Vascudyne

Vascudyne is a biotechnology company focused on developing and manufacturing regenerative biomaterials for soft tissue repair and replacement, particularly for cardiovascular applications. The company was officially launched in 2018, as a spin-out from the University of Minnesota, though it was founded in 2014 by Jeff Franco and Kem Schankereli. It is headquartered in Minnesota's Medical Alley.

The company’s core technology, TRUE™ Tissue, was co-invented and developed over decades by Dr. Robert Tranquillo, a Distinguished McKnight University Professor at the University of Minnesota, and his research colleague, Dr. Zeeshan Syedain, who now serves as Vascudyne's CEO. Dr. Tranquillo is a leading figure in cardiovascular tissue engineering, with a background in chemical and biomedical engineering. The technology was licensed from the university in 2017. This platform produces completely biological, acellular, off-the-shelf tissues from cells grown in a lab, without using any synthetic materials. This approach avoids the potential adverse immune responses associated with synthetic polymer-based scaffolds.

Vascudyne's products are designed to be fully integrated into the body, allowing them to regenerate, grow with the patient, and self-repair. This is a significant advantage over existing artificial tissues, which are rigid, cannot heal, and often require multiple replacement surgeries, especially in pediatric patients with congenital heart defects. Key applications include coronary artery bypass grafts, heart valve replacements, and vascular grafts for hemodialysis access. In July 2021, the company announced the successful first-in-human use of its TRUE™ Vascular Graft for hemodialysis patients. A recent grant from the Department of Defense will advance the development of a heart valve that can grow with children, potentially reducing the need for repeated open-heart surgeries.

The company's business model involves manufacturing and commercializing these engineered tissues for medical device and therapeutic use. Vascudyne operates from a 15,000 sq. ft. facility that includes ISO 7 cleanroom manufacturing space to support clinical trials and initial commercialization. The firm has raised significant capital, including a $10 million Series A round in 2021, to fund clinical trials, expand manufacturing capabilities, and develop new products from its platform technology.

Keywords: regenerative medicine, tissue engineering, cardiovascular devices, biomaterials, heart valve replacement, vascular grafts, hemodialysis access, TRUE Tissue, acellular tissue, off-the-shelf tissue, Robert Tranquillo, Zeeshan Syedain, University of Minnesota spin-out, soft tissue repair, biological implants, pediatric congenital heart defects, coronary artery bypass, medical device manufacturing, biotechnology, clinical trials