A NOvel FFR Measurement fOR accurate dEtermination of stenosis Functional severity in ischemic hEARt disease

Periodic Reporting for period 1 - NO_MORE_FEAR (A NOvel FFR Measurement fOR accurate dEtermination of stenosis Functional severity in ischemic hEARt disease)

Berichtszeitraum: 2015-01-01 bis 2015-05-31

Medis Medical Imaging Systems B.V. has investigated the marketing and commercial feasibility of FFRQCA as a novel approach to measure fractional flow reserve (FFR). The FFR measurement provides crucial information on the functional or physiologic significance of coronary obstructions, and is obtained from readily available 2D X-ray images based on 3D reconstruction and TIMI frame count for subsequent computational fluid dynamics. Our FFRQCA software package offers a safer, faster, and cost-efficient method for FFR measurement compared to the existing approach (expensive intravascular pressure wire), which is risky, time consuming and associated with additional X-ray radiation exposure to the patients.

This feasibility study comprised an inventory of stakeholders and their willingness to support the market introduction of FFRQCA, the assessment of market size and trends, a description of the current unmet needs, the opportunities and threats in the market, IP and FTO preliminary analysis and identification of regulatory and reimbursement demands in different countries, with the ultimate aim to confirm the commercial feasibility of FFRQCA and develop a sound business strategy. In addition, as part of the SME Phase I, we have improved the FFRQCA software solution in workflow and in obtaining additional clinical data for optimising the algorithm.

Based on the results of this feasibility study, we have concluded that this product can facilitate the proper selection of coronary narrowings to be treated or not during the interventional procedure. The product has high commercial viability and great potential to disrupt the FFR market within several years. In addition, we have created a detailed business development strategy to rapidly capture relevant markets, which is described in more detail in the business plan. In particular, we have developed a geographical-based commercialisation strategy, finance and pricing strategy and an IP and regulatory strategy for current and future product development. The very positive feedback as received from stakeholders, and confirmed again during the recent EuroPCR meeting in Paris, May 19-22, 2015 with more than 12.000 participants including both industry and physicians, has further strengthened our conviction that FFRQCA is a highly innovative and cost-effective solution with the potential to disrupt cardiac diagnosis and improve medical treatment through better stratification and post-procedural assessment.

Overview of the current clinical procedure and FFRQCA for FFR measurement

Periodic Reporting for period 1 - NO_MORE_FEAR (A NOvel FFR Measurement fOR accurate dEtermination of stenosis Functional severity in ischemic hEARt disease)

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