DALLAS - Spectral AI, Inc. (NASDAQ:MDAI), a Dallas-based company specializing in artificial intelligence (AI) for medical diagnostics, announced significant progress in its transition from development to commercialization. The company's CEO and Co-founder, Wensheng Fan, and Chairman of the Board, Richard Cotton, highlighted in a Letter to Shareholders the recent achievements and future expectations for its DeepView System, aimed at improving wound care assessment and treatment.
The letter revealed the acquisition of the largest contract in the company's history, a $149 million award from the Biomedical Advanced Research and Development Authority (BARDA), which will provide non-dilutive funding for ongoing product development and procurement. With regulatory approvals in the US and UK anticipated, Spectral AI expects to generate revenue across four platforms for burn and Diabetic Foot Ulcer (DFU) indications within the next three years, potentially starting in the second half of 2024.
Spectral AI has already achieved FDA and UKCA marking for its DeepView Snapshot® imaging technology and recently submitted its predictive software, DeepView AI®-Burn, for UKCA marking. Interim results from the company's DFU Clinical Study have been promising, and several clinical trials are underway to validate the DeepView System for wound healing assessments. A pivotal study in the US for burn treatment is in progress, with a submission to the FDA for approval expected in the first half of 2025.
The company also noted enhancements to its management team and Board of Directors, positioning it for its next phase of growth.
The information in this article is based on a press release.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.