Aclarion, Inc.,
(“Aclarion” or the “Company”)
(Nasdaq: ACON, ACONW), a healthcare technology
company that is leveraging biomarkers and proprietary augmented
intelligence (AI) algorithms to help physicians identify the
location of chronic low back pain, today provided a corporate
update. The update reviews the successful achievement of several
recent key milestones and provides perspective on the positive
implications of those catalysts as the Company continues to
establish Nociscan as a standard of care decision support tool for
the treatment of patients with chronic low back pain.
“We are excited with the recent positive success we have been
awarded as Aclarion has consistently achieved stated catalysts of
value creation that fall into a very concise framework proven to
bring disruptive technological advancements to standard of care in
the healthcare sector,” said Brent Ness, CEO of Aclarion. “We
intend to lead a positive diagnostic transformation in spine care
through clinical and economic evidence that proves the promising
value of Nociscan. The building blocks we have executed over the
past two years have recently led to the achievement of our most
important catalyst to date which is multiple private insurance
companies in the UK electing to pay for Nociscan. Payer coverage is
critical to driving Nociscan to standard of care. We are providing
this corporate update to share the process involved in achieving
this milestone, how that process is being replicated at many sites
throughout the U.S., how we are coordinating clinical studies in
support of payment, and why increasing payer coverage decisions are
critical catalysts for driving the valuation of our company. We are
clearly excited not only by our recent successes but even more so
for our upcoming near term catalysts.”
The cornerstone of Aclarion’s strategy to drive payer coverage
is to partner with Key Opinion Leader (KOL) physicians who see the
value of Nociscan in their practice and advocate for insurance
coverage so the physician can provide better care to more patients.
Aclarion now has a panel of 10 of the top spine surgeon leaders in
the world aligned and actively speaking on behalf of the efficacy
and clinical utility of adding Nociscan to the evaluation of
patients who suffer from chronic low back pain. “These KOLs are
participating in the collection of clinical data, they are engaging
insurance companies and benefits management entities to advocate
for coverage decisions and representing Nociscan as an important
technology worthy of societal endorsement,” said Ryan Bond, Chief
Strategy Officer of Aclarion. “We believe the quality of a
company’s KOL network is a direct reflection of the importance and
promise of any new technology and our list of KOLs is more like
that of a multibillion-dollar industry leader than an emerging
technology disruptor.”
Aclarion’s KOL advocacy strategy applied to the UK has led to
great success and is a model of what the Company expects to see
replicated with their KOLs in the United States. Physicians in the
UK originally set out to evaluate Nociscan technology across 30
patients to determine if the technology was helpful. After
comparing Nociscan to invasive discography across only 20 patients,
the UK physicians saw the value of Nociscan and converted their
trial agreement into a permanent commercial agreement between
Aclarion and The London Clinic, a major provider of spine care in
London. As part of that conversion, Aclarion was able to secure
increased payments. To ensure a large segment of their patients
would have unfettered access to Nociscan, the UK KOLs, in
conjunction with The London Clinic, then approached the largest
private health insurance providers in the UK for payment. Three of
the top four payers have now agreed to pay for Nociscan thus
far.
Payer coverage decisions like those achieved in the UK represent
potentially trajectory changing milestones as they pave the way for
broad physician adoption and predictable revenue. Aclarion is now
adding sales and marketing resources into London to accelerate this
adoption and the potential revenue inherent in these payer coverage
decisions. The Company is simultaneously executing this same
physician-led strategy throughout the United States through its KOL
panel.
To expand access to more KOLs, Aclarion entered into a strategic
partnership with ATEC, a major spine implant company with a
specific interest in leveraging pre-surgical data to drive better
outcomes through its Alpha-Informatics platform. The partnership
calls for leveraging ATEC’s extensive physician relationships to
expand Aclarion’s KOL advocacy strategy to additional surgeons.
In support of its mission to drive Nociscan to standard of care,
Aclarion has executed multiple commercial agreements providing
access to Nociscan at multiple MRI scanners in key markets such as
New York, New Jersey, Arizona, Colorado, and Michigan. This
groundwork will assist in executing the strategic agreement in
place with ATEC to evaluate the use of Nociscan with their KOLs.
“We believe in the importance of biochemical markers within the
treatment paradigm and by partnering with Aclarion, we can progress
toward a mutual objective to integrate and advance technologies
that improve the predictability and reproducibility of spine
patient care,” stated Pat Miles, CEO of ATEC.
The payer world consists of more than standard commercial health
insurance providers. In the U.S., personal injury and worker
compensation cases make up a large part of the low back pain market
and the stakes of securing the right diagnosis are extremely high.
In this market in particular, a premium is placed on data that is
objectively obtained and can help physicians determine the best
treatment options.
By partnering with Justin Kubeck, MD, an orthopedic spine
surgeon in New Jersey, Aclarion is expanding into the personal
injury and workers compensation market with the same physician-led
strategy that is driving positive results in London. Dr. Kubeck
explained, “I’ll be leading an effort to educate a discrete
population of attorneys and judges who adjudicate PI and WC cases
throughout the state on the potential benefits of Nociscan for
these high stake cases.”
For KOLs to be most effective in driving payers to cover
Nociscan, favorable clinical and economic data from clinical trials
is an important requirement. Evidence continues to mount in favor
of utilizing Nociscan to determine discogenic pain over the current
invasive gold standard of provocative discography and for making
treatment decisions when provocative discography data is not
available.
The Company was invited to participate in the National Institute
of Health’s (NIH) Biomarkers for Evaluating Spine Treatments (BEST)
Trial which enrolled over 800 patients at 12 leading academic
teaching institutions across the United States, with a subset of
200 undergoing advanced biomarker profiling, which included
Nociscan. Results from the trial are anticipated in the near term
while the revenue produced from the trial has helped fund
Aclarion’s march toward full commercial launch.
The Company has published two peer reviewed journal articles
based on the results of a pivotal study conducted by Dr. Matt
Gornet showing that clinical outcomes improved and were durable
after two years when Nociscan results were concordant with the
surgical treatment of a patient versus when surgery did not follow
the Nociscan data for identifying painful discs. Bob Eastlack, MD
stated, “This is an outcomes result, not just a clinical
equivalency to a gold standard diagnostic study. Outcomes are what
drive payer coverage decisions.”
To quantify the savings inherent in utilizing Nociscan across
the spine surgery population of the United States based on the
conclusions of the Gornet study, the Economic Value Analysis of Low
back pain (EVAL) analysis was commissioned and executed by the
Center for Disruptive Musculoskeletal Innovations (CDMI). The
results of EVAL concluded that the use of Nociscan improves
outcomes and reduces costs, conservatively saving the US healthcare
system nearly half a billion dollars annually and by more than
$1,700 per patient. EVAL was presented at the annual International
Society for the Advancement of Spine Surgery (ISASS) meeting and at
Spine Week in Melbourne Australia. Spine Week is a combination of
major spine societies that occurs once every 4 years. EVAL has been
submitted for publication in a major spine journal and Aclarion
expects to announce that publication shortly.
Building on the clinical success as evidenced by the Gornet
study and the favorable economic analysis of EVAL, the Company has
launched CLARITY, its flagship clinical study. CLARITY is a
prospective, randomized, multi-center trial comparing the outcomes
of patients undergoing surgery for chronic discogenic back pain
when Nociscan is used in the decision-making process versus when
Nociscan is not being used in the decisioning process. Based on the
results of the Gornet Trial, Aclarion believes CLARITY will result
in compelling data that will rapidly lead to coverage decisions
from every major insurance provider in the country and endorsements
from all the major spine societies. Nicholas Theodore, MD, FACS,
FAANS, Director of Neurosurgical Spine Center, Johns Hopkins, and
Professor of Neurosurgery, Orthopaedics and Biomedical Engineering
is the Principal Investigator for CLARITY.
Additional compelling peer-reviewed data has been published in
the International Journal of Spine Surgery that highlights Nociscan
as a Gold Standard for noninvasive identification for painful
lumbar discs. The LIFEHAB trial continues to pay for the use of
Nociscan in the 202-patient study as a key component in their
evaluation of surgical vs non-surgical treatment efficacy. The
Company expects to announce additional sponsor-supported research
studies that generate additional revenue.
Aclarion has expanded its IP position in the MR spectroscopy
space and leads on every relevant front as a platform technology
that leverages MR spectroscopy and biomarker data for the
identification of painful discs. Over the past two years, two key
patents have been added. One to expand our IP position when using
newer AI analysis techniques to analyze spectroscopy data to
identify biomarkers and another to identify bacterial biomarkers
associated with pain.
In the months ahead, investors can rely on continued success in
adding peer reviewed evidence publications, signing additional
commercial agreements, and most importantly, expanding positive
payer coverage decisions.
For more information about the BEST Trial, please visit:
www.besttrial.org
For information about BACPAC, please visit:
https://heal.nih.gov/research/clinical-research/back-pain
For more information about REACH, please visit:
www.bacpac-reach.org
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:ACONW)
過去 株価チャート
から 11 2024 まで 12 2024
Aclarion (NASDAQ:ACONW)
過去 株価チャート
から 12 2023 まで 12 2024