ATEV (SYMVESS)

July 27, 2026: Humacyte, Inc. (NASDAQ: HUMA) said the FDA accepted its IND for a first-in-human clinical study of its coronary tissue engineered vessel (CTEV) as a vascular conduit for coronary artery bypass grafting (CABG) in patients with coronary artery disease. The company expects to initiate a Phase 2a trial during the current quarter.

The FDA also approved the study design for the Phase 2a trial, which will enroll 10 adult CABG patients. Patency (blood flow) through the CTEV will be assessed two months post-implant, with follow-up for up to three years.

Humacyte cited supportive preclinical CABG model data in pigs, sheep, and baboons, including a recently published six-month baboon study in JACC: Basic to Translational Science reporting sustained patency, host recellularization with vascular smooth muscle and endothelial cells, and remodeling that reduced initial size mismatch versus right coronary arteries. CTEV remains investigational and is not approved for sale.