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

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

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
