First Patients Enrolled at UHealth – University of Miami in Aclarion’s Pivotal CLARITY Trial
Rhea-AI Summary
Aclarion (NASDAQ:ACON) has announced the enrollment of its first two patients at UHealth – University of Miami Health System in the pivotal CLARITY trial for its Nociscan technology. The study will evaluate Nociscan's effectiveness in improving surgical outcomes for chronic low back pain patients.
The CLARITY trial will enroll 300 patients across multiple US sites, with patients randomized in a 1:1 ratio between surgeons blinded and unblinded to Nociscan results. The trial's primary endpoint is measuring change in back pain at 12 months post-surgery, with interim results expected in Q2 2026.
Nociscan is the first evidence-supported SaaS platform that helps physicians identify painful discs in the lumbar spine through MR Spectroscopy and AI technology, addressing a condition affecting approximately 266 million people globally.
Positive
- First-of-its-kind technology using MR Spectroscopy and AI to identify painful discs
- Large-scale clinical trial with 300 patients across major US medical institutions
- Study timeline on track with interim results expected Q2 2026
- Potential to address massive market of 266 million chronic low back pain patients globally
Negative
- Results and payer coverage not guaranteed until trial completion
- Commercialization dependent on successful trial outcomes
Insights
Aclarion's CLARITY trial begins enrollment, testing whether Nociscan biomarker technology improves spine surgery outcomes, with results expected Q2 2026.
Aclarion has reached a notable milestone with the first two patients enrolled at University of Miami Health System for its pivotal CLARITY trial examining the Nociscan technology for chronic low back pain diagnosis. This prospective, randomized study will evaluate 300 patients across multiple US centers to determine if Nociscan's biomarker identification capabilities improve surgical outcomes.
The trial design is particularly robust - surgeons will be randomized 1:1 between those with access to Nociscan data and those without, allowing for clear assessment of the technology's impact on surgical decision-making and outcomes. The primary endpoint focuses on change in back pain at 12 months measured on a 100mm VAS Back scale compared to baseline.
The enrollment timeline appears on track, with interim results projected for Q2 2026. This timing is crucial for Aclarion, as positive results would support their reimbursement strategy. Dr. Nicholas Theodore of Johns Hopkins Medicine serves as principal investigator, with participation from other prestigious institutions including Northwestern Medicine and USC.
Nociscan represents a potential breakthrough in discogenic pain assessment, as it non-invasively quantifies chemical biomarkers associated with disc pain through MR Spectroscopy and AI algorithms. Success in this trial would address a significant clinical need, given the estimated 266 million people globally suffering from chronic low back pain and the current challenges in objectively identifying pain sources in the lumbar spine.
- Enrollment remains on track with internal interim results expected in Q2 2026
- Randomized study to evaluate 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. 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 that the UHealth – University of Miami Health System and the Miller School of Medicine enrolled its first two patients in the CLARITY (Chronic Low bAck pain Randomized Independent Trial studY) trial. The pivotal CLARITY study is designed to demonstrate Nociscan’s clinical and economic value in spine surgery.
“We are pleased to have enrolled our initial patients at the University of Miami Health System,” commented Gregory Basil, M.D., Director of Endoscopic Spine Surgery and Assistant Professor at UHealth and the Miller School. “CLARITY is an important trial for spine surgeons and their patients with low back pain. The additional information provided by Nociscan is challenging pre-conceived notions about the sources of low back pain and we look forward to understanding the correlation between surgical outcomes and the patient-specific biomarkers provided in the unblinded cohort.”
The CLARITY trial is a prospective, randomized multi-center study evaluating patients who are scheduled to undergo surgical treatment for discogenic back pain in up to two lumbar levels. 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 enrolling sites include Northwestern Medicine, Advocate Health, Texas Back Institute, and USC.
“The CLARITY trial is a major catalyst for driving long-term value as we believe these results will be an important milestone in securing broad payer coverage for Nociscan,” said Ryan Bond, Chief Strategy Officer of Aclarion. “Our timelines for the CLARITY trial remain on track due to the commitment of our trial investigators and their teams to help us generate the evidence needed to advance Nociscan and expand access to patients in need.”
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: info@aclarion.com
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.
ksmith@pcgadvisory.com
Media Contacts:
Jessica Starman
media@elev8newmedia.com
Kai Hill
UHealth – University of Miami Health System
khill@med.miami.edu
FAQ
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