LIFEHAB is a randomized controlled trial in Norway comparing lumbar interbody fusion surgery with multidisciplinary rehabilitation

Norway is a single-payer national health insurance system

LIFEHAB is targeting enrollment to begin in the second quarter of 2024

BROOMFIELD, CO - (NewMediaWire) - April 25, 2024 - 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 solution will be utilized in the upcoming LIFEHAB Trial in Norway. The randomized controlled trial studying 202 patients with low back pain greater than 1 year in duration will compare treatment outcomes between lumbar interbody fusion surgery and multidisciplinary rehabilitation.

“Diagnosing the source of chronic low back pain is  a significant challenge for clinicians,” said Dr. Ansgar Espeland. “At Haukeland University Hospital, our radiology team has participated in numerous clinical trials seeking to better understand the linkage between the diagnosis and treatment of chronic low back pain.  The LIFEHAB Trial is our latest effort to advance scientific understanding of chronic low back pain. The trial is headed by orthopedic surgeon Dr. Christian Hellum at Oslo University Hospital, Ulleval in cooperation with Dr. Sverre Mjones, Akershus University Hospital. We are pleased to have Nociscan as part of the trial, which we expect may provide important insights not available without Nociscan. LIFEHAB will evaluate treatment outcomes for 202 patients, comparing surgical fusion with multidisciplinary rehabilitation, a comparison we believe will help improve patient outcomes for this complicated ailment.” 

The Company believes the LIFEHAB trial combined with other compelling evidence, marks an important step toward achieving successful reimbursement in a single-payer national health insurance system like Norway’s, which was adopted in 1966.

Globally, 266 million people suffer from degenerative spine disease and low back pain. 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.  

LIFEHAB represents a new clinical trial involving Nociscan. “Aclarion is honored to be included in this ground-breaking clinical trial with global implications,” says Ryan Bond, Chief Strategy Officer of Aclarion. “Dr. Espeland and his colleagues have designed a powerful trial that will add important insights to the diagnostic treatment paradigm for low back pain. The LIFEHAB trial represents the fourth important trial since 2021 to utilize Nociscan, a testament to our growing body of evidence and the relative distinction of the Nociscan solution.”

For more information on the LIFEHAB Trial: https://classic.clinicaltrials.gov/ct2/show/NCT06169488

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.

Investor Contacts:

Kirin M. Smith

PCG Advisory, Inc.

646.823.8656

ksmith@pcgadvisory.com

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SPRIG Consulting

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