Nuwellis’ partner SeaStar Medical receives FDA approvable letter for SCD-PED

Nuwellis (NUWE) announced its strategic partner, SeaStar Medical Holding Corporation, received an Approvable Letter from the U.S. Food and Drug Administration, FDA, for its pediatric Selective Cytopheretic Device, SCD-PED. The SCD-PED will provide a new therapy option for children weighing 10 kilograms or more who have acute kidney injury and sepsis or a septic condition requiring continuous kidney replacement therapy in a hospital intensive care unit. The Approvable Letter indicates that SeaStar Medical’s Humanitarian Device Exemption application substantially meets the requirements for an Approval Order and outlines remaining administrative steps that must be finalized before the HDE can be active for commercialization. For the SCD-PED, these include revisions to product labeling and minor modifications to the post-approval study plan. Nuwellis and SeaStar Medical previously announced an exclusive U.S. license and distribution agreement for Nuwellis to distribute the SCD-PED. “We’re excited to collaborate with SeaStar Medical to bring this innovative product to market, which, upon FDA approval, will represent a new revenue stream for Nuwellis,” said Nestor Jaramillo, Jr., President and Chief Executive Officer of Nuwellis. “Most importantly, the clinical data used for the approval in support of the HDE application showed a 77% reduction in mortality rate and no dialysis dependency at Day 60.”