Up to 350-patient randomized NUC-CAP study to assess safety, organ support and organ dysfunction in sepsis; Axcellant appointed global CRO to support execution

ZURICH, SWITZERLAND, October 22, 2026 /EINPresswire.com/ -- Santersus AG (“Santersus” or the “Company”), a privately held therapeutic medical device company advancing its NucleoCapture^® selective blood purification platform, today announced the advancement of its NUC-CAP pivotal clinical study evaluating NucleoCapture in critically ill patients with sepsis.

NUC-CAP is a multicenter, randomized pivotal study expected to enroll up to 350 patients with sepsis and respiratory failure across clinical sites in the United States and Europe. Patients will be randomized 1:1 to receive either standard of care alone or standard of care with NucleoCapture. The study is designed to evaluate device-related safety and a primary effectiveness endpoint comprising all-cause mortality through Day 28 and Organ Support-Free Days (“OSFD”) through Day 28, evaluated using win ratio methodology.

The first interim analysis of 100 patients and an EU regulatory submission are targeted for the fourth quarter of 2027. CE certification and a potential EU market launch are targeted for the second quarter of 2028. Enrollment completion and a PMA submission are targeted for the second quarter of 2029, followed by potential PMA approval and a U.S. market launch in the fourth quarter of 2029.

The global sepsis therapeutics market is projected to reach approximately $5.6 billion by 2030.¹

The advancement of NUC-CAP represents an important transition for the NucleoCapture program into pivotal clinical development and further advances what is expected to become a key clinical program.

NucleoCapture is a proprietary extracorporeal adsorption technology designed to selectively remove circulating neutrophil extracellular traps (“NETs”) from the bloodstream. Elevated levels of NETs have been associated with inflammatory, thrombotic and organ-damaging processes in severe disease. In sepsis, where progressive organ dysfunction remains a major driver of morbidity and mortality, NUC-CAP is designed to evaluate whether removal of circulating NETs can translate into clinically meaningful benefit.

“The advancement of NUC-CAP into pivotal development is a significant milestone for Santersus because it moves NucleoCapture into a rigorous, multinational clinical program designed to evaluate endpoints that matter in the treatment of critically ill patients,” said James Ladtkow, Chief Executive Officer of Santersus AG. “Our objective is to build a robust body of clinical evidence around a differentiated therapeutic approach: directly removing circulating NETs that are associated with inflammatory, thrombotic and organ-damaging processes. With an up to 350-patient randomized study, global clinical infrastructure being established and Axcellant supporting execution, we believe we are putting the pieces in place to evaluate NucleoCapture in a disciplined and clinically meaningful way.”

Santersus has appointed Axcellant as the global clinical research organization supporting execution of NUC-CAP. Axcellant will provide capabilities across key elements of the program, including global clinical operations, study start-up, medical monitoring, pharmacovigilance and clinical program coordination.

The appointment provides Santersus with global clinical infrastructure to support a complex multinational pivotal study as site start-up and activation activities progress across participating regions.

“We are pleased to support Santersus in the global execution of NUC-CAP,” said Wojciech Kula, CEO of Axcellant. “The study represents an important clinical undertaking in a critically ill patient population, and our team will bring integrated clinical-development capabilities to support disciplined execution across participating regions.”

About Santersus AG

Santersus AG is a therapeutic medical device company developing NucleoCapture^® — its selective extracorporeal blood purification platform designed to selectively remove neutrophil extracellular traps (NETs) to treat acute and chronic conditions across critical care, autoimmunity and transplantation.

For more information, please visit www.santersus.com.

About Axcellant

Axcellant is a specialist global clinical research organization supporting biotechnology, pharmaceutical and medical-device companies in the development and execution of complex clinical programs.

Axcellant provides integrated capabilities across clinical strategy, regulatory support, clinical operations, medical monitoring, pharmacovigilance, data management and biostatistics, with experience in complex multinational studies.

For more information, please visit www.axcellant.com.

¹ Source: Grand View Research, Sepsis Therapeutics Market Size, Share & Trends Analysis Report, 2025–2030, January 2025.

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Santersus AG