Spectral AI’s DeepView system shows promise in burn care

DALLAS - Spectral AI (NASDAQ: MDAI), a Dallas-based predictive AI company with a market capitalization of $30.24 million, has announced the results of its Burn Validation Study, indicating that its DeepView® System has outperformed burn physicians in identifying non-healing tissue in burns. The study, which concluded in March 2025, is one of the largest burn trials in U.S. history. The company’s stock has shown strong momentum, gaining over 15% in the past week, though InvestingPro analysis suggests the stock may be slightly overvalued at current levels.

The DeepView System employs multi-spectral imaging and AI algorithms to predict the healing potential of burn wounds. It is non-invasive and designed for mobility within healthcare settings. The system was tested against a proprietary database of over 340 billion clinically validated data points. Despite reporting strong revenue growth of 44.52% in the last twelve months, InvestingPro data shows the company faces near-term financial challenges with an EBITDA of -$8.39 million.

The Burn Validation Study began in January 2024 and analyzed data from 164 patients, both adults and children, across U.S. burn centers and emergency departments. The study aimed to demonstrate the system’s ability to predict burn wound healing potential on the first day of injury, which could surpass current clinical methods.

Results showed that the DeepView System had a sensitivity of 86.6% at the image-wise level and 81.9% at the pixel-wise level, significantly higher than the clinical judgment annotation (CJA) of burn physicians, which scored 40.8% and 38.8%, respectively. The system also achieved a higher Dice Score, which measures the accuracy of wound area prediction, scoring 68.5% compared to the physicians’ 39.2%. However, in specificity, while the DeepView System’s image-wise specificity was 61.2%, physicians’ CJA scored higher at 79.1%, reflecting a more conservative assessment of burn areas.

Dr. J. Michael DiMaio, M.D., expressed satisfaction with the system’s predictive performance and hopes it will expedite patient care and reduce healthcare costs upon FDA approval. Spectral AI plans to submit these results to the FDA by the end of the second quarter of 2025, seeking De Novo Clearance and aiming for commercialization in early 2026, pending approval. Analysts maintain an optimistic outlook, with price targets ranging from $3.00 to $8.10, significantly above current trading levels. Investors can access detailed analysis and additional insights through InvestingPro, which offers comprehensive financial metrics and expert recommendations.

The development of the DeepView System is supported by federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; BARDA, under contract number 75A50123C00049.

Spectral AI is focused on medical diagnostics for wound care, with the DeepView System being its initial application in the burn care sector. The information in this article is based on a press release statement. Investors should note that Spectral AI will report its next earnings on March 27, 2025, potentially providing crucial updates on the DeepView System’s commercialization timeline and financial outlook.

In other recent news, Spectral AI, Inc. has announced its anticipated financial results for the year ending December 31, 2024. The company expects to exceed its market guidance with annual revenue surpassing $28 million, marking a record high in its history. This growth is largely attributed to its contract with the Biomedical Advanced Research and Development Authority (BARDA), which has also improved the company’s gross profit margin. Spectral AI has also completed pediatric enrollment for its U.S. Burn Pivotal Study, aiming to validate the AI-driven algorithm of its DeepView® System. The company plans to submit a request for De Novo classification to the FDA by the first half of 2025. Additionally, Spectral AI has expanded its global reach by installing its DeepView System in three Australian hospitals as part of its international expansion strategy. This move was facilitated by a partnership with PolyNovo Limited, allowing the use of the Australian Special Access Scheme for deployment. These developments reflect Spectral AI’s ongoing efforts to enhance wound care management and its commitment to advancing medical diagnostics through predictive AI technology.

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