Aclarion Delivers Strong Q1 2026 Results with 196% Annual Scan Volume Growth Reflecting Accelerating Clinical Adoption

• Triple-digit annual growth signals accelerating Nociscan adoption and integration into clinical workflows
• Advancing reimbursement and clinical milestones, with CLARITY trial interim readout anticipated in Q4 2026
• Strengthened IP footprint with new AI patent and 64 total issued and pending patents worldwide
• Announced $2.5 million share repurchase program
• Strong balance sheet, no debt and cash runway into the second half of 2027, reinforcing long-term growth strategy

BROOMFIELD, Colo., April 30, 2026 (GLOBE NEWSWIRE) -- Aclarion, Inc., ("Aclarion" or the "Company") (NASDAQ:ACON, ACONW)), a commercial-stage healthcare technology company leveraging biomarkers and proprietary augmented intelligence (AI) algorithms through its Nociscan^® platform to help physicians identify the location of chronic low back pain and support improved treatment success rates, today reported first quarter 2026 results highlighted by accelerating clinical adoption and strong execution across key strategic initiatives.

Market Adoption Momentum

• Nociscan scan volumes increased 196% year-over-year (Q1 2026 vs. Q1 2025)
• 64% sequential scan volume growth (Q1 2026 vs. Q4 2025)
• Growth was driven by both new account activation and deeper utilization within existing sites, signaling increasing integration into clinical workflows.
• Repeat usage trends reinforce the value proposition for Nociscan and position Aclarion for sustained expansion.

The opportunity for Nociscan remains significant. Each year, approximately 5.8 million lumbar MRIs¹ (without contrast) are performed in the U.S. for low back pain, highlighting a large population where additional insights into the source of pain may be valuable. As adoption expands, Aclarion believes this represents a potential $2 billion market opportunity¹ for technologies like Nociscan that can provide objective, data-driven evaluation of discogenic pain.

Catalysts Driving Growth

• Nociscan has been reimbursed for several months by Vitality, AXA, and Aviva—three of the four largest private insurers in the U.K. This early payer adoption provides meaningful validation and a pathway for broader coverage expansion.
• Launch of a targeted direct-to-patient campaign in the U.K. Campaign includes a new video featuring Mr. John Sutcliffe, Consultant Spinal Neurosurgeon at The London Clinic, one of the United Kingdom's leading private hospitals. The video is available here.
• Continued engagement with U.S. payers to establish coverage pathways through the deployment of the Nociscan Reimbursement Program.
  
  

Clinical and Product Developments

• Ongoing advancement of the CLARITY randomized trial designed to validate the clinical utility of Nociscan in guiding treatment decisions. Preliminary internal readout is expected in the second half of 2026 and an expected public disclosure of early interim results in late 2026.
• Seven ongoing clinical trials and multiple investigator-initiated real world evidence trials to support reimbursement discussions and the potential issuance of local coverage decisions by commercial insurance carriers.
• Newly issued patent covers use of AI in workflows of future products to accelerate company's ability to scale and enhance already strong gross margins.
• Intellectual property portfolio now totals 64 issued and pending patents worldwide, strengthening the company's long-term competitive moat.

Strong Financial Position

Aclarion enters this growth phase with a solid financial foundation. As of March 31, 2026, the Company had $19.0 million in cash with no outstanding debt and a clean capital structure.

There were 2,444,871 common shares outstanding as of March 31, 2026, and 2,882,371 outstanding on a fully diluted basis. On a fully diluted basis, this represents approximately $6.60 per share in cash.

Based on current operating plans and the effect of a $2,500,000 stock buyback program announced this week, the Company believes its existing cash resources are sufficient to fund operations into the second half of 2027.

Management Commentary

"Q1 represents a clear inflection for Aclarion," said Brent Ness, Chief Executive Officer of Aclarion. "Scan volume growth accelerated significantly, driven by increasing physician adoption and stronger execution with our recently hired Commercial Directors in the UK and the Eastern US. Importantly, we are still in the early stages of commercializing Nociscan into a large and underpenetrated market, with nearly 6 million lumbar MRIs performed annually in the U.S. alone. As adoption expands, Nociscan has the potential to address a multi-billion-dollar market opportunity."

For more News from Aclarion, please visit: Latest News

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

For more information on Nociscan, please email: info@aclarion.com

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, that usage trends will reinforce the value proposition for Nociscan and position Aclarion for sustained expansion, that the preliminary internal readout is expected in the second half of 2026 and an expected public disclosure of early interim results in late 2026, that the ongoing clinical trials and multiple investigator-initiated real world evidence trials will support reimbursement discussions and the potential issuance of local coverage decisions by commercial insurance carriers, that the newly issued patent will cover use of AI in workflows of future products to accelerate company's ability to scale and enhance already strong gross margins, statements regarding the expectation to execute the stock repurchase program, the Company's belief that its existing cash resources are sufficient to fund operations into the second half of 2027, and that as adoption expands, Nociscan has the potential to address a multi-billion-dollar market opportunity.   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, 2025, 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. 

1.   Data from AcuityMD.

Investor Contacts:

Kirin M. Smith

PCG Advisory, Inc.

ksmith@pcgadvisory.com

Media Contacts:

Jennie Kim

SPRIG Consulting

jennie@sprigconsulting.com