Spectral AI Expands Clinical Trial Sites for Pivotal U.S. Burn Study
Rhea-AI Summary
Spectral AI (Nasdaq: MDAI) announced the addition of two new clinical trial sites at the University of California San Diego and the University of Utah, expanding its 2024 U.S. Burn Pivotal Study sites to 14. This expansion aims to capture more burn patients from emergency departments, diversify the patient population, and advance towards completing the study by the end of the year. The study will validate the AI-driven algorithm of Spectral AI's DeepView™ System for burn indication, with an expected completion in Q4 2024. FDA approval of the DeepView™ System is anticipated in 2025.
Positive
- Expanded clinical trial sites to 14, enhancing patient diversity.
- Targeting completion of the pivotal study by Q4 2024.
- Potential FDA approval of DeepView™ System in 2025.
Negative
- No immediate revenue impact reported.
- Dependence on FDA approval for DeepView™ System market entry.
News Market Reaction
On the day this news was published, MDAI gained 3.31%, reflecting a moderate positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
DALLAS, July 03, 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 it has added two new U.S. Clinical Trial Sites for its 2024 Burn Pivotal Study: the University of California San Diego and the University of Utah.
These new locations expand the total number of U.S. Clinical Trial Sites to 14.
“These two new sites allow us to capture additional burn patients who enter through the Emergency Department and thus complement our existing trial site presence at burn centers across the country, establish our presence in new geographies, and advance us towards our objective of completing this study by the end of the year,” said Peter M. Carlson, Chief Executive Officer of Spectral AI. “Moreover, a broader base of clinical trial sites provides access to a more diverse patient population, reduces bias, and provides the opportunity to elevate the profile of our DeepView™ System across a wider range of clinicians and healthcare settings.”
The 2024 U.S. Burn Pivotal Study is designed to validate the AI-driven algorithm used by Spectral AI’s DeepView™ System for burn indication. The study is scheduled to be completed in the fourth quarter of 2024 and it is expected to be the final clinical trial before the Company seeks FDA approval of its DeepView™ System for burn indication in 2025.
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
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