Aclarion Adds UHealth, University of Miami Miller School of Medicine as CLARITY Trial Site
- Trial includes prestigious medical institutions like UHealth, Johns Hopkins Medicine, and Northwestern Medicine
- Study addresses a significant global health issue affecting 266 million people worldwide
- Nociscan is the first evidence-supported SaaS platform for noninvasively identifying painful discs
- Technology combines advanced MR Spectroscopy with AI for better diagnostic capabilities
- Results from the clinical trial won't be available for at least 12 months
- Large-scale trial of 300 patients may take significant time to complete enrollment
Insights
Aclarion's addition of UHealth as a CLARITY trial site strengthens their clinical study, enhancing credibility for their Nociscan diagnostic technology.
The addition of UHealth — University of Miami Health System as a CLARITY trial site represents a meaningful advancement for Aclarion's clinical validation strategy. This development strengthens the trial's institutional credibility by adding another prestigious academic medical center alongside Johns Hopkins, Northwestern Medicine, and other major research institutions.
The CLARITY trial's design is methodologically robust — a prospective, randomized multi-center study enrolling 300 patients with a 1:1 randomization ratio comparing outcomes between surgeons who have access to Nociscan data versus those who don't. This design directly tests whether Nociscan's biomarker technology meaningfully improves surgical decision-making and patient outcomes.
The primary endpoint of change in back pain at 12 months (measured on a 100mm VAS scale) is clinically relevant and directly addresses the technology's core value proposition. This endpoint will determine if Nociscan can help surgeons better select surgical candidates and approaches, potentially reducing failed back surgery syndrome cases.
From a market perspective, chronic low back pain represents an enormous addressable market (266 million people worldwide), and successful trial results could position Nociscan as a standard pre-surgical diagnostic tool. Aclarion is strategically pursuing the evidence-based medicine approach required for both regulatory clearance and payor adoption in the spine care marketplace.
The inclusion of Dr. Gregory Basil, who specializes in endoscopic spine surgery, is particularly relevant as minimally invasive approaches continue gaining traction in spine care, potentially expanding Nociscan's applicability across surgical techniques.
- UHealth — University of Miami Health System and the University of Miami Miller School of Medicine provide world-class research and renowned clinical expertise in spine surgery
- 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., June 10, 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 addition of UHealth — University of Miami Health System and the University of Miami Miler School of Medicine as a CLARITY (Chronic Low bAck pain Randomized Independent Trial studY) trial site. The landmark CLARITY study is designed to demonstrate Nociscan’s clinical and economic value in spine surgery.
“I have a particular interest in ‘ultra-minimally’ invasive approaches to the spine including endoscopic spine surgery,” said Gregory Basil, MD, of UHealth who is also Director of Endoscopic Spine Surgery and Assistant Professor at the University of Miami Miller School of Medicine, University of Miami. “We believe in customizing treatments to each patient’s pathology, goals, needs, and lifestyle, and in this regard, leveraging novel technologies, like Nociscan, to better understand our patient’s low back pain for personalized treatments. The CLARITY trial is a unique opportunity for me and my colleagues at the Miller School of Medicine to advance the spine industry and showcase the research capabilities at the University of Miami.”
UHealth in conjunction with the Miller School of Medicine, is the latest CLARITY trial site, joining Johns Hopkins Medicine, Northwestern Medicine, Advocate Aurora Research Institute, Texas Back Institute, and Keck Medicine at USC. The principal investigator for the trial is Dr. Nicholas Theodore of Johns Hopkins Medicine.
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.
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.
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FAQ
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