Humacyte Announces Publication of Preclinical Data on Use of the CTEV as a Coronary Artery Bypass Graft (CABG)

Core Insights - Humacyte, Inc. is advancing its coronary tissue engineered vessel (CTEV) into first-in-human studies for coronary artery bypass grafting (CABG) following promising preclinical results [1][4][5] Group 1: CTEV Development and Research - The CTEV has shown the ability to sustain blood flow, recellularize with host cells, and remodel to reduce size mismatch in a non-human primate model [1][3][7] - The study published in JACC indicates that all implanted CTEVs remained patent throughout a six-month follow-up, suggesting durability as a CABG conduit [3][7] - The CTEV is produced using the same bioengineering system as Humacyte's acellular tissue engineered vessel (ATEV) and is referred to as the small-diameter ATEV (sdATEV) [3] Group 2: Clinical Need and Market Opportunity - Cardiovascular disease is the leading cause of death globally, with coronary artery disease (CAD) affecting 1 in 20 adults aged 20 and older in the U.S. [2] - Current CABG procedures predominantly use saphenous vein grafts, which have a long-term patency failure rate of approximately 50% at 10 years [2] - There is a significant unmet clinical need for alternative conduits due to the limitations of available autologous veins or arteries [2] Group 3: Future Plans and Regulatory Pathway - Humacyte plans to file an Investigational New Drug (IND) application with the FDA in Q4 2025 to support the first-in-human study of the CTEV [4] - The company has reached agreements with the FDA based on a prior meeting, indicating a positive regulatory pathway [4][5]