BARCELONA, Spain and ST. PAUL, Minn., Oct. 08, 2026 (GLOBE NEWSWIRE) -- Vascudyne, Inc., 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. Together with recently published preclinical findings, 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 have 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
“For sixty years, bypass surgery has relied on a vessel taken from the patient’s own body, and often what is borrowed is not ideal,” said Zeeshan Syedain, PhD, Chief Executive Officer of Vascudyne. “In fact, we have heard from many patients about the pain of that second wound in their leg. We want to give surgeons a better option and spare patients the second incision. What we see at two years in the clinic, and at eighteen months in animals without anticoagulation, is very promising for Vascudyne’s tissue-engineered vessel. We believe our bioengineered blood vessels have the potential to transform not only coronary bypass surgery, but many cardiovascular diseases.”
“Finishing enrollment in our European clinical trial and now reporting two-year results is a major milestone for our bypass program,” said Abrielle Krouse, Director of Clinical Affairs at Vascudyne. “The clinical need is significant. More than 400,000 bypass surgeries are performed each year in the United States and Europe, yet many vein grafts fail within the first year, and roughly one in five patients has no good vein to use. A ready-to-use vessel that can regenerate into the patient’s own tissue could help to close that gap. Coronary bypass surgery is our first step. We are developing the same technology for other heart and blood vessel conditions where surgeons need implants that can become living, integrated tissue.”
About Vascudyne
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.
Media and investor contact
Katherine Lindsay
contact@vascudyne.com · vascudyne.com
Forward-looking statements: This release contains forward-looking statements regarding clinical development plans, regulatory progress and commercial potential. Clinical results from individual cases and preclinical models may not predict outcomes in larger trials.
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