Aclarion Announces First Patient Enrollments at Two Additional CLARITY Trial Sites and Provides Guidance on Expected Availability of Initial Data

• Northwestern and Scripps Health join two previously announced sites in achieving this critical patient enrollment milestone
• Seven leading U.S. spine centers have now completed the regulatory and operational requirements to screen and enroll patients in CLARITY
• First readout on interim data expected after initial cohort of patients achieves 3-month follow up visit in 3Q 2026
  
  
  
  

BROOMFIELD, Colo., Jan. 06, 2026 (GLOBE NEWSWIRE) -- 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, today announced that Northwestern Medicine and Scripps Health have enrolled their first patients in the company's pivotal CLARITY (Chronic Low bAck pain Randomized Independent Trial studY) trial, advancing enrollment progress in the trial.

The trial represents a key clinical and commercial catalyst for the company and is intended to support future reimbursement discussions in the U.S. With the latest enrollments by Northwestern and Scripps, four sites have enrolled one or more patients. Seven clinical sites have completed the required regulatory approvals, contracting, training, and study setup, enabling them to begin enrolling patients. These CLARITY sites include Texas Back Institute, University of Miami Health, Advocate Health, Northwestern Medicine, Scripps Health, Keck Medicine of USC, and Johns Hopkins University.

The company recently hired Jason Brosniak as Commercial Director for the Eastern U.S. and Andy Murillo as Director of Market Access to focus on driving CLARITY trial enrollment and adding more sites to accelerate enrollment progress. The company continues to actively evaluate additional sites to ensure it meets enrollment targets.

The CLARITY trial is a multi-site trial designed to evaluate whether incorporating Nociscan into standard surgical planning can improve outcomes that significantly exceed the current ~54% industry benchmarks for patients undergoing surgery for chronic low back pain. The study will enroll up to 300 patients, randomized between surgeons who are blinded-to-Nociscan results and unblinded-to-Nociscan results to guide surgical planning for Fusion/TDR.

The Company aims to enroll approximately 25% of patients by the end of Q2 2026. An initial readout on the results of this first cohort of patients will be internally available 90 days later upon the last patient completing their 3-month follow up visit. Additional patient data will be added to the initial readout on a rolling basis until enrollment is completed. Although Aclarion targets full enrollment of 300 patients by mid-2027, if statistically significant improvements are seen in the Nociscan group prior to reaching 300 patients, the trial may be terminated prior to full enrollment. The analysis will evaluate patient-reported pain outcomes using the Visual Analog Scale (VAS), the trial's primary endpoint, with comparisons to pre-surgical pain levels.

"The CLARITY trial is a foundational value-creation initiative for Aclarion, and we are encouraged by the pace of site activation, early enrollment, and completed surgeries," said Brent Ness, Chief Executive Officer of Aclarion. "Each patient enrolled and treated moves us one step closer to generating high-quality clinical evidence while reinforcing the commercial momentum we are building across the business."

Aclarion believes the continued expansion of high-quality clinical sites, combined with early surgical throughput, positions CLARITY to progress with increasing efficiency and predictability, supporting the Company's strategy to generate Level 1 evidence and drive long-term shareholder value.

An estimated 266 million people across the globe live with chronic low back pain, making it one of the most widespread health challenges. 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 and has the potential to drive better surgical outcomes for patients suffering from degenerative spine disease and low back pain worldwide.

For more information about CLARITY, please visit: CLARITY Trial

To find a Nociscan center, view our site map here.

For more information on Nociscan, please email: [email protected]

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. Forward-looking statements in this release include, among others, statements regarding the enrollment of patients in our ongoing clinical trial, the expected date of the internal interim results, the potential benefits of our Nociscan technology, and the Company's plans for future regulatory and commercialization activities. 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, 2024, 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.

[email protected]

Media Contacts:

Jessica Starman

[email protected]