Aclarion Appoints Nicholas Theodore, MD as Principal Investigator for CLARITY Post-Market Trial Evaluating Nociscan in the Diagnosis and Treatment of Chronic Low Back Pain
May 02 2023 - 7:00AM
via NewMediaWire – 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 that Nicholas
Theodore, MD, Director of Neurosurgical Spine Center at Johns
Hopkins University, will serve as the Principal Investigator in a
post-market, multi-site trial, that will further evaluate the role
of Nociscan in the diagnosis and surgical treatment of patients
suffering from chronic low back pain.
“Diagnosing the source of chronic low back pain has been an
industry conundrum for decades,” said Dr. Theodore. “Moreover, as
clinicians, we are challenged by important limitations with
alternative diagnostic tools like MRI and discography. Aclarion’s
Nociscan tool has already illustrated a unique and compelling
capability for objectively measuring pain-generating chemical
biomarkers in the lumbar spine, and I am equally interested in how
it may apply to measuring disc degeneration. I believe these
innovations will become foundational to the diagnosis and treatment
of chronic low back pain.”
On April 4th, 2023, the European Spine Journal published a peer
reviewed article titled “Magnetic resonance spectroscopy (MRS)
identification of chemically painful lumbar discs leads to improved
6-, 12-, and 24-month outcomes for discogenic low back pain
surgeries” by Matthew F. Gornet, MD et al. Success rates at 2 years
for discogenic low back pain (DLBP) surgeries were 85% for patients
whose treatment strategy was consistent with Nociscan-identified
discs, a 22 percentage point improvement over patients whose
treatment strategy was inconsistent with Nociscan-identified discs
(85% vs. 63%; p=0.07). The results suggest that Nociscan provides
valuable new information that can help physicians successfully
treat DLBP.
Building on the success of the recently published Gornet 2YR
clinical outcomes, CLARITY will expand the protocol of the Gornet
study to up to 14 sites and target enrollment of approximately 300
patients. Similar to Gornet, surgeons will be blinded to Nociscan
results while utilizing standard diagnostic imaging (MRI) and
physical examination to decide which discs to surgically treat in
each patient. After surgery, the outcomes of patients whose
surgically treated discs match the discs identified as painful by
Nociscan will be compared to the outcomes of patients where the
surgically treated discs did not match the discs Nociscan
identified as painful. It is expected that CLARITY will show
similar success as Gornet but in a much larger multicenter study
aimed at establishing Nociscan as a standard of care for surgical
decision making.
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,
giving physicians clarity to optimize treatment strategies.
CLARITY represents a new post-market clinical trial for
Aclarion. “Aclarion is excited to add this important evidence to
our portfolio and honored that Dr. Theodore from Johns Hopkins has
enthusiastically accepted the PI role,” says Brent Ness, CEO of
Aclarion. “CLARITY will add to the compelling two-year outcomes of
the Gornet trial and the cost-effectiveness health economics study
(EVAL).”As previously announced, Aclarion has been used in two
National Institutes of Health trials in the US (comeBACK and BEST)
focused on improved understanding of low back pain and the effect
of non-surgical treatment options.
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, 2022, 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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