Spectral AI Completes Pediatric Enrollment in Emergency Departments for U.S. Burn Pivotal Study
Rhea-AI Summary
Spectral AI (NASDAQ: MDAI) has completed pediatric enrollment at U.S. emergency departments for its U.S. Burn Pivotal Study, one of the largest domestic burn studies ever conducted. The study aims to validate the AI-driven algorithm used in the company's DeepView® System, which received FDA Breakthrough Device Designation in 2018.
The DeepView System combines multispectral imaging with an AI algorithm trained on over 340 billion clinically-validated data points to assess burn healing potential. The system provides immediate, binary predictions of wound healing to support clinical decision-making for treatment plans.
The company plans to submit a De Novo classification request to the FDA in the first half of 2025 based on the study's data.
Positive
- FDA Breakthrough Device Designation received in 2018
- Large proprietary database of 340+ billion clinically-validated data points
- Completion of pediatric enrollment in major U.S. burn study
- De Novo FDA submission planned for H1 2025
Negative
- None.
Insights
The completion of pediatric enrollment in emergency departments marks a crucial milestone in Spectral AI's U.S. Burn Pivotal Study, particularly significant given the unique challenges in conducting pediatric trials. The pediatric burn market represents a sensitive and high-stakes segment, where accurate assessment is paramount for optimal treatment outcomes.
The DeepView® System's approach to burn assessment represents a potential paradigm shift in clinical decision-making. The system's binary prediction model, supported by 340 billion data points, could significantly reduce the subjectivity in burn assessment - a persistent challenge in current clinical practice. This is particularly valuable in emergency settings where rapid, accurate decisions are critical for patient outcomes.
The planned De Novo classification request in H1 2025 is strategically significant. This regulatory pathway, chosen for novel devices without predicates, suggests DeepView's unique position in the market. While this route typically involves more rigorous evaluation than 510(k) clearance, successful classification could establish Spectral AI as the benchmark for future AI-driven burn assessment technologies.
The technology's key differentiators include:
- Multi-spectral imaging capability that likely captures data beyond visible light spectrum
- AI algorithm trained on an exceptionally large dataset
- Immediate assessment capability important for time-sensitive treatment decisions
- Validation across diverse patient populations, including the challenging pediatric segment
A successful De Novo classification could position Spectral AI to capture a significant share of the burn care market, estimated to grow substantially due to increasing demand for advanced wound care solutions. The completion of this pivotal study phase suggests the company is maintaining its development timeline, critical for both market entry and potential partnerships.
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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FAQ
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