FDA accepts Humacyte IND for clinical study in cardiovascular tissue engineering

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Daria Chernytska

29.07.2026

FDA accepts Humacyte IND for clinical study in cardiovascular tissue engineering — Humacyte wins FDA green light for CTEV

Humacyte announced that the U.S. Food and Drug Administration has accepted its Investigational New Drug (IND) application to begin the first-in-human clinical trial of the Coronary Tissue Engineered Vessel (CTEV) for use in coronary artery bypass grafting procedures.

This development represents a significant step toward introducing novel biological solutions for cardiovascular care. The CTEV, described as first-in-class and universally applicable, aims to provide an innovative approach to treating coronary artery disease. Further updates on trial timelines and patient enrollment are anticipated as Humacyte advances this next phase in the clinical development of tissue-engineered vascular conduits.

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