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FDA confirms fulfillment of post-approval study requirements for pediatric QUELIMMUNE therapy
ICUCWSeaStar Medical Holding Corp
The U.S. Food and Drug Administration has determined that the QUELIMMUNE Pediatric SAVE Surveillance Registry has fulfilled all post-approval study requirements outlined in the original Humanitarian Device Exemption approval for QUELIMMUNE. This regulatory confirmation allows hospitals to employ the therapy without the research infrastructure previously mandated by the registry, thereby expanding access to critically ill pediatric patients with sepsis-associated acute kidney injury requiring renal replacement therapy. The decision follows data presented at ASN Kidney Week 2026 showing a statistically significant improvement in 90-day survival for treated patients compared to historical cohorts. SeaStar Medical Holding Corporation is a commercial-stage healthcare company focused on transformational treatments for critically ill patients facing organ failure and potential loss of life.