Aclarion Announces Completion of First Nociscan Exams in LIFEHAB Trial

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 the completion of the first Nociscan exams for patients enrolled in the 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. Nociscan was selected for use in the study to help evaluate how magnetic resonance spectroscopy (MRS) biomarkers can identify patient improvement following treatment.

Patient enrollment in LIFEHAB began in the second quarter of 2024. The initial enrolled patients began completing Nociscan exams in the last week of August. Thus far six (6) patients have completed their Nociscan exams.

“We are excited to see the LIFEHAB Trial progressing on schedule and look forward to the results of the study and to the role we expect Nociscan data to play in not only helping physicians determine which discs to treat but in potentially helping to predict which treatment option is optimal for a particular patient,” said Brent Ness, Aclarion CEO. “Although we talk frequently about driving Nociscan to standard of care for clinical use, the research market is proving to be an early adopter of our technology.”

Aclarion is currently awaiting the results of a completed trial in Rome where Nociscan technology was used in a study evaluating regenerative technologies as well as the results of two NIH studies evaluating the role of Nociscan in treating chronic low back pain.

“We see Nociscan moving at an accelerated pace of adoption in the research market and look forward to announcing more partnerships as we continue to drive Nociscan to what we expect to be the gold standard for determining which discs to treat in research protocols on low back pain,” said Ryan Bond, Chief Strategy Officer of Aclarion.

Aclarion believes the results of the LIFEHAB trial, combined with other compelling evidence, marks a key step toward achieving successful reimbursement in a single-payer national health insurance system like Norway.

LIFEHAB is the latest customer-sponsored clinical trial involving Nociscan and the Company looks forward to announcing additional partnerships as Nociscan expands its adoption in the research market.

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, 2023, 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. SmithPCG Advisory, [e-mail]

Media Contacts:Jodi LambertiSPRIG [e-mail]