FDA Confirms SeaStar Medical's QUELIMMUNE SAVE Registry Fulfilled Post-Approval Requirements

SeaStar Medical Holding Corp

• FDA's CBER determined the QUELIMMUNE Pediatric SAVE Surveillance Registry met post-approval study requirements under the original Humanitarian Device Exemption.
• SAVE Registry data showed 90-day survival of 65.1% for QUELIMMUNE patients (N=43) versus 47.5% for KID cohorts (N=196), P=0.043.
• Registry patients showed no device-related adverse events; results were presented as a late-breaker at ASN Kidney Week 2026.
• FDA's decision lets hospitals use QUELIMMUNE without SAVE Registry research infrastructure, expanding access at centers that previously could not participate.
• CEO Eric Schlorff noted these children typically have about a 50% survival rate with traditional supportive care alone.