Periodic Reporting for period 1 - VARIXIO (Medical Device for automatic preparation of high quality foam for sclerotherapy of varicose veins) Berichtszeitraum: 2019-12-01 bis 2020-03-31 Zusammenfassung vom Kontext und den Gesamtzielen des Projekts The presence of varicose veins is one of the most common medical conditions, affecting approximately 25% of the adult population. Foam sclerotherapy is the most widely used treatment given its favourable efficacy and safety profile coupled with its simplicity and relatively low cost. Foam sclerotherapy requires the transformation of a sclerosing drug into foam, prior to its application. Current manual foam preparation techniques present important limitations in terms of quality, standardization, consistency, versatility and safety. The VARIXIO® device automates this process, standardising and greatly simplifying foam preparation, while adding quality, safety, and versatility to the treatment technique. Our solution will successfully solve the existing limitations of current foam preparation techniques, contributing to achieve an effective treatment for a wider spectrum of varicose vein types, as well as facilitating the work of health personnel in the application of the treatment. VARIXIO® will expand the use of foam sclerotherapy, improving the procedure and making it more convenient and efficient, resulting in higher product performance and significant indirect cost savings. Arbeit, die ab Beginn des Projekts bis zum Ende des durch den Bericht erfassten Berichtszeitraums geleistet wurde, und die wichtigsten bis dahin erzielten Ergebnisse During the 4 months of implementation of the project, we have achieved significant progress beyond the work plan presented in the proposal, demonstrating the technical commercial and financial feasibility of our project. Technically, we have analysed and improved the parameters and specifications required for an optimal product performance, allowing physicians to consistently prepare very high quality foam for the treatment of varicose veins of all sizes, even when very low concentrations of sclerosant are required. Commercially, our analysis confirms that the varicose vein treatment market is experiencing substantial growth, and that VARIXIO® can further contribute to the development of this market in the coming years, resulting from the convenience and versatility the device offers, when compared to current methods. Economically, we estimate that within the first 5 years of commercialisation, the commercial exploitation of VARIXIO® will achieve financial sustainability, provide an attractive return to the project’s investors, and become a source of employment creation for the company. Fortschritte, die über den aktuellen Stand der Technik hinausgehen und voraussichtliche potenzielle Auswirkungen (einschließlich der bis dato erzielten sozioökonomischen Auswirkungen und weiter gefassten gesellschaftlichen Auswirkungen des Projekts) VARIXIO® is the first device to automate the preparation of foam for sclerotherapy of varicose veins. This will add convenience, quality, and versatility. Most importantly, by simplifying the preparation of foam using physiological gases, VARIXIO® will add safety as well. The combination of factors will allow the use of foam sclerotherapy to be expanded to the treatment of varicose veins of all sizes, something which is not currently possible. In turn, this will result in an expansion of the market and, hopefully, an accelerated commercial development for the company, allowing it to further develop the VARIXIO® range and enter markets beyond Europe.