• Aclarion is steadily executing on a proven path toward standard of care.
• Ten prominent Key Opinion Leader (KOL) surgeons have formally engaged to partner with the company to drive market traction and reimbursement.
• Company is poised to report the critical metrics that drive the key catalysts of value creation.

BROOMFIELD, CO, Oct. 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 the posting of an updated Corporate Overview presentation to the investor section of the Company website at Aclarion+Corporate+Overview+Update+1+FINAL.pdf to reflect the achievement of key milestones since becoming a publicly traded company in April of 2022.

Brent Ness, CEO of Aclarion, stated, “Since our Nasdaq IPO, Aclarion has consistently achieved stated catalysts of value creation to bring our Nociscan technology to standard of care. We intend to lead a diagnostic transformation in spine care with clinical and economic evidence. The steps we have taken in a short timeframe demonstrate that leading surgeons and institutions see the value of our technology for improving outcomes and reducing costs and are partnering to help drive Nociscan to standard of care.”

A cornerstone of the Company’s strategy is to engage leading surgeons to use Nociscan technology to non-invasively identify painful discs and demonstrate superior surgical outcomes at a lower economic cost. Aclarion now has 11 of the top spine surgeon leaders in the world aligned and ready to speak on behalf of the efficacy and clinical utility of adding Nociscan to the evaluation of patients who suffer from chronic low back pain. These ten KOLs and one Surgeon Advisory Board leader are committed to integrating Nociscan into their clinical practices, participating in the collection of clinical data, and engaging payers to advocate for coverage decisions.

“Our list of KOLs, advisors, and consultants looks more like that of a multibillion-dollar industry leader than an emerging technology disruptor,” stated Ryan Bond, Chief Strategy Officer of Aclarion. “The next step in our march towards standard of care is to activate MRI centers for each of our surgeon customers. As we announce the onboarding of these MRI’s this will lead to increased scan volumes, the next key catalyst we will be reporting to investors. As scan volumes increase and our surgeons demonstrate to payers that they are getting better clinical outcomes at a lower overall cost, we expect this will result in positive coverage decisions from payers. Payer reimbursement is obviously one of the most important value creation catalysts for any new medical technology.”

Evidence continues to mount in favor of utilizing Nociscan to determine discogenic pain. The Company recently announced the publication of 2-year follow up data on the pivotal Gornet study. Results showed that the improved clinical outcomes demonstrated at one year for patients who underwent surgery at the disc levels identified as painful by Nociscan were durable at two years. “It is important to note that Gornet is a superior outcomes-based study, not just a clinical equivalency study to a gold standard diagnostic,” said Bob Eastlack, Orthopedic Surgeon at Scripps Clinic Torrey Pines in La Jolla, CA.

The economic benefit of the superior results associated with the Gornet study were subsequently evaluated by the Center for Disruptive Musculoskeletal Innovations (CDMI) through The Economic Value Analysis of Low Back Pain Study (EVAL). EVAL results demonstrated that Nociscan has the potential to save the U.S. Healthcare System nearly half a billion dollars annually and more than $1,700 per patient. EVAL was presented in May at both the International Society for the Advancement of Spine Surgery (ISASS) meeting and at Spine Week in Melbourne Australia. The study has been submitted for publication.

The Company was also selected to participate in the Biomarkers for Evaluating Spine Treatments (BEST) Trial funded by the NIH. BEST will enroll over 800 patients at 12 leading academic institutions across the United States, with a subset of 200 patients undergoing advanced biomarker profiling that includes Nociscan. BEST is a revenue generating trial where Nociscan is paid for each scan.

In Q4 of 2023, Aclarion will launch its pivotal CLARITY Trial, a national randomized control trial lead by Dr. Nick Theodore MD from Johns Hopkins Medicine as the Primary Investigator. This multi-site, multi-surgeon study will aim to replicate the surgical outcome success of the Gornet study on a national scale.

Jeff Thramann, M.D., Executive Chairman of Aclarion, concluded, “The Aclarion team is making great progress executing on the proven path for bringing a new technology to standard of care. An incredible KOL panel has been established and MRI activations for these surgeons will be announced over the coming months. The team will begin reporting the subsequent increase in scan volumes in 2024, which are a key near term metric for investors to follow as scan volume and the expected growing body of favorable clinical outcomes data from our KOLs and other surgeon customers will likely drive local payers to cover Nociscan as a first step towards national reimbursement. A favorable coverage decision is expected to be a major inflection point in the value of Aclarion.”

For more information about Aclarion, please visit: Aclarion

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 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.

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