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Appointment Paves the Way for Company’s Next Chapter in Commercialization Phase of AI-Powered DeepView Device for Predictive Wound Care
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Carlson Brings Proven Track Record of Operating and Financial Leadership, Including with Premier Wound Care Management Companies
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Wensheng Fan Transitions to Chief Innovation Strategist and Senior Advisor to the CEO
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Company Announces Preliminary 2023 R&D Revenue; Reaffirms Full Year Revenue Guidance for 2024 and Highlights First Quarter Momentum
Spectral AI, an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, announced that its Board of Directors (the “Board”) has appointed Peter M. Carlson, Spectral AI’s current Chief Financial Officer, as Chief Executive Officer and a member of the Board. He succeeds Wensheng Fan, who, after 14 years with Spectral AI, including nearly four as CEO, is transitioning to Chief Innovation Strategist and Senior Advisor to the CEO. Vincent S. Capone, Spectral AI’s General Counsel and Corporate Secretary, will assume the additional role of Chief Financial Officer.
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Mr. Carlson is an accomplished executive with a strong record of driving growth, along with operating and financial excellence, at times of transformation for numerous publicly traded companies, including at two Fortune 50 companies and at MiMedx Group, Inc., an innovation leader in advanced wound care. He joined Spectral AI as CFO in January 2024 following the Company’s debut on the NASDAQ Global Market.
“In his short time here, Pete has already distinguished himself as a skilled and experienced leader and a tremendous asset to Spectral AI. We are confident he is the right person to guide Spectral AI as we evolve from a late-stage development company and commercialize our revolutionary, AI-driven wound care technology,” said Richard Cotton, Chairman of the Board of Directors. “We are also delighted to appoint Vince to his expanded role, which leverages his extensive experience with life science and technology companies across legal, financial and accounting disciplines.”
Mr. Carlson said, “I am excited to become CEO at this pivotal time of opportunity and value creation for Spectral AI. Spectral AI’s breakthrough diagnostic technology and talented team provide an outstanding platform for growth as we redefine the standard of care for burns and diabetic foot ulcers. We believe these indications are just the start of what can be addressed with Spectral AI’s predictive clinical insight technology. I look forward to building on the team’s impressive work to date and lending my experience to ensure we establish the operating and financial foundation that is necessary to deliver on Spectral AI’s full potential.”
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Mr. Cotton continued, “On behalf of the entire Board, I want to thank Wensheng for his service to Spectral AI and his dedication to the Company since its founding in 2009. His contributions have enabled Spectral AI’s next stage of growth and success.”
Mr. Fan said, “It has been a privilege to lead Spectral AI since 2020 and work alongside among the brightest minds in the industry over the past 14 years. Together, we have created an industry leading innovator. I am proud of all we have accomplished and firmly believe that Spectral AI’s momentum is just beginning. Pete is the right person to serve as CEO as we progress from R&D to commercialization, and I look forward to supporting Pete as an advisor while I continue my focus on Spectral AI’s innovation.”
The Company also announced preliminary research and development revenue of approximately $18 million for the year ended December 31, 2023. In addition, the Company reaffirmed preliminary revenue guidance of approximately $28 million for full year 2024.
Spectral AI’s preliminary revenue guidance reflects first quarter momentum, including:
- Obtaining the final stage of UK Conformity Assessed (UKCA) authorization for its predictive software DeepView AI®-Burn.
- Enrollment of the first patient in the pivotal study to validate DeepView AI for burn size and healing assessment, seeking FDA marketing authorization for burn indication in late 2025;
- Development activity under the recent $149 million award from BARDA that provides non-dilutive funding for ongoing product development and procurement; and
- UKCA Mark and FDA Class 1 medical device classification of the Company’s proprietary imaging technology, DeepView Snapshot®.
Recent company milestones are expected to generate revenue across four separate platforms covering burn and DFU within the next three years, with the potential for initial commercial revenue as soon as the second half of 2024.
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