SeaStar Medical Holding Corporation has announced the publication of early post-approval clinical experience with its QUELIMMUNE™ (SCD-PED) therapy for pediatric acute kidney injury (AKI) in the journal Pediatric Nephrology. The data, collected from real-world use and the ongoing SAVE Registry post-approval study, demonstrated strong 90-day survival rates and a favorable safety profile, with no device-related adverse events reported. The SAVE Registry, initially requiring 300 patient enrollments, was reduced by the FDA to 50 after review of initial data. The outcomes will include 28-day safety, 90-day survival, and dialysis dependency, and the results will be compared to an existing control group. These findings are consistent with previous clinical trial data and have already been published.

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