SeaStar Medical says FDA confirmed QUELIMMUNE post-approval study requirements are fulfilled
SeaStar Medical announced that the FDA's Center for Biologics Evaluation and Research determined the QUELIMMUNE Pediatric SAVE Surveillance Registry has fulfilled the post-approval study requirements of the original Humanitarian Device Exemption approval. The company says the decision lets hospitals use QUELIMMUNE without the research infrastructure the registry required, which could expand access for critically ill children with sepsis-associated acute kidney injury. The filing gives no revenue, earnings, or financial figures.
Key points
- FDA's CBER determined the SAVE Registry met post-approval study requirements, announced November 3, 2026
- Registry results showed 90-day survival of 65.1% for QUELIMMUNE patients (N=43) versus 47.5% for comparison patients (N=196), P = 0.043
- SeaStar says hospitals may now use QUELIMMUNE without registry research infrastructure; the company will continue voluntary enrollment
The filing
Written by AI on Nov 9, 2026, 11:43 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on November 03, 2026.
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