Spectral AI Announces Last Patient Out in U.S. Burn Pivotal Study at Burn Centers
Spectral AI (Nasdaq: MDAI) announced the completion of patient visits in its U.S. Burn Pivotal Study, marking a significant milestone toward FDA submission of DeepView AI®-Burn in first half of 2025. The study, one of the largest domestic burn center studies ever conducted, will provide topline results in December 2024. DeepView AI®-Burn is a non-invasive device designed to assess burn wound healing potential by distinguishing between healing and non-healing tissue, providing immediate binary assessment to support clinical decision-making.
Spectral AI (Nasdaq: MDAI) ha annunciato il completamento delle visite ai pazienti nel suo Studio Pivotal sui Bruciature negli Stati Uniti, segnando un traguardo significativo verso la presentazione alla FDA di DeepView AI®-Burn nella prima metà del 2025. Lo studio, uno dei più grandi mai condotti in centri di ustioni domestici, fornirà risultati preliminari a dicembre 2024. DeepView AI®-Burn è un dispositivo non invasivo progettato per valutare il potenziale di guarigione delle ferite da ustione, distinguendo tra tessuti in via di guarigione e non, offrendo una valutazione binaria immediata per supportare il processo decisionale clinico.
Spectral AI (Nasdaq: MDAI) anunció la finalización de las visitas de pacientes en su Estudio Pivotal sobre Quemaduras en EE. UU., marcando un hito importante hacia la presentación a la FDA de DeepView AI®-Burn en la primera mitad de 2025. El estudio, uno de los más grandes realizados en centros de quemaduras en el país, proporcionará resultados preliminares en diciembre de 2024. DeepView AI®-Burn es un dispositivo no invasivo diseñado para evaluar el potencial de curación de las heridas por quemaduras, diferenciando entre tejidos en proceso de curación y no, ofreciendo una evaluación binaria inmediata para apoyar la toma de decisiones clínicas.
스펙트럴 AI (Nasdaq: MDAI)는 미국 화상 중재 연구에서 환자 방문 완료를 발표하였으며, 이는 2025년 상반기 [b]DeepView AI®-Burn[/b]의 FDA 제출을 향한 중요한 이정표입니다. 이 연구는 국내 화상센터에서 수행된 가장 대규모 연구 중 하나로, 2024년 12월에 주요 결과를 제공할 것입니다. DeepView AI®-Burn는 화상 상처의 치유 가능성을 평가하기 위해 치유되는 조직과 비치유 조직을 구분하는 비침습적 장치로, 임상적 의사결정을 지원하기 위해 즉각적인 이진 평가를 제공합니다.
Spectral AI (Nasdaq: MDAI) a annoncé l'achèvement des visites de patients dans son étude pivot sur les brûlures aux États-Unis, marquant une étape importante vers la soumission à la FDA de DeepView AI®-Burn au cours de la première moitié de 2025. L'étude, l'une des plus grandes jamais réalisées dans des centres de brûlures domestiques, fournira des résultats préliminaires en décembre 2024. DeepView AI®-Burn est un dispositif non invasif conçu pour évaluer le potentiel de guérison des plaies brûlées en distinguant entre tissu en guérison et tissu non en guérison, offrant une évaluation binaire immédiate pour soutenir la prise de décision clinique.
Spectral AI (Nasdaq: MDAI) gab bekannt, dass die Patientenbesuche in seiner US-Brennen-Pivotal-Studie abgeschlossen sind, was einen bedeutenden Meilenstein in Richtung der FDA-Einreichung von DeepView AI®-Burn in der ersten Jahreshälfte 2025 darstellt. Die Studie, eine der größten je in inländischen Brandzentren durchgeführten Studien, wird im Dezember 2024 erste Ergebnisse liefern. DeepView AI®-Burn ist ein nicht invasives Gerät, das entwickelt wurde, um das Heilungspotenzial von Brandwunden zu bewerten, indem es zwischen heilendem und nicht heilendem Gewebe unterscheidet und eine sofortige binäre Bewertung zur Unterstützung klinischer Entscheidungsprozesse bietet.
- Final clinical trial completion before FDA submission
- Topline results expected in December 2024
- On track for FDA submission in H1 2025
- None.
Insights
The completion of patient visits in the U.S. Burn Pivotal Study represents a significant milestone for Spectral AI. The DeepView AI®-Burn system addresses a important need in burn care by providing immediate, non-invasive assessment of burn wound healing potential. This technology could revolutionize the standard of care in burn treatment by enabling faster, more accurate treatment decisions.
The study's scope, being one of the largest domestic burn center studies, adds substantial credibility to the upcoming FDA submission. With topline results expected in December 2024 and FDA submission planned for early 2025, the company is maintaining a clear regulatory timeline. The binary assessment capability of DeepView AI®-Burn could significantly reduce the subjectivity in burn wound assessment, potentially improving treatment outcomes and standardizing care protocols across different healthcare settings.
This development carries significant market implications for MDAI, given its relatively small
The binary nature of DeepView AI®-Burn's assessment could drive adoption by reducing complexity in decision-making and potentially lowering healthcare costs. The technology's ability to broaden equity in burn care access could also expand the addressable market. Investors should monitor the December 2024 topline results as a critical catalyst that could impact the company's valuation.
Milestone Achievement Supports Planned FDA Submission of DeepView AI®-Burn in 2025
DALLAS, Oct. 30, 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 the final group of burn center patients in the Company’s U.S. Burn Pivotal Study have successfully completed their clinical visits.
One of the largest domestic burn center studies ever conducted, the U.S. Burn Pivotal Study is expected to be the final clinical trial before the Company seeks U.S. Food and Drug Administration (“FDA”) approval of its DeepView® System for burn indication (“DeepView AI®-Burn”) in the first half of 2025. DeepView AI®-Burn is a non-invasive, predictive medical device designed to distinguish between healing and non-healing tissue in order to provide clinicians with an immediate and binary assessment of a burn wound’s healing potential.
The Company expects to report topline results from this study in December 2024.
“The completion of this aspect of the U.S. Burn Pivotal Study marks a critical milestone on our path towards commercialization,” said Dr. J. Michael DiMaio, Chairman of the Board. “These results will form the foundation of our forthcoming U.S. regulatory submission and brings us one step closer to delivering a potentially groundbreaking advancement in burn wound assessment that can support clinical decision-making regarding next step treatment plans, broaden equity in access to burn care treatment, and improve clinical outcomes. I want to thank our investigators, their dedicated staff, and study enrollees for their support in this endeavor.”
About the U.S. Burn Pivotal Study
The U.S. Burn Pivotal Study was initiated in January 2024 and involves 160 adult and pediatric patients at 14 burn centers across the country. It is designed to validate the AI-driven closed loop algorithm used by DeepView AI®-Burn. Each patient underwent non-invasive imaging of their wound using DeepView AI®-Burn beginning at the initial clinical assessment and until the treatment plan was defined. An end image was required at 21 days following initial assessment.
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
When will Spectral AI (MDAI) release the topline results of its U.S. Burn Pivotal Study?
When does Spectral AI (MDAI) plan to submit DeepView AI-Burn for FDA approval?
What is the purpose of Spectral AI's (MDAI) DeepView AI-Burn system?
