Nuwellis, Inc. announced that its distribution partner, SeaStar Medical (SeaStar), received correspondence from the U.S. Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) indicating that the Agency considers SeaStar's Selective Cytopheretic Device (SCD) Pediatric (SCD-PED) to be approvable under a Humanitarian Device Exemption (HDE) for use in children weighing 10 kilograms or more with acute kidney injury (AKI) and sepsis or a septic condition requiring continuous kidney replacement therapy (CKRT) in the hospital intensive care unit (ICU). The correspondence indicates that an Approvable Letter is expected to be issued within a month. The Approvable Letter will outline conditions, including language for safety, probable benefit and labeling for intended use, which will be required for formal marketing approval.

In December of 2022, Nuwellis and SeaStar entered into a U.S. license and distribution agreement for SeaStar Medical's SCD for pediatric AKI. Under this agreement, Nuwellis will market and distribute the SCD through its direct salesforce to nephologists and intensive care physicians who are trained in pediatric extracorporeal therapy. 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 percent. Children who survive an AKI episode are at risk for long-term conditions, including chronic kidney disease (CKD).