Spectral AI completes pediatric burn study enrollment

This announcement is based on a press release statement from Spectral AI, and it contains forward-looking statements regarding the company’s plans and expectations for the DeepView® System. These statements are not guarantees of future performance and are subject to known and unknown risks and uncertainties. Analyst consensus data from InvestingPro shows high expectations for the company, with price targets ranging from $3 to $8.10 per share, though investors should note that the company is not expected to be profitable this year. Analyst consensus data from InvestingPro shows high expectations for the company, with price targets ranging from $3 to $8.10 per share, though investors should note that the company is not expected to be profitable this year.

The DeepView® System uses multi-spectral imaging combined with an AI algorithm to predict the healing potential of burns. This technology is designed to support clinicians in their decision-making by providing an immediate prediction of wound healing at the time of examination. The system has been trained and tested against a proprietary database containing over 340 billion clinically-validated data points. While the company operates with a moderate level of debt, InvestingPro subscribers can access detailed financial health scores and 7 additional exclusive ProTips to better understand the company’s potential.

Dr. J. Michael DiMaio, MD, Chairman of the Board at Spectral AI, expressed pride in the work of the investigators and the dedication of their staff and study enrollees. The data collected from the burn center patients involved in the study will be used to pursue a De Novo classification from the FDA, with the company expecting to submit the request within the first half of 2025.

Spectral AI specializes in predictive AI for medical diagnostics, focusing on wound care management, with initial applications for patients with burns and diabetic foot ulcers. The company aims to revolutionize wound care management by providing clinicians with an objective assessment of a wound’s healing potential before treatment.

The results of the U.S. Burn Pivotal Study will be instrumental for Spectral AI’s data science team and panel of burn experts to finalize years of research and bring this advancement in burn wound assessment to patients and healthcare providers in the United States.

This announcement is based on a press release statement from Spectral AI, and it contains forward-looking statements regarding the company’s plans and expectations for the DeepView® System. These statements are not guarantees of future performance and are subject to known and unknown risks and uncertainties.

In other recent news, Spectral AI, a Dallas-based artificial intelligence company, has reported several significant developments. The company has forecasted a record annual revenue exceeding $28 million, the highest in its history, attributed to increased efforts to fulfill its contract with the Biomedical Advanced Research and Development Authority. Spectral AI also anticipates a cash position of over $5 million.

Spectral AI is also facing potential delisting from the Nasdaq Stock Market due to non-compliance with the minimum market value requirement. In response, the company has requested a hearing before the Nasdaq Listing Qualifications Panel to present its compliance plan and seek an extension.

In a strategic move, Spectral AI has finalized its plan to spin off its intellectual property subsidiary, Spectral IP, into an independent publicly-traded entity. This decision is expected to enhance shareholder value and allow Spectral IP to explore opportunities beyond Spectral AI’s primary focus.

Additionally, Spectral AI has completed the final clinical visits for its U.S. Burn Pivotal Study, marking a significant step towards the planned submission for U.S. Food and Drug Administration approval of its DeepView AI®-Burn system in 2025. The company has also successfully completed a proof-of-concept for a module within its DeepView System, aimed at enhancing burn care treatment decisions.

Finally, Spectral AI secured over $850,000 from the Medical (TASE:PMCN) 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 of 2024, marking a 55% year-over-year increase, according to BTIG. These are the recent developments for Spectral AI.

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