Healthcare
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
About this update from Humacyte, Inc.
– 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 comp...