SeaStar Medical Announces Publication in Pediatric Nephrology of Positive Real-World Experience for QUELIMMUNE™ (SCD-PED) Therapy in Pediatric Acute Kidney Injury (AKI)

Core Insights - SeaStar Medical Holding Corporation announced positive early post-approval clinical experience for QUELIMMUNE therapy, showing strong survival rates in pediatric patients with Acute Kidney Injury (AKI) and sepsis [1][2][3] Group 1: Clinical Data and Outcomes - The SAVE Registry reported a 76% survival rate at Day 28 and Day 60, and a 71% survival rate at Day 90 for pediatric patients treated with QUELIMMUNE therapy [3] - No device-related adverse events or infections were observed in the first 21 patients, indicating a favorable safety profile [3][5] - Among patients treated with QUELIMMUNE and requiring extracorporeal membrane oxygenation (ECMO), a 60% survival rate was noted at Day 90 [4] Group 2: Regulatory and Adoption Insights - The FDA initially required 300 patients for the SAVE Registry but reduced the target to 50 after reviewing data from the first 21 patients [5] - QUELIMMUNE therapy has been adopted by several top-rated children's medical centers across the United States [6] Group 3: Company Background and Product Information - SeaStar Medical focuses on transforming treatments for critically ill patients facing organ failure, with QUELIMMUNE being its first commercial product approved in 2024 [12][13] - The Selective Cytopheretic Device (SCD) therapy aims to neutralize overactive immune cells and mitigate destructive hyperinflammation, with potential applications in various acute and chronic conditions [11]