Spectral AI completes pediatric enrollment for its pivotal burn study, aiming for FDA classification of its DeepView® System.
Quiver AI Summary
Spectral AI, a Dallas-based company specializing in AI-driven medical diagnostics, has completed pediatric enrollment for its U.S. Burn Pivotal Study, one of the largest domestic studies focused on burn healing potential. The study aims to validate the DeepView® System, which combines multi-spectral imaging and AI algorithms to assess the healing capability of burn injuries. The company intends to seek a De Novo classification from the U.S. FDA for the DeepView™ System in the first half of 2025, using data collected from burn center patients. The innovative system is designed to deliver immediate predictions about wound healing, aiding clinical decision-making and potentially improving patient outcomes while reducing healthcare costs.
Potential Positives
- Completion of pediatric enrollment marks a significant milestone in one of the largest domestic burn studies, enhancing the credibility and potential impact of the DeepView® System.
- The upcoming De Novo classification submission to the FDA for the DeepView™ System could facilitate its commercial use, potentially increasing market reach and revenues for Spectral AI.
- The DeepView® System combines advanced multi-spectral imaging with extensive clinical data, which positions it as an innovative diagnostic tool with the potential to improve patient outcomes in burn care.
- This research effort signifies Spectral AI's commitment to revolutionizing wound care and introduces an objective assessment tool that may transform clinical decision-making processes.
Potential Negatives
- The press release emphasizes the company's reliance on the U.S. FDA's De Novo classification process, which introduces a level of uncertainty and dependency on regulatory approval that could delay commercialization and impact financial projections.
- The inclusion of extensive forward-looking statements may signal to investors that there are inherent risks and uncertainties involved, possibly raising concerns about the company's future performance and actual outcomes compared to expectations.
- The report of the completion of pediatric enrollment in the burn study indicates that the company is still in the clinical trial phase, which may suggest that the product is not yet market-ready or validated for widespread use, possibly impacting investor confidence and market perception.
FAQ
What is the purpose of the U.S. Burn Pivotal Study?
The U.S. Burn Pivotal Study aims to validate the AI-driven algorithm of Spectral AI's DeepView™ System for burn indication.
What is the DeepView® System?
The DeepView® System is a predictive medical device that assesses burn healing potential using multi-spectral imaging and AI algorithms.
How does the DeepView™ System predict burn healing?
It distinguishes between healing and non-healing tissue to provide immediate predictions on burn wound healing at the time of examination.
When does Spectral AI plan to submit its De Novo classification request?
The Company expects to submit the De Novo classification request to the FDA in the first half of 2025.
What advancements does Spectral AI aim for in wound care management?
Spectral AI aims to revolutionize wound care management by providing faster and more accurate treatment decisions with the DeepView® System.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
DALLAS, Jan. 28, 2025 (GLOBE NEWSWIRE) -- Spectral AI (NASDAQ: MDAI) (“Spectral AI” or the “Company”) , developer of the AI-driven DeepView® System, which received Breakthrough Device Designation from the U.S. FDA in 2018, that uses multi-spectral imaging and algorithms to predict burn healing potential, today announced the completion of its pediatric enrollment at U.S. emergency departments for its U.S. Burn Pivotal Study. One of the largest domestic burn studies ever conducted, the U.S. Burn Pivotal Study is designed to validate the AI-driven algorithm used by the Company’s DeepView™ System for burn indication.
Using data from these burn center patients, the Company will pursue a De Novo classification from the U.S. Food and Drug Administration (“FDA”) for use of the DeepView™ System and expects to submit the request in the first half of 2025.
Spectral AI's DeepView™ System for burn indication is a predictive medical device that assesses the healing potential of burns by combining multispectral imaging with an AI-driven algorithm trained and tested against a proprietary database of more than 340 billion clinically-validated data points. By distinguishing between healing and non-healing tissue, the DeepView™ System provides an immediate and binary prediction of wound healing at examination that can support clinical decision-making regarding next step treatment plans.
“I am proud of the continuing work by our investigators, their dedicated staff and most critically study enrollees,” stated Dr. J. Michael DiMaio, MD, Chairman of the Board at Spectral AI. “The results of this U.S. Burn Pivotal Study will be used by our data science team and our panel of burn experts to complete years of work and bring this crucial advancement in burn wound assessment to patients and providers in the U.S.”
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. DeepView 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 of exceeding the current standard of care in the future, DeepView 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 DeepView , 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.
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