SeaStar Medical Advances NEUTRALIZE-AKI Trial with Over 60% Enrollment, Plans 2026 PMA Filing for SCD Therapy
Reuters
Aug 14
SeaStar Medical Advances NEUTRALIZE-AKI Trial with Over 60% Enrollment, Plans 2026 PMA Filing for SCD Therapy
SeaStar Medical Holding Corporation has announced significant progress in its clinical trials and market expansion. The company has reached the 50% patient enrollment milestone in its NEUTRALIZE-AKI pivotal clinical trial, with 125 of the anticipated 200 patients now enrolled. Interim analysis results from the trial's independent Data Safety Monitoring Review Board are expected in the third quarter of 2025. Additionally, SeaStar Medical has expanded its QUELIMMUNE customer base by securing three top-rated U.S.-based children's hospitals. Positive survival results have been reported for the first 20 pediatric patients treated with QUELIMMUNE in a commercial setting, as part of the SAVE Surveillance Registry. The company plans to file a Pre-Marketing Approval application for its Selective Cytopheretic Device therapy in 2026, contingent upon successful trial outcomes.
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