Health
SeaStar Medical Reports DSMB Recommendation to Continue the NEUTRALIZE-AKI Pivotal Trial in Adult Acute Kidney Injury
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
About this update from Seastar Medical Holding Corporation
[{"type":"image","alt":"SeaStar Medical","displaySize":"","headline":null,"caption":"SeaStar Medical","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":110,"url":"https://media.zenfs.com/en/globenewswire.com/4c7240b3e0b5bc01bb2108fbeef0b4c6"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/LUjJFfXNTg2cjq9rPHCJQQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTE1NDtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/4c7240b3e0b5bc01bb2108fbeef0b4c6","width":300,"height":110}},"lazy":false},{"type":"text","content":"Independent DSMB reports zero device-related safety issuesSupports potential clinical benefitTrial sample size re-estimated to strengthen statistical power","length":157,"tagName":"p"},{"type":"text","content":"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).","length":547,"tagName":"p"},{"type":"text","content":"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:","length":196,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"No device-related safety concerns, with zero device-related adverse events. This is consistent with the previously published safety profile of the SCD therapy as well as the preliminary results from the QUELIMMUNE SAVE pediatric registry.","length":238,"tagName":"p"}]},{"val":[{"type":"text","content":"A signal of potential clinical benefit in the treatment group across key study outcome measures.","length":96,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":334,"olType":false},{"type":"text","content":"To ensure the study is adequately powered to validate the potential clinical efficacy signal, the DSMB recommended increasing the total enrollment from 200 to 339 patients, consistent with the trial’s statistical analysis plan. ...