sphingotec raises €20 million from HBM and Wellington Partners
- 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 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.
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.
• 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 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