Humacyte wins FDA IND clearance for first-in-human CTEV study in coronary artery bypass grafting

Humacyte (Nasdaq: HUMA) announced on 27 July 2026 that the US Food and Drug Administration has accepted its Investigational New Drug (IND) application for a first-in-human clinical study of its coronary tissue engineered vessel (CTEV) in coronary artery bypass grafting (CABG). The company plans to initiate a Phase 2a study in CABG patients during the current quarter.

The cleared trial will evaluate the safety and efficacy of the CTEV as a vascular conduit in ten adult patients with coronary artery disease, assessing patency two months after implant with follow-up for up to three years. Humacyte frames the milestone as significant given that no new off-the-shelf conduits have been introduced for CABG in the past 40 years; the current standard relies on autologous vessels such as the saphenous vein, whose one-year graft patency can be as low as 75%.

The CTEV is a first-in-class, universally implantable bioengineered human blood vessel produced in the same manufacturing system as Humacyte's FDA-approved acellular tissue engineered vessel (ATEV). Progression into the clinic is supported by preclinical CABG studies in pigs, sheep and baboons; a six-month baboon study recently published in JACC: Basic to Translational Science showed the CTEV sustained patency and recellularised with host vascular cells. More than 400,000 coronary arterial grafts are placed each year in the United States.

Source: BioSpace, 27 July 2026.