The Helping to End Addiction Long-term® Initiative, or NIH HEAL Initiative®, is funding ground-breaking low back pain research.

The Back Pain Consortium (BACPAC) Research Program, a recipient of the NIH HEAL Initiative, is an effort to address the need for effective and personalized therapies for chronic low back pain (cLBP).

Two BACPAC trials utilizing Aclarion’s Nociscan platform include the Biomarkers for Evaluating Spine Treatments (BEST) clinical trial and the comeBACK clinical study.

BROOMFIELD, CO - (NewMediaWire) - November 01, 2023 - 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 the Nociscan decision support tool will be presented at the 2023 Fall Meeting for the NIH HEAL Initiative BACPAC Research Program on November 1-2, 2023. Aclarion will be presenting Nociscan, the first, evidence-supported , SaaS platform to noninvasively help physicians distinguish between painful and nonpainful discs in the lumbar spine. Nociscan is being utilized in the two leading low back pain trials within the HEAL Initiative – comeBACK and BEST.

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. Biomarkers for Evaluating Spine Treatments (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. The comeBACK clinical study takes a holistic approach to people suffering from cLBP by focusing on the evaluation of numerous biomarkers to help researchers develop better, safer, and more tailored treatment to every individual.

"Aclarion is honored to be a foundational part of these ground-breaking NIH studies focused on chronic low back pain, a condition affecting 266 million people around the world,” said Brent Ness, Chief Executive Officer. "We know through our own peer-reviewed, published evidence that knowing whether a particular disc is likely a pain generator or not is vital clinical data, which can lead to improved clinical and economic outcomes. 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."

For more information about BACPAC, please visit: https://heal.nih.gov/research/clinical-research/back-pain

For more information about the BEST Trial, please visit: www.besttrial.org

For more information about the comeBACK study, please visit: https://comeback.ucsf.edu/

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 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.

Investor Contacts:

Kirin M. Smith

PCG Advisory, Inc.

646.823.8656

ksmith@pcgadvisory.com 

Media Contacts:

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SPRIG Consulting

612.812.7477

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