By Chris Wack


SeaStar Medical Holding Corp. shares were up 6%, to $4.45, on Monday after the company said it submitted an investigational device exemption application to the U.S. Food and Drug Administration for its anti-inflammatory device to treat kidney injury.

The Denver medical-technology company said the investigational device exemption application requests FDA approval to initiate a study to evaluate the effectiveness of its selective cytopheretic device in reducing hyperinflammation in adults with acute kidney injury requiring continuous kidney replacement therapy.

The company said the randomized, controlled study is expected to enroll 200 subjects and begin in the first quarter of 2023, with interim results expected in the fourth quarter of 2023 and topline results and submission for pre-market approval in the third quarter of 2024.

The company said its selective cytopheretic device is a patented cell-directed extracorporeal therapy that selectively targets the most activated pro-inflammatory neutrophils and monocytes to stop the cytokine storm that causes organ failure and possible death in critically ill patients with kidney damage.

SeaStar Medical's selective cytopheretic device received breakthrough device designation from the FDA in May 2022.


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


(END) Dow Jones Newswires

01-09-23 1129ET