Periodic Reporting for period 1 - ClearPlasma (ClearPlasma is an innovative medical device that enhances coagulation properties for improved treatment of excessive bleeding.) Reporting period: 2019-11-01 to 2020-02-29 Summary of the context and overall objectives of the project Excessive bleeding is a medical emergency with limited treatment options and one of the main causes for mortality. Approximately 5 million people die every year around the world from accidental and non-accidental trauma. The current standard for treatment of excessive bleeding include treatments to induce the generation of blood clots and the transfusion of blood or plasma derivatives. These treatments have several shortcomings including obstructed blood vessels, low efficacy rate and inability to in stopping the bleeding in patient with coagulopathies. In order to address the challenge of managing excessive bleeding, ClearPlasma has developed an innovative filtration system that modifies human plasma to improve the treatment of massive bleeding and bleeding disorders. ClearPlasma enhances coagulation and stops the flow of blood, thus reducing the amount of blood required during a transfusion. This is achieved by extracting the proteins responsible for dissolving blood clots, thus allowing stable clots to form in a controlled manner. The overall objective of the feasibility study was to conduct clinical validation of the device and proceed for commercial sales. This project will help ClearPlasma to address the issue decline in blood donations by saving blood through promotion of coagulation in bleeding patients, reducing the number of plasma units needed for transfusion and hence reducing mortality and treatment costs. Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far PlasFree conducted a completed analysis of the technical and business potential of the its ClearPlasma device. The company was able to identify the markets which it will targeting and the strategy for its outreach of the respective market. It was established that the company will be adopting two-pronged approach to reach the market. PlasFree will be introducing the ClearPlasma device into the market through medical device distributors and also establishing its own sales team to mark its entry into the market. PlasFree formulated a robust industrialisation strategy and addressed risks and regulations which could impede the process of bringing the device to market. The necessary technical steps required to release a enter in the European market were analysed and a scale-up plan was outlined. 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 expected outcome is to optimize the mould for large scale manufacturing which will be achieved by the end of the Phase 2 project. PlasFree will also conduct the clincal validation of the ClearPlasma device to prove the safety and efficacy of the device. The clinical trial will involve 100 patients and it will be conducted in Italy and Israel. The ClearPlasma device will offer the most effective and cost-efficient solution on the market than most of the existing competitors. This will deliver a significant economic impact by reducing the the number of plasma units needed for transfusion and reducing the burden on hospitals and healthcare centres. The saving of blood will also help in addressing the challenge of shortage in blood donations and ensure its optimal use. device.png
