Periodic Reporting for period 2 - CathVision Cube (CathVision Cube: disruptive data-driven guidance for successful cardiac ablation therapy) Reporting period: 2020-08-01 to 2021-07-31 Summary of the context and overall objectives of the project Cardiac arrhythmias are projected to rise during next years. The most prevalent type, Atrial Fibrillation, is projected to increase in the EU from 8.8m in 2010 to 17.9m by the year 2060, leading to a strain on physicians and health systems. Thus, better ablation guiding tools will be necessary to help physicians more efficiently identify, characterise and treat arrhythmias, facilitating training of new electrophysiologists, while reducing procedure and medicine costs. Sex- specific CVD also needs to be better addressed, as it is currently often misdiagnosed in females due to smaller cardiac signals and standards based on male physiology. CathVision Cube is a low-noise electrophysiology (EP) recording system that combines a cutting-edge amplifier with AI assisted decision-making and easy-to-use user interface. Physicians will have access to exceptional EP signals thanks to proprietary hardware technology that reduces noise, prevents signal artefacts and improves signal quality. Doctors will also gain electrogram-driven clinical decision support through the intuitive and logical graphical interface of our AI-software, which allows proper identification of arrhythmogenic areas and guidance to a successful ablation – particularly important for less experienced EP physicians. Moreover, our system will enable data export to integrate seamlessly into the hospital environment and is also compatible with third-party equipment. The project have succesfully matured, piloted and prepared the CathVision Cube system for regulatory approval application in both the EU and US markets.The CathVision team expect to initiate commercialization CathVision Cube – the world first low-noise EP recording system and AI-assisted decision-making for physicians performing cardiac ablation therapy mid 2022. A successful CathVision Cube commercialization will create measurable impacts on our company, quantified as accumulated revenue of €457m in 5 years (2023-2027), accumulated operating profit of €348m, creating 45 FTE in our value chain, generating €1.35m in reduced annual costs per hospital and unlocking public savings of €1.1bn by 2025 . Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far The CathVision Cube has trough the project been matured to readiness for Pilot testing especially with a specific focus on Hardware maturation, software maturation and algorithm development. The CathVision Cube has achieved external Pre-Clinical safety testing success with testing by TÜV SÜD. In addition the Pre-Market CathVision Cube system has completed all verification and validation required according to standards for clinical investigations.The CathVision Cube project have successfully reviewed available basic research from 45 leading cardiac university hospitals in Europe for relevant methodology and licensable technology. The efforts have resulted in one in-licensed algorithm targeting atrial fibrillation ablation and several negotiations for further licenses. The project have succesfully completed piloting activities in three sites globally. Piloting activities was completed in 2021.The project have succesfully completed and initiated an FDA approval process for 510(k) approval.Through the project CathVision have contact with +100 potential clients, distribution partners and industry partners to further the market launch of the CathVision Cube.To support project development, market approval and post project financing the project activities has secured a 13 mEUR funding of CathVision ApSCathVision Cube project activites have been disseminated through, company website, press releases as well as AF symposium presentation by Dr. Pierre Jais.The CathVision cube project have created 14 new full time + 3 part time employees in CathVision ApS 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) The three main areas going beyond state-of-the-art is a) cardiac signal quality, b) AI algorithms and c) an EP system supporting AI. For a) and c), progress has been made to make the system ready for a clinical trial and for regulatory submissions for market approval. An inlicensed invention and further inventions in pipeline, qualify the progress under b) where new clinical support will be obtained from new methods not visible for the untrained eye. Expected results until end of project include Clinical validation of signal quality, of an AI algorithm and the EP system supporting AI. We aim at reducing hospital costs of €1.35M annually per installation, summing to potentially €1.1Bn in total by 2025. CathVision is expected to grow with 45 FTEs in the same period. We expect to reach annualized revenues in year 5 sustainable to support a more mature company based in Europe. The CathVision Cube system (Real life)
