Humacyte’s Vascular Tissue Graft Nabs FDA Authorization for 36-Month Shelf Life
Additional stability data showed the bioengineered vessel maintains quality specifications for three years under approved refrigeration, giving hospitals greater inventory flexibility for urgent vascular repairs.
Key Points
- The FDA has authorized extending Symvess shelf life from 18 months to 36 months under refrigerated storage.
- Humacyte said additional stability data showed Symvess continued to meet established quality specifications throughout the 36-month period.
- The longer dating period may give hospitals more flexibility to keep Symvess available for urgent vascular repairs while reducing waste.
Humacyte has received FDA authorization to extend the expiration dating period for Symvess, an acellular tissue engineered vessel (ATEV), from 18 months to 36 months when stored refrigerated at 2°C to 8°C (36°F to 46°F). Symvess is a bioengineered vascular conduit used in adults with extremity arterial injury when urgent revascularization is needed, and an autologous (sourced from the patient) vein graft is not feasible.
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The company said the extension is supported by additional stability data showing that Symvess continued to meet all established product quality specifications throughout the 36-month dating period under approved storage conditions. The storage requirements and approved clinical use remain unchanged.
Hospital Inventory Impact
The longer shelf life may help hospitals keep Symvess on hand for urgent vascular repairs, while simplifying inventory planning and reducing product waste. Because the product is available off the shelf, it can be used in the operating room without harvesting a vein from the patient, which avoids a second surgical site.
“This FDA authorization represents an important advancement in supporting the commercial availability of Symvess for hospitals and healthcare systems,” said Laura Niklason, MD, PhD, Founder, President and Chief Executive Officer of Humacyte. “Extending the shelf life to 36 months provides greater inventory flexibility while maintaining the same storage requirements and approved clinical use. We believe this enhancement will further facilitate hospital adoption and ensure surgeons have access to Symvess when urgent vascular repair is needed.”
Approved Use and Next Steps
The FDA approved Symvess in December 2024 for adults with extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss and an autologous (sourced from the patient) vein graft is not feasible.
Humacyte also said it expects to file a supplemental Biologics License Application in November 2026 to seek dialysis access as a second approved indication for the ATEV. For uses outside the approved extremity vascular trauma indication, Symvess remains investigational and has not been approved for sale by the FDA or other regulators.
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