ADVFN_chriscain
3 weeks ago
The global market potential for Spectral AI’s Deep View system and MSI technology is vast, spanning multiple high-growth sectors including medical diagnostics, digital health, wound care, military applications, and cosmetics. Assuming clinical validation, this technology could achieve wide-scale adoption within a decade, driven by its versatility, accuracy, non-invasiveness, and ability to integrate with AI for personalized treatment plans. With the development of lower-cost, handheld devices, the market reach could expand dramatically, bringing MSI technology to a global audience across both clinical and consumer sectors.
tw0122
7 months ago
Spectral AI Announces New US Government Contract to Further Accelerate the Development of the Handheld Version of DeepView™ Wound Imaging System
Source: GlobeNewswire Inc.
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 a new contract with the Defense Health Agency (DHA) and the US Army Medical Material Development Activity (USAMMDA) that provides significant additional support for the development of the handheld version of DeepView™ Wound Imaging System called DeepView SnapShot® M.
This newly secured contract is valued at over $500,000 and will build on the previous awards from other U.S. Government Agencies focused on advancing the handheld, DeepView Snapshot® M, that bring this total for just the DeepView SnapShot® M to greater than $6 million. The ultimate goal of the contract and this targeted non-dilutive funding is to optimize the functionality and size of the device and to ensure its combat readiness. These optimizations will, in turn, increase the device’s potential for a portable, handheld version for home health care and related invaluable assistance to medical professionals in many settings.
“Spectral AI is proud to partner with DHA and the USAMMDA on this crucial initiative. This award further validates Spectral AI’s technology and the importance of a battlefield burn solution we are focusing on,” stated Pete Carlson, CEO of Spectral AI. “We firmly believe that this collaboration will make a profound impact, as the miniaturization of medical devices is essential for introducing innovative medical care to a wider range of clinical settings and patients. This development reaffirms Spectral AI's dedication to shaping the future of accessible medical care and solidifies its position as a trailblazer in AI-driven healthcare innovation.”
The Company has previously announced other significant non-dilutive financial support from the US Government that with this award announced today, now totals over $250 million, including $150 million awarded in the last six months.
About Spectral AI
Spectral AI, Inc. is a Dallas-based predictive AI company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, with initial applications involving patients with burns and diabetic foot ulcers. The Company is working to revolutionize the management of wound care by “Seeing the Unknown®â€ť with its DeepView® System. DeepView® is a predictive diagnostic device that offers clinicians an objective and immediate assessment of a wound’s healing potential prior to treatment or other medical intervention. With algorithm-driven results and a goal of substantially exceeding the current standard of care in the future, DeepView® is expected to provide faster and more accurate treatment insight towards value care by improving patient outcomes and reducing healthcare costs. For more information about DeepView®, visit www.spectral-ai.com.
jedijazz
8 months ago
$MDAI News: Spectral AI Appoints Dr. J. Michael DiMaio to Board of Directors
Spectral AI, Inc.
Mon, Feb 12, 2024, 8:00 AM EST
In This Article:
MDAI
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MDAIW
Spectral AI, Inc.
The Company’s two largest stockholders holding approximately 45% of the Company’s outstanding shares have extended their lock-up agreements for an additional 180 days
DALLAS, Feb. 12, 2024 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on the unmet need for improved medical diagnostics to allow faster and more accurate treatment decisions in wound care, today announces the appointment of Dr. J. Michael DiMaio to its Board of Directors, effective February 7, 2024. Dr. DiMaio joins the Board as a non-executive member to fill the vacancy left by the departure of Mr. Michael Murphy.
Dr. Michael DiMaio is one of the Company’s founders and previously served as the Company’s Chief Executive Officer and Chairman of the Board of Directors from 2011 to 2020. In 2020, he exited his positions with the Company and amicably resolved a dispute that had arisen at that time. He is the Chief of Staff and a practicing board-certified general, cardiac and thoracic surgeon at Baylor Scott & White-The Heart Hospitals, one of the busiest cardiovascular programs in the United States. Currently the hospitals that he oversees are rated with the highest quality scores by the Society of Thoracic Surgeons, Society of Vascular Surgery, and the American College of Cardiology. He supervises more than 650 physicians across six facilities that perform approximately 25,000 cardiovascular procedures annually.
Dr. DiMaio earned his medical degree from the University of Miami and completed his internal medicine, general surgery, and cardiothoracic surgery residencies at Duke University Medical Center and performed research under an NIH-sponsored grant. He has been elected or served as a member on many distinguished medical organizations including the American Surgical Association, Society of Thoracic Surgeons, American College of Surgeons, American Association of Thoracic Surgery, American Heart Association, American Burn Association, International Society of Heart and Lung Transplantation, American Society of Transplant Surgeons, and the Southern Thoracic Surgical Association.
He has authored nearly 500 peer-reviewed publications and abstracts, and directs a research group that has produced over 1000 publications in medical journals that include JAMA, New England Journal of Medicine, Lancet, Science, and Circulation. Dr. Michael DiMaio has served as an editorial board member or reviewer for some the most prestigious medical journals in the world and has served as a grant reviewer for the National Institutes of Health (NIH), the American Heart Association, and the U.S. Department of Defense in an addition to serving on international medical guideline committees.
In clinical trials, he has been the principal investigator for numerous medical drugs and devices that have received FDA approval and commercialization. He has been awarded over $150 million funding from the NIH, the American Heart Association, the National Science Foundation, the U.S. Department of Defense, the Department of Health and Human Services, and the Biomedical Advanced Research Development Authority (BARDA). Currently, he oversees more than 120 clinical trials at the Baylor Scott & White Research Institute and serves as Chairman of the Cardiovascular Research Review Committee for the health care system.
"I am pleased to welcome back Dr. Michael DiMaio to Spectral AI’s Board of Directors," said Richard Cotton, Chairman of the Board of Directors. "Dr. DiMaio’s deep knowledge and application of innovative medical device technologies, decades of direct patient care, and experiences within some of the United States’ preeminent medical systems and current leadership make him uniquely qualified to support the planned commercialization and ongoing development of our DeepView™ System.”
"I have spent a great deal of my career developing technologies that improve patient outcomes while delivering tangible value across the healthcare spectrum and founded this company with the intent to fill the unmet clinical need for a decision-assist device to improve wound care management,” said Dr. DiMaio. “I believe that the Company’s AI-driven wound imaging and assessment technology platform is poised to deliver on those objectives, and I am very pleased to be in a position to help advance this exciting technology towards commercialization of current and future indication developments.”
The Company also announced that Dr. DiMaio and Erich Spangenberg, who together hold approximately 45% of the Company’s outstanding shares, have each agreed to an additional six-month extension of the current lock-up of their outstanding shares pursuant to the Registration Rights/Lock-Up Agreement entered into by each of them in connection with the Company’s business combination transaction in September 2023.
About Spectral AI
Spectral AI, Inc. is a Dallas-based predictive AI company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, with initial applications involving patients with burns and diabetic foot ulcers. The Company is working to revolutionize the management of wound care by “Seeing the Unknown®â€ť with its DeepView® System. DeepView® is a predictive diagnostic device that offers clinicians an objective and immediate assessment of a wound’s healing potential prior to treatment or other medical intervention. With algorithm-driven results and a goal of substantially exceeding the current standard of care in the future, DeepView® is expected to provide faster and more accurate treatment insight towards value care by improving patient outcomes and reducing healthcare costs. For more information about DeepView®, visit www.spectral-ai.com.
Forward Looking Statements
Certain statements made in this release are “forward looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s strategy, plans, objectives, initiatives and financial outlook. When used in this press release, the words “estimates,” “projected,” “expects,” “anticipates,” “forecasts,” “plans,” “intends,” “believes,” “seeks,” “may,” “will,” “should,” “future,” “propose” and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements.
These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside Company’s control, that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. As such, readers are cautioned not to place undue reliance on any forward-looking statements.
Investors should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” sections of the Company’s filings with the SEC, including the Registration Statement and the other documents filed by the Company. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements.
Contacts
Investors
Equity Group
Devin Sullivan
Conor Rodriguez
Managing Director
Analyst
dsullivan@equityny.com
crodriguez@equityny.com
Media
Russo Partners
David Schull
(858) 717-2310
david.schull@russopartnersllc.com
jedijazz
8 months ago
$MDAI Spectral AI Announces Publication of Letter to Shareholders
DALLAS, Feb. 05, 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 the publication of a Letter to Shareholders from the Company's CEO and Co-founder, Wensheng Fan, and Chairman of the Board, Richard Cotton.
The Letter to Shareholders addresses the Company's progress along multiple fronts as it continues to evolve from a late-stage development company towards commercialization of its AI-driven DeepView System. The Company believes that this proprietary platform technology can revolutionize the standard of care in wound assessment and treatment for burn and Diabetic Foot Ulcer ("DFU") indications.
Highlights of the Letter to Shareholder include:
-- The largest contract in the Company's history, a $149 million award from
BARDA that provides non-dilutive funding for ongoing product development
and procurement.
-- An expectation that, pending regulatory authorization in the US and UK,
the Company will generate revenue across four separate platforms covering
burn and DFU within the next three years, with the potential for initial
commercial revenue as soon as the second half of 2024.
-- FDA and UKCA marking of the Company's proprietary imaging technology,
DeepView Snapshot(R), as well as the recent submission of the Company's
predictive software, DeepView AI(R)-Burn, to the UK regulatory body for
UKCA marking.
-- Promising interim results for the Company's DFU Clinical Study and
multiple ongoing clinical trials designed to validate the DeepView System
for wound healing assessments, including the initiation of a pivotal
study in the US for Burn and an anticipated 1H 2025 submission to the FDA
for US approval for this indication.
-- Appointments that have added strength and depth to the Company's
management team and Board of Directors.
The Letter to Shareholders was filed on Form 8-K with the Securities and Exchange Commission and is available free of charge at www.sec.gov. A copy of the letter is also accessible at the Investor Relations section of the Company's website at https://investors.spectral-ai.com/.
About Spectral AI
Spectral AI, Inc. is a Dallas-based predictive AI company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, with initial applications involving patients with burns and diabetic foot ulcers. The Company is working to revolutionize the management of wound care by "Seeing the Unknown(R) " with its DeepView(R) System. DeepView(R) is a predictive diagnostic device that offers clinicians an objective and immediate assessment of a wound's healing potential prior to treatment or other medical intervention. With algorithm-driven results and a goal of substantially exceeding the current standard of care in the future, DeepView(R) is expected to provide faster and more accurate treatment insight towards value care by improving patient outcomes and reducing healthcare costs. For more information about DeepView(R) , visit www.spectral-ai.com.
Forward Looking Statements
Certain statements made in this release are "forward looking statements" within the meaning of the "safe harbor" provisions of the United States Private Securities Litigation Reform Act of 1995, including statements regarding the Company's strategy, plans, objectives, initiatives and financial outlook. When used in this press release, the words "estimates, " "projected," "expects," "anticipates," "forecasts," "plans," "intends, " "believes," "seeks," "may," "will," "should," "future," "propose" and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements.
These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside Company's control, that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. As such, readers are cautioned not to place undue reliance on any forward-looking statements.
Investors should carefully consider the foregoing factors and the other risks and uncertainties described in the "Risk Factors" sections of the Company's filings with the SEC, including the Registration Statement and the other documents filed by the Company. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements.
Contacts
Investors
Equity Group
Devin Sullivan
Managing Director
dsullivan@equityny.com
Conor Rodriguez
Analyst
crodriguez@equityny.com
Media
Russo Partners
David Schull
(858) 717-2310
david.schull@russopartnersllc.com
Press Release: https://www.marketwatch.com/press-release/spectral-ai-announces-publication-of-letter-to-shareholders-a9abe93c?mod=mw_quote_news_seemore