First Patient Enrolled in Aclarion’s Groundbreaking CLARITY Trial

Rhea-AI Summary

Aclarion (NASDAQ:ACON) has announced the enrollment of its first patient in the CLARITY trial at the Texas Back Institute. The trial aims to evaluate Nociscan's clinical and economic value in spine surgery. Nociscan is a SaaS platform that helps physicians identify sources of chronic low back pain using MR Spectroscopy and AI technology.

The CLARITY trial will enroll 300 patients across multiple US sites, studying 1- or 2-level discogenic low back pain surgical treatments. The randomized study will compare outcomes between surgeons with and without access to Nociscan data. The company expects interim results in Q2 2026, with the primary endpoint measuring changes in back pain at 12 months post-surgery.

Positive

• First patient enrolled in CLARITY trial, marking significant progress in clinical validation
• Partnership with prestigious institutions including Texas Back Institute, Johns Hopkins Medicine, and Northwestern Medicine
• Large-scale study with 300 patients across multiple high-volume US sites
• Addresses global market of 266 million people suffering from degenerative spine disease

Negative

• Results not expected until Q2 2026, indicating a lengthy validation process
• Requires successful completion of trial to validate clinical effectiveness
• Faces challenge of proving superiority over existing diagnostic methods

Insights

Medical Technology Researcher

First patient enrolled in Aclarion's CLARITY trial evaluating Nociscan's ability to improve surgical outcomes for chronic low back pain.

The enrollment of the first patient in Aclarion's CLARITY trial represents a significant milestone in the clinical validation pathway for their Nociscan platform. This randomized trial will evaluate 300 patients across multiple prestigious institutions including Texas Back Institute, Johns Hopkins, Northwestern Medicine, and others - lending substantial credibility to the study design.

The trial's methodology is particularly robust, employing a 1:1 randomization ratio between surgeons blinded to Nociscan data versus those with access to it before performing spine surgeries (Fusion/TDR). This will directly measure whether Nociscan's biomarker analysis improves surgical outcomes - with the primary endpoint measuring back pain reduction at 12 months post-surgery.

Nociscan's technology represents a potentially significant advancement in spine care. Current diagnostic approaches for discogenic pain have limitations in objectively identifying which discs are causing pain. By using MR Spectroscopy and AI to analyze chemical biomarkers associated with disc pain, Nociscan offers an objective, non-invasive approach to a traditionally subjective diagnostic challenge.

The addressable market is substantial - with approximately 266 million people worldwide suffering from degenerative spine disease and low back pain. If the CLARITY trial demonstrates Nociscan's ability to improve surgical outcomes, it could establish a new standard of care in spine surgery patient selection.

However, investors should note the extended timeline - with interim results not expected until Q2 2026. This enrollment represents just the beginning of a lengthy clinical validation process, and commercial impact would depend on positive trial results that are still approximately a year away.

• The first CLARITY patient was enrolled at the Texas Back Institute, a world leader in advancing spine technology, science, and education, as well as patient care
• CLARITY is a 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)
• Company reaffirms internal interim results of CLARITY expected in Q2 2026

BROOMFIELD, Colo., June 25, 2025 (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 first patient enrollment in the CLARITY (Chronic Low bAck pain Randomized Independent Trial studY) trial evaluating Nociscan’s clinical and economic value in spine surgery. The first patient was enrolled at the Texas Back Institute.

“Texas Back Institute has a long history of advancing spine care through clinical trial research,” said Alexander Satin, MD, board-certified orthopedic spine surgeon and principal investigator for the CLARITY trial. “We have followed the advancements from Aclarion and their Nociscan platform. The CLARITY trial will allow us to observe patient-specific critical pain biomarker data and the relationship with surgical outcomes. Our physicians and research leaders have extensive experience treating patients with chronic low back pain and we are pleased to participate in this important trial, including enrollment of the first patient.”

The CLARITY trial is a prospective, randomized multi-center study evaluating patients who are scheduled to undergo surgical treatment of 1- or 2- level discogenic low back pain. The study will enroll 300 patients at multiple high-volume sites across the US and all patients will receive a Nociscan prior to surgery. The study will be randomized at a 1:1 ratio of surgeons blinded-to-Nociscan and unblinded-to-Nociscan to guide the surgical treatment (Fusion / TDR). 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 principal investigator for the trial is Dr. Nicholas Theodore of Johns Hopkins Medicine. Other sites that have been activated include Northwestern Medicine, Advocate Aurora Research Institute, Keck Medicine at USC and UHealth - University of Miami Health System and University of Miami Miller School of Medicine.

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 and has the potential to drive better surgical outcomes.

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. 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.
ksmith@pcgadvisory.com

Media Contacts:

Jennie Kim
SPRIG Consulting
jennie@sprigconsulting.com

FAQ

What is the CLARITY trial for Aclarion's (ACON) Nociscan technology?

The CLARITY trial is a randomized clinical trial evaluating Nociscan's ability to improve surgical outcomes for chronic low back pain, enrolling 300 patients across multiple US sites.

When will Aclarion (ACON) release CLARITY trial results?

Aclarion expects to release interim results of the CLARITY trial in Q2 2026.

How many patients will be enrolled in Aclarion's CLARITY trial?

The CLARITY trial will enroll 300 patients at multiple high-volume sites across the US, with a 1:1 randomization ratio between surgeons blinded and unblinded to Nociscan results.

Which medical centers are participating in Aclarion's CLARITY trial?

Participating centers include Texas Back Institute, Johns Hopkins Medicine, Northwestern Medicine, Advocate Aurora Research Institute, Keck Medicine at USC, and UHealth - University of Miami Health System.

What is the primary endpoint of Aclarion's CLARITY trial?

The primary endpoint is the change in back pain as measured on a 100mm VAS Back scale at 12 months compared to baseline.