Humacyte (HUMA) 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 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.
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