Nuwellis provides regulatory update on SeaStar Medical’s SCD-PED

Nuwellis announced that its distribution partner, SeaStar Medical, 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. “This regulatory update is an important milestone for our partner, SeaStar, who intends to follow the regulatory path laid out by the FDA for marketing approval to commercialize SCD for the pediatric indication by the end of 2023,” said Nestor Jaramillo, Jr., President and CEO of Nuwellis. “Nuwellis’ pediatric team is excited to finally bring this lifesaving therapy to serve the needs of its growing network in the pediatric clinical community.”