Spectral AI Achieves 25% Patient Enrollment at Emergency Departments for U.S. Burn Pivotal Study and Adds Two New Clinical Trial Sites
Spectral AI (Nasdaq: MDAI) has reached 25% patient enrollment at Emergency Departments (EDs) for its U.S. Burn Pivotal Study. The company has also added two new ED Clinical Trial Sites: MedStar Washington Hospital Center and the University of Utah, expanding participating EDs to 11 facilities. This study aims to validate the AI-driven algorithm used by Spectral AI's DeepView® System for burn indication.
The company has completed adult and pediatric patient enrollment at U.S. burn centers for the study. Spectral AI plans to submit a De Novo request to the FDA in Q2 2025, seeking classification of DeepView AI®-Burn as a Class II medical device. The DeepView® System is designed to provide immediate predictions of wound healing on Day One, supporting clinical decision-making for burn treatment plans.
Spectral AI (Nasdaq: MDAI) ha raggiunto il 25% di arruolamento dei pazienti nei Pronto Soccorso (ED) per il suo Studio Pivotal sugli U.S. Burn. L'azienda ha anche aggiunto due nuovi Siti Clinici per la sperimentazione nei Pronto Soccorso: MedStar Washington Hospital Center e University of Utah, portando a 11 il numero totale di strutture partecipanti. Questo studio mira a convalidare l'algoritmo guidato dall'IA utilizzato dal sistema DeepView® di Spectral AI per l'indicazione delle ustioni.
L'azienda ha completato l'arruolamento di pazienti adulti e pediatrici nei centri ustionati degli U.S. per lo studio. Spectral AI prevede di presentare una richiesta De Novo alla FDA nel secondo trimestre del 2025, cercando la classificazione di DeepView AI®-Burn come dispositivo medico di Classe II. Il sistema DeepView® è progettato per fornire previsioni immediate sulla guarigione delle ferite già dal primo giorno, supportando il processo decisionale clinico per i piani di trattamento delle ustioni.
Spectral AI (Nasdaq: MDAI) ha alcanzado el 25% de inscripción de pacientes en los Departamentos de Emergencias (ED) para su Estudio Pivotal de U.S. Burn. La empresa también ha añadido dos nuevos Sitios de Ensayos Clínicos en ED: MedStar Washington Hospital Center y University of Utah, expandiendo los ED participantes a 11 instalaciones. Este estudio tiene como objetivo validar el algoritmo impulsado por IA utilizado por el sistema DeepView® de Spectral AI para indicar quemaduras.
La empresa ha completado la inscripción de pacientes adultos y pediátricos en centros de quemaduras de EE. UU. para el estudio. Spectral AI planea presentar una solicitud De Novo a la FDA en el segundo trimestre de 2025, buscando la clasificación de DeepView AI®-Burn como un dispositivo médico de Clase II. El sistema DeepView® está diseñado para proporcionar predicciones inmediatas sobre la curación de heridas desde el Día Uno, apoyando la toma de decisiones clínicas para los planes de tratamiento de quemaduras.
Spectral AI (Nasdaq: MDAI)는 미국 화상 주요 연구를 위한 응급실(ED)에서 환자 등록률 25%를 달성했습니다. 회사는 MedStar Washington Hospital Center와 University of Utah라는 두 개의 새로운 응급실 임상 시험 사이트를 추가하여 참여하는 응급실을 11개 시설로 확대했습니다. 이 연구는 Spectral AI의 DeepView® 시스템의 화상 지시를 위해 사용되는 AI 기반 알고리즘을 검증하는 것을 목표로 합니다.
회사는 이 연구를 위해 미국 화상 센터에서 성인 및 소아 환자 등록을 완료했습니다. Spectral AI는 2025년 2분기에 FDA에 DeepView AI®-Burn을 II 클래스 의료기기로 분류해 달라는 De Novo 요청을 제출할 계획입니다. DeepView® 시스템은 첫날부터 상처 치유에 대한 즉각적인 예측을 제공하여 화상 치료 계획에 대한 임상 의사 결정을 지원하도록 설계되었습니다.
Spectral AI (Nasdaq: MDAI) a atteint un taux de recrutement de 25 % de patients dans les services d'urgence (ED) pour son étude pivot sur les brûlures aux États-Unis. L'entreprise a également ajouté deux nouveaux sites d'essai clinique ED : MedStar Washington Hospital Center et University of Utah, portant le nombre total d'ED participants à 11 installations. Cette étude vise à valider l'algorithme dirigé par IA utilisé par le système DeepView® de Spectral AI pour l'indication de brûlures.
L'entreprise a complété l'enregistrement de patients adultes et pédiatriques dans les centres de brûlures américains pour l'étude. Spectral AI prévoit de soumettre une demande De Novo à la FDA au deuxième trimestre 2025, demandant la classification de DeepView AI®-Burn en tant que dispositif médical de classe II. Le système DeepView® est conçu pour fournir des prédictions immédiates sur la guérison des plaies dès le premier jour, soutenant la prise de décision clinique pour les plans de traitement des brûlures.
Spectral AI (Nasdaq: MDAI) hat 25% der Patientenrekrutierung in den Notaufnahmen (ED) für seine wichtige US-Studie über Verbrennungen erreicht. Das Unternehmen hat auch zwei neue Klinische Prüfstandorte in EDs hinzugefügt: MedStar Washington Hospital Center und University of Utah, womit die teilnehmenden EDs auf insgesamt 11 Einrichtungen erweitert werden. Diese Studie zielt darauf ab, den KI-gestützten Algorithmus zu validieren, der vom DeepView®-System von Spectral AI für die Indikation von Verbrennungen verwendet wird.
Das Unternehmen hat die Rekrutierung von erwachsenen und pädiatrischen Patienten in den US-Verbrennungszentren für die Studie abgeschlossen. Spectral AI plant, im 2. Quartal 2025 einen De Novo-Antrag bei der FDA einzureichen, um die Klassifizierung von DeepView AI®-Burn als Medizinprodukt der Klasse II zu beantragen. Das DeepView®-System ist darauf ausgelegt, bereits am ersten Tag sofortige Vorhersagen zur Wundheilung zu liefern und die klinische Entscheidungsfindung für Behandlungspläne bei Verbrennungen zu unterstützen.
- Achieved 25% patient enrollment at Emergency Departments for U.S. Burn Pivotal Study
- Added two new ED Clinical Trial Sites, expanding to 11 participating facilities
- Completed adult and pediatric patient enrollment at U.S. burn centers
- Plans to submit De Novo request to FDA in Q2 2025 for DeepView AI®-Burn classification
- None.
Insights
The announcement of 25% patient enrollment at Emergency Departments for Spectral AI's U.S. Burn Pivotal Study is a significant milestone in the company's clinical development. This progress, coupled with the addition of two new ED Clinical Trial Sites, demonstrates momentum in their research efforts. The study's focus on validating the AI-driven DeepView® System for burn indication could potentially address a critical gap in burn care.
The declining access to specialized burn treatment in the U.S. highlights the potential market need for Spectral AI's technology. If successful, DeepView AI®-Burn could provide important support to ED clinicians who increasingly face the challenge of assessing burn severity without specialized expertise.
The completion of adult and pediatric enrollment at burn centers and the planned De Novo submission to the FDA in Q2 2025 are key near-term catalysts. A Class II medical device classification, if granted, would be a significant regulatory achievement, potentially accelerating the path to market.
However, investors should note that clinical trial success and regulatory approval are not guaranteed. The company's relatively small market cap of
DALLAS, Sept. 24, 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 it has achieved
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 (“DeepView AI®-Burn”).
“We are continuing to build momentum and advance towards achieving our ED enrollment goals,” said Peter M. Carlson, Chief Executive Officer of Spectral AI. “Access to specialized burn treatment in the United States has declined significantly, resulting in an increasing number of front-line ED clinicians assuming the initial responsibility of assessing the severity and healing trajectory of a burn wound. We believe that the use of DeepView AI®-Burn can deliver burn expert-level clinical support to a busy, oftentimes chaotic, ED setting.”
As previously announced, the Company has completed both adult and pediatric patient enrollment at U.S. burn centers for the U.S. Burn Pivotal Study. Using data from these burn center patients, the Company will pursue a De Novo submission to the U.S. Food and Drug Administration (“FDA”) requesting classification of DeepView AI®-Burn as a Class II medical device. The Company expects to submit this request to the FDA in the second quarter of 2025.
Spectral AI's DeepView® System for burn indication is designed to distinguish between healing and non-healing tissue by providing an immediate and binary prediction of wound healing on Day One that can support clinical decision-making regarding next step treatment plans.
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
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Investors:
The Equity Group
Devin Sullivan
Managing Director
dsullivan@equityny.com
Conor Rodriguez
Analyst
crodriguez@equityny.com
FAQ
What is the current enrollment status of Spectral AI's U.S. Burn Pivotal Study?
How many Emergency Department Clinical Trial Sites are now participating in Spectral AI's study?
When does Spectral AI (MDAI) plan to submit its De Novo request to the FDA for DeepView AI®-Burn?
What is the purpose of Spectral AI's DeepView® System for burn indication?
