Humacyte’s sdATEV device shows efficacy in artery bypass trial in primates

Humacyte (HUMA) Presents Preclinical Results of Small-Diameter ATEV(TM) for Coronary Artery Bypass Grafting at American Heart Association’s Scientific Sessions 2024 – sdATEVs maintained sustained patency throughout the six-month study – – sdATEV was observed to recellularize with host cells and remodel to effectively reduce the initial size mismatch between the sdATEV and the animal’s native artery – Humacyte presented positive preclinical results of the small-diameter acellular tissue engineered vessel – sdATEV – in a non-human primate model of coronary artery bypass grafting, or CABG. In the six-month 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. The preclinical results were presented in a poster at The American Heart Association’s Scientific Sessions 2024 meeting on November 16 in Chicago. All sdATEVs maintained patency throughout the study. The baboon study provided an effective model for demonstrating the feasibility, mechanical durability and capacity for host-cell remodeling of the sdATEV for CABG. After implantation, the sdATEV was observed to recellularize with host cells and remodel to form a multi-layered tissue including transanastomotic neomedial tissue that effectively reduced the initial size mismatch with the RCA. The neomedial tissue observed at six months was predominantly composed of quiescent contractile smooth muscle cells under a lining of functional endothelial cells. There are over 400,000 CABG procedures each year in the U.S. The ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.