FDA Grants Breakthrough Device Designation for SeaStar Medical’s Selective Cytopheretic Device for Adults Undergoing Chronic Dialysis

This represents the fourth indication granted a Breakthrough Device Designation for the SCD by FDA

DENVER, Nov. 06, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces the receipt of a Breakthrough Device Designation 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.

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