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

• 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

August 27, 2026
In a prospective, real-world study of 1,436 critically ill ICU patients, proenkephalin A 119–159 (penKid) provided clinically relevant information across AKI severity and during kidney replacement therapy (KRT). PenKid addressed a key unmet need in KRT management by identifying, with greater precision than standard biomarkers, patients at high risk of KRT liberation failure – helping to avoid stopping therapy too early. The findings support a future role for penKid in helping to standardize one of the few intensive care processes where the need for better decision support is widely acknowledged and current tools remain insufficient. Hennigsdorf, Germany – August 27, 2026 – SphingoTec GmbH announces the publication of new real-world data on proenkephalin A 119–159 (penKid) in critically ill patients. The data, published in Annals of Intensive Care, add to the growing body of evidence supporting penKid as a functional biomarker for kidney function and help inform clinical decision-making in AKI and KRT (1). In a prospective observational study at Heidelberg University Hospital, penKid was measured in 1,436 critically ill patients, including 138 patients receiving KRT for liberation analyses. The findings showed that penKid rose with AKI severity and, unlike serum creatinine and urine output, distinguished stage 3 AKI patients with and without an acute KRT requirement. In contrast to serum creatinine, penKid also differentiated acute KRT patients from those with pre-existing kidney failure and on chronic hemodialysis prior ICU admission, even while KRT treatment was ongoing (1). The study further showed that penKid levels increased progressively from the start of KRT, while serum creatinine decreased under treatment. Following successful liberation from KRT, penKid declined, whereas higher levels were seen in cases of liberation failure. In multivariable analysis, penKid was the strongest independent predictor of liberation failure and outperformed serum creatinine. A penKid cut-off of ≥250 pmol/L provided more than 90% specificity for liberation failure (1). By identifying patients at high risk of unsuccessful liberation, penKid may help clinicians make KRT discontinuation decisions more objectively, reduce the risk of stopping therapy too early, and support more standardized decision-making across critical care settings. “These data are important because they address a real-world clinical problem: how to better assess kidney function and support KRT decisions when standard markers fall short,” said Deborah Bergmann, CEO of SphingoTec. “penKid provides clinicians with an objective, real-time measurable parameter that may help support more informed and consistent kidney-related decisions in critical care.” Christian Nusshag, MD, Department of Nephrology, Heidelberg University Hospital, said: “Current markers often leave clinicians with an incomplete picture. Our findings suggest that penKid may help standardize decision-making by providing additional, actionable information on kidney integrity and recovery.” About penKid, scientific insights PenKid is a biomarker that enables real-time assessment of kidney function. Unlike conventional markers such as serum creatinine, penKid levels are not influenced by inflammation or other confounding factors like age or sex. Studies have shown that penKid allows earlier detection of AKI, predicting changes in serum creatinine up to 48 hours before conventional diagnostic criteria are met. This early detection capability is particularly valuable in critically ill patients, including those with sepsis or septic shock. Additionally, penKid has shown potential for monitoring renal recovery under KRT and could help predict successful liberation from KRT. 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, and bioactive Adrenomedullin 1-52 (bio-ADM), a biomarker for the assessment of endothelial function in conditions like acute heart failure. Discover more on www.sphingotec.com References (1) Gabriel DC, Sauer P, Happel R, et al. Proenkephalin A for Assessing Kidney Integrity and Guiding KRT Liberation Decisions in Critically Ill Patients. Annals of Intensive Care. 2026. DOI: 10.1016/j.aicoj.2026.100113. Media Contact: Email: press@sphingotec.com Phone +49-3302-20565-0 SphingoTec GmbH Neuendorfstr. 15A 16761 Hennigsdorf, Germany
August 19, 2026
Hennigsdorf, Germany – August 19, 2026 – Over the coming months, SphingoTec will be present at a series of leading conferences in diagnostics and critical care medicine. These engagements reflect the company’s ongoing commitment to advancing biomarker-driven solutions that support earlier and more precise clinical decision-making in acute and critical care settings. The company’s conference schedule includes: DGAI (Deutsche Gesellschaft für Anästhesiologie und Intensivmedizin), September 16-18, 2026, Kassel, Germany Kongress für Nephrologie 2026 (DGFN / Deutsche Gesellschaft für Nephrologie), October 08-11, 2026, Leipzig, Germany ESICM Lives, October 10-14, 2026, Lisbon, Portugal – SphingoTec will co-host a Scientific Symposium together with business partner Boditech, focusing on innovations in sepsis diagnostics. In parallel, new clinical data on penKid in a multicenter sepsis study will be presented as a poster at the ESICM congress. ASN Kidney Week 2026, Denver, CO, USA, October 22–25, 2026 – penKid takes center stage in the poster sessions with the abstract “Proenkephalin Predicts Severe AKI in High-Risk Patients” Medica, November 16-19, 2026, Düsseldorf, Germany – Focus on expanding SphingoTec’s international industry network and advancing partnering opportunities for its biomarker portfolio. DIVI (Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin), December 2-4, 2026, Hamburg, Germany  “These events bring together clinicians, researchers, and industry partners who share our goal of improving outcomes for patients in critical care,” said Deborah Bergmann, CEO of SphingoTec. “By presenting our latest data and engaging in direct dialogue, we aim to strengthen collaborations that translate biomarker innovation into real clinical value.” 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, and bioactive Adrenomedullin 1-52 (bio-ADM), a biomarker for the assessment of endothelial function in conditions like acute heart failure. Discover more on www.sphingotec.com Media Contact: Email: press@sphingotec.com Phone +49-3302-20565-0 SphingoTec GmbH Neuendorfstr. 15A 16761 Hennigsdorf, Germany