Spectral AI Announces Successful Results from its Burn Validation Study of the DeepView System
Spectral AI (NASDAQ: MDAI) has announced successful results from its Burn Validation Study of the DeepView® System, a revolutionary AI-driven device that predicts burn healing potential using multi-spectral imaging. The study, one of the largest burn trials in U.S. history, involved 164 patients (115 adult, 49 pediatric) across multiple burn centers.
The DeepView System significantly outperformed burn physicians in identifying non-healing tissue, demonstrating:
- 86.6% image-wise sensitivity vs. 40.8% for physicians
- 81.9% pixel-wise sensitivity vs. 38.8% for physicians
- 68.5% Dice Score vs. 39.2% for physicians
- 61.2% image-wise specificity vs. anticipated 36.0%
The company plans to submit these results to the FDA by Q2 2025, targeting De Novo Classification approval in early 2026, followed by immediate commercialization upon approval.
Spectral AI (NASDAQ: MDAI) ha annunciato risultati positivi dal suo Burn Validation Study del sistema DeepView®, un dispositivo rivoluzionario guidato dall'IA che prevede il potenziale di guarigione delle ustioni utilizzando l'imaging multispettrale. Lo studio, uno dei più grandi trial sulle ustioni nella storia degli Stati Uniti, ha coinvolto 164 pazienti (115 adulti, 49 pediatrici) in vari centri per ustioni.
Il sistema DeepView ha superato significativamente i medici specializzati nel riconoscere i tessuti non in guarigione, dimostrando:
- 86,6% di sensibilità per immagine rispetto al 40,8% per i medici
- 81,9% di sensibilità per pixel rispetto al 38,8% per i medici
- 68,5% di Dice Score rispetto al 39,2% per i medici
- 61,2% di specificità per immagine rispetto al previsto 36,0%
L'azienda prevede di presentare questi risultati alla FDA entro il secondo trimestre del 2025, puntando all'approvazione della classificazione De Novo all'inizio del 2026, seguita dalla commercializzazione immediata una volta ottenuta l'approvazione.
Spectral AI (NASDAQ: MDAI) ha anunciado resultados exitosos de su Estudio de Validación de Quemaduras del Sistema DeepView®, un dispositivo revolucionario impulsado por IA que predice el potencial de curación de quemaduras utilizando imágenes multispectrales. El estudio, uno de los más grandes ensayos de quemaduras en la historia de EE. UU., involucró a 164 pacientes (115 adultos, 49 pediátricos) en múltiples centros de quemaduras.
El Sistema DeepView superó significativamente a los médicos en la identificación de tejido no cicatrizado, demostrando:
- 86.6% de sensibilidad por imagen frente al 40.8% de los médicos
- 81.9% de sensibilidad por píxel frente al 38.8% de los médicos
- 68.5% de Dice Score frente al 39.2% de los médicos
- 61.2% de especificidad por imagen frente al 36.0% anticipado
La empresa planea presentar estos resultados a la FDA para el segundo trimestre de 2025, con el objetivo de obtener la aprobación de Clasificación De Novo a principios de 2026, seguida de una comercialización inmediata tras la aprobación.
스펙트럴 AI (NASDAQ: MDAI)는 다중 스펙트럼 이미징을 사용하여 화상 치유 가능성을 예측하는 혁신적인 AI 기반 장치인 DeepView® 시스템의 화상 검증 연구에서 성공적인 결과를 발표했습니다. 이 연구는 미국 역사상 가장 큰 화상 시험 중 하나로, 여러 화상 센터에서 164명의 환자(성인 115명, 소아 49명)가 참여했습니다.
DeepView 시스템은 비치유 조직을 식별하는 데 있어 화상 의사들보다 훨씬 뛰어난 성과를 보였으며, 다음과 같은 결과를 보여주었습니다:
- 86.6%의 이미지별 민감도, 의사의 40.8% 대비
- 81.9%의 픽셀별 민감도, 의사의 38.8% 대비
- 68.5%의 다이스 점수, 의사의 39.2% 대비
- 61.2%의 이미지별 특이도, 예상 36.0% 대비
회사는 2025년 2분기까지 FDA에 이 결과를 제출할 계획이며, 2026년 초에 De Novo 분류 승인을 목표로 하고 있으며, 승인이 나면 즉시 상용화할 예정입니다.
Spectral AI (NASDAQ: MDAI) a annoncé des résultats positifs de son étude de validation des brûlures du système DeepView®, un dispositif révolutionnaire piloté par IA qui prédit le potentiel de guérison des brûlures grâce à l'imagerie multispectrale. L'étude, l'une des plus grandes études sur les brûlures de l'histoire des États-Unis, a impliqué 164 patients (115 adultes, 49 pédiatriques) dans plusieurs centres de brûlures.
Le système DeepView a significativement surpassé les médecins dans l'identification des tissus non cicatrisés, démontrant :
- 86,6 % de sensibilité par image contre 40,8 % pour les médecins
- 81,9 % de sensibilité par pixel contre 38,8 % pour les médecins
- 68,5 % de Dice Score contre 39,2 % pour les médecins
- 61,2 % de spécificité par image contre 36,0 % prévu
L'entreprise prévoit de soumettre ces résultats à la FDA d'ici le deuxième trimestre 2025, visant une approbation de classification De Novo début 2026, suivie d'une commercialisation immédiate après approbation.
Spectral AI (NASDAQ: MDAI) hat erfolgreiche Ergebnisse aus seiner Burn Validation Study des DeepView® Systems bekannt gegeben, einem revolutionären KI-gesteuerten Gerät, das das Heilungspotenzial von Verbrennungen mithilfe von multispektraler Bildgebung vorhersagt. Die Studie, eine der größten Verbrennungsstudien in der Geschichte der USA, umfasste 164 Patienten (115 Erwachsene, 49 Kinder) in mehreren Verbrennungszentren.
Das DeepView-System übertraf Verbrennungsspezialisten erheblich bei der Identifizierung von nicht heilendem Gewebe und zeigte:
- 86,6% Bildsensitivität im Vergleich zu 40,8% für Ärzte
- 81,9% Pixelsensitivität im Vergleich zu 38,8% für Ärzte
- 68,5% Dice Score im Vergleich zu 39,2% für Ärzte
- 61,2% Bildspezifität im Vergleich zu den erwarteten 36,0%
Das Unternehmen plant, diese Ergebnisse bis zum 2. Quartal 2025 der FDA vorzulegen, mit dem Ziel, Anfang 2026 die Genehmigung der De Novo-Klassifizierung zu erhalten, gefolgt von einer sofortigen Kommerzialisierung nach Genehmigung.
- DeepView System significantly outperformed physicians in burn assessment accuracy
- Large-scale validation study completed with 164 patients
- Technology ready for FDA submission by Q2 2025
- Immediate commercialization preparedness upon potential FDA approval
- Federal funding support from BARDA under contract
- FDA approval not guaranteed
- Commercialization timeline dependent on regulatory approval
- Lower specificity (61.2%) compared to physicians (79.1%)
Insights
Spectral AI's successful completion of its Burn Validation Study represents a significant clinical milestone that substantially derisks the company's path to commercialization. The study's results demonstrating the DeepView System's superior performance over burn physicians—with
The clear regulatory timeline with FDA submission expected by Q2 2025 and potential De Novo clearance in early 2026 establishes a concrete pathway to market. Investors should note that government backing through BARDA funding (contract 75A50123C00049) adds credibility and financial support for Spectral AI's development efforts.
For a company with a market cap of only
The De Novo regulatory pathway indicates this is a novel device without predicates, which while presenting some regulatory uncertainty, also underscores the innovative nature of the technology and potential first-mover advantages in the marketplace. Spectral AI's statement about being prepared to commercialize immediately upon approval suggests manufacturing arrangements are already in place, reducing operational risk.
The DeepView System's performance metrics in the Burn Validation Study reveal impressive technological capabilities with profound clinical implications. The system achieved more than double the sensitivity of experienced burn physicians (
While physicians demonstrated higher specificity (
The system's non-invasive, cart-based design offers considerable workflow advantages in acute care settings. The technology's ability to provide objective assessment on day one of injury could dramatically compress the assessment timeline, enabling faster treatment decisions and potentially reducing complications from delayed interventions.
The inclusion of 49 pediatric patients in the study is particularly noteworthy, as burn assessment in children presents unique challenges due to anatomical and physiological differences. The study's comprehensive design across multiple burn centers strengthens the validity of its findings and suggests the technology could be deployed across various healthcare settings, from specialized burn units to emergency departments, expanding its potential market reach.
- DeepView® System outperforms burn physicians in identifying non-healing tissue
- Landmark Burn Validation Study, one of the largest in U.S. history, confirms DeepView’s performance
- Spectral AI plans FDA submission by mid-2025, targeting De Novo Clearance and rapid commercialization to transform burn care
DALLAS, March 17, 2025 (GLOBE NEWSWIRE) -- Spectral AI (NASDAQ: MDAI) (“Spectral AI” or the “Company”), developer of the AI-driven DeepView® System, that uses multi-spectral imaging and AI algorithms to predict burn healing potential, announced the successful results of the performance of its DeepView System in connection with the completion of its Burn Validation Study. Spectral AI’s DeepView System is being developed as a predictive device to offer clinicians an immediate and objective assessment of a burn wound’s healing potential prior to treatment or other medical intervention. The image processing algorithm employed by the DeepView System utilizes multispectral imaging that is trained and tested against a proprietary database of more than 340 billion clinically validated data points. The DeepView System is non-invasive and cart-based, allowing for exceptional mobility within the healthcare setting.
The Burn Validation Study, which began in January 2024 and concluded in March 2025, represented one of the largest burn trials ever conducted in the United States. The Company enrolled and analyzed data obtained from 164 total patients comprised of 115 adult and 49 pediatric patients in burn centers and emergency departments across the U. S. in its Burn Validation Study. The goal of the Burn Validation Study was to further demonstrate the innovative and versatile nature of Spectral AI’s DeepView technology, as well as its ability to predict burn wound healing potential on the first day of injury with greater performance and speed than the methods currently used today. The Burn Validation Study results, together with rigorous statistical analysis, illustrate that the DeepView System continues to outperform the clinical judgment of burn physicians by a large margin.
The Burn Validation Study results assessed the sensitivity, specificity and Dice score of the DeepView System at both a pixel-level and image-wise level against the clinical judgment of burn physicians. Key findings included the following:
- Sensitivity: The DeepView System demonstrated a statistically significant improvement in identifying non-healing tissue compared to burn physicians, as judged on sensitivity. At the image-wise level, the DeepView System scored
86.6% while clinical judgment annotation (CJA) of burn physicians scored40.8% . At the pixel-wise level, the DeepView System scored81.9% and CJA of burn physicians scored38.8% . - Dice Score: The DeepView System achieved statistically significant higher Dice Scores when compared to those derived from burn physicians’ CJA, representing the improved pixel-wise evaluation between predicated and true segmented wound areas with the DeepView System performing at
68.5% and burn physician’s CJA at39.2% . - Specificity: The Deepview System significantly outperformed the anticipated results for image-wise specificity in segmenting non-healing wound areas with a result of
61.2% (versus an anticipated result of36.0% ) and CJA of79.1% reflecting burn physician’s conversative assessment of burn areas.
“We believe these are excellent results and we are thrilled with the analysis of our DeepView System in our Burn Validation Study,” said Dr J. Michael DiMaio, M.D. “The DeepView System exceeded our expectations in terms of predictive performance. Following the FDA’s review, if authorized by the agency, our hope is that this tool will provide an objective and immediate prediction of non-healing burn tissue to expedite patient care and reduce system costs across the board. I would like to thank Jeffrey C. Carter, MD, FACS, the principal investigator for the Burn Validation Study, our entire team at Spectral AI, and especially the patients and esteemed clinicians who participated in this Study. We look forward to bringing this predictive diagnostic tool to the United States marketplace as soon as possible.”
Spectral AI plans to submit these results to the FDA as part of its regulatory submission by the end of the second quarter of 2025 and hopes to have the FDA grant the De Novo Classification Request of the DeepView System in early 2026. Based on its current manufacturing arrangements, Spectral AI will be prepared to commercialize the DeepView System in the United States, if ultimately approved, as soon as approval is obtained.
This project is being supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; BARDA, under contract number 75A50123C00049.
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. The Company is working to revolutionize the management of wound care by “Seeing the Unknown®” with its DeepView® System. The DeepView® System is being developed as a predictive device to offer clinicians an objective and immediate assessment of a burn 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, the DeepView® System is expected to provide fast and 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.
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FAQ
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