Humacyte, Inc., was incorporated in Delaware on July 1, 2020. The company is a commercialization stage biotechnology platform company dedicated to the development of universally implantable bioengineered human tissue on a commercial scale. Its main product, Symvess, is a cell-free tissue-engineered blood vessel approved by the US Food and Drug Administration for vascular catheters in the event of limb artery injury. The company is also developing a similar product line for other vascular and non-vascular applications. 

Humacyte announced that CEO Laura Niklason will participate in a fireside chat at the H.C. Wainwright 28th Annual Global Investment Conference on September 16, 2026. The company's management will also be available for one-on-one meetings. Humacyte is a biotechnology platform company developing universally implantable, bioengineered human tissues. Its acellular tissue engineered vessel (ATEV) was approved by the FDA in December 2024 for vascular trauma treatment and is currently in late-stage clinical trials for other vascular applications.

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Humacyte CEO to Present at H.C. Wainwright Global Investment Conference

Humacyte has received FDA authorization to extend the expiration dating period of Symvess, a bioengineered human tissue, from 18 months to 36 months when stored refrigerated at 2°C to 8°C. The extended shelf life is supported by additional stability data demonstrating that Symvess continues to meet all established quality specifications throughout the 36-month dating period. This extension is expected to simplify inventory planning, reduce product waste, and facilitate hospital adoption of Symvess. Symvess was approved by the FDA in December 2024 as a vascular conduit for adults with extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss and an autologous vein graft is not feasible.

FDA Extends Shelf Life of Humacyte's Symvess to 36 Months

Humacyte's Symvess has received FDA approval for an extended shelf life of 36 months, up from 18 months, supported by additional stability data. The extended shelf life allows hospitals to keep Symvess on hand for urgent vascular repairs and simplifies inventory planning. Symvess, approved in December 2024, is a bioengineered human tissue used as a vascular conduit for adults with extremity arterial injury when urgent revascularization is needed. Humacyte plans to file a supplemental Biologics License Application in November 2026.

FDA Extends Symvess Shelf Life to 36 Months

Humacyte announces FDA extension of Symvess expiration dating from 18 to 36 months. The change is supported by additional stability data demonstrating Symvess meets quality specifications throughout the extended dating period. This helps hospitals keep Symvess on hand for urgent vascular repairs while simplifying inventory planning and reducing product waste.

<p>Humacyte to file SymVess dialysis access BLA in Nov. 2026</p>

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