FDA Grants Breakthrough Device Designation for SeaStar Medical’s Selective Cytopheretic Device for Adults Undergoing Chronic Dialysis
SeaStar Medical Holding Corporation (ICU)
Company Research
Source: GlobeNewswire
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 i
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- SeaStar Medical Activates 14th Hospital for its Adult AKI Pivotal TrialGlobeNewswire
- SEASTAR ALERT: Bragar Eagel & Squire, P.C. is Investigating SeaStar Medical Holding Corp on Behalf of Long-Term Stockholders and Encourages Investors to Contact the FirmGlobeNewswire
- SeaStar Medical Projects Multibillion-Dollar Market Potential for its Selective Cytopheretic Device in Initial Target IndicationsGlobeNewswire
- SeaStar Medical to Hold Business Update Conference Call on December 11, 2024GlobeNewswire
- SeaStar Medical Activates Sentara Norfolk General Hospital and Provides Enrollment Update in Adult AKI Pivotal TrialGlobeNewswire
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Sec Filings
- 12/19/24 - Form 8-K
- 12/3/24 - Form 3
- 12/3/24 - Form 3
- ICU's page on the SEC website