Spectral AI Announces Publication Of Letter To Shareholders

Author: Benzinga Newsdesk | February 05, 2024 10:09am

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 publication of a Letter to Shareholders from the Company's CEO and Co-founder, Wensheng Fan, and Chairman of the Board, Richard Cotton.

 

The Letter to Shareholders addresses the Company's progress along multiple fronts as it continues to evolve from a late-stage development company towards commercialization of its AI-driven DeepView System. The Company believes that this proprietary platform technology can revolutionize the standard of care in wound assessment and treatment for burn and Diabetic Foot Ulcer ("DFU") indications.

Highlights of the Letter to Shareholder include:

• The largest contract in the Company's history, a $149 million award from BARDA that provides non-dilutive funding for ongoing product development and procurement.
• An expectation that, pending regulatory authorization in the US and UK, the Company will 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.
• FDA and UKCA marking of the Company's proprietary imaging technology, DeepView Snapshot®, as well as the recent submission of the Company's predictive software, DeepView AI®-Burn, to the UK regulatory body for UKCA marking.
• Promising interim results for the Company's DFU Clinical Study and multiple ongoing clinical trials designed to validate the DeepView System for wound healing assessments, including the initiation of a pivotal study in the US for Burn and an anticipated 1H 2025 submission to the FDA for US approval for this indication.
• Appointments that have added strength and depth to the Company's management team and Board of Directors.
  
   

The Letter to Shareholders was filed on Form 8-K with the Securities and Exchange Commission and is available free of charge at www.sec.gov. A copy of the letter is also accessible at the Investor Relations section of the Company's website at https://investors.spectral-ai.com/.

Posted In: MDAI