Periodic Reporting for period 1 - TriSol System (A heart valve prosthesis and delivery system intended to replace damaged tricuspid valves and prevent right ventricle dysfunction) Periodo di rendicontazione: 2018-09-01 al 2018-12-31 Sintesi del contesto e degli obiettivi generali del progetto In Europe, an estimated 16.8M people are affected by heart valve disease (HVD) each year. Tricuspid regurgitation (TR) is a HVD which occurs when the tricuspid valve fails to close properly, causing blood to flow backward into the right atrium. Many cases of TR are accompanied by Right Ventricle (RV) Dysfunction. The gold standard methods for tricuspid valve diseases are standard open-heart surgery and transcatheter valve replacement. However, high-risk interventions require long recovery time and in-hospital stays and have significant hospital mortality (more than 10%). Due to the high risk related to the surgical procedure, most of the patients cannot be treated. As such, there is a significant unmet clinical need for a transcatheter solution to TR. Trisol is introducing the Trisol System, a transcatheter tricuspid valve replacement system for treating severe TR and preventing RV dysfunction. The Trisol valve is constructed out of nitinol frame with specially designed sail-like leaflet. A flexible delivery system is used to position the valve into the heart with support arms anchoring to the tricuspid physiological site. The Trisol System allows cardiologists to perform a quick and safe implant procedure (30 minutes compared to 4-6 hours of standard surgery) thus increasing the number of treated population and reducing in-hospital and recovery time. Moreover, it will increase heart performance and reduce the risk of mortality typical of open-heart surgeries. Lavoro eseguito dall’inizio del progetto fino alla fine del periodo coperto dalla relazione e principali risultati finora ottenuti Trisol undertook a full analysis of both the technical and business potential of the Trisol System concluding that it will be highly valuable for the medical industry and specifically for cardiology. Trisol defined the remaining activities to reach commercialisation including preclinical testing and First-In-Human study to demonstrate the safety and efficacy of the valve when used for tricuspid valve replacement procedure. Following the FIH trial, Trisol will carry out a larger trial to advance to CE Marking. Trisol utilised the feasibility study to validate the regulatory pathway, and secure key medical and strategic partners to assist in the product development and later commercialisation. Trisol also analysed in detail the go-to-market strategy to define the approach for accelerated and effective market uptake. Progressi oltre lo stato dell’arte e potenziale impatto previsto (incluso l’impatto socioeconomico e le implicazioni sociali più ampie del progetto fino ad ora) The expected outcome of the project is to successfully scale-up production, perform validation and verification activities including the final preclinical study; and validate the safety and efficacy of the Trisol System in the First-In-Human clinical trial. The results will then be used to expand to a wider clinical trial and achieve CE Marking for commercialisation in Europe. The Trisol System will enable increased clinical use of transcatheter heart valves. The Trisol System development will boost economic growth and create jobs within Trisol, and have a wider impact on the European market. Trisol Valve
