- Advocate Health actively participates in research studies and is an innovator in technology, including spine
- The CLARITY trial is 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., May 05, 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 Advocate Aurora Research Institute, part of Advocate Health, as a CLARITY (Chronic Low bAck pain Randomized Independent Trial studY) site. CLARITY is a pivotal, randomized trial designed to demonstrate Nociscan's clinical and economic value in spine surgery.
"Advocate Aurora Research Institute conducts hundreds of unique research projects each year to advance healthcare worldwide. From groundbreaking clinical trials to academic and biorepository research – we're translating the latest findings into better care, prevention strategies and treatments for patients and their families," said Patrick Sugrue, MD, Neurosurgeon at Advocate Health.
"In addition to our vast clinical trial work, our spine surgeons diagnose and treat many patients who suffer from chronic low back pain, which is difficult to diagnose. Aclarion's innovative Nociscan platform provides physicians with an advanced, adjunctive diagnostic tool for evaluating low back pain. We are pleased to participate in the CLARITY trial, a post-market, randomized controlled study examining Nociscan's impact on discogenic low back pain surgical outcomes," added Dr. Sugrue.
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.
"Millions of people worldwide suffer from chronic low back pain yet identifying the source of pain is not clearcut with traditional imaging. Nociscan aims to change that by enabling physicians to ‘see' the difference between painful and non-painful discs so they can create more precise treatment plans," said Ryan Bond, Chief Strategy Officer at Aclarion. "We are honored to work with Dr. Sugrue and Advocate Health on the CLARITY trial to demonstrate the clinical value of 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 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: [email protected]
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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