Welcome to our dedicated page for Spectral AI news (Ticker: MDAI), a resource for investors and traders seeking the latest updates and insights on Spectral AI stock.
Spectral AI, Inc. (Nasdaq: MDAI) is an artificial intelligence company dedicated to advancing medical diagnostics, particularly in wound care. The company's flagship product, the DeepView™ System, is a cutting-edge multispectral imaging (MSI) device designed to assist physicians in making accurate and timely treatment decisions. This innovative technology leverages proprietary algorithms to differentiate between damaged and healthy tissue, producing critical Day One healing assessments within seconds.
Spectral AI's DeepView System has received FDA Breakthrough Device Designation due to its potential to significantly improve patient outcomes. The primary focus of the company lies in the research and development of this system. Notably, a substantial portion of its funding comes from the Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services.
In recent developments, Spectral AI was honored with the Commitment to Quality Achievement Award by the Texas Manufacturer Assistance Center (TMAC) for their attainment of the UKCA Mark. This accolade underscores the company’s dedication to maintaining the highest standards of quality while working towards the commercialization of DeepView technology.
The company frequently updates its stakeholders through conference calls and presentations, which can be accessed via the investor relations section of its website. This proactive communication strategy ensures transparency and keeps investors well-informed about the company's progress and financial health.
Investor Relations Contacts:
Devin Sullivan, Managing Director at The Equity Group, can be reached at dsullivan@equityny.com.
Conor Rodriguez, Analyst at The Equity Group, can be contacted at crodriguez@equityny.com.
Media Contacts:
David Schull of Russo Partners can be reached at david.schull@russopartnersllc.com or (858) 717-2310.
Spectral AI (NASDAQ: MDAI) announced it believes it has regained compliance with Nasdaq Listing Rule 5550(b)(2) by maintaining a market value of listed securities above $35 million for 10 consecutive business days. The company, which develops the DeepView® System (an AI-driven technology with FDA Breakthrough Device Designation for burn healing prediction), has notified Nasdaq and awaits official confirmation of compliance.
Spectral AI (NASDAQ: MDAI) announced significant progress in the development of its DeepView® System, an AI-driven wound diagnostics platform. National burn care leaders have contributed over 511 in-person physician days for training and validation studies, plus 250 additional days in proof-of-concept studies. The collaboration includes three former/current presidents and ten board members of the American Burn Association, along with two editors-in-chief of leading burn journals.
The DeepView® System, which received FDA Breakthrough Device Designation in 2018 and UKCA mark for burn indications, combines advanced algorithms with medical imaging to predict wound healing potential. This unprecedented level of expert participation enhances the dataset's credibility and reliability, positioning DeepView® as a potential future standard in burn care diagnostics.
Spectral AI (NASDAQ: MDAI) has completed software enhancements for its DeepView SnapShot® M and DeepView AI-Burn® system in the UK. The updates, based on real-world clinician feedback, aim to improve diagnostic accuracy, workflow integration, and patient care.
The regulatory milestone allows implementation of updated software on currently deployed systems in the UK, where the devices are authorized as separate products. The enhancement also benefits Australian burn centers operating under the Approved Prescriber Program, ensuring access to Spectral AI's advanced diagnostic technology.
According to Board Chairman Dr. J. Michael DiMaio, UK authorization and technical documentation support device usage in both UK hospitals and Australian TGA approval processes. The company reports encouraging feedback from UK implementations.
Spectral AI (NASDAQ: MDAI) has completed the truthing process for all burn center images across the US, a important step in training its DeepView® System for wound healing prediction. The company is now expanding to emergency department image review. The truthing process involves gathering 'ground truth' data through early treatment images, biopsies, 21-day assessments, and expert evaluations. The company has assembled over 3,000 biopsied images in its tissue dataset. Having completed enrollment and image collection for the BARDA burn study, Spectral AI expects data results in late December to support an FDA De Novo submission in H1 2025, aiming for Class II medical device classification for the DeepView AI®-Burn system.
Spectral AI (NASDAQ: MDAI) announced the repricing of its 8,433,333 publicly-traded common share purchase warrants from $11.50 to $2.75 per share. The warrants, trading under symbol MDAIW, will be repriced following a twenty-day notice period to warrant holders. If all warrants are exercised for cash, the company could receive up to $23 million in net proceeds. The repricing applies uniformly to all outstanding warrants and was executed under the Company's discretion as permitted by the Warrant Agreement.
Spectral AI (NASDAQ: MDAI) announced progress on its DeepView SnapShot® M device following feedback from Brooke Army Medical Center and the U.S. Army Medical Research Institute. The device, supported by over $7.2 million in non-dilutive government funding since 2018, uses AI-powered multispectral imaging for rapid wound assessment in military settings. The technology received FDA Breakthrough Device Designation in 2018 and is trained on 340 billion clinically validated data points. The global mobile medical imaging market, valued at $14.78 billion in 2023, is projected to reach $18.4 billion by 2030.
Spectral AI has secured up to $5 million in equity financing through an at-the-market transaction, to be completed in two tranches. The funds will partially be used to retire outstanding obligations with Yorkville Advisors. This financing supports the company's progress toward FDA submission for its DeepView AI®-Burn system, targeted for first half of 2025. The transaction, involving equity and pre-funded warrants with institutional investors, strengthens the company's balance sheet and operational flexibility. The company continues to receive non-dilutive U.S. Government funding to advance its AI-driven diagnostic solutions in wound care.
Spectral AI (Nasdaq: MDAI) announced its Q3 2024 financial results, highlighting a 138% increase in research and development revenue to $8.2 million, driven by Project BioShield and other U.S. Government contracts. The company's gross margin improved to 44.9%, while general and administrative expenses declined to $4.6 million. Operating loss narrowed to $0.9 million, and net loss decreased to $1.5 million, or $0.08 per share. Spectral AI completed the last patient visit in its U.S. Burn Pivotal Study, with top-line results expected in Q4 2024, and remains on track for a Q2 2025 FDA submission for its DeepView AI®-Burn system. The company announced plans to spin off its Spectral IP subsidiary. As of September 30, 2024, Spectral AI had $3.7 million in cash and short-term notes payable of $5.0 million. The company reiterated its FY 2024 revenue guidance of approximately $28.0 million.
Spectral AI (NASDAQ: MDAI) announced plans to spin off its subsidiary Spectral IP through a transaction with Sauvegarder Investment Management. The spinoff aims to maximize shareholder value by creating a separate entity focused on IP monetization, while Spectral AI retains its core medical diagnostics business. All 26 patents and 38 patent applications will remain with Spectral AI.
The transaction, expected to complete within 90 days, will distribute Spectral IP stock to Spectral AI shareholders. Post-spinoff, Spectral IP will be renamed SIM IP Inc., focusing on IP-based financing and monetization across healthcare, semiconductors, AI, and IoT sectors. The subsidiary will be led by Erich Spangenberg as CEO and headquartered in Miami, Florida.
Spectral AI (Nasdaq: MDAI) announced the completion of patient visits in its U.S. Burn Pivotal Study, marking a significant milestone toward FDA submission of DeepView AI®-Burn in first half of 2025. The study, one of the largest domestic burn center studies ever conducted, will provide topline results in December 2024. DeepView AI®-Burn is a non-invasive device designed to assess burn wound healing potential by distinguishing between healing and non-healing tissue, providing immediate binary assessment to support clinical decision-making.
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