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Spectral AI Expands Clinical Trial Sites for Pivotal U.S. Burn Study

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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.

Expanding the clinical trial sites for Spectral AI's pivotal burn study is an important development. This expansion to include the University of California San Diego and the University of Utah is strategic for several reasons. Firstly, it increases the diversity and number of patients involved in the study, which can enhance the reliability of the results. By having a broader patient base, the study can provide more comprehensive data on how well the DeepView™ System performs across different demographics and medical settings.

Another important aspect is geographical diversity. Different regions might present variations in the types of burns and treatment methodologies, which can provide a more robust validation of the AI-driven algorithm. Moreover, including prominent institutions like these can bolster the study's credibility and potentially accelerate acceptance within the medical community.

For retail investors, this move can be seen as a positive step toward securing FDA approval. A successful pivotal study is a significant milestone and typically a precursor to FDA submission and approval. This means that if the study results are favorable, Spectral AI could be one step closer to bringing their product to market, which could potentially drive revenue growth.

Overall, the addition of these clinical trial sites strengthens the company's position and underscores their commitment to thorough, scientifically rigorous validation of their technology.

The addition of new clinical trial sites can also be interpreted from a market penetration perspective. By establishing presence in new geographies, Spectral AI is not only expanding their clinical trial but also potentially laying the groundwork for future market entry. Visibility in different regions can help build relationships with local healthcare providers and pave the way for smoother commercial rollout post-FDA approval.

Moreover, it provides the company with the chance to showcase the DeepView™ System to a wider audience of clinicians. Early exposure and feedback from varied healthcare environments can be invaluable for refining the product and tailoring it to meet market needs more effectively.

From an investor's viewpoint, these steps indicate an active and strategic approach to product development and market readiness. It suggests that Spectral AI is not merely focused on passing clinical trials but is taking proactive measures to ensure their product's success post-approval.

Examining Spectral AI’s expansion of clinical trial sites from a financial viewpoint reveals some key implications. Typically, increasing the number of sites involves higher operational costs due to logistics, additional staffing and resource allocation. However, this can be viewed as an investment in the company’s future.

If the pivotal study concludes successfully and leads to FDA approval, the potential return on investment could be significant. FDA approval could open up substantial market opportunities for Spectral AI's DeepView™ System, leading to revenue generation and market share growth in the wound care diagnostics sector.

It’s also important to note that the company’s ability to secure and manage multiple trial sites might signal strong operational capabilities and effective management, which are positive indicators for investors.

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

What recent expansion did Spectral AI announce for its 2024 Burn Pivotal Study?

Spectral AI announced the addition of two new clinical trial sites at the University of California San Diego and the University of Utah, expanding the total to 14 sites.

When is the completion date for Spectral AI's 2024 Burn Pivotal Study?

The study is scheduled to be completed in the fourth quarter of 2024.

What is the purpose of Spectral AI's 2024 Burn Pivotal Study?

The study aims to validate the AI-driven algorithm of the DeepView™ System for burn indication.

What is Spectral AI's stock symbol?

Spectral AI's stock symbol is MDAI.

When does Spectral AI expect to seek FDA approval for the DeepView™ System?

Spectral AI anticipates seeking FDA approval for the DeepView™ System in 2025.

Spectral AI, Inc.

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