Periodic Reporting for period 1 - Filterlex (Filterlex is a unique, full-body, embolic protection device for Trans-catheter Aortic Valve Implantation procedures.) Reporting period: 2018-11-01 to 2019-02-28 Summary of the context and overall objectives of the project Filterlex Medical Ltd is a med-tech company with the vision is to provide the best-in-class embolic protection device (EPD) for reducing the risk of stroke and other complications during catheter-based left-heart procedures. The CAPTIS® concept and unique structure was created out of deep understanding and knowledge of the unmet need and product limitations of current solutions available on the market. The company’s mission is to make TAVI procedure safe to increase treatment options for high-risk patients who need heart valve procedures. Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far Throughout the duration of the project, Filterlex defined the preliminary updates of the CAPTIS® system, reviewed its development plan, supply chain, and scouted for third parties to support in the development stage and the distribution channels. The market segments and opportunities have also been evaluated, defining the TAM and SAM. A commercialisation strategy has been established. The Phase 1 feasibility assessment has determined that a development plan for the CAPTIS® system is technically and commercially viable, and that further engineering, manufacturing and commercialisation plan should be pursued. The SME Instrument Phase 2 funding could provide the correct amount of funding and support to allow the stated activities to be implemented successfully. Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far) In the current economic climate, European healthcare systems face challenges to reduce the healthcare expenditure in an effort to reduce public sector deficits while maintaining quality. Approximately 17 million people in Europe and over 8 million people in the US suffer from heart valve diseases, 43% of which suffers from Aortic Stenosis (AS). The aging of the population worldwide will result in increasing numbers of elderly patients, among whom heart disease is the leading cause of death. For AS patients the most common treatment is valve replacement through Transcatheter Aortic Valve Implantation (TAVI). During TAVI, embolic debris are generated from the natural aortic valve area and from the passage of large-calibre catheters through a diseased and calcified aortic arch. If not properly removed, these debris are released into the vascular system, reaching and damaging the brain or other organs by reducing or blocking blood flow. The CAPTIS® system is a novel intra-aortic Embolic Protection Device (EPD) for deflecting, capturing and removing embolic particles during TAVI procedure. filterlex-01407-1.png
