for real-time assessment of kidney function, and Dipeptidyl Peptidase 3 (DPP3), a unique biomarker for cardiac depression. IVD tests for SphingoTec’s proprietary biomarkers are made available as sphingotest® microtiter plate tests as well as point-of-care tests on the Nexus IB10 immunoassay platform. SphingoTec’s subsidiary Nexus Dx Inc. (San Diego, CA, USA) produces the tests alongside a broad menu of established and commonly used tests for acute and critical care.

About Nexus Dx Inc. and the Nexus IB10 Platform

Nexus Dx Inc., a wholly-owned subsidiary of SphingoTec, headquartered in San Diego, CA, USA, is a global provider of a near patient testing system and advanced diagnostic solution. The company is improving patient care by providing the medical community with rapid and reliable information at the point of care (POC), delivering patient information when and where it is needed most. The company has invested over $160m to develop and market the IB10 analyser system which, without the need for sample preparation, automatically separates plasma from whole blood with subsequent reliable and quantitative detection of biomarkers in the plasma by means of antibodies. With a hands-on-time of less than 3 minutes the easy-to-use system provides in only 20 minutes test results for biomarkers that are crucial in the management of critical care patients. The portfolio of IB10 assays includes tests for established critical care parameters such as Procalcitonin, Troponin I, CK-MB, Myoglobin, NT-proBNP, and D-Dimer as well as tests for SphingoTec’s proprietary biomarkers such as DPP3, a unique and proprietary biomarker for cardiac depression, Proenkephalin (penKid), a unique and proprietary biomarker for real-time assessment of kidney function, and bioactive Adrenomedullin (bio-ADM), a unique and proprietary biomarker for endothelial function.

Contact

Ruxandra Lenz

Sr. Manager Marketing and Communications

SphingoTec GmbH

Neuendorfstr. 15 A

16761 Hennigsdorf

Tel. +49-3302-20565-0

press[at]sphingotec.com

www.sphingotec.com

Endothelial Function Biomarker bio-ADM to Support Risk Stratification and Clinical Management of COVID-19 Patients

Tue, 28 Oct 2025 09:29:13 GMT

Bioactive Adrenomedullin (bio-ADM) is an established biomarker for the real-time assessment of endothelial function in critical care settings
Endothelial dysfunction plays a central role in the pathophysiology of COVID-19
Data from the German University Hospital RWTH Aachen show that endothelial function biomarker bio-ADM can support the management of COVID-19 patients
Elevated bio-ADM levels indicate disease severity and predict the need for extracorporeal organ assist in COVID-19 patients
SphingoTec has made available to the critical care community a rapid point of care test for measuring bio-ADM levels at the point of need

Aachen, Germany and Hennigsdorf/Berlin, Germany, May 4, 2021 – German University Hospital Uniklinik RWTH Aachen (“Uniklinik RWTH Aachen”) and diagnostics company SphingoTec GmbH (“SphingoTec”) today announced that the endothelial function biomarker bio-ADM aids in the early risk stratification and management of patients suffering from severe COVID-19, in need for escalated intensive care treatment (1). A team lead by the clinical researchers at Uniklinik RWTH Aachen has shown that high bio-ADM levels indicate the severity of the acute respiratory distress syndrome (ARDS), the subsequent need for organ support, and poor outcomes in severely ill COVID-19 patients. Bioactive Adrenomedullin (bio-ADM) is a hormone regulating endothelial function and has been previously validated in over 35.000 patients with diseases where endothelial dysfunction plays a key role, such as sepsis, septic shock, cardiogenic shock, and acute heart failure.

According to the recently published data (1), high bio-ADM levels predict a severe course of COVID-19 infection at admission and identify patients with deteriorating lung function at high risk to develop severe ARDS. Furthermore, the data demonstrate that high bio-ADM levels identify those patients in need of extracorporeal organ assist, such as mechanical ventilation, veno-venous extracorporeal membrane oxygenation (ECMO), renal replacement therapy (RRT).

Prof. Gernot Marx, (Director of the Department of Operative Intensive Care Medicine and Intermediate Care at Uniklinik RWTH Aachen) commented, “In the management of COVID-19 patients there is a high need for early risk stratification biomarkers that allows us to allocate resources and timely plan for therapy escalation. Endothelial dysfunction is a central mechanism in the pathophysiology of many critical care conditions, including COVID-19. The information provided by the bio-ADM measurements has convinced us to include it in our clinical routine measurements. “

These findings confirm and extend previous studies in critical care patients where bio-ADM indicates severe complications in sepsis (2,3), acute heart failure (4), and cardiogenic shock (5). High bio-ADM levels indicate severe hypotension, edema formation, ionotropic/vasopressor use, need for organ support, such as mechanical ventilation, and subsequent organ failure. Being a dynamic biomarker, low or decreasing bio-ADM blood levels indicate improved outcomes (3).

Dr. Andreas Bergmann, CEO and founder of SphingoTec, said, “By monitoring the endothelial dysfunction early in COVID-19 patients, clinicians can timely identify those patients with an unfavorable disease progression. To further support the management of critically ill patients, we have made available the assay for bioactive Adrenomedullin as a rapid near-patient test.”

The CE marked point of care assay for measuring bio-ADM levels is commercialized under the brand name IB10 sphingotest® bio-ADM®. The rapid test runs on SphingoTec`s automated Nexus IB10 point-of-care platform and quantitatively measures levels of bio-ADM directly in blood samples and delivers results after 20 minutes.

References

(1) Simon T-P et al. Prognostic Value of Bioactive Adrenomedullin in Critically Ill Patients with COVID-19 in Germany: An Observational Cohort Study. Journal of Clinical Medicine.

2021, 10, 1667. doi.org/10.3390/jcm10081667

(2) Mebazaa A et al. Circulating adrenomedullin estimates survival and reversibility of organ failure in sepsis: the prospective observational multinational Adrenomedullin and Outcome in Sepsis and Septic Shock-1 (AdrenOSS-1) study. Critical care. Dec 21 2018;22(1):354.

(3) Caironi P et al. Circulating Biologically Active Adrenomedullin (bio-ADM) Predicts Hemodynamic Support Requirement and Mortality During Sepsis. Chest. Aug 2017;152(2):312-320.

(4) Ter Maaten JM et al. Bio-adrenomedullin as a marker of congestion in patients with new-onset and worsening heart failure. European journal of heart failure. Jun 2019;21(6):732-743.

(5) Tolppanen H et al. Adrenomedullin: a marker of impaired hemodynamics, organ dysfunction, and poor prognosis in cardiogenic shock. Annals of intensive care. Dec 2017;7(1):6.

Uniklinik RWTH Aachen

About SphingoTec

SphingoTec GmbH ("SphingoTec"; Hennigsdorf near Berlin, Germany) develops and markets innovative in vitro diagnostic (IVD) tests for novel and proprietary biomarkers for the diagnosis, prediction and monitoring of acute medical conditions. SphingoTec's proprietary biomarker portfolio includes bioactive Adrenomedullin (bio-ADM), a unique biomarker for real-time assessment of endothelial function in conditions like sepsis or congestive heart failure, Proenkephalin (penKid), a unique biomarker for real-time assessment of kidney function, and Dipeptidyl Peptidase 3 (DPP3), a unique biomarker for cardiac depression. IVD tests for SphingoTec’s proprietary biomarkers are made available as sphingotest® microtiter plate tests as well as point-of-care tests on the Nexus IB10 immunoassay platform.SphingoTec’s subsidiary Nexus Dx Inc. (San Diego, CA, USA) produces the tests alongside a broad menu of established and commonly used tests for acute and critical care.

About bio-ADM

IB10 sphingotest® bio-ADM® is a rapid point-of-care (POC) immunoassay for the in vitro quantitative determination of bioactive Adrenomedullin (bio-ADM), a hormone maintaining endothelial function. The endothelium contributes to blood pressure and separates blood from the surrounding tissue. Elevated blood levels of bio-ADM predict blood pressure break down and leaky vessels resulting in oedema. Imbalanced endothelial function is the major cause of shock ultimately resulting in organ dysfunction and death. Early identification of an imbalance in endothelial function allows guidance of vasopressor and diuretic therapy in critically ill patients to improve outcomes.

Press contact

Dr. Mathias Brandstädter

Leitung Unternehmenskommunikation

Uniklinik RWTH Aachen

Pauwelsstraße 30

52074 Aachen

Telefon: 0241 80-89893

mbrandstaedter@ukaachen.de

www.ukaachen.de

Ruxandra Lenz

Sr. Manager Marketing and Communications

SphingoTec GmbH

Neuendorfstr. 15 A

16761 Hennigsdorf

Germany

Tel. +49-3302-20565-0

press@sphingotec.com

www.sphingotec.com

New diagnostic tool for the management of patients with sepsis: Dipeptidyl Peptidase 3 (DPP3)

Tue, 28 Oct 2025 09:27:42 GMT

DPP3 has been shown to be a cardiac depression factor and a marker for refractory shock
DPP3 outperforms Lactate and Procalcitonin on the short-term prognosis in sepsis
Changes in the DPP3 levels indicate the worsening or improving of the patient’s condition
DPP3 markedly guides intensivists in the management of septic patients

Hennigsdorf/Berlin, Germany, March 23, 2021 – Diagnostics company SphingoTec GmbH (“SphingoTec”) announced today the first published data (1) on the biomarker DPP3 that can predict the evolution of organ function and survival in septic patients. Measured on top of routinely used standard parameters, such as Lactate and Procalcitonin, DPP3 is an early indicator of short-term outcomes and patient severity. Sepsis is a medical emergency caused by a dysregulated host response to an infection, with mortality rates increasing rapidly for each hour that appropriate treatment is delayed (2). The rapid evolution of sepsis into its severe form, septic shock, raises the need for more precise and faster testing to support better clinical decision-making.

DPP3 is an enzyme at the core of a newly discovered disease mechanism responsible for cardiovascular depression and short-term organ failure in critically ill patients. Although intracellular DPP3 is involved in normal metabolic processes (3), massive cell death leads to DPP3 release into the bloodstream. Circulating DPP3 inactivates Angiotensin II, a hormone regulating the renin-angiotensin-aldosterone system (RAAS), which ultimately controls hemodynamics (4,5). Angiotensin II depletion leads to cardiovascular depression (6,7,9,10) and reduced vascular tone (6,8), a hemodynamic instability that quickly escalates in multiple organ failure. DPP3 was already shown to add value in various critical care settings such as cardiogenic shock (7,9) and burn shock (10).

The data from the prospective observational multi-center AdrenoOSS-1 study enrolling about 600 patients with sepsis and septic shock have shown that DPP3 levels can predict multiple short-term organ failure and the need for organ support therapies in this population (1). High or increasing DPP3 blood levels precede organ injury and predict the need for vasopressor/inotropic use, mechanical ventilation, and renal replacement therapy. DPP3 blood levels also reflect patient severity, with septic shock patients having a significantly higher DPP3 concentration than patients with severe sepsis (1,3). The study data further show that low or decreasing levels of DPP3 in the first 24 hours of ICU admission predict an improvement of organ function and better outcomes. The dynamic nature of the biomarker can guide intensivists in the early management of septic shock patients.

Dr. Andreas Bergmann, founder of various companies, where new tools to fight sepsis mortality are developed, and CEO of critical care diagnostics company SphingoTec commented: “This newly discovered biomarker makes it easy to identify a distinct pathophysiological mechanism leading to mortality in sepsis and uncovers the etiology of clinical symptoms. The published data show that measuring DPP3 levels add value in the clinical practice by early revealing organ injury and adding information on top of standard parameters. This can help guide intensivists in the early management of septic patients.“

The in vitro diagnostic test for DPP3 is available as a microtiter plate as well as a near-patient rapid test (IB10 sphingotest® DPP3). SphingoTec has made the test available for the critical care community to further assess the clinical utility of the DPP3 biomarker in acute care settings.

References

1. Blet et al (2021), Monitoring Circulating dipeptidyl peptidase 3 (DPP3) predicts improvement of organ failure and survival in sepsis: a prospective observational multinational study, Crit Care, DOI: https://doi.org/10.1186/s13054-021-03471-2

2. Bai et al (2014) Early versus delayed administration of norepinephrine in patients with septic shock Crit Care..DOI:https://doi.org/10.1186/s13054-014-0532-y

3. Rehfeld et al (2019). Novel Methods for the Quantification of Dipeptidyl Peptidase 3 (DPP3) Concentration and Activity in Human Blood Samples. J Appl Lab Med. DOI: 10.1373/jalm.2018.027995

4. Picod et al (2020), Alteration of the Renin-Angiotensin-Aldosterone System in Shock: Role of the Dipeptidyl Peptidase 3, Am J Respir Crit Care Med, 2020, DOI: 10.1164/rccm.202010-3873LE

5. Jha et al (2020), Dipeptidyl peptidase 3 modulates the renin–angiotensin system in mice, J Biol Chem., DOI: 10.1074/jbc.RA120.014183.

6. Deniau et al.(2020) Inhibition of circulating dipeptidyl-peptidase 3 restores cardiac function in a sepsis-induced model in rats: A proof of concept study. PloS One. DOI: doi.org/10.1371/journal.pone.0238039

7. Takagi et al.(2019) Circulating dipeptidyl peptidase 3 and alteration in haemodynamics in cardiogenic shock: results from the OptimaCC trial. Eur J Heart Fail., DOI: 10.1002/ejhf.1600

8. van Lier (2020), Promotion of vascular integrity in sepsis through modulation of bioactive adrenomedullin and dipeptidyl peptidase 3, J. Intern. Med., DOI: doi.org/10.1111/joim.13220

9. Deniau et al. (2019), Circulating dipeptidyl peptidase is a myocardial depressant factor: dipeptidyl peptidase 3 inhibition rapidly and sustainably improves haemodynamics. Eur J Heart Fail. DOI : 10.1002/ejhf.1601

10. Dépret et al.(2020) Circulating dipeptidyl peptidase-3 at admission is associated with circulatory failure, acute kidney injury and death in severely ill burn patients. Crit Care , DOI: https://doi.org/10.1186/s13054-020-02888-5

About SphingoTec

SphingoTec GmbH ("SphingoTec"; Hennigsdorf near Berlin, Germany) develops and markets innovative in vitro diagnostic (IVD) tests for novel and proprietary biomarkers for the diagnosis, prediction and monitoring of acute medical conditions, such as sepsis, acute heart failure, circulatory shock, and acute kidney injury in order to support patient management and provide guidance for treatment strategies. SphingoTec's proprietary biomarker portfolio includes bioactive Adrenomedullin (bio-ADM), a biomarker for real-time assessment of endothelial function in conditions like sepsis or congestive heart failure, Proenkephalin (penKid), a biomarker for real-time assessment of kidney function, and Dipeptidyl Peptidase 3 (DPP3), a biomarker for cardiac depression. IVD tests for SphingoTec’s proprietary biomarkers are made available as sphingotest® microtiter plate tests as well as point-of-care tests on the Nexus IB10 immunoassay platform by SphingoTec’s subsidiary Nexus Dx Inc. (San Diego, CA, USA) alongside a broad menu of established and commonly used tests for acute and critical care. www.sphingotec.com

About DPP3

sphingotest® DPP3 measures Dipeptidyl peptidase 3 an active enzyme which, when released into the blood, inactivates Angiotensin II, a hormone that is important for heart function. The depletion of Angiotensin II affects the renin-angiotensin-aldosterone system (RAAS), ultimately leading to cardiovascular depression and reduced vascular tone, a deadly combination in need of selective treatment strategies. The DPP3 release is a newly identified disease mechanism explaining short-term organ failure in critically ill patients. Early identification of DPP3 release may allow better patient stratification and earlier therapy escalation to improve outcomes.

Press contact

Ruxandra Lenz

Sr. Manager Marketing and Communications

SphingoTec GmbH

Neuendorfstr. 15 A

16761 Hennigsdorf

Tel. +49-3302-20565-0

press@sphingotec.com

www.sphingotec.com

Two distinct pathways leading to the development of septic shock pave the way for personalized medicine in sepsis

Tue, 28 Oct 2025 09:22:39 GMT

Researchers have published new insights into the causes of mortality in sepsis
Loss of endothelial function is induced through two different pathophysiological processes and is a major driver of septic shock, a life-threatening drop in blood pressure
The first pathway originates in the loss of the endothelial barrier triggering an increased production of the repair hormone bioactive Adrenomedullin (bio-ADM), which also has the undesired side effect of vasodilation
The second threat acting on the endothelial function is the release of the protease DPP3 into the bloodstream which degrades angiotensin II, a process resulting in decreased vascular tone and cardiac output
The different pathways require different treatment strategies thus opening new approaches for personalized medicine in sepsis
New diagnostics for quantification of bio-ADM and DPP3 are available as laboratory and near-patient rapid tests
Biomarker-guided approaches for therapies targeting these pathways are showing promising results

Hennigsdorf/Berlin, Germany, February 18, 2021 – Diagnostics company SphingoTec GmbH (SphingoTec) announced today that two distinct processes are involved in the development of septic shock and that SphingoTec’s biomarkers for endothelial function (vascular integrity) and cardiovascular depression allow early identification of these underlying mechanisms requiring different interventions. Sepsis, a global burden with nearly 50 million cases worldwide, is a life-threatening condition that is diagnostically and therapeutically underserved. With the availability of such pathway-specific biomarkers, new avenues for diagnosing and monitoring sepsis are opened and biomarker-guided trials for personalized therapies targeting these mechanisms are enabled.

Researchers have summarized the available evidence (1) on two distinct pathophysiological processes leading to endothelial dysfunction and the subsequent development of shock and organ failure in sepsis. The two biologically active molecules acting on the vasculature and influencing patient outcomes are bioactive Adrenomedullin (bio-ADM) and Dipeptidyl peptidase 3 (DPP3). One distinct pathway originates in the loss of endothelial barrier integrity, causing edema and the loss of intravascular volume. To compensate for this leakage, the production of the repair hormone bio-ADM is increased. But bio-ADM has also the second function of vascular relaxation, therefore the increased production leads to a dangerous side effect of vasodilation, generating a loss of tissue resistance which ultimately culminates in shock. Data from the observational study AdrenOSS-1 show (3) that elevations of bio-ADM levels reflect the loss of endothelial function and translate into poor outcome in sepsis. Furthermore, the results of the biomarker-guided AdrenOSS-2 trial (2) confirm that this pathway is a valid therapeutic target. According to the second underlying mechanism accountable for the loss of the endothelial function, the depletion of angiotensin II affects the renin-angiotensin-aldosterone system (RAAS), ultimately leading to a cardiovascular depression (4,5) and reduced vascular tone, a deadly combination in need of selective treatment strategies. The main process generating the depletion of the cardiovascular stimulating hormone angiotensin II is the release of the protease DPP3 into the bloodstream through sepsis-induced cell damage (6).

Personalized medicine has shown significant progress in areas such as oncology or cardiology, but in intensive care units, it has remained challenging to identify biomarkers that facilitate personalized treatments. In the context of a life-threatening condition such as septic shock, taking therapeutic decisions is time-critical, aiming to respond in the best possible way and especially on a patient-specific basis. The review (1) summarizes that the biomarkers bio-ADM and DPP3 can identify these pathways, supporting an early and precise diagnosis and monitoring of sepsis patients. Moreover, data from the biomarker-guided interventional study AdrenOSS-2 show that clinical trials can benefit from the use of biomarker as an enrichment strategy. Within the AdrenOSS-2 study, patients with sepsis-associated endothelial dysfunction were identified by increased bio-ADM to receive therapy with placebo or Adrecizumab (2), an antibody targeting the loss of vascular integrity by maintaining protective bio-ADM concentrations in the blood. When excluding patients with additionally high DPP3 blood concentrations, outcomes could further be improved. Therapies blocking DPP3-activity have also been shown to improve outcomes in various preclinical models. (7)

Dr. Andreas Bergmann, founder of various companies fighting sepsis mortality and CEO of critical care diagnostics company SphingoTec commented: “Following a deep understanding of the disease biology, we have developed diagnostic solutions that can now unravel the etiology of the mortality drivers in sepsis. The evidence confirms the utility of our biomarkers in supporting clinicians make more informed decisions and ultimately improve patient management. “

The new diagnostics for quantification of bio-ADM and DPP3 are available as microtiter plate assays as well as point-of-care tests on the Nexus IB10 immunoassay platform. The Nexus IB10 analyzer provides test results on whole blood samples in only 20 minutes and can be flexibly deployed in emergency departments, intensive care units, and any laboratory setting.

References

(1) van Lier (2020), Promotion of vascular integrity in sepsis through modulation of bioactive adrenomedullin and dipeptidyl peptidase 3, J. Intern. Med., DOI: doi.org/10.1111/joim.13220

(2) Geven et al (2019)A double-blind, placebo-controlled, randomised, multicentre, proof-of-concept and dose-finding phase II clinical trial to investigate the safety, tolerability and efficacy of adrecizumab in patients with septic shock and elevated adrenomedullin concentration (AdrenOSS-2), BMJ, DOI: 10.1136/bmjopen-2018-024475

(3) Mebazaa (2018), Circulating adrenomedullin estimates survival and reversibility of organ failure in sepsis: the prospective observational multinational Adrenomedullin and Outcome in Sepsis and Septic Shock-1 (AdrenOSS-1) study , Crit Care DOI:

(4) Jha et al (2020), Dipeptidyl peptidase 3 modulates the renin–angiotensin system in mice, J Biol Chem

., DOI: 10.1074/jbc.RA120.014183.

(5) Takagi et al (2020), Circulating dipeptidyl peptidase 3 and alteration in haemodynamics in cardiogenic shock: results from the OptimaCC trial, Eur J Heart Fail, DOI: 10.1002/ejhf.1600

(6) Bet et al (2021) Monitoring circulating dipeptidyl peptidase 3 (DPP3) predicts improvement of organ failure and survival in sepsis: a prospective observational multinational study. Crit Care DOI: doi.org/10.1186/s13054-021-03471-2

(7) Deniau et al (2020) Circulating dipeptidyl peptidase 3 is a myocardial depressant factor: dipeptidyl peptidase 3 inhibition rapidly and sustainably improves haemodynamics, Eur J Heart Fail, DOI: 10.1002/ejhf.1601.

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About SphingoTec

SphingoTec GmbH ("SphingoTec"; Hennigsdorf near Berlin, Germany) develops and markets innovative in vitro diagnostic (IVD) tests for novel and proprietary biomarkers for the diagnosis, prediction and monitoring of acute medical conditions, such as sepsis, acute heart failure, circulatory shock, and acute kidney injury in order to support patient management and provide guidance for treatment strategies. SphingoTec's proprietary biomarker portfolio includes bioactive Adrenomedullin (bio-ADM), a biomarker for real-time assessment of endothelial function in conditions like sepsis or congestive heart failure, Proenkephalin (penKid), a biomarker for real-time assessment of kidney function, and Dipeptidyl Peptidase 3 (DPP3), a biomarker for cardiac depression. IVD tests for SphingoTec’s proprietary biomarkers are made available as sphingotest® microtiter plate tests as well as point-of-care tests on the Nexus IB10 immunoassay platform by SphingoTec’s subsidiary Nexus Dx Inc. (San Diego, CA, USA) alongside a broad menu of established and commonly used tests for acute and critical care.

About bio-ADM®

sphingotest® bio-ADM® measures bioactive Adrenomedullin (bio-ADM), a hormone maintaining endothelial function. The endothelium contributes to blood pressure and separates blood from the surrounding tissue. Elevated blood levels of bio-ADM® predict blood pressure break down and leaky vessels resulting in oedema. Imbalanced endothelial function is the major cause of shock ultimately resulting in organ dysfunction and death. Early identification of an imbalance in endothelial function allows guidance of vasopressor and diuretic therapy in critically ill patients to improve outcomes. Learn more about bio-ADM® at www.sphingotec.com

About DPP3

sphingotest® DPP3 measures Dipeptidyl peptidase 3 an active enzyme which, when released into the blood, inactivates angiotensin II, a hormone that is important for heart function. The depletion of angiotensin II affects the renin-angiotensin-aldosterone system (RAAS), ultimately leading to cardiovascular depression and reduced vascular tone, a deadly combination in need of selective treatment strategies. The DPP3 release is a newly identified disease mechanism explaining short-term organ failure in critically ill patients. Early identification of DPP3 release may allow better patient stratification and earlier therapy escalation to improve outcomes. www.sphingotec.com

Proenkephalin (penKid®) included in the ADQI consensus statements publication as functional kidney biomarker for the management of AKI patients

Tue, 07 Oct 2025 20:58:45 GMT

The latest consensus meeting of international experts in critical care and nephrology supports the use of novel biomarkers in the prevention and management of Acute Kidney Injury (AKI)
The consensus recommends using a combination of damage and functional biomarkers together with clinical information for routine practice
Proenkephalin (penKid®), the kidney function biomarker, proposed as a marker for the assessment of AKI progression and kidney recovery
The CE-IVD marked assay for penKid® is available for point of care usage on the fully automated Nexus IB10 platform

Hennigsdorf/Berlin, Germany, December 16, 2020 – Diagnostics company SphingoTec GmbH (“SphingoTec”) announced today that the Acute Disease Quality Initiative (ADQI) recommends the use of novel biomarkers for AKI, including functional biomarkers as penKid®. Since AKI is affecting 1 in 3 Intensive Care Unit (ICU) patients [1], and the current standard of care diagnostics has considerable sensitivity and specificity limitations, there is an urgent need to implement new biomarkers to assist a better management of AKI.

The current consensus recommendations [2] support clinicians in making more informed decisions and improve outcomes with biomarker guided management of AKI patients, including triage, diagnosis, and guidance of therapy. Among the main recommendation of the ADQI meeting is the use of novel biomarkers to assess AKI progression and kidney recovery. The consensus statements highlight the performance and added value of penKid® for the prediction of duration and recovery of AKI. Based on the results of a multicenter trial (3), the presented evidence shows that penKid® concentration is significantly lower in AKI patients with improving kidney function when compared to patients without kidney recovery. Additional data (4) is used by the experts in ADQI to convey that significantly higher penKid® levels are indicating those patients with major adverse kidney events, patients with persistent AKI, and those who had worsening of kidney function. Furthermore, the consensus statement also underlines that penKid® is an earlier biomarker than today’s standard of care diagnostics in identifying the patients with worsening kidney function.

Prof. Peter Pickkers (Radboud University, Nijmegen), member of the ADQI explained “Since the last evaluation of novel AKI biomarkers 9 years ago, we have collected enough evidence now to consider the usage of functional and damage biomarkers in the prediction and management of AKI. Although many novel biomarkers can measure the damage that already occurred in the kidneys, there are few choices available for measuring the kidney function. Besides Cystatin C, penKid is the only novel functional biomarker available for clinical routine practice.”

The kidney function biomarker penKid® was previously validated in over 40.000 patients and published data [5] demonstrate that penKid® can detect the presence and severity of AKI and enables the identification of patients at high risk of unfavorable outcomes. Moreover, previous findings from the AdrenOSS 1, a 24-centers study, show that penKid® not only diagnoses AKI earlier than today’s standard of care, but it also indicates the renal recovery. [4] The utility of penKid® has been proved both in adult and children population. [6]

Dr. Andreas Bergmann, CEO and founder of SphingoTec stated “We are excited that penKid® has been recognized by ADQI as a suitable functional kidney biomarker. Not only that penKid® reflects kidney function and true GFR independent of inflammation and comorbidities, but unpublished clinical data could complement the consensus recommendation to further evaluate the functional biomarker’s role in defining the optimal timing for initiating and stopping kidney replacement therapy.”

To support timely treatment decisions that are likely to improve patient management in critical care patients, SphingoTec makes available the CE-IVD marked assay for penKid® on its proprietary Nexus IB10 platform. The fully automated point-of-care analyzer uses whole blood, delivers results in only 20 minutes, and can be flexibly deployed in near-patient as well as laboratory settings.

References:

(1) Ponce et al (2016), Acute kidney injury: risk factors and management challenges in developing countries, Int J Nephrol Renovasc Dis., DOI: 10.2147/IJNRD.S104209

(2) Ostermann et al (2020), Recommendation on Acute Kidney Injury Biomarkers From the Acute Disease Quality Initiative Consensus Conference | Consensus Statement, Critical Care Medicine, DOI: 10.1001/jamanetworkopen.2020.19209

(3) Caironi et al (2018), Circulating proenkephalin, acute kidney injury, and its improvement in patients with severe sepsis or shock. Clin Chem; DOI:10.1373/clinchem.2018.288068

(4) Hollinger et at (2018), Proenkephalin A 119-159 (Penkid) Is an Early Biomarker of Septic Acute Kidney Injury: The Kidney in Sepsis and Septic Shock (Kid-SSS) Study, Kidney Int Rep, DOI: 10.1016/j.ekir.2018.08.006

(5) Marino et al (2015), Diagnostic and short-term prognostic utility of plasma proenkephalin (pro-ENK) for acute kidney injury in patients admitted with sepsis in the emergency department, J Nephrol, DOI 10.1007/s40620-014-0163-z

[6] Hartman et al (2020), Proenkephalin as a New Biomarker for Pediatric Acute Kidney Injury - Reference Values and Performance in Children Under One Year of Age, Clin Chem Lab Med, doi: 10.1515/cclm-2020-0381.

About penKid®

IB10 sphingotest® penKid® measures Proenkephalin (penKid®), a stable fragment of the kidney stimulating hormone Enkephalin. penKid® has been demonstrated to be a real-time surrogate biomarker for glomerular filtration rate, the gold standard to assess renal function. Measuring penKid® blood concentrations allows for timely information on kidney function in critically ill patients. Early assessment of worsening and improving of renal function on intensive care units and in emergency departments allows adjustment of nephrotoxic drug administration and the initiation of kidney-protective strategies to prevent acute kidney injury and thereby improve outcomes.

About SphingoTec

SphingoTec GmbH ("SphingoTec"; Hennigsdorf near Berlin, Germany) develops and markets innovative in vitro diagnostic (IVD) tests for novel and proprietary biomarkers for the diagnosis, prediction and monitoring of acute medical conditions, such as sepsis, acute heart failure, circulatory shock, and acute kidney injury in order to support patient management and provide guidance for treatment strategies. SphingoTec's proprietary biomarker portfolio includes bioactive Adrenomedullin (bio-ADM®), a unique biomarker for real-time assessment of endothelial function in conditions like sepsis or congestive heart failure, Proenkephalin (penKid®), a unique biomarker for real-time assessment of kidney function, and Dipeptidyl Peptidase 3 (DPP3), a unique biomarker for cardiac depression. In addition, SphingoTec develops a portfolio of novel biomarkers, which predict the risks of developing obesity, breast cancer and cardiovascular diseases. IVD tests for SphingoTec’s proprietary biomarkers are made available as sphingotest® microtiterplate tests as well as point-of-care tests on the Nexus IB10 immunoassay platform by SphingoTec’s subsidiary Nexus Dx Inc. (San Diego, CA, USA) alongside a broad menu of established and commonly used tests for acute and critical care.

About Nexus Dx Inc. and the IB10 Platform

Nexus Dx Inc., a wholly-owned subsidiary of SphingoTec, headquartered in San Diego, CA, USA, is a global provider of a near patient testing system and advanced diagnostic solution. The company is improving patient care by providing the medical community with rapid and reliable information at the point of care (POC), delivering patient information when and where it is needed most. The company has invested over $160m to develop and market the IB10 analyzer system which, without the need for sample preparation, automatically separates plasma from whole blood with subsequent reliable and quantitative detection of biomarkers in the plasma by means of antibodies. With a hands-on-time of less than 3 minutes the easy-to-use system provides in only 20 minutes test results for biomarkers that are crucial in the management of critical care patients. The portfolio of IB10 assays includes tests for established critical care parameters such as Procalcitonin, Troponin I, CK-MB, Myoglobin, NT-proBNP, and D-Dimer as well as tests for SphingoTec’s proprietary biomarkers such as Proenkephalin (penKid®), a unique and proprietary biomarker for real-time assessment of kidney function, and bioactive Adrenomedullin (bio-ADM®), a unique and proprietary biomarker for endothelial function.

Contact

SphingoTec GmbH

Ruxandra Lenz

Sr. Manager Marketing and Communications

Neuendorfstr. 15 A

16761 Hennigsdorf

Germany

Tel. +49-3302-20565-0

press@sphingotec.de

www.sphingotec.com

Uniklinik RWTH Aachen is the first hospital to implement SphingoTec's innovative biomarkers in clinical routine with the aim of making intensive care diagnostics more precise

Tue, 07 Oct 2025 20:57:19 GMT

The biomarkers for the real-time assessment of kidney function (penKid®) and endothelial function (bio-ADM®) are pioneering new diagnostic pathways in critical care settings
Following a positive initial clinical evaluation of penKid® and bio-ADM®, the University Hospital RWTH Aachen has transferred the innovative diagnostic tools into clinical routine
The novel biomarkers enable a better diagnosis and monitoring of organ function

Aachen, Germany and Hennigsdorf/Berlin, German, December 10, 2020 – The Uniklinik RWTH Aachen (“Uniklinik RWTH Aachen”) has successfully translated the collaboration for research and biomarker validation with SphingoTec GmbH (“SphingoTec”) into clinical routine. The routine measurements of the innovative biomarkers are providing organ-specific information for monitoring critical care conditions such as sepsis and acute kidney injury and support clinical decisions to improve patient outcomes.

Uniklinik RWTH Aachen is one of Germany’s most modern hospitals due to the way it integrates diagnostics and therapy, research and teaching under the same roof. Following a patient-centric approach, Uniklinik RWTH Aachen has adopted innovative pathways in intensive medicine by introducing these new diagnostic tools for monitoring organ function of critically ill patients. The routine measurements of penKid® and bio-ADM® provide clinicians with more insights on the disease pathology and etiology of clinical symptoms and facilitate more efficient, timely, and adequate treatment.

Prof. Dr. Gernot Marx, the Director of the Clinic for Operative Intensive Care and Intermediate Care at Uniklinik RWTH Aachen explained: “Critically ill patients are highly dynamic with many complications interfering in the diagnostics process, thus a very challenging environment for introducing innovations. We have been looking for a long time for the right diagnostic tools to allow us a faster and better diagnosis, risk stratification, and monitoring of the disease progression so that we can provide the best available treatment immediately for acute cases. The first routine measurements do confirm the utility and value of these novel diagnostic biomarkers in clinical decision-making and ultimately in maximizing the patient’s benefit. “

In intensive care units, 1 in 3 patients is developing acute kidney injury [1]. The existing diagnostic parameters for the determination of renal function or kidney damage, which are routinely used as standard procedure, have a considerable time delay or are influenced by inflammation or other diseases. These limitations are underlining the need for more precise tools to support clinical decisions. The biomarker penKid® offers real-time information about the kidney function with the first measurement and without being influenced by co-morbidities or the frequently occurring inflammation in critically ill patients [2,3,4]. Moreover, penKid® shows the best representation of the current kidney function, measured by the glomerular filtration rate (true GFR). [5]

World-wide, sepsis is accountable for 1 in 5 deaths [6]. Reduced organ perfusion in shock, which can be determined by existing laboratory values, is the culprit for the fatal course, but it can be induced by various factors. The loss of endothelial function is often a main cause for shock in sepsis, but it could not be detected by blood-based tests so far. The measurement of the bio-ADM® biomarker now allows for the first time the direct assessment of endothelial function in real time [7,8,9] independent of co-morbidities and inflammation, thus supporting precise and rapid treatment decisions.

Dr. Andreas Bergmann, founder and CEO of SphingoTec added: “We are excited that the initial clinical evaluation ended in a successful translation of the biomarkers into clinical routine. The comprehensive amount of routine data on our biomarkers collected by Prof. Gernot Marx and his team will allow us to deepen our knowledge of the biomarkers and to explore further application areas. Encouraged by this implementation of our novel diagnostic tools at the frontlines of medical care, we intend to offer them in a near future on a larger scale in other European countries.”

References

[1] Ponce et. al. (2016), Acute kidney injury: risk factors and management challenges in developing countries Int. J. Nephrol. Renovasc. Dis., DOI: 10.2147/IJNRD.S104209

[2] Hollinger et. al. (2018) Proenkephalin A 119-159 (Penkid) Is an Early Biomarker of Septic Acute Kidney Injury: The Kidney in Sepsis and Septic Shock (Kid-SSS) Study, Kidney Int Rep, DOI: 10.1016/j.ekir.2018.08.006

[3] Siong Chan (2018) Proenkephalin in heart failure

[4] Beunders et. al. (2017) Proenkephalin (PENK) as a novel biomarker for kidney function.

[5] Beunders, R. et al. (2019), Proenkephalin compared to conventional methods to assess kidney function in critically ill sepsis patients, Shock,, doi:10.1097/SHK.0000000000001510

(6) Rudd et al (2020), Global, regional, and national sepsis incidence and mortality, 1990–2017: analysis for the Global Burden of Disease Study, The Lancet, DOI: doi.org/10.1016/S0140-6736(19)32989-7

(7) Geven (2018): Vascular Effects of Adrenomedullin and the anti-Adrenomedullin Antibody Adrecizumab in Sepsis. Shock. doi: 1097/SHK.0000000000001103

(8) Mebazaa (2018): Circulating adrenomedullin estimates survival and reversibility of organ failure in sepsis: the prospective observational multinational Adrenomedullin and Outcome in Sepsis and Septic Shock (AdrenOSS-1) study. doi:10.1186/s13054-018-2243-2

(9) Caironi (2017): Circulating biologically active adrenomedullin (bio-ADM) predicts hemodynamic support requirement and mortality During Sepsis. Chest. doi: 10.1016/j.chest.2017.03.035.

Uniklinik RWTH Aachen

The Uniklinik RWTH Aachen is a supramaximal care provider that combines patient-oriented medicine and nursing, teaching and research at an international level. With 36 specialist clinics, 28 institutes and five interdisciplinary units, the University Hospital covers the entire medical spectrum. Excellently qualified teams of doctors, nurses and scientists are competently committed to the health of the patients. The bundling of patient care, research and teaching in one central building offers the best conditions for intensive interdisciplinary exchange and close clinical and scientific networking. Around 8.000 employees provide patient-oriented medicine and care according to recognised quality standards. With 1.400 beds, the University Hospital treats around 50.000 inpatient and 200.000 outpatient cases per year.

About SphingoTec

SphingoTec GmbH ("SphingoTec"; Hennigsdorf near Berlin, Germany) develops and markets innovative in vitro diagnostic (IVD) tests for novel and proprietary biomarkers for the diagnosis, prediction and monitoring of acute medical conditions, such as sepsis, acute heart failure, circulatory shock, and acute kidney injury in order to support patient management and provide guidance for treatment strategies. SphingoTec's proprietary biomarker portfolio includes bioactive Adrenomedullin (bio-ADM®), a biomarker for real-time assessment of endothelial function in conditions like sepsis or congestive heart failure, Proenkephalin (penKid®), a biomarker for real-time assessment of kidney function, and Dipeptidyl Peptidase 3 (DPP3), a biomarker for cardiac depression. IVD tests for SphingoTec’s proprietary biomarkers are made available as sphingotest® microtiter plate tests as well as point-of-care tests on the Nexus IB10 immunoassay platform by SphingoTec’s subsidiary Nexus Dx Inc. (San Diego, CA, USA) alongside a broad menu of established and commonly used tests for acute and critical care.

About penKid®

sphingotest® penKid® measures Proenkephalin (penKid®), a stable fragment of the kidney stimulating hormone Enkephalin. penKid® has been demonstrated to be a real-time surrogate biomarker for glomerular filtration rate, the gold standard to assess renal function. Measuring penKid® blood concentrations allows for timely information on kidney function in critically ill patients. Early assessment of worsening and improving of renal function on intensive care units and in emergency departments allows adjustment of nephrotoxic drug administration and the initiation of kidney-protective strategies to prevent acute kidney injury and thereby improve outcomes. Learn more about penKid® at http://www.youtube.com/watch?v=6SYhs7it4R4

About bio-ADM®

sphingotest® bio-ADM® measures bioactive Adrenomedullin (bio-ADM®), a hormone maintaining endothelial function. The endothelium contributes to blood pressure and separates blood from the surrounding tissue. Elevated blood levels of bio-ADM® predict blood pressure break down and leaky vessels resulting in oedema. Imbalanced endothelial function is the major cause of shock ultimately resulting in organ dysfunction and death. Early identification of an imbalance in endothelial function allows guidance of vasopressor and diuretic therapy in critically ill patients to improve outcomes. Learn more about bio-ADM® at http://www.youtube.com/watch?v=52lrrRNb0k4

Press contact

Dr. Mathias Brandstädter

Leitung Unternehmenskommunikation

Uniklinik RWTH Aachen

Pauwelsstraße 30

52074 Aachen

Telefon: 0241 80-89893

mbrandstaedter@ukaachen.de

www.ukaachen.de

Ruxandra Lenz

Sr. Manager Marketing and Communications

SphingoTec GmbH

Neuendorfstr. 15 A

16761 Hennigsdorf

Tel. +49-3302-20565-0

press@sphingotec.de

www.sphingotec.com

SphingoTec, BHR Pharmaceuticals ink agreement for distribution of SphingoTec’s acute care portfolio in the UK and Ireland

Tue, 07 Oct 2025 20:55:33 GMT

BHR specializes in innovative diagnostic solutions for point of care
Collaboration focuses on SphingoTec’s proprietary assays for bio-ADM®, penKid® and DPP3
Investigator-initiated study in COVID-19 at Guy’s & St Thomas’ Hospital and King's College Hospital NHS Trust

Warwickshire, United Kingdom and Hennigsdorf, Germany, September 29, 2020 - BHR Pharmaceuticals Ltd (“BHR”) and SphingoTec GmbH (“SphingoTec”) today announced that they have signed a distribution agreement for the commercialization of SphingoTec’s portfolio of diagnostics solutions in acute and critical care in UK and Ireland.

The collaboration in particular focuses on the UK market introduction of SphingoTec’s point-of-care tests for novel and proprietary biomarkers in critical care targeting diagnostically underserved conditions such as sepsis, acute heart failure, acute kidney injury, and recently severe COVID-19. These products include tests for bio-ADM®, penKid®, and DPP3 allowing for the early diagnosis and monitoring of endothelial dysfunction, kidney dysfunction, and cardiac depression, respectively. The tests are made available on SphingoTec’s Nexus IB10 platform, a fully automated rapid immunoassay point-of-care instrument, that provides accurate test results within only 20 minutes and can be flexibly deployed in laboratories, emergency departments, intensive care units, and doctors’ offices.

Established in 1990, BHR has grown to become a UK market leader in the provision of point-of-care diagnostics. BHR specializes in sourcing new advanced and progressive technology from around the world and delivering these innovative products to the UK market. Bharat Vadukul, Director of BHR commented “BHR is delighted to be appointed exclusive distribution partners for the Nexus IB10 system in the United Kingdom and Ireland. This product further strengthens the strategic fit with our existing product portfolio. With the Nexus IB10 system, BHR’s comprehensive package of Point-of-Care testing devices will enhance the ability of Specialists in the Renal and Cardiology sectors to better manage their patients, saving lives and improve their all-important quality of life.”

Dr. Andreas Bergmann, CEO of SphingoTec, echoes those sentiments. He noted, “We are very much looking forward to our collaboration with BHR who have been very successful in promoting the IB10 platform in the past. We also believe that they are excellent strategic partners for providing rapid and novel solutions needed by clinicians in managing critically ill patients and will support us in our long-term strategy to improve patient outcomes in acute and critical care conditions.”

To address the specific challenges provided by COVID-19 in the UK, the companies collaborate with Dr. Marlies Ostermann, MD, Ph.D. at Guy’s & St Thomas’ Hospital/London, United Kingdom, who initiated a two-center study also including King's College Hospital NHS Trust to further investigate the added value of SphingoTec’s biomarkers in developing individualized management strategies for severely ill COVID-19 patients(1). Dr. Ostermann commented: “There is an urgent need to assess and monitor organ function of COVID-19 patients in real-time. After a first positive evaluation of these novel biomarkers, we have decided to further investigate their use in clinical practice in delivering information on the underlying pathogenesis in patients with COVID-19. “

To discover more about the Nexus IB10 and SphingoTec’s portfolio of diagnostic solutions for acute and critical care, please visit sphingotec.com. For more information on the BHR Pharmaceuticals portfolio, please visit www.bhr.co.uk

(1) clinicaltrials.gov/ct2/show/NCT04408365

About Sphingotec

SphingoTec GmbH ( “SphingoTec”; Hennigsdorf near Berlin, Germany) develops and markets innovative in-vitro diagnostic (IVD) tests for novel and proprietary biomarkers for the diagnosis, prediction and monitoring of acute medical conditions, such as sepsis, acute heart failure, circulatory shock, and acute kidney injury in order to support patient management and provide guidance for treatment strategies. SphingoTec's proprietary biomarker portfolio includes Bioactive Adrenomedullin(bio-ADM®), a unique biomarker for real-time assessment of endothelial function in conditions like sepsis or congestive heart failure, Proenkephalin (penKid®), a unique biomarker for real-time assessment of kidney function, and Dipeptidyl Peptidase 3 (DPP3), a unique biomarker for cardiac depression. IVD tests for SphingoTec’s proprietary biomarkers are made available as sphingotest® microtiterplate tests as well as point-of-care tests on the Nexus IB10 immunoassay platform by SphingoTec’s subsidiary Nexus Dx Inc. (San Diego, CA, USA) alongside a broad menu of established and commonly used tests for acute and critical care.

About BHR Pharmaceuticals

BHR Pharmaceuticals Ltd is a market leading company in the field of point-of-care diagnostics within healthcare, moving appropriate tests from the lab closer to the patient to better manage and treat people. This helps shorten patient pathways, improves the patient experience, and improves efficiency for doctors, nurses and other healthcare professionals. BHR has challenges the conventions of laboratory medicine by showing that point-of-care diagnostics save time, money and improves health.

Contact

SphingoTec GmbH

Ruxandra Lenz

Sr. Manager Marketing and Communications

Neuendorfstr. 15 A

16761 Hennigsdorf

Germany

Tel. +49-3302-20565-0

press@sphingotec.de

www.sphingotec.com

SphingoTec’s kidney function biomarker penKid® accurately detects acute kidney injury in infants

Tue, 07 Oct 2025 20:53:56 GMT

penKid® (Proenkephalin), a unique biomarker for the real-time assessment of kidney function
Novel data now demonstrate that penKid® also accurately predicts acute kidney injury in infants and provides substantial additional value on top of the diagnostic standard of care

Hennigsdorf/Berlin, Germany, August 27, 2020 – Diagnostics company SphingoTec GmbH (“SphingoTec”) announced today the publication of first data (1), proving that its real-time kidney function biomarker penKid® is a reliable biomarker for the diagnosis of acute kidney injury (AKI) in infants. With the incidence of pediatric AKI increasing globally, there is a high need for non-invasive, diagnostic solutions to improve the early diagnosis of AKI in children to prevent adverse events and improve recovery.penKid® is an established biomarker for detecting AKI in adults. The current study shows that reference values for penKid® in children are much higher than in adults. However, when considering these higher reference values in critically ill children under one year of age, high or increasing penKid® concentrations accurately predict AKI and its severity.

Dr. Andreas Bergmann, CEO of SphingoTec, commented: “The data confirm, that penKid® predicts AKI also in challenging settings such as the pediatric critical care. In critically ill children, AKI has a high prelevance, is associated with poor outcomes and the possibilities for pharmacological intervention are limited. Therefore, the early detection of AKI is paramount in improving the prognosis for these children.”

In children admitted to hospital, AKI is a common complication especially among those requiring intensive care, affecting up to 51% admitted to ICU (2). Pediatric AKI is often diagnosed too late for successful therapeutic interventions leading to adverse outcomes and chronic kidney impairment. The data from the recent study highlight that penKid® has the potential to address this diagnostic shortcoming. The study data add to the rapidly growing body of evidence in by now more than 30,000 adult patients, showing that penKid® is an early and accurate indicator for the worsening or improvement of kidney function. Importantly, penKid® is independent of inflammation and comorbidities and, as recently published, the most accurate surrogate marker for true glomerular filtration rate (true GFR) in patients with renal impairment (3) and hence ideally suited for the real-time assessment of kidney function and the early prediction of AKI.

References

(1) Hartman et al (2020), Proenkephalin as a New Biomarker for Pediatric Acute Kidney Injury - Reference Values and Performance in Children Under One Year of Age, Clin Chem Lab Med, doi: 10.1515/cclm-2020-0381.

(2) Sutherland et al (2015) AKI in Hospitalized Children: Comparing the pRIFLE, AKIN, and KDIGO Definitions, Clin J Am Soc Nephrol, doi: 10.2215/CJN.01900214.

(3) Beunders, R. et al.(2020), Proenkephalin compared to conventional methods to assess kidney function in critically ill sepsis patients, Shock, doi:10.1097/SHK.0000000000001510

About sphingotec

SphingoTec GmbH ("SphingoTec"; Hennigsdorf near Berlin, Germany) develops and markets innovative in vitro diagnostic (IVD) tests for novel and proprietary biomarkers for the diagnosis, prediction and monitoring of acute medical conditions, such as sepsis, acute heart failure, circulatory shock, and acute kidney injury in order to support patient management and provide guidance for treatment strategies. SphingoTec’s proprietary biomarker portfolio includes Bioactive Adrenomedullin (bio-ADM®), a unique biomarker for real-time assessment of endothelial function in conditions like sepsis or congestive heart failure, Proenkephalin (penKid®), a unique biomarker for real-time assessment of kidney function, and Dipeptidyl Peptidase 3 (DPP3), a unique biomarker for cardiac depression. IVD tests for SphingoTec’s proprietary biomarkers are made available as sphingotest® microtiterplate tests as well as point-of-care tests on the Nexus IB10 immunoassay platform by SphingoTec’s subsidiary Nexus Dx Inc. (San Diego, CA, USA) alongside a broad menu of established and commonly used tests for acute and critical care.

About penKid®

sphingotest® penKid® measures proenkephalin (penKid®), a stable fragment of the kidney stimulating hormone enkephalin. penKid® has been demonstrated to be a real-time surrogate biomarker for glomerular filtration rate, the gold standard to assess renal function. Measuring penKid® blood concentrations allows for timely information on kidney function in critically ill patients. Early assessment of worsening and improving of renal function on intensive care units and in emergency departments allows adjustment of nephrotoxic drug administration and the initiation of kidney-protective strategies to prevent acute kidney injury and thereby improve outcomes.

Contact

SphingoTec GmbH

Ruxandra Lenz

Sr. Manager Marketing and Communications

Neuendorfstr. 15 A

16761 Hennigsdorf

Germany

Tel. +49-3302-20565-0

press@sphingotec.de

www.sphingotec.com

SphingoTec Issues Convertible Note Facility

Tue, 07 Oct 2025 20:52:08 GMT

Hennigsdorf, Germany August 19, 2020 – Diagnostic company SphingoTec GmbH (SphingoTec) today announced that the Company has issued a non-brokered, unsecured convertible note facility amounting to EUR 5 million that was fully subscribed by current and new investors. The proceeds of the transaction will bridge to a larger financing round planned for later this year or early 2021 to fund the further growth of the company, in particular the commercialization of the company’s innovative diagnostic products for critical care in Europe, the required scale up of manufacturing capabilities and gaining access to the U.S. market.

About SphingoTec

SphingoTec GmbH ( “SphingoTec”; Hennigsdorf near Berlin, Germany) develops and markets innovative in-vitro diagnostic (IVD) tests for novel and proprietary biomarkers for the diagnosis, prediction and monitoring of acute medical conditions, such as sepsis, acute heart failure, circulatory shock, and acute kidney injury in order to support patient management and provide guidance for treatment strategies. SphingoTec's proprietary biomarker portfolio includes Bioactive Adrenomedullin (bio-ADM®), a unique biomarker for real-time assessment of endothelial function in conditions like sepsis or congestive heart failure, Proenkephalin (penKid®), a unique biomarker for real-time assessment of kidney function, and Dipeptidyl Peptidase 3 (DPP3), a unique biomarker for cardiac depression. IVD tests for SphingoTec’s proprietary biomarkers are made available as sphingotest® microtiterplate tests as well as point-of-care tests on the Nexus IB10 immunoassay platform by SphingoTec’s subsidiary Nexus Dx Inc. (San Diego, CA, USA) alongside a broad menu of established and commonly used tests for acute and critical care.

SphingoTec to present at Solebury Trout's Summer Private Company Showcase

Tue, 07 Oct 2025 20:50:22 GMT

Hennigsdorf/Berlin, Germany – August 6, 2020 – Diagnostics company SphingoTec GmbH (“SphingoTec”) today announced that Dr Andreas Bergman, CEO, and Ferdinand Von Humboldt, CFO, will be presenting a corporate overview at the Summer Private Company Showcase, hosted by Solebury Trout on August 10, 2020.

SphingoTec develops and markets in-vitro diagnostic tests for novel and proprietary biomarkers in diagnostically underserved acute and critical care conditions to improve patient outcomes. The company makes its assays for real-time assessment of kidney function, endothelial function and cardiac depression available on its fully integrated Nexus IB10 point-of-care platform.

Presentation Details:

Date: August 10, 2020

Time: 4:00 p.m. CEST

Please click the following link to register:

troutaccess.com/index.php/c/Summer2020PCS

About SphingoTec

SphingoTec to present at LifeSci Partners' Summer Symposium

Tue, 07 Oct 2025 20:49:24 GMT

Hennigsdorf/Berlin, Germany – July 31, 2020 – Diagnostics company SphingoTec GmbH (“SphingoTec”) today announced that Dr Andreas Bergman, CEO, and Ferdinand von Humboldt, CFO, will be presenting a corporate overview at the Private Healthcare Company Virtual Summer Symposium, hosted by LifeSci Partners on August 4 and 5, 2020.

Presentation Details:

Date: August 4, 2020

Time: 3:30 p.m. CEST

Please click the following link to register: https://lifesci.events/SummerSymposium

About SphingoTec

SphingoTec launches point-of-care test for bio-ADM, a biomarker for life threatening endothelial dysfunction

Tue, 07 Oct 2025 20:48:18 GMT

Endothelial dysfunction is driving pathophysiological processes such as congestion in heart failure, shock in sepsis, and lung dysfunction in COVID-19
Bioactive Adrenomedullin (bio-ADM®) is a proprietary biomarker for real-time assessment of endothelial function in acute and critical care settings.
High blood levels of bio-ADM® have been shown to predict septic shock, to diagnose residual congestion in heart failure, and the need for organ support in critically ill patients, including COVID-19
IB10 sphingotest® bio-ADM® runs on SphingoTec`s automated Nexus IB10 point-of-care platform and quantitatively measures levels of bio-ADM® directly in blood samples

Hennigsdorf/Berlin, Germany, July 22, 2020 – Diagnostics company SphingoTec GmbH (“SphingoTec”) today announced the launch of its IB10 sphingotest® bio-ADM®, a CE-IVD-marked point-of-care test to quantitatively determine blood levels of Bioactive Adrenomedullin (bio-ADM®). Blood levels of bio-ADM® reflect in real-time the functional status of the endothelium, the inner cell sheet of blood vessels. The test is made available on the company`s rapid point-of-care platform Nexus IB10 that uses whole blood samples without any pre-processing, requires less than three minutes hands-on-time, and delivers results after 20 minutes. Nexus IB10 can be flexibly deployed in laboratories or near-patient settings such as intensive care units (ICUs) and Emergency Departments (EDs).

In numerous studies on more than 22,000 patients admitted to ICUs and EDs, bio-ADM® has been shown to predict distortions of the inner cell sheet of blood vessels, the endothelium (1). Failure of the endothelial function has been demonstrated to precede edema and the life-threatening blood pressure drop that causes shock and multiorgan failure e.g. in patients with sepsis at ICUs and EDs (2-3). In heart failure patients, bio-ADM® blood-levels reliably and objectively reflect tissue congestion and residual congestion (4). Recent data show that elevated blood levels of this functional biomarker also identifies patients in the general ICU patient population who require immediate life-saving therapeutic interventions (5). In ICU patients with severe COVID-19, endothelial dysfunction has been identified to play a crucial role in the disease progression, thus providing a rationale to monitor bio-ADM® to guide the therapy stabilizing the endothelium (6).

Dr. Andreas Bergmann, CEO and founder of SphingoTec commented: “The endothelial function plays a key role in a large number of critical care conditions, such as sepsis, septic shock, acute heart failure, and COVID-19. A distortion in the endothelial function predicts the patient’s progression to a critical stage. Therefore, bio-ADM® screening can identify high-risk patients who require early life-saving therapeutic intervention. With the launch of this rapid test for bio-ADM® on our widely established Nexus IB10 immunoassay platform, we aim to support earlier treatment decisions and improve outcomes of acute care patients.”

The IB10 sphingotest® bio-ADM® assay is commercialized in Europe and other regions that accept CE-IVD certification through SphingoTec’s network of distribution partners for the Nexus IB10 platform, together with a broad menu of standard tests for acute and critical care.

###

References:

(1) Geven (2018): Vascular Effects of Adrenomedullin and the anti-Adrenomedullin Antibody Adrecizumab in Sepsis. Shock. doi: 1097/SHK.0000000000001103

(2) Mebazaa (2018): Circulating adrenomedullin estimates survival and reversibility of organ failure in sepsis: the prospective observational multinational Adrenomedullin and Outcome in Sepsis and Septic Shock (AdrenOSS-1) study. doi:10.1186/s13054-018-2243-2

(3) Caironi (2017): Circulating biologically active adrenomedullin (bio-ADM) predicts hemodynamic support requirement and mortality During Sepsis. Chest. doi: 10.1016/j.chest.2017.03.035.

(4) ter Maaten (2019): Bio-adrenomedullin as a marker of congestion in patients with new-onset and worsening heart failure, Eur J Heart Fail. doi:10.1002/ejhf.1437

(5) Lemasle (2020): Bioactive Adrenomedullin, Organ Support Therapies, and Survival in the Critically Ill: Results from the French and European Outcome Registry in ICU Study, Crit. Care. Med, doi: 10.1097/CCM.0000000000004044

(6) Varga (2020): Endothelial cell infection and endotheliitis in COVID-19, Lancet, doi.org/10.1016/S0140-6736(20)30937-5

About SphingoTec

SphingoTec GmbH ("SphingoTec"; Hennigsdorf near Berlin, Germany) develops and markets innovative in vitro diagnostic (IVD) tests for novel and proprietary biomarkers for the diagnosis, prediction and monitoring of acute medical conditions, such as sepsis, acute heart failure, circulatory shock, and acute kidney injury in order to support patient management and provide guidance for treatment strategies. SphingoTec's proprietary biomarker portfolio includes Bioactive Adrenomedullin (bio-ADM®), a unique biomarker for real-time assessment of endothelial function in conditions like sepsis or congestive heart failure, Proenkephalin (penKid®), a unique biomarker for real-time assessment of kidney function, and Dipeptidyl Peptidase 3 (DPP3), a unique biomarker for cardiac depression. In addition, SphingoTec develops a portfolio of novel biomarkers, which predict the risks of developing obesity, breast cancer and cardiovascular diseases. IVD tests for SphingoTec’s proprietary biomarkers are made available as sphingotest® microtiterplate tests as well as point-of-care tests on the Nexus IB10 immunoassay platform by SphingoTec’s subsidiary Nexus Dx Inc. (San Diego, CA, USA) alongside a broad menu of established and commonly used tests for acute and critical care.

About Nexus Dx Inc. and the IB10 Platform

Nexus Dx Inc., a wholly-owned subsidiary of SphingoTec, headquartered in San Diego, CA, USA, is a global provider of a near patient testing system and advanced diagnostic solution. The company is improving patient care by providing the medical community with rapid and reliable information at the point of care (POC), delivering patient information when and where it is needed most. The company has invested over $160m to develop and market the IB10 analyzer system which, without the need for sample preparation, automatically separates plasma from whole blood with subsequent reliable and quantitative detection of biomarkers in the plasma by means of antibodies. With a hands-on-time of less than 3 minutes the easy-to-use system provides in only 20 minutes test results for biomarkers that are crucial in the management of critical care patients. The portfolio of IB10 assays includes tests for established critical care parameters such as Procalcitonin, Troponin I, CK-MB, Myoglobin, NT-proBNP, and D-Dimer as well as tests for SphingoTec’s proprietary biomarkers such as DPP3, an assay for Dipeptidyl Peptidase 3, a unique and proprietary biomarker for cardiac depression, Proenkephalin (penKid®), a unique and proprietary biomarker for real-time assessment of kidney function and the IB10 assay for bioactive Adrenomedullin (bio-ADM®), a unique and proprietary biomarker for endothelial function.

About bio-ADM®

Contact

SphingoTec GmbH

Ruxandra Lenz

Sr. Manager Marketing and Communications

Neuendorfstr. 15 A

16761 Hennigsdorf

Germany

Tel. +49-3302-20565-0

press@sphingotec.de

www.sphingotec.com

Sphingotec’s critical care biomarkers early diagnose risk of loss of endothelial, kidney and heart function in severely ill COVID-19 patients

Tue, 07 Oct 2025 20:45:59 GMT

Results of a consensus meeting of clinical experts investigating sphingotec’s diagnostic solutions for acute and critical care in COVID-19.
sphingotec’s biomarkers penKid, bio-ADM, and DPP3 previously shown to predict the need for organ support in numerous critical care conditions also have utility in risk stratification of severely ill COVID-19 patients.

Hennigsdorf/Berlin, Germany, June 18, 2020 – Diagnostics company SphingoTec GmbH (“sphingotec”) announced today the results of a working group meeting of clinical experts that discussed the utility of sphingotec’s diagnostic solutions for acute and critical care in supporting the triage, diagnosis, and management of severely ill COVID-19 patients. The experts representing European medical centers agreed that novel biomarkers are required for triaging and monitoring of these patients to optimally make use of the available medical resources and improve outcomes.

Diagnostic tests for sphingotec’s organ-specific biomarkers for monitoring the endothelial and kidney function are currently investigated on-site in COVID-19 patients in hospitals in Germany, Switzerland, United Kingdom, France and Italy. Serial measurements of sphingotec’s real-time endothelial function biomarker bio-ADM, kidney function biomarker penKid and cardiac depressant factor DPP3 were performed in these centers to investigate their utility in the management of COVID-19 patients. In a working meeting, the investigators discussed their initial findings to develop a consensus on the diagnostic needs for severely ill Covid-19 patients and how sphingotec’s biomarkers can address these needs.

Prof. Thorsten Brenner (Essen University Hospital/Essen, Germany) commented: “To identify high risk patients, we need early and specific markers for organ failure to be measured already in the emergency departments. PenKid is a very promising biomarker that we are currently investigating for the triage and the monitoring of organ support therapies of COVID-19 patients with impaired kidney function.”

Previously gathered evidence confirmed the central role of bioactive Adrenomedullin and endothelial function in sepsis patients. First feedback on the biomarker bio-ADM in severe COVID-19 describes a strong correlation between high bio-ADM blood levels and the severity of the disease and the need for organ support which can assist in a more accurate and objective risk stratification.

Further investigations with DPP3, penKid and bio-ADM are ongoing in countries strongly affected by the COVID-19 pandemic, such as France, Italy and United Kingdom as well as in the United States and Asia. The main objective is to confirm the utility of sphingotec’s biomarkers in the management of COVID-19 patients.

Dr. Marlies Ostermann, MD, PhD (Guy’s & St Thomas’ Hospital/London, United Kingdom) commented: “There is an urgent need to assess and monitor organ function of COVID-19 patients in real- time. After a first positive evaluation of these novel biomarkers we have decided to further investigate their use in clinical practice. Especially in the intensive care units, we need biomarkers for monitoring of organ support therapies. This information will also enable us to develop strategies for individualized management of this high-risk group.”

The rapidly evolving COVID-19 pandemic has challenged health systems world-wide, with about 5% of patients requiring admission to intensive care units (ICU). Among the main complications that include respiratory, cardiovascular and kidney diseases, an emerging body of evidence shows that endothelial function (1) plays a central role in severe COVID-19 patients. Previous clinical data from more than 22,000 patients demonstrate that high bio-ADM levels independently from inflammation and co-morbidities indicate distortions in the endothelial barrier function, the inner cell sheet of blood vessels. Loss of this barrier function is considered a key driver in the development of hypotension and subsequent septic shock with loss of organ perfusion in sepsis patients (2). According to a Chinese Study in Wuhan, among the non-surviving COVID-19 patients, sepsis was present in all cases (3).

Another frequently occurring complication in COVID-19 patients is loss of kidney function. Proenkephalin (penKid) has been demonstrated to be the most accurate surrogate marker for true glomerular filtration rate in patients with renal impairment, without being biased by co-morbidities.

DPP3, sphingotec’s novel biomarker for hemodynamic instability and cardiac depression, is a major cause of short-term organ failure when released in an uncontrolled manner into the blood stream. Previously published data (4,5) has shown that high blood levels of DPP3 strongly predict poor outcome in patients with cardiogenic shock.

Dr. Andreas Bergmann, founder and CEO of sphingotec said: “To support the critical care community in the management of acute care patients, including COVID-19 patients, we have made available rapid tests for our biomarkers penKid®, bio-ADM® and DPP3 on our whole-blood Nexus IB10 point-of-care platform.”

The novel biomarker tests complement a wide-range of assays for acute care settings that are already available on sphingotec’s widely used Nexus IB10 point-of-care platform that can be flexibly deployed in laboratory as well as near-patient settings such as emergency departments and intensive care units.

References:

(1) Varga et al (2020): Endothelial cell infection and endothelitis in COVID-19, DOI:https://doi.org/10.1016/S0140-6736(20)30937-5

(2) Mebazaa et al (2018): Circulating adrenomedullin estimates survival and reversibility of organ failure in sepsis: the prospective observational multinational Adrenomedullin and Outcome in Sepsis and Septic Shock-1 (AdrenOSS-1) study, Crit Care, doi: 10.1186/s13054-018-2243-2

(3) Zhou et at (2020): Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Doi: doi.org/10.1016/S0140-6736(20)30566-3

(4) Takagi (2019) Circulating dipeptidyl-peptidase 3 and alteration in hemodynamics in cardiogenic shock: Results from the OptimaCC Trial, European Journal of Heart Failure, doi: 10.1002/ejhf.1600

(5) Deniau (2019) Circulating dipeptidyl peptidase-3 is a myocardial depressant factor: DPP3 inhibition rapidly and sustainably improves hemodynamics, European Journal of Heart Failure, doi: 10.1002/ejhf.1601

About sphingotec

SphingoTec GmbH ("sphingotec"; Hennigsdorf near Berlin, Germany) develops and markets innovative in vitro diagnostic (IVD) tests for novel and proprietary biomarkers for the diagnosis, prediction and monitoring of acute medical conditions, such as sepsis, acute heart failure, circulatory shock, and acute kidney injury in order to support patient management and provide guidance for treatment strategies. sphingotec's proprietary biomarker portfolio includes Bioactive Adrenomedullin (bio-ADM®), a unique biomarker for real-time assessment of endothelial function in conditions like sepsis or congestive heart failure, Proenkephalin (penKid®), a unique biomarker for real-time assessment of kidney function, and Dipeptidyl Peptidase 3 (DPP3), a unique biomarker for cardiac depression. In addition, sphingotec develops a portfolio of novel biomarkers, which predict the risks of developing obesity, breast cancer and cardiovascular diseases. IVD tests for sphingotec’s proprietary biomarkers are made available as sphingotest® microtiterplate tests as well as point-of-care tests on the Nexus IB10 immunoassay platform by sphingotec’s subsidiary Nexus Dx Inc. (San Diego, CA, USA) alongside a broad menu of established and commonly used tests for acute and critical care.

About bio-ADM®

About DPP3

IB10 sphingotest® DPP3 is a rapid point-of-care (POC) immunoassay for the in vitro quantitative determination of Dipeptidyl peptidase 3 an active enzyme which, when released into the blood, inactivates angiotensin II, a hormone that is important for the heart function. This inactivation leads to hemodynamic instability and consequently cardiac depression. The DPP3 release is a newly identified disease mechanism explaining short-term organ failure in critically ill patients. Early identification of DPP3 release may allow better patient stratification and earlier therapy escalation to improve outcomes.

About penKid®

Contact

SphingoTec GmbH

Ruxandra Lenz

Sr. Manager Marketing and Communications

Neuendorfstr. 15 A

16761 Hennigsdorf

Germany

Tel. +49-3302-20565-0

press@sphingotec.de

www.sphingotec.com

The cardiac depressant factor DPP3 is predicting organ failure in burn patients

Tue, 07 Oct 2025 20:43:38 GMT

DPP3 is a highly dynamic marker for predicting and monitoring cardiac depression in burn patients
High DPP3 blood concentrations are indicating multiple organ failure and poor outcomes
sphingotec commercializes a rapid CE-IVD test for DPP3 on its proprietary point-of-care platform Nexus IB10

Hennigsdorf/Berlin, Germany, May 14, 2020 – Diagnostics company SphingoTec GmbH (“sphingotec”) and 4TEEN4 Pharmaceuticals GmbH (“4TEEN4”) announced today the publication of new data showing that high blood levels of Dipeptidyl Peptidase 3 (DPP3) are indicating upcoming multiple organ failure and mortality risk in burn patients. DPP3 is a proprietary biomarker of 4TEEN4 for hemodynamic instability and cardiac depression. sphingotec has in-licensed global rights to develop and commercialize in vitro diagnostic (IVD) tests for the DPP3 biomarker from 4TEEN4 and made it available on its proprietary Nexus IB10 point-of-care platform.

The results from the recent study1 provide evidence that DPP3 blood concentrations in severely ill burn patients are indicating fatal outcomes. The data also shows that high DPP3 concentration in the blood is linked to circulatory failure, cardiac depression, and acute kidney injury. Decreasing DPP3 levels in the blood, on the other hand, indicate a substantially reduced risk of mortality.

According to a newly identified disease mechanism, the release of the cardiac depressant factor DPP3 into the bloodstream is a major cause of short-term organ failure: DPP3 is an enzyme that is present in many cell types and normally plays an important role in the recycling of cellular proteins. When massive uncontrolled cell death occurs, like in the case of burn patients, DPP3 is released into the bloodstream where it degrades angiotensin II, a peptide hormone controlling the heart function. Unphysiologically low levels of angiotensin II rapidly lead to cardiac depression and ultimately organ failure. Previously published data2,3 provided evidence that poor outcome of patients with severe heart failure or cardiogenic shock are caused by DPP3. Furthermore, the causal role of DPP3 in cardiac depression could be reproduced in several model systems.

“The new data adds to the growing body of evidence that places the cardiac depressant factor DPP3 in strong connection with short-term organ failure and high mortality in critical care settings. We have already started a collaboration with the critical care community to provide our fully automated DPP3 point-of-care test to support the management of acute care patients,” said Dr. Andreas Bergmann, CEO and founder of sphingotec.

The IVD test for DPP3 is commercialized under the brand name IB10 sphingotest® DPP3 and is designed and validated for use in conjunction with sphingotec’s fully automated Nexus IB10 whole blood point-of-care platform, delivering results within 20 minutes. This new test complements a wide-range of assays for acute care settings that are already available on this widely used point-of-care platform that can be flexibly deployed in laboratory as well as near-patient settings such as emergency departments and intensive care units.

References

(1) Dépret (2020) Circulating dipeptidyl peptidase-3 at admission is associated with circulatory failure, acute kidney injury and death in severely ill burn patients, Critical Care. doi: 10.1186/s13054-020-02888-5.

(2) Takagi (2019) Circulating dipeptidyl-peptidase 3 and alteration in hemodynamics in cardiogenic shock: Results from the OptimaCC Trial, European Journal of Heart Failure, doi: 10.1002/ejhf.1600

(3) Deniau (2019) Circulating dipeptidyl peptidase-3 is a myocardial depressant factor: DPP3 inhibition rapidly and sustainably improves hemodynamics, European Journal of Heart Failure, doi: 10.1002/ejhf.1601

###

About sphingotec

About 4TEEN4

4TEEN4 Pharmaceuticals GmbH (“4TEEN4”) is a biopharmaceutical company developing Procizumab, a humanized antibody targeting human Dipeptidyl Peptidase 3 (DPP3) for the treatment of critically ill patients suffering from cardiac depression and multiple organ failure. 4TEEN4 licenses its proprietary biomarker DPP3 to make it available for diagnostic use in indications as acute heart failure, cardiogenic shock, septic shock and other critical care conditions. The company was established in 2013 in Hennigsdorf near Berlin, Germany, by Dr. Andreas Bergmann, CEO of 4TEEN4, as part of his Medicine4Future Initiative.

About DPP3

Contact

SphingoTec GmbH

Ruxandra Lenz

Sr. Manager Marketing and Communications

Neuendorfstr. 15 A

16761 Hennigsdorf

Germany

Tel. +49-3302-20565-0

press@sphingotec.de

www.sphingotec.com

sphingotec expands leadership team and appoints Achim Plum as Managing Director and Chief Commercial Officer

Tue, 07 Oct 2025 20:40:52 GMT

Hennigsdorf/Berlin, Germany, April 16, 2020 - Diagnostics company SphingoTec GmbH ("sphingotec", Hennigsdorf, Germany) today announced that it has appointed Dr. Achim Plum as Managing Director and Chief Commercial Officer (CCO) of the company. As CCO, Dr. Plum will focus on driving the global commercialization of sphingotec’s IVD solutions for novel biomarkers for acute and critical care settings and their adoption on multiple IVD instrument platforms, such as sphingotec’s proprietary point-of-care platform Nexus IB10 for rapid testing at the point of need.

“With sphingotec advancing to an end-to-end diagnostic solutions provider with international presence, I am delighted to welcome Dr. Plum to our leadership team,” said Andreas Bergmann, Founder, Managing Director and CEO of sphingotec. “Dr. Plum’s extensive business experience, as well as his broad management expertise in the diagnostics industry, will strengthen our organization and help scale it to an integrated global commercial operation providing unique diagnostic solutions for highly unmet needs in acute and critical care.”

Dr. Achim Plum has more than 18 years of management and commercial experience in the diagnostics industry with a focus on innovative diagnostics solutions, biomarker development and commercialization, and personalized medicine. As CCO of sphingotec he is in charge of all business and commercial operations of the company. After having worked with sphingotec as a business advisor since May 2019, he in April 2020 joined sphingotec full-time from a position as Executive Board Member and Chief Business Officer of the Curetis Group, developing and commercializing molecular diagnostic solutions for infectious diseases. Before Curetis, he held senior management positions at Siemens Healthcare where he was responsible for global Diagnostic and BioScience Technology & Innovation. Prior to Siemens, Dr. Plum worked for eight years for the cancer molecular diagnostics company Epigenomics, lastly as SVP Business & Strategy, the molecular diagnostics that developed and commercializes the first FDA-cleared liquid biopsy colorectal cancer screening test. Dr. Plum studied Genetics, Cell Biology, and Biochemistry in Bonn, Germany, and Norwich UK. He obtained his Ph.D. in Molecular Genetics from the University of Bonn in 1999.

Dr. Achim Plum commented: “I am very excited to now fully join the sphingotec team. As an advisor to the company since May last year I got increasingly impressed by sphingotec’s biomarker innovations and the enormous body of evidence and network of key opinion leaders supporting their unique utility in acute and critical care. With our Nexus IB10 point-of-care testing platform, we are well-positioned to rapidly implement our solutions in hospitals worldwide and significantly improving the outcomes of critically ill patients by providing clinicians with actionable and timely information.”

Sphingotec’s portfolio proprietary tests for the real-time assessment and monitoring of endothelial function (IB10 sphingotest® bio-ADM®), kidney function (IB10 sphingotest® penKid®), and cardiac depression (IB10 sphingotest® DPP3) is made available on its proprietary immunoassay point-of-care platform, Nexus IB10, that also features a broad menu of established routine tests tailored to point-of-care use. For the broad availability of its diagnostic solutions on multiple platforms for central laboratories, sphingotec pursues a licensing strategy with global players in the diagnostics industry.

About sphingotec

sphingotec GmbH ("sphingotec"; Hennigsdorf near Berlin, Germany) develops and markets innovative in vitro diagnostic (IVD) tests for novel and proprietary biomarkers for the diagnosis, prediction and monitoring of acute medical conditions, such as sepsis, acute heart failure, circulatory shock, and acute kidney injury in order to support patient management and provide guidance for treatment strategies. sphingotec's proprietary biomarker portfolio includes bioactive adrenomedullin (bio-ADM®), a unique biomarker for real-time assessment of endothelial function in conditions like sepsis or congestive heart failure, Proenkephalin (penKid®), a unique biomarker for real-time assessment of kidney function, and Dipeptidyl Peptidase 3 (DPP3), a unique biomarker for cardiac depression. In addition, sphingotec develops a portfolio of novel biomarkers, which predict the risks of developing obesity, breast cancer and cardiovascular diseases. IVD tests for sphingotec’s proprietary biomarkers are made available as sphingotest® microtiterplate tests as well as point-of-care tests on the Nexus IB10 immunoassay platform by sphingotec’s subsidiary Nexus Dx Inc. (San Diego, CA, USA) alongside a broad menu of IB10 tests for established biomarkers for acute and critical care.

Contact

SphingoTec GmbH

Ruxandra Lenz

Neuendorfstr. 15 A

16761 Hennigsdorf

Germany

Tel. +49-3302-20565-0

press@sphingotec.de www.sphingotec.com

SphingoTec's endothelial function biomarker bio-ADM® improves risk stratification of sepsis patients at ICUs

Tue, 07 Oct 2025 20:38:37 GMT

New study data show that monitoring blood levels of sphingotec’s endothelial function biomarker bio-ADM® on top of guideline parameter lactate improves risk stratification of sepsis patients admitted to intensive care units
Monitoring of both, lactate and bio-ADM®, in sepsis patients allows early identification of patients that require immediate intervention at admission to the ICU.
Sphingotec is set to launch a point-of-care bio-ADM® assay running on its proprietary automated Nexus IB10 instrument in mid-2020.

Hennigsdorf/Berlin, Germany, March 5, 2020 - Diagnostics company SphingoTec GmbH ("sphingotec", Hennigsdorf Germany) today reported on new data on the utility of endothelial function biomarker bioactive Adrenomedullin (bio-ADM®). The data show that bio-ADM® allows identification of sepsis patients who are at high risk of fatal outcomes despite low or decreasing levels of the routinely monitored parameter lactate. Lactate, a parameter that identifies reduced blood oxygenation of tissue, is routinely used as a reference in the diagnosis of septic shock. However, lactate is rather unspecific to sepsis and insensitive. This limitation can be overcome by monitoring, in addition to lactate, the blood levels of bio-ADM®, a biomarker that can reliably detect blood vessel leakage, one of the main causes of septic shock.

According to recent findings published in Critical Care[1], data from over 500 sepsis patients enrolled in the AdrenOSS-1 study demonstrate the added value of bio-ADM® to lactate monitoring. The AdrenOSS-1 study investigators could show that even though normalizing lactate levels indicate a significantly decreased risk of mortality, an additional measurement of bio-ADM® blood levels can help identify those patients that are still at risk of fatal outcomes despite their lower lactate levels. Among septic patients with decreasing lactate, high bio-ADM® levels identified patients who had a 4-time higher mortality risk than patients with low bio-ADM levels. According to the authors of the study, measurement of bio-ADM® on top of lactate may help refine risk stratification and thus guide resuscitation during sepsis.

Lactate has been used for more than 30 years to monitor organ hypoperfusion in sepsis patients. However, lactate blood levels are influenced by many other physiological and pathological processes. Clinical data from more than 22,000 patients demonstrate that high bio-ADM® levels independently from inflammation and co-morbidities indicate distortions in the barrier function of the inner cell sheet of blood vessels, the endothelium. Loss of this barrier function is considered a key driver in the development of hypotension and eventually septic shock with loss of organ perfusion in sepsis patients[2]. According to sphingotec’s research, bio-ADM® can explain about 60% of the fatal outcomes in sepsis.

“Our biomarker bio-ADM® can reliably support acute care physicians in identifying high-risk sepsis patients” said Dr. Andreas Bergmann, founder and CEO of sphingotec. “We are set to launch the fully automated CE-IVD-marked point-of-care bio-ADM® assay on our widely established Nexus IB10 immunoassay instrument by mid-2020. We are convinced that this rapid test for bio-ADM® will support earlier treatment decisions and thereby will assist clinical decisions that may improve the outcomes of patients at ICUs and emergency departments.”

References

1. Benjamin G. Chousterman et al (2020): Added value of serial bio-adrenomedullin measurement in addition to lactate for the prognosis of septic patients admitted to ICU,. doi:10.1186/s13054-020-2794-x

2. Mebazaa et al (2018): Circulating adrenomedullin estimates survival and reversibility of organ failure in sepsis: the prospective observational multinational Adrenomedullin and Outcome in Sepsis and Septic Shock-1 (AdrenOSS-1) study, Crit Care, doi: 10.1186/s13054-018-2243-2

Bioactive Adrenomedullin, measured with sphingotec’s bio-ADM® assay plays a key role in septic shock patients as top-line results of AdrenOSS-2 Phase II Study indicate

Tue, 07 Oct 2025 20:36:54 GMT

Bioactive Adrenomedullin is a biomarker for endothelial dysfunction and allows the prediction of septic shock as elevated blood levels of bio-ADM® predict blood pressure break down and blood vessel leakage resulting in edema
AdrenOSS-2 Phase II trial shows that modulating the Adrenomedullin plasma level with the therapeutic antibody Adrecizumab demonstrates an improvement of survival in patients with septic shock
Increased bio-ADM® levels were used as inclusion criteria in the AdrenOSS-2 Phase II trial to identify patients with endothelial dysfunction
sphingotec to launch IB10 sphingotest® bio-ADM® a rapid immunoassay for bioactive Adrenomedullin on its Nexus IB10 point-of-care platform mid 2020

Hennigsdorf/Berlin, Germany, February 24, 2020 - Diagnostics company SphingoTec GmbH ("sphingotec", Hennigsdorf, Germany) today announced that data from the AdrenOSS-2 study indicate a modulating role of bioactive Adrenomedullin in septic shock. Topline results of the AdrenOSS-2 Phase II trial released on February 21, 2020 by its sponsor Adrenomed AG (Adrenomed) showed an increase in survival for patients with septic shock when treated with Adrecizumab. Adrecizumab targets bioactive Adrenomedullin and modulates endothelial function. Septic shock is the most severe form of sepsis, a medical emergency with high mortality. In the trial, blood levels of bioactive Adrenomedullin were measured with sphingotec’s quantitative bio-ADM® immunoassay as inclusion criteria.

Bioactive Adrenomedullin has been previously validated in over 22,000 patients as an endothelial function biomarker whose detection in the blood provides dynamic information on the patients’ progression in sepsis. High or rising blood levels of bioactive Adrenomedullin indicate a disbalance in the endothelial function leading to edema and shock while decreasing levels have been linked to improved patient outcomes. Based on this evidence, bioactive Adrenomedullin is not only a valid biomarker for endothelial function but was also qualified as a biotarget and led to the subsequent development of Adrecizumab, a therapeutic antibody to treat septic shock.

In the AdrenOSS-2 Phase II trial, which was designed to evaluate the safety, tolerability, and efficacy of Adrecizumab, increased bio-ADM® levels were used as an inclusion criterion to select those patients with septic shock, which have an endothelial dysfunction. The trial enrolled a total of 301 patients with septic shock and was carried out in multiple clinical trial centers in Belgium, France, Germany, and The Netherlands.

In this proof-of-concept trial, patients received Adrecizumab or placebo on top of standard of care treatment. The study achieved its primary endpoint: Adrecizumab demonstrated a favorable safety profile and was well tolerated. In addition, a lower all-cause mortality for Adrecizumab-treated patients was observed when compared to placebo.

AdrenOSS-2’ principal investigator Pierre-François Laterre commented: “Using bioactive Adrenomedullin blood levels as inclusion criteria allowed us to select the patients who have endothelial dysfunction. Measuring bioactive Adrenomedullin in a routine situation, furthermore allowed us to better understand the utility of this biomarker as a diagnostic tool as we saw that bioactive Adrenomedullin gave information on top of clinical standard parameters to assess patients’ severity. We will now go ahead to further investigate use-cases of bioactive Adrenomedullin as a biomarker in the clinical routine.”

Dr. Andreas Bergmann, founder and CEO of sphingotec commented: “Following our approach of diving deep into the biology of the disease, we have developed biomarkers that support clinicians in identifying the root causes of progression in sepsis. While the current trial indicates that using bioactive Adrenomedullin as a biomarker can help identifying those patients who could benefit in the future from Adrecizumab, the utility of this biomarker expands far beyond this and supports already today the early clinical decision making and monitoring of treatment success in sepsis.”

To support the critical care community in the timely assessment of endothelial function in sepsis and other acute and critical care conditions, sphingotec will launch IB10 sphingotest® bio-ADM®, a rapid test for bioactive Adrenomedullin that will be deployed on the company’s proprietary point-of-care platform, the Nexus IB10 immunoassay analyzer.

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About sphingotec SphingoTec GmbH

("sphingotec"; Hennigsdorf near Berlin, Germany) develops and markets innovative in vitro diagnostic (IVD) tests for novel and proprietary biomarkers for the diagnosis, prediction and monitoring of acute medical conditions, such as sepsis, acute heart failure, circulatory shock, and acute kidney injury in order to support patient management and provide guidance for treatment strategies. sphingotec's proprietary biomarker portfolio includes Bioactive Adrenomedullin (bioADM®), a unique biomarker for real-time assessment of endothelial function in conditions like sepsis or congestive heart failure, Proenkephalin (penKid®), a unique biomarker for real-time assessment of kidney function, and Dipeptidyl Peptidase 3 (DPP3), a unique biomarker for cardio-renal pathway disruptions leading to acute organ dysfunction. In addition, sphingotec develops a portfolio of novel biomarkers, which predict the risks of developing obesity, breast cancer and cardiovascular diseases. IVD tests for sphingotec’s proprietary biomarkers are made available as sphingotest® microtiterplate tests as well as point-of-care tests on the Nexus IB10 immunoassay platform by sphingotec’s subsidiary Nexus Dx Inc. (San Diego, CA, USA) alongside a broad menu of IB10 tests for established biomarkers for acute and critical care.

About Nexus Dx Inc. and the IB10 Platform

Nexus Dx Inc., a wholly-owned subsidiary of sphingotec, headquartered in San Diego, CA, USA, is a global provider of a near patient testing system and advanced diagnostic solution. The company is improving patient care by providing the medical community with rapid and reliable information at the point of care (POC), delivering patient information when and where it is needed most. The company has invested over $160m to develop and market the IB10 analyzer system which, without the need for sample preparation, automatically separates plasma from whole blood with subsequent reliable and quantitative detection of biomarkers in the plasma by means of antibodies. With a hands-on-time of less than 3 minutes the easy-to-use system provides in only 20 minutes test results for biomarkers that are crucial in the management of critical care patients. The portfolio of IB10 assays includes tests for established critical care parameters such as Procalcitonin, Troponin I, CK-MB, Myoglobin, NTproBNP, and D-Dimer as well as tests for sphingotec’s proprietary biomarkers such as DPP3, an assay for Dipeptidyl Peptidase 3, a unique and proprietary biomarker for cardio-renal pathway disruptions leading to acute organ dysfunction, and Proenkephalin (penKid®), a unique and proprietary biomarker for real-time assessment of kidney function. An IB10 assay for bioactive Adrenomedullin (bio-ADM®), a unique and proprietary biomarker for endothelial function is expected to be launched later in 2020.

About bio-ADM®

sphingotest® bio-ADM® measures blood levels of bioactive adrenomedullin (bio-ADM®), a hormone maintaining endothelial function. The endothelium contributes to blood pressure and separates blood from the surrounding tissue. Elevated blood levels of bio-ADM® predict blood pressure break down and leaky vessels resulting in oedema. Imbalanced endothelial function is the major cause of shock ultimately resulting in organ dysfunction and death. Early identification of an imbalance in endothelial function allows guidance of vasopressor and diuretic therapy in critically ill patients to improve outcomes. About Adrecizumab Adrenomed’s first-in-class drug candidate Adrecizumab targets adrenomedullin (ADM) to rescue endothelial barrier function (= vascular integrity). Binding of the monoclonal antibody Adrecizumab to ADM in the blood traps and stabilizes the peptidehormone resulting in increased ADM concentrations within the blood vessels. The complex of ADM and Adrecizumab in the blood is still active. This way, Adrecizumab treatment boosts Adrenomedullin’s protective effects on the endothelial barrier. www.adrenomed.com

Contact

SphingoTec GmbH

Ruxandra Lenz

Neuendorfstr. 15 A

16761 Hennigsdorf Germany

Tel. +49-3302-20565-0

press@sphingotec.de

www.sphingotec.com

Novel Data on SphingoTec's Biomarkers for acute and critical care setting to be presented at AKI & CRRT 2020

Tue, 07 Oct 2025 20:32:32 GMT

Numerous talks and posters on sphingotec’s acute care biomarkers in the scientific program of the conference
sphingotec to host symposium “Relevant Pathways, Novel Diagnostic and Therapeutic Approaches in Acute Organ Dysfunction”

Hennigsdorf, Germany, February 21, 2020 - SphingoTec GmbH (“sphingotec”) today announced that novel data on its acute care biomarkers Proenkephalin (penKid®) and Dipeptidyl Peptidase 3 (DPP3) will be presented at the 25th International Conference on Advances in Critical Care Nephrology (AKI & CRRT 2020) taking place in San Diego, CA, USA, on February 24-27, 2020.

AKI & CCRT 2020 Presentations on penKid® and DPP3

In the scientific program of the conference, clinical researchers will present the latest results from studies investigating these two critical care biomarkers and their utility in diagnosing kidney injury. In a session on translating biomarker discoveries to clinical care, Peter Pickkers (Radboud University | RU · Department of Intensive Care, Nijmegen, The Netherlands) will present data demonstrating that sphingotec’s kidney function marker penKid® is a reliable surrogate for assessing true glomerular filtration rate (true GFR) in patients with renal insufficiency. Previous studies demonstrated that penKid® is a real-time kidney function biomarker, which is independent of inflammation and other co-morbidities. In another session, Matthieu Legrand (University of California, San Francisco | UCSF · Department of Anesthesia and Perioperative Care, USA) will provide evidence showing that sphingotec’s biomarker DPP3 is one cause for short-term kidney dysfunction and is highly associated with the development of acute kidney injury (AKI) in patients with severe burns. Being at the core of a newly discovered disease mechanism, DPP3 has been shown to play a causal role in short-term organ dysfunction when released into the bloodstream upon massive cell death in several acute and critical care conditions.

Sphingotec Symposium at AKI & CCRT 2020

In a symposium organized by sphingotec titled “Relevant Pathways, Novel Diagnostic and Therapeutic Approaches in Acute Organ Dysfunction” leading clinical researchers will further discuss pathways leading to acute organ dysfunctions in critically ill patients as well as a novel diagnostic solution to assess the involvement of such pathways in acute and critical care conditions. Beyond providing an overview of novel biomarkers for monitoring kidney function, endothelial function, and DPP3-mediated heart and kidney dysfunction, the speakers will also share findings that are qualifying these biomarkers as biotargets.

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Oral Presentations at AKI & CRRT 2020

Session: Bench to Bedside: Translating Discoveries to Clinical Care, February 24, 2020

“Proenkephalin: Is it the New GFR Marker?” presented by Peter Pickkers (Radboud University | RU · Department of Intensive Care)

Session: Acute Kidney Injury (AKI): Pathophysiology, February 25, 2020

“DPP3 in Critical Illness: Another Piece of the Puzzle” presented by Matthieu Legrand (University of California, San Francisco | UCSF · Department of Anesthesia and Perioperative Care)

Poster Presentation at AKI & CRRT 2020

Title: Proenkephalin, a Novel Biomarker for Kidney Function, is Earlier in Detecting Acute Kidney Injury Compared to Creatinine.

Authors R Beunders, M Meekes, J Struck, P Pickkers

Title: Proenkephalin Predicts Renal Dysfunction, Organ Failures, Renal Replacement Therapy, and Mortality in Sepsis

Authors H Kim, M Hur, J Struck, A Bergmann, S Di Somma

Title: penKid Proenkephalin A 119–159 effectively predicts Acute Kidney Injury, Multiple Organ Failure, Mortality particularly among septic patients at the ER with seemingly intact renal function

Authors M Rosenqvist, K Bronton, O Hartmann, A Bergmann, J Struck & O Melander

About sphingotec

SphingoTec GmbH ("sphingotec"; Hennigsdorf near Berlin, Germany) develops and markets innovative in vitro diagnostic (IVD) tests for novel and proprietary biomarkers for the diagnosis, prediction and monitoring of acute medical conditions, such as sepsis, acute heart failure, circulatory shock, and acute kidney injury in order to support patient management and provide guidance for treatment strategies. sphingotec's proprietary biomarker portfolio includes Bioactive Adrenomedullin (bio-ADM®), a unique biomarker for real-time assessment of endothelial function in conditions like sepsis or congestive heart failure, Proenkephalin (penKid®), a unique biomarker for real-time assessment of kidney function, and Dipeptidyl Peptidase 3 (DPP3), a unique biomarker for cardio-renal pathway disruptions leading to acute organ dysfunction. In addition, sphingotec develops a portfolio of novel biomarkers, which predict the risks of developing obesity, breast cancer and cardiovascular diseases. IVD tests for sphingotec’s proprietary biomarkers are made available as sphingotest® microtiterplate tests as well as point-of-care tests on the Nexus IB10 immunoassay platform by sphingotec’s subsidiary Nexus Dx Inc. (San Diego, CA, USA) alongside a broad menu of IB10 tests for established biomarkers for acute and critical care.

SphingoTec's biomarker penKid® shows best representation of true glomerular filtration rate and has utility in patients with sever burns two studies show

Tue, 07 Oct 2025 20:31:10 GMT

In-depth method comparison by Dutch group shows that sphingotec's proprietary kidney function biomarker penKid® is currently the most accurate surrogate marker for true glomerular filtration rate in patients with renal impairment
Data by PRONOBURNS group show that penKid® accurately predicts acute kidney injury (AKI) in patients with burns, adding benefit on top of standard testing
Since January 2020, an automated CE-marked IVD penKid® assay developed for sphingotec's proprietary point-of-care platform Nexus IB10 is available for use in critical care settings

Hennigsdorf/Berlin, Germany, February 19, 2020 - Diagnostics company SphingoTec GmbH ("sphingotec", Hennigsdorf Germany) today announced the publication of two studies demonstrating that its kidney function biomarker Proenkephalin (penKid®) is the most accurate surrogate for assessing true glomerular filtration rate (true GFR) and is reliably predictive for acute kidney injury (AKI) in patients with severe burns. Although AKI is a major complication in critically ill patients, current diagnostic standard methods do not properly and timely diagnose impaired renal function. The two recently published studies add to the rapidly growing body of evidence suggesting that penKid® can address this highly unmet diagnostic need.

In Shock[1], a team headed by Prof. Peter Pickkers from Radboud UMC (Nijmegen, The Netherlands) confirmed by in-depth diagnostic method comparison in patients with impaired kidney function that penKid® levels properly reflect kidney function. While today’s standard of care uses estimations of the glomerular filtration rate (eGFR) to assess renal impairment, the current study shows that these methods overestimate true GFR with over 30%. The published findings demonstrate that penKid® can add value by properly reflecting true GFR that can otherwise only be measured using in vivo clearance of iohexol, an invasive method too laborious and time-consuming for clinical routine use.

Another study published in the Journal of Burns[2] reports for the first time that high penKid® plasma levels at admission to the intensive care unit (ICU) were associated with the risk for developing AKI in patients with severe burns, where mortality rates range from 30-70%.The new data suggest, that the current renal function- and AKI standard markers should be complemented with penKid® values for accurately quantifying the kidney function in critically ill patients.

Dr. Andreas Bergmann, CEO of sphingotec, commented: “penKid® is an early renal function biomarker that is not biased by co-morbidities while reflecting true GFR. penKid® has been tested for the first time to identify ICU patients with severe burns that need rapid and aggressive intervention to prevent mortality caused by AKI.”

To support timely treatment decisions that are likely to improve patient management in critical care patients, sphingotec launched a fully automated CE-IVD-marked penKid® assay on its Nexus IB10 platform in January 2020. This new test complements a wide-range of assays for acute care settings that are already available on this widely used point-of-care platform that can be flexibly deployed in near-patient as well as laboratory settings.

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References

1. Beunders, R. et al., Proenkephalin compared to conventional methods to assess kidney function in critically ill sepsis patients, Shock,, doi:10.1097/SHK.0000000000001510

2. Depret, F. et al, PenKid measurement at admission is associated with outcome in severely ill burn patients, J.Burns, doi: doi.org/10.1016/j.burns.2020.01.002

About sphingotec

SphingoTec GmbH ("sphingotec"; Hennigsdorf near Berlin, Germany) develops and markets innovative in vitro diagnostic (IVD) tests for novel and proprietary biomarkers for the diagnosis, prediction and monitoring of acute medical conditions, such as sepsis, acute heart failure, circulatory shock, and acute kidney injury in order to support patient management and provide guidance for treatment strategies. sphingotec's proprietary biomarker portfolio includes Bioactive Adrenomedullin (bio-ADM®), a unique biomarker for real-time assessment of endothelial function in conditions like sepsis or congestive heart failure, Proenkephalin (penKid®), a unique biomarker for real-time assessment of kidney function, and Dipeptidyl Peptidase 3 (DPP3), a unique biomarker for cardio-renal pathway disruptions leading to acute organ dysfunction. In addition, sphingotec develops a portfolio of novel biomarkers, which predict the risks of developing obesity, breast cancer and cardiovascular diseases. IVD tests for sphingotec’s proprietary biomarkers are made available as sphingotest® microtiterplate tests as well as point-of-care tests on the Nexus IB10 immunoassay platform by sphingotec’s subsidiary Nexus Dx Inc. (San Diego, CA, USA) alongside a broad menu of IB10 tests for established biomarkers for acute and critical care.

About penKid®

About Nexus Dx Inc. and the IB10 Platform

Nexus Dx Inc., a wholly-owned subsidiary of sphingotec, headquartered in San Diego, CA, USA, is a global provider of a near patient testing system and advanced diagnostic solution. The company is improving patient care by providing the medical community with rapid and reliable information at the point of care (POC), delivering patient information when and where it is needed most. The company has invested over $160m to develop and market the IB10 analyzer system which, without the need for sample preparation, automatically separates plasma from whole blood with subsequent reliable and quantitative detection of biomarkers in the plasma by means of antibodies. With a hands-on-time of less than 3 minutes the easy-to-use system provides in only 20 minutes test results for biomarkers that are crucial in the management of critical care patients. The portfolio of IB10 assays includes tests for established critical care parameters such as Procalcitonin, Troponin I, CK-MB, Myoglobin, NT-proBNP, and D-Dimer as well as tests for sphingotec’s proprietary biomarkers such as DPP3, an assay for Dipeptidyl Peptidase 3, a unique and proprietary biomarker for cardio-renal pathway disruptions leading to acute organ dysfunction, and Proenkephalin (penKid®), a unique and proprietary biomarker for real-time assessment of kidney function. An IB10 assay for bioactive Adrenomedullin (bio-ADM®), a unique and proprietary biomarker for endothelial function is expected to be launched later in 2020.

Hitado GmbH becomes Nexus IB10 distributor for Sphingotec in Germany an Switzerland

Tue, 07 Oct 2025 20:29:22 GMT

Norderstedt and Hennigsdorf, Germany, January 14, 2020 – Hitado GmbH (Hitado), a Sysmex point-of-care subsidiary, and SphingoTec GmbH (sphingotec) have signed an exclusive distribution agreement for the commercialisation of the Nexus IB10 diagnostic platform by Hitado in Germany. Further, Sysmex Suisse AG will commercialise the platform in Switzerland.

The Nexus IB10 platform is a fully automated rapid immunoassay point-of-care platform, that provides accurate test results within only 20 minutes and features a broad menu of tests relevant in near-patient settings, e.g. cardiovascular parameters such as troponin I, NT-proBNP, D-dimer, CK-MB and myoglobin. Further novel and proprietary tests that are developed by sphingotec and provide solutions for highly unmet diagnostic needs in sepsis, acute heart failure and acute kidney injury will complement the existing menu of IB10 test making the platform a unique solution for acute and critical care.

The CE-IVD-marked system meets the requirements of near-patient testing and can be flexibly deployed in laboratories, emergency departments, intensive care units, and doctors’ offices.

Regarding this new distribution agreement, Hitado’s CEO André Michel commented, “We are delighted to be appointed as the exclusive distribution partner for Nexus IB10 in Germany and Switzerland. This product is a strategic fit with our existing product portfolio and will separate us from our competitors, providing customers with a comprehensive package of patient-near testing devices.”

Andreas Bergmann, CEO of sphingotec, echoes those sentiments. He noted, “We are very much looking forward to our collaboration with Hitado and Sysmex who have been very successful in promoting the IB10 platform in the past. We also believe that they are excellent strategic partners for providing rapid and novel solutions needed by clinicians in managing critically ill patients and will support us in our long-term strategy to improve patient outcomes in acute and critical care conditions.”

The Nexus IB10 platform was originally developed and commercialised by Samsung under the brand name Samsung LabgeoIB10. Following the acquisition of Samsung’s subsidiary Nexus Dx Inc. (San Diego, CA, USA), the manufacturer of the IB10 platform, by sphingotec in 2018, Nexus IB10 is now exclusively represented by sphingotec and made available through sphingotec’s global network of distribution partners.

To discover more about the Nexus IB10 and sphingotec’s portfolio of diagnostic solutions for acute and critical care, please visit sphingotec.com. For more information on the Hitado point-of-care portfolio, please visit hitado.de.

About Hitado GmbH

Hitado was founded 44 years ago as a provider of diagnostic solutions for hospitals and laboratories and is the leader provider of near-patient diagnostics in Germany. Today, they are a part of the Sysmex Group, a global leader in in-vitro diagnostics. Their portfolio includes highly specific rapid tests for diverse applications including cancer screening, cardiac diagnostics, pregnancy, infection and metabolic diagnostics to specialised point-of-care testing systems. To discover more about Hitado, visit hitado.de.

About sphingotec

SphingoTec GmbH ("sphingotec"; Hennigsdorf near Berlin, Germany) develops and markets innovative in-vitro diagnostic (IVD) tests for novel and proprietary biomarkers for the diagnosis, prediction and monitoring of acute medical conditions, such as sepsis, acute heart failure, circulatory shock, and acute kidney injury in order to support patient management and provide guidance for treatment strategies. sphingotec's proprietary biomarker portfolio includes bioactive adrenomedullin (bio-ADM®), a unique biomarker for real-time assessment of endothelial function in conditions like sepsis or congestive heart failure, Proenkephalin (penKid®), a unique biomarker for real-time assessment of kidney function, and Dipeptidyl Peptidase 3 (DPP3), a unique biomarker for cardio-renal pathway disruptions leading to acute organ dysfunction. In addition, sphingotec develops a portfolio of novel biomarkers, which predict the risks of developing obesity, breast cancer and cardiovascular diseases. IVD tests for sphingotec’s proprietary biomarkers are made available as sphingotest® microtiterplate tests as well as point-of-care tests on the Nexus IB10 immunoassay platform by sphingotec’s subsidiary Nexus Dx Inc. (San Diego, CA, USA) alongside a broad menu of IB10 tests for established biomarkers for acute and critical care.

SphingoTec launches IVD Test for Kidney Function Biomarker penKid® on Nexus IB10 POCT Platform

Tue, 07 Oct 2025 20:25:32 GMT

sphingotec launches a CE-marked point-of-care IVD assay for Proenkephalin (penKid®), the company‘s proprietary biomarker for real-time assessment of kidney function in critical care settings
IB10 sphingotest® penKid® runs on sphingotec's automated Nexus IB10 point-of-care platform and quantitatively measures levels of penKid® directly in whole blood samples
penKid® is a functional kidney biomarker reflecting the actual glomerular filtration rate and thus allows monitoring of renal function in real-time
penKid® enables earlier prediction and more precise monitoring of acute kidney injury than the current standard-of-care

Hennigsdorf/Berlin, Germany, January 13, 2020 - Diagnostics company SphingoTec GmbH ("sphingotec", Hennigsdorf near Berlin, Germany) today announced the launch of its IB10 sphingotest® penKid®, a CE-IVD-marked point-of-care test for Proenkephalin (penKid®), the biomarker that allows real-time assessment of kidney function with a simple blood test. The test is made available on the company’s rapid point-of-care platform Nexus IB10 that uses whole blood samples without any pre-processing, requires less than three minutes hands-on-time, delivers test results after 20 minutes and can be flexibly deployed in laboratories or near-patient settings such as intensive care units (ICUs) and Emergency Departments (EDs).

In studies on more than 30,000 patients admitted to ICUs and EDs, penKid® has been demonstrated to be a real-time surrogate biomarker for glomerular filtration rate[1], the gold standard to assess kidney function. In contrast to other markers, penKid® is an early predictor of worsening and improving kidney function independently from co-morbidities and inflammation[2,3].

penKid® as a functional kidney biomarker has been demonstrated to provide significant clinical utility in numerous critical care settings:

– penKid® blood levels at admission to ICUs and EDs can identify patients at a high risk to develop acute kidney injury (AKI) as elevated blood levels of penKid® indicate kidney dysfunction in critically ill patients much earlier than the current standard of care4.

– penKid® blood levels during hospitalization can be used for real-time monitoring of kidney function. In critical care conditions (such as sepsis, acute heart failure) or after the administration of nephrotoxic drugs, which trigger kidney damage, elevated blood levels of penKid® reflect compromised kidney function. The normalization of kidney function is rapidly mirrored by decreasing levels of penKid®. Hence, penKid® allows for individualized dosing of medicines with nephrotoxic side-effects.

– penKid® blood levels at discharge identify patients who have low levels of this biomarker that can be safely discharged from the hospital while elevated biomarker levels identify patients with sublinical AKI5 that require further attention.

Worldwide AKI is affecting 13 million patients and puts other 26 million at risk. In the ICUs, 1 out of 3 patients will develop AKI6.

Dr. Andreas Bergmann, CEO and founder of sphingotec commented: "Testing and monitoring of blood levels of Proenkephalin with our IB10 sphingotest® penKid® allows not only for the stratification of patients at risk for acute kidney injury at admission to the hospital but also facilitates the monitoring of kidney function in real-time throughout the entire patient care cycle. We strongly believe that making penKid® testing available on a rapid point-of-care platform has a unique potential to enable timely therapy decision by physicians at ICUs and EDs and thereby improve patient outcomes.”

The IB10 sphingotest® penKid® will be made available at the end of January 2020 to the critical care community for further clinical evaluation. The assay is commercialized in Europe and other regions that accept CE-IVD certification through sphingotec’s network of distribution partners for the Nexus IB10 platform, together with a broad menu of standard tests for acute and critical care.

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References

1. Donato L. et al., (2018): Analytical performance of an immunoassay to measure proenkephalin, Clin Biochem., doi: 10.1016/j.clinbiochem.2018.05.010

2. Emmens JE et al. (2019): Proenkephalin, an opoid system surrogate marker, as a novel comprehensive renal marker in heart failure, Circ. Haeart Fail., doi: 10.1161/CIRCHEARTFAILURE.118.005544

3. Gayat E. et al, (2018) Back-to-back comparison of penKID with NephroCheck® to predict acute kidney injury at admission in intensive care unit, Critical Care, doi: 10.1186/s13054-018-1945-9

4. Caironi P. et al. (2018): Circulating proenkephalin, acute kidney injury, and its improvement in patients with severe sepsis or shock, Clin.Chem., doi 10.1373/clinchem.2018.288068

5. Rosenqvist, M. (2019): Proenkephalin A 119–159 (penKid) – a novel biomarker for acute kidney injury in sepsis: an observational study, doi: 10.1186/s12873-019-0283-9

6. Ponce, D. (2016): Acute kidney injury: risk factors and management challenges in developing countries, Int J Nephrol Renovasc Dis., doi: 10.2147/IJNRD.S104209

About sphingotec

SphingoTec GmbH ("sphingotec"; Hennigsdorf near Berlin, Germany) develops and markets innovative in vitro diagnostic (IVD) tests for novel and proprietary biomarkers for the diagnosis, prediction and monitoring of acute medical conditions, such as sepsis, acute heart failure, circulatory shock, and acute kidney injury in order to support patient management and provide guidance for treatment strategies. sphingotec's proprietary biomarker portfolio includes bioactive adrenomedullin (bio-ADM®), a unique biomarker for real-time assessment of endothelial function in conditions like sepsis or congestive heart failure, Proenkephalin (penKid®), a unique biomarker for real-time assessment of kidney function, and Dipeptidyl Peptidase 3 (DPP3), a unique biomarker for cardio-renal pathway disruptions leading to acute organ dysfunction. In addition, sphingotec develops a portfolio of novel biomarkers, which predict the risks of developing obesity, breast cancer and cardiovascular diseases. IVD tests for sphingotec’s proprietary biomarkers are made available as sphingotest® microtiterplate tests as well as point-of-care tests on the Nexus IB10 immunoassay platform by sphingotec’s subsidiary Nexus Dx Inc. (San Diego, CA, USA) alongside a broad menu of IB10 tests for established biomarkers for acute and critical care.

About Nexus Dx Inc. and the IB10 Platform

Nexus Dx Inc., a wholly-owned subsidiary of sphingotec, headquartered in San Diego, CA, USA, is a global provider of a near patient testing system and advanced diagnostic solution. The company is improving patient care by providing the medical community with rapid and reliable information at the point of care (POC), delivering patient information when and where it is needed most. The company has invested over $160m to develop and market the IB10 analyzer system which, without the need for sample preparation, automatically separates plasma from whole blood with subsequent reliable and quantitative detection of biomarkers in the plasma by means of antibodies. With a hands-on-time of less than 3 minutes the easy-to-use system provides in only 20 minutes test results for biomarkers that are crucial in the management of critical care patients. The portfolio of IB10 assays includes tests for established critical care parameters such as Procalcitonin, Troponin I, CK-MB, Myoglobin, NT-proBNP, and D-Dimer as well as tests for sphingotec’s proprietary biomarkers such as DPP3, an assay for Dipeptidyl Peptidase 3, a unique and proprietary biomarker for cardio-renal pathway disruptions leading to acute organ dysfunction, and Proenkephalin (penKid®), a unique and proprietary biomarker for real-time assessment of kidney function. An IB10 assay for bioactive Adrenomedullin (bio-ADM®), a unique and proprietary biomarker for endothelial function is expected to be launched by mid-2020.

About penKid®

sphingotec’s proprietary biomarker Proenkephalin (penKid®) is a functional kidney biomarker that works in whole blood, is independent from comorbidities and inflammation and provides timely information about changes in kidney function. penKid® is a surrogate marker for the gold standard of glomerular filtration rate (GFR) and indicates two days earlier than the standard-of-care the development of acute kidney injury (AKI) in critically ill patients. These features enable physicians to predict, diagnose, and closely monitor worsening and improving kidney function in emergency departments and intensive care units.

SphingoTec transforms into end-to-end diagnostic solutions provider and exclusively represents Nexus Dx IB10 immunoassay portfolio

Wed, 17 Sep 2025 04:59:01 GMT

• Following the acquisition and integration of former Samsung subsidiary Nexus Dx Inc., sphingotec becomes a fully integrated diagnostic solutions provider

• Nexus Dx IB10 POC immunoassay platform (formerly branded as Samsung LabgeoIB10) including its entire test portfolio for critical care environments will be marketed through sphingotec’s distributor network

• After introducing the assay for DPP3, a biomarker for short-term organ dysfunction, sphingotec will continue to add novel critical care tests to the IB10 test menu in 2020, including penKid®, a proprietary kidney function biomarker and bio-ADM®, a proprietary endothelial function biomarker

Hennigsdorf, Germany, and San Diego, CA, USA, January 09, 2020 – The German diagnostics company sphingotec GmbH (Hennigsdorf, Germany) today announced that through its network of regional and local distribution partners it will exclusively offer the Nexus Dx IB10 immunoassay platform together with a broad portfolio of commonly used tests for acute and critical care. The biomarker company has also started to launch a series of novel proprietary tests on the Nexus IB10 point-of-care platform to aid in the diagnose and monitor life-threatening conditions such as sepsis, acute kidney injury and heart failure.

Following the acquisition of Nexus Dx from Samsung in 2018, sphingotec has obtained all rights to Nexus Dx’s unique IB10 immunoassay platform for simple and rapid testing of diagnostic parameters for acute and critical care utilized in point-of-care settings such as emergency departments (EDs) and intensive care units (ICUs). Using disposable low-cost reagents discs, the instrument can perform up to three diagnostic parameters on one test disc in only 20 minutes using routinely available whole blood samples. The Nexus IB10 platform, formerly branded Samsung LabgeoIB10, has sold more than 1,800 systems since its introduction in 2012. The IB10 instrument is one of the most commonly used point-of-care immunoassay platforms throughout Europe and beyond. The CE-IVD-marked IB10 analyzer and test portfolio, which was previously commercialized by Samsung’s partner ThermoFisher Scientific, will now be exclusively represented by sphingotec and made available through sphingotec’s global network of distribution partners.

While initially marketed with a broad range of blood tests and test panels routinely used in EDs and ICUs such as tests for Troponin I, NT-proBNP, D-Dimer, sphingotec has begun implementing a series of new CE-IVD-marked assays for its proprietary biomarkers for the diagnosis and monitoring of life-threating acute and critical care conditions. This includes the recently introduced IB10 sphingotest® DPP3, an assay for Dipeptidyl Peptidase 3, a protein whose elevated blood levels are a major cause for heart and kidney dysfunction in patients with acute heart failure, sepsis and other critical conditions. Further, near-term launches include an IB10 assay for penKid®, a novel biomarker for the real-time assessment of kidney function, and an IB10 assay for bio-ADM®, a biomarker for real-time assessment of endothelial function, planned to be launched in early and mid-2020, respectively.

Using the assays for DPP3, penKid® and bio-ADM® on the IB10 platform, clinicians will have parameters available that provide actionable information needed to aid in the diagnosis and monitoring of critically ill patients and may significantly improve the management of patients with sepsis, septic shock, cardiogenic shock, and organ failure.

“With the integration of Nexus IB10 platform and the set-up of our own distribution-based sales channel, sphingotec has transformed from a developer of unique biomarkers to a fully integrated commercial provider of complete solutions for innovative rapid diagnostic testing at the point-of-need in acute care settings,” said Dr. Andreas Bergmann, CEO of sphingotec GmbH. “Providing rapid and novel solutions needed by clinicians in managing critically ill patients is part of our long-term strategy to reduce mortality in the ICU´s and ED´s.”

sphingotec will ensure continuous supply of IB10 consumables to all former ThermoFisher Scientific customers. Customers can place supply requests through sphingotec’s website at sphingotec.com for referral to the sphingotec IB10 distributor in their respective region.

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About sphingotec

sphingotec GmbH ("sphingotec"; Hennigsdorf near Berlin, Germany) develops and markets innovative in vitro diagnostic (IVD) tests for novel and proprietary biomarkers for the diagnosis, prediction and monitoring of acute medical conditions, such as sepsis, acute heart failure, circulatory shock, and acute kidney injury in order to support patient management and provide guidance for treatment strategies. sphingotec's proprietary biomarker portfolio includes bioactive adrenomedullin (bio-ADM®), a unique biomarker for real-time assessment of endothelial function in conditions like sepsis or congestive heart failure, Proenkephalin (penKid®), a unique biomarker for real-time assessment of kidney function, and Dipeptidyl Peptidase 3 (DPP3), a unique biomarker for cardio-renal pathway disruptions leading to acute organ dysfunction. In addition, sphingotec develops a portfolio of novel biomarkers, which predict the risks of developing obesity, breast cancer and cardiovascular diseases. IVD tests for sphingotec’s proprietary biomarkers are made available as sphingotest® microtiterplate tests as well as point-of-care tests on the Nexus IB10 immunoassay platform by sphingotec’s subsidiary Nexus Dx Inc. (San Diego, CA, USA) alongside a broad menu of IB10 tests for established biomarkers for acute and critical care.

About Nexus Dx Inc. and the IB10 Platform

Nexus Dx Inc., a wholly-owned subsidiary of sphingotec, headquartered in San Diego, CA, USA, is a global provider of a near patient testing system and advanced diagnostic solution. The company is improving patient care by providing the medical community with rapid and reliable information at the point of care (POC), delivering patient information when and where it is needed most. The company has invested over $160m to develop and market the IB10 analyzer system which, without the need for sample preparation, automatically separates plasma from whole blood with subsequent reliable and quantitative detection of biomarkers in the plasma by means of antibodies. With a hands-on-time of less than 3 minutes the easy-to-use system provides in only 20 minutes test results for biomarkers that are crucial in the management of critical care patients. The portfolio of IB10 assays includes tests for established critical care parameters such as Procalcitonin, Troponin I, CK-MB, Myoglobin, NT-proBNP, and D-Dimer as well as tests for sphingotec’s proprietary biomarkers such as DPP3, an assay for Dipeptidyl Peptidase 3, a unique and proprietary biomarker for cardio-renal pathway disruptions leading to acute organ dysfunction. The IB10 assay for bioactive Adrenomedullin (bio-ADM®), a unique and proprietary biomarker for endothelial function and the assay for Proenkephalin (penKid®), a unique and proprietary biomarker for real-time assessment of kidney function, will be launched later in 2020.

bio-ADM®

sphingotest® bio-ADM® measures blood levels of bioactive adrenomedullin (bio-ADM®), a hormone maintaining endothelial function. The endothel contributes to blood pressure and separates blood from the surrounding tissue. Elevated blood levels of bio-ADM® predict blood pressure break down and leaky vessels resulting in oedema. Imbalanced endothel function is the major cause of shock ultimately resulting in organ dysfunction and death. Early identification of an imbalance in endothelial function allows guidance of vasopressor and diuretic therapy in critically ill patients to improve outcomes.

About DPP3

IB10 sphingotest® DPP3 measures Dipeptidyl peptidase 3 an active enzyme which, when released into the blood, degrades hormones that maintain organ function. Inactivation of such hormones by DPP3 results in organ dysfunction and subsequent death. The DPP3 release is a newly identified pathway explaining most of the deaths in critically ill patients as it is causal for short-term organ dysfunction. Early identification of DPP3 release allows better patient stratification and early interventions to improve outcomes.

About penKid®

Contact

SphingoTec GmbH

Ruxandra Lenz

PR & Market Communications Manager

Neuendorfstr. 15A

16761 Hennigsdorf

Germany

Tel. +49-3302-20565-34

press@sphingotec.de

www.sphingotec.com

sphingotec’s endothelial function biomarker bio-ADM® predicts need for organ support in general ICU patient population

Wed, 17 Sep 2025 04:49:36 GMT

Data from more than 2,000 patients enrolled in the FROG-ICU study demonstrate that high levels of bioactive adrenomedullin (bio-ADM®) predict the need for organ support, ionotropes, and vasopressors in the general patient population at admission to the intensive care unit (ICU).
bio-ADM® screening of patients admitted for septic or non-septic reasons supports stratification of risk patients that need immediate therapeutic intervention due to an elevated risk of organ failure.
sphingotec will launch a CE-marked IVD point-of-care assay for bio-ADM® rapid testing on its proprietary Nexus IB10 immunoassay platform in mid-2020.

Hennigsdorf/Berlin, Germany, December 23, 2019 - Diagnostics company SphingoTec GmbH ("sphingotec", Hennigsdorf, Germany) today announced a publication in Critical Care1 with data on 2,000 ICU patients demonstrating that sphingotec‘s proprietary biomarker bio-ADM® (Bioactive Adrenomedullin) not only identifies high-risk patients for septic shock at admission but also identifies patients in the general ICU patient population who require immediate life-saving therapeutic intervention.

In an observational ancillary study to the FROG-ICU study, high blood levels of bio-ADM® at admission to the ICU were an early predictor of the requirement for organ support and treatment with ionotropes and vasopressors. Elevated bio-ADM® blood levels were also significantly associated with a prolonged length of ICU stay and fatal outcomes within 28 days post-admission, whereas low levels of bio-ADM® at admission were associated with positive outcomes.

This study is the largest published investigation on bio-ADM® in a patient cohort of which about 25% of patients suffered from sepsis and 75% of patients had conditions that were not sepsis-related. According to principal investigator Prof. Alexandre Mebazaa (Hôpital Lariboisière, Paris, France), the results demonstrate that bio-ADM® is not only a biomarker indicating impaired endothelial function in patients with septic shock as previously shown2, but also identifies further ICU patients who require rapid therapeutic intervention at admission due to distortion in endothelial function, which is independently associated with malperfusion of organs.

Previous data from more than 20,000 patients provide evidence, that high blood levels of bio-ADM® reflect impaired endothelial function independently from inflammation and other co-morbidities. High bio-ADM® blood levels indicate distortions in the barrier function of the endothelium before the patients progress to a critical stage. Failure of endothelial function has been demonstrated to precede the life-threatening blood pressure drop that causes shock and multiorgan failure e.g. in patients with sepsis at ICUs and in emergency departments (EDs) 2-3. Each year, 6 million people die from sepsis, one of the largest contributors to global disease burden causing $24 billion in direct annual costs to the U.S. healthcare system alone. As elevated bio-ADM® blood levels precede septic shock, bio-ADM® screening can identify risk patients who require early life-saving therapeutic intervention.

“The new study results add data to the broad body of existing evidence that our biomarker bio-ADM® can reliably support critical care physicians in identifying high-risk patients when they first present at the ICU,” said Dr. Andreas Bergmann, founder and CEO of sphingotec. “We are set to launch the fully automated CE-IVD-marked point-of-care bio-ADM® assay on our widely established Nexus IB10 immunoassay platform by mid-2020. We are convinced that this rapid test for bio-ADM® will support earlier treatment decisions and improve outcomes of patients at ICUs and emergency departments.”

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References

Lemasle L. et al., (2018): Bioactive Adrenomedullin, Organ Support Therapies, and Survival in the Critically Ill: Results from the French and European Outcome Registry in ICU Study. Crit Care Med. doi: 1097/CCM.0000000000004044

Mebazaa A. et , (2018): Circulating adrenomedullin estimates survival and reversibility of organ failure in sepsis: the prospective observational multinational Adrenomedullin and Outcome in Sepsis and Septic Shock (AdrenOSS-1) study. doi:10.1186/s13054-018-2243-2

Geven C. et al., (2018): Vascular Effects of Adrenomedullin and the anti-Adrenomedullin Antibody Adrecizumab in Sepsis. Shock. doi: 1097/SHK.0000000000001103

About bio-ADM®

As a marker of endothelial function, bioactive Adrenomedullin (bio-ADM®) enables both prediction of circulatory shock before blood pressure decline, e.g. in septic patients, and diagnosis of residual congestion in acute heart failure patients. Data from more than 20,000 patients provide evidence, that high plasma levels of bio-ADM® reflect impaired endothelial function independently from inflammation and other co-morbidities. High bio-ADM® plasma levels indicate distortions in the barrier function of the endothelium before the patients progress to a critical stage. Failure of endothelial function has been demonstrated to precede the life-threatening blood pressure drop that causes shock and multiorgan failure e.g. in patients with sepsis at ICUs and in emergency departments (EDs). As elevated bio-ADM® plasma levels precede septic shock, bio-ADM® screening can identify risk patients who require early life-saving therapeutic intervention.

About sphingotec

SphingoTec GmbH ("sphingotec"; Hennigsdorf near Berlin, Germany) develops and markets innovative in vitro diagnostic (IVD) tests for novel and proprietary biomarkers for the diagnosis, prediction and monitoring of acute medical conditions, such as sepsis, acute heart failure, circulatory shock, and acute kidney injury in order to support patient management and provide guidance for treatment strategies. sphingotec's proprietary biomarker portfolio includes bioactive adrenomedullin (bio-ADM®), a unique biomarker for real-time assessment of endothelial function in conditions like sepsis or congestive heart failure, Proenkephalin (penKid®), a unique biomarker for real-time assessment of kidney function, and Dipeptidyl Peptidase 3 (DPP3), a unique biomarker for cardio-renal pathway disruptions leading to acute organ dysfunction. In addition, sphingotec develops a portfolio of novel biomarkers, which predict the risks of developing obesity, breast cancer and cardiovascular diseases. IVD tests for sphingotec’s proprietary biomarkers are made available as sphingotest® microtiterplate tests as well as point-of-care tests on the Nexus IB10 immunoassay platform by sphingotec’s subsidiary Nexus Dx Inc. (San Diego, CA, USA) alongside a broad menu of IB10 tests for established biomarkers for acute and critical care.

About Nexus Dx Inc. and the IB10 Platform

Nexus Dx Inc., a wholly-owned subsidiary of sphingotec, headquartered in San Diego, CA, USA, is a global provider of a near patient testing system and advanced diagnostic solution. The company is improving patient care by providing the medical community with rapid and reliable information at the point of care (POC), delivering patient information when and where it is needed most. The company has invested over $160m to develop and market the IB10 analyzer system which, without the need for sample preparation, automatically separates plasma from whole blood with subsequent reliable and quantitative detection of biomarkers in the plasma by means of antibodies. With a hands-on-time of less than 3 minutes the easy-to-use system provides in only 20 minutes test results for biomarkers that are crucial in the management of critical care patients. The portfolio of IB10 assays includes tests for established critical care parameters such as Procalcitonin, Troponin I, CK-MB, Myoglobin, NT-proBNP, and D-Dimer as well as tests for sphingotec’s proprietary biomarkers such as DPP3, an assay for Dipeptidyl Peptidase 3, a unique and proprietary biomarker for cardio-renal pathway disruptions leading to acute organ dysfunction. The IB10 assay for bioactive Adrenomedullin (bio-ADM®), a unique and proprietary biomarker for endothelial function and the assay for Proenkephalin (penKid®), a unique and proprietary biomarker for real-time assessment of kidney function, will be launched later in 2020.

sphingotec’s biomarker penKid® predicts septic acute kidney injury at time of admission to emergency department

Mon, 19 May 2025 15:30:14 GMT

Sphingotec reports study data demonstrating that its proprietary renal function biomarker penKid® (Proenkephalin) predicts acute kidney injury (AKI), multi-organ failure and mortality in sepsis patients presenting to the emergency department (ED).
High penKid® plasma levels identified all ED patients with hidden AKI and AKI at admission and reflected worsening of kidney function.
penKid® point-of-care (POC) implementation in EDs could eliminate current limitations of AKI prediction in septic patients allowing physicians to adjust treatment and therapy monitoring of patients with suspected AKI.
An automated CE-marked IVD penKid® assay running on sphingotec’s POC platform Nexus IB10 will be launched in Q1 2020.

Hennigsdorf/Berlin, Germany, December 20, 2019 - Diagnostics company SphingoTec GmbH ("sphingotec", Hennigsdorf Germany) today reported on the publication of novel study results of its proprietary kidney function biomarker penKid® in BMC Emergency Medicine1. The data from a prospective study enrolling 588 septic patients demonstrate that penKid® accurately predicted acute kidney injury (AKI), multiorgan failure (MOF) and mortality in unselected sepsis patients at presentation to the emergency department (ED). Furthermore, increasing penKid® blood levels indicated worsening kidney function.

While organ dysfunction is a hallmark of sepsis, the renal system is being particularly susceptible. One in two patients with septic shock develop AKI and are at increased risk of both severe morbidity and higher mortality. In the current study, the admission levels of penKid® and serum creatinine (SCr) were corelated with patient outcomes. SCr is the current diagnostic standard and is used to calculate the estimated glomerular filtration rate (eGFR), a surrogate parameter quantifying kidney function. In the study, elevated penKid® blood levels at admission predicted all septic patients who developed AKI. Furthermore, high penKid® levels independently from eGFR, identified patients with subclinical AKI at ED admission, who could not be identified by SCr values. penKid® also predicted multiorgan failure and 28-day mortality.

Previously published clinical data from patients with sepsis admitted to intensive care units (ICUs) have provided evidence, that elevated blood levels of penKid® at admission predict AKI, worsening kidney function, organ failure and mortality independently from inflammation and other co-morbidities2. The new results demonstrate that penKid® can also identify AKI patients in a routine ED setting, in which therapy decision making is currently delayed due to the fact that eGFR assessment requires serial measurements2 and creatinine metabolism is affected by inflammation, fluid overload and the use of nephrotoxic agents3-4. Based on the study results, penKid® is a reliable marker for the detection and monitoring of subclinical AKI.

“These study results demonstrate for the first time that penKid® provides physicians at the emergency department with urgently needed information, which is complementary to the current diagnostic toolbox and enables the detection of AKI, particularly in patients with hidden AKI risk,” said Dr. Andreas Bergmann, founder and CEO of sphingotec. “To support timely treatment decisions that are likely to improve outcomes in critical care patient, we will launch in Q1-2020 a fully automated CE-IVD-marked point-of-care penKid® assay on the established Nexus IB10 platform.”

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1. Rosenqvist, M. (2019): Proenkephalin A 119–159 (penKid) – a novel biomarker for acute kidney injury in sepsis: an observational study, BMC Emerg Med. doi: 10.1186/s12873-019-0283-9

2. Caironi P, et al. (2018): Circulating Proenkephalin, acute kidney injury, and its improvement in patients with severe Sepsis or shock. Clin Chem. doi: 10.1373/clinchem.2018.288068

3. Moledina DG, et al. (2018): Phenotyping of acute kidney injury: beyond serum Creatinine. Semin Nephrol. doi: 10.1016/j.semnephrol.2017.09.002.

4. Ronco C. (2016): Acute kidney injury: from clinical to molecular diagnosis. Critical Care. Doi: 10.1186/s13054-016-1373-7.

About sphingotec

SphingoTec GmbH ("sphingotec"; Hennigsdorf near Berlin, Germany) develops and markets innovative in vitro diagnostic (IVD) tests for novel and proprietary biomarkers for the diagnosis, prediction and monitoring of acute medical conditions, such as sepsis, acute heart failure, circulatory shock, and acute kidney injury in order to support patient management and provide guidance for treatment strategies. sphingotec's proprietary biomarker portfolio includes bioactive adrenomedullin (bio-ADM®), a unique biomarker for real-time assessment of endothelial function in conditions like sepsis or congestive heart failure, Proenkephalin (penKid®), a unique biomarker for real-time assessment of kidney function, and Dipeptidyl Peptidase 3 (DPP3), a unique biomarker for cardio-renal pathway disruptions leading to acute organ dysfunction. In addition, sphingotec develops a portfolio of novel biomarkers, which predict the risks of developing obesity, breast cancer and cardiovascular diseases. IVD tests for sphingotec’s proprietary biomarkers are made available as sphingotest® microtiterplate tests as well as point-of-care tests on the Nexus IB10 immunoassay platform by sphingotec’s subsidiary Nexus Dx Inc. (San Diego, CA, USA) alongside a broad menu of IB10 tests for established biomarkers for acute and critical care.

About penKid®

Proenkephalin (penKid®) is a unique and proprietary biomarker for real-time assessment of kidney function. penKid® is a functional kidney marker that works in plasma, is independent from comorbidities and inflammation and provides timely information about the changing kidney function in critically ill patients. sphingotest® penKid® is a surrogate marker for the gold standard of glomerular filtration rate (GFR) and indicates two days earlier than the standard-of-care the development of acute kidney injury (AKI) in critically ill patients. These features enable physicians to predict, diagnose and closely monitor worsening and improving kidney function on intensive care units or emergency departments.

About Nexus Dx Inc. and the IB10 Platform

Nexus Dx Inc., a wholly-owned subsidiary of sphingotec, headquartered in San Diego, CA, USA, is a global provider of a near patient testing system and advanced diagnostic solution. The company is improving patient care by providing the medical community with rapid and reliable information at the point of care (POC), delivering patient information when and where it is needed most. The company has invested over $160m to develop and market the IB10 analyzer system which, without the need for sample preparation, automatically separates plasma from whole blood with subsequent reliable and quantitative detection of biomarkers in the plasma by means of antibodies. With a hands-on-time of less than 3 minutes the easy-to-use system provides in only 20 minutes test results for biomarkers that are crucial in the management of critical care patients. The portfolio of IB10 assays includes tests for established critical care parameters such as Procalcitonin, Troponin I, CK-MB, Myoglobin, NT-proBNP, and D-Dimer as well as tests for sphingotec’s proprietary biomarkers such as DPP3, an assay for Dipeptidyl Peptidase 3, a unique and proprietary biomarker for cardio-renal pathway disruptions leading to acute organ dysfunction. The IB10 assay for bioactive Adrenomedullin (bio-ADM®), a unique and proprietary biomarker for endothelial function and the assay for Proenkephalin (penKid®), a unique and proprietary biomarker for real-time assessment of kidney function, will be launched later in 2020.

sphingotec’s proprietary biomarker bio-ADM® detects residual congestion in patients with heart failure

Mon, 19 May 2025 15:28:41 GMT

Data from more than 1,200 patients of the PROTECT study demonstrate that high levels of the endothelial function biomarker bio-ADM® (bioactive Adrenomedullin) indicate residual congestion of heart failure patients.
Endothelial dysfunction, indicated by high bio-ADM® levels, leads to fluid leakage from blood vessels and ultimately resulting in tissue congestion.
With 25% of heart failure patients being readmitted to hospitals due to acute decompensation, bio-ADM® is the only biomarker whose measurements can guide therapy with diuretics and support more informed decisions on discharging patients from hospitals.

Hennigsdorf/Berlin, Germany, December 16, 2019 - Diagnostics company SphingoTec GmbH (sphingotec) today announced the publication of new study results in the European Journal of Heart Failure1 demonstrating that its proprietary endothelial function biomarker bio-ADM® reliably diagnoses tissue congestion and residual congestion. Residual congestion is a critical, yet highly under-diagnosed condition in heart failure patients often leading to complications after the patient was discharged from the hospital.

In more than 1,200 patients enrolled in the PROTECT study, high bio-ADM® plasma levels indicated insufficient response to diuretics and a substantially higher risk for short-therm rehospitalization and mortality. According to the principal investigator, Dr. Adrian Voors (University Hospital Groningen, The Netherlands), the study data confirm bio-ADM® as a biomarker for tissue congestion that complements BNP as a biomarker for cardiac wall stress.

Specifically, the PROTECT study results show that bio-ADM® is the only biomarker that allows identification of residual congestion and the need for continued therapeutic intervention with diuretics.

About 95% of patients with acute heart failure show fluid overload and tissue congestion with lung edema as the most fatal complication. Previous clinical data from more than 20,000 patients have demonstrated that bio-ADM® plasma levels specifically indicate endothelial function independent of inflammation and other co-morbidities2-3. High bio-ADM® levels indicate distortions in the barrier function of the endothelium causing fluid leakage into tissue. Today, 25% of acute heart failure patients discharged from hospitals are readmitted within 30 days, mostly because of residual congestion with subclinical manifestation at the time of discharge. By measuring the levels of bio-ADM® in blood it becomes possible to assess congestion status and identify patients with residual congestion that are in need of further intervention measures. This may considerably reduce the risk of complications after the patient is discharged and decrease the need for readmission to the hospital. Hence, a diagnostic test for bio-ADM® that indicates subclinical residual congestion may improve the quality of care and patient outcomes while reducing costs associated with readmission.

“These study results confirm that bio-ADM® is a biomarker for endothelial function, which allows physicians to identify patients with residual congestion,” said Dr. Andreas Bergmann, founder and CEO of sphingotec. “By providing diagnostic tools that support a more informed management of heart failure patients we achieve another milestone in our strategy to fight mortality in critically ill patients”.

sphingotec develops novel biomarkers for the diagnosis of critical care conditions and makes them available as rapid tests on its point-of-care immunoassay analyzer, Nexus IB10. The CE-IVD-marked IB10 assay for bio-ADM® will be launched mid-2020. The IB10 sphingotest® bio-ADM® test complements a recently introduced IB10 assay for DPP3, a protein whose elevated blood levels are a major cause for loss of heart and kidney function. Future launches of Nexus IB10 tests also include in early 2020 the assay for penkid®, a novel biomarker for the real-time assessment of kidney function. In addition to the assays for sphingotec’s properitary biomarkers, the IB10 platfrom features a broad menu of routine tests for critical care and other conditions that benefit from rapid testing in near-patient settings.

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References

1.Pandhi (2019): The clinical value of pre-discharge bio-adrenomedullin as a marker of residual congestion and high risk of heart failure hospital readmission. Eur J Heart Fail. doi: 10.1002/ejhf.1693

2.Voors et a. (2018) Adrenomedullin in heart failure pathophysiology and therapeutic application. Eur J Heart Fail. doi:10.1002/ejhf.1366

3.Ter Maaten J. et al., (2019): Bio-adrenomedullin as a marker of congestion in patients with new-onset and worsening heart failure. Eur J Heart Fail. doi: 10.1002/ejhf.1437

About sphingotec

SphingoTec GmbH ("sphingotec"; Hennigsdorf near Berlin, Germany) develops and markets innovative in vitro diagnostic (IVD) tests for novel and proprietary biomarkers for the diagnosis, prediction and monitoring of acute medical conditions, such as acute heart failure, circulatory shock, and acute kidney injury in order to support patient management and provide guidance for treatment strategies. sphingotec's assay portfolio includes sphingotest® bio-ADM® the assay for bioactive adrenomedullin, a unique biomarker for real-time assessment of endothelial function in conditions like sepsis or congestive heart failure, sphingotest® penKid®, the assay for proenkephalin, a unique biomarker for real-time assessment of kidney function and IB10 sphingotest® DPP3, an assay for Dipeptidyl Peptidase 3, a unique biomarker for signaling pathway disruptions leading to acute organ dysfunction. Along with the Nexus IB10 POC platform by its subsidiary Nexus Dx Inc. (San Diego, CA, USA) acquired from Samsung in 2018, sphingotec markets a portfolio of established and novel biomarkers for acute care. In addition, sphingotec developed a portfolio of novel biomarkers, which predict the risks of obesity, breast cancer and cardiovascular diseases.

About bio-ADM®

As a marker of endothelial function, bio-ADM® enables both prediction of circulatory shock before blood pressure decline, e.g. in septic patients, and diagnosis of residual congestion in acute heart failure patients.

SphingoTec to Present Novel Acute Care Biomarkers and Point-of-Care Diagnostic Solutions at Medica 2019

Mon, 19 May 2025 15:27:14 GMT

Hennigsdorf, Germany, November 15, 2019 - SphingoTec GmbH (“sphingotec”) today announced that latest advancements in the development of its portfolio of novel biomarkers and diagnostic solutions will be showcased at Medica 2019 in Düsseldorf, Germany. To improve the management of critically ill patients in acute care settings through timely diagnostic, sphingotec has started making available novel biomarkers that complement a broad menu of existing standard of care tests on its Nexus IB10 point-of-care platform.

Sepsis, septic shock, and acute failure of vital organs such as heart and kidney, are diagnostically underserved medical conditions in critical care settings. Based on a deep understanding of the disease biology, sphingotec has developed novel biomarkers to tackle these unmet needs through diagnostic solutions that allow early identification and monitoring of critically ill patients. sphingotec’s near-term pipeline of novel assays on the Nexus IB10 platform includes:

IB10 sphingotest® DPP3 launched in August 2019 is the first CE-IVD point-of-care biomarker test able to quantify DPP3 blood-plasma levels, a novel and unique biomarker for assessing cardio-renal pathway disruptions leading to short-term organ dysfunction 1, 2. DPP3 is at the core of a novel disease mechanism that has a causal role in cardiac and renal dysfunction.

IB10 sphingotest® penKid®, to be launched in early 2020 as a CE-IVD test, is the first point-of-care assay for Proenkephalin, a unique and proprietary biomarker for real-time assessment of kidney function. Previous studies on more than 30,000 critically ill patients admitted to emergency departments (EDs) or intensive care units (ICUs) with congestive heart failure 3 or sepsis 4 demonstrated that Proenkephalin levels change dynamically with the actual kidney function independently from comorbidities or inflammation 5. The biomarker allows monitoring of renal function in real-time and facilitates earlier detection and more precise monitoring of acute kidney injury than the current standard-of-care.

IB10 sphingotest® bio-ADM® to be launched in mid-2020, is a first point-of-care assay for bioactive Adrenomedullin, a unique biomarker for real-time assessment of endothelial function [6]. Data from more than 20,000 patients confirm that measuring bio-ADM® levels adds value to clinical decision making in ICUs and EDs. Increased blood levels of bioactive Adrenomedullin have been demonstrated to precede endothelial dysfunction, vascular leakage subsequent systemic vasodilation and shock in sepsis 7. Furthermore, it has been shown that elevated levels of bioactive Adrenomedullin indicate the loss of endothelial function leading to congestion in heart failure [8]. IB10 sphingotest® bio-ADM® not only supports earlier clinical interventions but also the monitoring of treatment success.

The Nexus IB10 point-of-care technology provides test results on whole blood sample in only 20 minutes and can be flexibly deployed in emergency departments, intensive care units, and any laboratory setting. In addition to the increasing menu of assays for proprietary biomarkers, the platform features a broad menu of 8 rapid tests for acute care settings including parameters such as the Troponin-I, NT-proBNP, and D-Dimer. Following the acquisition of Nexus Dx Inc., San Diego, USA, in 2018 from the Korean manufacturer Samsung, sphingotec markets the Nexus IB10 point-of-care platform through its continuously expanding distribution network.

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Visit sphingotec at Medica 2019

sphingotec showcases its Nexus IB10 instrument and test portfolio as well as its proprietary biomarkers for acute care conditions at Medica 2019 and welcomes healthcare professionals as well as distributors and diagnostics and pharmaceutical industry representatives interested in partnering at its booth G52 in hall 3.

References

[1] Takagi et. al. (2019) Circulating dipeptidyl-peptidase 3 and alteration in hemodynamics in cardiogenic shock: Results from the OptimaCC Trial, European Journal of Heart Failure

[2] Deniau et. al. (2019) Circulating dipeptidyl peptidase-3 is a myocardial depressant factor: DPP3 inhibition rapidly and sustainably improves hemodynamics, European Journal of Heart Failure

[3] Siong Chan (2018) Proenkephalin in heart failure

[4] Hollinger et. al. (2018) Proenkephalin A 119-159 (Penkid) Is an Early Biomarker of Septic Acute Kidney Injury: The Press Release Kidney in Sepsis and Septic Shock (Kid-SSS) Study

[5] Beunders et. al. (2017) Proenkephalin (PENK) as a novel biomarker for kidney function.

[6] Geven et. al. (2018) Geven 2018 Vascular effects of adrenomedullin and the anti-adrenomedullin antibody Adrecizumab in sepsis

[7] Mebazaa et. al. (2018) Circulating adrenomedullin estimates survival and reversibility of organ failure in sepsis: the prospective observational multinational Adrenomedullin and Outcome in Sepsis and Septic Shock-1

(AdrenOSS-1) study

[8] ter Maaten et. al.(2019) Bio-adrenomedullin as a marker of congestion in patients with new-onset and worsening heart failure

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About sphingotec

SphingoTec GmbH (“sphingotec”; Hennigsdorf by Berlin, Germany) develops and markets innovative in vitro diagnostic IVD tests for novel and proprietary biomarkers for the diagnosis, prediction and monitoring of acute medical conditions, such as acute heart failure, circulatory shock, and acute kidney injury in order to support patient management and provide guidance for treatment strategies. sphingotec’s assay portfolio includes sphingotest® bio-ADM® the assay for bioactive adrenomedullin, a unique biomarker for real-time assessment of vascular integrity in conditions like sepsis or congestive heart failure, sphingotest® penKid®, the assay for proenkephalin, a unique biomarker for real-time assessment of kidney function and sphingotest® DPP3, an assay for Dipeptidyl Peptidase 3, a unique biomarker for signaling pathway disruptions leading to acute organ dysfunction. Along with the Nexus IB10 POC platform by its subsidiary Nexus Dx Inc. (San Diego, CA, USA) acquired from Samsung in 2018, sphingotec markets a standard marker portfolio for acute care. In addition, sphingotec developed a portfolio of novel biomarkers, which predict the risks of obesity, breast cancer and cardiovascular diseases.

Novel Data on sphingotec’s penKid® Kidney Function Assay to be Presented at 32nd ESICM Annual Congress 2019

Mon, 19 May 2025 15:25:36 GMT

Hennigsdorf, Germany, September 26, 2019 - SphingoTec GmbH (“sphingotec”) today announced that novel data on its sphingotest® penKid® assay for Proenkephalin, a unique and proprietary biomarker for real-time assessment of kidney function, will be presented at the 32nd Annual Congress of the European Society of Intensive Care Medicine (ESICM) taking place in Berlin on September 28 to October 2, 2019. In the scientific program of the conference, clinical researchers will present findings from numerous studies investigating the utility of Proenkephalin in various clinical settings using the sphingotest® penKid® microtiter plate assay. To make this innovative test for the management of critically ill patients in acute care setting more readily available, sphingotec plans to launch the test on its proprietary Nexus IB10 point-of-care platform later this year. The IB10 sphingotest® penKid® assay for Proenkephalin will provide test results on whole blood sample in only 20 minutes and can be flexibly deployed in emergency departments, intensive care units and any laboratory setting.

ESICM 2019 Presentations and Posters on Proenkephalin and penKid®

In a session on acute kidney injury, François Dépret (Hôpitaux Universitaires Saint-Louis – Lariboisière – Fernand-Widal, Paris, France) will present data demonstrating that proenkephalin measured with penKid® at admission of severely ill burn patients is predictive of outcome. In the same session, François Dépret will present data that the penKid® assay could detect sub-clinical acute kidney injury in two independent patient cohorts paving the way for earlier therapeutic intervention. The finding that Proenkephalin is an earlier marker of acute kidney injury compared to creatinine, the current standard test for kidney damage, is further confirmed by data that will be presented by Remi Beunders (Radboud University Medical Center, Nijmegen, the Netherlands).

In sessions on critical care nephrology, François Dépret will present a poster on the prognostic value of kidney biomarkers including Proenkephalin at the time of discharge of patients from the intensive care unit, while Remi Beunders will present an equation that allows estimating glomerular filtration rate, an important parameter of kidney function, in critically ill patients based on Proenkephalin blood levels measured by the penKid® assay.

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Oral Presentations at ESICM 2019

Session: AKI - Epidemiology and early diagnosis, October 1, 2019

“PenKid at admission is predictive of outcome in severely ill burn patients: A report from the PRONOBurn cohort” - presented by François Dépret (Hôpitaux Universitaires Saint-Louis – Lariboisière – Fernand-Widal, Paris, France)

“Sub-clinical acute kidney injury detection using penKid®: A report from the FROG-ICU and AdrenOSS-1 cohorts”- presented by François Dépret (Hôpitaux Universitaires Saint-Louis – Lariboisière – Fernand-Widal, Paris, France)

“Proenkephalin, a novel biomarker for kidney function, is earlier in detecting acute kidney injury compared to creatinine” - presented by Remi Beunders (Radboud University Medical Center, Nijmegen, the Netherlands)

Poster Presentations at ESICM 2019

Session: AKI - Critical Care Nephrology 1, September 30, 2019

“One-year prognostic value of kidney biomarkers at discharge from the intensive care unit” – presented by François Dépret (Hôpitaux Universitaires Saint-Louis – Lariboisière – Fernand-Widal, Paris, France)

Session: AKI - Critical Care Nephrology 2, October 1, 2019

“An equation to estimate glomerular filtration rate in critically ill patients using the novel biomarker proenkephalin” – presented by Remi Beunders (Radboud University Medical Center, Nijmegen, the Netherlands)

About sphingotec

SphingoTec GmbH (“sphingotec”;Hennigsdorf by Berlin, Germany) develops and markets innovativein vitro diagnostic IVD tests for novel and proprietarybiomarkers for the diagnosis, prediction and monitoring of acute medical conditions, such as acute heart failure, circulatory shock, and acute kidney injury in order to support patient management and provide guidance for treatment strategies. sphingotec’s assay portfolio includes sphingotest® bio-ADM® the assay for bioactive adrenomedullin, a unique biomarker for real-time assessment of vascular integrity in conditions like sepsis or congestive heart failure, sphingotest® penKid®, the assay for proenkephalin, a unique biomarker for real-time assessment of kidney function and sphingotest® DPP3, an assay for Dipeptidyl Peptidase 3, a unique biomarker for signalling pathway disruptions leading to acute organ dysfunction.Along with the Nexus IB10 POC platform by its subsidiary Nexus Dx Inc. (San Diego, CA, USA) acquired from Samsung in 2018, sphingotec markets a standard marker portfolio for acute care. In addition, sphingotec developed a portfolio of novel biomarkers, which predict the risks of obesity, breast cancer and cardiovascular diseases.

Dipeptidyl Peptidase 3 (DPP3) cause of acute myocardial depression: sphingotec launches first IVD test for DPP3 on Nexus IB10 Point-of-Care platform

Mon, 19 May 2025 15:24:25 GMT

sphingotec launched the very first CE-marked IVD assay for Dipeptidyl Peptidase 3 (DPP3), a novel biomarker able to assess outcomes in patients with cardiogenic shock at admission for further clinical validation through the critical care community
IB10 sphingotest® DPP3 is now available on sphingotec’s proprietary automated Nexus IB10 point-of-care platform and quantitatively measures levels of circulating DPP3 in whole blood and plasma samples
Data presented by Prof. Alexandre Mebazaa at ESC Congress 2019 in Paris provide evidence for a novel disease mechanism in which circulating DPP3 has a causal role in cardiac and renal dysfunction
Further results presented by Prof. Mebazaa demonstrate that effects of pathological concentrations of DPP3 were immediately reversed in pre-clinical disease models upon injection of Procizumab, an anti-DPP3-antibody in preclinical development by 4TEEN4 Pharmaceuticals
sphingotec has in-licensed global rights to distribute DPP3 on Nexus IB10 from 4TEEN4 Pharmaceuticals GmbH for diagnostic purposes in multiple indications
The novel DPP3 test complements sphingotec’s portfolio of IVD tests for acute care biomarkers, including vascular function marker bio-ADM®and kidney function marker penKid®,designed to support decision making at ICUs and EDs

Paris, France, and Hennigsdorf/Berlin, Germany, August 31, 2019 - Diagnostics company SphingoTec GmbH (“sphingotec”, Hennigsdorf near Berlin, Germany) today launched IB10 sphingotest® DPP3, the first CE-IVD-marked point-of-care biomarker test able to quantify DPP3 blood-plasma levels, a novel and unique biomarker predicting outcomes in patients with cardiogenic shock at admission to intensive care units (ICUs). The DPP3 biomarker indicates angiotensin II and enkephalin signaling pathway disruptions leading to acute, short-term organ dysfunction. sphingotec will make the test initially available to the critical care community for further assessment of the clinical utility of the DPP3biomarkerin critical care settings. The assay is designed and validated for use with sphingotec’s fully automated Nexus IB10 whole blood point-of-care platform for rapid testing in laboratories, emergency departments and intensive care units together with a menu of standard critical care tests also available on the Nexus IB10 instrument.

DPP3 is at the core of a novel disease mechanism presented by Prof. Alexandre Mebazaa (Hôpital Lariboisière, Paris) today at ESC Congress 2019 (organised by the European Society of Cardiology ESC, Paris) and was described in detail in two high-ranking peer-reviewed publications by Prof. Mebazaa and co-workers also published today1,2.Results from independent clinical studies provide evidence that outcomes of patients with cardiogenic shock are associated with DPP3 blood concentrations. The scientists hypothesize that DPP3 is released from cells into the bloodstream upon cell death and degrades central mediators of cardiovascular function, angiotensin II as well as kidney function mediator enkephalin.

In blood samples from patients with cardiogenic shock enrolled in the OptimaCC3(N=57) and the CardShock4 (174 patients) studies, sustained high or increasing DPP3 plasma levels were associated with a significantly reduced cardiac left ventricular ejection fraction, impaired kidney function, and a markedly increased risk of mortality while decreasing levels of DPP3 were associated with higher survival. The causal role of DPP3 was further substantiated by studies in pre-clinical models in which injection of DPP3 impaired heart and kidney function. All these effects were immediately reversed in vivo following administration of the pre-clinical stage anti-DPP3 antibody Procizumab in a severe acute heart failure model. Procizumab is developed by the biopharmaceutical company 4TEEN4 Pharmaceuticals GmbH (“4TEEN4”). 4TEEN4 has recently licensed DPP3 rights to sphingotec for diagnostic purposes.

“DPP3 represents a unique biomarker at the core of a novel disease mechanism with high potential utility in diagnosing organ dysfunction and predicting outcome in cardiogenic shock as well as in a range of other acute care indications”, said Prof. Mebazaa.

Dr. Andreas Bergmann, CEO and founder of sphingotec commented: “The new disease mechanism investigated by Prof Mebazaa has huge potential to provide novel diagnostic and therapeutic options in a range of acute care settings with high unmet clinical need. To better understand clinical utility of DPP3 in the management of acute care patients, we invite the critical care community to collaborate with us in the further evaluation of this promising biomarker with our fully automated DPP3 point-of-care test in laboratory and near-patient settings.”

Takagi (2019) Circulating dipeptidyl-peptidase 3 and alteration in hemodynamics in cardiogenic shock: Results from the OptimaCC Trial, European Journal of Heart Failure

Deniau (2019) Circulating dipeptidyl peptidase-3 is a myocardial depressant factor: DPP3 inhibition rapidly and sustainably improves hemodynamics, European Journal of Heart Failure

gov NCT 01367743

gov NCT 1374867

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About Acute Heart Failure

Heart failure is a state of reduced cardiac output, in which the heart cannot pump blood through the body effectively. When symptoms appear suddenly, or a person experiences rapid worsening of existing symptoms of heart failure, this is called acute heart failure (AHF) or acute decompensated heart failure (ADHF). This condition can be life threatening and should be urgently evaluated by a physician, as outcomes can be affected by early and appropriate treatment. Heart failure is a common condition affecting more than 30 million people world-wide. Typical symptoms of acute heart failure include shortness of breath, tiredness and swelling of the feet and legs (congestion). Treatment typically involves supporting breathing and adjusting the blood pressure and, where necessary, removing excess fluid from the body by diuretic treatment. There is no cure, but long-term treatment involving medications and rehabilitation can improve the heart’s function.

About Cardiogenic Shock

Cardiogenic shock is an emergency with mortality rates up to 50 %. Most cases of cardiogenic shock occur after myocardial infarction and are defined by persistent low cardiac output state resulting in arterial hypotension, shortness of breath, reduced organ perfusion. Refractory cardiogenic shock presents as persistent organ hypoperfusion despite the administration of vasoactive treatments. Early initiation of mechanical circulatory support, early percutaneous coronary intervention, inotropes, and heart transplantation may improve outcomes for patients with cardiogenic shock.

About DPP3

Human Dipeptidyl Peptidase 3 (DPP3) is an ubiquitously expressed and highly conserved enzyme. DPP3 cleaves various bioactive peptides, such as such as angiotensin II, enkephalins. The most prominent substrate of DPP3 is angiotensin II, the central effector of the renin–angiotensin system (RAS), implicating extracellular DPP3 in the regulation of the RAS. RAS is activated in cardiovascular diseases, sepsis and septic shock and angiotensin II, in particular, has been shown to modulate many cardiovascular functions including the control of blood pressure and cardiac remodelling.

About Nexus Dx Inc. and the IB10 Platform

Nexus Dx Inc., a wholly owned subsidiary of sphingotec,headquartered in San Diego, CA, USA, is a global provider of a near patient testing system and advanced diagnostic solution. The company is improving patient care by providing the medical community with rapid and reliable testing at the point of care (POC), delivering patient information when and where it is needed most. The company has invested over $160m to develop and market the IB10 analyser system which, without the need for sample preparation, automatically separates plasma from whole blood with subsequent reliable and quantitative detection of biomarkers in the plasma by means of antibodies. With a hands-on-time of less than 3 minutes the easy-to-use system provides in only 20 minutes test results for biomarkers that are crucial in the management of critical care patients such as Procalcitonin, Troponin I, CK-MB, Myoglobin, NT-proBNP, and D-Dimer. sphingotecs proprietary test sphingotest® DPP3, an assay for Dipeptidyl Peptidase 3, a unique biomarker for signalling pathway disruptions leading to acute organ dysfunction was recently launched on Nexus IB10. Near-term product launches on Nexus IB10 will include: IB10 sphingotest® bio-ADM®, an assay for bioactive Adrenomedullin, a unique biomarker for real-time assessment of vascular integrity, and IB10 sphingotest® penKid®, an assay for Proenkephalin, a unique biomarker for real-time assessment of kidney function.

About sphingotec

SphingoTec GmbH (“sphingotec”;Hennigsdorf by Berlin, Germany) develops and markets innovativein vitro diagnostic IVD tests for novel and proprietarybiomarkers for the diagnosis, prediction and monitoring of acute medical conditions, such as acute heart failure, circulatory shock, and acute kidney injury in order to support patient management and provide guidance for treatment strategies. sphingotec’s assay portfolio includes sphingotest® bio-ADM® the assay for bioactive adrenomedullin, a unique biomarker for real-time assessment of vascular integrity in conditions like sepsis or congestive heart failure, sphingotest® penKid®, the assay for proenkephalin, a unique biomarker for real-time assessment of kidney function and sphingotest® DPP3, an assay for Dipeptidyl Peptidase 3, a unique biomarker for signalling pathway disruptions leading to acute organ dysfunction. Along with the Nexus IB10 POC platform by its subsidiary Nexus Dx Inc. (San Diego, CA, USA) acquired from Samsung in 2018, sphingotec markets a standard marker portfolio for acute care. In addition, sphingotec developed a portfolio of novel biomarkers, which predict the risks of obesity, breast cancer and cardiovascular diseases.

sphingotec reveals novel results on bioactive adrenomedullin for diagnosis and therapy monitoring of septic shock at the 39th International Symposium on Intensive Care and Emergency Medicine (ISICEM)

Mon, 19 May 2025 15:21:55 GMT

sphingotec reveals novel results on bioactive adrenomedullin for diagnosis and therapy monitoring of septic shock at the 39th International Symposium on Intensive Care and Emergency Medicine (ISICEM)

Data from more than 20,000 patients show that bio-ADM® adds value to clinical decision-making at ICUs and EDs because it is the only biomarker that allows early prediction of septic shock
bio-ADM® allows starting life-saving interventions such as early
administration of vasopressors which will benefit about 20% of sepsis patients
bioADM® is used for patient selection in an ongoing phase II trial with therapeutic antibody Adrecizumab
bio-ADM® POC test for rapid decision-making at ICUs and EDs will be launched by H1/2019

HENNIGSDORF, GERMANY - March 19, 2019 - Diagnostics company SphingoTec GmbH reports novel applications of bio-ADM® (bio-active adrenomedullin), the very first biomarker capable to diagnose the onset of septic shock, allowing physicians earliest life-saving therapeutic interventions in sepsis critical care. At the 39th International Symposium on Intensive Care and Emergency Medicine (ISICEM, 19–22 March, 2019, Brussels), Prof Peter Pickkers (Radbound umc Nijmegen, The Netherlands) will report that bio-ADM® is used to select patients at high risk for septic shock for treatment with the antibody Adrecizumab (Adrenomed AG, Hennigsdorf, Germany), which is being evaluated in an ongoing Phase II study on patients with early septic shock.

bio-ADM® is the only biomarker capable of diagnosing endothelial dysfunction, which has been demonstrated to precede the life-threatening blood pressure break down that causes multi-organ failure, shock and death of sepsis patients at intensive care units (ICUs) and in emergency departments (EDs). In studies on more than 20,000 patients, high bio-ADM® plasma levels (>70pg/ml) have been shown to predict the onset of septic shock, 28-day mortality and vasopressor demand independently of co-morbidities or inflammation. Without bio-ADM® testing, norepinephrine administration is initiated about 3.1 ± 2.5 hours after the onset of septic shock [1]. Every 1-hour of treatment delay is associated with a 5.3% increase in mortality. Early identification of patients running into shock will thereby statistically benefit one out of five septic shock patients (20%). As decreasing bio-ADM® levels have been linked to improved outcomes in clinical testing and pilot routine testing, bio-ADM® not only supports early clinical decision making but also monitoring of response to therapeutic intervention.

According to Pickkers, the further utility of bio-ADM® testing is provided by the selection of high-risk patients in clinical trials. Lack of stratification out of the highly heterogeneous sepsis population has been a major cause of failure in more than 60 late-stage trials with potential sepsis therapeutics in the past 20 years. Adrenomed AG is developing an antibody that leads to enrichment of bio-ADM® in the vessel lumen, where the vasoactive peptide hormone restores vascular integrity.

“It’s a great advantage that we are able to improve patient enrichment using sphingotest® bio-ADM® in order to demonstrate the efficacy of Adrecizumab”, commented Dr. Andreas Bergmann founder of both, sphingotec and Adrenomed, and CEO of sphingotec. “However, we should be aware that the diagnostic utility of bio-ADM® goes far beyond patient enrichment, as a single bio-ADM® measurement can exclude or diagnose endothelial dysfunction and thus assist critical care specialists to save lives in patients who most urgently need rapid therapeutic intervention.” Dr.Bergmann is the co-founder of BRAHMS/ThermoFisher Scientific and co-inventor of procalcitonin, a sepsis diagnostic with an annual turnover of $600m. He is currently working to establish fully automated blood POC testing of bio-ADM® as well as establishing an innovative critical care biomarkers on the Nexus IB 10 platform, by summer 2019.

[1] Xiaowu Bai et al., Early vs delayed administration of epinephrine in patients

with septic shock. Critical Care 18: 532

About SphingoTec GmbH: SphingoTec GmbH (Hennigsdorf, Germany) is developing and marketing innovative biomarkers such as penKid® and bioADM® for prediction, diagnosis and therapy monitoring of AKI, congestive heart failure and septic shock, as well as the Nexus IB10 POC testing immunoassay platform acquired from Samsung-subsidiary Nexus Dx Inc. in May 2018. The company, founded by Dr. Andreas Bergmann in 2002, is additionally developing a pipeline of novel biomarkers which can predict the risks of obesity, breast cancer and cardiovascular diseases.

About bio-ADM®: As a marker of vascular integrity, bio-ADM® enables both predictions of circulatory shock 48 h before blood pressure breakdown, e.g. in septic patients, and diagnosis of diuretic-resistant congestion in acute heart failure patients.

sphingotec announces new data on the kidney function marker proenkephalin (penKid®) presented at 24th International Conference on Advances in Critical Care Nephrology

Mon, 19 May 2025 15:20:03 GMT

sphingotec announces new data on the kidney function marker proenkephalin (penKid®) presented at 24th International Conference on

Advances in Critical Care Nephrology

Medical leaders in renal critical care presented study data at the 24th AKI & CRRT conference supporting the hypothesis that plasma penKid® levels reflect kidney function in critically ill burn patients, heart failure patients, and sepsis patients closing the gap to near-time diagnosis and monitoring of acute kidney injury (AKI).
Peer-reviewed results from the Valsartan Heart Failure Trial (Val-HeFT) comparing the biological variation of renal biomarker tests demonstrate that sphingotest® penKid® is the very first diagnostic test capable to rule out AKI with a single measurement and best-in-class in terms of early diagnosis.
Medical leaders recommend to include low penKid® levels as exclusion criterion for AKI in triaging and for routine testing at emergency departments.
Critical care experts announced to evaluate clinical utility of sphingotest® penKid® in renal transplant function/dysfunction.
Automated point-of-care (POC) penKid® testing on NEXUS IB 10 platform to be launched at intensive care units (ICUs) and emergency departments (EDs) by summer 2019.

HENNIGSDORF, GERMANY - March 14, 2019 - German diagnostics company SphingoTec GmbH (Hennigsdorf) announced that leaders in critical care nephrology have confirmed clinical utility of the company’s glomerular filtration biomarker penKid® for early diagnosis, exclusion and monitoring of acute kidney injury (AKI). Data from prospective, observational studies presented at the 24th International Conference on Advances in Critical Care Nephrology (AKI & CRRT; 26 Feb-1 March, 2019) in San Diego demonstrate that penKid® is suitable to guide treatment decisions at ICUs and EDs.

At the AKI & CRRT conference, Prof. Matthieu Legrand (Critical Care Medicine & Burn Unit at Hôpital Lariboisière Paris, France) reported results from a substudy of the PRONOburn cohort that enrolled 113 burn patients admitted to burn intensive care units (ICUs). High penKid® levels at admission (> 80 pmol/L) were sufficient to predict acute kidney injury (AKI) even when other indicators such as the SOFA score gave no sufficient information (p<0.001). In sepsis patients, enrolled in the FROG-ICU and AdrenOSS-1 cohorts, including more than 1,100 patients, elevated penKid® plasma levels identified sub-AKI while creatinine values remained normal (1 out of 4 patients). Sub-AKI was associated

with worse outcomes.

Peer-reviewed data [1] on the biological variation of four AKI biomarker tests in patients with stable heart disease presented by Dr. Alan Wu (UCLA, San Francisco) demonstrated that penKid® is best suited for early diagnosis of renal insufficiency in clinical practice. Data from 85 individuals enrolled in the Valsartan Heart Failure Trial (Val-HeFT) support that penKid® testing would be of value in managing patients in EDs and ICUs. Commenting on the results, key opinion leaders suggested to add penKid® measurements to AKI routine testing for triaging and monitoring, which today only allows delayed information using available biomarkers.

“The biovariability of a biomarker is a key attribute, but not tested for many of the novel kidney markers. penKid® shows a low variability – allowing information with the first measurement,” said Dr. Wu. “penKid® has a huge value to rule out patients in EDs,” confirmed Prof. Salvatore Di Somma, Head of Emergency Medicine Sant'Andrea Hospital, Rome, Italy. sphingotec showed data from pilot routine testing, which has already begun at undisclosed ICUs and EDs in Germany. Study leaders confirmed that triaging will be supported by penKid® information, because the marker can rule out AKI as BNP rules out Heart Failure. David Bruno, Director of the University of Maryland Transplant Surgery Program announced starting tests with penKid® to predict graft function recovery in kidney transplantation.

Plasma penKid® is a surrogate marker for disturbed renal glomerular filtration rate (GFR), which reflects kidney function. Previous studies on more than 30,000 critically ill patients admitted to EDs or ICUs with congestive heart failure [2] or sepsis [3] demonstrated that penKid® levels change dynamically with the actual kidney function independently from comorbidities or inflammation [4]. penKid® levels rise up to 48 hours prior to those of creatinine preceding kidney injury (AKI), which affects about 25 percent of patients admitted to ICUs.

By the end of H1/2019, sphingotec will launch a penKid® point-of-care (POC) test on its fully automated Nexus IB10 POC testing platform for use in EDs and ICUs. The platform allows measurement of up to five critical care biomarker tests in one run within 20 minutes without any sample preparation.

[1] Wu, A., Anand, I. (2018) Biological variation of plasma proenkephalin: data from a stable heart failure cohort.

[2] Chan S. et al. (2018) Proenkephalin in Heart Failure; Kanagala P. et al.: Proenkephalin and prognosis in heart failure with preserved ejection fraction: a GREAT network study.

[3] Hollinger et al. (2018) Proenkephalin A 119-159 (Penkid) Is an Early Biomarker of Septic Acute Kidney Injury: The Press Release Kidney in Sepsis and Septic Shock (Kid-SSS) Study

[4] Beunders, R. et al. (2017) Proenkephalin (PENK) as a novel biomarker for kidney function.

About SphingoTec GmbH: SphingoTec GmbH (Hennigsdorf, Germany) is developing and marketing innovative biomarkers such as penKid® and bioADM® for prediction, diagnosis and therapy monitoring of AKI, congestive heart failure and septic shock, as well as the Nexus IB10 POC testing immunoassay platform acquired from Samsung-subsidiary Nexus Dx Inc. in May 2018. The company, founded by Dr. Andreas Bergmann in 2002, in addition is developing a pipeline of novel biomarkers which can predict the risks of obesity, breast cancer and cardiovascular diseases.

About International Conference on Advances in Critical Care Nephrology: The AKI & CRRT conference provides a comprehensive review of advances in clinical care, research and technology in critical care medicine with a focus on the

kidney and renal support techniques.

About penKid®: penKid® is the very first functional kidney marker that works in blood. penKid® is independent from comorbidities and inflammation and provides timely information about the changing kidney function in critically ill patients. sphingotest® penKid® is non-inferior to the gold standard in vivo measurement of glomerular filtration rate (GFR). These features enable physicians to diagnose and closely monitor worsening and improving kidney function in critically ill patients.

Endothelial disruption: Rapid translation from bench to bedside

Mon, 19 May 2025 15:18:30 GMT

Hennigsdorf, Germany 25. January 2019 - bio-ADM, the very first blood biomarker capable to diagnose when blood vessels become leaky (endothelial dysfunction), is set to make a rapid carrier at intensive care units (ICUs) and emergency departments (EDs) of hospitals. Data from pilot clinical routine testing presented at the 2nd Scientific Symposium on Endothelial Disruption (18. December 2018) in Berlin impressively confirmed results from previous tests on 30,000 patients with acute heart failure (AHF) and severe sepsis indicating that bio-ADM testing improves medical decision making to prevent mortality, organ damage and re-hospitalization. An automated point-of- care (POC) test measuring bio-ADM both as a biomarker and as a companion diagnostic to a therapeutic antibody (Adrecizumab) that repairs endothelial dysfunction, will be launched by H1/2019 by SphingoTec GmbH. However, bio- ADM is just the first representative of a full pipeline of diagnostic blood proteins reflecting disturbed signaling pathways underlying disorders of unmet medical need.
Late in 2017, key opinion leaders (KOLs) in the field of heart failure (AHF) and sepsis presented data supporting that elevated levels of the vasoactive peptide hormone Adrenomedullin (ADM) indicate when blood vessels become leaky and that such endothelial dysfunction precedes bad outcomes in congestive heart failure (AHF) and septic shock. New clinical data presented at the 2nd Scientific Symposium on Endothelial Disruption (18 December 2018, Berlin, Germany) demonstrated that the first diagnostic test measuring the biologically active form of Adrenomedullin (sphingotest® bio-ADM®, SphingoTec GmbH, Hennigsdorf, Germany) is on a good way to be translated to bedside very rapidly as key opinion leaders at the meeting confirmed actionable clinical utility of bio- ADM testing in sepsis and AHF.

From clinical trials to routine testing
New data on pilot routine testing of bio-ADM in patients with sepsis presented at the meeting in Berlin suggest that the new diagnostic concept could enter broader routine testing very soon. According to representative case studies, elevated blood levels of bio-ADM at admission, which remained high, were a strong predictor for mortality. Daily monitoring of bio-ADM levels identified the outcome and response to therapy in sepsis patients: if bio-ADM levels remained high or rose above the cut-off value of 70 pg/ml, patients died. When bio-ADM levels dropped below the cut-off, patients survived. Even when inflammation biomarkers such as PCT or CRP pointed to recovery, high bio-ADM levels were an independent predictor of bad outcome and non-response to therapy, the study leaders told European Biotechnology pointing to the need of those patients to receive immediate critical care. The medical interest was to generate data from clinical practice and translate them into therapy decisions, they said. Routine tests with more patients, even in AHF, are currently in planning.

Automated test to be launched in H1/2019
While the routine testing was conducted with a manual version of a bio-ADM sandwich immunoassay (see photo), confirmatory data may be generated with a fully automated test that runs on the established Nexus IB 10 point-of-care (POC) testing platform of German SphingoTec GmbH. The company announced at the meeting that it will launch such a fully automated bio-ADM test particularly suited to the needs of ICUs and EDs in H1/2019 latest. Nexus IB 10 is a market-established microfluidic POC testing platform currently used by over 1,000 hospitals including ICUs/EDs that allows measurement of a test panel of up to five acute care blood biomarkers.
Academic leaders in emergency medicine reported further progress regarding clinical utility with the biomarker of endothelial dysfunction. Several lectures in Berlin confirmed the diagnostic and therapeutic utility of bio-ADM monitoring of therapy response. “In septic shock patients, bio-ADM levels reflect the pathophysiological relaxation of vascular tone 1-2 days before clinical signs of shock appear”, stressed Prof. Dr. Salvatore Di Somma, Head of Emergency Medicine (ED) at University La Sapienza, Rome. According to Di Somma, data from a clinical multicenter study on approx. 1,000 sepsis patients (ALBIOS) admitted to the ED demonstrated that plasma bio-ADM levels increased with the severity of disease, correlated with the requirement for intensive care such as immediate vasopressor therapy and 28-day mortality rate. Di Somma confirmed that, “serial measurement of bio-ADM may add important information to levels measured at admission”. Almost 100% of sepsis patients with high bio-ADM levels at admission whose bio-ADM blood level dropped below 70 pg bio- ADM/ml blood 4 days post-admission survived.

Medical utility in AHF patients
According to further data presented at the meeting, bio-ADM testing also cuts time to diagnosis and appropriate treatment in the medically underserved area of congestive acute heart failure (AHF). “Monitoring of this biomarker of endothelial dysfunction can inform clinical decision making in order to reduce patients’ mortality, in-hospital length of stay and re-hospitalization rate,” stressed Di Somma pointing to results of multi-center studies that proved that bio-ADM levels identified patients with residual congestion before discharge – a main cause of mortality, kidney damage, and re-hospitalization of AHF patients.
“The issue in heart failure is congestion and thus the identification of patients that require immediate diuretic therapy”, explained heart failure biomarker and critical care expert Prof. Dr. Alexandre Mebazaa (Head AP-HP, Hôpital Lariboisière Paris) pointing to data from a meta-analysis of studies on 3,000 patients with acute heart failure in which elevated bio-ADM levels at admission preceded development of life-threatening pulmonary edema and/or interstitial edema. Data from PD Dr. Hans-Dirk Duengen proved that elevated/rising bio- ADM levels identified high-risk patients with worsening heart failure requiring immediate diuretic therapy. He supported Di Somma’s view that bio-ADM monitoring might help to support discharge decisions in acute heart failure by diagnosing residual congestion.

Enhancing medical utility by therapeutic targeting of bio-ADM
Speaking in Berlin, Prof. Dr. Pierre François Laterre, St Luc Hospital, Brussels, told European Biotechnology that bio-ADM testing definitely provides an added value to sepsis patients, as the biomarker determines the amount of vasopressors needed by sepsis patients early in the process, and thus helps prevent bad outcomes. In AHF patients, bio-ADM was the first blood biomarker capable to diagnose residual congestion prior to discharge of AHF patients that did not sufficiently respond to diuretic therapy resulting in re-hospitalization, death and kidney damage, he said.
Laterre added that medical utility of diagnostic bio-ADM monitoring is set to improve in the future. A clinical Phase II trial assessing efficacy of Adrecizumab, a therapeutic antibody targeting bio-ADM, conducted by Laterre, will have Phase II read-out in sepsis patients this summer. The target is reduction of mortality in 300 sepsis patients with bad prognosis as identified by a bio-ADM level above 70 pg /ml at admission. This would qualify bio-ADM as companion diagnostic to targeted antibody therapy resolving endothelial dysfunction
According to data published in 2018, Adrecizumab binds Adrenomedullin at its C-terminus and does not affect receptor-binding and subsequent cAMP signaling, which had been previously shown to support vascular integrity and block vascular leakage. Adrecizumab thus repairs endothelial dysfunction, providing a targeted therapy to improve outcomes both in sepsis but also in AHF.
According to preclinical and Phase I data provided by Tobias Schürholz (University Rostock) and the group of Peter Pickkers (University Nijmegen), binding to Adrecizumab additionally protects bio-ADM from proteolytic degradation thus improving the half-life of the vasoactive peptide hormone in blood.
A Phase II trial will start enrollment of 300 AHF patients this year to evaluate the clinical safety and efficacy of Adrecizumab in patients with AHF.
Experts such as Dr. Allan Jaffe from Mayo Clinic in Rochester or Prof. Dr. Michael Bauer from University Jena, stressed that bio-ADM as a companion diagnostic would enable an optimal therapy choice both in sepsis as well as in patients with congestive heart failure.

A new way of personalized medicine
According to serial entrepreneur Dr. Andreas Bergmann, founder of sphingotec and Adrenomed, bio-ADM is just the first in a series of blood biomarkers/therapeutic targets set to improve outcomes in medically underserved conditions. “Our strategy is to identify protein biomarkers indicating severe medical disorders in the blood of patients. These biomarkers enable us to look for potential therapeutic targets and validate if these have an effect on humans following the blood biomarker read-out.” Bergmann, who co- founded and sold BRAHMS AG for €330M to Thermo Fisher Scientific, said his companies have the financial freedom to quit unsuccessful projects early and follow just the best approach that adds value to current medical standards. “We are thus delighted about the positive feedback from the scientific community on our bio-ADM approach”, commented Bergmann the outcome of the symposium.

sphingotec raises €20 million from HBM and Wellington Partners

Mon, 19 May 2025 15:16:37 GMT

Diagnostics company SphingoTec GmbH successfully closed €20 million growth equity financing round led by international specialist investors HBM Healthcare Investments, HBM BioCapital II LP (HBM) and Wellington Partners
Proceeds will be used to launch the NEXUS IB 10 point-of-care (POC) platform and the novel acute biomarker blood tests sphingotest® penKid® and sphingotest® bio-ADM®
Ability to timely measure kidney and endothelial function/dysfunction in acute kidney failure, heart failure and shock addresses large unmet needs in emergency and intensive care medicine.
Board of Sphingotec will comprise senior diagnostics industry experts including Dr. Gerald Möller, former CEO of Boehringer Mannheim.

HENNIGSDORF, Germany - October 8, 2018 - German diagnostics company SphingoTec GmbH has closed a €20m growth equity financing round led by international healthcare specialist investors HBM and Wellington Partners.

Sphingotec will primarily use the proceeds to roll out the fully automated IB 10 point-of-care (POC) platform for testing of a broad panel of acute blood biomarkers, which had been acquired in May 2018 through an acquisition of Samsung-subsidiary Nexus Dx Inc. Already more than 1,000 intensive care units (ICUs), emergency departments, smaller hospitals and larger practices in Europe and the Middle East are using the platform on a regular basis with more than 100,000 tests performed per year.

Sphingotec will also make its proprietary, highly innovative acute blood biomarkers bio-ADM® and penKid® available on this POC platform to ICUs and emergency departments. bio-ADM® is a marker of endothelial integrity that indicates when blood vessels become leaky. In clinical tests on patients with congestion in heart failure, bio-ADM was the only biomarker capable to predict residual congestion of patients with acute heart failure (AHF), who did not respond sufficiently to loop diuretics. . Residual, diuretic-resistant congestion is the major reason for re-hospitalization and post-discharge mortality in AHF. Automatic bio-ADM® POC testing thus solves an unmet medical need, that causes high cost for healthcare systems. Furthermore, bio-ADM® is a first in class-biomarker predicting circulatory shock in sepsis patients – another condition with unmet medical need.

penKid® is a first in class blood-based biomarker capable to timely monitor kidney function in high-risk patients by giving direct information on the true Glomerular Filtration Rate (GFR), the gold standard to assess kidney function. The functional kidney biomarker penKid® has been clinically shown to diagnose and monitor acute kidney injury (AKI) in earliest stages of congestion in acute heart failure.

Congestive heart failure affects 26 million patients globally and costs $24bn annually. Each year, 8 million people die from sepsis, 700,000 by acute kidney injury (AKI).

As part of the financing, Dr. Matthias Fehr, Investment Advisor at HBM Partners and Dr. Rainer Strohmenger, Managing Partner at Wellington Partners, Dr. Ute Kilger, Partner at Boehmert & Boehmert, Dr. Method Miklus, former COO of B.R.A.H.M.S and Dr. Gerald Möller, former CEO of Boehringer Mannheim will join the Board of sphingotec.

“We are delighted to have gained the support from HBM and Wellington Partners, which enables us to bring our innovative biomarkers much faster to ICUs and emergency departments, where they can support decision-making in diagnostically underserved conditions such as septic shock, acute heart failure and acute kidney injury,” said Dr. Andreas Bergmann, CEO and founder of SphingoTec GmbH. “Starting in Central Europe, a growing distributor network will allow the timely introduction of a complete solution for the hospital acute point of care market in AKI, AHF and sepsis diagnosis and monitoring.”

“Sphingotec’s acute biomarker tests target a global multibillion Euro market opportunity in a field of high unmet medical need. We are convinced that the company’s biomarker portfolio has the potential to significantly improve decision making in acute settings,” commented Dr. Matthias Fehr, Investment Advisor at HBM Partners.

Dr. Rainer Strohmenger, Managing Partner at Wellington Partners, commented: “The addition of sphingotec’s functional blood biomarkers, whose clinical utility have already been proven on tens of thousands of patients, to the market-validated IB10 POC testing immunoassay platform closes a major current gap in diagnostic testing in critical care. The company’s biomarker tests are designed to allow timely monitoring of endothelial and kidney function as well as the effects of therapeutic interventions, which is crucial for physicians at ICUs and emergency departments.”

About SphingoTec GmbH: SphingoTec GmbH (Hennigsdorf, Germany) is developing and marketing innovative biomarkers penKid® and bio-ADM® for prediction, diagnosis and therapy monitoring of AKI, congestive heart failure and septic shock, as well as the Nexus IB10 POC testing immunoassay platform acquired from Samsung-subsidiary Nexus Dx Inc. in May 2018. The company, founded by Dr. Andreas Bergmann in 2002, in addition is developing a pipeline of novel biomarkers which can predict the risks of obesity, breast cancer and cardiovascular diseases.

About HBM Healthcare Investments Ltd: HBM Healthcare Investments invests in the healthcare sector. The company holds and manages an international portfolio of promising companies in the human medicine, biotechnology, medical technology, and diagnostics sectors and related areas. Many of these companies have their lead products already available on the market or at an advanced stage of development. The portfolio companies are closely tracked and actively guided in their strategic direction. This is what makes HBM Healthcare Investments an interesting alternative to investments in Big pharma and biotechnology companies. HBM Healthcare Investments, with funds under management of more than € 1 bn, has an international shareholder base and is listed on SIX Swiss Exchange (HBMN).

About Wellington Partners:

Wellington Partners is a leading European Venture Capital firm investing in early- and growth-stage Life Science companies, active in the fields of Therapeutics, Medical Technology, Diagnostics, Digital Health and Industrial Biotechnology. With funds totaling more than € 1.0 billion, thereof €400 million committed to Life Sciences, Wellington Partners has been actively supporting world-class private companies translating true innovation into successful businesses of exceptional growth. Since 1998 Wellington Partners has invested in 42 Life Science start-ups, including diagnostic companies MTM Laboratories (acquired by Roche), Definiens (acquired by AZ/Medimmune) and Oxford Immunotec (NASDAQ: OXFD).

About bio-ADM®: As a marker of vascular integrity, bio-ADM® enables both diagnosis of diuretic resistant congestion in acute heart failure patients and the prediction of circulatory shock two days before blood pressure breakdown, e.g. in septic patients.

A biomarker-assisted diuretics therapy in patients with congestive heart failure/cardio-renal syndrome, by simultaneous measurement of bio-ADM® and penKid®, targets lower re-hospitalization and mortality rates.

sphingotec is adding an advanced POC testing platform to portfolio

Mon, 19 May 2025 15:15:27 GMT

SphingoTec GmbH will offer its next-generation sepsis, heart failure and acute kidney injury biomarkers penKid® and bio-ADM® on NEXUS IB 10 point-of-care (POC) testing platform, originally developed by Nexus Dx
penKid® and bio-ADM® are first-in-class biomarkers to diagnose and monitor real-time kidney function and endothelial dysfunction which lead to shock in sepsis and congestion in acute heart failure
POC testing of penKid® and bio-ADM® is set to add significant clinical benefit to emergency departments and intensive care units allowing on-site diagnosis, monitoring, and guidance in therapies of sepsis, decongestion in heart failure and acute kidney injury, thereby improving outcomes in acute heart failure, sepsis and other acute settings.

May 22, 2018 – Hennigsdorf/San Diego – German diagnostics company SphingoTec GmbH (Hennigsdorf) and Nexus Dx (San Diego) have combined their technology platforms to market sphingotec’s CE-marked acute biomarkers penKid® and bio-ADM® on Nexus’ market-validated POC testing immunoassay platform IB10 to substantially improve decision-making in emergency departments (EDs) and intensive care units (ICUs).

This merger of technologies under the jointly owned holding company Polaris MediNet, LLC. allows emergency physicians for the first time to predict and monitor septic shock, monitor kidney function in acute settings and to monitor and diagnose congestion, including residual congestion – the major reason for re-hospitalization and post-discharge mortality in acute heart failure (AHF) – in emergency departments within a few minutes from whole blood without any sample preparation.

Each year, 8 million people die from sepsis, 700,000 thereof by acute kidney injury (AKI). Sepsis causes $24 billion in direct annual costs for the U.S. healthcare system while acute heart failure’s annual cost of $31 billion is expected to double by 2030. Details of the transaction are subject to confidentiality.

The capability of bio-ADM® to predict circulatory shock in sepsis patients and to predict and monitor residual, diuretic-resistant congestion has been clinically proven by sphingotec in clinical studies with over 20,000 Asian and Caucasian patients[1][2][3]. Furthermore, the functional kidney marker, penKid®, has been shown to predict, diagnose and monitor kidney dysfunction [4][5][6]. penKid® is a real-time surrogate marker for true (actual) kidney function (true GFR) allowing emergency physicians to timely monitor real-time kidney function in acute settings.

The Nexus IB10 POC platform is an easy-to-handle POC system, allowing the detection of biomarkers from whole blood with accuracy and precision. Thus, it is a great tool to bring valuable biomarkers to the physicians in ED and ICU.

“We are delighted to shortly start European distribution of our acute care biomarkers for therapy monitoring and adjustment on a great POC testing platform,” said Dr. Andreas Bergmann, founder and CEO of SphingoTec GmbH.

“The addition of sphingotec’s next-generation biomarkers to the IB10 platform will allow the timely introduction of a complete solution for the hospital acute point of care market in AKI, AHF and sepsis diagnosis and monitoring,” said Nam Shin, CEO of Nexus Dx Inc.

[1] Caironi et. al (2017) Circulating Biologically Active Adrenomedullin (bio-ADM) Predicts Hemodynamic Support Requirement and Mortality During Sepsis

[2] Marino et al. (2014) Plasma adrenomedullin is associated with short term mortality

[3] Kremer et al. (2017) bio-ADM: a novel marker of congestion in patients with acute heart failure

[4] Beunders et al. (2017) Proenkephalin (PENK) as a Novel Biomarker for Kidney Function

[5] Siong Chan et al. (2018) Proenkephalin in Heart Failure

[6] Ng et al. (2017) Proenkephalin, Renal Dysfunction, and Prognosis in Patients with Acute Heart Failure

About SphingoTec GmbH: SphingoTec GmbH develops innovative biomarkers for diagnosis, prediction and monitoring of acute medical conditions, such as acute heart failure, acute kidney injury and circulatory shock, in order to support patient management and provide guidance for treatment strategies. Furthermore, sphingotec develops biomarkers for the risk prediction of common diseases, such as obesity, cardiovascular diseases and breast cancer, in order to support prevention strategies.

About Nexus Dx Inc.: Nexus Dx, is a global provider of Near Patient Testing systems and advanced diagnostic solutions. The company is improving patient care by providing the medical community with rapid and reliable information at the point of care (POC), delivering patient information when and where it is needed most. The company has invested over $160 million to develop and market the IB10 analyzer system, a disc-based microfluidic immunoassay platform in which a rotating disk automatically separates plasma from whole blood for further analyses. Results of POC testing of troponin I, a cardiac Tnl/CK-MB/Myoglobin panel, NT-proBNP, NT-proBNP/Troponin I and a D-dimer Test are available within 20 minutes.

About Polaris MediNet, LLC : Polaris MediNet (San-Diego) is a holding company jointly owned by Nam Shin, CEO of Nexus Dx and SphingoTec GmbH.

About penKid®: penKid® is the very first functional kidney marker that works in plasma, is independent from comorbidities and inflammation and provides timely information about the changing kidney function in critically ill patients. sphingotest® penKid® is non-inferior to the gold standard in vivo measurement of glomerular filtration rate (GFR) and penKid® indicates two days earlier than the gold standard serum creatinine in patients developing acute kidney injury (AKI). These features enable physicians to predict, diagnose and closely monitor worsening and improving kidney function in critically ill patients. In congestive heart failure, penKid® allows to adjust diuretics dosage to the situation in individual patients.

About bio-ADM®: As a marker of acute vascular dysfunction, bio-ADM® enables both prediction of circulatory shock 48 h before blood pressure breakdown, e.g. in septic patients, and diagnosis of diuretic resistant congestion in acute heart failure patients.

biomarker-assisted diuretics therapy in patients with congestive heart failure/cardio-renal syndrome, by simultaneous measurement of bio-ADM® and penKid®, targets lower re-hospitalization and mortality rates. Since 2017, sphingotest®bio-ADM® and sphingotest®penKid® immunoassays are distributed in Germany and Austria by bestbion Dx and marketed in China under an agreement with Shuwen Biotech Co. Ltd.

About congestive heart failure: About 26 million people globally suffer from congestive heart failure. The characteristic loss of pump function of the heart triggers cardiac remodeling – the heart gets stiffer, fibrotic, and cannot pump enough blood into the circulatory system. The lower pump efficacy causes lower oxygen saturation and results in congestion, which means that blood returning to the heart through the veins backs up, resulting in higher venous pressure and causing fluids to build up in the tissues (edema). About 80% of patients with congestive heart failure are also at risk to develop edema, because their microvasculature becomes leaky due to venous hypertension. Physicians try to prevent the worst case – deadly lung edemas – by administration of loop diuretics, which can reduce hypertension by increasing water excretion. However, not all patients fully respond to diuretics. Incomplete response to diuretics therapy is the most common cause of re-hospitalization and post discharge mortality in patients with congestive heart failure. It’s not yet fully understood why patients with congestive heart failure often experience acute kidney injury (AKI). However, there is growing evidence that AKI can be attributed to congestion („cardio-renal syndrome“) and that, vice versa, AKI can trigger heart problems. Management of fluid balance with loop diuretics is challenging – if too much fluid is excreted from tissues, this will support development of AKI. On the other hand, if too little fluid is excreted, lung edemas could return. Besides that, a large proportion of patients with congestive heart failure does not fully respond to diuretics treatment, leading to undetected residual congestion. To date, physicians have no means to identify these patient group at discharge, resulting in high re-hospitalization and post-discharge mortality rates.

Septic shock i s defined as a life-threatening organ dysfunction due to dysregulated host response to a proven or suspected infection which leads to a decline of Mean Arterial Pressure (MAP) < 65 mmHg, which is refractory to fluid resuscitation and requires vasopressors. Refractoriness to fluid resuscitation is defined as a lack of response to the administration of 30 mL of fluid per kilogram of body weight or is determined according to a clinician’s assessment of inadequate hemodynamic results.

Medical leaders support novel theragnostic approach to help patients with leaky blood vessels

Mon, 19 May 2025 15:12:28 GMT

HENNIGSDORF, Germany 05. January 2018 — Disorders caused by a leaky vasculature are more common than most people think. Despite ICU treatment, one third of the 27 million patients globally that suffer from sepsis, and up to 20% of the more than 5 million US patients with congestive heart failure die every year from their condition. Other disorders that involve a disturbed barrier function of the endothel , the innermost cell layer of blood vessels, include diabetes, migraine or inflammatory diseases. Medical opinion leaders have now confirmed evidence that adrenomedullin, a central regulator of endothelial function, could serve both as a diagnostic biomarker and a therapeutic target in disorders caused by endothelial dysfunction.

Until now, physicians had no means to identify patients with bad sepsis prognosis and those heart failure patients with congestion who relapse due to residual disease at discharge. International medical leaders have now compiled clinical data from more than 10,000 patients suffering from sepsis and congestive heart failure, whose survival was linked to blood levels of the peptide hormone adrenomedullin. Results presented in Berlin identify the active form of adrenomedullin, dubbed bio-ADM, as a biomarker that predicts development of septic shock and for the first time allows doctors to identify heart failure patients, who will relapse despite decongestive treatment with loop diurectics. While sepsis supportive treatment causes annual healthcare cost of nearly $24bn, congestive heart failure treatment and rehospitalisation costs due to unidentified residual disease totaled at $31bn in the US alone. The latter annual cost is expected to double by 2030.

A diagnostic test for bio-ADM , developed and marketed by diagnostics company Sphingotec in Europe and China, is already in place. An adrenomedullin-specific therapeutic antibody, developed by Berlin-based Adrenomed AG, has just entered proof-of-concept studies in septic shock patients; a Phase II study in patients with decompensated heart failure is expected to start in 2018. According to serial entrepreneur Andreas Bergmann, founder of both companies and co-founder of BRAHMS (taken over in 2009), “bio-ADM is a general indicator for endothelial dysfunction and the need of vascular repair.”

Clinical data from more than 4,000 Caucasian and Asian sepsis patients presented at the scientific symposium “Endothelial dysfunction – Adrenomedullin as a diagnostic and therapeutic target” demonstrate that low bio-ADM plasma levels (<70pg/mg) at baseline were linked to a good outcome. In contrast, bio-ADM levels above that cut-off value were linked to significantly higher mortality (up to 13-fold), organ dysfunction and high vasopressor demand. As bio-ADM levels rose 24+ hours before septic shock occurred it allowed both early intervention and therapy monitoring. bio-ADM indicated endothelial integrity in sepsis patients at emergency departments, ICUs and patients with surgical sepsis.

Further clinical data from more than 6,000 patients with acute and chronic heart failure suffering from congestion and edema caused by high venous pressure and vascular fluid leakage, demonstrate that high bio-ADM levels predicted residual congestion, rehospitalisation and 180-day mortality. Measuring bio-ADM levels is the very first method that allows identification of patients with acute heart failure that have residual congestion and mustn’t be discharged in order to prevent rehospitalisation and death.

Using adrenomedullin as a therapeutic target seems to be a next logical step.

Preclinically, Adrecizumab, a humanized antibody that binds adrenomedullin without affecting its receptor binding in the endothel, led to a 40% survival benefit in mice. In two Phase I trials the first-in-class antibody showed excellent safety and tolerability in sepsis patients. Pharmakokinetic and pharmacodynamic data suggest that antibody stabilizes adrenomedullin’s half-life from 22 minutes to several days and that antibody binding leads to a redistribution from the vessel interstitium to its lumen, where is closes in gaps in the endothelium and thus restores the blood vessels barrier function. A Phase II trail on 300 patients with early septic shock is underway, while a Phase II study in congestive heart failure patients is in preparation and is expected to start in 2018.

About the speakers at the scientific symposium

Prof. Dr. Inder Anand, Department of Cardiovascular Medicine, University of Minnesota Medical School,
VA Medical Center Minneapolis MN and ‪San Diego, USA
Prof. Dr. Aw Tar Choon, Changi General Hospital, Singapore
Prof. Dr. Javed Butler, Chief of the Cardiology Divisionat Stony Brook School of Medicine, USA
Prof. Dr Salvatore Di Somma, Director Emergency Medicine, University La Sapienza, Rome, Italy
Asj-Prof. Dr. Hans-Dirk Düngen, Head Multicentric Studies Cardiology, Charité Berlin, Germany
Prof. Dr. Mina Hur, Director Department of Laboratory Medicine, Konkuk University Seoul, Korea
Prof. Dr Pierre-Francois Laterre, Head of the medical-surgical intensive care unit at St. Luc Hospital, Brussels, Belgium
Dr. Roberto Latini, Istituto di Ricerche Farmacologiche Mario Negri Milano, Italy
Prof. Dr. Gernot Marx, Director Operative Intensive Care and Intermediate Care, University Clinic Aachen, Germany
Prof. Alexandre Mebazaa, Head AP-HP, Hôpital Lariboisière Paris, France
Prof. Dr. Olle Melander, Principal investigator at Hypertension and Cardiovascular Disease, Lund University Malmö, Sweden
Prof. Dr. Marco Metra, Department of Medical and Surgical Specialties. Universita degli Studi di Brescia, Italy
Prof. Leong L. Ng, Principal Investigator, Department of Cardiovascular Sciences, University Leicester, UK
Prof. Dr. Peter Pickkers, Department of Intensive Care. Radboud University, Nijmegen, The Netherlands
Prof. Adriaan A. Voors, Director of the Heart Failure Clinic and the Outpatient Clinic of the.Department of Cardiology, UMC Groningen, The Netherlands

About congestive heart failure: About 5 million US-Americans suffer from congestive heart failure. The characteristic loss of pump function of the heart triggers cardiac remodeling – the heart gets stiffer, fibrotic, and cannot pump enough blood into the circulatory system. The lower pump efficacy causes lower oxygen saturation and results in congestion, which means that blood returning to the heart through the veins backs up, resulting in higher venous pressure and causing fluids to build up in the tissues (edema). About 80% of patients with congestive heart failure are also at risk to develop edema, because their microvasculature becomes leaky due to venous hypertension. Physicians try to prevent the worst case – deadly lung edemas – by administration of loop diuretics, which can reduce hypertension by increasing water excretion. However, not all patients fully respond to diuretics. Incomplete response to diuretics therapy is the most common cause of re-hospitalization and post discharge mortality in patients with congestive heart failure. It’s not yet fully understood why patients with congestive heart failure often experience acute kidney injury (AKI). However, there is growing evidence that AKI can be attributed to congestion („cardio-renal syndrome“) and that, vice versa, AKI can trigger heart problems. Management of fluid balance with loop diuretics is challenging – if too much fluid is excreted from tissues, this will support development of AKI. On the other hand, if too little fluid is excreted, lung edemas could return. Besides that, a large proportion of patients with congestive heart failure does not fully respond to diuretics treatment, leading to undetected residual congestion. To date, physicians have no means to identify these patient group at discharge, resulting in high re-hospitalization and post-discharge mortality rates.

About septic shock Septic shock is defined as a life-threatening organ dysfunction due to dysregulated host response to a proven or suspected infection which leads to a decline of Mean Arterial Pressure (MAP) < 65 mmHg, which is refractory to fluid resuscitation and requires vasopressors. Refractoriness to fluid resuscitation is defined as a lack of response to the administration of 30 mL of fluid per kilogram of body weight or is determined according to a clinician’s assessment of inadequate hemodynamic results

About Adrenomedullin Adrenomedullin is a strong vaso-regulatory hormone released by smooth muscle cells and the endothelium. It is a key regulator of blood pressure and vascular tone and plays a pivotal role in the regulation of the endothelial barrier function.

About Adrecizumab Adrecizumab is a proprietary humanized monoclonal Adrenomedullin-specific antibody, as first-in-class therapy for the treatment and prevention of impaired vascular integrity, which is a hallmark of septic shock. Adrecizumab showed excellent safety & tolerability as well as high efficacy in a variety of preclinical animal models, mimicking human standard of care treatment on ICU. In several resuscitated vascular integrity models (mouse, rat, pig), Adrecizumab reduced vascular leakage, stabilized the circulation, by restoring blood pressure, normalized fluid balance and reduced vasopressor demand, improved renal function and reduced mortality from septic shock by 50%. The excellent tolerability and safety of Adrecizumab was confirmed in two clinical Phase-I studies in healthy subjects with and without LPS challenge.

About SphingoTec GmbH: SphingoTec GmbH (Hennigsdorf, Germany) develops innovative biomarkers for prediction, diagnosis and therapy monitoring of AKI, congestive heart failure and septic shock. The company, founded by Dr. Andreas Bergmann in 2002, has also in its portfolio biomarkers which can predicts risks of obesity, breast cancer and cardiovascular diseases.

About Adrenomed Adrenomed AG is a privately financed biopharmaceutical company, based in Hennigsdorf near Berlin, Germany, with the mission to improve survival by improving vascular integrity in critically ill patients. Its lead candidate, Adrecizumab, a monoclonal antibody therapy targeting the vasoactive adrenomedullin system, is in clinical testing for early septic shock. Impaired vascular integrity is a pathology observed in a variety of medical conditions. A further indication besides sepsis and early septic shock is acute decompensated heart failure.

Ortho Clinical Diagnostics and sphingotec Announce Strategic Agreement Regarding Novel Biomarker for Decreasing Re-hospitalizations in Heart Failure

Mon, 19 May 2025 15:09:51 GMT

HENNIGSDORF, Germany 07. December 2017 — Ortho Clinical Diagnostics (Ortho), a global leader of in vitro diagnostics, and SphingoTec GmbH today announced a long-term, global strategic agreement regarding the endothelial function marker, biologically active Adrenomedullin (sphingotest® bio-ADM®), which measures patients’ rate of recovery from acute heart failure, providing critical information to physicians making treatment decisions. The agreement allows Ortho to use the sphingotest® bio-ADM® immunoassay on Ortho’s automated VITROS® Immunodiagnostics and Integrated Systems for small-, mid- and high-volume clinical laboratories. Product availability is subject to local regulatory requirements.

“Ortho is committed to the continued expansion of our menu offerings, through both internal research and development programs and strategic collaborations,” said Robert Yates, Ortho’s chief operating officer. “Our strategic agreement regarding the sphingotest® bio-ADM® assay positions us to bring this novel cardiac biomarker to a broad range of clinical labs around the world.”

Congestion in acute heart failure, which is mainly caused by endothelial dysfunction, is a serious medical problem and a main driver of re-hospitalizations in these patients. Next to the wide use of natriuretic peptides mainly for the diagnosis of heart failure, accurate determination of residual congestion during and after treatment is a high unmet medical need, to assess the adequacy of acute heart failure therapy.[1] In particular, residual heart congestion at hospital discharge is associated with a high risk of re-hospitalization and mortality, emphasizing the need for assessing and monitoring the adequacy of decongestion therapy throughout hospitalization.[2] bio-ADM® has been investigated in numerous clinical studies, showing its suitability to accurately diagnose residual congestion, monitor treatment effectiveness and determine suitability of patients for hospital discharge.

"Working with Ortho Clinical Diagnostics will help us deliver our standardized sphingotest® bio-ADM® assay to laboratories around the world to help them efficiently diagnose heart failure patients with residual congestion, in time for meaningful intervention, including a potential change in medication, to take place.” said Andreas Bergmann, founder and general manager of SphingoTec GmbH.

About sphingotest® bio-ADM® The CE marked sphingotest® bio-ADM® immunoassay from SphingoTec GmbH measures the bioactive form of Adrenomedullin, a peptide-hormone that is essential in maintaining the endothelial barrier function. sphingotest® bio-ADM® is indicated for use as an aid in monitoring de-congestion in patients hospitalized with acute heart failure.

About SphingoTec GmbH SphingoTec GmbH develops innovative biomarkers for diagnosis, prediction and monitoring of acute medical conditions, such as acute heart failure, acute kidney injury and circulatory shock, in order to support patient management and provide guidance for treatment strategies. Furthermore, sphingotec develops biomarkers for the prediction of health risks, such as obesity, cardiovascular diseases and breast cancer, in order to support prevention strategies.

For more information, visit www.sphingotec.com

About The VITROS®Systems The VITROS® Chemistry, Immunodiagnostics and Integrated Systems from Ortho Clinical Diagnostics is a portfolio of products and patented enabling technologies which help clinical laboratories diagnose, monitor and treat disease. VITROS® Products are engineered to help clinical laboratories with organizational, operational and economic challenges.

About Ortho Clinical Diagnostics Ortho Clinical Diagnostics is a global leader of in vitro diagnostics serving the clinical laboratory and immunohematology communities. Across hospitals, hospital networks, blood banks and labs in more than 125 countries and territories, Ortho's high-quality products and services enable health care professionals to make better-informed treatment decisions. For the immunohematology community, Ortho's blood typing products help ensure every patient receives blood that is safe, the right type and the right unit. Ortho brings sophisticated testing technologies, automation, information management and interpretation tools to clinical laboratories around the world to help them run more efficiently and effectively and improve patient care. Ortho's purpose is to improve and save lives with diagnostics, and it does that by reimagining what's possible. This is what has defined Ortho for more than 75 years, and it's what drives Ortho forward. For more information, visit www.orthoclinicaldiagnostics.com

Daan Kremer, Biniyam G. Demissei and Adriaan A. Voors (2017) bio-ADM: Novel Marker of tissue Congestion in ADHF Patients. MEMC GREAT Meeting, Lisbon 08-09-2017
Parinello G. et al. (2015) Heart Fail Rev. January; 20(1): 13–24
Kremer D. et al. (2017) European Journal of Heart Failure; 19 (Suppl. S1) 5-601
Costanzo M.R. Heart Fail Rev (2012) 17:313–324
Sam L. Teichman, Alan S. Maisel, and Alan B. Storrow, (2015) Challenges in Acute Heart Failure Clinical Management: Optimizing Care Despite Incomplete Evidence and Imperfect Drugs. Crit Pathways in Cardiol. 14: 12–24

sphingotec®, sphingotest®, the sphingotec and sphingotest logos and bio-ADM® are registered trademarks of SphingoTec GmbH in Europe. For information regarding trademarks and other intellectual property applicable to this product, please see www.sphingotec.com .

sphingotec Announces Collaboration with Mayo Clinic for Evaluation and Use of Biomarkers

Mon, 19 May 2025 15:06:55 GMT

HENNIGSDORF, Germany 01. December 2017 — Researchers from other institutions can request to have their studies performed using these biomarkers.

SphingoTec GmbH , a biotechnology company that develops biomarkers for the detection and management of diseases, has recently signed an agreement with Mayo Clinic to collaborate on the evaluation and use of several biomarkers that may improve the diagnosis of certain disease states, including kidney disease, breast cancer, sepsis, and cardiovascular disease.

Through this agreement, Mayo Clinic will evaluate the biomarkers proenkephalin (penKid) and three others for research and potential routine clinical use. penKid is the only blood-based biomarker that provides timely information on the current status of kidney function; it signals worsening or improvement in kidney function better than established methods, particularly in critically ill patients.

“Biomarkers like penKid provide the potential to guide treatment and help patients at an increased risk of kidney failure,” says Andreas Bergmann, Ph.D., founder of SphingoTec GmbH. “This collaboration with Mayo Clinic will help provide research and diagnostics for all four assays that we hope will aid in curing, and ultimately preventing, life-threatening diseases.”

Other biomarkers discovered at sphingotec labs that Mayo Clinic will evaluate include:

proneurotensin (pro-NT) for the risk assessment of developing breast cancer in women.
adrenomedullin (bio-ADM) for the prediction of shock in patients with sepsis.
high-sensitivity growth hormone (vr-hGH) for the prediction of cardiovascular disease in men.

“With this collaboration, Mayo Clinic can serve as a U.S.-based testing center for any physician or scientist interested in evaluating these assays for their own research questions,” says Leslie Donato, Ph.D., clinical chemist and co-director of Cardiovascular Laboratory Medicine at Mayo. “We can run their samples on these analytically validated tests, and together, we can help determine the clinical utility for these biomarkers, ultimately better serving all of our patients.”

About sphingotec

The biotechnology company SphingoTec GmbH, headquartered in Hennigsdorf, Germany, was founded in 2002. sphingotec aims to reduce or eliminate the risk of serious diseases such as cancer, cardiovascular diseases, and kidney conditions. The process starts before the disease has actually developed: using biomarkers to indicate susceptibility for a specific disease provides healthy individuals with the knowledge that they are at risk. What makes the approach so special is that the biomarkers also create a starting point for preventative strategies at the same time, as evidence-based recommendations on how to reduce risks are always an integral part of the complete concept. Further information can be found on our website at www.sphingotec.de.

About Mayo Clinic

Mayo Clinic is a nonprofit organization committed to clinical practice, education and research, providing expert, whole-person care to everyone who needs healing. For more information, visit https://www.mayoclinic.org/about-mayo-clinic or https://newsnetwork.mayoclinic.org/.

Review paper on Proenkephalin as a Novel Biomarker for Kidney Function

Mon, 19 May 2025 15:04:55 GMT

HENNIGSDORF, Germany 13. October 2017 — SphingoTec GmbH announces in the early release of September 2017 issue of the Journal of Applied Laboratory Medicine the first review about proenkephalin[1] to aid in the still cumbersome assessment of real kidney function and detection of acute kidney injury.

Acute kidney injury is a common and devastating medical condition. Up to 75 % of all critically ill patients have been found to develop AKI – incidence rising. US hospitals alone see 1.7 million cases of AKI and have limited clinical information for prediction, diagnosis and management of the disease hinting towards the global challenge of undiagnosed AKI.

International leading physicians and researchers in the field of kidney diseases, laboratory medicine, intensive and emergency care report, that the detection of proenkephalin as a stable surrogate marker of enkephalins is possible using the commercially available sphingotest® penKid® assay. The review highlights, that numerous clinical studies demonstrated proenkephalin to be a more accurate and timely biomarker to detect real kidney function compared with serum creatinine. Furthermore, the researchers found an ideal correlation with gold standard techniques such as inulin clearance and related methods, to determine the true GFR. In various patient groups, including patients with heart failure or sepsis proenkephalin concentrations have been shown to predict deterioration of kidney function and subsequent clinical outcomes independently from inflammation or other comorbidities. sphingotec is continuously working with its network of researchers and clinicians to confirm these results in further clinical studies.

About sphingotest® penKid®

The sphingotest® penKid® immunoassay from SphingoTec GmbH measures proenkephalin, a stable surrogate marker for the kidney stimulating hormone enkephalin, indicative for the actual need for kidney stimulation. sphingotest® penKid® predicts the future change in serum creatinine up to two days in advance and is unaffected by inflammation or comorbidities. Today, the sphingotest® penKid® has been evaluated in more than 25,000 patients.

About SphingoTec GmbH

SphingoTec GmbH develops innovative biomarkers for diagnosis, prediction and monitoring of acute medical conditions, such as acute heart failure, acute kidney injury and circulatory shock, in order to support patient management and provide guidance for treatment strategies. Furthermore, sphingotec develops biomarkers for the prediction of health risks, such as obesity, cardiovascular diseases and breast cancer, in order to support prevention strategies.

SphingoTec GmbH was established in 2002 and is located in Hennigsdorf near Berlin, Germany. CEO Dr. Andreas Bergmann was one of the founders of B.R.A.H.M.S. AG. As former Chief Research Officer, he was responsible for the development of the “gold standard” sepsis biomarker Procalcitonin (B.R.A.H.M.S. PCT™). For more information, visit www.sphingotec.com.

[1] Remi Beunders, Joachim Struck, Alan H.B. Wu, Alexander Zarbock, Salvatore Di Somma, Ravindra L. Mehta, Jay L. Koyner, Mitra K. Nadim, Alan S. Maisel, Patrick T. Murray, Sean-Xavier Neath, Allan Jaffe and Peter Pickkers (2017) Proenkephalin (PENK) as a Novel Biomarker for Kidney Function The Journal of Applied Laboratory Medicine: An AACC Publication Sep 2017, jalm.2017.023598; DOI: 10.1373/jalm.2017.023598

sphingotec®, sphingotest® and penKid®, are registered trademarks of SphingoTec GmbH in Europe. For information regarding trademarks and other intellectual property applicable to this product, please see www.sphingotec.com.

sphingotec and Shuwen Biotech partner to market sphingotec´s biomarkers portfolio in China

Mon, 19 May 2025 15:03:15 GMT

Hennigsdorf-Berlin 14. August 2017

German diagnostic company SphingoTec GmbH (Hennigsdorf) and Chinese Company Shuwen Biotech Co. Ltd (Deqing) have signed an agreement to market Sphingotec’s biomarkers portfolio in China.

Under the agreement, Shuwen will directly develop and market Sphingotec reliable immunoassays. For acute care, these are the Sphingotest® penKid and Sphingotest® bio-ADM tests, set to improve therapy monitoring and outcomes in intensive care units and emergency departments.

For the “Medicine of the Future” predictive test field, the sphingotest® pro-NT, sphingotest® pro-ENK, sphingotest® vr-hGH and sphingotest® ApoE4 are set to improve prediction and hence timely prevention of life-threatening diseases such as breast cancer, cardiovascular disease and Alzheimer, respectively.

In the acute care field, bio-ADM is a biomarker for vascular dysfunction, oftentimes causing worsening or escalation of conditions in various disease states. For example, bio-ADM predicts septic shock in critically ill patients and thus can guide treatment choices. In congestive heart failure, bio-ADM is the first biomarker that identifies patients having (residual) edema, caused by incomplete response or therapy resistance to decongestion therapy with loop diuretics. Septic shock is the most expensive conditions treated in the US hospital with a mortality rate of up to 80%, while unidentified residual congestion is the major cause for re-hospitalization and post-discharge mortality in congestive heart failure patients causing 30% of deaths and global annual cost of US$39bn.

penKid is a kidney function biomarker predictive for development of acute kidney Injury (AKI), a condition that complicates up to 30% of all hospital admission and that widely increase mortality and length of stay.

„We are delighted that Shuwen will distribute our biomarker portfolio in China“, said Dr. Andreas Bergmann, founder and CEO of SphingoTec GmbH. „Our patent-protected assays support physicians with information needed to improve patient management in acute settings and in prevention of life-threatening diseases“.

„The introduction of sphingotec tests is a major step forward for the Chinese healthcare system“, said Jay Z. Zhang, CEO of Shuwen Biotech. „Both acute care and disease prevention will vastly benefit from the sphingotec® biomarkers by supporting timely and clear clinical decision making to change patient outcome.

About penKid: penkid is the very first plasma marker to monitor renal function, which is independent from comorbidities and inflammation and provides timely information about the changing kidney function in critically ill patients. sphingotest® penKid is non-inferior to the gold standard in vivo measurement of glomerular filtration rate (GFR) and penkid is elevated about 24-48 h earlier than the standard marker serum creatinine in patients developing acute kidney injury (AKI). These features enable physicians to predict, diagnose and closely monitor worsening and improving kidney function in critically ill patients. In congestive heart failure, penKid allows to adjust diuretics dosage to the situation in individual patients.

About bio-ADM: As a marker of acute vascular endothelial dysfunction, bio-ADM enables both prediction of circulatory shock, e.g. in septic patients, and prediction of residual, diuretic resistant congestion in acute heart failure patients. bio-ADM plasma levels below the cut-off value of 70 pg/ml indicate successful diuretic therapy.

About pro-NT & pro-ENK: pro-NT is a strong risk predictor for the development of breast cancer in the next five years. This predictive power can be further enhanced by the measurement of Sphingotest® pro-ENK, which results can be added on top of pro-NT to further quantify the risk of developing breast cancer. In contrast to genetic testing that solely focus on the encoded predisposition to develop breast cancer, pro-NT and pro-ENK values represent the phenotype and show to change following lifestyle adjustments.

About vr-HgH: vr-hGH allows for the assessment of future onset of cardiovascular events in male, such as stroke and myocardial infarction, with a predictive power that largely overshadow the currently known measured parameters like troponin and natriuretic peptides.

About ApoE4 : ApoE4 is a reliable and simple method to detect Apolipoprotein 4, a protein that is widely known to be connected to the future onset of Alzhaimer Disease. Sphingotest® ApoE4 is much simpler and cost-effective than the currently used genetic tests.

SphingoTec GmbH (Hennigsdorf, Germany) develops innovative biomarkers for prediction, diagnosis and therapy monitoring of AKI, congestive heart failure and septic shock. The company, founded by Dr. Andreas Bergmann in 2002, has also in its portfolio biomarkers which can predicts risks of obesity, breast cancer and cardiovascular diseases.

Shuwen Biotech Co. LTD Based in China and led by U.S. and European diagnostic industry veterans, Shuwen Biotech is engaged in licensing, developing, marketing and distributing innovative products and services for disease diagnosis and personalized medicine. The company strives to provide China’s doctors and their patients with a comprehensive menu of the most innovative products and services for improved disease prediction, screening, diagnosis, prognosis and treatment in the areas of cancer, maternal fetal medicine, acute care, and preventive testing.

sphingotec and bestbion dx partner to market predictive biomarkers for guidance of therapy in acute heart failure and septic shock

Mon, 19 May 2025 15:01:35 GMT

Hennigsdorf-Berlin/Cologne 14. May 2017

German diagnostics company SphingoTec GmbH (Hennigsdorf) and bestbion dx GmbH (Cologne) have signed an agreement to market sphingotec’s innovative sepsis and congestive heart failure test (sphingotest® bio-ADM) and acute kidney function monitoring assay (sphingotest® penKid). Under the agreement, bestbion dx will market both biomarker assays, set to improve therapy monitoring and outcomes in intensive care units and emergency departments, in Germany and Austria.

bio-ADM is a biomarker for vascular dysfunction, which allows to predict septic shock and thus can guide treatment choices. In congestive heart failure, bio-ADM is the first biomarker that identifies patients having (residual) edema and patients at high risk to develop life-threating residual (i.e. lung) edemas, caused by incomplete response or therapy resistance to decongestion therapy with loop diuretics. Unidentified residual congestion is the major cause for re-hospitalization and post-discharge mortality in congestive heart failure patients causing 30% of deaths and global annual cost of US$39bn. penKid is a kidney function biomarker predictive for acute kidney failure (AKI), which frequently occurs in congestive heart failure patients receiving diuretics. Monitoring of congestive heart failure patients, who receive diuretics, with both, bio-ADM and penKid, thus allows physicians to prevent AKI while excluding incomplete decongestion.

sphingotest® penKid and sphingotest® bio-ADM complement bestbion dx’s portfolio of marketed assays in the area of congestive heart failure. The company already markets an assay for ST2, an innovative biomarker that detects cardiac remodeling early on and opens the avenue to early intervention and an optimized adjustment of congestive heart failure therapies.

„We are delighted that bestbion dx will distribute our acute care biomarker assays for therapy monitoring and adjustment“, said Dr. Andreas Bergmann, founder and CEO of SphingoTec GmbH. „Our biomarker assays support physicians with information to monitor and adjust the diuretics therapy to the need of each individual patient suffering from congestion“.

„sphingotec’s tests complement our portfolio of marketed biomarker assays to monitor congestive heart failure“, said Werner Dummert, Sales Director of bestbion dx. „ penKid, bio-ADM and ST2 are a dream team for physicians, as they can contribute to significant improvements in the adjustment of beta-blocker and diuretics dosage in congestive heart failure and associated acute kidney injury. The collaboration with sphingotec perfectly reflects bestbion dx’s mission statement „Rescue and sustain lives“.

About congestive heart failure: About 1.8 million Germans and 250.000-300.000 Austrians suffer from congestive heart failure. The characteristic loss of pump function of the heart triggers cardiac remodeling – the heart gets stiffer, fibrotic, and cannot pump enough blood into the circulatory system. The lower pump efficacy causes lower oxygen saturation and results in congestion, which means that blood returning to the heart through the veins backs up, resulting in higher venous pressure and causing fluids to build up in the tissues (edema). About 80% of patients with congestive heart failure are at risk to develop edema, because their microvasculature becomes leaky due to venous hypertension. Physicians try to prevent the worst case – deadly lung edemas – by administration of loop diuretics, which can reduce hypertension by increasing water excretion. However, not all patients fully respond to diuretics. Incomplete response to diuretics therapy is the most common cause of re-hospitalization and post discharge mortality in patients with congestive heart failure. It’s not yet fully understood why patients with congestive heart failure often experience acute kidney injury (AKI). However, there is growing evidence that AKI can be attributed to congestion („cardio-renal syndrome“) and that, vice versa, AKI can trigger heart problems. Management of fluid balance with loop diuretics is challenging – if too much fluid is excreted from tissues, this will support development of AKI. On the other hand, if too little fluid is excreted, lung edemas could return. Besides that, a large proportion of patients with congestive heart failure does not fully respond to diuretics treatment, leading to undetected residual congestion. To date, physicians have no means to identify these patient group at discharge, resulting in high re-hospitalization and post-discharge mortality rates.

A biomarker-assisted diuretics therapy in patients with congestive heart failure, by simultaneous monitoring of bio-ADM and penKid levels, promises lower re-hospitalization and mortality rates.

About ST2: ST2 is a fibrosis marker rapidly indicating cardiac remodeling. It can be used for prognosis and therapy monitoring and dosage adjustment of beta-blocker therapy in patients with congestive heart failure, which has been shown to reduce mortality and re-hospitalization.

SphingoTec GmbH (Hennigsdorf, Germany) develops innovative biomarkers for prediction, diagnosis and therapy monitoring of AKI, congestive heart failure and septic shock. The company, founded by Dr. Andreas Bergmann in 2002, has also in its portfolio biomarkers which can predicts risks of obesity, breast cancer and cardiovascular diseases.

bestbion dx GmbH (Cologne, Germany) is one of the European-leading distributor of innovative diagnostic and prognostic assays with outstanding track-record in Germany and Austria. The private company was founded in 2011 by Bernd Stammel and focuses on microbiology, infectious diseases, molecular biology, cardiology and point-of-care testing.

Good microcirculation indicates increased lifespan

Mon, 19 May 2025 14:57:33 GMT

Hennigsdorf, Germany – 05. September 2016

A study on centenarians links sphingotec’s biomarker bio-Adrenomedullin (bio-ADM) to longevity. Human longevity has been previously linked by researchers to genetic factors, calorie restriction, and certain life-style factors such as physical activity or the Mediterranean diet. Now, Italian researchers from La Sapienza University in Rome have identified an additional factor, which significantly contributes to a longer life. In a pilot study on some of the oldest people of the world, they discovered that the perfusion of organs and muscles of the centenarians was as efficient as that in people who were 30 years younger. Results of the CIAO (Cilento Intitiative on Aging Outcome) pilot study,presented today in the Italian town of Pollica, suggest that low blood levels of the peptide hormone.

Adrenomedullin (bio-ADM) are an indicator for such a good microcirculation. Making longevity measurable has long been a scientific goal as it could open up the avenue to a systematic identification of factors contributing to an extended life span.

Prof. Salvatore Di Somma and his team carried out comprehensive health and life style assessments of two study groups that live in the Cilento region, located in the province of Salerno in southern Italy: In the first were 29 so-called ‘SuperAgers’ (median age 92 years), while the second was made up of 52 younger relatives (median age 60 years, living in the same household) who are expected to live just as long because they have the same genetic background and have been exposed to the same environmental and lifestyle factors. Blood biomarker analyses were carried out by the diagnostic company sphingotec (Hennigsdorf, Germany). It measured levels of the heart-function biomarker MRproANP, as well as a marker for kidney function (penKid) and bio-ADM. The last is a regulator of vasodilation and blood vessel integrity, which both affect blood pressure. The results were compared to those of a cohort of 194 healthy persons (median age 63.9 years), who were monitored over eight years in the earlier Malmö Preventive Project (MPP, Principal Investigator Professor Olle Melander, Lund University, Sweden).

As expected, low values of MR-proANP and penKid among the subjects in the two younger control groups indicated no signs of heart or kidney dysfunction. In contrast, both biomarkers were elevated in the SuperAgers, possibly due to the process of organ aging. However, even though the older group had levels of the two biomarkers that were as high as those found in patients experiencing heart failure (HF) or acute kidney injury (AKI), they were in clinically good condition. Surprisingly, in the group of SuperAgers, the bio-ADM values – which are often pathologically elevated in HF or AKI patients – were as low as those in both reference groups.

“Very low concentrations of this biomarker indicate a well-functioning endothelial and microcirculatory system allowing good blood perfusion of organs and muscles,“ concludes Di Somma. A good microcirculation is what makes marathon runners perform better at the same heart rate than the average man or woman on the street.

“We are excited about the connection between bio-ADM levels and a good microcirculation as an indicator for good quality of life”, says sphingotec founder Andreas Bergmann, who was instrumental in developing the bio-ADM assay. “If bio-ADM proves to be a reliable biomarker for longevity this will open up the avenue to a systematic analysis of the factors contributing to longevity“, he adds. ”We are excited to contribute to the identification of lifestyle factors ensuring a good microcirculation.” The researchers are currently planning to extend the pilot study to 2,000 people from the Cilento region. One major goal of the follow-up study is to investigate whether certain components of the local Mediterranean diet could affect the bio-ADM level. The cuisine typical to the region traditionally uses number of plants native to the area. Another idea is to bring people with high bio-ADM levels to Cilento and measure whether the local environment has an effect on levels of the microcirculation biomarker.

The CIAO (Cilento Intitiative on Aging Outcome) study was designed to identify life style, genetic and epigenetic factors contributing to longevity in the Cilento region. With an average life expectancy of 92 years for women (Italian average: 84) and 85 years for men (Italian average: 79), the Cilento has one of the world’s highest concentrations of centenarians – even higher than in Okinawa (Japan), the most intensively investigated centenarian hotspot. The contributors to the current pilot study were identified through local physicians who acquired the informed consent of their patients. A mobile bus equipped with all instrumentation for a comprehensive health assessment was used to visit the study participants. Additionally, blood samples for biomarker analysis were taken and participants were interviewed about their life style habits.

Microcirculation describes blood flow through the smallest vessels (capillaries) in the circulatory system. In these regions, oxygen and nutrients are directly delivered to cells, while metabolic debris, toxins and CO2 are winnowed out. Blood pressure and body temperature is also controlled by the microcirculation through dilation or constriction of the capillary network that penetrates muscles, organs and skin. If put end-to-end, the body’s capillaries would stretch 90,000-110,000 kilometers – more than twice the circumference of Earth. If placed side-by-side, they would cover an area the size of two football fields (500-700 sqm). On average, people have around 200-300 capillaries/mm2, but endurance athletes like runners can have up to 40% more (300-500 capillaries/mm2). This contributes to better muscle perfusion, oxygen supply and performance.

Salvatore Di Somma (63), Professor of Internal Medicine at the University La Sapienza in Rome, is the organizer of the CIAO pilot study. Strong personal links have given him unique access to the population of centenarians living in the Cilento. In previous studies, he identified rosemary as an ethnobotanically conserved part of the local Mediterranean cuisine that might could be contributing to longevity in the region. Conserved gene variants associated with longevity were also identified in Cilento’s population in the Southern Italy Centenarian Study (SICS). The variants affect insulin sensitivity (FOXOA3, CAMMIV), RNA editing (ADARB1+2) and the aromatase pathway (Cyp19,ESR1). Additionally, a unique profile of lipids in the membrane of red blood cells (erythrocytes) was identified in 2008 within the the framework of the SICS study

Centenarian hotspots: Several regions have been identified by National Geographic writer Dan Buettner as longevity hotspots. They include Okinawa (Japan), Sardinia (Italy), Nicoya (Costa Rica), Icaria (Greece) and a group of Seventh-day Adventists living in Loma Linda (US, California). The Cilento, a mountainous region 150 kilometres south from Naples, is another hotspot of centenarians. Although it didn’t earn a mention in Buettner’s book on the so-called “Blue zones” of centenarians, people who live there are getting older than in Okinawa, Japan, the world's very best-studied longevity hot-spot. Life expectation of women living in the Cilento (92 years) is 8 years above the Italian average; and that of men (85 years) 6 years above, anyway.

Adrenomedullin is a soluble peptide hormone. Mainly released by the inner layer of blood vessels (endothelial cells), its biological function is to control vasodilation, an important regulator of blood pressure and organ perfusion. In several studies involving more than 16.000 patients, the plasma level of the bioactive Adrenomedullin (bio-ADM) has been proven to predict and provide an early diagnosis for circulation dysfunction. For instance, bio-ADM blood levels rise 2-3 days before septic shock occurs. Elevated levels of bio-ADM are a specific indicator of vasodilation and leakage from microcirculatory capillaries, which in sepsis patients subsequently lead to severe hypotension, malperfusion of organs (for which the body can’t compensate by increasing the heart rate), shock and multiple organ failure. Low bio-ADM blood levels, in contrast, are a specific indicator for an intact microcirculation, ensuring good muscle and organ blood supply without any cardiovascular stress.

SphingoTec GmbH (Hennigsdorf, Germany) develops innovative biomarkers for the early diagnosis, prediction and monitoring of severe medical conditions, such as cardiovascular diseases, sepsis, kidney dysfunction and cancer, supporting treatment and prevention strategies.

Located on the outskirts of Berlin, the company was established in 2002. Its founder Dr. Andreas Bergmann was one of the founders of B.R.A.H.M.S. AG, which has become part of ThermoFisher Scientific. As the company‘s former Chief Research Officer, he was responsible for the development of the “gold standard” sepsis biomarker Procalcitonin (B.R.A.H.M.S. PCT™).

DISCLAIMER

This press release contains forward-looking statements, which reflect the Company's current expectations regarding future events. These statements can be identified by the fact that they do not relate strictly to historical or current facts. Forward-looking statements often include words such as "anticipates," "estimates," "expects," "projects," "intends," "plans," "believes" and words and terms of similar substance in connection with discussionsof future operating or financial performance. Although the company believes its expectations are based onreasonable assumptions, these forward-looking statements are subject to numerous uncertainties, which could cause actual results to differ materially from those anticipated. The Company disclaims any obligation to update these statements.

Does the Hormone Neurotensin Hold the Key to a Longer Life?

Mon, 19 May 2025 14:54:53 GMT

Hennigsdorf, Germany – May 12, 2016

Excess weight and obesity, as well as the cardiovascular diseases and diabetes that these conditions are associated with, rank among the most widespread conditions in the world's most developed countries. In the U.S. alone, nearly 70 percent of the population is overweight, and 35 percent is obese, according to the World Health Organization. In an article published in the scientific journal , Swedish and U.S. researchers demonstrate the link for the very first time between neurotensin values and the development of obesity. The hormone neurotensin can show when men and women of normal weight are at risk of becoming overweight and developing the diseases associated with carrying excess weight.

Researchers at the University of Malmö in Sweden have already used two major population studies to show the link between an increased concentration of the hormone neurotensin and the risk of developing certain diseases, in particular, cardiovascular diseases, diabetes and breast cancer. Now, in their latest article published in Nature, Swedish and U.S. researchers have proven that the level of neurotensin in the blood indicates whether individuals of normal weight could become obese.

Their work shows that neurotensin holds the key to how individuals utilize and absorb fat. Long known as the "fat insulin," neurotensin is released in the small intestine, particularly when animal fats are consumed. The results now published in Nature show that neurotensin is the decisive link between fat intake and the risk of developing certain diseases. People with a low fasting level of neurotensin tend not to become obese despite consuming fat and have a low risk of developing cardiovascular diseases, diabetes and breast cancer.

Researchers at biotechnology company sphingotec in Henningsdorf, Germany, have developed the sphingotest® pro-NT test that allows blood levels of neurotensin to be measured for the first time.

"Unlike genetic factors, the concentration of neurotensin in the blood is a variable that can change depending on eating habits and other lifestyle factors," explains Dr. Andreas Bergmann, founder and owner of sphingotec. "People with a low neurotensin level have a better chance of living longer and staying healthy."

Neurotensin levels can be measured as part of routine diagnostic processes using the sphingotest® pro-NT test, which is evaluated in labs using a fasting EDTA blood sample and a standard laboratory immunodiagnostic procedure (Immunoassay). For more on sphingotec and its sphingotest® pro-NT test, please visit www.sphingotec.com.

About sphingotec:

The biotechnology company SphingoTec GmbH, headquartered in Hennigsdorf, Germany was founded in 2002. sphingotec aims to reduce or eliminate the risk of serious diseases such as cancer, cardiovascular diseases and kidney conditions. The process starts before the disease has actually developed: using biomarkers to indicate susceptibility for a specific disease provides healthy individuals with the knowledge that they are at risk. What makes the approach so special is that the biomarkers also create a starting point for preventative strategies at the same time, as evidence-based recommendations on how to reduce risks are always an integral part of the complete concept. Further information can be found on our website at www.sphingotec.de

Researchers Link Low Levels of Pro-Enkephalin to Future Breast Cancer in Healthy Women

Mon, 19 May 2025 14:51:30 GMT

sphingotec announces the publication of trial results showing the strong association between low pro-enkephalin (pro-ENK) levels in plasma and incident breast cancer

Cambridge, Mass. – July 15, 2015 – sphingotec LLC announced today that the results of two studies examining the association between proenkephalin (pro-ENK) and incident breast cancer were published online in the Journal of Clinical Oncology. The studies, which were conducted by researchers at Skåne University Hospital in Malmö, Sweden and together encompass almost 3,500 subjects, demonstrated a strong association between low plasma concentration of the opioid precursor peptide pro-ENK and increased breast cancer risk in middle-aged and post-menopausal women independent from other possible risk factors.

Although experimental studies have established that enkephalins and related opioid hormones can inhibit the growth of cancer cells, these are the first studies to investigate whether plasma concentration of pro-ENK can predict near-term breast cancer risk in healthy women. The strong association between concentrations of pro-ENK and incident breast cancer found during these studies indicates that pro-ENK is a viable tool for predicting breast cancer risk.

The results represent a potential breakthrough in helping women without a known family history of breast cancer understand their own risk. Current tools such as the GAIL risk score are helpful, but the parameters included in the score are non-modifiable, have only weak prognostic power and do not address an individual’s risk. And while mammography is effective at detecting early stage breast cancer, there is ongoing concern about over-diagnosis and missed cases. There is a great need for biomarkers that can identify women at highest risk so that appropriate interventional measures can be taken to prevent clinical manifestation of life-threatening breast cancer.

“Our goal is to prevent deaths related to breast cancer,” said Dr. Andreas Bergmann, founder and CEO for sphingotec. “We have now identified two promising biomarkers to achieve this goal: proneurotensin* (pro-NT) and proenkephalin, which have been demonstrated now in two independent cohorts to predict risk in healthy women. The results of these studies imply great promise for the future of breast cancer prevention. We believe these findings will aid in helping women better understand their breast cancer risk so they can take the appropriate measures for preventing this devastating disease.”

To conduct the first study, Melander et al. measured pro-ENK in fasting plasma from 1,929 healthy women with a mean age of 59 years old participating in the Malmö Diet and Cancer Study (MDCS) and used Cox proportional hazards models to relate pro-ENK to incidence of breast cancer during 15 years of follow up. In the second study, using a case-control design, they sampled 1,569 women from the Malmö Preventive Project with a mean age of 70 years old and used multivariate adjusted logistic regression models to relate pro-ENK and to risk of breast cancer during the observation period.

Results of this study appear online in the Journal of Clinical Oncology.

*Melander et al. JAMA. 2012;308(14):1469-1475

Authors: Olle Melander, Marju Melander, Jonas Manjer, Peter Almgren, Peter Nilsson, Gunnar Engström, Bo Hedblad, Signe Borquist, Ute Kilger, Jennifer Suhr, Oliver Hartmann, Joachim Struck, Andreas Bergmann and Mattias Belting

Majority of Women Do Not Discuss Breast Cancer Risks with Healthcare Provider

Mon, 19 May 2025 14:48:31 GMT

Cambridge, Mass. – May 5, 2015 sphingotec, LLC, a developer of predictive diagnostic tests for cancer, cardiovascular diseases and kidney function, today announced the results of a survey gauging women’s understanding of breast cancer risk factors and their perceptions of common breast cancer screening methods.

The survey was conducted in conjunction with a national, independent health information resource for women, and found that of the 464 anonymous respondents, the majority of women do not discuss breast cancer risk factors or the guidelines and limitations of mammography screenings with their healthcare providers.

“Mammograms remain an important screening tool and can save lives by helping detect some cases of breast cancer early, however women are not aware of the limitations of mammography, nor are they aware of their personal risk factors leading to breast cancer, according to the survey,” said Karla Gonye, president, sphingotec, LLC. “The results of the survey give us insight into the market need for breast cancer biomarkers beyond BRCA 1/2 and further indicate the desire for more risk predictive tests so that women and their doctors can make more informed decisions about their risk of breast cancer.”

The top findings from the survey include:

Overwhelmingly, women want to know more about their personal risk for breast cancer, but rarely or never discuss their risk factors with a healthcare provider.

Nearly all women (99 percent) expressed interest in understanding their personal risk for breast cancer.

However, 65 percent rarely or never discuss their breast cancer risk factors with a healthcare provider, a concerning statistic given that breast cancer is the most common cancer among women.

Those surveyed identified family history (94 percent), use of hormone replacement therapy (73 percent), smoking (64 percent) and age (58 percent) as the top risk factors for breast cancer.

Despite conflicting recommendations around the frequency of mammogram screening and growing evidence that annual screenings can lead to added expense and anxiety due to false-positive results, the majority of women still get annual mammograms.

Sixty-four percent of women get a mammogram once a year.

Nineteen percent get a mammogram every two to three years.

Given that mammograms miss one in five occurrences of breast cancer1, mammography screenings need to be complemented with new and more affordable prognostic tools for assessing and predicting breast cancer risk.

Upon receiving a normal mammogram result, more than half of women (55 percent) believed that they were cancer free, but only 45 percent were aware of the limitations of mammograms in the early detection of breast cancer.

Ninety-six percent of women indicated they want a simple and affordable blood test to determine breast cancer risk.

1National Cancer Institute, https://www.cancer.gov/cancertopics/types/breast/mammograms-fact-sheet

Survey Methodology

This independent survey was conducted online through SurveyMonkey on behalf of sphingotec from April 20 – 23, 2015 among 464 anonymous women living in the United States. Ninety percent of the women surveyed were over the age of 40 and 10 percent were between 20 – 39 years old.

About sphingotec

The biotechnology company SphingoTec GmbH, headquartered in Hennigsdorf, Germany with U.S. operations in Cambridge, Massachusetts, was founded in 2002. sphingotec develops diagnostic methods for prediction, prevention, intervention strategies and early treatment of diseases in the fields of cancer, cardiovascular diseases and kidney function. Using biomarkers to indicate susceptibility for a specific disease provides individuals with knowledge that they are at risk. The biomarkers therefore create a starting point where intervention strategies can be employed, as evidence-based recommendations on how to reduce risks are always an integral part of the complete concept. The company’s sphingotest pro-NT and sphingotest pro-ENK tests take a unique approach to breast cancer prediction that is unlike any other risk assessment test currently available. The tests identify the concentration of the peptides neurotensin (NT) and enkaphalin (ENK) in the blood, which can then determine individual risk levels. Further information can be found on our website www.sphingotec.com.

sphingotec at the St. Gallen International Breast Cancer Conference

Mon, 19 May 2025 14:08:13 GMT

Cambridge, Mass. – Feb. 4, 2015 – sphingotec LLC announced today that the findings from its research seeking to improve breast cancer risk stratification for guiding hormone replacement therapy has been selected for presentation at the 14th annual St. Gallen International Breast Cancer Conference in Vienna, Austria, March 18 – 21, 2015. The poster will be presented by Dr. Uwe Hantke.

sphingotec’s study assessed how plasma pro-neurotensin (pro-NT) and pro-enkephalin (pro-ENK) help predict whether women have high or low risk for developing breast cancer so physicians can make a more informed decision on whether to use hormone replacement therapy. The results concluded that both plasma pro-NT and pro-ENK provide new and independent information above and beyond commonly known breast cancer risk factors that can improve risk stratification.

As further evidence of the power of pro-NT and pro-ENK risk prediction, a theoretical model demonstrated that 10 out of 123 breast cancer occurrences could have potentially been avoided if clinicians knew their patients’ pro-NT and pro-ENK levels put them in an extremely high-risk group and used this information to avoid HRT.

Although extensive research has been conducted around the risks and benefits of HRT there is disagreement on whether the benefits outweigh the risks. According to The Centers for Disease Control and Prevention (CDC), those who caution against using HRT often refer to the increased risk of endometrial and breast cancer associated with using estrogen, especially for extended lengths of time. Those who advocate for its use often point out that HRT appears to reduce the risk of osteoporosis, heart disease and Alzheimer’s disease in addition to alleviating menopausal symptoms. The controversy surrounding HRT leaves clinicians and their patients feeling uncertain about individual breast cancer risk, one of the most common types of cancer for women.

“Studies have shown that hormone replacement therapy can increase the risk of breast cancer, but it varies greatly based on each woman’s individual characteristics and risk factors,” said Dr. Andreas Bergmann, CEO of SphingoTec GmbH. “There is a huge unmet need for improved risk stratification to help doctors decide whether to recommend hormone replacement therapy. We believe our research will enable doctors and their patients to make a more educated decision on whether this treatment is right for them.”

To conduct the study, sphingotec researchers measured pro-ENK and pro-NT in fasting plasma from 1,929 women participating in the Malmö Diet and Cancer Study and used Cox proportional hazards models to relate pro-ENK and pro-NT to first breast cancer events within 15 years of follow up. For the cohort design, they sampled 1,569 women from the Malmö Preventive Project and used multivariate adjusted logistic regression models to relate pro-ENK and pro-NT to first breast cancer events during the observation period. They then analyzed subgroups of women who received HRT to assess the performance of each marker.

This study supports sphingotec’s mission to reduce the incidence of major illnesses such as cancer, cardiovascular conditions and kidney disease through tests that can detect individual risk factors. sphingotec has developed two simple blood tests, sphingotest® pro-NT and the sphingotest® pro-ENK that identifies the concentration of these peptides in the blood. The biomarkers are independently associated with the development of breast cancer above other commonly known risk factors and are applicable to all females, regardless of genetic predispositions. Both pro-neurotensin and pro-enkephalin assays will be available to the U.S. and European markets later this year.

sphingotec also announced today that the breast cancer biomarkers pro-NT and pro-ENK will be featured in a mid-morning session at the American Association of Clinical Chemistry (AACC) Annual Meeting & Clinical Lab Expo in Atlanta, Georgia July 26 – 30, 2015. A panel of leading researchers will address the gaps and limitations in breast cancer prevention programs and how emerging biomarkers can help clinicians and laboratorians address the key challenges. The panelists are:

Dr. Max Wicha, distinguished professor of oncology and director of the Comprehensive Cancer Center at University of Michigan

Dr. Allan Jaffe, M.D., Mayo Clinic cardiologist and division chair, Clinical Core Laboratory Services

Dr. Alan Maisel, director of the Coronary Care Unit and Heart Failure Program at the VA San Diego Healthcare System, Professor of medicine at University of California, San Diego.

sphingotec and GeneNews Limited/Innovative Diagnostics Laboratory (IDL) Sign a Licensing and Cooperation Agreement for the U.S. Market

Mon, 19 May 2025 14:00:40 GMT

Cambridge, Mass. – October 14, 2014 – SphingoTec GmbH, headquartered in Hennigsdorf, Germany with U.S. operations in Cambridge, Massachusetts, today announced that it has out-licensed two of its biomarker assays—sphingotest® pro-NT and sphingotest® pro-ENK—to GeneNews Limited (TSX:GEN). The biomarker assays will aid physicians in risk assessment for breast cancer in females in the general population. sphingotec discovers and develops blood tests to detect cancer, cardiovascular conditions and kidney disease in high-risk patients.

GeneNews expects to add sphingotest pro-NT to the menu of advanced cancer assays offered by its U.S. joint venture, Innovative Diagnostic Laboratory LLP (IDL), by early 2015. GeneNews/IDL will be the first major U.S. laboratory to sell and market sphingotec’s innovative breast cancer risk tests, allowing potentially millions of women to better understand their individual near-term risk of breast cancer. The company is also evaluating the potential expansion of IDL’s testing menu in the area of breast cancer risk prediction through the addition of sphingotest pro-ENK and other biomarker candidates.

GeneNews is committed to helping IDL become a leader in molecular diagnostics and personalized medicine, serving as a strong commercialization outlet for advanced cancer tests. Taking a "multi-view" approach to the diagnosis and treatment of cancer, IDL is working to assemble—through a combination of internal pipeline development, third-party licenses and potential acquisitions—a robust menu of novel, ‎patent-protected cancer assays to be offered throughout the U.S.“We are excited to sign this agreement with GeneNews, especially during Breast Cancer Awareness Month,” said Dr. Andreas Bergmann, founder and managing director of SphingoTec GmbH. “Our partnership will allow sphingotec’s markers to be available to potentially millions of women in the U.S. It is our common goal to lower the incidence of breast cancer by providing tests that are reliable, cost-effective and accessible for patients at risk regardless of health coverage status.”

“sphingotest pro-NT is the third advanced cancer assay added to our offering menu beyond our ColonSentry blood test,” said GeneNews Executive Chairman James R. Howard-Tripp. “We believe sphingotest pro-NT represents a major step forward in breast cancer detection and management, and we are looking forward to making it available to U.S. physicians nationwide through IDL as soon as possible.”

Breast cancer is the second leading cause of cancer death in U.S. women, exceeded only by lung cancer. The American Cancer Society estimates that, in 2014, approximately 232,670 new cases of invasive breast cancer will be diagnosed in women, and approximately 40,000 women will die from the disease. As with most cancers, early identification of high-risk women and intervention are the keys to improved clinical decision making.

Unlike other blood tests on the market that look for genetic indicators for breast cancer, sphingotest pro-NT is a simple blood test for the determination of proneurotensin (pro-NT). sphingotest pro-NT detects the release of the satiety hormone neurotensin and is applicable to all female individuals, regardless of genetic predispositions. A study published in the peer-reviewed Journal of the American Medical Association (JAMA) in October 2012 demonstrated that the determination of proneurotensin levels offered a substantial advantage in prediction of breast cancer (O. Melander et al. [2012]. Plasma Pro-Neurotensin Independently Predicts Cardiometabolic Diseases, Breast Cancer, and Death In Women. Journal of the American Medical Association, 308[14], 1469-1475).

In addition, experts in the fields of breast cancer treatment and biomarker research also support the work sphingotech is conducting.

“Breast cancer risk prediction is a major advancement for science because it’s one of the main ways we can detect and treat high-risk individuals appropriately,” said Dr. Max S. Wicha, MD, professor of internal medicine and director of the University of Michigan’s Comprehensive Care Center. “This could be the future of lowering the incidence of breast cancer.”

“It is exciting to see that inexpensive, blood-based protein biomarkers are now available for detecting women who are at high risk for breast cancer, even when the family history is completely negative,” said Dr. Alan S. Maisel, professor of medicine at the University of California San Diego and director of the Coronary Care Unit and Heart Failure Program at the Veterans Affairs San Diego Healthcare System.