Humacyte (HUMA) Announces Preclinical Results of Small-Diameter Human Acellular Vessel in Coronary Artery Bypass Grafting

HAV remained patent and host-cell remodeling was observed in non-human primate model --

-- Preclinical study represents milestone in the development of small-diameter HAVs for use in cardiac bypass surgery --

-- Results presented at Advanced Therapies Week 2022 --

Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced results from the first preclinical study of the use of Humacyte’s small-diameter (3.5mm) Human Acellular Vessel (HAV) in coronary artery bypass grafting (CABG), which were presented at Advanced Therapies Week. The HAV maintained patency and exhibited host-cell remodeling and regeneration in a non-human primate model.

CABG, performed approximately 400,000 times each year in the U.S., is a surgical procedure where a vascular graft is placed to bypass occluded coronary arteries and restore blood flow to the heart. Saphenous vein grafts are used in 80-90% of CABG procedures but have shown a 30% failure rate at one year.

In the preclinical study, the 3.5mm HAVs were implanted into primates following ligation of the native right coronary artery, and the primates were studied for six months. The HAVs that have been examined to date, one being explanted at six months, remained patent and vascular host-cell repopulation was observed. The preclinical surgeries were performed by Alan P. Kypson, M.D., cardiothoracic surgeon, University of North Carolina Rex Hospital, and Adam Williams, M.D., cardiothoracic surgeon, Duke University, in collaboration with Duke’s Division of Laboratory Animal Resources and Department of Surgery.

“Coronary artery bypass grafting is one of the most common surgical procedures in the U.S., but it currently requires surgically harvesting a saphenous vein for grafting. The quality and availability of the venous conduit is a critically important factor in a successful CABG and the potential to eliminate vein harvesting with a universally implantable, readily available acellular vessel is exciting,” said Dr. Kypson, who presented the results today. “Results observed in this preclinical study indicated the small-diameter HAV was an effective replacement vessel for CABG surgery in baboons, a primate that is phylogenically similar to humans, which supports the continued investigation of HAV in CABG.” Dr. Kypson has led the large animal preclinical development of Humacyte’s vessels in CABG for more than a decade.

Humacyte plans to evaluate the safety and efficacy of these small-diameter HAVs in additional preclinical primate CABG studies designed to support first-in-human clinical trials. The 3.5mm diameter HAV has smaller product dimensions but is manufactured using a similar process as Humacyte’s 6mm HAV system currently being evaluated in advanced-stage clinical trials in vascular trauma, arteriovenous access for hemodialysis, and peripheral arterial disease. The production of the functional 3.5mm HAV is indicative of the potentially broad application of Humacyte’s proprietary bioengineered tissue platform and manufacturing processes. Humacyte also presented preclinical data on the 3.5mm HAV in pediatric heart disease at the American Heart Association’s Scientific Sessions 2021. The HAV is an investigational product candidate and is not currently approved for sale by the U.S. Food and Drug Administration or any international regulatory authority.

“We believe these results further underscore the promise of our bioengineered tissue platform beyond our 6mm clinical-stage vascular indications and moving towards cardiac surgical procedures,” said Laura Niklason, M.D., Ph.D., Founder, President and Chief Executive Officer of Humacyte. “We were pleased to see the small-diameter HAV remained patent and to have observed vascular host-cell repopulation comparable to clinical data observed in multiple 6mm HAV clinical studies. We look forward to continuing to evaluate the small-diameter HAV in CABG and Blalock-Taussig-Thomas shunt, and to exploring the potential of our off-the-shelf regenerative medicine technology in a range of indications with critical unmet medical needs.”

The presentation will be available on Humacyte.com.

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