SeaStar Medical announces BDD from U.S. FDA CBER for SCD

SeaStar Medical (ICU) announces the receipt of a Breakthrough Device Designation, BDD, from the U.S. Food and Drug Administration’s, FDA, Center for Biologics Evaluation and Research, CBER, for the Company’s patented, first-in-class, cell-directed Selective Cytopheretic Device, SCD, to treat chronic systemic inflammation in end-stage renal disease, ESRD, patients who require chronic hemodialysis, also known as chronic dialysis. More than 480,000 individuals in the U.S. with ESRD are treated by in-center hemodialysis at least three times a week at a cost of approximately $100,000 per patient per year.