Spectral MD Holdings Ltd (AIM:SMD) said it completed enrolment for a training study to support the development of its DeepView Wound Imaging Solution in diagnosing the severity of diabetic foot ulcers (DFUs).
With the aim of supporting its applications for regulatory approval in the US and EU, the company enrolled 150 adults across six sites in the US. Completion is expected by the end of next month.
The DeepView Wound Imaging Solution, which has already received a ‘breakthrough designation’ for burns from the US Food & Drug Administration (FDA), is an artificial intelligence-driven imaging device that can tell accurately and within seconds whether a burn or DFU will heal naturally or require surgery.
Spectral MD said the DFU images and clinical data collected in the study will be incorporated into the database for the development of a DeepView’s machine learning algorithm for DFU healing assessment as well as providing key data for a planned validation study that is expected to start around March next year.
Chief executive Wensheng Fan said the images and data collected from the 150 subjects will be “instrumental in improving the early healing assessment of DeepView for DFU”, which he said currently has a clinical accuracy of 83.3%.
If all goes to plan with its FDA and CE mark applications, Fan and the board are targeting commercialisation of the DFU application towards the end of 2022.
DFU is a severe chronic diabetic complication that consists of lesions in the deep tissues associated with neurological disorders and peripheral vascular disease in the lower limbs. It is the most frequently recognised, complex and costly symptom of diabetes and can lead to limb amputation if left undiagnosed, misdiagnosed or untreated.
Spectral said the use of DeepView in the assessment toolkit would provide a significant improvement to the current standard of care, resulting in faster application of advanced therapy, better wound healing and reduced overall hospital visits and utilisation.
Fan added: “Crucially, the enrolment completion highlights that we are on track regarding the company's expected milestones outlined at the time of our June 2021 IPO.”