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

Company Overview - SeaStar Medical Holding Corporation has successfully treated its first patient with QUELIMMUNE™, an FDA-approved therapy for acute kidney injury (AKI) in pediatric patients [1][2] - The company aims to provide widespread access to QUELIMMUNE, which has shown potential to save lives and reduce dialysis dependency in severely ill children [2] Product Details - QUELIMMUNE is a patented cell-directed extracorporeal therapy that targets activated proinflammatory neutrophils and monocytes, restoring them to a reparative state [4] - The treatment process takes about 15 minutes and requires a full course of therapy lasting three to seven days, with the SCD-PED cartridge replaced every 24 hours [4] Clinical Impact - Approximately 4,000 children in the U.S. require continuous kidney replacement therapy annually, with a mortality rate of around 50% [2] - Clinical trials indicate that children treated with QUELIMMUNE had a 77% survival rate without dialysis dependency at 60 days, with no serious adverse events reported [2] Market Opportunity - The adult AKI population is significantly larger than the pediatric population, representing a multibillion-dollar market opportunity for SeaStar Medical [5] - The company is currently enrolling patients in the adult NEUTRALIZE-AKI pivotal clinical trial, expanding its therapeutic reach [5] Company Mission - SeaStar Medical is focused on redefining extracorporeal therapies to mitigate excessive inflammation's impact on vital organs, aiming to provide life-saving solutions for critically ill patients [6]