Aclarion to Present 2-year Follow Up Data on Pivotal Clinical Trial Linking Nociscan to Better Surgical Outcomes for Discogenic Low Back Pain

Rhea-AI Summary

Aclarion Inc. (NASDAQ: ACON, ACONW) announced promising two-year results from its pivotal clinical trial on Nociscan, showing that 87% of patients treated for chronic discogenic low back pain reported significant clinical improvement. Results will be discussed at the Annual State of Spine Surgery Think Tank in Mexico, along with a plan for future clinical studies. Aclarion aims to position Nociscan as the standard of care, leveraging its technology to distinguish painful discs and improve cost-effectiveness in treatment. Initial economic analysis results are expected in Q4 2022.

Positive

• 87% of patients treated with Nociscan reported significant improvement after two years.
• The clinical trial results highlight Nociscan's potential to improve treatment outcomes.
• Aclarion plans to initiate several clinical studies, including a definitive randomized control trial in Q3 2022.

Negative

• None.

Superior Clinical Outcomes for Nociscan^TM Proving to be Durable at Two Years

Two Year Results and the Schedule of Future Clinical Trials to be Outlined at the Annual State of Spine Surgery Think Tank 2022

SAN MATEO, CA / ACCESSWIRE / June 22, 2022 / Aclarion, Inc. ("Aclarion" or the "Company") (NASDAQ:ACON)(NASDAQ:ACONW), a healthcare technology company that is leveraging biomarkers and proprietary algorithms to identify the location of chronic low back pain, announced today that the Company will be participating in the 17^th Annual State of Spine Surgery Think Tank in Los Cabos, Mexico, June 22-25, 2022, where it will be presenting 2-year follow up data on its pivotal clinical trial published in the European Spine Journal in 2019. The company will also outline its schedule for release of an economic analysis report and initiation of future clinical studies aimed at establishing Nociscan as a standard of care for chronic low back pain.

Nociscan is the first evidence-supported SaaS platform to noninvasively help physicians distinguish between painful and nonpainful discs in the lumbar spine. The technology leverages magnetic resonance spectroscopy (MRS) and proprietary algorithms to identify and analyze chemical biomarkers in the discs demonstrated to be associated with pain. When used with other diagnostic tools, the Aclarion solution provides critical insights into the location of the patient's lower back pain, giving physicians clarity to optimize treatment strategies.

On Friday, June 24^th, Nociscan will be showcased in a presentation titled, "Aclarion: Resolving the Discogenic Low Back Pain Dilemma," to be presented by Robert Eastlack, MD, Division Head, Spine Surgery, Scripps Clinic Medical Group. "I was introduced to Aclarion's pioneering innovation several years ago," stated Dr. Eastlack. "Nociscan objectively measures pathological disc pain in a noninvasive manner, which addresses one of the biggest problems in our industry. Aclarion's solution provides me with never-before-available, critical information that helps me better diagnose and treat my chronic low back pain patients."

In a paper published in the European Spine Journal in 2019, 97% of patients who had surgical intervention for chronic discogenic low back pain met the criteria for significant clinical improvement at one year follow up if all the discs identified as painful by Nociscan were included in the patient's surgical treatment. This compared to only 54% of patients meeting the criteria for success when a painful disc identified by Nociscan was excluded from treatment or a nonpainful disc was included in treatment. After two years of follow up, these results are proving to be durable with 87% of patients who had surgery at all discs identified as painful by Nociscan continuing to show significant clinical improvement.

"The durability of the treatment response highlights the potential of Nociscan to improve outcomes while significantly lowering the cost of care. We will be building on these results by engaging an economic analysis team at a prominent academic institution to quantify the cost savings expected to result from the improvement in clinical outcomes we are now showing to be durable," said Brent Ness, the CEO of Aclarion. "We expect initial results of the EVAL analysis to be released in Q4 of this year."

As part of the presentation, Dr. Eastlack will also outline the schedule of clinical trials Aclarion will be initiating this year to build upon the existing body of evidence supporting the efficacy of Nociscan.

Ryan Bond, Chief Strategy Officer of Aclarion, added, "Our mantra is to lead with overwhelming clinical evidence. We believe this two-year follow up data is a compelling first step that we will build upon through a comprehensive clinical strategy that includes the initiation of CLARITY, a definitive prospective randomized control trial we will initiate in Q3 of this year."

Aclarion is using recent IPO funding to focus on securing favorable coverage decisions from payers. This includes utilizing existing peer-reviewed publications and clinical results to pursue immediate coverage decisions for Nociscan, a non-invasive and objective diagnostic, as an alternative to discogram, an invasive procedure that is painful by design. The Company is already engaging payers for these coverage decisions and will report on favorable results as they develop. In addition, the Company is pursuing an aggressive clinical strategy to become standard of care for the treatment of low back pain. This clinical strategy includes not only CLARITY, but additional clinical studies called BACPAC BEST and BOND. The Company will report on the initiation of each of these studies as they launch in 2022.

About Aclarion, Inc.

Aclarion is a healthcare technology company that leverages Magnetic Resonance Spectroscopy ("MRS"), proprietary biomarkers and algorithms to optimize clinical treatments. Aclarion's technology addresses the $134.5B U.S. low back and neck pain market. The Company is currently utilizing Artificial Intelligence ("AI") to assist in quality control processes that flag spectroscopy data indicative of a poor MRS study. The Company is also researching the application of AI and machine learning platforms to analyze both the raw spectroscopy data and the post-processed signal to evaluate whether AI platforms can more efficiently and more effectively associate MRS data with clinical outcomes.

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 Prospectus dated April 21, 2022 as filed with the Securities and Exchange Commission on April 25, 2022 under Rule 424(b)(4), 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

SOURCE: Aclarion Inc.

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https://www.accesswire.com/706113/Aclarion-to-Present-2-year-Follow-Up-Data-on-Pivotal-Clinical-Trial-Linking-Nociscan-to-Better-Surgical-Outcomes-for-Discogenic-Low-Back-Pain

FAQ

What significant results did Aclarion present for Nociscan?

Aclarion reported that 87% of patients treated with Nociscan showed significant clinical improvement after two years.

When will Aclarion release its economic analysis report?

Aclarion expects to release the initial results of its economic analysis in Q4 2022.

What is the purpose of the upcoming clinical trials mentioned in the press release?

The upcoming clinical trials aim to further establish Nociscan as a standard of care for chronic low back pain and to build upon existing evidence.

How does Nociscan differentiate between painful and nonpainful discs?

Nociscan uses magnetic resonance spectroscopy and proprietary algorithms to analyze chemical biomarkers associated with pain.

What impact could Nociscan have on the treatment of low back pain?

Nociscan has the potential to improve clinical outcomes while lowering healthcare costs associated with chronic low back pain treatment.