SeaStar Medical Announces DSMB-Backed Continuation and Expanded Enrollment of Pivotal NEUTRALIZE-AKI Trial for Acute Kidney Injury Therapy

Reuters

2025/09/25

SeaStar Medical Announces DSMB-Backed Continuation and Expanded Enrollment of Pivotal NEUTRALIZE-AKI Trial for Acute Kidney Injury Therapy

SeaStar Medical Holding Corporation has announced that the independent Data Safety Monitoring Review Board (DSMB) has recommended continuation of the NEUTRALIZE-AKI pivotal trial evaluating the Selective Cytopheretic Device $(SCD)$ therapy in adult patients with acute kidney injury (AKI) requiring continuous renal replacement therapy (CRRT). The DSMB reported no device-related safety concerns and identified a signal of potential clinical benefit in the treatment group across key study outcomes. To strengthen statistical power, the DSMB advised increasing total enrollment from 200 to 339 patients. As of the latest update, 137 patients have been enrolled, and study completion is projected near the end of 2026. Results from the trial have not yet been presented, as patient enrollment is ongoing.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Seastar Medical Holding Corporation published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9534782-en) on September 24, 2025, and is solely responsible for the information contained therein.

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The DSMB reported no device-related safety concerns and identified a signal of potential clinical benefit in the treatment group across key study outcomes. To strengthen statistical power, the DSMB advised increasing total enrollment from 200 to 339 patients. As of the latest update, 137 patients have been enrolled, and study completion is projected near the end of 2026. Results from the trial have not yet been presented, as patient enrollment is ongoing.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<em>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. 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SeaStar Medical Holding Corporation has announced that the independent Data Safety Monitoring Review Board  has recommended continuation of the NEUTRALIZE-AKI pivotal trial evaluating the Selective Cytopheretic Device  therapy in adult patients with acute kidney injury  requiring continuous renal replacement therapy . The DSMB reported no device-related safety concerns and identified a signal of potential clinical benefit in the treatment group across key study outcomes. To strengthen statistical power, the DSMB advised increasing total enrollment from 200 to 339 patients. As of the latest update, 137 patients have been enrolled, and study completion is projected near the end of 2026. 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The DSMB reported no device-related safety concerns and identified a signal of potential clinical benefit in the treatment group across key study outcomes. To strengthen statistical power, the DSMB advised increasing total enrollment from 200 to 339 patients. As of the latest update, 137 patients have been enrolled, and study completion is projected near the end of 2026. Results from the trial have not yet been presented, as patient enrollment is ongoing.\n      \n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Seastar Medical Holding Corporation published the original content used to generate this news brief via GlobeNewswire (Ref. 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