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SmartClot: Personalized platform for the combined evaluation of platelet and coagulation factor in haemostasis or during antithrombbotic therapy

Periodic Reporting for period 1 - Smart Clot (SmartClot: Personalized platform for the combined evaluation of platelet and coagulation factor in haemostasis or during antithrombbotic therapy)

Reporting period: 2018-08-01 to 2018-11-30

Cardiovascular diseases (CVDs) are the leading cause of mortality globally, causing 3.9 million deaths annually in EU. However, early identification and control of patients at high risk of suffering CVDs can potentially reduce these figures.
We at SediciDodici have developed an innovative in-vitro diagnostic device called Smart Clot, which can provide a global quantitative assessment of platelet and coagulation function in blood samples within minutes from obtaining patients´ specimen, which can be life-saving in conditions of surgical or medical emergency. Based on the current prototype, which consists on an analysis equipment and a perfusion cartridge mostly used manually, we intend to produce a low-cost and improved version. Thus, the project will be oriented towards obtaining the automation and scale-up of the platform, software development and implementation, and clinical validation.
The FS confirms the uniqueness of our innovation, its technical feasibility and commercial profitability.
Technical FS defines the current prototype (TRL 7), and the improvement to be done, outlines and validates the work plan to scale-up the platform and gain capability for large deployment once we reach the market, and analyses technical risks and their contingency and mitigation measures.
Commercial FS offers an in-depth study on cardiovascular medical device market, evaluates the existing solutions to diagnose CVDs (competitors) and the regulatory and certification framework, conducts a IPR study to confirm our freedom to operate, and defines an exploitation and dissemination plan.
Financial FS makes a production cost assessment of the project (~€2.5 million) and offers a business projections analysis for the first 5-years of commercialization.
Smart Clot will reduce burden of CVDs by improving the medical prevention technology already available. Additionally, it will also have a positive impact for the company´s growth, reaching a ROI of 2.60 by the end of 2024.
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