Aclarion Launches Second Clinical Utility and Economic (CLUE) Trial Site With First Surgeon in New Jersey

CLUE is a Multi-center Trial to Identify how Often Nociscan’s AI Data Changes the Initial Treatment Plan for Patients With Chronic Low Back Pain

Dr. Justin Kubeck Will Initiate CLUE in New Jersey at Ocean Pain and Spine in Toms River

BROOMFIELD, CO, Aug. 29, 2024 (GLOBE NEWSWIRE) -- Aclarion, Inc., (“Aclarion” or the “Company”) (Nasdaq: ACON, ACONW), a healthcare technology company that is leveraging biomarkers and proprietary augmented intelligence algorithms to help physicians identify the location of chronic low back pain, announced today the expansion of the multi-center CLUE Trial to New Jersey. Justin Kubeck, MD, orthopedic spine surgeon and founder of Ocean Pain and Spine in Toms River, NJ will join an expanding network of spine surgeons participating in CLUE to build a growing body of data supporting the real-world value of adding Nociscan’s AI generated data to existing diagnostic evaluation methods for the treatment of chronic low back pain.

Dr. Kubeck is the second surgeon to join CLUE since the trial was announced earlier this month, joining Dr. John Keller, a neurosurgical spine surgeon in Michigan. The Company expects a steady cadence of spine surgeons to join CLUE in the coming months to rapidly provide compelling data to payers as to how frequently Nociscan has a significant impact on the decision-making process during the critical stage when surgeons are planning the optimal treatment for their patient. 

“I always tell new patients that we need to see what makes sense for their individual circumstances – whether it’s medication, or therapy, or ultimately, surgery,” explained Dr. Kubeck. “There is a protocol that I follow; I don’t ever just go in and do surgery. For me, developing the best treatment plan for an individual patient is very proceduralized. Once we determine the problem, then I say, ‘Here’s what you can expect, here are your options, and here is what we will decide together.’ Nociscan will be an invaluable decision support tool when evaluating diagnosis and treatment.”

Globally, 266 million people suffer 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. Biomarker data is entered into proprietary algorithms to highlight 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.

"Real world evidence is incredibly valuable when evaluating the influence and utility of an emerging diagnostic tool and when this evidence can be rapidly secured by experienced surgeons through a trial like CLUE, it becomes a critical tool for driving early payer coverage decisions,” stated Ryan Bond, Chief Strategy Officer at Aclarion. “We welcome the inbound interest that has launched our CLUE trial at multiple sites and encourage others to reach out at if they are interested in bringing Nociscan to their patients and participating in the CLUE trial.”

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 .

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, 2023, 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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