700457Renephra Ltd. Validating commercial opportunity for a novel medical device to treat fluid overloadClosedGRD Proof of MarketInnovate UKThe objective of the proposed study is to evaluate a commercial potential for the proposed novel minimally invasive device for fluid overload treatment and to shape a business plan for advancing commercialization of this technology. The TSB funding of this project will enable the technology to progress to the stage where private funding can be raised to develop a regulatory compliant medical device. Many disease states cause patients to retain fluid, such as kidney failure, heart failure, liver failure and cancer. This build up of fluid, causes breathlessness, decreased function of vital organs, swelling of extremities, and ultimately death. Fluid overload is a major and growing problem and a significant proportion of the 3 million patients with chronic kidney disease and 26 million with chronic heart failure are fluid overloaded. Current solutions to this problem are limited. When diuretics fail, which occurs in 30% cases – the only other option is dialysis or ultrafiltration. However this not suitable for everyone, is debilitating and costly. Renephra uses proprietary methods of fluid extraction based on removal of the fluid that lies superficially within the skin, rather than from the blood as with traditional treatments. Such a device would be wearable and portable as well as being minimally invasive. This will offer a better quality of life for patients and keep them at home thus reducing costs by decreasing requirement for hospitalisation. Proof of principle (human) data has been generated over the last year. The next step and aims of proposed research is to is to validate and size the commercial potential for the proposed device and to produce the new business plan. Such proof of market evidence will enable the company to raise funding for product development to CE Mark. This project and TSB support is therefore essential to develop a device with an immediate and real clinical need but which currently has no solution.