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)
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.
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