By Chris Wack


SeaStar Medical Holding shares were up 10% to $1.60 after the U.S. Food and Drug Administration granted a Humanitarian Device Exemption Approval Order to the company's pediatric selective cytopheretic device.

The FDA's approval order applies to use in children weighing 10 kilograms or more with acute kidney injury due to sepsis or a septic condition requiring kidney replacement therapy.

The company said this is its first product in its newly branded Quelimmune product family, and the Quelimmune pediatric device can now be commercially marketed as a Humanitarian Use Device.

The initial commercial launch of Quelimmune for pediatric acute kidney injury is expected in the coming weeks by SeaStar Medical's U.S. license and distribution partner Nuwellis, with a full commercial program to follow.

The FDA granted HDE approval to the Quelimmune pediatric device based upon clinical results showing safety and probable clinical benefit to critically ill children with acute kidney injury who have few treatment options.


Write to Chris Wack at chris.wack@wsj.com


(END) Dow Jones Newswires

02-22-24 1006ET