Humacyte plans to submit an Investigational New Drug (IND) application to the FDA for its small-diameter (3.5mm) acellular tissue engineered vessel (sdATEV) in coronary artery bypass grafting (CABG) surgeries. This decision follows a productive meeting with the FDA and positive preclinical results in a primate CABG model, demonstrating successful patency, recellularization, and remodeling of the sdATEV. Previously, only the 6.0mm ATEV had been tested in humans, specifically for vascular trauma, hemodialysis access, and peripheral artery disease.

This advancement is potentially transformative for cardiac surgery. Current CABG procedures often rely on the patient’s saphenous vein, which has limitations. Vein grafts frequently fail within a year, and harvesting them can cause complications like infections and prolonged hospital stays. Some patients lack suitable veins altogether. The sdATEV offers a readily available, off-the-shelf alternative, potentially eliminating these issues and broadening the pool of eligible CABG candidates.

Preclinical studies showed the sdATEV remained open and functional over six months, integrated with the host tissue, and adapted to the size difference between the graft and the native artery. This addresses a key challenge in CABG surgery – ensuring long-term graft patency and minimizing complications associated with vein harvesting. Over 400,000 CABG procedures are performed annually in the United States, highlighting the potential market impact of a successful sdATEV.

A successful IND application and subsequent clinical trials could revolutionize CABG procedures. The sdATEV could become the standard conduit, improving patient outcomes, reducing complications, and streamlining surgical procedures. This development also reinforces Humacyte’s position as a leader in bioengineered tissue technology, expanding its potential applications beyond vascular trauma and into the broader cardiovascular field.

Source link: https://www.globenewswire.com/news-release/2025/01/21/3012571/0/en/Humacyte-Announces-Planned-IND-Filing-in-2025-to-Support-First-In-Human-Clinical-Study-of-Small-Diameter-ATEV-for-Coronary-Artery-Bypass-Grafting.html

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Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.