Spectral AI Announces Last Patient Out in U.S. Burn Pivotal Study at Burn Centers

Rhea-AI Summary

Spectral AI (Nasdaq: MDAI) announced the completion of patient visits in its U.S. Burn Pivotal Study, marking a significant milestone toward FDA submission of DeepView AI®-Burn in first half of 2025. The study, one of the largest domestic burn center studies ever conducted, will provide topline results in December 2024. DeepView AI®-Burn is a non-invasive device designed to assess burn wound healing potential by distinguishing between healing and non-healing tissue, providing immediate binary assessment to support clinical decision-making.

Positive

• Final clinical trial completion before FDA submission
• Topline results expected in December 2024
• On track for FDA submission in H1 2025

Negative

• None.

Insights

Medical Research Analyst

The completion of patient visits in the U.S. Burn Pivotal Study represents a significant milestone for Spectral AI. The DeepView AI®-Burn system addresses a important need in burn care by providing immediate, non-invasive assessment of burn wound healing potential. This technology could revolutionize the standard of care in burn treatment by enabling faster, more accurate treatment decisions.

The study's scope, being one of the largest domestic burn center studies, adds substantial credibility to the upcoming FDA submission. With topline results expected in December 2024 and FDA submission planned for early 2025, the company is maintaining a clear regulatory timeline. The binary assessment capability of DeepView AI®-Burn could significantly reduce the subjectivity in burn wound assessment, potentially improving treatment outcomes and standardizing care protocols across different healthcare settings.

Financial Analyst

This development carries significant market implications for MDAI, given its relatively small $26.2M market cap. The successful completion of the pivotal trial's patient visits reduces clinical development risk and positions the company for a potential FDA submission in 2025. The burn care market represents a substantial commercial opportunity, with the global burn care market projected to grow significantly.

The binary nature of DeepView AI®-Burn's assessment could drive adoption by reducing complexity in decision-making and potentially lowering healthcare costs. The technology's ability to broaden equity in burn care access could also expand the addressable market. Investors should monitor the December 2024 topline results as a critical catalyst that could impact the company's valuation.

Milestone Achievement Supports Planned FDA Submission of DeepView AI^®-Burn in 2025

DALLAS, Oct. 30, 2024 (GLOBE NEWSWIRE) -- 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 announced that the final group of burn center patients in the Company’s U.S. Burn Pivotal Study have successfully completed their clinical visits.

One of the largest domestic burn center studies ever conducted, the U.S. Burn Pivotal Study is expected to be the final clinical trial before the Company seeks U.S. Food and Drug Administration (“FDA”) approval of its DeepView^® System for burn indication (“DeepView AI^®-Burn”) in the first half of 2025. DeepView AI^®-Burn is a non-invasive, predictive medical device designed to distinguish between healing and non-healing tissue in order to provide clinicians with an immediate and binary assessment of a burn wound’s healing potential.

The Company expects to report topline results from this study in December 2024.

“The completion of this aspect of the U.S. Burn Pivotal Study marks a critical milestone on our path towards commercialization,” said Dr. J. Michael DiMaio, Chairman of the Board. “These results will form the foundation of our forthcoming U.S. regulatory submission and brings us one step closer to delivering a potentially groundbreaking advancement in burn wound assessment that can support clinical decision-making regarding next step treatment plans, broaden equity in access to burn care treatment, and improve clinical outcomes. I want to thank our investigators, their dedicated staff, and study enrollees for their support in this endeavor.”

About the U.S. Burn Pivotal Study

The U.S. Burn Pivotal Study was initiated in January 2024 and involves 160 adult and pediatric patients at 14 burn centers across the country. It is designed to validate the AI-driven closed loop algorithm used by DeepView AI^®-Burn. Each patient underwent non-invasive imaging of their wound using DeepView AI^®-Burn beginning at the initial clinical assessment and until the treatment plan was defined. An end image was required at 21 days following initial assessment.

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 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

FAQ

When will Spectral AI (MDAI) release the topline results of its U.S. Burn Pivotal Study?

Spectral AI will report topline results from the U.S. Burn Pivotal Study in December 2024.

When does Spectral AI (MDAI) plan to submit DeepView AI-Burn for FDA approval?

Spectral AI plans to seek FDA approval for DeepView AI-Burn in the first half of 2025.

What is the purpose of Spectral AI's (MDAI) DeepView AI-Burn system?

DeepView AI-Burn is a non-invasive device designed to distinguish between healing and non-healing tissue, providing immediate assessment of burn wound healing potential.