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

这项拟议研究的目的是评估拟议的用于液体过载治疗的新型微创设备的商业潜力，并制定推进该技术商业化的商业计划。TSB对该项目的资助将使该技术发展到可以筹集私人资金开发符合监管要求的医疗设备的阶段。许多疾病状态导致患者保留液体，如肾衰竭，心力衰竭，肝功能衰竭和癌症。这种液体的积累，导致呼吸困难，重要器官功能下降，四肢肿胀，最终死亡。液体超负荷是一个日益严重的问题，在300万慢性肾脏疾病患者和2600万慢性心力衰竭患者中，有很大一部分是液体超负荷的。目前解决这一问题的办法是有限的。当30%的病例发生利尿剂失效时，唯一的其他选择是透析器或超滤。然而，这并不适合每个人，是衰弱和昂贵的。Renephra使用专有的液体提取方法的基础上，去除液体liessuperior内的皮肤，而不是从血液与传统的治疗。这样的设备将是可穿戴的、便携式的，并且是微创的。这将为患者提供更好的生活质量，并使他们留在家中，从而通过减少住院需求来降低成本。下一步和目标的拟议研究是要验证和规模的商业潜力为proposeddevice和生产新的商业计划。这种市场证据的证明将使公司能够筹集资金，用于产品开发CE标志。因此，该项目和TSB支持对于开发具有立即和真实的临床需求但目前没有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.