Aclarion Launches Second Clinical Utility and Economic (CLUE) Trial Site With First Surgeon in New Jersey
August 29 2024 - 6:57AM
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 expansion of the multi-center CLUE Trial to New
Jersey. Justin Kubeck, MD, orthopedic spine surgeon and founder of
Ocean Pain and Spine in Toms River, NJ will join an expanding
network of spine surgeons participating in CLUE to build a growing
body of data supporting the real-world value of adding Nociscan’s
AI generated data to existing diagnostic evaluation methods for the
treatment of chronic low back pain.
Dr. Kubeck is the second surgeon to join CLUE since the trial
was announced earlier this month, joining Dr. John Keller, a
neurosurgical spine surgeon in Michigan. The Company expects a
steady cadence of spine surgeons to join CLUE in the coming months
to rapidly provide compelling data to payers as to how frequently
Nociscan has a significant impact on the decision-making process
during the critical stage when surgeons are planning the optimal
treatment for their patient.
“I always tell new patients that we need to see what makes sense
for their individual circumstances – whether it’s medication, or
therapy, or ultimately, surgery,” explained Dr. Kubeck. “There is a
protocol that I follow; I don’t ever just go in and do surgery. For
me, developing the best treatment plan for an individual patient is
very proceduralized. Once we determine the problem, then I say,
‘Here’s what you can expect, here are your options, and here is
what we will decide together.’ Nociscan will be an invaluable
decision support tool when evaluating diagnosis and treatment.”
Globally, 266 million people suffer from degenerative spine
disease and low back pain. Aclarion’s Nociscan solution is the
first evidence-supported SaaS platform to noninvasively help
physicians distinguish between painful and nonpainful discs in the
lumbar spine. Nociscan objectively quantifies chemical biomarkers
demonstrated to be associated with disc pain. Biomarker data is
entered into proprietary algorithms to highlight 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.
"Real world evidence is incredibly valuable when evaluating the
influence and utility of an emerging diagnostic tool and when this
evidence can be rapidly secured by experienced surgeons through a
trial like CLUE, it becomes a critical tool for driving early payer
coverage decisions,” stated Ryan Bond, Chief Strategy Officer at
Aclarion. “We welcome the inbound interest that has launched our
CLUE trial at multiple sites and encourage others to reach out at
info@aclarion.com if they are interested in bringing Nociscan to
their patients and participating in the CLUE trial.”
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
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