Humacyte (NASDAQ:HUMA) shares climbed ~77% in the premarket on Friday after the bioengineered tissue maker announced the FDA approval of Symvess, an off-the-shelf, implantable vascular conduit indicated for arterial injury.

According to the FDA labeling, Symvess will be available for adults with arterial injury in extremities. It will be indicated when an autologous vein graft is not feasible when there is a risk of near-term limb loss, and in other cases for urgent revascularization.

“SYMVESS approval in this first indication for arterial injury repair is a milestone for regenerative medicine overall, as well as for Humacyte,” CEO Laura Niklason remarked.

The Durham, North Carolina-based company said it has already recruited and trained sales personnel in preparation for the product’s commercial launch.

HUMA’s marketing application for Symvess is backed by real-world data and results from its V005 pivotal Phase 2/3 clinical study, which met its primary goals in patients with arterial injuries due to traumatic events such as gunshot wounds.