SeaStar Medical(US:ICU) Globenewswire·2026-02-09 13:20Core Insights - SeaStar Medical Holding Corporation announced the publication of early post-approval clinical experience of the QUELIMMUNE therapy in Pediatric Nephrology, demonstrating strong survival data and a favorable safety profile [2][3][4] Group 1: Clinical Data and Outcomes - The QUELIMMUNE therapy showed a 76% survival rate at Day 28 and Day 60, and a 71% survival rate at Day 90 among the first 21 pediatric patients with Acute Kidney Injury (AKI) and sepsis [4] - The therapy is associated with a 50% reduction in patient mortality at 60 days compared to historical data, consistent with results from prior clinical trials [4][10] - Among patients treated with QUELIMMUNE and extracorporeal membrane oxygenation (ECMO), a 60% survival rate was observed at Day 90 [5] Group 2: Safety Profile - No device-related adverse events or infections were reported in the initial patient cohort, indicating a favorable safety profile for the QUELIMMUNE therapy [4][6] - The absence of immunosuppressive effects further supports the therapy's safety in critically ill pediatric patients [4] Group 3: Regulatory and Research Framework - The SAVE Registry, a post-approval surveillance registry, is designed to collect additional safety and clinical effectiveness data for QUELIMMUNE therapy, initially requiring the enrollment of 300 patients, later reduced to 50 after discussions with the FDA [6][9] - The QUELIMMUNE therapy was approved under a Humanitarian Device Exemption, necessitating participation in the SAVE Registry for real-world data collection [9][14] Group 4: Broader Implications and Adoption - The QUELIMMUNE therapy has been adopted by several nationally recognized children's medical centers in the U.S., indicating growing acceptance and potential for broader application [7] - The therapy aims to address the urgent need for effective treatments for critically ill pediatric patients facing life-threatening conditions due to AKI and sepsis [13][14]