Confirms predictive value of Nociscan for identifying painful discs.

Nociscan demonstrated a sensitivity of 100% and a specificity of 80% compared to provocative discography (PD), suggesting Nociscan provides better information to surgeons.

BROOMFIELD, CO, March 04, 2024 (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 the clinical paper, Establishing a Gold Standard for Noninvasive Identification of Painful Lumbar Discs: Prospective Comparison of Magnetic Resonance Spectroscopy vs Low-Pressure Provocation Discography by the International Journal of Spine Surgery, the official scientific journal of the International Society for the Advancement of Spine Surgery (ISASS).

Verifying lumbar disc pain has been a clinical challenge. Low-pressure provocative discography (PD) has served as the gold standard, despite well-documented drawbacks including being highly invasive and presenting difficult-to-interpret results. Despite the small sample size of the study, this newly published prospective comparison study clearly demonstrates that Nociscan results accurately identify discs that are known to be painful according to provocative discogram.

Achieving a result of 100% sensitivity (5/5 lumbar discs) means that in this study if discography indicates a disc is painful, then Nociscan will also indicate that the disc is painful. On the other hand, with a specificity of 80% (8/10 lumbar discs), this means that when discography indicates a disc is not-painful, Nociscan will disagree 20% of the time by indicating the disc actually contains the biomarkers consistent with a painful disc.

The Company believes it is this ability of Nociscan to objectively measure pain biomarkers that gives surgeons better information than discogram to inform their surgical decision making. The Company further believes that this differentiation from discogram is the reason Aclarion was able to demonstrate improved surgical outcomes with Nociscan in the Gornet study.

Ryan Bond, Chief Strategy Officer, Aclarion stated, "This prospective comparison of Nociscan against the historical benchmark, provocative discography, illustrates powerful conclusions. The authors of the paper have dedicated their careers to advancing the scientific understanding of low back pain pathology, while also striving to improve treatment outcomes. This paper adds to Aclarion's growing body of evidence for Nociscan as providing valuable information for the non-invasive identification of painful lumbar discs."

Aclarion's proprietary decision-support tool, Nociscan, is the first evidence-supported SaaS platform to non-invasively 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.

"In 2023, we published the durability of 2-year clinical outcomes in a hallmark study by Dr. Gornet and others," said Brent Ness, CEO, Aclarion. "Today's announcement expands on prior research supporting Nociscan and further advances our stated objective to lead with overwhelming evidence on our journey to become the standard of care within the low back pain industry. Soon we will launch our national multicenter clinical trial, CLARITY, an outcomes study designed to further evaluate the role of Nociscan in the diagnosis and surgical treatment of patients suffering from chronic low back pain. We look forward to introducing Nociscan to a growing number of physicians and patients."

Access to the publication can be found here.
https://www.ijssurgery.com/content/early/2024/02/23/8574

Aclarion is sponsoring the upcoming 3 ^rd Annual Sonntag Spine Symposium, March 22, 2024. Visit us there to learn more about the Nociscan solution.

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.

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