By John Vandermosten, CFA
READ THE FULL MDAI RESEARCH REPORT
Spectral AI, Inc. (NASDAQ:MDAI) announced a big change in its leadership ranks on October 14th. Founder Dr. J. Michael DiMaio returns as chairman of the Board of Directors and will guide the newly created Office of the Chairman (OC) to assume day to day operational responsibilities for running the company. The OC will include CFO and General Counsel Vincent Capone, Chief Commercialization Officer Jeremiah Sparks, Interim Chief Operating Officer Stan Micek and General Manager Louis Percoco. The team will report directly to the board. CEO Pete Carlson will relinquish his role and serve as a consultant over the next 15 months.
Dr. DiMaio has set the priorities of becoming more focused on finances, the regulatory pathway forward in burn and interacting with BARDA. On the finances front, while BARDA is supporting the majority of the research and development, Spectral wants to augment this funding with private capital to help with development and support the commercialization into some of the areas that do not receive direct BARDA funding. Spectral is orienting its efforts around the planned FDA submission for the DeepView AI-Burn in 2Q:25. Spectral will pursue a De Novo submission and request classification as a Class II medical device.
We see the change as streamlining the company’s efforts towards the advancement of DeepView burn diagnostic towards FDA approval and developing relationships to support financing in pursuit of this objective. The focus on the burn diagnostic includes efforts and sales in the UK which provide real-world experience using the device that can help in the eventual marketing of the product after approval. Additionally, the SnapShot M product, which recently received additional funding from the Medical Technology Enterprise Consortium (MTEC) will help extend this burn diagnosis to mobile settings, first on the battlefield and later in other areas such as ambulances.
Near term will center upon continued enrollment in the emergency department trial and preparation of the De Novo application for DeepView by 2Q:25. Assuming normal review times, the FDA could grant approval by 1H:26.
Spectral AI Video Series
Select management and front-line research and development team members provided details on Spectral’s relationship with BARDA, the difference between hyperspectral imaging and multispectral imaging, and details on the development of the company’s device.
See selected interviews with Spectral AI’s team below:
➢ CFO Vince Capone Elaborates on BARDA Partnership
➢ Director of Data Science, Jihang Wang Shares DeepView’s Features
➢ Director of Data Science, Jihang Wang Compares Hyperspectral and Multispectral Imaging
➢ Director of Data Science, Jihang Wang, Explains the DeepView Device
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