First Pediatric Patient Treated in a Commercial Setting with SeaStar Medical's FDA-Approved QUELIMMUNE Therapeutic Device

Core Viewpoint - SeaStar Medical has successfully treated its first patient with QUELIMMUNE, a therapy for acute kidney injury (AKI) in pediatric patients, meeting FDA requirements for timely treatment [5]. Company Overview - SeaStar Medical is a commercial-stage medical technology company focused on developing cell-directed extracorporeal therapies to mitigate excessive inflammation in critically ill patients [8]. - The company’s first product, QUELIMMUNE, is a Selective Cytopheretic Device (SCD) that targets activated proinflammatory cells to restore them to a reparative state [7]. Product Details - QUELIMMUNE is FDA-approved for treating pediatric patients with AKI who weigh 10 kilograms or more and require kidney replacement therapy [5]. - The treatment process involves using a disposable SCD-PED cartridge connected to an existing hemodialysis system, with an average treatment duration of three to seven days [7]. - Clinical trials indicate that children treated with QUELIMMUNE have a 77% survival rate without dialysis dependency at 60 days post-treatment, with no serious device-related adverse events reported [10]. Market Opportunity - The adult AKI population is significantly larger than the pediatric population, representing a multibillion-dollar market opportunity for SeaStar Medical [3]. - Approximately 4,000 children in the U.S. require continuous kidney replacement therapy annually, with a high mortality rate of around 50% [10].