On Thursday, the FDA granted full approval to Humacyte, Inc.'s (NASDAQ:HUMA) Symvess (acellular tissue-engineered vessel-tyod) 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.

Symvess, or the ATEV, is a first-in-class bioengineered human tissue designed to be a universally implantable vascular conduit for arterial replacement and repair.

Also Read: Delay Hits Humacyte's Bioengineered Human Tissue Implant For Vascular Trauma Injuries, FDA Extends Time To Review

While harvesting vein from a trauma patient takes valuable surgical time, Symvess is available off-the-shelf and does not require further injuring the patient to obtain vascular repair material.

Humacyte's application included results from the V005 pivotal Phase 2/3 clinical study, as well as real-world evidence from the treatment of wartime injuries in Ukraine under a humanitarian aid program.

Symvess was used to repair many types of traumatic injuries, including car accidents, gunshot wounds, blast wounds, and industrial accidents.

Symvess may be removed from its packaging and ready for implantation within minutes, and does not involve creating additional incisions in already-injured patients.

Last month, Humacyte announced a registered direct offering of approximately $15.0 million.

Price Action: At last check on Friday, HUMA stock was up 58.1% at $5.47 during the premarket session.

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