By Colin Kellaher


Humacyte has won U.S. Food and Drug Administration priority review for its application seeking approval of its Human Acellular Vessel bioengineered tissue in certain patients with vascular trauma.

The Durham, N.C., clinical-stage biotechnology platform company on Friday said the application covers the product in urgent arterial repair following extremity vascular trauma when synthetic graft isn't indicated and when autologous vein use isn't feasible.

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period.

Humacyte said the agency set a target action date of Aug. 10 for the application, which is supported by results from a Phase 2/3 clinical trial and outcomes of real-world use under a humanitarian aid program to treat wartime trauma injuries in Ukraine.


Write to Colin Kellaher at colin.kellaher@wsj.com


(END) Dow Jones Newswires

02-09-24 0834ET