ST. PAUL, Minn., Aug. 21, 2026 (GLOBE NEWSWIRE) — Vascudyne, Inc. today announced the publication in Nature Communications of results supporting an off-the-shelf bioengineered blood vessel for coronary artery bypass grafting (CABG)—an option that does not currently exist commercially and that could free a procedure performed on hundreds of thousands of patients each year from its dependence on harvesting vessels from the patient’s own body.
In a large-animal coronary bypass model, the company’s 4 mm acellular tissue-engineered vessel, stabilized by a laser-cut nitinol external support, achieved 100% patency at six months and remained open through 550 days — 18 months — with all anticoagulation stopped at day 180 and never resumed. To date, no off-the-shelf coronary graft has been shown to stay open without anticoagulants. On explant, the conduits had been rebuilt by the recipient into living tissue: lined with endothelium, repopulated with smooth muscle, free of thrombus, and stronger than the veins they were designed to replace.
CABG remains the standard of care for complex multivessel disease, and its long-term success has always been limited to the quality of the harvested vessels. Several clinical trials have demonstrated limitation of saphenous vein grafts including early occlusions. Harvesting those veins requires a second surgical site, increases operating time, and can lead to wound complications and delayed recovery. A large and growing share of patients—the elderly, those with peripheral vascular disease, those with venous insufficiency, or those whose veins were already harvested in a previous operation—simply do not have a vessel available, preventing them from receiving a life-extending operation.
Unlike autologous veins, whose quality varies with the very comorbidities that brought the patient to surgery, a manufactured vessel is standardized and quality-controlled, providing the same conduit for the healthy 55-year-old and the diabetic 78-year-old with prior harvest and peripheral disease. It eliminates the leg incision and related complications while shortening the operation. Unlike the synthetic grafts that have repeatedly failed at coronary diameters, it is biological: designed to regenerate, become endothelialized, and ultimately become the patient’s own living, healthy blood vessel.
“The patients I worry about are those who need bypass the most and have the least available grafts,” said Matthew Soule, MD, Associate Professor of Cardiothoracic Surgery at the University of Minnesota, a Vascudyne medical advisor, and a co-author on the study. “Someone comes in with diabetes, peripheral vascular disease, veins that were harvested fifteen years ago, and that means bypass with an unhealthy vessel, or an incomplete revascularization, or we do not offer the operation at all. Every cardiac surgeon has had that conversation with a patient and their family.”
“An off-the-shelf conduit could potentially change what I can offer that patient. I open a package instead of opening an arm or leg. I am not limited by what their disease has already taken from them, and I am not adding a wound in a patient who heals poorly. That is the opportunity here. This study showed me that a bioengineered vessel can perform in the coronary position, and that the regenerated conduits kept working after anticoagulation was stopped. Clinical translation of these results would be very meaningful for my patients.”
This technology has already advanced to first-in-human trials for coronary bypass, where early clinical results demonstrated procedural feasibility and device safety at 12-month follow-up on a standard direct oral anticoagulant regimen published in JACC Case Reports earlier this year.
“There is no commercial off-the-shelf conduit for coronary bypass today, despite hundreds of thousands of procedures being performed in the US alone,” said Zeeshan H. Syedain, PhD, Chief Executive Officer of Vascudyne and senior author on the manuscript. “The industry spent decades developing synthetic materials to address a biological problem, with disappointing results. A conduit that the patient’s body regenerates into its own living blood vessel is an exciting opportunity to address this unmet need.”
“For a medtech industry that has struggled to find genuinely new growth in open cardiac surgery, the performance of regenerative conduits in this study shows significant potential for patient benefit and investment opportunity. Shorter operations, fewer harvest-site complications, fewer reinterventions for graft failure, and access to patients who are currently turned away.”
The authors note the study’s limitations, including the use of a healthy ovine model that does not reproduce human coronary artery disease. The Vascudyne acellular tissue-engineered vessel is investigational and is not approved for commercial sale in the United States or the European Union.
About Vascudyne. Vascudyne, Inc. is a clinical stage medical device company developing completely biological, off-the-shelf tissue-engineered vessels and valves for cardiovascular disease. The company’s conduits are grown from human cells and then decellularized, making them non-immunogenic and able to be stocked on the shelf, and are designed to be repopulated by the recipient’s own cells after implantation. Vascudyne is headquartered in St. Paul, Minnesota, with European operations in Copenhagen, Denmark. Learn more at vascudyne.com.
Media contact. Katherine Lindsay, Vascudyne, Inc. — contact@vascudyne.com
Publication. Krouse A, Soule M, Gross C, McMahon M, Benkofske J, Syedain ZH. “18 Month patency of acellular bioengineered regenerative conduit as coronary artery bypass.” Nature Communications ([Sept. X], 2026). DOI: 10.1038/s41467-026-77065-3
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/89eda8a0-478e-4ef5-af3d-14065b3deae0
