Spectral MD completes enrolment for AI training study

Predictive analytics specialist Spectral MD announced completion of enrolment for its United States-based burn artificial intelligence (AI) training study on Monday, supported by the Biomedical Advanced Research and Development Authority (BARDA).

The AIM-traded company said the study was intended to test its proprietary AI algorithms and optical technology for wound care.

It used data collected from adult and paediatric subjects enrolled in the study to finalise the ‘DeepView AI-Burn’ algorithm, and make sample size determinations for its US burn AI validation study, which was expected to start in the second half of this year.

The training study was conducted across 11 leading burn centres in the US.

In August last year, it was expanded to include additional paediatric sites and emergency departments, with BARDA's support.

The completion of enrolment for the study fulfilled the company's contractual requirements with BARDA, with Spectral MD now focussed on completing the necessary requirements for the upcoming validation study.

It said the validation study would generate an independent dataset with subjects enrolled across different US study sites from the training study.

That, the board said, was a requirement for the US Food and Drug Administration (FDA) to remove bias from the results ahead of the company's DeepView AI-Burn FDA regulatory submission, planned for 2024.

“The completion of enrolment in our burn AI training study represents a significant milestone for Spectral MD, as it meets our contractual obligations with BARDA, paving the way for the final stage of clinical development for DeepView AI-Burn,” said chief executive officer Wensheng Fan.

“With BARDA's invaluable support, we anticipate initiating our burn AI validation study in the second half of 2023, and we remain committed to our partnership to deliver a non-invasive imaging platform for the US government that enables physicians to accurately and instantaneously assess the severity of burns in mass-casualty events.”

At 0804 BST, shares in Spectral MD Holdings were down 2.81% at 27.7p.

Reporting by Josh White for Sharecast.com.