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Humacyte Announces Planned IND Filing in 2025 to Support First-In-Human Clinical Study of Small-Diameter ATEV™ for Coronary Artery Bypass Grafting
– Plans for filing an IND was agreed with the FDA in a recent meeting – – Positive preclinical results of the small-diameter ATEV were recently presented at
About this update from Humacyte, Inc.
[{"type":"text","content":"– Plans for filing an IND was agreed with the FDA in a recent meeting – – Positive preclinical results of the small-diameter ATEV were recently presented at The American Heart Association’s Scientific Sessions 2024 meeting – DURHAM, N.C., Jan. 21, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced that it plans to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to allow first-in-human clinical testing of the small-diameter (3.5mm) acellular tissue engineered vessel (sdATEV) in coronary artery bypass grafting (CABG). The Company’s current plans for filing an IND are based on the outcome of a recent meeting held with the FDA, including agreements reached with the agency. To date only the 6.0mm configuration of the ATEV has been studied in human trials, specifically in studies conducted in vascular trauma repair, arteriovenous (AV) access for hemodialysis, and peripheral artery disease (PAD). To enable the IND filing, the sdATEV has been studied in multiple preclinical CABG models. The results of a six-month preclinical study in primates were presented in November 2024 at The American Heart Association’s Scientific Sessions 2024 meeting. In the preclinical CABG model, the sdATEV was observed to sustain patency (blood flow), recellularized with the animals’ host cells, and remodeled to effectively reduce the initial size mismatch between the sdATEV and the animals’ native artery. “We are very pleased to be moving closer to human clinical studies of the sdATEV in CABG, and our planned IND filing and initiation of first-in-human study after the FDA clearance will be a major milestone for Humacyte,” said Laura Niklason, M.D., Ph.D., Founder and Chief Executive Officer of Humacyte. “Our preclinical results suggest that the sdATEV may be a promising off-the-shelf alternative to native vessel grafts in CABG, and we look forward to evaluating this possibility in human clinical studies.” There are over 400,000 CABG procedures each year in the United States and the surgery has been shown to improve the survival and quality of life for many patients with coronary artery disease. The current conduits used for CABG are autologous vessels including the left interna...