Initial findings from the EVAL study are expected to be released in Q4 2022

Study initiated to assess impact of Nociscan on the cost of care for chronic low back pain (CLBP) patients

Promising initial clinical evaluations with 87% of patients treated at discs identified as painful by Nociscan continuing to show significant clinical improvements at a two-year follow-up

BROOMFIELD, CO / ACCESSWIRE / July 20, 2022 / Aclarion, Inc., ("Aclarion" or the "Company") (NASDAQ:ACON)(NASDAQ: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 launch of the Economic Value Analysis of Low back pain (EVAL) study; a rigorous healthcare economic study to assess the impact of the Nociscan solution on the cost of care for patients suffering from chronic low back pain (CLBP). The University of California at San Francisco and the Center for Disruptive Musculoskeletal Innovations (CDMI), which is funded by the National Science Foundation, is conducting the study using outcomes data from previously published clinical studies.

Initial findings from the EVAL study are expected to be released in Q4 2022. The Company expects results of this study to provide strong economic support for the utilization of Nociscan in the assessment of CLBP and to use this data to accelerate coverage decisions from insurance companies and self-insured employers.

"Throughout my career, I have been interested in the nexus of health economics and spine care. Chronic low back pain has an important healthcare and social cost, and the EVAL study is valuable in guiding an evidence-based approach to appropriate care for patients with symptomatic disc degeneration," said Dr. Sigurd Berven, Professor of Orthopedic Surgery at University of California San Francisco School of Medicine. "Aclarion's Nociscan solution is truly groundbreaking technology in the assessment of CLBP, and the EVAL study will provide a clear picture of the economic impact that Nociscan can have for the US healthcare system and for the appropriate management of patients with low back pain."

Nociscan is 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 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.

"Aclarion is committed to our mission of improving the lives of people suffering from debilitating back pain," said Brent Ness, CEO and Board Director at Aclarion. "Nociscan helps physicians improve treatment strategies by identifying the source of a patient's low back pain. Initial clinical evaluations have been very promising with 87% of patients who were treated at discs identified as painful by Nociscan continuing to show significant clinical improvements at a two-year follow-up. Compare that to surgical success rates of between 41-57% for conventional low back pain procedures and you can see the incredible opportunity for Nociscan to dramatically reduce the cost of care for CLBP patients, which is a major portion of the single largest healthcare spend in the US. The EVAL study is an important body of work for everyone involved in the treatment of CLBP patients, and we eagerly await the results of this academic work."

Chronic low back pain is a global healthcare problem, with approximately 255 million people worldwide suffering from degenerative spine disease and low back pain. In the US alone, over $134B annually is spent on low back and neck pain.^[1] Conventional imaging and diagnostics provide valuable structural information on the state of a patient's spine but struggle to identify the source of the pathogenic pain, contributing to low surgical success rates (41-57%), especially for those with discogenic low back pain.^[2],[3]

"An evidence-based process for accurate identification of a source for low back pain is valuable to improve cost-effectiveness of operative and non-operative management strategies," said Leslie Wilson, PhD, Professor in the Department of Medicine and the Department of Clinical Pharmacy at University of California San Francisco.

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.

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.

UCSF Disclosure

The information stated above was prepared by Aclarion and reflects solely the opinion of Aclarion. Nothing in this statement shall be construed to imply any support or endorsement of Aclarion or any of its products by the Regents of the University of California, its officers, agents, and employees. In addition, Dr. Sigurd Berven and Leslie Wilson, 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

^[1] Ravindra VM, Global Spine Journal (2018) 8(8): 784-794

^[2] Wei J, Song Y, et al. Comparison of artificial total disc replacement versus fusion for lumbar disc disease: a meta-analysis of randomized controlled trials. Int Orthop. 2013; 37(7):1315-1325

^[3] Ibrahim T, Tieyjeh IM, et al. Surgical versus nonsurgical treatment of chronic low back pain: a meta-analysis of randomized trials. Int Orthop. 2008; 32(1):107-113

SOURCE: Aclarion Inc.