Welcome to our dedicated page for Spectral AI news (Ticker: MDAIW), a resource for investors and traders seeking the latest updates and insights on Spectral AI stock.
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) 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.
Spectral AI (Nasdaq: MDAI), an AI company specializing in medical diagnostics for wound care, has announced its upcoming Q3 2024 financial results release. The results will be disclosed on November 6, 2024, after market close, followed by a conference call at 5:00 pm Eastern Time. Investors can participate via phone (U.S.: 833-630-1956, International: 412-317-1837) or access the webcast through the company's investor relations website.
Spectral AI (Nasdaq: MDAI) announces the return of founder Dr. J. Michael DiMaio as Chairman of the Board of Directors. The company, focused on AI-driven medical diagnostics for wound care, aims to enhance its leadership for the next growth stage. Richard Cotton will remain on the Board as Audit Committee head and Lead Independent Director.
Dr. DiMaio, a cardiothoracic surgeon with over 30 years of experience, brings extensive medical expertise and leadership to his role. The company has formed an Office of the Chairman to manage daily operations and support the development and commercialization of the DeepView® System. This office will focus on engagement with BARDA, FDA, commercialization efforts, and strategic relationships.
In this transition, Peter Carlson will step down as CEO and Board member but continue as a consultant. Spectral AI remains committed to advancing AI-driven healthcare solutions, including opportunities through its subsidiary, Spectral IP, Inc.
Spectral AI (Nasdaq: MDAI) has completed a proof-of-concept for its wound measurement technology that calculates the total body surface area (TBSA) of burns. This technology, integrated into the DeepView® System for burn indication (DeepView AI®-Burn), provides fast, accurate, and standardized measurements to improve patient treatment decisions.
Unlike current methods, Spectral AI's technology utilizes image capture to deliver distance, area, and volume measurements with sub-millimetric accuracy, without manual markers. It generates burn size and depth calculations in seconds, aiding clinicians in treatment decisions. The company believes this technology offers a more comprehensive representation of acute burn injuries and could potentially change the standard of care in burn wound treatment.
Spectral AI (Nasdaq: MDAI) has reached 25% patient enrollment at Emergency Departments (EDs) for its U.S. Burn Pivotal Study. The company has also added two new ED Clinical Trial Sites: MedStar Washington Hospital Center and the University of Utah, expanding participating EDs to 11 facilities. This study aims to validate the AI-driven algorithm used by Spectral AI's DeepView® System for burn indication.
The company has completed adult and pediatric patient enrollment at U.S. burn centers for the study. Spectral AI plans to submit a De Novo request to the FDA in Q2 2025, seeking classification of DeepView AI®-Burn as a Class II medical device. The DeepView® System is designed to provide immediate predictions of wound healing on Day One, supporting clinical decision-making for burn treatment plans.
FAQ
What is the current stock price of Spectral AI (MDAIW)?
What is Spectral AI focused on?
What is the significance of the DeepView System?
What recent achievement did Spectral AI have?
Who is Louis Percoco?
What does TMAC aim to achieve?
