Humacyte, Inc. announced the publication of preclinical results assessing its coronary tissue engineered vessel (CTEV) as a graft in coronary artery bypass surgery (CABG) in a non-human primate model. According to the company, the CTEV remained open (patent) for six months, recellularized with host cells, and remodeled to reduce size mismatch with the animal’s native artery.
The study, published in JACC: Basic to Translational Science, involved five adult baboons undergoing CABG to the right coronary artery using CTEV conduits. The company said all implanted vessels maintained blood flow throughout the study period and displayed formation of multi-layered tissue including neomedial tissue at the graft-native vessel junction to address the initial diameter mismatch.
Humacyte claims the CTEV (also referred to as small-diameter ATEV or sdATEV), a 3.5mm bioengineered vessel, may serve as a durable alternative to conventional grafts, especially given limitations in long-term patency rates of saphenous vein grafts and lack of suitable autologous vessels in many patients.
To advance development, the company said it plans to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration in the fourth quarter of 2025 to enable first-in-human studies in CABG.
