Conditions
& Treatments
Utility for patients
Combating recurrent surgeries, life-long blood thinning medication, implant rejections, complications, and poor quality of life.
Value for providers
Developing off the shelf implants that are easy to handle, targeting high patency rates and reduced complications that can lead to high patient satisfaction and hospital ratings.
CORONARY ARTERY BYPASS
Harvested native vessels used for CABG include the left internal mammary artery, saphenous vein grafts, right internal mammary artery, radial artery, and gastroepiploic artery. There are several CABG complications, such as stroke, wound infection, graft failure, renal failure, postoperative atrial fibrillation, and death. Minimally invasive CABG procedures started in the mid-1990s seek to avoid open heart surgery but still require harvesting native vessels. Graft failures occur due to acute bypass graft thrombosis, intimal hyperplasia, graft inflammation, and early graft atherosclerosis.
> 600,000
> 41%
0
VASCUDYNE’S SOLUTION: CORONARY ARTERY BYPASS GRAFTS
Vascudyne’s tissue technology has the potential to eliminate many of the issues surgeons encounter with harvested native vessels due to our conduit’s regenerative, non-calcific, and non-immunogenic properties. Coupled with native vessel-like mechanical properties that can minimize intimal hyperplasia risk, our conduits could offer patients an attractive long-term and off-the-shelf solution.
HEART VALVE REPLACEMENT
Two primary replacement options are available: mechanical valves and biological (tissue) valves. Mechanical valves are long-lasting and better suited for younger patients but require lifelong anticoagulation therapy to prevent blood clots and carry an increased risk of major bleeding, stroke, and other complications. Biological valves, derived from animal (xenografts) or human tissue (homografts), provide more natural blood flow and can be delivered either through open heart surgery or percutaneously as transcatheter valves. However, their limited lifespan due to structural valve deterioration often necessitates reoperation, especially in younger individuals, and increased mortality.
> 25,000
> 200,000
25%
Syedain ZH et al. Biologically engineered valved conduits for right ventricular outflow tract repair evaluated for 52 weeks in growing lambs. Cardiovasc Res. 2025;121:674 (conducted at the University of Minnesota) Click to Enlarge
VASCUDYNE’S SOLUTION: HEART VALVE REPLACEMENTS
Vascudyne's engineered tissue heart valves are designed to mimic the structure and function of native heart valves, with the ability to integrate into the patient’s tissue and potentially grow or remodel over time. This regenerative potential may reduce the need for reoperation, while addressing durability issues associated with traditional biological valves.
Early research suggests that Vascudyne’s technology could revolutionize heart valve replacement by combining the benefits of both mechanical and biological valves while minimizing their limitations. Our heart valve design targets are high mechanical durability, regenerative potential, non-thrombogenic, no calcification or endocarditis risk, no need for anticoagulation therapy, and suited for surgical or percutaneous procedures as either stented or stentless valves.
VASCULAR REPAIR
Peripheral bypass surgery risks include wound infection, bleeding, pneumonia, conduit occlusion, and peripheral nerve damage. When native vessels are unavailable or not suitable as bypass conduits, synthetic grafts, most commonly polytetrafluoroethylene (PTFE) or polyester (Dacron®), are used. Immediate conduit-related complications include acute thrombosis and bleeding, while long-term issues include infection and occlusion secondary to intimal hyperplasia.
20-45%
36.8%
25-35%
VASCUDYNE’S SOLUTION: VASCULAR REPAIR CONDUITS AND PATCHES
Vascudyne’s conduits can be produced in a range of shapes and sizes addressing all the different peripheral vasculature surgical needs. Conduit length is especially important as femoropopliteal grafts needed may be up to 28 cm in length. Our tissue manufacturing process can produce long segment conduits, and the engineered tissue’s regenerative and 100% biological properties have the potential to overcome the limitations and complications of synthetic grafts currently used.
PEDIATRIC CARDIOVASCULAR REPAIR
Two major limitations of current clinical materials used for blood vessel or heart valve repair are their limited durability and inability to grow with the child. As the child grows, these synthetic components often become too small or less effective, requiring repeated surgical replacements and reoperations to accommodate the child's development.
>34,000
33%
9.9%
Syedain ZH et al. Biologically engineered valved conduits for right ventricular outflow tract repair evaluated for 52 weeks in growing lambs. Cardiovasc Res. 2025;121:674 (conducted at the University of Minnesota) Click to Enlarge
VASCUDYNE’S SOLUTION: PEDIATRIC CARDIOVASCULAR CONDUITS AND PATCHES
Vascudyne’s tissue-engineered valves, vessels, valved conduits, and patches have the potential to grow and adapt over time, reducing or eliminating the need for repeated surgeries. The University of Minnesota has already demonstrated somatic growth in preclinical in vivo studies. This program is funded through grants and in collaboration between Vascudyne, Mayo Clinic, and the University of Minnesota.
Our completely biological tissues show promise for long-term durability, regeneration, and non-immunogenicity that are critical attributes for the pediatric population.
HEMODIALYSIS ACCESS
Common challenges with existing arteriovenous grafts are infection, stenosis, calcification, inflammation, hemorrhage, and thrombosis. These complications cause tremendous difficulties for ESRD patients, significantly affecting quality of life and longevity.
518,970
40%
79%
VASCUDYNE’S SOLUTION: HEMODIALYSIS ACCESS CONDUITS
Vascudyne’s off-the-shelf tissue conduits may offer significant benefits to patients by eliminating the need for fistula maturation and hemodialysis delays.
Our biological tissues may mitigate patient risks due to our conduit’s potential for non-calcification, non-immunogenicity, infection-resistance, and regeneration.
SOFT TISSUE RECONSTRUCTION
Soft tissue repair and reconstruction procedures cover a broad range including tumor removal, laceration repair, maxillofacial surgery, hand surgery, burn care, hernia repair, peripheral nerve repair, and cosmetic surgery.
When autografts are not available, allografts, xenografts, and synthetic biomaterials are used to repair soft tissue defects but they often result in complications such as infection, graft rejection, graft failure, hematomas, seromas, foreign body synovitis, nerve injury, and tissue ischemia due to lack of vascularization. Skin grafts have an additional set of potential complications such as wound dehiscence, scarring, bleeding, prolonged erythema, hypo/hyperpigmentation, and undue postoperative pain.
> 40%
20-90%
33.3%
VASCUDYNE’S SOLUTION: SOFT TISSUE RECONSTRUCTIVE BIOMATERIALS
Vascudyne’s platform technology is well suited for soft tissue repair and replacement applications. Tissues can be manufactured in a wide variety of shapes and sizes, from nerve wraps to challenging anatomical sites such the elbow.
Our off-the-shelf tissue grafts are available without self-tissue sacrifice and donor site morbidity complications of autografts. The biological nature of our tissues has the potential to support vascularization and regeneration for full integration with host tissue, while holding the promise of infection resistance and non-immunogenicity.
These are investigational uses that have not been approved by any health authority. Safety and efficacy have not been established and there is no guarantee that pipeline products or investigational uses will receive approval from health authorities.
Copyright 2025 | Vascudyne, Inc.
