Sea Star Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces receipt of U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for its patented, first-in-class, cell-directed Selective Cytopheretic Device (SCD) for use with patients in the hospital intensive care unit (ICU) with acute kidney injury (AKI) and acute on chronic liver failure. This is the third Breakthrough Device Designation granted by the FDA to Sea Star
Medical for the SCD device, and is expected to expedite the clinical development and regulatory review of the SCD for use in this patient population.
Medical for the SCD device, and is expected to expedite the clinical development and regulatory review of the SCD for use in this patient population.