Developing commercialisation potential of our patented point-of-care neuropathy assessment device

Peripheral neuropathy is an increasingly common condition affecting 2.3 million people in the UK (4.5% of the population), and can lead to loss of sensation in fingers and toes. It has many causes but mainly due to diabetes, in which it affects about 60% of patients with diabetes worldwide. Loss of sensation in the feet, together with poor vascular perfusion, can lead to ulceration and amputation.

Diabetes UK reports that diabetes-related amputations in England have reached an all-time high of 135/week or more than 7000/year. They advocate that with good diabetes and footcare up to 80% of these amputations can be avoided.

NICE guidelines recommend regular foot surveillance, at least annually and then more frequently, to reduce morbidity by prompt treatment.

However, diabetic neuropathy may be asymptomatic and remain undiagnosed for several years, so regular screening is vital to identify the at-risk foot. Currently, patients with peripheral neuropathy have to travel to hospital annually and have no way of self-testing. Such infrequent assessment can lead to under-recognition of neuropathy and harm to the patient.

Our solution is a patented smartphone based point-of-care testing (POCT) device for diagnosis and grading of peripheral neuropathy.

The device uses the vibration motor within a smart-phone, controlled by our developed app and applied through an attachment probe to grade the sensory reduction related to neuropathy.

Our scientific endeavour is therefore focused on (i) conducting a clinical study on patients with varying levels of neuropathy to evaluate the device, (ii) developing an app and the calibration software to support a wider range of smartphones (iPhone, Android, Windows), (iii) producing a wide range of attachment probes and investigating one size fits all, (iv) stakeholder engagement to identify commercialisation opportunities (v) conduct an economic analysis to inform the commercialisation plan