FDA Confirms SeaStar Medical Has Fulfilled the Post-Approval Study Requirements for QUELIMMUNE® for the Treatment of Sepsis-Associated Acute Kidney Injury (AKI) in Pediatric Patients

DENVER, Nov. 03, 2026 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transformational treatments for critically ill patients facing organ failure and potential loss of life, announced today the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) has determined that the QUELIMMUNE Pediatric SAVE Surveillance Registry (SAVE Registry) has fulfilled the post-approval study requirements as outlined in the original Humanitarian Device Exemption (HDE) approval of QUELIMMUNE.