SeaStar ships first QUELIMMUNE product order to U.S. distribution partner

SeaStar Medical Holding Corporation reports the initial commercial sale of QUELIMMUNE-Pediatric to its U.S. license and distribution partner, Nuwellis, Inc. QUELIMMUNE is SeaStar Medical’s Selective Cytopheretic Device-Pediatric, a patented cell-directed extracorporeal therapy that selectively targets the most highly activated neutrophils and monocytes responsible for hyperactive immune response. QUELIMMUNE is approved by the U.S. Food and Drug Administration as a Humanitarian Use Device under a Humanitarian Device Exemption to treat pediatric acute kidney injury in patients weighing 10 kilograms or greater with sepsis or a septic condition requiring kidney replacement therapy. “It’s highly gratifying to ship our first commercial QUELIMMUNE product order to Nuwellis for these patients,” said Eric Schlorff, CEO of SeaStar Medical. “QUELIMMUNE is a best-in-class therapy that across two pediatric clinical studies has been shown to have a probable benefit of reducing mortality and decreasing dialysis dependency in these severely ill children. We expect prestigious pediatric hospitals to meet the HDE requirements this quarter, with a more robust commercial rollout in the fourth quarter of 2024.”