BARDA approval of additional $18.8m funding

Funds will expand the DeepView training clinical study for burn wounds

Total funding commitments of c. $93m received from BARDA to date to support the development of Spectral MD’s artificial intelligence and multi-spectral imaging for wound healing assessment

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 the commitment of additional funding of $18.8 million from the US Biomedical Advanced Research and Development Authority (BARDA), which will be used to expand the current clinical training study of Spectral MD’s DeepView® Wound Imaging System for burn wound healing assessment.

This contract option funding of $18.8 million under Option 1B of Spectral MD’s current contract with BARDA follows the $20.6 million awarded under Option 1A which was exercised by BARDA in March 2021 to execute the first stage of the clinical training study at five sites to train the DeepView® AI algorithm.  The Option 1B funding announced today will allow Spectral MD to accelerate initiation of the second stage of this clinical training study. The second stage will expand from five to a total of ten clinical sites, and from 100 to a total of 250 clinical subjects and is expected to continue until Q4 2022. The DeepView® Wound Imaging System received Breakthrough Device Designation from the U.S. Food and Drug Administration (“FDA”) in 2018 for its burn indication and aims to provide burn wound healing predictions on Day 1 to assist a physician’s decision on treatment choices to reduce the patient’s pain and suffering, improve clinical outcomes, and decrease the economic burden for the patient, hospital, and payor.

The study, which commenced on 9 August 2021, remains focused on collecting burn wound data from real-world clinical patients, representative of the US Burn population, including adult and paediatric subjects. This data will allow Spectral MD to complete the development and training of the DeepView® Wound Imaging System algorithm and finalize the system for the validation clinical study prior to submission for FDA clearance.

Spectral MD has received total funding commitments from BARDA to date of approximately $93 million. Between 2013 and 2019, under the previous contract, the company received $26 million in funding from BARDA. Under the current contract initiated in 2019, BARDA has to-date awarded $66.8 million in funding, including $27.3 million awarded in July 2019; $20.6 million awarded under the Option 1A in March 2021; and $18.8 million under Option 1B announced today. The initial $27.3 million funding from BARDA has led to the development of the SnapShot DeepView Wound Imaging System into a highly portable, proprietary snapshot multi-spectrum imaging technology that can capture broad optical bands of wound tissue data in high resolution within milliseconds. This contract also contains an option to fund an additional $22.1 million at a later date for the validation studies. 

Wensheng Fan, Chief Executive Officer of Spectral MD, said: “We are grateful for the additional award of $18.8 million from BARDA which was originally expected for March 2022. Due to the strong collaboration between BARDA, Spectral MD, and our clinical partners, we were able to have the successful kickoff of the study at the first five sites which has enabled the award of this funding earlier than anticipated. The Option 1B funding award will allow us to build a more streamlined training clinical study for the AI algorithm for DeepView^®, enabling better timing and cost savings for our studies across the US, and helping to reduce the risks in clinical trials associated with COVID. BARDA’s support has allowed Spectral MD to achieve many important milestones and this latest funding will further accelerate our development of DeepView.”

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

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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.