Core Insights - SeaStar Medical Holding Corporation has introduced QUELIMMUNE therapy at Texas Children's Hospital, which is a potential life-saving treatment for pediatric patients with acute kidney injury (AKI) due to sepsis [1][2] - The QUELIMMUNE therapy has shown a 77% survival rate compared to standard care, indicating a 50% reduction in loss of life in this patient population [1][4] - The therapy is designed to neutralize over-active immune cells and mitigate hyperinflammation, which is critical in treating AKI [2][8] Company Overview - SeaStar Medical is a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure [9] - The QUELIMMUNE therapy is the only FDA-approved product for life-threatening AKI in critically ill pediatric patients [9] - The company has received Breakthrough Device Designation for six therapeutic indications, facilitating a faster approval process [9] Clinical Data and Trials - Clinical data published in Kidney Medicine supports the efficacy of QUELIMMUNE, showing no dialysis required for survivors at Day 60 post-ICU discharge [1][6] - SeaStar Medical is conducting the NEUTRALIZE-AKI pivotal trial to evaluate the safety and efficacy of SCD therapy in adults with AKI [3][7] - The primary endpoint of the NEUTRALIZE-AKI trial includes a composite of 90-day mortality or dialysis dependency [7] Market Impact - The introduction of QUELIMMUNE addresses a significant unmet need for organ-sparing therapies in pediatric patients [2] - The therapy aims to reduce healthcare costs associated with prolonged ICU stays and reliance on dialysis [3] - SeaStar Medical was awarded the 2025 Corporate Innovator Award by the National Kidney Foundation for its contributions to pediatric AKI treatment [6]
SeaStar Medical Expands QUELIMMUNE Adoption for Critically Ill Pediatric Patients with Acute Kidney Injury (AKI)