Humacyte’s ATEV Evaluated After Long-Term Clinical Use

November 24, 2025—Humacyte, Inc. announced that multiple presentations on the company’s acellular tissue-engineered vessel (ATEV) were delivered at the VEITHsymposium. Among them, Luigi Pascarella, MD, presented “In Vivo Regeneration of Bioengineered Blood Vessels: Histologic Evaluation of Acellular Tissue Engineered Vessels After Long-Term Clinical Use,” which highlighted the ATEV’s ability to remodel into living vascular tissue.

According to the company, the study used immunochemistry to analyze tissue samples from ATEVs implanted in patients, taken up to 200 weeks postimplantation. The ATEVs were decellularized at the end of the production process to eliminate immunogenicity and allow them to be universally implanted into any patient without fear of rejection.

Postimplantation analysis of the ATEVs revealed progressive recellularization with host cells, including smooth muscle cells and endothelial cells, transforming the ATEV into a multilayered living tissue similar to that of native blood vessels, noted the company.

“Observing these acellular tissue-engineered vessels transform into living, self-repairing vascular tissue over time is nothing short of remarkable,” commented Dr. Pascarella in Humacyte’s press release. “The evidence of host cell integration and adaptive remodeling gives us real hope for a future where vascular grafts are not just replacements but regenerative solutions. The ATEV’s ability to remodel into living vascular tissue capable of self-repair, combined with its absence of immunogenicity, supports its potential as a durable and biocompatible conduit for treating vascular disease and injury.”

Additional presentations on the ATEV at VEITHsymposium were summarized in Humacyte’s press release, available on the company’s website here.

In December 2024, the company announced FDA approval for the ATEV for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss and when an autologous vein graft is not feasible. For other uses, ATEV is an investigational product that has not been approved for sale by the FDA or any other regulatory agency.