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.

“This is our first Breakthrough Device Designation award for the SCD in a chronic indication. We appreciate the FDA’s continued recognition of the SCD’s potential to save lives and improve patient outcomes by targeting dysregulated immune responses. With this and the three prior Breakthrough Device Designations granted by the FDA, our addressable patient population in the U.S. has now reached at least 745,000 patients annually,” said Eric Schlorff, SeaStar Medical CEO, “This designation holds numerous benefits including enhanced access to FDA resources resulting in faster development, as well as priority review by the FDA, early access to patients and the potential for differentiated market positioning.”

“Patients with ESRD face an unacceptably high disease burden to include chronic fatigue, malnutrition, repeat hospitalizations, and a 42% five-year survival. Unfortunately, interventions directed at improving overall outcomes have largely been ineffective,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. “Systemic inflammation is a major driver that leads to these poor outcomes. Initial data shows that the SCD has the potential to address chronic systemic inflammation in a safe and effective manner that could improve survival, quality of life and other relevant clinical outcomes. We intend to prove this out such that concurrent SCD therapy can be made available for patients undergoing chronic dialysis.”