Investing.com — Shares of Humacyte Inc. soared +56% in pre-open trading Friday following the announcement that the U.S. Food and Drug Administration (FDA) has granted full approval for its SYMVESS product. The bioengineered human tissue is designed for use as a vascular conduit in arterial replacement and repair, marking a significant advance in regenerative medicine and trauma care.
The FDA’s endorsement of SYMVESS comes after clinical testing showed high rates of patency and low rates of amputation and infection. This approval provides a new treatment option for patients with arterial injuries, offering a universally implantable solution that is ready for use without the need for additional invasive procedures to harvest veins. The company has also prepared a highly experienced sales team for the upcoming commercial launch.
SYMVESS, also known as ATEV™, is a first-in-class product that was observed to have positive outcomes in both civilian and military clinical studies, including those involving wartime injuries in Ukraine. The technology is seen as a game-changer, especially in combat zones where infections are prevalent and alternatives to autologous vein grafts have been inadequate.
Following the FDA’s approval, H.C. Wainwright analyst Vernon Bernardino raised his price target on Humacyte stock to $15 from $12. He believes the approval significantly increases the probability of success for SYMVESS, stating, “We raise our weighted-probability of success (POS) assumption for Symvess to 70% from our prior 60%. We forecast Symvess realizes sales of $17.1M in 2025. We propose Humacyte stock be considered a core holding over the next 12-month timeframe.”
The company’s trajectory has been closely monitored since the Regenerative Medicine Advanced Therapy (RMAT) designation was granted in May 2023, followed by a Priority Review in February 2024. The recent FDA approval is a culmination of these efforts, positioning Humacyte for a strong entry into the market with its innovative product.
SYMVESS is specifically indicated for adult patients requiring vascular conduits for extremity arterial injury to prevent imminent limb loss when an autologous vein graft is not feasible. This approval could potentially set a new standard for treating traumatic vascular injuries, which have not seen significant innovation in decades.
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