SeaStar Medical (NASDAQ:ICU) has received breakthrough device designation from the FDA for its Selective Cytopheretic Device for the treatment of ICU patients with hepatorenal syndrome.
The device is being tested as a treatment for acute kidney injury in patients with chronic liver failure so that they may regain enough kidney function to be considered for a liver transplant.
SeaStar has been developing SCD as a treatment for hyperinflammation, known as cytokine storm, a life-threatening condition that can develop when the body’s immune system responds too aggressively to injury or infection, such as acute kidney injury.
Sea Star went public in 2022 through a SPAC merger with LMF Acquisitions Opportunities.
SeaStar Medical gets FDA breakthrough status for cytokine storm device
