Humacyte has announced the publication of new preclinical data as part of a study evaluating the coronary tissue engineered vessel (CTEV) as a coronary artery bypass graft (CABG) conduit in a non-human primate model.
In the study, published in JACC: Basic to Translational Science, the CTEV was observed to sustain blood flow, recellularise with the animals’ host cells, and remodel to reduce the initial size mismatch between the CTEV and the animals’ native artery.
“Innovation in CABG has been stagnant for far too long,” said Alan Kypson (UNC REX Hospital, Raleigh, USA). “Our results suggest that we may be on the verge of a new option—one that remodels to match the native artery and recellularises with host cells, potentially providing superior patency relative to saphenous vein grafts. The CTEV has the potential to address a significant unmet clinical need in coronary bypass surgery and ultimately improve patient outcomes.”
CABG, a procedure that improves blood flow to the heart by using the internal mammary artery and saphenous vein to bypass narrowed or blocked coronary arteries, is a standard of care treatment for coronary artery disease. However, saphenous vein grafts—used in 80%-90% of CABG cases—can have poor long-term patency. Many patients also lack usable autologous veins or arteries due to prior harvest, ablation, or poor quality, highlighting the unmet clinical need for alternative conduits.
The recent study follows five adult baboons undergoing CABG to the right coronary artery with the CTEV. All CTEVs remained patent throughout the six-month study. At the end of follow-up, the CTEV was observed to have recellularised with host cells to form a multi-layered tissue, including transanastomotic neomedial tissue that effectively reduced the initial size mismatch with the right coronary artery (RCA). The results suggest that the CTEV may be a durable alternative CABG conduit.
The CTEV is 3.5mm blood vessel produced in the same bioengineering manufacturing system as Humacyte’s acellular tissue engineered vessel (ATEV). The CTEV is also referred to as the small-diameter ATEV, or sdATEV.
Humacyte also announced that it plans to advance the CTEV into its first-in-human study in CABG. To support human study, the company anticipates filing an investigational new drug (IND) application with the US Food and Drug Administration (FDA) during the fourth quarter of 2025. The company’s current plans for filing an IND are based on the outcome of a meeting held early this year with the FDA, including agreements reached with the agency.
“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, 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 is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.
