Company Announcements

Spectral MD Holdings, Ltd

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

Grant of share options and cash bonus

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, announces that it has granted options ("Options") over 2,175,000 common stock of US$0.001 each in the Company ("Common Stock ") to various employees of the Company, including Wensheng Fan, CEO of the Company. All Options are granted under the 2018 Long Term Incentive Plan, vest over a three year period from the date of grant, and expire after ten years. Details are as follows:

In addition the Company is granting a year-end bonus of $225,000 to Mr. Fan, CEO of Spectral MD, in recognition of the substantive contribution to long term shareholder value achieved during 2021 through significant accomplishments and milestones, including in particular (i) securing additional non-dilutive funding of US$40.5 million from various US Government agencies to further the Company's mission in burns, device miniaturization and other critical initiatives, (ii) the completion of enrolment of 150 patients in the Company's DFU study.

This year end bonus is in addition to a previous cash bonus of $60,000 awarded to Mr. Fan during 2021 upon receipt of the Company's BARDA Option 1b contract significantly ahead of schedule. Mr. Fan's aggregate cash bonus in respect of the year to 31 December 2021 was therefore $285,000 (the "Aggregate CEO Bonus").

Related Party Transaction

As a Director of the Company, Wensheng Fan is considered to be a "related party" as defined under the AIM Rules and accordingly, the Aggregate CEO Bonus constitutes a related party transaction for the purposes of Rule 13 of the AIM Rules.

Martin Mellish, Erich Spangenberg, Richard Cotton, Cynthia Cai and Gerry Beaney, being the Directors independent of the transaction, consider, having consulted with SP Angel Corporate Finance LLP, the Company's Nominated Adviser, that the terms of the Aggregate CEO Bonus are fair and reasonable insofar as the Company's shareholders are concerned.

Market Abuse Regulation (MAR) Disclosure

The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014 as it forms part of UK domestic law by virtue of the European Union (Withdrawal) Act 2018 ('MAR'). Upon the publication of this announcement via Regulatory Information Service ('RIS'), this inside information is now considered to be in the public domain.

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About Spectral MD:                                                                                       

Using its DeepView® Wound Imaging Solution, an internally developed AI technology and multispectral imaging solution that has received FDA Breakthrough Designation for the burn indication, Spectral MD is able to distinguish between non-healing and healing human tissue invisible to the naked eye. Spectral MD currently is able to provide 'Day One' healing assessments for burn wounds and diabetic foot ulcers with other applications being explored.

Spectral MD has to date received substantial support from the U.S. government with contracts from institutions such as Biomedical Advanced Research and Development Authority, National Science Foundation, National Institute of Health and Defense Health Agency in support of the burn application for its DeepView® solution, with total grant funding received to date from all of these organisations of over $93 million, including $40.5 million received in 2021. This grant funding is non-dilutive to our shareholders and the Company believes it validates the important nature of our mission and technology. The Company leverages this funding to support R&D efforts that are applicable to burn, DFU and potentially other indications where DeepView® can play an important role in Day 1 wound healing assessment.

The Company has two principal trading subsidiaries, Spectral MD, Inc. and Spectral MD UK Limited.

DeepView®

DeepView® is a predictive analytics platform that integrates proprietary AI algorithms and advanced optical technology for wound healing predictions. 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.

·    The DeepView® data extraction consists of proprietary optics that are able to collect millions of data points 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 66.7 billion pixels with an ever-growing input of clinically validated data points.

·    The AI algorithm then produces a predictive wound healing assessment 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 clinician 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 lack of patient follow-up or risking patient noncompliance with standard wound therapy. For burn wounds, the clinician can make an immediate and objective determination to identify appropriate candidates for surgery as well as determining what specific areas of the burn wound will require skin grafting. DeepView®'s current accuracy for determining the healing potential of burn wounds is 92 percent in adults and 88 percent in children, compared with current physician accuracy of 50 to 70 percent. The current clinical accuracy of DeepView® is 83 percent for DFUs.  Both of these accuracy percentages are expected to increase with additional R&D efforts, including clinical studies.

Notification and public disclosure of transactions by persons discharging managerial responsibilities and persons closely associated with them.