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Spectral AI Inc is an AI company, focused on predictive medical diagnostics. Spectral is devoting substantially all of its efforts towards the research and development of its DeepView System, an internally developed MSI device that has designated FDA BDD status. Its DeepView System uses proprietary algorithms to distinguish between damaged and healthy human tissue invisible to the naked eye, providing Day One healing assessments in seconds. The Company's output is specifically engineered to allow the physician to make a more accurate, timely, and informed decision regarding the treatment of the patient's wound.
Latest News: DALLAS, April 30, 2024 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced that the company received the Commitment to Quality Achievement Award from the Texas Manufacturer Assistance Center (TMAC) for their UKCA Mark Attainment. “Spectral AI is honored to be recognized as an upcoming leader in the Texas Manufacturing space,” said Louis Percoco, Spectral AI’s General Manager. “Our mission is to bring innovation and solutions to wound care through the company’s DeepView™ technology with the utmost quality and a strong manufacturing backbone is vital as we continue driving towards commercialization of the product. We are proud to be part of the local business infrastructure and appreciate the support and recognition for the focus the team brought to the table by the Texas manufacturing community.” TMAC, which is associated with the Manufacturing Extension Partnership (MEP) of the National Institute of Standards and Technology (NIST) aims for Texas manufacturers to achieve profitable growth and increased competitiveness. The non-profit program supports Texas manufacturers by granting business management consulting services, new technologies implementation, operations streamlining, workforce development, and strategic planning. Their services extend beyond manufacturers and also include distribution, logistics, construction, healthcare, and government entities. This award heralds in a new era of quality excellence and leadership for Spectral AI as they move toward product commercialization.
Spectral AI (NASDAQ: MDAI), developer of the AI-driven DeepView® System for burn healing prediction, has provided detailed instructions for retail investors on exercising publicly-traded warrants (NASDAQ: MDAIW). The process requires investors to: contact their broker's corporate actions department, ensure sufficient funds for the $2.75 per warrant exercise price plus fees, submit an exercise request with warrant details, and wait for MDAI common shares to be deposited into their account. If exercising fewer warrants than owned, investors will receive a new warrant for remaining shares. The company notes that individual brokers may have additional requirements.
Spectral AI (NASDAQ: MDAI), developer of the DeepView® System for burn healing prediction, announced receiving a 'moot' letter from Nasdaq on December 20, 2024, confirming its compliance with all applicable listing standards for continued listing on the Nasdaq Capital Market. The company's DeepView® System, which received FDA Breakthrough Device Designation in 2018, uses multi-spectral imaging and algorithms to predict burn healing potential. Dr. Michael DiMaio, Chairman of the Board, expressed satisfaction with maintaining compliance and highlighted ongoing progress towards FDA submission.
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.
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