NIH funded Biomarkers for Evaluating Spine Treatments (BEST) Trial launching this quarter

BEST to study the role of biomarkers in optimizing the treatment of chronic low back pain

Nociscan^TM to be commercially active across seven participating major academic medical centers

BROOMFIELD, CO / ACCESSWIRE / September 19, 2022 / $Aclarion (ACON.US)$$ACLARION INC C/WTS (TO PUR COM) (ACONW.US)$, ("Aclarion" or the "Company") , 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 their participation in the Biomarkers for Evaluating Spine Treatments (BEST) Trial funded through the Helping to End Addiction Long-term^SM Initiative, or NIH HEAL Initiative^SM.

BEST will enroll over 800 patients at 12 leading academic teaching institutions across the United States, with a subset of 200 undergoing advanced biomarker profiling, which includes Nociscan.

Chronic low back pain (cLBP) is a leading cause of opioid addiction in the U.S., and the NIH is addressing the opioid crisis through this initiative. Armed with $150M in funding, the NIH HEAL Initiative launched the Back Pain Consortium (BACPAC) Research Program to study cLBP and recommend a definitive clinical trial to personalize cLBP treatments for each patient based on their specific biomarker profiles. BEST is the clinical trial BACPAC has designed to study the use of biomarkers as a means of optimizing the clinical treatment journey for cLBP patients.

"Aclarion has already published compelling data demonstrating that Nociscan is a highly accurate, noninvasive alternative to discogram for identifying painful discs, and that the use of Nociscan for surgical planning can dramatically improve outcomes for patients undergoing fusion or disc replacement surgery for discogenic low back pain," said Jeff Thramann, MD, Executive Chairman, Aclarion. "We believe that knowing whether a particular disc is likely a pain generator or not is vital clinical data, that together with other biomarkers being studied under BEST, will provide clinicians with great insight into the optimal treatment path for each patient. We look forward to understanding how our technology can be helpful to physicians in guiding treatment at the earliest stages of chronic low back pain evaluation"

"It is an honor to have Nociscan selected as a biomarker to be evaluated in the BEST Trial and we look forward to expanding our commercial footprint into the leading academic medical centers participating in this study," stated Brent Ness, CEO of Aclarion.

Since 2021, Aclarion has been providing biomarker data to BACPAC through the REACH center at University of California, San Francisco. Aclarion's proprietary decision-support tool, Nociscan, 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.

"Currently, we have many evidence-based treatments for chronic low back pain, but we don't have a good understanding of how to use biomarkers to guide treatment decisions. Biomarkers are specific characteristics that may be different for different people but can be reliably measured and reproduced. I am hopeful that after the BEST Trial, doctors will be better able to use biomarkers to guide decision making to select the optimum, tailored treatment for people living with chronic low back pain", said Matt Mauck, MD, PhD, University of North Carolina at Chapel Hill, School of Medicine.

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 .

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 Prospectus dated April 21, 2022, as filed with the Securities and Exchange Commission on April 25, 2022 under Rule 424(b)(4), 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.

Disclosure

This research was supported by the National Institutes of Health through the NIH HEAL Initiative under award number 1U24AR076730-01.

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or its NIH HEAL Initiative.

Nothing in this statement shall be construed to imply any support or endorsement of Aclarion or any of its products by the University of North Carolina, their officers, agents, and employees. In addition, Matt Mauck, MD, PhD, will not receive any compensation from Aclarion.

Investor Contacts:

Kirin M. Smith
PCG Advisory, Inc.
646.823.8656
ksmith@pcgadvisory.com

Media Contacts:

Jodi Lamberti
SPRIG Consulting
612.812.7477
jodi@sprigconsulting.com

SOURCE: Aclarion Inc.