SeaStar Medical's NEUTRALIZE-AKI trial enrollment reaches 125 patients, 16th site activated.

SeaStar Medical has reached over 60% enrollment in its NEUTRALIZE-AKI clinical trial with 125 of 200 anticipated patients enrolled. The company has activated its 16th clinical trial site and remains on track for an interim analysis of the first 100 patients in the third quarter of 2025.

SeaStar Medical Holding Corporation (Nasdaq: ICU) has made significant progress in its NEUTRALIZE-AKI pivotal clinical trial, reaching over 60% enrollment with 125 of 200 anticipated patients enrolled. The company has activated its 16th clinical trial site, Methodist Hospital Metropolitan in San Antonio, Texas, and remains on track for an interim analysis of the first 100 patients in the third quarter of 2025 [2].

The NEUTRALIZE-AKI trial is designed to enroll up to 200 adult patients with acute kidney injury (AKI) requiring continuous renal replacement therapy (CRRT). The primary endpoint of the trial is a composite of 90-day mortality or dialysis dependency of patients treated with SCD therapy in addition to CRRT, compared to the control group receiving only CRRT. The trial's secondary endpoints include mortality at 28 days, ICU-free days in the first 28 days, major adverse kidney events at Day 90, and dialysis dependency at one year [2].

SeaStar Medical's SCD therapy has been granted Breakthrough Device Designation by the FDA for the treatment of adult AKI requiring CRRT. The company's Chief Medical Officer, Kevin Chung, MD, stated, "We are very pleased to reach this new enrollment milestone in the NEUTRALIZE-AKI pivotal trial. We are also thrilled to welcome Methodist Hospital Metropolitan as a key addition to our clinical trial sites" [2].

The interim analysis, conducted by the trial's independent Data Safety Monitoring Review Board (DSMB), will validate the therapy's safety profile and efficacy potential. The company intends to disclose only the top-line decision from the analysis by the DSMB to preserve the integrity of the ongoing trial [2].

SeaStar Medical's progress in the NEUTRALIZE-AKI trial underscores its commitment to transforming treatments for critically ill patients facing organ failure and potential loss of life. The company's ability to reach over 60% enrollment in a short period and activate additional clinical trial sites demonstrates its effectiveness in patient recruitment and trial management.

References:
[1] https://www.globenewswire.com/news-release/2025/08/05/3127167/0/en/Purespring-Therapeutics-receives-UK-CTA-approval-for-Phase-I-II-clinical-trial-of-PS-002-in-patients-with-primary-IgA-nephropathy-IgAN.html
[2] https://www.globenewswire.com/news-release/2025/08/06/3128341/0/en/SeaStar-Medical-Reaches-New-Enrollment-Milestone-in-NEUTRALIZE-AKI-Pivotal-Trial-of-SCD-Therapy-for-Adult-Patients-with-Acute-Kidney-Injury-AKI.html