Sepsis Device Enters Pivotal Trial
The NucleoCapture study tests whether removing neutrophil extracellular traps improves outcomes, with FDA approval targeted for 2029 if results hold.
Updated on Nov. 5, 2026 in Biotech
Live Poll
Should new medical devices be tested in clinical trials before treating sepsis patients?
Santersus has advanced NUC-CAP, a multicentre, randomised pivotal study of its investigational NucleoCapture blood-purification device in critically ill patients with sepsis and respiratory failure. Axcellant has been appointed global contract research organization for the study, which is at the pivotal stage rather than an approved therapy.
Why it matters
The trial tests whether removing neutrophil extracellular traps from the bloodstream can improve outcomes in sepsis, a condition the World Health Organization linked to roughly 11 million deaths in 2017. NETs have been associated with inflammatory and clotting processes and organ injury when excessive, which is why a device targeting them is being studied as an adjunctive therapy.
The study's primary effectiveness endpoint combines all-cause mortality through day 28 with organ support-free days through day 28, a composite measure that captures survival and recovery together. No measured performance figures for NucleoCapture are available yet, so its effect relative to standard of care remains untested.
The players
Santersus
A company developing NucleoCapture, an investigational extracorporeal blood-purification device for sepsis that targets neutrophil extracellular traps.
Axcellant
A contract research organization appointed as global CRO for the NUC-CAP pivotal sepsis study.
The details
NucleoCapture is an investigational extracorporeal blood-purification technology, meaning blood is routed outside the body through a device and returned after treatment. It removes circulating neutrophil extracellular traps — web-like structures of DNA and proteins released by immune cells called neutrophils — through selective extracorporeal adsorption, a process in which target molecules bind to a material inside the device. In the NUC-CAP study, participants are randomised 1:1 to standard of care alone or standard of care plus NucleoCapture.
Timeline
NucleoCapture received FDA Breakthrough Device Designation as an adjunctive sepsis treatment in 2022.
Santersus is targeting an interim analysis of NUC-CAP in Q4 2027.
Santersus plans a PMA submission to the FDA in Q2 2029, with potential approval and US launch in Q4 2029.
The Tech Race
NucleoCapture advances from its 2022 FDA Breakthrough Device Designation into a pivotal randomised trial, a step toward a PMA submission planned for Q2 2029. The study is positioned as an adjunctive extracorporeal approach alongside standard sepsis care rather than a replacement for it.
Patients with sepsis and respiratory failure are the population this study enrols, but the device is not available outside the trial, and no commercial availability or pricing has been announced. Any clinical use would depend on trial results and regulatory approval, with a US launch no earlier than the planned Q4 2029 timeline.
The takeaway
Watch the interim analysis of the NUC-CAP study, targeted for Q4 2027, for the first data on whether NucleoCapture affects sepsis outcomes. Any result will be measured against the composite day-28 endpoint of mortality and organ support-free days.
What happens next
Santersus is targeting an interim analysis of the NUC-CAP study in Q4 2027, followed by a planned PMA submission to the FDA in Q2 2029 and a targeted EU launch in Q2 2028 following potential CE certification.
Further reading
For broader context on how novel treatments move through regulators, see Biotech coverage across the United States.
Source note: This article includes information reported by PharmaTimes.
Live Poll
Should new medical devices be tested in clinical trials before treating sepsis patients?
