USFDANov 3, 2026, 08:22 AM
SeaStar Medical's QUELIMMUNE Therapy Meets FDA Post-Approval Requirements
AI Summary
SeaStar Medical Holding Corp announced that the FDA's Center for Biologics Evaluation and Research (CBER) has determined that the QUELIMMUNE Pediatric SAVE Surveillance Registry has fulfilled its post-approval study requirements. This FDA decision is expected to significantly expand access to the QUELIMMUNE therapy for critically ill pediatric patients with life-threatening Acute Kidney Injury (AKI). Data from the SAVE Registry presented at ASN Kidney Week 2026 showed a clinically meaningful and statistically significant improvement in 90-day survival for QUELIMMUNE patients compared to control cohorts, with no device-related adverse events reported.
Key Highlights
- FDA's CBER determined QUELIMMUNE Pediatric SAVE Surveillance Registry fulfilled post-approval study requirements.
- This decision expands access to QUELIMMUNE therapy for critically ill pediatric patients with life-threatening AKI.
- SAVE Registry data showed a 65.1% 90-day survival for QUELIMMUNE patients vs. 47.5% for control cohorts.
- No device-related adverse events were reported in the SAVE Registry.
- QUELIMMUNE therapy was approved under a Humanitarian Device Exemption in February 2024.
- Clinical trials showed a 77% survival rate for QUELIMMUNE treated patients vs. standard of care.
Price Impact
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