SeaStar Medical Announces FDA Approval of Reduction in Mandatory Enrollment for SAVE Surveillance Registry Evaluating QUELIMMUNE™ Safety for Pediatric AKI
SeaStar Medical Holding Corporation (ICU)
Company Research
Source: GlobeNewswire
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 and Drug Administration (FDA) has approved a reduction in the mandatory enrollment size of the SAVE Surveillance Registry from the originally-required 300 patients to only 50 patients. This new 50-patient registry size will satisfy the post-approval surveillance requirement by the FDA as outlined in the original Humanitarian Device Exemption (HDE) approval and indicates that FDA believes that continued device safety can be successfully shown with fewer patients than originally required. T
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News
- SeaStar Medical to Present at Upcoming NobleCon21 Investor ConferenceGlobeNewswire
- SeaStar Medical Announces Appointment of Michael Messinger as CFOGlobeNewswire
- SeaStar Medical to Report Third Quarter Financial Results on November 13, 2025GlobeNewswire
- SeaStar Medical Reports Positive Early Results for QUELIMMUNE Therapy in Pediatric Acute Kidney Injury (AKI) at the 5th International Symposium on Acute Kidney Injury in ChildrenGlobeNewswire
- SeaStar Medical Reports DSMB Recommendation to Continue the NEUTRALIZE-AKI Pivotal Trial in Adult Acute Kidney InjuryGlobeNewswire
ICU
Sec Filings
- 11/20/25 - Form 424B5
- 11/17/25 - Form 8-K
- 11/14/25 - Form DEF
- ICU's page on the SEC website