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

这项拟议的研究的目的是评估拟议的用于液体超载治疗的新型微创设备的商业潜力，并为推进这项技术的商业化制定商业计划。该项目的TSB资金将使这项技术发展到可以筹集私人资金来开发符合监管规定的医疗设备的阶段。许多疾病状态会导致患者保留液体，如肾衰竭、心力衰竭、肝功能衰竭和癌症。这种液体的积聚会导致呼吸困难、重要器官功能下降、四肢肿胀，最终导致死亡。液体超载是一个主要且日益严重的问题，在300万慢性肾脏疾病患者和2600万慢性心力衰竭患者中，有很大一部分人是液体超载。目前对这个问题的解决方案是有限的。当利尿剂失效时，30%的病例会发生这种情况--唯一的另一种选择是透析器或超滤。然而，这并不适合每个人，这会使人虚弱且成本高昂。Renephra使用专利的液体提取方法，其基础是去除皮肤表面的液体，而不是像传统治疗方法那样从血液中提取液体。这样的设备将是可穿戴和便携的，而且是最小的侵入性。这将为患者提供更好的生活质量，并使他们留在家里，从而通过减少住院要求来降低成本。过去一年已经产生了原则(人)数据。下一步和拟议研究的目标是验证和确定拟议设备的商业潜力，并制定新的商业计划。这样的市场证据将使公司能够为CE Mark筹集产品开发资金。因此，该项目和TSB支持对于开发一种具有即时和真实的临床需求但目前尚无解决方案的设备至关重要。

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.