Aclarion, Inc.: Aclarion Provides Corporate Update Highlighting Scan Volume Growth and Key Upcoming Catalysts

• Nociscan YOY scan volume increased 132% from Q2 2024 to Q2 2025 fueled by new physician adoption and insurance company coverage in the UK
• Company has achieved two consecutive quarters of scan volume growth for the first time and expects continued QOQ growth for the remainder of the year
• Cost-effectiveness analysis demonstrating Nociscan is more effective and less costly than provocative discography published in peer-reviewed journal adding critical evidence in support of payer coverage
• Pivotal CLARITY trial proceeding on schedule with first patient enrolled to validate Nociscan's ability to improve surgical outcomes for chronic low back pain, with internal interim results expected in Q2 2026
• Reaffirms cash runway through Q3 2026 to prove out the key catalysts of demonstrating significant scan volume growth and visibility into the success of CLARITY
  

BROOMFIELD, Colo., Aug. 05, 2025 (GLOBE NEWSWIRE) -- Aclarion, Inc., ("Aclarion" or the "Company") (Nasdaq: ACON, ACONW), a commercial-stage 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 announced that scan volume has achieved significant year over year growth of 132% from 2Q24 to 2Q25 and has demonstrated two consecutive quarters of growth for the first time.

Scan volume growth is a key catalyst for driving revenue and securing favorable payments from insurance companies. Given the steady cadence of new physician adoption, the activation of new commercial sites in the U.S., CLARITY study sites completing the onboarding process, and the approval from three of the top four private insurance payers in the UK to cover Nociscan, the Company believes it is on a steady trajectory to deliver consistent quarter over quarter scan volume growth through the remainder of 2025 and beyond.

Aclarion is pursuing two core key catalysts to drive value.

The first is scan volume growth in the UK where the obstacle of not having approval from insurers to pay for Nociscan has been removed. Over 5.2 million people in the UK now have access to Nociscan through their insurance provider. This market serves as a bellwether for all future markets where reimbursement precedes broad physician adoption. The Company is pursuing an aggressive strategy in this market to drive awareness and adoption, first through our partners at The London Clinic, and then throughout the London market. In an encouraging sign, early results in the UK are driving the majority of Nociscan volume increases the Company is currently reporting and management expects to see this accelerate.

"The first half of 2025 was marked by significant scan volume growth as we continue to gain commercial traction and build upon the clinical and economic evidence through real-world studies and the CLARITY trial," states Brent Ness, CEO, Aclarion. "Seeing the volume grow in London following the positive coverage example of Axa, Vitality and Aviva in the UK market with our customer, The London Clinic, validates our strategy and fuels our confidence that the payer community will move to encourage use of Nociscan leading to consistent revenue growth."

The second key catalyst the Company is focused on to drive value is the CLARITY trial, as results of this trial are expected to be a critical drive to securing widespread insurance coverage in the United States. The Company believes CLARITY represents the first ever prospective randomized trial to link a non-invasive AI (augmented intelligence) algorithm to better surgical outcomes for patients with low back pain. With chronic low back pain being part of the highest cost diagnosis in the U.S., and clinical results from surgical intervention showing an average success rate of only 54% across the literature, the importance of additional information for surgeons to better match their surgical plan to the pain their patient is experiencing is critical. Nociscan provides this information by objectively measuring the biomarkers in each disc that have been demonstrated to correlate with pain.

CLARITY is designed to prove that when a surgeon uses Nociscan in conjunction with their current surgical planning process, they achieve successful surgical outcomes for chronic low back pain that far exceed the industry average of 54%.

The Company has now engaged eight Phase I sites with four sites fully onboarded and activated: Texas Back Institute, University of Miami Health, Advocate Health, and Northwestern Medicine. The remaining 4 Phase I sites are expected to be activated by end of year. The Texas Back Institute enrolled the first patient in June and the Company is on track to fully enroll all 300 patients by Q4 2026.

As the CLARITY trial progresses, the Company will be conducting an internal analysis of three month clinical outcomes to get a preliminary look at how impactful Nociscan is in driving better early clinical outcomes. Although the formal CLARITY protocol calls for evaluating outcomes at the standard one and two year follow up milestones, management believes three month outcomes will provide highly predictive information about the ultimate formal results of the trial. The Company expects to have visibility into a meaningful number of three month patients in the second quarter of 2026. This information is expected to be a significant milestone and key catalyst for the Company.

Additional 2025 key milestones and highlights include:

• EVIDENCE and PUBLICATIONS. A core component of driving payment coverage for Nociscan is building clinical evidence and more specifically, getting this evidence published in peer-reviewed journals. In 2Q25, Clinicoeconomics and Outcomes Research published an independent cost-effectiveness analysis of Nociscan, led by a renowned healthcare economist from UCSF. The analysis concluded that Nociscan is more effective and less costly than provocative discography, illustrating that Nociscan saves $1,712 per patient and improves surgical success rates by 10%. In addition to the cost-effectiveness analysis, Aclarion continues to invest in the development of real-world evidence with customers in the UK and US. Finally, in 4Q24, Siemens Healthineers published a featured Nociscan Case Study on their global website, MAGNETOM WORLD. Siemens Healthineers is a global market share leader in medical imaging, in-vitro diagnostics, and advanced therapies.
  
• CUSTOMERS. In the absence of Category I coverage by private health insurance companies in the U.S., and Aclarion's focus on driving scan volume in the UK, the Company remains very selective with regards to adding new customers outside of the UK. Three strategic U.S. customers were added in the first half of 2025, including Scripps Health in San Diego and the Spine Institute of Louisiana, both of whom are prioritizing development of real-world evidence. Additionally Medical Imaging Center of Southern California expanded Nociscan access to a second location in Santa Monica. Aclarion will continue to add customer sites in markets with strategic relevance and customers committed to excellence in spine care.
  
• CONFERENCES. A key component to securing payment for Nociscan in the U.S. is demonstrating the support of surgeons and securing the backing of key spine societies. Participating in professional conferences is a leading strategy to establish relevance and credibility amongst surgeons and their societies. In 1H25, Aclarion participated in six important industry conferences where use of MR Spectroscopy was discussed as a distinct innovation in low back pain. Nociscan specifically was presented by leading spine surgeons at three different conferences: the 28^th Annual Selby Spine Conference, the 2025 Spine Summit, and the 20^th Annual State of Spine Surgery Think Tank. The Company will continue to participate in key industry conferences in 2H25 including Bridging the Gap, the International Society of Pain & Neuroscience (ISPN) conference in London, Sonntag Spine Symposium, the NASS 40^th Annual Meeting, The Radiological Society of North America, and the Minimally Invasive Spine Society.
  
• INTELLECTUAL PROPERY. In February, Aclarion secured its 24^th US patent to protect expanded applications of Magnetic Resonance Spectroscopy (MRS) data processing to identify pain and infection biomarkers throughout the body. Currently Aclarion holds 24 US-issued patents, 13 European issued patents, as well as several pending patent applications. The Company is in the process of auditing its intellectual property portfolio to evaluate spinning off additional companies in partnership with private investors to optimize the value of the patent portfolio for shareholders without increasing burn.
  
• FUNDING. At the end of 1Q25, Aclarion announced a funding update that included raising nearly $15M (net) cash on hand, as well as eliminating all debt, no preferred equity, and no warrants with strike prices near the current market. These funding activities helped to ensure that Aclarion is fully NASDAQ compliant and funded to execute on the strategic objectives highlighted in company communications and outlined in this update. The Company reaffirms it is adequately funded through Q3 2026 to prove out the key catalysts of demonstrating significant scan volume growth in the UK and securing early visibility into the success of CLARITY.
  

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. Aclarion's Nociscan solution is the first evidence-supported SaaS platform to noninvasively help physicians distinguish between painful and nonpainful discs in the lumbar spine. Nociscan objectively quantifies chemical biomarkers demonstrated to be associated with disc pain and has the potential to drive better surgical outcomes.

For more information about CLARITY, please visit: CLARITY Trial

To find a Nociscan center, view our site map here.

For more information on Nociscan, please email: [e-mail]

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, 2024, 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.
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Media Contacts:

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SPRIG Consulting
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