By Chris Wack


SeaStar Medical Holding Corp. shares were up 20%, to $5.76, in premarket trading after the company said that the U.S. Food and Drug Administration approved its investigational device exemption application to conduct a pivotal study evaluating the effectiveness of its Selective Cytopheretic Device in reducing hyperinflammation in adults with acute kidney injury requiring continuous kidney replacement therapy.

The company said it plans to begin enrollment in this 200-patient randomized, controlled trial in March.

SeaStar currently expects to generate interim study results during the fourth quarter of 2023 and topline study results and submission of a Pre-market Approval application in the second half of 2024.

The study's primary endpoint is a composite of 90-day mortality and dialysis dependency of patients treated with SCD in addition to CKRT standard of care, compared with the control group receiving CKRT standard of care.

The company's Selective Cytopheretic Device is a patented, cell-directed extracorporeal therapy that selectively targets the most highly activated pro-inflammatory neutrophils and monocytes to stop the cytokine storm that can cause organ failure and death. The SCD received FDA Breakthrough Device Designation in May 2022.


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


(END) Dow Jones Newswires

02-09-23 0936ET