Spectral AI Completes Burn Center Enrollment for U.S. Burn Pivotal Study
Spectral AI (Nasdaq: MDAI) has completed adult and pediatric patient enrollment at U.S. burn centers for its U.S. Burn Pivotal Study, one of the largest domestic burn studies ever conducted. This milestone advances the commercialization timeline for the company's DeepView™ System for burn indication. The study aims to validate the AI-driven algorithm used by DeepView™, which assesses burn healing potential using multi-spectral imaging and a proprietary database of over 340 billion clinically validated data points.
Spectral AI plans to submit a De Novo classification request to the FDA in Q2 2025 for the use of DeepView™ in burn centers. The system has shown superior accuracy in assessing burn wounds compared to current standards. The company is continuing to enroll patients at Emergency Departments, with a subsequent 510(k) application planned for ED use following FDA approval for burn centers.
Spectral AI (Nasdaq: MDAI) ha completato l'arruolamento di pazienti adulti e pediatrici nei centri per le ustioni negli Stati Uniti per il suo Studio Pivotal U.S. Burn, uno dei più grandi studi sulle ustioni mai condotti nel paese. Questo traguardo avanza la tempistica di commercializzazione del DeepView™ System per le indicazioni relative alle ustioni. Lo studio mira a convalidare l'algoritmo basato sull'IA utilizzato da DeepView™, che valuta il potenziale di guarigione delle ustioni utilizzando immagini multispettrali e un database proprietario di oltre 340 miliardi di punti di dati clinicamente convalidati.
Spectral AI prevede di presentare una richiesta di classificazione De Novo all'FDA nel secondo trimestre del 2025 per l'uso di DeepView™ nei centri per le ustioni. Il sistema ha mostrato una precisione superiore nella valutazione delle ferite da ustione rispetto agli standard attuali. L'azienda continua ad arruolare pazienti nei Pronto Soccorso, con una successiva richiesta 510(k) prevista per l'uso nei Pronto Soccorso dopo l'approvazione dell'FDA per i centri per le ustioni.
Spectral AI (Nasdaq: MDAI) ha completado la inscripción de pacientes adultos y pediátricos en los centros de quemaduras de EE. UU. para su Estudio Pivotal de Quemaduras en EE. UU., uno de los más grandes estudios de quemaduras jamás realizados en el país. Este hito avanza el cronograma de comercialización del DeepView™ System para la indicación de quemaduras. El estudio tiene como objetivo validar el algoritmo impulsado por IA utilizado por DeepView™, que evalúa el potencial de curación de quemaduras utilizando imágenes multispectrales y una base de datos propietaria de más de 340 mil millones de puntos de datos clínicamente validados.
Spectral AI planea presentar una solicitud de clasificación De Novo a la FDA en el segundo trimestre de 2025 para el uso de DeepView™ en centros para quemaduras. El sistema ha demostrado una precisión superior en la evaluación de heridas por quemaduras en comparación con los estándares actuales. La empresa sigue inscribiendo pacientes en los Departamentos de Emergencia, con una solicitud 510(k) prevista para su uso en el DE tras la aprobación de la FDA para los centros de quemaduras.
스펙트럴 AI (Nasdaq: MDAI)는 미국의 화상 센터에서 성인 및 소아 환자의 등록을 완료하였으며, 미국 화상 주요 연구(U.S. Burn Pivotal Study)는 미국에서 수행된 가장 큰 화상 연구 중 하나입니다. 이 이정표는 화상 치료를 위한 DeepView™ System의 상용화 일정도 앞당깁니다. 이 연구는 멀티 스펙트럴 이미징과 3400억 개 이상의 임상 검증 데이터 포인트로 구성된 독점 데이터베이스를 사용하여 화상 치유 잠재력을 평가하는 DeepView™에서 사용하는 AI 기반 알고리즘의 검증을 목표로 합니다.
스펙트럴 AI는 2025년 2분기에 DeepView™를 화상 센터에서 사용하기 위한 De Novo 분류 요청을 FDA에 제출할 계획입니다. 이 시스템은 현재 표준에 비해 화상 상처를 평가하는 데 있어 더 높은 정확성을 보여주었습니다. 회사는 응급실에서 환자 등록을 계속 진행 중이며, 화상 센터에 대한 FDA 승인을 받은 후 응급실 사용을 위한 510(k) 신청이 예정되어 있습니다.
Spectral AI (Nasdaq: MDAI) a complété l'inscription de patients adultes et pédiatriques dans des centres de brûlures aux États-Unis pour son Étude Pivotal des Brûlures aux États-Unis, l'une des plus grandes études nationales sur les brûlures jamais réalisées. Cette étape fait progresser le calendrier de commercialisation du Système DeepView™ pour l'indication de brûlures. L'étude vise à valider l'algorithme piloté par l'IA utilisé par DeepView™, qui évalue le potentiel de guérison des brûlures en utilisant une imagerie multispectrale et une base de données propriétaire de plus de 340 milliards de points de données cliniquement validés.
Spectral AI prévoit de soumettre une demande de classification De Novo à la FDA au cours du deuxième trimestre 2025 pour l'utilisation de DeepView™ dans les centres de brûlure. Le système a montré une précision supérieure dans l'évaluation des blessures par brûlure par rapport aux normes actuelles. L'entreprise continue d'inscrire des patients dans les services d'urgence, avec une demande ultérieure 510(k) prévue pour un usage aux urgences après approbation de la FDA pour les centres de brûlure.
Spectral AI (Nasdaq: MDAI) hat die Rekrutierung von erwachsenen und pädiatrischen Patienten in US-Verbrennungszentren für seine US Burn Pivotal Study abgeschlossen, einer der größten inländischen Studien zu Brandverletzungen, die je durchgeführt wurden. Dieser Meilenstein fördert den Zeitplan für die Kommerzialisierung des DeepView™ Systems zur Behandlung von Brandverletzungen. Die Studie zielt darauf ab, den KI-gesteuerten Algorithmus, der von DeepView™ verwendet wird, zu validieren, welcher das Heilungspotenzial von Verbrennungen mithilfe von multispektraler Bildgebung und einer proprietären Datenbank von über 340 Milliarden klinisch validierten Datenpunkten bewertet.
Spectral AI plant, im zweiten Quartal 2025 einen De Novo-Klassifizierungsantrag bei der FDA für die Verwendung von DeepView™ in Verbrennungszentren einzureichen. Das System hat eine überlegene Genauigkeit bei der Beurteilung von Brandwunden im Vergleich zu den aktuellen Standards gezeigt. Das Unternehmen setzt die Rekrutierung von Patienten in Notaufnahmen fort, während ein anschließender 510(k)-Antrag für die Verwendung in Notaufnahmen nach der Genehmigung durch die FDA für Verbrennungszentren geplant ist.
- Completed burn center enrollment for U.S. Burn Pivotal Study ahead of schedule
- Advances commercialization timeline for DeepView™ System
- Plans to submit De Novo classification request to FDA in Q2 2025
- DeepView™ System demonstrated superior accuracy compared to current standard of care
- Enrolled 160 patients in less than eight months, potentially one of the fastest enrolling burn studies in the U.S.
- Emergency Department enrollments expected to continue into 2025, potentially delaying full commercialization
Insights
The completion of burn center enrollment for Spectral AI's U.S. Burn Pivotal Study is a significant milestone in the development of the DeepView™ System. With 160 patients enrolled in less than eight months, this study's rapid progress is noteworthy in the field of burn research. The DeepView™ System's ability to provide immediate, binary predictions of wound healing on Day One could revolutionize burn treatment decision-making.
The system's AI-driven algorithm, trained on over 340 billion clinically validated data points, suggests a robust foundation for accurate burn assessment. If the DeepView™ System demonstrates superior accuracy compared to current standards, it could lead to more precise treatment plans, potentially reducing unnecessary procedures and improving patient outcomes. However, the true impact will depend on the study's results and subsequent FDA approval.
Spectral AI's accelerated enrollment completion is a positive indicator for the company's operational efficiency and the medical community's interest in the DeepView™ System. This milestone potentially advances the product commercialization timeline, with the De Novo classification request now expected in Q2 2025. A faster-than-anticipated path to market could provide Spectral AI with a competitive advantage in the medical diagnostics sector.
Investors should note that while this progress is promising, the company still faces regulatory hurdles. The pending FDA approval for burn centers and subsequent 510(k) application for emergency departments represent critical checkpoints. If approved, the DeepView™ System could capture a significant share of the burn care market, potentially driving revenue growth. However, the financial impact remains speculative until regulatory approvals are secured and market adoption rates can be assessed.
Milestone Achievement Advances Commercialization Timeline for DeepView™ System for Burn Indication
DALLAS, Aug. 27, 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 the completion of adult and pediatric patient enrollment at U.S. burn centers 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 in burn centers and expects to submit the request in the second quarter of 2025.
“We met our burn center enrollment goal much sooner than anticipated due to the dedication of our team and the support of study participants,” said Peter M. Carlson, Chief Executive Officer of Spectral AI. “This milestone achievement will allow us to begin data analysis and advances our product commercialization timeline,” Carlson added.
Spectral AI's DeepView™ System for burn indication is a predictive medical device that assesses the healing potential of burns by combining multi-spectral 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 on Day One that can support clinical decision-making regarding next step treatment plans. The DeepView™ System has demonstrated superior accuracy in assessing burn wounds compared to the current standard of care.
“I am proud of the incredible work by our investigators, their dedicated staff and most critically study enrolees,” stated Dr. Jeffrey Carter, MD, Principal Investigator of the Pivotal Study. “We enrolled 160 patients in less than eight months, in what we believe to be one of the fastest enrolling burn studies ever completed in the U.S. The results 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.”
The Company is continuing to enroll patients at Emergency Departments (ED) as part of the U.S. Burn Pivotal Study, with such enrollments expected to continue into 2025. A subsequent 510(k) application will be submitted for the use of the DeepView™ System in EDs following the completion of the ED enrollment, associated data analysis, and the receipt of FDA approval for the use of the DeepView™ System in burn centers.
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.
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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:
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Devin Sullivan
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dsullivan@equityny.com
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Analyst
crodriguez@equityny.com
FAQ
What is the significance of Spectral AI completing burn center enrollment for its U.S. Burn Pivotal Study?
How does Spectral AI's DeepView™ System work for burn assessment?
When does Spectral AI (MDAI) expect to submit its FDA De Novo classification request for the DeepView™ System?
What are Spectral AI's plans for Emergency Department use of the DeepView™ System?
