SeaStar Medical Announces Completion of FDA Enrollment Requirement for SAVE Surveillance Registry Evaluating QUELIMMUNE Safety for Pediatric AKI
SeaStar Medical Holding Corporation (ICU)
Company Research
Source: GlobeNewswire
DENVER, March 05, 2026 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company, announced today that it has completed the required enrollment in the SAVE Registry, a Post-Approval Study (PAS) required by the FDA that is designed to confirm the safety of the QUELIMMUNE™ therapy as a treatment for children with acute kidney injury (AKI) due to sepsis or a septic condition requiring renal replacement therapy (RRT). The registry has successfully enrolled 50 patients, and the company will be reporting the 28-day safety results from the SAVE Registry to the FDA upon completion of its analysis of the data. “The early results from the SAVE Registry, as published recently in the prestigious, peer-reviewed journal Pediatric Nephrology, have provided valuable clinical outcomes data on both the safety and probable benefit of our QUELIMMUNE therapy,” stated Eric Schlorff, CEO of SeaStar Medical. “We look forward to evaluating the safety data
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News
- Life Sciences Virtual Investor Forum Presentations Now Available for Online ViewingGlobeNewswire
- Life Sciences Virtual Investor Forum Agenda Announced for March 11th & 12thGlobeNewswire
- SeaStar Medical to Present at the Life Sciences Investor Forum on March 11thGlobeNewswire
- SeaStar Medical (NASDAQ:ICU) was given a new $6.00 price target on by analysts at Maxim Group.MarketBeat
- SeaStar Medical Announces Publication in Pediatric Nephrology of Positive Real-World Experience for QUELIMMUNE™ (SCD-PED) Therapy in Pediatric Acute Kidney Injury (AKI)GlobeNewswire
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Sec Filings
- 2/13/26 - Form SCHEDULE
- 2/10/26 - Form 4
- 2/10/26 - Form 4
- ICU's page on the SEC website