SeaStar Medical Completes FDA-Mandated Enrollment for QUELIMMUNE Pediatric AKI Safety Registry

Reuters03-05

SeaStar Medical Completes FDA-Mandated Enrollment for QUELIMMUNE Pediatric AKI Safety Registry

SeaStar Medical Holding Corporation said it has completed required enrollment in the FDA-mandated SAVE Surveillance Registry, a post-approval study designed to confirm the safety of its QUELIMMUNE therapy for children with acute kidney injury due to sepsis or a septic condition requiring renal replacement therapy. The registry has enrolled 50 patients; the company said it will analyze the data and submit 28-day safety results to the FDA in the coming months. SeaStar also noted that early SAVE Registry results have already been published in the peer-reviewed journal Pediatric Nephrology.

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: 202603050820PRIMZONEFULLFEED9666273) on March 05, 2026, and is solely responsible for the information contained therein.

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