Aclarion Appoints Nicholas Theodore, MD as Principal Investigator for CLARITY Post-Market Trial Evaluating Nociscan in the Diagnosis and Treatment of Chronic Low Back Pain

Rhea-AI Summary

Aclarion, a healthcare technology company, announced a post-market trial to evaluate the role of Nociscan in diagnosing and treating chronic low back pain. The trial will be led by Dr. Nicholas Theodore of Johns Hopkins University. Nociscan has shown promise in objectively measuring pain-generating biomarkers in the spine. The trial aims to expand on previous successful outcomes and establish Nociscan as a standard of care.

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• Aclarion announced a post-market trial to evaluate Nociscan in diagnosing and treating chronic low back pain. Nociscan has shown a unique capability for measuring pain-generating biomarkers in the spine. The trial aims to establish Nociscan as a standard of care, building on previous successful outcomes.

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• None.

Nicholas Theodore, MD, FACS, FAANS, is Director of Neurosurgical Spine Center, Johns Hopkins, and Professor of Neurosurgery, Orthopaedics and Biomedical Engineering

CLARITY is a Post-market, Multi-site Trial That Will Further Evaluate the Role of Nociscan in the Diagnosis and Surgical Ttreatment of Chronic Low Back Pain.

CLARITY is Targeted to Begin in the Second Half of 2023.

BROOMFIELD, CO, May 02, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – 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 that Nicholas Theodore, MD, Director of Neurosurgical Spine Center at Johns Hopkins University, will serve as the Principal Investigator in a post-market, multi-site trial, that will further evaluate the role of Nociscan in the diagnosis and surgical treatment of patients suffering from chronic low back pain.

“Diagnosing the source of chronic low back pain has been an industry conundrum for decades,” said Dr. Theodore. “Moreover, as clinicians, we are challenged by important limitations with alternative diagnostic tools like MRI and discography. Aclarion’s Nociscan tool has already illustrated a unique and compelling capability for objectively measuring pain-generating chemical biomarkers in the lumbar spine, and I am equally interested in how it may apply to measuring disc degeneration.  I believe these innovations will become foundational to the diagnosis and treatment of chronic low back pain.”

On April 4th, 2023, the European Spine Journal published a peer reviewed article titled “Magnetic resonance spectroscopy (MRS) identification of chemically painful lumbar discs leads to improved 6-, 12-, and 24-month outcomes for discogenic low back pain surgeries” by Matthew F. Gornet, MD et al. Success rates at 2 years for discogenic low back pain (DLBP) surgeries were 85% for patients whose treatment strategy was consistent with Nociscan-identified discs, a 22 percentage point improvement over patients whose treatment strategy was inconsistent with Nociscan-identified discs (85% vs. 63%; p=0.07). The results suggest that Nociscan provides valuable new information that can help physicians successfully treat DLBP.

Building on the success of the recently published Gornet 2YR clinical outcomes, CLARITY will expand the protocol of the Gornet study to up to 14 sites and target enrollment of approximately 300 patients. Similar to Gornet, surgeons will be blinded to Nociscan results while utilizing standard diagnostic imaging (MRI) and physical examination to decide which discs to surgically treat in each patient. After surgery, the outcomes of patients whose surgically treated discs match the discs identified as painful by Nociscan will be compared to the outcomes of patients where the surgically treated discs did not match the discs Nociscan identified as painful. It is expected that CLARITY will show similar success as Gornet but in a much larger multicenter study aimed at establishing Nociscan as a standard of care for surgical decision making.  

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, giving physicians clarity to optimize treatment strategies.

CLARITY represents a new post-market clinical trial for Aclarion. “Aclarion is excited to add this important evidence to our portfolio and honored that Dr. Theodore from Johns Hopkins has enthusiastically accepted the PI role,” says Brent Ness, CEO of Aclarion. “CLARITY will add to the compelling two-year outcomes of the Gornet trial and the cost-effectiveness health economics study (EVAL).”As previously announced, Aclarion has been used in two National Institutes of Health trials in the US (comeBACK and BEST) focused on improved understanding of low back pain and the effect of non-surgical treatment options.

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, 2022, 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.
646.823.8656
ksmith@pcgadvisory.com

Media Contacts:
Jodi Lamberti
SPRIG Consulting
612.812.7477
jodi@sprigconsulting.com

FAQ

What is the purpose of the trial?

The trial aims to evaluate the role of Nociscan in diagnosing and treating chronic low back pain.

Who is leading the trial?

Dr. Nicholas Theodore of Johns Hopkins University is leading the trial.

What is Nociscan?

Nociscan is a tool developed by Aclarion that objectively measures pain-generating biomarkers in the spine.

What are the expected outcomes of the trial?

The trial aims to establish Nociscan as a standard of care for surgical decision making in chronic low back pain.

What previous successful outcomes is the trial building on?

The trial is building on the successful outcomes of the Gornet trial, which showed improved outcomes for discogenic low back pain surgeries using Nociscan.