Spectral AI Inc. Stock Price, News & Analysis

Spectral AI (NASDAQ: MDAI) reported its Q4 and full-year 2024 financial results, highlighting significant achievements in its AI-driven wound care diagnostics business. The company's research and development revenue reached $30 million in 2024, marking a 63.5% increase from 2023, primarily driven by their BARDA PBS contract.

Key financial metrics include Q4 2024 R&D revenue of $7.6 million and a gross margin of 44.0%. The company reported a full-year net loss of $15.3 million. As of December 31, 2024, cash stood at $5.2 million, with additional Q1 2025 financing of $11.2 million through debt and equity.

Notable achievements include successful results from the US Burn Validation Study, where their DeepView System demonstrated 86.6% sensitivity in identifying non-healing tissue, significantly outperforming burn physicians' 40.8%. The company plans FDA submission in Q2 2025 and anticipates first commercial revenue in H2 2025.

Spectral AI (NASDAQ: MDAI) has secured up to $15 million in debt financing from Avenue Venture Opportunities Fund II, with an initial draw of $8.5 million. The company also raised $2.7 million in equity financing from institutional and existing investors.

The financing agreement spans three years with an interest-only payment period of 15-24 months, depending on milestone achievement. A second financing tranche, contingent on FDA clearance of the DeepView System, includes an additional $6.5 million in debt and a $7.0 million equity raise.

The deal includes warrant coverage of 8.5% with an exercise price of $1.80 per share, and a six-month market standstill period. With total cash now exceeding $14 million, Spectral AI aims to accelerate the U.S. commercialization of its AI-driven DeepView System, designed to predict burn healing potential using multi-spectral imaging and AI algorithms.

Spectral AI (NASDAQ: MDAI), developer of the AI-driven DeepView® System for burn healing prediction, announced that its subsidiary Spectral IP (to be renamed SIM IP) has filed a registration statement with the SEC for a planned IPO spinoff. The subsidiary has applied to list on the Nasdaq Capital Market under the symbol 'SMIP'.

The DeepView® System, which received FDA Breakthrough Device Designation in 2018, utilizes multi-spectral imaging and AI algorithms. Dominari Securities will serve as the lead underwriter, with Revere Securities as co-underwriter. The number of shares and price range are yet to be determined.

The registration statement (File Number: 333-285935) was filed on March 20, 2025. The offering will proceed only after SEC effectiveness and will be made available through a prospectus.

Spectral AI (NASDAQ: MDAI) has announced successful results from its Burn Validation Study of the DeepView® System, a revolutionary AI-driven device that predicts burn healing potential using multi-spectral imaging. The study, one of the largest burn trials in U.S. history, involved 164 patients (115 adult, 49 pediatric) across multiple burn centers.

The DeepView System significantly outperformed burn physicians in identifying non-healing tissue, demonstrating:

• 86.6% image-wise sensitivity vs. 40.8% for physicians
• 81.9% pixel-wise sensitivity vs. 38.8% for physicians
• 68.5% Dice Score vs. 39.2% for physicians
• 61.2% image-wise specificity vs. anticipated 36.0%

The company plans to submit these results to the FDA by Q2 2025, targeting De Novo Classification approval in early 2026, followed by immediate commercialization upon approval.

Spectral AI (NASDAQ: MDAI) has completed the installation of three DeepView System devices in Australia, marking a significant expansion of its AI-driven burn assessment technology. The installations were completed at Concord Repatriation General Hospital in Sydney, Royal Adelaide Hospital in Adelaide, and Fiona Stanley Hospital in Perth.

The DeepView System, which received FDA Breakthrough Device Designation in 2018, utilizes multispectral imaging and AI algorithms to provide immediate, objective assessments of burn wound healing potential. The system leverages a proprietary database of over 340 billion clinically validated data points and is designed as a non-invasive, cart-based solution for healthcare mobility.

The deployment was facilitated through the Australian Special Access Scheme (SAS) in partnership with PolyNovo These installations will support the company's commercial roll-out strategy and FDA submission through real-world device trials and clinician evaluations.

Spectral AI (NASDAQ: MDAI) has issued a correction to its earlier announcement regarding the scheduling of its 2024 fourth quarter and full year financial results. The company will now release its financial results on Thursday, March 27, 2025, after market close, followed by a conference call at 5:00 pm Eastern Time.

Spectral AI, known for its DeepView® System which received FDA Breakthrough Device Designation in 2018, specializes in using multi-spectral imaging and AI algorithms to predict burn healing potential. Investors can participate in the conference call by dialing 844-481-3008 (U.S.) or 412-317-1892 (International). A simultaneous webcast will be available through the Events & Presentations section of the company's Investor Relations webpage.

Spectral AI (NASDAQ: MDAI), developer of the AI-driven DeepView® System for burn healing prediction, has scheduled its fourth quarter and full year 2024 financial results announcement for March 27, 2025, after market close.

The company will host a conference call at 5:00 pm Eastern Time to discuss the results. Investors can participate by dialing 844-481-3008 (U.S.) or 412-317-1892 (International). A simultaneous webcast will be available through the Events & Presentations section of Spectral AI's Investor Relations website.

The DeepView® System, which received FDA Breakthrough Device Designation in 2018, utilizes multi-spectral imaging and AI algorithms to predict burn healing potential.

Spectral AI (NASDAQ: MDAI) has announced the completion of its debt obligations with Yorkville Advisors, strengthening its financial position. The company, which develops the AI-powered DeepView® System for burn healing prediction, maintains access to up to $17.5 million in additional financing through an existing standby equity purchase agreement.

The DeepView® System, which received FDA Breakthrough Device Designation in 2018, utilizes multi-spectral imaging and AI algorithms to predict burn healing potential. The company is progressing toward its FDA submission with the aim of implementing its technology in burn care institutions across the United States.

Spectral AI (NASDAQ: MDAI) has completed data analysis for its U.S. Burn Pivotal Study, one of the largest domestic burn studies ever conducted. The study validates the AI-driven algorithm used in the company's DeepView® System, which received FDA Breakthrough Device Designation in 2018.

The DeepView® System combines multispectral imaging with AI algorithms to predict burn wound healing potential, leveraging over 340 billion clinically-validated data points. The system provides immediate, binary predictions of wound healing on the day of injury, aiding clinical decision-making for treatment.

The company reports strong metrics when comparing the DeepView® System's performance to burn and emergency room physicians in determining wound healing potential. Spectral AI plans to submit a De Novo classification request to the FDA by June 2025 for the system's use in burn care.