Spectral MD Holdings Ltd (AIM:SMD) has said its AI-based diabetic foot ulcer (DFU) diagnostic, DeepView improved the accuracy of treatment by 86% from day one, according to interim results of an ongoing trial
Early indications had suggested an 81% improvement, but this has risen by five percentage points as the trial has progressed, said Spectral MD.
Aims of the study were to halve the size of the ulcers within four weeks, which Spectral said is key for any treatment being considered as the current standard of care involves a ‘wait-and-see’ approach for up to 30 days.
Spectral noted that the DFU study is currently running at five clinical sites in the US with an initial 100 patients out of a target of 200 enrolled, stating it will use the new data as part of a US Food & Drug Administration (FDA) approval submission this year.
In a statement, Niko Pagoulatos, Spectral MD’s chief operating officer, commented: "We are encouraged by the interim observations from the DFU Clinical Study. The results from the interim analysis further validate how the DeepView technology could significantly help transform the lives of people suffering from diabetic foot ulcers."
Dr Brock Linden, the study’s principal investigator, added that the results were extremely encouraging in a condition that is "unusually challenging" to treat.
Elsewhere, Spectral MD said that its US government-funded Deepview burn treatment study is now fully enrolled. It will be carried out at eleven hospitals with additional paediatric sites and be completed in the first half of this year.