DALLAS - Spectral AI, Inc. (NASDAQ:MDAI), a company specializing in artificial intelligence for medical diagnostics, has announced its regulatory strategy to introduce its DeepView® System, designed for burn assessments, to the U.S. market. The DeepView AI®-Burn, which was granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) in 2018, utilizes multi-spectral imaging and AI algorithms to predict burn healing potential.
The company has recently completed patient enrollment for its U.S. Burn Pivotal Study, which includes both adult and pediatric patients at U.S. burn centers. Trudy Estridge, Sr. Director of Regulatory Affairs at Spectral AI, indicated that the DeepView AI®-Burn possesses unique characteristics not found in FDA-approved or cleared alternatives. Consequently, Spectral AI aims to submit a De Novo request in the second quarter of 2025 for classification of DeepView AI®-Burn as a Class II medical device, a category for low- to medium-risk devices without existing predicates.
The DeepView® System offers clinicians an immediate binary prediction of wound healing, which can guide treatment decisions. The technology has been trained and tested against a database of over 340 billion clinically validated data points, distinguishing between healing and non-healing tissue.
Peter M. Carlson, CEO of Spectral AI, expressed gratitude for the support from employees, consultants, government partners, and study participants. He emphasized the company's commitment to advancing the standard of care with their DeepView® System, which may expedite commercialization of additional applications.
The DeepView® System aims to enable expedited treatment, reduce complications, improve patient outcomes, and efficiently allocate healthcare resources. This announcement is based on a press release statement from Spectral AI.
In other recent news, Spectral AI, a Dallas-based artificial intelligence firm, has secured over $850,000 from the Medical Technology Enterprise Consortium (MTEC) for the development of its handheld predictive burn wound healing device, DeepView SnapShot M®. This latest award brings the total non-dilutive government funding for the product to over $7 million. In addition, the company's patent portfolio has grown by 30%, now totaling 26 patents, which are integral to Spectral AI's future commercialization initiatives.
Spectral AI's R&D revenue has seen a significant increase, and according to an analysis by BTIG, the company projects full-year 2024 R&D revenue to be approximately $28 million, marking a 55% year-over-year increase. The company has also expanded its clinical trial sites for the 2024 Burn Pivotal Study, adding the University of California San Diego and the University of Utah to its network.
Furthermore, Spectral AI has urged Nasdaq and state securities regulators in Florida, Louisiana, and Texas to investigate possible manipulative trading practices affecting its stock. The company's board member and largest shareholder, Erich Spangenberg, is leading this effort.
The company has also announced a collaboration with PolyNovo Limited to introduce the DeepView System in Australia, aiming to improve burn care. These are among the recent developments for Spectral AI.
InvestingPro Insights
As Spectral AI, Inc. (NASDAQ:MDAI) progresses towards the potential FDA approval of its DeepView AI®-Burn system, it's important for investors to consider the company's financial health and stock performance. According to InvestingPro data, Spectral AI has a market capitalization of $21.83 million and has generated revenue of $22.53 million in the last twelve months as of Q2 2024. Despite a modest revenue growth of 0.3% during this period, the company has faced challenges with a significant operating income margin deficit of -51.84%.
The stock performance of Spectral AI has seen a substantial decline over the past six months, with a price total return of -54.42%. This trend is consistent with the InvestingPro Tip that the stock has fared poorly over the last month and has taken a big hit over the last six months. Additionally, analysts do not anticipate the company will be profitable this year, which aligns with the negative P/E ratio of -0.98, indicating that the company is currently not profitable.
InvestingPro Tips also suggest that the company operates with a moderate level of debt and does not pay a dividend to shareholders. These insights could be crucial for investors considering the company's long-term growth potential, especially as it navigates the regulatory landscape for its medical device technology. For a deeper dive into Spectral AI's financials and stock performance, investors can access a total of 7 InvestingPro Tips available at: https://www.investing.com/pro/MDAI.
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