Humacyte Announces FDA Acceptance of IND for First-In-Human Clinical Study of CTEV for Coronary Artery Bypass Grafting

– Phase 2a study of CTEV in coronary artery bypass grafting (CABG) is expected to start this quarter –

– Progression of CTEV into human study supported by positive preclinical results presented at multiple scientific meetings and in a recent publication –

DURHAM, N.C., July 27, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced that the Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for a first-in-human clinical study of the coronary tissue engineered vessel (CTEV) in coronary artery bypass grafting (CABG). Humacyte plans to initiate a Phase 2a study of the CTEV in CABG patients during the current quarter.

“No new off-the-shelf conduits have been introduced for CABG in the past 40 years, and our IND clearance and upcoming Phase 2a study are major milestones for the CTEV as a potential innovation in CABG,” said Laura Niklason, M.D., Ph.D., Founder and Chief Executive Officer of Humacyte. “Our preclinical results suggest that the CTEV may be a promising off-the-shelf alternative to saphenous vein grafts in CABG, and we look forward to evaluating this prospect in its first human clinical study.”

The FDA has approved Humacyte’s study design for a first-in-human clinical trial titled “A Phase 2a Study for the Evaluation of Safety and Efficacy of Humacyte's Coronary Tissue Engineered Vessel (CTEV) as a Vascular Conduit for Coronary Artery Bypass Grafting in Patients with Coronary Artery Disease,” to be conducted in ten adult patients. An assessment of patency (blood flow) through the CTEV will be performed two months after implant, and patients will be followed for up to three years.

There are over 400,000 coronary arterial grafts placed each year in the United States, and the surgery has been shown to improve the survival and quality of life for many patients with coronary artery disease. The current conduits used for CABG are autologous vessels, including the internal mammary artery, the radial artery and saphenous vein, which is used in the majority of CABG operations. However, saphenous vein graft (SVG) patency at one year is often as low as 75%, and SVG harvesting from the patient can result in variable vein quality as well as surgical wound complications, such as infection, that can prolong hospitalization and require additional surgical interventions. In addition, a number of patients do not have adequate saphenous vein available for use in surgical bypass.

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). CTEV is designed to be available off-the-shelf, and does not require further injuring the patient to obtain arterial replacement material. In preparation for the planned Phase 2a study, the CTEV has been studied in preclinical CABG models in pigs, sheep and baboons. The results of a six-month preclinical study in baboons were recently published in JACC: Basic to Translational Science and the CTEV was observed to sustain patency, recellularize with host vascular smooth muscle and endothelial cells, and remodel to effectively reduce the initial size mismatch between the CTEV and the animals’ right coronary arteries.

The CTEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. For uses other than the FDA approval in the extremity vascular trauma indication, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.

Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s Biologics License Application for the acellular tissue engineered vessel (ATEV) in the vascular trauma indication was approved by the FDA in December 2024. ATEVs are also currently in late-stage clinical trials targeting other vascular applications, including arteriovenous (AV) access for hemodialysis and peripheral artery disease (PAD). Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com..

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