MDAI Spectral AI Inc

Spectral AI (NASDAQ: MDAI) (“Spectral AI” or the “Company”), developer of the AI-driven DeepView® System, which received Breakthrough Device Designation from the U.S. Food and Drug Administration (“FDA”) in 2018 and uses multi-spectral imaging and AI algorithms to predict burn healing potential, today announced the completion of the installation of three of the DeepView System devices in Australia.   The Company, in partnership with global medical device company and burn wound therapy leader PolyNovo Limited (“PolyNovo”). The Company was able to utilize the Australian Special Access Scheme (SAS) to deploy three DeepView Systems at the Concord Repatriation General Hospital in Sydney, the Royal Adelaide Hospital in Adelaide and the Fiona Stanley Hospital in Murdoch (Perth). The installation of these devices will support the Company’s eventual commercial roll-out based on clinician evaluations and experiences using the device.

Spectral AI’s DeepView System is a predictive device that offers clinicians an immediate and objective assessment of a burn wound’s healing potential prior to treatment or other medical intervention. The image processing algorithm employed by the DeepView System utilizes multispectral imaging that is trained and tested against a proprietary database of more than 340 billion clinically validated data points. The DeepView System is non-invasive and cart-based, allowing for exceptional mobility within the healthcare setting.

"I am eager to start using DeepView on our patients. The imaging advancements have a definite potential to enhance patient care and improve outcomes, this technology was what we have been waiting for for many years and I'm looking forward to seeing how they can make a meaningful difference in treating our burn patients," stated Professor Peter Maitz, Director of the Burn Unit at Concord Repatriation General Hospital.

“We are pleased with the expansion of the use of our DeepView System in Australia, the support from PolyNovo and look forward to the evaluations and response from treating physicians,” stated Dr. J. Michael DiMaio, MD, Chairman of the Board at Spectral AI. “These real-world device trials underscore the transformative impact of the DeepView® System and its attendant use of artificial intelligence in burn wound care, offering clinicians an immediate, data-driven assessment tool that can improve treatment decisions and patient outcomes. I am proud to note that we are now in the field in two continents, gaining real world experience and response to the DeepView System. All of this will support our near-term FDA submission.”

About Spectral AI

Spectral AI, Inc. is a Dallas-based predictive AI company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, with initial applications involving patients with burns and diabetic foot ulcers. The Company is working to revolutionize the management of wound care by “Seeing the Unknown®” with its DeepView® System. The DeepView® System is a predictive device that offers clinicians an objective and immediate assessment of a burn wound’s healing potential prior to treatment or other medical intervention. With algorithm-driven results and a goal of exceeding the current standard of care in the future, the DeepView® System is expected to provide faster and more accurate treatment insight towards value care by improving patient outcomes and reducing healthcare costs. For more information about the DeepView® System, visit www.spectral-ai.com.

Forward-Looking Statements

Certain statements made in this release are “forward looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s strategy, plans, objectives, initiatives and financial outlook. When used in this press release, the words “estimates,” “projected,” “expects,” “anticipates,” “forecasts,” “plans,” “intends,” “believes,” “seeks,” “may,” “will,” “should,” “future,” “propose” and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside Company’s control, that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. As such, readers are cautioned not to place undue reliance on any forward-looking statements.

Investors should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” sections of the Company’s filings with the SEC, including the Registration Statement and the other documents filed by the Company. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements.

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