Spectral AI Announces Confirmation of Compliance of its Nasdaq Listing Requirements
Spectral AI (NASDAQ: MDAI), developer of the DeepView® System for burn healing prediction, announced receiving a 'moot' letter from Nasdaq on December 20, 2024, confirming its compliance with all applicable listing standards for continued listing on the Nasdaq Capital Market. The company's DeepView® System, which received FDA Breakthrough Device Designation in 2018, uses multi-spectral imaging and algorithms to predict burn healing potential. Dr. Michael DiMaio, Chairman of the Board, expressed satisfaction with maintaining compliance and highlighted ongoing progress towards FDA submission.
Spectral AI (NASDAQ: MDAI), sviluppatore del Sistema DeepView® per la previsione della guarigione delle ustioni, ha annunciato di aver ricevuto una lettera di 'moot' da Nasdaq il 20 dicembre 2024, confermando la sua conformità a tutti gli standard di quotazione applicabili per il mantenimento della quotazione sul Nasdaq Capital Market. Il sistema DeepView® dell'azienda, che ha ricevuto nel 2018 la Designazione di Dispositivo Innovativo dalla FDA, utilizza imaging multi-spettrale e algoritmi per prevedere il potenziale di guarigione delle ustioni. Il Dr. Michael DiMaio, Presidente del Consiglio, ha espresso soddisfazione per il mantenimento della conformità e ha evidenziato i progressi in corso verso la presentazione alla FDA.
Spectral AI (NASDAQ: MDAI), desarrollador del Sistema DeepView® para la predicción de la curación de quemaduras, anunció que recibió una carta de 'moot' de Nasdaq el 20 de diciembre de 2024, confirmando su cumplimiento con todos los estándares de listado aplicables para su continua inclusión en el Nasdaq Capital Market. El Sistema DeepView® de la compañía, que recibió la Designación de Dispositivo Innovador de la FDA en 2018, utiliza imágenes multispectrales y algoritmos para predecir el potencial de curación de las quemaduras. El Dr. Michael DiMaio, Presidente de la Junta, expresó su satisfacción por mantener la conformidad y destacó el progreso continuo hacia la presentación a la FDA.
스펙트럴 AI (NASDAQ: MDAI)는 화상 치유 예측을 위한 DeepView® 시스템 개발자로서, 2024년 12월 20일에 나스닥으로부터 '무의미한' 서신을 받았다고 발표했습니다. 이는 나스닥 자본 시장에서 지속적인 상장을 위한 모든 적용 가능한 상장 기준을 준수하고 있음을 확인했습니다. 이 회사의 DeepView® 시스템은 2018년에 FDA 혁신 기기 지정을 받은 시스템으로, 다중 스펙트럼 이미징 및 알고리즘을 사용하여 화상 치유 잠재력을 예측합니다. 의장인 마이클 디마이오 박사는 준수 상태를 유지한 것에 대한 만족감을 표현하며, FDA 제출을 위한 지속적인 진행 상황을 강조했습니다.
Spectral AI (NASDAQ: MDAI), développeur du système DeepView® pour la prévision de la guérison des brûlures, a annoncé avoir reçu le 20 décembre 2024 une lettre de 'moot' de Nasdaq, confirmant sa conformité à tous les standards de cotation applicables pour un maintien continu de sa cotation sur le Nasdaq Capital Market. Le système DeepView® de la société, qui a reçu la désignation de dispositif phare de la FDA en 2018, utilise imagerie multispectrale et algorithmes pour prédire le potentiel de guérison des brûlures. Dr. Michael DiMaio, Président du Conseil, a exprimé sa satisfaction quant au maintien de la conformité et a souligné les avancées en cours vers la soumission à la FDA.
Spectral AI (NASDAQ: MDAI), Entwickler des DeepView®-Systems zur Vorhersage der Heilung von Brandverletzungen, gab bekannt, am 20. Dezember 2024 ein 'moot'-Schreiben von Nasdaq erhalten zu haben, das die Einhaltung aller geltenden Listungsstandards für die fortgesetzte Listung am Nasdaq Capital Market bestätigt. Das DeepView®-System des Unternehmens, das 2018 die FDA-Zulassung als Durchbruchgerät erhielt, nutzt mehrspektrale Bildgebung und Algorithmen, um das Heilungspotenzial von Brandverletzungen vorherzusagen. Dr. Michael DiMaio, Vorsitzender des Vorstands, äußerte seine Zufriedenheit über die Einhaltung und hob die fortschreitenden Fortschritte zur Einreichung bei der FDA hervor.
- Confirmed compliance with Nasdaq listing requirements
- Avoided potential delisting risk
- Previously received FDA Breakthrough Device Designation for DeepView® System
- None.
Insights
The confirmation of Nasdaq compliance is a stabilizing factor for Spectral AI, removing a significant regulatory overhang that could have resulted in delisting. For a micro-cap company with a market value of just
The more significant aspect to monitor is their progress toward FDA submission for the DeepView® System. As a Breakthrough Device Designation holder since 2018, successful FDA approval could dramatically expand their market opportunity in burn diagnosis. Yet, the timeline and probability of regulatory success remain uncertain, making this a speculative investment case heavily dependent on clinical and regulatory outcomes.
The DeepView® System represents an innovative application of AI in burn assessment, traditionally a subjective process requiring significant clinical expertise. The technology's ability to leverage multi-spectral imaging with algorithmic analysis could potentially standardize and improve accuracy in predicting burn healing trajectories. For context, burn assessment accuracy directly impacts treatment decisions, length of hospital stays and overall patient outcomes.
The Breakthrough Device Designation from the FDA, while promising, is now over 5 years old. The extended timeline between designation and submission suggests potential technical or clinical validation challenges. The company's micro-cap status also raises questions about their resource capacity to complete the extensive validation studies typically required for novel AI-driven medical devices.
DALLAS, Dec. 23, 2024 (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, is pleased to announce that on December 20, 2024 the Company received a “moot” letter from Nasdaq confirming that the Company has regained compliance with all applicable listing standards for its continued listing on the Nasdaq Capital Market and that a further hearing regarding the Company’s compliance is no longer necessary.
“I am thrilled to announce that we continue to successfully meet our Nasdaq’s compliance standards,” said Dr. Michael DiMaio, Chairman of Spectral AI’s Board of Directors. “This confirmation reflects our team’s hard work and commitment. We are equally excited about the progress we are making towards our submission to the FDA, as we continue to innovate and strive for excellence in serving our stakeholders and the medical community.”
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 intention to separate its Spectral IP subsidiary from the Company, and each Company’s strategy, plans, objectives, initiatives, strategic goals, financial outlook or other non-historical matters. 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. Spectral AI undertakes no obligation to update any forward-looking statements except as otherwise required by law.
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