Abstract

Advanced therapies and regenerative medicine are one of the most promising fields of future medicine, and tissue-engineering is one of its cornerstones.
The severe and incurable stages of Chronic Venous Insufficiency (CVI) currently affect at least 1.5M patients in the EU and North America alone, with an approximately 300,000 new patients diagnosed every year. The disease significantly impacts quality of life and puts numerous patients out of work or into disability programs. CVI is a major burden to patients, employers, and health care systems. VERIGRAFT estimates that its first product, the personalised tissue-engineered vein (P-TEV), has the potential to cure patients with severe CVI and enable them to return to a normal life.
VERIGRAFT is just about to initiate a unique clinical trial program where P-TEV will be used to treat CVI. We have received approval for the first trial by the European authorities. The trial in Europe will be first of its kind worldwide, and one of the first tissue-engineered products tested in controlled clinical trials in Europe. The presentation will describe the road from an unmet medical need to a market authorisation for this novel Advanced Medicinal Therapy Product (ATMP). Funding and commercial aspects of this development will also be covered. Finally, a series of other tissue-engineered product under development will be highlighted.
Key items of the presentation:
• Commercialisation of a unique ATMP, from bench to bedside
• Generation of personalised tissue-engineered transplants
• Use of regenerative medicine to address so far incurable diseases
• Organ transplantation without the severe risks of immunosuppression