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Improving diagnostics of respiratory diseases and boosting the COMAC MEDICAL Ltd. competitiveness and growth by validation of fractional EBT biomarker through new method of measurement and device

Periodic Reporting for period 1 - FrEBT (Improving diagnostics of respiratory diseases and boosting the COMAC MEDICAL Ltd. competitiveness and growth by validation of fractional EBT biomarker through new method of measurement and device)

Reporting period: 2015-09-01 to 2015-10-31

During Phase1 of Horizon2020 SME Instrument, Comac Medical examined the novelty and commercialization potential of the validation of single breath Fractional Exhaled Breath Temperature biomarker through new method and medical device.
The SME proved through patentability and freedom to operate (FTO) search reports, market, technical, economic, financial and risk assessment analysis, the technical feasibility and commercial potential of a breakthrough innovation, which the company wants to exploit and commercialize. The FTO and novelty analysis concluded that the device is a new solution for diagnosis of inflammatory and degenerative processes in the lungs with no direct analogues on the market, which led SME to fill a patent application. A licensing strategy foresees subcontracting of non-characteristic operations for the SME such as manufacturing of prototypes, production and commercialization.
According to the feasibility study and business innovation plan, the innovative idea will allow the company to increase its internal growth and international presence by expanding operations to countries in Western Europe and beyond. The innovative method and device are aligned with Comac Medical business strategy to gather extensive knowledge in the area of clinical trials for medical devices and specialization in lung diseases, which will increase its market share in terms of clinical studies and competitive advantages at national, European and international level.
The single breath Fractional Exhaled Breath Temperature method and device offer a timely response to EU and global challenges related to respiratory diseases, which cause high levels of morbidity and mortality (WHO:ca.1 mln deaths annually, of which 2/3 occur in EU-28) and constitute a significant economic burden. It is a unique solution that can find a wide application both in clinical practice of pulmonologists and in the development of more personalized respiratory drugs by the pharmaceutical sector.
The feasibility study, proved that the innovative concept has the potential to be developed to the level of market maturity. On the basis of the financial implications and economic viability of the idea, Comac Medical intends to proceed with the business innovation project. Future funding obtained through Phase 2 of the Horizon 2020 SME Instrument will accelerate the process and be used to finance the conduct of the clinical trials needed to validate the novel biomarker and medical device, and to prepare the product for commercialization.
According to the main actions in the GA number 696579 Comac Medical conducted feasibility study, followed by business innovation plan. The deliverables were generated on the basis of the following 6 steps of activities: 1. Description of the innovative solution; 2. Market and Technical Feasibility; 3. Financial/Economic Feasibility; 4. Organisational/Managerial Feasibility; 5. Intellectual Property Management; 6. Risk Assessment; and Business Innovation Plan, containing mission statement, business environment analysis, SWOT analysis, competitor and market analysis; potential partners, marketing plan, financial and operational plan.
Outputs from the feasibility study report and the business innovation plan are as follows: a comprehensive report of the steps described above, containing information about: the non-existence of best alternative to the innovative solution in terms of technological and methodological points of view; the possibilities for licensing of the product, the filling a market niche and the needed technical facilities for the project implementation in Phase 2 and 3; the financial implications and the economic viability of the project; the project management structure and possible developments; the potential risks and system for their avoidance and management; knowledge protection steps taken. The business innovation plan of the SME showed that the company will increase its internal growth and international presence through the innovation. The novel method and device are aligned with Comac Medical business strategy to gather extensive knowledge in the area of clinical trials for medical devices and specialization in lung diseases, which will increase its market share in terms of clinical studies and its competitive advantages at national, European and international level.
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