Renephra Ltd. Validating commercial opportunity for a novel medical device to treat fluid overload

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The objective of the proposed study is to evaluate a commercial potential for the proposednovel minimally invasive device for fluid overload treatment and to shape a business plan foradvancing commercialization of this technology. The TSB funding of this project will enablethe technology to progress to the stage where private funding can be raised to develop aregulatory compliant medical device.Many disease states cause patients to retain fluid, such as kidney failure, heart failure, liverfailure and cancer. This build up of fluid, causes breathlessness, decreased function of vitalorgans, swelling of extremities, and ultimately death. Fluid overload is a major and growingproblem and a significant proportion of the 3 million patients with chronic kidney disease and26 million with chronic heart failure are fluid overloaded. Current solutions to this problemare limited. When diuretics fail, which occurs in 30% cases – the only other option is dialysisor 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 liessuperficially within the skin, rather than from the blood as with traditional treatments. Such adevice would be wearable and portable as well as being minimally invasive. This will offer abetter quality of life for patients and keep them at home thus reducing costs by decreasingrequirement for hospitalisation.Proof of principle (human) data has been generated over the last year. The next step and aimsof proposed research is to is to validate and size the commercial potential for the proposeddevice and to produce the new business plan. Such proof of market evidence will enable thecompany to raise funding for product development to CE Mark. This project and TSBsupport is therefore essential to develop a device with an immediate and real clinical need butwhich currently has no solution.