SeaStar Medical Holding Corporation and Nuwellis, Inc. announced an exclusive U.S. license and distribution agreement by Nuwellis of SeaStar Medical's Selective Cytopheretic Device (SCD) for the treatment of acute kidney injury (AKI) in children. Nuwellis will market and distribute the SCD through its direct salesforce to nephrologists and intensive care physicians who are trained in pediatric extracorporeal therapy. SeaStar Medical expects the U.S. Food and Drug Administration (FDA) to complete a substantive review of a Humanitarian Device Exemption (HDE) for the use of SCD in children (>20 kg.) with AKI during the first quarter of 2023, with a potential commercial introduction in the second quarter of 2023.

SCD is a patented, cell-directed extracorporeal therapy that selectively targets the most activated pro-inflammatory neutrophils and monocytes to stop the cytokine storm that frequently causes organ failure and possible death in critically ill patients. The therapy works with CKRT to target and neutralize pro-inflammatory neutrophils and monocytes, allowing the body to return to homeostasis. Clinical studies have demonstrated SCD's potential to eliminate dialysis dependency, shorten ICU time and restore the lives of critically ill patients.

Each year in the U.S. approximately 4,000 children with AKI require CKRT and those patient profiles are associated with high mortality. The mortality rate in children with AKI requiring CKRT is approximately 50%. Children who survive an AKI episode are at risk for long-term conditions, including chronic kidney disease (CKD).