DURHAM, N.C., July 27, 2026
Humacyte, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for the company’s first-in-human clinical study evaluating the Coronary Tissue Engineered Vessel (CTEV) in Coronary Artery Bypass Grafting (CABG). The Phase 2a clinical trial is expected to begin during the current quarter and will enroll 10 adult patients with coronary artery disease. The study will evaluate the safety, efficacy, and graft patency of the off-the-shelf bioengineered blood vessel, with blood flow assessed two months after implantation and patient follow-up continuing for up to three years. The milestone marks a significant advancement in Humacyte’s efforts to expand its portfolio of regenerative vascular therapies for cardiovascular disease.
CTEV Designed to Address Limitations of Traditional Bypass Grafts
The CTEV is a first-in-class, universally implantable bioengineered human blood vessel manufactured using the same platform as Humacyte’s FDA-approved Acellular Tissue Engineered Vessel (ATEV). Unlike conventional saphenous vein grafts (SVGs) that require harvesting blood vessels from patients, the CTEV is designed as an off-the-shelf vascular conduit, potentially eliminating additional surgical procedures and reducing complications associated with vein harvesting. According to the company, more than 400,000 coronary artery grafts are performed annually in the United States, yet traditional vein grafts may experience patency rates as low as 75% after one year, while also posing risks of wound infection, inconsistent vein quality, and prolonged hospitalization. The company believes its engineered vessel could provide a standardized alternative for patients who lack suitable autologous veins for bypass surgery.
Preclinical Data Supported FDA IND Acceptance
Humacyte’s IND submission was supported by encouraging preclinical studies conducted in pigs, sheep, and baboons, with results presented at multiple scientific conferences and recently published in JACC: Basic to Translational Science. In the six-month baboon study, the CTEV maintained long-term patency, demonstrated recellularization with host endothelial and vascular smooth muscle cells, and remodeled to reduce the initial size mismatch between the implanted vessel and native coronary arteries. These findings suggest that the engineered vessel has the potential to integrate with the body’s natural vascular system while maintaining blood flow. Company Founder and Chief Executive Officer Laura Niklason, M.D., Ph.D., stated that no new off-the-shelf conduits have been introduced for CABG in more than 40 years, describing the FDA clearance and upcoming human trial as a major milestone in advancing cardiovascular regenerative medicine.
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Humacyte Expands Regenerative Medicine Pipeline
The acceptance of the IND further strengthens Humacyte’s position in the field of bioengineered human tissues and regenerative medicine. The company previously received FDA approval for its ATEV in the treatment of extremity vascular trauma and continues late-stage clinical development in arteriovenous access for hemodialysis and peripheral artery disease (PAD). Additional research programs are underway in pediatric heart surgery, type 1 diabetes, and other tissue-engineering applications. While the CTEV remains an investigational product and has not yet received regulatory approval for commercial use, the initiation of the Phase 2a first-in-human study represents an important step toward evaluating whether bioengineered vascular grafts can improve long-term outcomes for patients undergoing coronary artery bypass surgery and potentially transform future standards of cardiovascular care.
Source: Humacyte, press release
