Humacyte, Inc. announced plans to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration in the fourth quarter of 2025 for its coronary tissue engineered vessel (CTEV) in coronary artery bypass grafting (CABG). The announcement follows the publication of promising preclinical data in JACC: Basic to Translational Science demonstrating the potential of this bioengineered vessel as a durable alternative to current bypass graft options.
Breakthrough Preclinical Results
The study, titled "Acellular Tissue Engineered Vessels as Coronary Artery Bypass Grafts," evaluated the CTEV in five adult baboons undergoing CABG to the right coronary artery. All implanted CTEVs remained patent throughout the six-month study period and demonstrated remarkable adaptive capabilities. The vessels recellularized with host cells to form multi-layered tissue, including transanastomotic neomedial tissue that effectively reduced the initial size mismatch with the right coronary artery.
"Innovation in CABG has been stagnant for far too long," said Alan Kypson, MD, FACS, Cardiothoracic Surgeon at UNC REX Hospital. "Our results suggest that we may be on the verge of a new option — one that remodels to match the native artery and recellularizes with host cells, potentially providing superior patency relative to saphenous vein grafts."
Addressing Critical Unmet Medical Need
Cardiovascular disease remains the leading cause of death worldwide, comprising one in every three deaths in the United States in 2023. Coronary artery disease affects 1 in 20 adults aged 20 and older, making CABG a critical therapeutic intervention. However, current treatment options face significant limitations.
Saphenous vein grafts, used in 80%-90% of CABG cases, demonstrate poor long-term patency with approximately 50% failing at 10 years. Many patients also lack usable autologous veins or arteries due to prior harvest, ablation, or poor quality, highlighting the urgent need for alternative conduits. Remarkably, no novel CABG conduits have gained routine clinical use for the past half century.
Technology and Manufacturing
The CTEV is a 3.5mm blood vessel produced using the same bioengineering manufacturing system as Humacyte's acellular tissue engineered vessel (ATEV™). Also referred to as the small-diameter ATEV or sdATEV, the CTEV represents an extension of Humacyte's proven tissue engineering platform.
The company's broader ATEV platform has already achieved significant regulatory milestones. Humacyte's Biologics License Application for the ATEV in extremity vascular trauma was approved by the FDA in December 2024, and ATEVs are currently in late-stage clinical trials for other vascular applications, including arteriovenous access for hemodialysis and peripheral artery disease.
Path to Clinical Development
Humacyte's plans for filing the IND are based on agreements reached with the FDA during a meeting held earlier this year. The company intends to advance the CTEV into its first-in-human study in CABG following regulatory approval.
"We're pleased that this new publication of preclinical data demonstrates the promise of CTEVs as an alternative for native vessel grafts in CABG," said Laura Niklason, M.D., Ph.D., Founder and Chief Executive Officer of Humacyte. "As one of the leading causes of early death, coronary artery disease poses unique challenges for patient care. We are looking forward to proceeding into the first-in-human study of the CTEV in CABG and hopefully offering surgeons another option for treating this disease."
The CTEV represents a potentially transformative advancement in cardiac surgery, offering the possibility of improved long-term outcomes for patients requiring coronary artery bypass grafting. If successful in human trials, it could become the first novel CABG conduit to enter routine clinical use in decades.
