SeaStar up on FDA's humanitarian exception approval for kidney device

SeaStar Medical Holding

22/02/2024 13:41

** Shares of medical device maker SeaStar Medical Holding
 ICU.O  rise ~18% to $1.71 premarket
    ** Co says the U.S. FDA has granted a Humanitarian Device
Exemption (HDE) approval for use of co's device in children
below 10 kilograms with acute kidney injury (AKI)
    ** Says, initial commercial launch of the Selective
Cytopheretic Device (SCD) Pediatric (SCD-PED) is expected in the
coming weeks
    ** AKI is a condition in which one's kidneys suddenly stop
working properly and can range from minor loss of kidney
function to complete kidney failure
    ** An HDE is exempt from certain effectiveness requirements
and is subject to certain profit and use restrictions
    ** Up to last close, stock down 48.2% in the last 12 months

    

 (Reporting by Christy Santhosh)
 ((Christy.Santhosh@thomsonreuters.com))