Humacyte Unveils Preclinical Success Of Bioengineered Coronary Vessel Ahead Of FDA Human Trial Plans

Humacyte, Inc. (NASDAQ:HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced the publication of new preclinical data as part of a study evaluating the coronary tissue engineered vessel (CTEV) as a coronary artery bypass graft conduit in a non-human primate model. In the study, published in JACC: Basic to Translational Science, a specialist journal launched by the Journal of the American College of Cardiology (JACC), the CTEV was observed to sustain blood flow, recellularize with the animals' host cells, and remodel to reduce the initial size mismatch between the CTEV and the animals' native artery.

"Innovation in CABG has been stagnant for far too long," said Alan Kypson, MD, FACS, Cardiothoracic Surgeon, UNC REX Hospital. "Our results suggest that we may be on the verge of a new option — one that remodels to match the native artery and recellularizes with host cells, potentially providing superior patency relative to saphenous vein grafts. The CTEV has the potential to address a significant unmet clinical need in coronary bypass surgery and ultimately improve patient outcomes."

Cardiovascular disease is the leading cause of death worldwide, comprising one in every three deaths in the United States in 2023. The most common form is coronary artery disease (CAD), which affects 1 in 20 adults aged 20 and older. Coronary artery bypass grafting, a procedure that improves blood flow to the heart by using the internal mammary artery and saphenous vein to bypass narrowed or blocked coronary arteries, remains the current standard of care. However, saphenous vein grafts - used in 80%-90% of CABG cases - demonstrate poor long-term patency, with approximately 50% failing at 10 years. Many patients also lack usable autologous veins or arteries due to prior harvest, ablation, or poor quality, highlighting the unmet clinical need for alternative conduits. For the past half century, no novel CABG conduits have gained routine clinical use.

The recent JACC study, titled "Acellular Tissue Engineered Vessels as Coronary Artery Bypass Grafts", follows five adult baboons undergoing CABG to the right coronary artery with the CTEV. All CTEVs remained patent throughout the 6-month study. At the end of follow-up, the CTEV was observed to have recellularized with host cells to form a multi-layered tissue, including transanastomotic neomedial tissue that effectively reduced the initial size mismatch with the right coronary artery (RCA). The results suggest that the CTEV may be a durable alternative CABG conduit. The CTEV is 3.5mm blood vessel produced in the same bioengineering manufacturing system as Humacyte's acellular tissue engineered vessel (ATEV™). The CTEV is also referred to as the small-diameter ATEV, or sdATEV.

Humacyte also announced that it plans to advance the CTEV into its first-in-human study in CABG. To support human study, the Company anticipates filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) during the 4th Quarter of 2025. The Company's current plans for filing an IND are based on the outcome of a meeting held early this year with the FDA, including agreements reached with the agency.