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Many heart-failure patients suffer from excessive fluid accumulation, causing swelling and breathing problems. Some of these patients do not respond to treatment with water pills (diuretics). Such patients need frequent admissions to hospital for intravenous diuretics and in extreme cases, dialysis. This is inconvenient for patients, sometimes has little effect and is very expensive. This project aims to further develop a concept of a new medical device for the relief of fluid accumulation. The device will remove fluid directly from underneath the skin. The skin is pierced with tiny (micro) needles and a vacuum is used to draw-up the fluid into a drainage bag. The device will be used at home by patients and carers; therefore, reducing the need for hospitalisation. It has been shown to be safe and does not cause pain. The project aims to validate an early stage functional prototype of the device in a pilot clinical study at the Manchester Royal Infirmary in heart failure patients with excessive fluid accumulation. To deliver this project successfully, we have assembled a team with a very strong track record, expertise and credibility in all areas: clinical science, product design and development, usability studies, patient and public engagement, regulatory and commercial.

"Many heart-failure patients suffer from excessive fluid accumulation, causing swelling and breathing problems. Some of these patients do not respond to treatment with water pills (diuretics). Such patients need frequent admission to hospital for intravenous diuretics and in extreme cases, dialysis. This is inconvenient for patients, sometimes has little effect and is very expensive. This project aims to further develop a concept of a new medical device for the relief of fluid accumulation. The device will remove fluid directly from underneath the skin. The skin is pierced with tiny (micro) needles and a vacuum is used to draw-up the fluid into a drainage bag. The device will be used at home by patients and carers; therefore reducing the need for hospitalisation. It has been shown to be safe and does not cause pain. The project aims to show the device is economically viable to be developed as treatment option for heart failure patients with excessive fluid accumulation. To deliver this project successfully, we have a team with a very strong track record, expertise and credibility in all areas: patient and public engagement, clinical science, product design and development, regulatory and commercial."

The 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.

Dialysis is the current mainstream treatment for patients suffering kidney failure. During treatment the quality of life for patients is very poor, treatment in hospital three times a week prevents many patients from working, survival rates are less than 50% at 5 years, and the cost to the state approximates £30k per annum per patient. We have a technology capable of eventually replacing dialysis with a minimally invasive, efficacious and pain-free treatment at a significantly lower cost. Mathematical modelling confirms that the idea is feasible, and preprototype testing was encouraging. We require funding to design and build a prototype device that will then be tested in clinical studies. The project represents a highly proactive approach to a chronic condition. The technology could address a number of key concerns: the ability to eventually safely self-treat at home will dramatically reduce hospital admissions, and daily therapy has been demonstrated to improve the quality of health of renal patients. This therapy will significantly reduce the cost of renal care, which even in many advanced economies has resulted in patients waiting for treatment due to lack of resources. The technology is anticipated to offer a superior alternative to predialysis patients who retain some kidney function, delaying or even removing the need for their entry into a dialysis programme. The device will enable effective solutions to be tailored to patients needs: treatment can be delivered in the home at a time that fits with their lifestyle, and selective toxin capture can be patient specific.