India, Oct. 7 -- SeaStar Medical Holding Corp. (ICU), a commercial-stage healthcare company, said the U.S. FDA has granted Breakthrough Device Designation to its Selective Cytopheretic Device (SCD) therapy for treating hyperinflammation in adults with sepsis or a septic condition.
Sepsis is a life-threatening condition in which the body mounts an uncontrolled response to infection that can lead to organ dysfunction and death. SeaStar said sepsis affects about 1.7 million U.S. adults annually and contributes to nearly one in three in-hospital deaths.
The SCD therapy is designed to selectively modulate overactive immune cells involved in destructive hyperinflammation. It works within an existing continuous renal replacement therapy system t...