Humacyte, Inc. announced the publication of 6-Year Outcomes of a Phase 2 Study of Human-Tissue Engineered Blood Vessels for Peripheral Arterial Bypass, in the Journal of Vascular Surgery – Vascular Science. The publication describes the long-term analysis of the Company's Phase 2 clinical trial evaluating the bioengineered HAV as a conduit in patients with symptomatic peripheral artery disease (PAD). The researchers concluded that the infection-resistant, off-the-shelf human acellular vessel could provide a durable alternative conduit in the arterial circuit setting, to restore lower extremity blood supply in patients with peripheral artery disease.

This paper reports that the overall secondary patency rate for the Phase 2 study at 72 months, including all patients originally enrolled, was estimated by Kaplan Meier analysis to be 60%. There was no evidence of graft rejection or infection. Additionally, no patients underwent amputation of the affected limb out to six years, a meaningful clinical and quality of life result as amputation is a common outcome in many severe PAD patients.

No patients reported pain at rest or ischemic ulcers on the affected legs. Researchers reported that these data have demonstrated the durability of the HAV and suggest the occurrence of cellular remodeling by the host. The HAV has been evaluated in eight clinical studies in the U.S., Europe, and Israel, including an ongoing Phase 2/3 clinical trial in vascular trauma and an ongoing Phase 3 trial as a hemodialysis access in end-stage kidney disease.

The HAV is an investigational product and has not been approved for sale by the U.S. Food and Drug Administration or any international regulatory agency.