On January 21, 2025, Humacyte, Inc. announced its plan to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) in 2025. This filing aims to enable first-in-human clinical testing of the small-diameter (3.5mm) acellular tissue engineered vessel (sdATEV) in coronary artery bypass grafting (CABG).
The decision to proceed with the IND filing follows a recent meeting with the FDA, where agreements were reached regarding the development path. Preclinical studies in CABG models, including a six-month primate study, showed the sdATEV sustained patency, recellularized with host cells, and remodeled to reduce size mismatch with native arteries.
This advancement is significant as CABG procedures are performed over 400,000 times annually in the United States, and current conduits like saphenous vein grafts have limitations. The sdATEV offers a potential off-the-shelf alternative, addressing a major unmet need in cardiovascular surgery.
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