University of Minnesota Technology Commercialization announced the formal launch of Vascudyne Inc., a startup company based in Stillwater, Minn., focused on the development of biologically engineered tissue for medical device and therapeutics applications. The technology offers a regenerative capacity unavailable until now in materials and devices used for medical treatment.
Vascudyne’s technology is based on discoveries by University researcher Robert Tranquillo, Ph.D., professor in the departments of Biomedical Engineering and Chemical Engineering & Materials Science in the College of Science and Engineering, and researchers in his lab, Zeeshan Syedain, Ph.D., senior research associate, and Lee Meier, B.S., staff scientist and present MD/Ph.D. student.
Vascudyne Engineered Tissue is based on decellularized collagenous tissue grown in a simple bioreactor from human dermal fibroblasts in fibrin gel. The resulting tissue has biological and mechanical properties very similar to native tissue and should regenerate and grow with the patient based on preclinical studies. This completely biological, off-the-shelf biomimetic material has the potential to move medical device technologies beyond the supply, durability, and hemocompatibility limitations of current synthetic and native tissue options.
“We are excited about the prospects of this material grown from skin cells becoming a clinical reality with its commercialization by Vascudyne,” said Tranquillo, “given its success in our preclinical studies and its potential as a platform technology for many applications.”
The technology was recently awarded several patents and successfully used in University preclinical studies as a heart valve and a vascular graft, which demonstrated unprecedented somatic growth. The vascular graft studies were published in Nature Communications and Science Translational Medicine.
“The need for cardiovascular replacement parts has never been greater, and this need is expected to grow significantly in the near future,” said Luke Brewster, MD, Ph.D., assistant professor of surgery in Division of Vascular Surgery at the Emory University School of Medicine, who was not involved in developing the technology. “Biologically compatible replacement tissue for cardiovascular disease is the Holy Grail for patients and clinicians, who have not seen a full step forward in these technologies since the 1950s. Professor Tranquillo’s innovative cardiovascular tissue platform is well positioned to help the field take this important step into the future.”
Vascudyne has completed Phase I of its technology plan, the translation of the technology from the University setting to its Stillwater facility, and has implemented pilot-scale manufacturing capable of producing engineered tissue to support preclinical animal studies and first-in-human clinical trials.
Vascudyne plans to initially pursue two products utilizing the University-developed engineered tissue: a new generation of small-diameter vascular conduits and a transcatheter-delivered valve intended for right-side heart applications. Both projects are in planning for preclinical studies in 2019, to be followed by regulatory submissions for early clinical trials.
Next, the company will continue optimizing and growing its operations while implementing this material into novel medical device designs. For this work, Vascudyne is offering limited opportunities for commercial clients to pursue this novel material in their own medical device technology.