SMD.L Regulatory News (SMD)

Spectral MD Holdings, Ltd

("Spectral MD" or the "Company")

Burn Image Assessment Study ("BIAS") Results

Study assesses Emergency Medicine Physicians' ability to measure burn depth

LONDON, U.K. AND DALLAS, TX, U.S. Spectral MD Holdings, Ltd. (AIM: SMD), a predictive analytics company with proprietary AI algorithms and optical technology for faster and more accurate treatment decisions in wound care, announces results from its Burn Image Assessment Study (BIAS).

Over one million people in the US and 250,000 in the UK seek evaluation for burn injuries in emergent or urgent care settings every year. A major component of the initial evaluation includes burn wound assessment. Literature shows that burn care providers typically assess the depth of burn wounds incorrectly in about 25-30% of injuries, partly because burn wound evaluation has no adjunctive labs to aid in the determination of healing versus non-healing burn wounds.

The objective of the Burn Injury Assessment Study (BIAS) is to obtain data in assessment of burn depth by experts across the spectrum of Emergency Medicine (EM) providers. BIAS collected data from emergency room providers at national conferences. Using a tablet-based data entry device, emergency medicine participants enrolled in the study completed a brief questionnaire followed by a series of five scenarios of thermal burn injuries each with images from American Burn Association (ABA)-verified burn centers. Participants were asked to provide an overall treatment recommendation for each burn scenario. In addition, they were asked to draw the regions of non-healing burn wound areas within the provided images. Their performance was evaluated by comparing their drawings with healing/non-healing areas pre-established by burn expert review of each burns' 21-day healing assessment.

Dr. Jeff Carter, Chief Medical Consultant of Spectral MD, and Treasurer of the American Burn Association presented the results in a podium presentation titled, "Results from the Emergency Medicine Burn Injury Assessment Study" at the American College of Emergency Physicians Scientific Assembly on 2 October, 2022.

The results from this study indicated that in reviewing pictures of burn wounds that were so severe they would not have healed, emergency department (ED) practitioners selected that no surgery was needed and advised treatment with local wound care in 82% of patients. This would have resulted in surgical delays in four out of five patients. For healing wounds, ED practitioners selected local wound care in only 31% of the images. When matched pixel for pixel, ED practitioners had an accuracy of 74%, meaning that about a quarter of the wounds were inaccurately assessed. This is well below the current performance of Spectral MD's DeepView™ Wound Imaging System.

Dr. Jeff Carter stated: "It is surprising to find that 31% of clinical judgment suggested that surgery or referral was necessary for burns that would actually heal with local wound care, which leads to unnecessary surgery and waste of resources."

This study emphasizes the unmet clinical need for technologies which can improve evaluation of burn wound healing. In a natural disaster or mass casualty incident, large numbers of burn casualties could overwhelm an already strained healthcare system, and EM providers would be called upon to perform large volumes of burn wound assessment. Improvements in evaluating burn wound healing are essential to aid emergency room providers in the appropriate treatment of burn-injured patients. The BIAS results further support the Company's belief that the DeepView™ Wound Imaging System will be transformative in improving the current standard of care, resulting in faster application of advanced therapy, better wound healing, and meaningful clinical outcomes.

This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50119C00033.

Learn more about BARDA: https://www.medicalcountermeasures.gov/

Funding support for DeepView®'s use in burn triage and treatment decisions has also been provided by U.S. National Science Foundation (NSF), U.S. National Institutes of Health (NIH) and U.S. Defense Health Agency (DHA).

For further information please contact:

About Spectral MD:

We are a dedicated team of forward-thinkers striving to revolutionize the management of wound care by "Seeing the Unknown" ® with our DeepView® Wound Imaging System.

www.spectralmd.com

info@spectralmd.com