Aclarion Launches the Clinical Utility and Economic (CLUE) Trial to Quantify How Often Nociscan’s AI Generated Biomarker Data Changes Surgical Treatment Plans
21 8월 2024 - 8:57PM
Aclarion, Inc.,
(“Aclarion” or the “Company”) (Nasdaq: ACON,
ACONW), a healthcare technology company that is leveraging
biomarkers and proprietary augmented intelligence algorithms to
help physicians identify the location of chronic low back pain,
announced today the launch of the multi-center CLUE Trial to
quantify how often a surgeon changes their original treatment plan
once they have access to proprietary Nociscan data. Data from CLUE
will provide tremendous insight into the real-world value of adding
the Nociscan decision support tool to existing diagnostic
evaluation methods for the treatment of chronic low back pain.
“Diagnosing the source of chronic low back pain is a significant
challenge for clinicians and often results in the omission or
inclusion of treatment on discs that do not correlate to improved
clinical outcomes,” said Ryan Bond, Chief Strategy Officer of
Aclarion. “Evidence points to a significant improvement in outcomes
when Nociscan information is added to the treatment planning
process. CLUE is specifically designed to quickly determine how
influential Nociscan is in evaluating which discs a physician
decides to treat.”
Aclarion announced the launch of CLARITY earlier this year to
definitively demonstrate better surgical outcomes when Nociscan
data is included in the surgical decisioning process. CLARITY is a
gold standard, multicenter, prospective randomized trial. CLUE is
aimed at providing near term insights into the probability of
success of CLARITY by quantifying how often Nociscan data results
in a surgeon changing their original treatment decision.
“CLUE represents an opportunity to study the use of Nociscan in
an independent and scalable fashion. Any physician with
access to Nociscan can easily access this survey tool to build
their own evidence and body of data to use when advocating for
insurance coverage of Nociscan,” said Brent Ness, Chief Executive
Officer of Aclarion. “The format for CLUE closely follows the
evidence strategy demonstrated by HeartFlow, whose findings
ultimately rewrote the patient pathway for assessing coronary
artery disease. We remain committed to leading with evidence as we
work to change the way data is used to improve outcomes in chronic
low back pain, the highest cost diagnosis in healthcare
worldwide.”
About Aclarion, Inc.
Aclarion is a healthcare technology company that leverages
Magnetic Resonance Spectroscopy (“MRS”), proprietary signal
processing techniques, biomarkers, and augmented intelligence
algorithms to optimize clinical treatments. The Company is first
addressing the chronic low back pain market with Nociscan, the
first, evidence-supported, SaaS platform to noninvasively help
physicians distinguish between painful and nonpainful discs in the
lumbar spine. Through a cloud connection, Nociscan receives
magnetic resonance spectroscopy (MRS) data from an MRI machine for
each lumbar disc being evaluated. In the cloud, proprietary signal
processing techniques extract and quantify chemical biomarkers
demonstrated to be associated with disc pain. Biomarker data is
entered into proprietary algorithms to indicate if a disc may be a
source of pain. When used with other diagnostic tools, Nociscan
provides critical insights into the location of a patient’s low
back pain, giving physicians clarity to optimize treatment
strategies. For more information, please visit
www.aclarion.com.
Forward Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, Section 27A of the Securities Act of 1933 and Section 21E of
the Securities Exchange Act of 1934 about the Company’s current
expectations about future results, performance, prospects and
opportunities. Statements that are not historical facts, such as
“anticipates,” “believes” and “expects” or similar expressions, are
forward-looking statements. These forward-looking statements are
based on the current plans and expectations of management and are
subject to a number of uncertainties and risks that could
significantly affect the Company’s current plans and expectations,
as well as future results of operations and financial condition.
These and other risks and uncertainties are discussed more fully in
our filings with the Securities and Exchange Commission. Readers
are encouraged to review the section titled “Risk Factors” in the
Company’s Annual Report on Form 10-K for the year ended December
31, 2023, as well as other disclosures contained in the Prospectus
and subsequent filings made with the Securities and Exchange
Commission. Forward-looking statements contained in this
announcement are made as of this date and the Company undertakes no
obligation to publicly update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise.
Investor Contacts:Kirin M. SmithPCG Advisory,
Inc.646.823.8656ksmith@pcgadvisory.com
Media Contacts:Jodi LambertiSPRIG
Consulting612.812.7477jodi@sprigconsulting.com
Aclarion (NASDAQ:ACON)
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Aclarion (NASDAQ:ACON)
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