Quarterly Nociscan scan volumes increased 114% year-over-year in Q4 2025
Annual Nociscan scan volumes increased 69% year-over-year in 2025
Debt-free balance sheet with $12.0 million in cash as of December 31, 2025, extending cash runway into 2027 and providing strategic flexibility for continued commercial growth
Company aims to enroll approximately 25% of patients in CLARITY trial by the end of Q2 2026, with the first internal readout on interim data anticipated in Q3 2026

BROOMFIELD, Colo., Jan. 08, 2026 (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 provided a comprehensive corporate update, including financial results and strategic progress as the Company enters 2026 advancing its proprietary Nociscan platform.

Market Adoption & Growth Momentum

During 2025, Aclarion continued to build on its mission to transform the diagnosis of chronic low back pain achieving 69% year-over-year scan volume growth.

Nociscan scan volumes increased +114% year-over-year in Q4 2025 – marking the third consecutive quarter of year-over-year growth across U.S., UK, and E.U. sites.
Aclarion remains focused on expanding its commercial presence within key UK and U.S. healthcare markets. Efforts during the period included:
- The addition of 9 new imaging centers in 2025
- The addition of 22 new physician users in 2025
- Expansion of team with key leadership and commercial hires in the U.S. and UK

Strategic and Operational Highlights

Continued advancement of Nociscan platform, with progress across clinical validation, commercial readiness, and customer engagement initiatives.
Strengthened clinical evidence base, including ongoing and planned studies supporting the clinical and economic value of Nociscan.
Expanded engagement with healthcare providers and payors, aimed at improving adoption and reimbursement pathways.
Disciplined capital management, focused on extending operational runway while prioritizing value-creating milestones.
Ongoing evaluation of strategic partnerships and growth opportunities to accelerate commercialization and market penetration.
Bolstered intellectual property footprint with 4 new issued patents in 2025, with a total of 52 issued patents worldwide covering Aclarion's core technology and specific applications.

Clinical and Product Developments

Launching the CLARITY trial in 2025 at 7 activated sites illustrates Aclarion's ongoing commitment to leading with evidence and lays the groundwork for future commercial expansion.
2025 publications of real-world evidence demonstrate clinical utility and economic value.
- Cost-effectiveness analysis published in ClincoEconomics and Outcomes Research in April. 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%.
- MR Spectroscopy and Low Back Pain: A Novel Cloud-based Solution, Nociscan published in Special Pain Issue of the International Journal of Spine Surgery (IJSS) in December. The featured article included a technology overview of Nociscan and highlighted a successful case study.

In 2026, the Company expects to:

Advance clinical validation efforts:
- Accelerate enrollment with goal of enrolling approximately 25% of patients in the CLARITY trial by the end of Q2 2026. An initial readout will be internally available after the initial cohort of patients complete their 3-month follow up visit.
- Complete and publish multiple investigator-initiated real world evidence trials.
- Expand major MRI manufacturer access growing the available global market size by greater than 30%.
Support broader clinician education and awareness initiatives through accelerated participation at societal-sponsored CME events.
Continue refining workflow integration to support scalability in clinical practice by launching version 2.8 of our Nociscan software in Q1.
Actively collaborate with multiple commercial payers in the US market to evaluate broad reimbursement coverage of Nociscan.

Financial Highlights

As of December 31, 2025, the Company had $12.0 million in cash and no debt. During fiscal 2025, the Company successfully raised over $22.0 million in equity financing, strengthening its balance sheet and providing capital to support continued execution of its strategic and operational plans.

There were 854,371 common shares and 28,000 prefunded warrants outstanding as of December 31, 2025. On a fully diluted basis, this represents approximately $13.65 per share in cash.

Based on current operating plans, the Company believes its existing cash resources are sufficient to fund operations into the first half of 2027.

Management Commentary

"We are pleased with the progress Aclarion has made in strengthening our financial position, expanding clinical traction, and advancing Nociscan toward broader adoption," said Brent Ness, CEO of Aclarion.

"Despite the early-stage nature of our commercial activities, the growth in scan volume particularly in the UK where we enjoy commercial payer reimbursement, and meaningful capital raises during 2025, reflect both momentum and investor confidence. We remain focused on execution through leadership team investments, evidence generation, and strategic partnerships to drive long-term value for patients, providers, payers and shareholders."

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. Forward-looking statements in this release include, among others, statements regarding the enrollment of patients in our ongoing clinical trial, the expected date of the internal interim results, the potential benefits of our Nociscan technology, and the Company's plans for future regulatory and commercialization activities, as well as the cash need to fund operating into 2027. 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.

ksmith@pcgadvisory.com

Media Contacts:

Jessica Starman

media@elev8newmedia.com

Aclarion Provides 2025 Update and 2026 Corporate Outlook