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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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This article Why Is Bioengineered Human Tissue-Focused Humacyte Stock Surging On Friday? originally appeared on Benzinga.com

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