Modic Changes (MC) are MRI Findings Associated With Endplate Damage, Neoinnervation, and Chronic Low Back Pain (cLBP)

MR Spectroscopy (MRS) Measurement of Intradiscal Propionic Acid (PA) can Clarify MC Etiology and Help Stratify MC Patients to Potentially Inform Better Treatment Decisions for cLBP Patients

Results Presented at the 50th International Society for the Study of the Lumbar Spine (ISSLS) Annual Meeting 2024

BROOMFIELD, CO - (NewMediaWire) - September 27, 2024 - 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, announced today that the Nociscan solution was utilized to better understand Modic changes (MC) in patients suffering from chronic low back pain (cLBP). The prospective study of 88 patients with low back pain for greater than 3 months was presented at the 50^th International Society for the Study of the Lumbar Spine Annual Meeting 2024 in Milan, Italy.

“The goal of the REACH Center at UCSF is to clarify the biopsychosocial mechanisms of chronic low back pain — the interconnection between biology, biomechanics, psychology, and socio-environmental factors — which will be foundational for personalized, effective care,” said Aaron Fields, PhD. “Our team is using a variety of validated diagnostic tests to understand the causes of cLBP, including MC. Our prospective study compared intradiscal propionic acid (PA) levels adjacent to vertebral endplates with MC. We evaluated disc tissue non-invasively by using MRS and Nociscan. The results challenge the notion that the disc environment is sterile. Furthermore, PA levels may be useful for understanding why some patients with MC improve or respond to treatment while others do not.”

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.

Globally, 266 million people suffer from spinal degeneration and low back pain. There are several potential causes and in recent years vertebral endplate irregularities and Modic changes have become an important area of research and development. When Modic changes are present on MRI it is important to understand whether those changes are associated with an infection in the disc. There is currently no noninvasive method to diagnose disc infection. Recognizing that PA is a metabolite of a bacteria commonly found in disc infections, the UCSF team utilized Nociscan to measure PA as a way to stratify patients with Modic changes for potential personalized treatment. Future research may include treating cLBP patients with have high levels of PA with antibiotics as a first line of treatment to evaluate whether this improves clinical outcomes.  

“Aclarion’s focus is to provide physicians with new noninvasive information they can use to help make better decisions about patient care,” said Ryan Bond, Chief Strategy Officer. “It is rewarding to see clinicians recognizing the ability of Nociscan technology to identify biomarkers and thinking about how that information can potentially be used to provide personalized treatment plans aimed at improving patient outcomes. We congratulate the UCSF team for their innovative research and important presentation and look forward to additional developments as they become available.”

For more information on ISSLS and the Study:  Magnetic resonance spectroscopy biomarker of Modic changes with bacterial etiology

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.

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