Spectral MD Holdings Ltd (AIM:SMD) said it is initiating a clinical validation study of its DeepView wound imaging system to support a regulatory filing for the use of the technology to assess people with diabetic foot ulcers (DFUs).
Up to 200 people will be assessed as part of the evaluation.
Recruitment is expected to be complete by November, with the data to be used to support the company’s US Food & Drug Administration and European CE Mark applications.
Currently, the AI-driven system has a diagnostic accuracy is 81% in DFUs, though it is hoped this will improve as more patients are screened.
In burns, the imaging device can tell with 92% accuracy whether a wound will heal naturally or require surgery.
Its use in burns saves time and money – and for the patient, it can prevent a protracted and painful convalescence. The wait-and-see approach deployed by doctors can take up to three weeks; DeepView works in seconds.
The deployment in diabetic foot ulcers, open wounds that are often slow to heal and need to be dressed regularly, would open a potentially huge new market for the technology.
The cost of diabetes in the US alone is put at US$237bn. Around 30% of these costs are associated with care for diabetic foot disease.
For the DFU indication, the company estimates there are over 57,000 sites that DeepView could be placed in the US with 20,000 sites within the EU and UK. The group is expecting to book its first US sales in the fourth quarter of next year and UK and EU sales in the second half of 2023.
Dr Alisha Oropallo, the national principal investigator for the study, said: "For patients with diabetes, foot ulcers can impact their quality of life and lead to complicated infections and potential amputation.
“I look forward to participating in this study as DeepView has significant potential to improve the current standard of care, resulting in faster application of advanced therapy, better wound healing and reduced overall hospital visits and utilisation."