Aclarion Welcomes NYU Langone Health to CLARITY Trial Network, Now Enrolling at Eleven Sites

• NYU Langone Health is a nationally recognized academic medical center with deep expertise in spine surgery, minimally invasive procedures, robotic spine surgery, and clinical research

• CLARITY is 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., Sept. 29, 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 NYU Langone Health 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 NYU Langone Spine Center is one of the nation's most comprehensive spine care programs, offering both nonsurgical and surgical treatment of degenerative spine conditions. Ranked No. 1 in the nation for neurology and neurosurgery and No. 2 for Orthopedic Surgery by U.S. News & World Report, the Spine Center serves more than 25,000 patients each year, with its surgical team performing more than 4,700 procedures annually. The program takes a collaborative approach to care, bringing together orthopedic surgeons, neurosurgeons, physiatrists, and rehabilitation specialists under one roof.

"Every patient who comes to me with chronic low back pain has a story — potentially years of trying to find answers, manage symptoms, and get their life back. As surgeons, we owe it to them to use appropriate tools to understand what is truly driving their pain before we recommend treatment,” said Jeffrey A. Goldstein, MD, Director, Spine Surgery Fellowship Program and Clinical Professor of Orthopedic Surgery and Neurosurgery, NYU Grossman School of Medicine, NYU Langone Health.

NYU Langone Health 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, Texas Spine Care Center, and University of Arizona College of Medicine – Phoenix. The principal investigator for the trial is Dr. Nicholas Theodore, Chairman of Neurosurgery at the University of Arizona College of Medicine – Phoenix at Banner – University Medical Center Phoenix.

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.

"NYU Langone Health is one of the most respected academic medical centers in the country, and Dr. Goldstein is widely recognized for his expertise in spine surgery and his commitment to innovation and research," said Ryan Bond, Chief Strategy Officer of Aclarion. "Their addition to the CLARITY network reflects the growing interest among leading institutions in the clinical value Nociscan can bring to surgical decision-making for chronic low back pain."

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 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:

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SPRIG Consulting
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