Aclarion Announces Publication of 2YR Outcomes in Groundbreaking Clinical Trial

Rhea-AI Summary

Aclarion, a healthcare technology company focused on chronic low back pain, announced significant findings from a clinical trial involving 78 patients. The trial demonstrated an 85% success rate for surgeries targeting discs identified by Nociscan, marking a 22 percentage point improvement over treatments not aligned with Nociscan results (85% vs. 63%; p=0.07). Nociscan, an augmented intelligence platform, measures pain biomarkers without invasive procedures like discography. This two-year durability data, published in the European Spine Journal, emphasizes the platform's potential to aid physicians in optimizing treatment strategies. Aclarion plans to continue clinical trials to further validate these findings and present additional economic benefits at upcoming conferences.

Positive

• 85% success rate for surgeries targeting Nociscan-identified discs.
• 22 percentage point improvement in outcomes compared to non-Nociscan aligned treatments.
• Nociscan offers a non-invasive method for identifying painful discs, enhancing diagnostic accuracy.
• Durability of results supports ongoing commitment to changing low back pain treatment standards.
• Plans for additional clinical trials and presentations at spine society meetings to further establish Nociscan's benefits.

Negative

• None.

Success rate at 2 years for discogenic low back pain surgeries was 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)

Nociscan is the first augmented intelligence platform to measure pain biomarkers in the lumbar spine

BROOMFIELD, CO, April 24, 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 the publication of two-year durability data which demonstrates improved surgical outcomes for discogenic low back pain (DLBP) surgeries at chemically painful lumbar discs identified by Nociscan.

The multi-year, single site clinical trial comprised 78 patients who received surgery for DLBP following standard clinical work-up including MRI and provocative discography. Nociscan was performed on all patients but was not available in the surgical decision-making process. The patient outcomes were evaluated using the Oswestry Disability Index (ODI) scoring scale (100 points), a common clinical outcomes measure for low back pain, where surgical success was defined using an industry-standard improvement of 15 points or more between surgeries that were concordant versus discordant with Nociscan results. Surgical success rates at 2 years illustrates a 22 percentage point improvement (p = 0.07) between the two groups. The results suggest that Nociscan provides valuable new information that can help physicians successfully treat DLBP.

Matthew Gornet, MD, orthopedic surgeon and lead author, stated, “The two-year surgical outcomes of the clinical trial are significantly clear on the primary (ODI) endpoint. I believe Nociscan is something that will accurately help all physicians treating chronic low back pain, and I believe it can change the standard of care. I feel uncomfortable now moving forward in treatment of low back pain patients without the information Nociscan provides, like a cardiologist who does not have an echocardiogram.” Dr. Gornet is a fellowship-trained spine surgeon, accomplished author, and national leader in treating patients with chronic low back pain.

Chronic low back pain (cLBP) is a global healthcare problem with approximately 266 million people worldwide suffering from degenerative spine disease and low back pain. “For decades, the source of low back pain has been difficult to precisely identify. Provocative discography is an effective diagnostic tool for discogenic pain, but it is invasive, painful, expensive, and unfavorable with patients. MRI has become a standard diagnostic for back pain, but MRI cannot differentiate between discs that are painful and those that are merely aging. Nociscan objectively measures pain biomarkers in an MRI-like experience, without the negative attributes of discography,” said Ryan Bond, Chief Strategy Officer at Aclarion.

"The durability of the 2-year outcomes is a hallmark achievement. These important results will serve as the cornerstone of Aclarion’s on-going commitment to leading with clinical evidence and changing the standard of care for low back pain. In addition, the Economic Value Analysis of Low back pain (EVAL) abstract, a healthcare economics study completed by CDMI illustrating dominant economic and clinical benefits for Nociscan, has been submitted for presentation at upcoming spine society meetings. Aclarion is moving forward with additional clinical trials, which collectively will expand on the impressive foundational evidence compiled by Dr. Gornet and team,” said Brent Ness, CEO at Aclarion.

“The two year durable results of the Gornet Trial, published in the reputable European Spine Journal, add to the mounting evidence supporting the logical conclusion that knowing the source of pain enables better treatment planning and eventual outcomes,” stated Robert Eastlack, MD, Head of the Division of Spine Surgery at Scripps Clinic in San Diego, CA. “The fact that this is a surgical outcome trial, not just a comparison to the accuracy of other existing diagnostic tools, bolsters my confidence in using Nociscan in my practice.”

Access to publication can be found here: https://pubmed.ncbi.nlm.nih.gov/37014434/

Aclarion will be hosting a company symposium at SPINEWEEK 2023, May 1-5. For more information about SPINEWEEK 2023, please visit: www.spineweek.org

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 are the results of Aclarion's clinical trial for Nociscan?

The clinical trial showed an 85% surgical success rate for discs identified by Nociscan, which is a 22 percentage point improvement over surgeries not aligned with Nociscan results.

What is Nociscan?

Nociscan is an augmented intelligence platform that measures pain biomarkers in the lumbar spine, helping physicians identify the source of chronic low back pain.

What does the two-year durability data imply for Aclarion?

The two-year durability data suggests that Nociscan can significantly improve surgical outcomes for patients with discogenic low back pain.

When will Aclarion present additional findings on Nociscan?

Aclarion plans to present additional economic and clinical findings related to Nociscan at upcoming spine society meetings.