SeaStar Medical Reports DSMB Recommendation to Continue the NEUTRALIZE-AKI Pivotal Trial in Adult Acute Kidney Injury
SeaStar Medical Holding Corporation (ICU)
Company Research
Source: GlobeNewswire
Independent DSMB reports zero device-related safety issuesSupports potential clinical benefitTrial sample size re-estimated to strengthen statistical power DENVER, Sept. 24, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life, announced today that the independent Data Safety Monitoring Review Board (DSMB) has recommended the continuation of the NEUTRALIZE-AKI pivotal trial of the Selective Cytopheretic Device (SCD) therapy in adult patients with acute kidney injury (AKI) requiring continuous renal replacement therapy (CRRT). The interim analysis by the independent DSMB evaluated the safety and potential clinical benefit of the first 100 patients enrolled in the NEUTRALIZE-AKI pivotal clinical trial. The DSMB reported: No device-related safety concerns, with zero device-related adverse events. This is consisten
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News
- SeaStar Medical Announces FDA Approval of Reduction in Mandatory Enrollment for SAVE Surveillance Registry Evaluating QUELIMMUNE™ Safety for Pediatric AKIGlobeNewswire
- SeaStar Medical to Present at Upcoming NobleCon21 Investor ConferenceGlobeNewswire
- SeaStar Medical Announces Appointment of Michael Messinger as CFOGlobeNewswire
- SeaStar Medical to Report Third Quarter Financial Results on November 13, 2025GlobeNewswire
- SeaStar Medical Reports Positive Early Results for QUELIMMUNE Therapy in Pediatric Acute Kidney Injury (AKI) at the 5th International Symposium on Acute Kidney Injury in ChildrenGlobeNewswire
ICU
Sec Filings
- 11/20/25 - Form 424B5
- 11/17/25 - Form 8-K
- 11/14/25 - Form DEF
- ICU's page on the SEC website