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SeaStar Medical Announces FDA Approval of Reduction in Mandatory Enrollment for SAVE Surveillance Registry Evaluating QUELIMMUNE™ Safety for Pediatric AKI

FDA lowers surveillance requirement to 50 patients from 300 patients in original HDE approval based on assessment of first 21 SAVE Surveillance Registry patients Compelling efficacy data to date along with completion of registry expected to expand QUELIMMUNE market opportunity DENVER, Dec. 02, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company, announced today the Center for Biologics Evaluation and Research (CBER) of the U.S. Food a

articleSeastar Medical Holding CorporationDecember 2, 202510/company/lmf-acquisition-opportunities-inc/news/seastar-medical-announces-fda-approval-132700462
SeaStar Medical Announces FDA Approval of Reduction in Mandatory Enrollment for SAVE Surveillance Registry Evaluating QUELIMMUNE™ Safety for Pediatric AKI

About this update from Seastar Medical Holding Corporation

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Food and Drug AdministrationSeaStarSurveillanceacute kidney injuryRenal Replacement Therapypediatric patientssurvival ratepatient registryQUELIMMUNEhistorical data