Vascudyne's Lab-Grown Vessel Passes 2-Year Clinical Test

BARCELONA, Spain and ST. PAUL, Minn., Oct. 08, 2026 /CourierPR/ -- Vascudyne, a clinical-stage medical device company developing off-the-shelf bioengineered implants designed to regenerate into the patient’s own living tissue, today announced the presentation of two-year clinical data for its acellular tissue-engineered vessel used as a coronary artery bypass graft. The data further support the potential of Vascudyne’s bioengineered tissue platform to provide living graft replacements without the need for tissue harvest from the patient. The results are being presented at the 40th EACTS Annual Meeting in Barcelona, Spain.

The problem today’s bypass surgery depends on borrowing a vessel from the patient. In coronary artery bypass surgery, a surgeon creates a new route for blood to flow around a blocked artery in the heart. To do that, they need a replacement blood vessel, and today the only option is to borrow one from the patient. That means a second incision, often in the leg, along with extra pain, scarring, and recovery time. Even then, the borrowed vein is not always healthy enough to use. Many leg veins used in bypass surgery narrow or close within the first year, and about one in five patients has no suitable vein to use at all. There is currently no approved, ready-to-use small blood vessel that surgeons can simply take off the shelf.

A different approach: a vessel grown in the laboratory. Vascudyne grows human tissue blood vessels in a bioreactor and then removes all the living cells, leaving behind the natural collagen-based structure. Because no cells remain, the body does not reject it, and the vessel can be stored on a hospital shelf until a surgeon needs it. After implantation, the patient’s own cells move in and gradually turn it into living tissue. The goal is a graft that becomes part of the patient.

The patient results: two years and sustained blood flow. The case presented at EACTS describes a patient who received the lab-grown vessel during coronary artery bypass surgery. Imaging performed repeatedly over two years showed that the bioengineered vessel remained open, with blood flowing normally. Throughout follow-up there was no clotting, abnormal swelling of the vessel, bleeding, major heart event, or problem related to the device. This is the longest documented clinical patency, or continuous blood flow, reported to date for a Vascudyne tissue-engineered vessel. Further, Vascudyne has recently completed enrollment in its European CABG feasibility clinical study.

What animal studies show: blood flow maintained after blood thinners were stopped. Separately from the patient case above, Vascudyne recently published an 18-month study in sheep in the journal Nature Communications. The bioengineered vessels, used as coronary bypass grafts, maintained function. Blood thinners (anticoagulation) were then stopped, and the lab-grown vessels remained patent and functional for the rest of the 18-month study. Explant analysis demonstrated living blood vessels. The detail that matters most was inside the vessel. Healthy blood vessels are lined with a thin layer of cells called the endothelium, that keeps blood flowing without clotting. A manufactured graft starts out without this lining. These vessels grew that lining, which is why they could stay open after the blood thinners were stopped. When examined at the end of the study, they had become living blood vessels. To the company’s knowledge, this is the first published evidence of lab-grown vessels in the heart that developed a working inner lining and stayed open for a full year after blood thinners were stopped.

How we envision improvement in coronary disease patient care in coming years.

Vascudyne, Inc. is a clinical-stage medical device company based in St. Paul, Minnesota. Its technology, developed at the University of Minnesota, grows human tissue in bioreactors and then removes the cells, creating ready-to-use implants that do not require anti-rejection drugs and that the patient’s own cells turn into living tissue after implantation. The company is developing implants for heart bypass surgery, repair of heart defects in children, and heart valve replacement. Vascudyne manufactures its products in-house under GMP in dual ISO 7 clean rooms. Vascudyne’s devices are investigational and are not approved for commercial use.