SMD.L Regulatory News (SMD)

9 August 2021

Spectral MD Holdings, Ltd

("Spectral MD" or the "Company" or the Group")

Spectral MD hosts event to launch a multi-center clinical study for burn wounds

Start of multi-center clinical study to further develop its DeepView® Wound Imaging System and burn wound-healing prediction AI Algorithm

LONDON, U.K AND DALLAS, TX, U.S - Spectral MD Holdings, Ltd. (AIM:SMD), a predictive analytics company that develops proprietary AI algorithms and optical technology for faster and more accurate treatment decisions in wound care, hosted a successful two-day kickoff event at its Dallas headquarters on 29 July - 30 July to introduce the start of the Option 1A Training Study, a multi-center clinical study that will support the further development of its DeepView® Wound Imaging System.

Spectral MD welcomed physicians, clinical coordinators, and researchers from five clinical candidate sites across the United States to the kick-off event. Over the two-days, Spectral MD showcased its next generation, user-friendly DeepView® technology to physicians, clinical coordinators, and researchers from the five candidate sites. The Spectral MD team participated in valuable conversations and training with the physicians about the clinical protocol, DeepView® in clinical practice, and further refinement to the AI algorithm.

The DeepView® algorithm training study will build upon promising results from the proof-of-concept study to advance the technology of the DeepView® system, which has been granted FDA Breakthrough Device Designation Status. The data collected from the upcoming training study will be used to bolster the Company's existing clinical database to train the AI algorithm and improve the DeepView® technology in early burn wound healing assessment. Study enrollment will initiate at the five clinical sites this month and is expected to conclude in February 2022. The training study will collect data from 100 adult and pediatric subjects to further develop DeepView®'s AI algorithm.

The kick-off meeting is an important milestone for the Company in fulfilling its contractual requirements with the Biomedical Advanced Research and Development Authority (BARDA). BARDA is part of the Office of the Assistant Secretary for Preparedness and Response at the U.S Department of Health and Human Services. The execution of the multi-center clinical training study is also a key milestone highlighted as part of the Company's recent Initial Public Offering and Admission to AIM. The Company is working to provide BARDA and the United States government with a non-invasive imaging platform that can accurately assist physicians with instantaneous triage of burn patients in a mass-casualty event by fitting Spectral MD's DeepView® into the continuum of burn care.

Wensheng Fan, Spectral MD's Chief Executive Officer, said: "We thank BARDA for their continued commitment and support. The successful completion of this clinical trial represents a key milestone in the development of the DeepView® technology." 

Dr. Jeffrey Carter, Chief Medical Consultant, and National Principal Investigator for the training study, stated: "I expect this study to be a significant step in progressing the development of this transformative technology. We will work with all the participating clinical sites to ensure high quality data and clinical engagement."

Dr. William Hickerson, the Medical Monitor for the upcoming training study, and past President of the American Burn Association, commented: "This important clinical study will provide training data for Spectral MD's DeepView® AI algorithm development. I look forward to working with Spectral MD, BARDA, and all clinical investigators throughout this study."

Funding and technical support for development of the DeepView® Wound Imaging System is provided by the Biomedical Advanced Research and Development Authority (BARDA), under the Assistant Secretary for Preparedness and Response (ASPR), within the U.S. Department of Health and Human Services, under ongoing USG Contract No. 75A50119C00033. For more information about BARDA, refer to https://www.medicalcountermeasures.gov/.

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About Spectral MD Holdings, Ltd. (www.spectralmd.com)

Using its DeepView® Wound Imaging Solution, an internally developed AI technology and multispectral imaging system which has designated FDA Breakthrough Device, Spectral MD is able to distinguish between damaged and healthy human tissue invisible to the naked eye, providing 'Day One' healing assessments for burn wounds and diabetic foot ulcers (DFU).

Spectral MD has to date received substantial support from the US government with contracts from institutions such as Biomedical Advanced Research and Development Authority (BARDA), National Science Foundation (NSF), National Institute of Health (NIH) and Defense Health Agency (DHA) in support of the burns application for its DeepView® system.

The Company has one principal trading subsidiary, Spectral MD, Inc., and has set up a subsidiary in the UK from which it will be growing its business in the UK and EU.

DeepView®

DeepView® is a predictive analytics platform that combines AI algorithms and medical imaging for wound prediction. It is non-invasive, non-radiation, non-laser and does not require the use of injectable dye. This integration can be characterised into four distinct components: DeepView® imaging, data extraction, AI model building and AI wound healing prediction.

· The DeepView® imaging technology consists of patented proprietary multi-spectral optics and sensors that can classify wound tissue physiology and capture the viability of various biomarkers within the skin. The imaging technology extracts appropriate clinical data, processes the image and displays a comparison of the original image next to an image with a colour overlay of the non-healing portions of the wound. The image acquisition takes 0.2 seconds and the output takes approximately 20 to 25 seconds.

· DeepView®'s proprietary optics are able to extract millions of data points or AI model features from each raw image. This information is then used to build and continually improve the AI model, which is trained and tested against a proprietary database of more than 53 billion pixels with ever-growing clinically-validated data points.

· The AI algorithm then produces a wound healing prediction in the form of an objective, accurate, and immediate binary wound healing prediction. This prediction is graphically represented to the clinician through a coloured overlay of the original image that annotates the non-healing portion of the wound.

DeepView® is designed to allow clinicians to make a more accurate, timely and informed decision regarding the treatment of the patient's wound. In the case of DFUs, a non-healing assessment would provide the physician with the appropriate justification to use an advanced wound care therapy on 'Day One' as opposed to waiting 30 days and potentially losing the patient to follow-up or risking patient noncompliance with standard wound therapy. The current clinical accuracy of DeepView® is 83 per cent. for DFUs. For burn wounds, the clinician can make an immediate and objective determination for appropriate candidates for surgery as well as determining what specific areas of the burn wound will require skin grafting. DeepView®'s current accuracy for burn wounds is 91 per cent., compared with current physician accuracy of 50 per cent. to 70 per cent. DeepView® demonstrates a much higher diagnostic accuracy for burn wounds and DFUs.