Spectral MD, Inc. (“SMD”), a subsidiary of
Spectral AI, Inc. (Nasdaq: MDAI; MDAIW) (“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 it has been
awarded a new contract valued at up to $149 million by the
Biomedical Advanced Research and Development Authority (BARDA),
part of the Administration for Strategic Preparedness and Response
(ASPR) within the U.S. Department of Health and Human Services. The
contract is for the advanced development of the DeepView® System,
the Company’s AI-driven burn wound imaging technology, to be used
at emergency departments, trauma centers and burn centers, for both
routine burn care and as a medical countermeasure for use in burn
mass casualty incidents (BMCI).
This multi-year contract includes an initial
award of nearly $55 million to support the clinical validation and
FDA clearance of DeepView® for commercial marketing and
distribution purposes, a major milestone that enables the
technology to become a key component of the U.S. government’s BMCI
preparedness efforts. The initial award places up to 30 DeepView®
devices at various burn centers and emergency rooms to support the
clinical validation study and will transition to being used in
routine care upon FDA clearance. The contract also includes options
with an additional total value of approximately $95 million and can
be exercised for additional product development, procurement, and
deployment of DeepView® at U.S. emergency departments, trauma
centers and burn centers in a phased approach. These deployments
will enable SMD to conduct health economic and outcome research to
support broader clinical adoption of the DeepView® System.
Previously in 2013 and 2019, SMD was awarded
BARDA contracts totaling $123 million, of which $101 million has
been committed to date. Together with this new contract, it brings
the total potential support from BARDA to nearly $251 million. This
new contract represents the largest contract ever awarded to
SMD.
“We appreciate that our DeepView® platform has
been selected to address a critical need in preparing our country
for possible BMCI events,” said Wensheng Fan, the Company’s CEO.
“This is a significant contract award that enables us to accelerate
the late-stage clinical development and commercialization of our
DeepView® System. We are most grateful to BARDA for enabling us to
help physicians and their burn patients who will benefit from the
use of DeepView®. For the first time, there will be an accurate and
objective solution in burn wound healing assessment to guide
treatment. Spectral MD is committed to the development of impactful
medical technologies, and we will aim to bring DeepView® to market
as quickly as possible.”
Jeffrey Carter, M.D., the Company’s Chief
Medical Consultant, added, “The current standard of care for burn
wound assessment that is crucial in determining next-step treatment
relies largely on the clinical judgement of physicians. However,
diagnostic accuracy can be as low as 50%. This unmet clinical need
is dramatically magnified in the event of a BMCI, where the ability
to triage burn patients rapidly and properly would be crucial in
allocating valuable resources and managing the surgical burden. The
DeepView® technology represents a new paradigm in the assessment of
burn wounds and can provide meaningful clinical guidance to
physicians in their diagnosis and treatment recommendations.”
This work supports BARDA’s mission to identify
medical countermeasures which help counter the effects of a BMCI
and address the current limitations within the United States’ burn
care infrastructure. According to the American Burn Association,
1.1 million Americans suffer from burn injuries each year, with
500,000 presenting to emergency departments, and 40,000 requiring
hospitalization. In contrast to this demand, only two percent of
U.S. hospitals have burn centers, and there are only about 250 burn
surgeons in the United States.
To bridge this gap in care, the Company’s
DeepView® System, which received Breakthrough Device Designation
from the FDA in 2017 for its burn indication, integrates
proprietary imaging technology and AI-enabled algorithms to see
deep below the surface of the skin to distinguish between healthy
and damaged tissue. By seeing what the human eye cannot, DeepView®
delivers a binary wound healing prediction to assist physicians in
determining whether a burn will heal on its own or if surgery is
required. Studies with DeepView® have demonstrated a burn
diagnostic accuracy rate of 92% on Day 1, well above the estimated
>50% accuracy of non-specialists and even the estimated 70%
accuracy of burn specialist assessments.
This project is being supported in whole or in
part with federal funds from the Department of Health and Human
Services; Administration for Strategic Preparedness and Response;
BARDA, under contract number 75A50123C00049. The findings and
conclusions have not been formally disseminated by the Department
of Health and Human Services and should not be construed to
represent any agency determination or policy.
About Spectral MDSpectral MD,
Inc., is a subsidiary of Spectral AI, Inc., 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 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:The
Equity GroupDevin SullivanManaging
Directordsullivan@equityny.com
Conor
RodriguezAnalystcrodriguez@equityny.com
Media:Russo
PartnersDavid Schull or Guillermo Ruiz, M.D., Ph.D.Russo
Partners(858) 717-2310david.schull@russopartnersllc.com
Guillermo Ruiz, M.D., Ph.D.Russo Partners(858)
717-2310Guillermo.ruiz@russopartnersllc.com
Spectral AI (NASDAQ:MDAI)
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Spectral AI (NASDAQ:MDAI)
過去 株価チャート
から 6 2023 まで 6 2024