I-Corps: Translation Potential of a Tissue-Engineered Vein Valve

The broader impact of this I-Corps project is based on the development of a tissue-engineered vein valve intended as an effective treatment option for venous ulcer patients. If left untreated, this condition can lead to repeated ulcers and eventual amputation, inflating healthcare costs and resulting in significant patient suffering. Previous attempts at prosthetic vein valves have failed to combat the increased thrombogenicity (producing coagulation of the blood) of the venous system leading to device failure within weeks. The solution explored in this project could be the first device capable of providing a curative solution to these patients, transforming venous patient care. This I-Corps project utilizes experiential learning coupled with a first-hand investigation of the industry ecosystem to assess the translation potential of the technology. The solution is based on the development of a novel tissue-engineered vein valve prosthesis that mimics the aligned collagen structure of native leaflets, providing a foundation for mechanical durability and endothelialization of the tissue material. The solution is a bileaflet valve encompassing a nitinol stent which, together with the innovative fabrication technique, is the basis for a filed patent application. The tissue engineered collagen material grown on the stent is a platform technology. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.