Humacyte Gets FDA's Full Approval for Universally Implantable Bioengineered Human Tissue; Shares Soar Premarket

MT Newswires Live12-20 19:10

Humacyte (HUMA) said late Thursday that the US Food and Drug Administration granted full approval for SYMVESS, a bioengineered human tissue designed to be universally implantable.

Shares of the company rose more than 35% in recent premarket activity Friday.

The approval is for SYMVESS' use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss and when autologous vein graft is not feasible.

In clinical testing, SYMVESS was observed to have "high rates of patency, or blood flow, and low rates of amputation and infection," the company said, adding that the commercial launch of the treatment is "upcoming."

Price: 4.70, Change: +1.24, Percent Change: +35.84

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