Spectral MD kicks off EU diabetic foot ulcer study as a prelude to regulatory sign-off
Spectral MD Holdings Ltd (AIM:SMD), the US-based predictive analytics company, has partnered with the Royal College of Surgeons in Ireland’s Skin Wounds and Trauma Research Centre to carry out its EU clinical study for diabetic foot ulcer (DFU) application.
DFU is a chronic wound affecting millions of people each year and it is the most common symptom of diabetes, costing a fortune in healthcare.
Spectral MD’s DeepView technology enables quick and accurate treatment decisions for patients with the painful condition.
The clinical study is set to monitor DFU patients for 12 weeks and will enhance the DeepView AI-DFU algorithm.
It will also provide support for regulatory submissions of the technology in the UK, US and EU this year.
The technology is designed to make an early diagnosis of non-healing DFUs possible, which will improve patient outcomes and quality of life.
This EU clinical study will complement the interim results that the company announced in January for DeepView AI-DFU, which had an 86% diagnostic accuracy on day one for a 50% DFU size reduction by week four.
“The initiation of the EU study is an important milestone for the company,” said Wensheng Fan, CEO of Spectral MD. “Data collected from this collaboration will strengthen the predictive capability of the DeepView technology for early-stage wound assessment.”