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Medical technology & services

Spectral MD developing Deepview diagnostic 'exceptionally well' says Stifel

Spectral MD now expects to complete enrolment in the DFU study this half year

Analysts at US broker Stifel said that the improvement in performance by Spectral MD Holdings Ltd's (AIM:SMD) DeepView diagnostic in its ongoing diabetic foot ulcer (DFU) trial is an encouraging sign.

Deepview was able to predict with 86% accuracy from day one whether or not a DFU would achieve 50% wound closure after four weeks, up from 81% in an earlier study.

"The importance of this is that in the US, patients with DFUs currently have to wait 30 days until a wound fails to heal before advanced therapies can be used," said the Stifel analysts.

Spectral MD now expects to complete enrolment in the DFU study this half year with results available in mid-2023 allowing for a US Food & Drug Administration (FDA) filing in the second half.

In burn treatments, Spectral MD is in constant communication with the US agency BARDA to develop its infrastructure readiness for a commercial contract.

The Stifel analysts said: "If results from the training study confirm earlier data that showed DeepView was 92% accurate in diagnosing whether a burn needed grafting or not, then we expect BARDA to exercise its $21.9mln option to fund a planned clinical validation burns study."

They noted that Spectral MD continues to execute the development of DeepView in both burns and DFUs "exceptionally well".

“We forecast the launch of DeepView in DFUs in the US in 2024 with sales of US$145m by 2029. We continue to forecast the first significant sales of DeepView for use in burns in 2025 with sales of US$118m by 2029," the analysts concluded.

Stifel has a target price of 155p on Spectral MD shares compared with the current level of 33.5p, up 6.4% today.

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