Aclarion Announces Addition of University of Arizona College of Medicine – Phoenix as CLARITY Trial Site

• University of Arizona College of Medicine – Phoenix is home to a leading neurosurgery and orthopedic spine program with deep expertise in complex spine surgery and a strong commitment to clinical research and innovation

• Ten sites now actively enrolling in CLARITY study, a prospective, randomized clinical trial designed to demonstrate Nociscan’s ability to improve surgical outcomes for chronic low back pain

• Nociscan® aims to become the gold standard in identifying sources of low back pain through MR Spectroscopy (MRS) and Augmented Intelligence (AI)

BROOMFIELD, Colo., Aug. 20, 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 the University of Arizona College of Medicine – Phoenix as a new clinical site in its CLARITY (Chronic Low bAck pain Randomized Independent Trial studY) trial. The groundbreaking CLARITY study is designed to demonstrate Nociscan’s clinical and economic value in spine surgery.

The University of Arizona College of Medicine – Phoenix is home to a nationally recognized neurosurgery and orthopedic spine program with expertise in complex and minimally invasive spine surgery, advanced neuromodulation, and translational research. The program’s integration of clinical care, research and education makes it a natural fit for the CLARITY trial network.

“Chronic low back pain remains one of the most challenging problems in spine surgery, not because we lack the ability to treat it, but because identifying the precise disc responsible for a patient’s pain has historically been imprecise. When I agreed to serve as Principal Investigator for the CLARITY trial, it was because I believed Nociscan represented a meaningful advance in our ability to objectively measure the chemical biomarkers associated with disc pain,” said Nicholas Theodore, MD, FACS, FAANS, Chairman of Neurosurgery, University of Arizona College of Medicine – Phoenix at Banner – University Medical Center Phoenix, and Principal Investigator, CLARITY trial. “Having the University of Arizona College of Medicine – Phoenix participate as a trial site allows my team to contribute directly to generating the evidence needed to establish Nociscan as a standard of care for surgical decision making in chronic low back pain.”

The University of Arizona College of Medicine – Phoenix joins a growing network of high-volume CLARITY trial sites including Johns Hopkins University, Northwestern Medicine, Advocate Aurora Research Institute, Texas Back Institute, Keck Medicine at USC, UHealth — University of Miami Health System, Scripps Health, Lanman Spinal Neurosurgery, and Texas Spine Care Center.

The CLARITY trial is a 300-patient, prospective, randomized, multi-center study evaluating Nociscan in patients undergoing surgical treatment (Fusion / TDR) for discogenic low back pain. The primary endpoint is change in back pain as measured on a 100mm VAS Back at 12 months compared to baseline, with several secondary endpoints collected. The company anticipates having an initial internal data readout and an expected public disclosure of early interim results in Q4 2026.

“Having Dr. Theodore’s institution as an active CLARITY trial site adds another dimension to his leadership as Principal Investigator,” said Ryan Bond, Chief Strategy Officer of Aclarion. “The University of Arizona College of Medicine – Phoenix brings exceptional clinical and research capabilities to the trial, and we are proud to have Dr. Theodore and his team contributing directly to the evidence we are building for Nociscan.”

Chronic low back pain is a global healthcare problem with approximately 266 million people worldwide suffering 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. When used with other diagnostic tools, Nociscan provides critical insights into the location of a patient’s low back pain and demonstrates a 97% surgical success rate when all Nociscan-positive discs are treated.

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: info@aclarion.com

All organizations cited and/or quotes from individuals not part of Aclarion have reviewed and approved the contents herein.

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 growing interest in integrating Nociscan into real-world clinical workflows, having an initial internal data readout and the expected public disclosure of early interim results in Q4 2026 and, the continued expansion of the CLARITY trial to generate the high-quality evidence needed to advance Nociscan. 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, 2025, 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.
ksmith@pcgadvisory.com

Media Contacts:

Jennie Kim
SPRIG Consulting
jennie@sprigconsulting.com