Santersus Advances NUC-CAP Sepsis Pivotal Study
The randomized trial will test whether the NucleoCapture blood-purification device improves outcomes in critically ill patients with sepsis and respiratory failure.
Updated on Nov. 5, 2026 in Biotech
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Santersus has advanced NUC-CAP, a multicentre, randomised pivotal study of its investigational NucleoCapture technology. Axcellant has been appointed global contract research organization for the study.
Why it matters
Sepsis remains a major global killer, with World Health Organization estimates for 2017 counting approximately 48.9 million cases and 11 million sepsis-associated deaths worldwide. NucleoCapture is being tested as an adjunctive treatment in critically ill patients, a population where new therapeutic options are scarce.
The trial will enroll up to 350 patients randomized 1:1 to standard of care with or without NucleoCapture, with a primary endpoint measured through day 28. Efficacy results are not yet available, and the study has not reported outcomes.
The players
Santersus
Santersus is the company developing NucleoCapture and sponsoring the NUC-CAP pivotal study.
Axcellant
Axcellant is a contract research organization that was appointed global CRO for the NUC-CAP study.
The details
NucleoCapture removes neutrophil extracellular traps from the bloodstream through selective extracorporeal adsorption. NETs have been linked to inflammatory and thrombotic processes and organ injury when excessive, and the NUC-CAP study enrolls critically ill sepsis patients with respiratory failure.
Timeline
2022: NucleoCapture received FDA Breakthrough Device Designation as an adjunctive sepsis treatment.
Q4 2027: Targeted interim analysis of the NUC-CAP study.
Q2 2028: Planned EU launch following potential CE certification.
Q2 2029: Planned PMA submission to the FDA.
Roadmap
NucleoCapture's Breakthrough Device Designation from the FDA in 2022 signals regulatory priority for adjunctive sepsis therapies. The NUC-CAP study moves the device from early evidence toward a premarket approval submission planned for 2029.
If approved, NucleoCapture would add a new adjunctive option for critically ill sepsis patients receiving standard care. The device's real-world availability and cost remain undetermined until the trial reports and regulators act.
The takeaway
Sepsis treatment is an area where adjunctive therapies are urgently needed, and the NUC-CAP trial will show whether targeting neutrophil extracellular traps improves survival and organ support outcomes. Readers should watch for the interim analysis in late 2027.
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.
Further reading
Explore more biotech developments shaping treatments for critical illness.
Source note: This article includes information reported by PharmaTimes.
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