Spectral AI Highlights Unprecedented Collaboration with National Leaders in Burn Care for DeepView™ System Training and Validation Studies
12 Dezembro 2024 - 10:00AM
Spectral AI (NASDAQ: MDAI) (“Spectral AI” or the “Company”),
developer of the AI-driven DeepView® System, which received
Breakthrough Device Designation from the U.S. FDA in 2018, that
uses multi-spectral imaging and algorithms to predict burn healing
potential, today announced that national leaders in burn care have
dedicated more than an estimated 511 in-person days of physician
engagement to the training and validation studies for the DeepView™
System for U.S. Food and Drug Administration (FDA) submission. This
does not include more than an estimated 250 additional days that
these experts devoted in Proof-of-Concept studies.
This extraordinary collaboration includes
participation from physicians across the country who are national
leaders in burn care. They include three current or former
presidents, and ten board members/past board members of the
national burn organization, the American Burn Association, and two
editors-in-chief of leading medical burn journals. This level of
participation by such esteemed professionals represents an
unprecedented investment of time and expertise to work with
Spectral AI’s team to develop artificial intelligence
algorithm.
Spectral AI’s patented DeepView® technology is
an AI-driven wound diagnostics platform that combines advanced
algorithms with medical imaging to predict wound healing potential
that has been Breakthrough Designated by the FDA. The platform
relies on a specialized dataset, allowing it to identify critical
patterns and deliver compelling clinical insights. This unique
collaboration with a world-class team of burn experts enhances the
dataset's credibility and reliability as well as underscores the
study's groundbreaking nature.
“This level of cooperation represents an
unprecedented amount of time and effort for national leaders in
burn care,” said Dr. Jeffrey Carter, M.D., Principal Investigator
of the studies. “We are deeply grateful for the leadership of Dr.
Michael DiMaio and the engagement of this exceptional group of
clinicians.”
Dr. Michael DiMaio, Chairman of Spectral AI’s
board of directors, added, “I am extremely proud of our Spectral AI
team and the fact that we have been able to include some of our
country’s most highly regarded burn experts in DeepView’s training
and validation study. These experts allow the algorithm to be
trained by the best-in-class clinicians with countless years of
experience. This joint effort reflects our unwavering commitment to
ensuring the DeepView® System becomes a gold-standard tool in burn
care.”
DeepView® received a significant endorsement in
2018 when it was granted the Breakthrough Device Designation from
the U.S. FDA. This recognition, coupled with the achievement of the
United Kingdom Conformity Assessed (UKCA) mark for burn indications
earlier this year, positions DeepView® as a potential game-changer
in medical diagnostics.
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®” with its DeepView® System.
DeepView is a predictive 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 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 intention to separate its Spectral IP subsidiary from the
Company, and each Company’s strategy, plans, objectives,
initiatives, strategic goals, financial outlook or other
non-historical matters. 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. Spectral AI undertakes no obligation to
update any forward-looking statements except as otherwise required
by law.
For Media and Investor Relations, please contact:
David KugelmanAtlanta Capital Partners LLC(866) 692-6847 Toll
Free - U.S. & Canada(404) 281-8556 Mobile and WhatsAppEmail:
dk@atlcp.com
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