MDAI Spectral AI Inc

Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today provided an overview of a study conducted by the American Burn Association (“ABA”) highlighting the physical and economic barriers to burn care access faced by rural and pediatric patients.

The Company also discussed how its DeepView® System for burn indication can help broaden equity in access to burn treatment while optimizing healthcare resources.

Each year, approximately 400,000 individuals in the United States receive medical treatment for burn injuries, necessitating immediate access to specialized care to minimize morbidity and mortality. Unfortunately, the number of certified burn centers has declined from 180 to approximately 125 over the last three decades, revealing an alarming contraction in access to specialized critical treatment.

A recent study published in the Journal of Burn Care & Research January/February 2024, titled "Access to Certified Burn Centers in the United States: The Geospatial and Transport Cost of Transfer," conducted by the American Burn Association (ABA), highlights the uneven distribution of ABA-verified burn centers across the nation. The findings indicate significant disparities, particularly affecting rural populations and pediatric patients, who face additional barriers to timely care.

Key findings of the study include:

• Geographical Disparities: Pediatric patients travel an average of 30.5 miles further than adults to reach the nearest burn center. This distance increases the cost of transport significantly, with pediatric air transport costing $947.30 more and ground transport $245 more compared to adults.
• Rural vs. Urban Access: Rural patients face a 50.02% increase in travel distance to burn centers compared to their urban counterparts. Transportation costs for rural patients are nearly double those for urban patients, with air transport costing $5,678 more and ground transport $491.20 more.

• Economic Burden: The study estimates that rural patients encounter higher costs due to longer distances and less efficient transportation options. Air transport, often necessary in remote areas, contributes substantially to these increased costs.

These disparities are particularly pronounced in the Mountain West and Southeastern regions of the United States, where access to both adult and pediatric burn centers is critically low. The limitations in specialized burn care access not only hinder timely treatment but also exacerbate the long-term health outcomes for those affected.

“Specialized burn centers are critical to minimizing burn-associated morbidity and mortality, and the disparity in access to these facilities, especially in rural areas and among children, poses a significant risk to our communities,” said Peter M. Carlson, Chief Executive Officer of Spectral AI. “A compounding factor of this care gap is the associated increase in transportation costs. For both adults and pediatric patients, an accurate wound assessment is critical in determining the appropriate treatment protocol. Whether the patient is seen at a specialized burn center or local emergency department, we believe that empowering healthcare providers with a technology that provides an immediate, objective, and binary wound healing assessment is a vital piece of the wound care puzzle.”

Spectral AI’s DeepView® System image processing algorithm utilizes multispectral imaging, trained and tested against a proprietary database of more than 340 billion clinically validated data points, to deliver a rapid and objective assessment that aids healthcare providers in assessing the healing potential of a burn wound. The DeepView® System wound healing assessment platform empowers clinicians at all levels with the insights necessary for timely and informed treatment decisions.

Spectral AI’s DeepView® System for burn indication received UKCA Authorization in February 2024 and commercial sales in the UK are expected to commence this year.

The Company recently announced the completion of adult and pediatric patient enrollment at U.S. burn centers for its U.S. Burn Pivotal Study, one of the largest domestic burn studies ever conducted. Using data from these burn center patients, the Company will pursue a De Novo classification from the U.S. Food and Drug Administration for use of the DeepView® System in burn centers and expects to submit the request in the second quarter of 2025.

The ABA emphasizes the critical need for better burn care, particularly in underserved regions, to ensure that all individuals have equal access to critical treatments. For more information on burn injury statistics and the need for equitable access to care, please visit ABA.org.

About Spectral AISpectral 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 wound’s healing potential prior to treatment or other medical intervention. With algorithm-driven results and a goal to change the current standard of care, 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. 

Investors: The Equity Group Devin Sullivan Managing Director dsullivan@equityny.com 

Conor Rodriguez Analyst crodriguez@equityny.com