Spectral AI Completes Burn Center Enrollment for U.S. Burn Pivotal Study
August 27 2024 - 8:00AM
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 completion
of adult and pediatric patient enrollment at U.S. burn centers for
its U.S. Burn Pivotal Study. One of the largest domestic burn
studies ever conducted, the U.S. Burn Pivotal Study is designed to
validate the AI-driven algorithm used by the Company’s DeepView™
System for burn indication.
Using data from these burn center patients, the
Company will pursue a De Novo classification from the U.S. Food and
Drug Administration (“FDA”) for use of the DeepView™ System in burn
centers and expects to submit the request in the second quarter of
2025.
“We met our burn center enrollment goal much
sooner than anticipated due to the dedication of our team and the
support of study participants,” said Peter M. Carlson, Chief
Executive Officer of Spectral AI. “This milestone achievement will
allow us to begin data analysis and advances our product
commercialization timeline,” Carlson added.
Spectral AI's DeepView™ System for burn
indication is a predictive medical device that assesses the healing
potential of burns by combining multi-spectral imaging with an
AI-driven algorithm trained and tested against a proprietary
database of more than 340 billion clinically validated data points.
By distinguishing between healing and non-healing tissue, the
DeepView™ System provides an immediate and binary prediction of
wound healing on Day One that can support clinical decision-making
regarding next step treatment plans. The DeepView™ System has
demonstrated superior accuracy in assessing burn wounds compared to
the current standard of care.
“I am proud of the incredible work by our
investigators, their dedicated staff and most critically study
enrolees,” stated Dr. Jeffrey Carter, MD, Principal Investigator of
the Pivotal Study. “We enrolled 160 patients in less than eight
months, in what we believe to be one of the fastest enrolling burn
studies ever completed in the U.S. The results will be used by our
data science team and our panel of burn experts to complete years
of work and bring this crucial advancement in burn wound assessment
to patients and providers in the U.S.”
The Company is continuing to enroll patients at
Emergency Departments (ED) as part of the U.S. Burn Pivotal Study,
with such enrollments expected to continue into 2025. A subsequent
510(k) application will be submitted for the use of the DeepView™
System in EDs following the completion of the ED enrollment,
associated data analysis, and the receipt of FDA approval for the
use of the DeepView™ System in burn centers.
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. The
DeepView System 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 to change the current standard
of care, the DeepView System 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
the DeepView System, 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.
Investors: The Equity
Group Devin Sullivan Managing
Director dsullivan@equityny.com
Conor Rodriguez Analyst crodriguez@equityny.com
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