DALLAS - Spectral AI, Inc. (NASDAQ:MDAI), a Dallas-based artificial intelligence company specializing in medical diagnostics, announced today that it has completed the final clinical visits for its U.S. Burn Pivotal Study. This study is a significant step towards the company's planned submission for U.S. Food and Drug Administration (FDA) approval of its DeepView AI®-Burn system in the first half of 2025.
The U.S. Burn Pivotal Study, which began in January 2024, is one of the largest domestic burn center studies ever conducted, involving 160 adult and pediatric patients across 14 burn centers in the United States. The study aims to validate the AI-driven closed-loop algorithm of the DeepView AI®-Burn, a non-invasive, predictive medical device that helps clinicians distinguish between healing and non-healing tissue in burn wounds.
Patients in the study underwent non-invasive imaging with the DeepView AI®-Burn from the initial clinical assessment through to the definition of a treatment plan. A final image was required 21 days after the initial assessment. Topline results from the study are expected to be reported in December 2024.
Dr. J. Michael DiMaio, Chairman of the Board at Spectral AI, expressed gratitude to the investigators, staff, and study enrollees for their contributions to the study and emphasized the potential impact of DeepView AI®-Burn on clinical decision-making, access to burn care treatment, and clinical outcomes.
Spectral AI focuses on revolutionizing wound care management with its DeepView™ System, which aims to provide clinicians with an objective and immediate assessment of a wound's healing potential before treatment. The company is initially targeting applications for patients with burns and diabetic foot ulcers.
The completion of the U.S. Burn Pivotal Study is a critical milestone for Spectral AI as it moves closer to commercializing its technology and potentially changing the current standard of care in wound management. This news is based on a press release statement from Spectral AI.
In other recent news, Spectral AI, Inc. has made significant strides in its operations. The company has completed a proof-of-concept for a module within its DeepView System, designed to enhance burn care treatment decisions. Additionally, Spectral AI has expanded its clinical trial sites for its U.S. Burn Pivotal Study, which aims to validate the AI-driven algorithm of its DeepView System. The company plans to submit a De Novo request to the FDA in the second quarter of 2025 for classification of the device.
Spectral AI has secured over $850,000 from the Medical Technology Enterprise Consortium for the development of its handheld predictive burn wound healing device, DeepView SnapShot M®. The company's R&D revenue is projected to reach approximately $28 million for the full-year 2024, marking a 55% year-over-year increase, according to an analysis by BTIG.
The company's patent portfolio has grown by 30%, now totaling 26 patents. Finally, Spectral AI has urged Nasdaq and state securities regulators in Florida, Louisiana, and Texas to investigate possible manipulative trading practices affecting its stock. These are the recent developments for Spectral AI, Inc.
InvestingPro Insights
As Spectral AI (NASDAQ:MDAI) advances towards its FDA submission for the DeepView AI®-Burn system, investors should consider some key financial metrics and insights from InvestingPro.
The company's market capitalization stands at $26.66 million, reflecting its current valuation in the medical technology sector. Despite the promising developments in its burn study, Spectral AI is not yet profitable, with a negative P/E ratio of -2.04 over the last twelve months as of Q2 2024. This aligns with an InvestingPro Tip indicating that analysts do not anticipate the company will be profitable this year.
However, Spectral AI has shown strong recent momentum. The stock has seen a significant return of 35.85% over the last month, and a 12.5% return in just the past week. This short-term performance could be attributed to investor optimism surrounding the completion of the U.S. Burn Pivotal Study.
Revenue growth is a mixed picture, with a modest 0.3% increase over the last twelve months, but a more impressive 75.91% growth in the most recent quarter (Q2 2024). This acceleration in quarterly revenue growth could be a positive sign as the company approaches potential commercialization of its DeepView AI®-Burn system.
It's worth noting that Spectral AI operates with a moderate level of debt, which may provide some financial flexibility as it moves towards FDA submission and potential market launch. However, investors should be aware that the company's short-term obligations exceed its liquid assets, which could pose challenges in the near term.
For those interested in a deeper analysis, InvestingPro offers additional tips and metrics beyond what's discussed here. In fact, there are 7 more InvestingPro Tips available for Spectral AI, providing a more comprehensive view of the company's financial health and market position.
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