ACON Aclarion Inc

Aclarion, Inc., (“Aclarion” or the “Company”) (Nasdaq: ACON, ACONW), a healthcare technology company that is leveraging biomarkers and proprietary augmented intelligence (AI) algorithms to help physicians identify the location of chronic low back pain, today provided a corporate update. The update reviews the successful achievement of several recent key milestones and provides perspective on the positive implications of those catalysts as the Company continues to establish Nociscan as a standard of care decision support tool for the treatment of patients with chronic low back pain.

“We are excited with the recent positive success we have been awarded as Aclarion has consistently achieved stated catalysts of value creation that fall into a very concise framework proven to bring disruptive technological advancements to standard of care in the healthcare sector,” said Brent Ness, CEO of Aclarion. “We intend to lead a positive diagnostic transformation in spine care through clinical and economic evidence that proves the promising value of Nociscan. The building blocks we have executed over the past two years have recently led to the achievement of our most important catalyst to date which is multiple private insurance companies in the UK electing to pay for Nociscan. Payer coverage is critical to driving Nociscan to standard of care. We are providing this corporate update to share the process involved in achieving this milestone, how that process is being replicated at many sites throughout the U.S., how we are coordinating clinical studies in support of payment, and why increasing payer coverage decisions are critical catalysts for driving the valuation of our company. We are clearly excited not only by our recent successes but even more so for our upcoming near term catalysts.”

The cornerstone of Aclarion’s strategy to drive payer coverage is to partner with Key Opinion Leader (KOL) physicians who see the value of Nociscan in their practice and advocate for insurance coverage so the physician can provide better care to more patients. Aclarion now has a panel of 10 of the top spine surgeon leaders in the world aligned and actively speaking on behalf of the efficacy and clinical utility of adding Nociscan to the evaluation of patients who suffer from chronic low back pain. “These KOLs are participating in the collection of clinical data, they are engaging insurance companies and benefits management entities to advocate for coverage decisions and representing Nociscan as an important technology worthy of societal endorsement,” said Ryan Bond, Chief Strategy Officer of Aclarion. “We believe the quality of a company’s KOL network is a direct reflection of the importance and promise of any new technology and our list of KOLs is more like that of a multibillion-dollar industry leader than an emerging technology disruptor.”

Aclarion’s KOL advocacy strategy applied to the UK has led to great success and is a model of what the Company expects to see replicated with their KOLs in the United States. Physicians in the UK originally set out to evaluate Nociscan technology across 30 patients to determine if the technology was helpful. After comparing Nociscan to invasive discography across only 20 patients, the UK physicians saw the value of Nociscan and converted their trial agreement into a permanent commercial agreement between Aclarion and The London Clinic, a major provider of spine care in London. As part of that conversion, Aclarion was able to secure increased payments. To ensure a large segment of their patients would have unfettered access to Nociscan, the UK KOLs, in conjunction with The London Clinic, then approached the largest private health insurance providers in the UK for payment. Three of the top four payers have now agreed to pay for Nociscan thus far.

Payer coverage decisions like those achieved in the UK represent potentially trajectory changing milestones as they pave the way for broad physician adoption and predictable revenue. Aclarion is now adding sales and marketing resources into London to accelerate this adoption and the potential revenue inherent in these payer coverage decisions. The Company is simultaneously executing this same physician-led strategy throughout the United States through its KOL panel.

To expand access to more KOLs, Aclarion entered into a strategic partnership with ATEC, a major spine implant company with a specific interest in leveraging pre-surgical data to drive better outcomes through its Alpha-Informatics platform. The partnership calls for leveraging ATEC’s extensive physician relationships to expand Aclarion’s KOL advocacy strategy to additional surgeons.

In support of its mission to drive Nociscan to standard of care, Aclarion has executed multiple commercial agreements providing access to Nociscan at multiple MRI scanners in key markets such as New York, New Jersey, Arizona, Colorado, and Michigan. This groundwork will assist in executing the strategic agreement in place with ATEC to evaluate the use of Nociscan with their KOLs. “We believe in the importance of biochemical markers within the treatment paradigm and by partnering with Aclarion, we can progress toward a mutual objective to integrate and advance technologies that improve the predictability and reproducibility of spine patient care,” stated Pat Miles, CEO of ATEC.

The payer world consists of more than standard commercial health insurance providers. In the U.S., personal injury and worker compensation cases make up a large part of the low back pain market and the stakes of securing the right diagnosis are extremely high. In this market in particular, a premium is placed on data that is objectively obtained and can help physicians determine the best treatment options.

By partnering with Justin Kubeck, MD, an orthopedic spine surgeon in New Jersey, Aclarion is expanding into the personal injury and workers compensation market with the same physician-led strategy that is driving positive results in London. Dr. Kubeck explained, “I’ll be leading an effort to educate a discrete population of attorneys and judges who adjudicate PI and WC cases throughout the state on the potential benefits of Nociscan for these high stake cases.”

For KOLs to be most effective in driving payers to cover Nociscan, favorable clinical and economic data from clinical trials is an important requirement. Evidence continues to mount in favor of utilizing Nociscan to determine discogenic pain over the current invasive gold standard of provocative discography and for making treatment decisions when provocative discography data is not available.

The Company was invited to participate in the National Institute of Health’s (NIH) Biomarkers for Evaluating Spine Treatments (BEST) Trial which enrolled over 800 patients at 12 leading academic teaching institutions across the United States, with a subset of 200 undergoing advanced biomarker profiling, which included Nociscan. Results from the trial are anticipated in the near term while the revenue produced from the trial has helped fund Aclarion’s march toward full commercial launch.

The Company has published two peer reviewed journal articles based on the results of a pivotal study conducted by Dr. Matt Gornet showing that clinical outcomes improved and were durable after two years when Nociscan results were concordant with the surgical treatment of a patient versus when surgery did not follow the Nociscan data for identifying painful discs. Bob Eastlack, MD stated, “This is an outcomes result, not just a clinical equivalency to a gold standard diagnostic study. Outcomes are what drive payer coverage decisions.”

To quantify the savings inherent in utilizing Nociscan across the spine surgery population of the United States based on the conclusions of the Gornet study, the Economic Value Analysis of Low back pain (EVAL) analysis was commissioned and executed by the Center for Disruptive Musculoskeletal Innovations (CDMI). The results of EVAL concluded that the use of Nociscan improves outcomes and reduces costs, conservatively saving the US healthcare system nearly half a billion dollars annually and by more than $1,700 per patient. EVAL was presented at the annual International Society for the Advancement of Spine Surgery (ISASS) meeting and at Spine Week in Melbourne Australia. Spine Week is a combination of major spine societies that occurs once every 4 years. EVAL has been submitted for publication in a major spine journal and Aclarion expects to announce that publication shortly.

Building on the clinical success as evidenced by the Gornet study and the favorable economic analysis of EVAL, the Company has launched CLARITY, its flagship clinical study. CLARITY is a prospective, randomized, multi-center trial comparing the outcomes of patients undergoing surgery for chronic discogenic back pain when Nociscan is used in the decision-making process versus when Nociscan is not being used in the decisioning process. Based on the results of the Gornet Trial, Aclarion believes CLARITY will result in compelling data that will rapidly lead to coverage decisions from every major insurance provider in the country and endorsements from all the major spine societies. Nicholas Theodore, MD, FACS, FAANS, Director of Neurosurgical Spine Center, Johns Hopkins, and Professor of Neurosurgery, Orthopaedics and Biomedical Engineering is the Principal Investigator for CLARITY.

Additional compelling peer-reviewed data has been published in the International Journal of Spine Surgery that highlights Nociscan as a Gold Standard for noninvasive identification for painful lumbar discs. The LIFEHAB trial continues to pay for the use of Nociscan in the 202-patient study as a key component in their evaluation of surgical vs non-surgical treatment efficacy. The Company expects to announce additional sponsor-supported research studies that generate additional revenue.

Aclarion has expanded its IP position in the MR spectroscopy space and leads on every relevant front as a platform technology that leverages MR spectroscopy and biomarker data for the identification of painful discs. Over the past two years, two key patents have been added. One to expand our IP position when using newer AI analysis techniques to analyze spectroscopy data to identify biomarkers and another to identify bacterial biomarkers associated with pain.

In the months ahead, investors can rely on continued success in adding peer reviewed evidence publications, signing additional commercial agreements, and most importantly, expanding positive payer coverage decisions.

For more information about the BEST Trial, please visit: www.besttrial.org

For information about BACPAC, please visit: https://heal.nih.gov/research/clinical-research/back-pain

For more information about REACH, please visit: www.bacpac-reach.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, 2023, 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. SmithPCG Advisory, Inc.646.823.8656ksmith@pcgadvisory.com

Media Contacts:Jodi LambertiSPRIG Consulting612.812.7477jodi@sprigconsulting.com