Spectral AI Adds Three New Clinical Trial Sites To Expedite Emergency Department Patient Enrollment

Rhea-AI Summary

Spectral AI (Nasdaq: MDAI) has added three new U.S. Clinical Trial Sites for its 2024 Burn Pivotal Study, bringing the total to 16 sites including burn centers and Emergency Departments. The new sites are:

• University Medical Center Burn Center at Texas Tech University Health Sciences Center
• Tampa General Hospital Burn Center
• University of South Alabama Health Emergency Department

The study aims to validate the AI-driven algorithm used by Spectral AI's DeepView™ System for burn indication. It's expected to be the final clinical trial before seeking FDA approval in 2025. The DeepView™ System uses multispectral imaging and a database of over 340 billion clinically validated data points to provide rapid, objective burn wound assessments.

Positive

• Expansion of clinical trial sites to 16, potentially accelerating patient enrollment
• DeepView™ System's potential to improve burn wound assessment in emergency settings
• Progress towards FDA approval for burn indication in 2025
• Large proprietary database of 340 billion clinically validated data points supporting the AI algorithm

Negative

• None.

Insights

Medical Research Analyst

The addition of three new clinical trial sites by Spectral AI is a significant step forward in their 2024 Burn Pivotal Study. By expanding to 16 locations, the company is enhancing the robustness and credibility of their research. This expansion will likely accelerate patient enrollment, which is important for timely data collection and subsequent analysis. The involvement of reputable institutions and esteemed clinicians also adds to the study's credibility and potential for successful outcomes. If the study results are positive, it will pave the way for FDA approval in 2025, making the DeepView™ System a potentially transformative tool in burn care diagnostics.

This advancement is substantial because it addresses a critical need in emergency medicine—rapid and accurate burn assessment. The DeepView™ System's AI-driven approach utilizes extensive data points to provide objective diagnostic support, which can significantly improve patient outcomes and healthcare efficiency.

Financial Analyst

From a financial perspective, the expansion of clinical trial sites for Spectral AI's DeepView™ System is a positive development. The move is likely to expedite the trial process, bringing the company closer to FDA approval and eventual market launch. FDA approval can have a substantial impact on Spectral AI's financial performance, potentially leading to increased revenue streams and market share in the medical diagnostics sector. Investors should note that the successful completion of these trials and subsequent FDA approval could significantly enhance the company's valuation.

However, it's also important to consider the costs involved in expanding clinical trials. While this investment might strain short-term financials, the long-term benefits could outweigh these initial expenditures if the trials lead to successful FDA approval and market adoption.

Market Research Analyst

The announcement by Spectral AI to add three new clinical trial sites is a strategic move that aligns with the broader trends in the healthcare diagnostics market. The use of AI and multispectral imaging in medical diagnostics is gaining traction and Spectral AI's DeepView™ System is well-positioned to capitalize on this trend. The potential to provide rapid and accurate burn wound assessments addresses a significant gap in current emergency department practices, offering a competitive advantage.

The inclusion of prestigious institutions and experienced clinicians in the trial bolsters the market perception of the DeepView™ System, enhancing its credibility and acceptance among healthcare providers. If FDA approval is secured, the system could see robust adoption, given the increasing demand for AI-driven diagnostic tools. This can lead to substantial market penetration and revenue growth for Spectral AI.

DALLAS, July 23, 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 three new U.S. Clinical Trial Sites for its 2024 Burn Pivotal Study: University Medical Center (UMC) Burn Center at Texas Tech University Health Sciences Center led by principal investigator Alan Pang, M.D., Tampa General Hospital Burn Center led by principal investigator Jared Troy, M.D., and University of South Alabama (USA) Health Emergency Department led by Andrew Bright, D.O.

These new locations expand the total number of U.S. Clinical Trial Sites to 16, comprised of both burn centers and Emergency Departments (EDs).

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 expected to be the final clinical trial before the Company seeks FDA approval of its DeepView™ System for burn indication in 2025.

“We believe that the potential of our AI-driven DeepView™ System to support the timely and accurate triage of a burn wound patient in a busy, sometimes chaotic, ED setting can deliver benefits across the healthcare ecosystem,” said Peter M. Carlson, Chief Executive Officer of Spectral AI. “Having an objective diagnostic tool can lead to immediate interventions that impact the treatment and outcome of burn wounds, while supporting improved institutional efficiencies. The addition of these new sites brings us closer to completing the 2024 Burn Pivotal Study and seeking FDA approval for the DeepView™ System for burn indication in 2025. We are grateful for the support of these esteemed clinicians and institutions in supporting our research and bringing true innovation to burn wound assessment and treatment.”

The Company’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 U.S. pivotal study is currently enrolling patients at leading burn centers and EDs across the U.S., with esteemed principal investigators overseeing the research.

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 are the new clinical trial sites added by Spectral AI (MDAI) for its 2024 Burn Pivotal Study?

Spectral AI added three new U.S. Clinical Trial Sites: University Medical Center Burn Center at Texas Tech University Health Sciences Center, Tampa General Hospital Burn Center, and University of South Alabama Health Emergency Department.

How many total clinical trial sites does Spectral AI (MDAI) now have for its 2024 Burn Pivotal Study?

With the addition of three new sites, Spectral AI now has a total of 16 U.S. Clinical Trial Sites, including both burn centers and Emergency Departments.

When does Spectral AI (MDAI) expect to seek FDA approval for its DeepView™ System for burn indication?

Spectral AI expects to seek FDA approval for its DeepView™ System for burn indication in 2025, following the completion of the 2024 Burn Pivotal Study.

What technology does Spectral AI's (MDAI) DeepView™ System use for burn wound assessment?

Spectral AI's DeepView™ System uses multispectral imaging and an AI-driven algorithm trained on over 340 billion clinically validated data points to provide rapid and objective burn wound assessments.