DENVER, April 08, 2025 (GLOBE NEWSWIRE) — SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life, announced today that the U.S. Food and Drug Administration (FDA) has granted SeaStar Medical two new Breakthrough Device Designations for its Selective Cytopheretic Device (SCD) therapy. The two new Breakthrough Device Designations are indicated for the treatment of systemic inflammatory response in 1) adult patients undergoing cardiac surgery and 2) pediatric patients undergoing cardiac surgery towards prevention of post-operative adverse complications and outcomes. Approximately 15 percent of the estimated 300,000 adults that undergo cardiac surgery each year are considered high risk and, we believe, could benefit most from the SCD therapy to prevent post-surgical complications. Of the 40,000 pediatric patients that undergo congenital heart surgery each year, we believe that approximately one third might benefit from SCD therapy.