SeaStar Medical announces first pediatric patient treated with QUELIMMUNE

SeaStar Medical Holding reports treatment of the first patient in a commercial setting with QUELIMMUNE, its U.S. Food and Drug Administration, FDA, -approved, patented cell-directed extracorporeal therapy to treat acute kidney injury, AKI, in pediatric patients weighing 10 kilograms or greater with sepsis or a septic condition requiring kidney replacement therapy, KRT. With this development, the Company has now met the August 20, 2024 FDA deadline to begin patient treatments, which is designated in the FDA’s approval of QUELIMMUNE. “This commercial milestone is highly gratifying to the SeaStar Medical team that has worked so hard to make QUELIMMUNE available to patients in need. Results from completed clinical trials show the potential of QUELIMMUNE to save the lives and decrease dialysis dependency of these severely ill children with AKI, and we are dedicated to ensuring widespread access to our therapeutic device,” said Eric Schlorff, CEO of SeaStar Medical. “We have now met the FDA’s requirement for a timely first treatment.”