Nuwellis partner SeaStar Medical receives FDA HDE for Quelimmune

Nuwellis (NUWE) announced its distribution partner, SeaStar Medical Holding Corporation (ICU) has received Humanitarian Device Exemption from the U.S. Food and Drug Administration for Quelimmune, its pediatric Selective Cytopheretic Device. Quelimmune provides a new therapy option for children weighing 10 kg or more who have acute kidney injury and sepsis or a septic condition requiring continuous kidney replacement therapy in a hospital intensive care unit. Nuwellis has an exclusive U.S. license and distribution agreement with SeaStar Medical to distribute Quelimmune and will market and distribute the device to nephrologists and intensive care physicians who are trained in pediatric extracorporeal therapy. With FDA HDE in place for Quelimmune, Nuwellis will begin commercial launch activities at targeted medical centers, with further commercial expansion expected later in the first half of 2024.