Endothelial disruption: Rapid translation from bench to bedside
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.
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.
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