The PD Safe is designed to identify potentially fatal infection in dialysis patients. This Microbiosensor device is aimed at patients with kidney failure who are being treated using peritoneal dialysis therapy (PD) and acts as an early warning system for peritoneal infection.
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Peritoneal dialysis therapy (PD) is the lowest cost and least lifestyle compromising form of renal dialysis however less than 10% of patients on renal replacement therapy are on PD. Recurrent infections are a major cause of failure and patients are required to identify possible symptoms of infection themselves. Symptoms are not specific or detectable until an infection has become well-established and can lead to a delay in time to diagnosis and treatment.
The device aims to overcome this by plugging into existing PD waste fluid tubing, detecting bacteria and flagging an emerging infection before symptoms present via a colour change in a readout window.
Microbiosensor completed a pilot clinical investigation of the device at the Manchester University NHS Foundation Trust (MFT) renal centre, following funding from Health Innovation Manchester AHSN.
The project has strengthened the design of a larger study to assess the device and has helped the company secure a £1.4million investment to support Microbiosensor through its final product development.
The funding from Health Innovation Manchester helped Microbiosensor improve its understanding of clinical trial management at an NHS Trust and strengthen the design of a subsequent study. It has made a significant contribution to Microbiosensor’s efforts to bring its medical device technology to market.
Gordon Barker, CEO of Microbiosensor.
How did the Innovation Exchange help?
The PD Safe device study was funded through a £50,000 award from the Health Innovation Manchester Energise Innovation Fund, which is specifically designed to support clinicians, academics and companies develop proof of concept or prototyping projects for a defined clinical application. It enabled the company to test the PD Safe prototype device on real clinical samples for the first time to confirm device safety and provide key performance data with real clinical samples, demonstrating the device is effective in diagnosing infection.
Support and advice from Health Innovation Manchester throughout the pilot clinical trial has helped Microbiosensor de-risk its technology and improve its understanding of clinical trial management at a major NHS Trust, enabling it to plan a subsequent and larger study within the NHS. A key outcome of the second study will be a CE-mark submission and, if successful, formal European market approval for the company’s first medical device product.
Impact & Outcomes
Success of the pilot clinical investigation enabled the company to secure a £1.4million investment from the Northern Powerhouse Investment Fund (managed by Maven Capital Partners) and the Greater Manchester and Cheshire Fund (managed by Catapult Ventures) to support the company through its final product development stages.
A second larger study has been designed and will take place at Manchester Royal Infirmary. This is to assess the sensitivity of the PD test, demonstrate patient self-use and investigate clinical benefits of the device.