Aclarion Publishes CEO Shareholder Letter Highlighting Continued Scan Volume Growth and Advancing Clinical Program in Third Quarter 2026

Aclarion expects its $14.2 million cash balance to fund the 300-patient CLARITY trial and provide runway into the second half of 2027.

Rhea-AI Summary

Aclarion (ACON) published a CEO shareholder letter highlighting 85% year-over-year scan volume growth in the third quarter of 2026. Scan volume grew 117% for the nine months ended September 30, 2026.

The CLARITY trial expanded to eleven clinical sites, with revised enrollment criteria intended to accelerate recruitment. Aclarion said overall trial duration remains on track and plans an update on enrollment progress and anticipated initial readout timing by year-end.

Cash totaled $14.2 million, which the company expects to provide runway into the second half of 2027 and fully fund the 300-patient CLARITY trial. The European Spine Journal published peer-reviewed data supporting magnetic resonance spectroscopy (MRS) as a potential viable alternative to provocative discography. Aclarion views its expanding clinical evidence base as supporting reimbursement initiatives in the United Kingdom and United States.

6 points · 1 major

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0 major · 0 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Major point. Forward-looking: it has not happened yet and may not happen.$14.2 million cash provides anticipated runway into the second half of 2027 and resources to fully fund 300-patient CLARITY.
• Moderate pointScan volume grew 85% year-over-year in Q3 2026 and 117% for the nine months ended September 30, 2026.
• Moderate point. Forward-looking: it has not happened yet and may not happen.CLARITY expanded to eleven clinical sites, with revised enrollment criteria intended to accelerate recruitment.
• Minor point. Forward-looking: it has not happened yet and may not happen.CLARITY trial duration remains on track; Aclarion plans enrollment and anticipated initial readout timing updates by year-end.
• Minor pointPeer-reviewed European Spine Journal data support MRS as a potential viable alternative to provocative discography.
• Minor point. Forward-looking: it has not happened yet and may not happen.Expanding clinical evidence is expected by Aclarion to support United Kingdom and United States reimbursement initiatives.

Negative

• None.

Key Figures

Q3 scan volume growth: 85% year-over-year Nine-month scan volume growth: 117% CLARITY sites: 11 clinical sites +3 more

Q3 scan volume growth

85% year-over-year

Third quarter 2026

Nine-month scan volume growth

117%

Nine months ended September 30, 2026

CLARITY sites

11 clinical sites

Enrolling under updated criteria

Cash

$14.2 million

Company-reported cash; anticipated runway into the second half of 2027

CLARITY trial size

300 patients

Company says available resources fully fund the trial

Enrollment update timing

By year-end

Anticipated update on enrollment progress and initial readout timing

Historical Context

2 past events · Latest: Oct 08

2 events

1. Oct 08

   CLARITY criteria update

   24h Move

   -1.7%

   Enrollment had not supported the initial Q4 readout; revised criteria were approved at nine of eleven sites.

2. Sep 29

   CLARITY site expansion

   24h Move

   -2.5%

   Established the 11-site, 300-patient trial design and its 12-month primary endpoint.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

biomarkers

1 terms

biomarkers medical

"a healthcare technology company that is leveraging biomarkers"

Biomarkers are measurable indicators found in the body, such as substances in blood or tissues, that reveal information about health or disease. For investors, they can signal how well a medical treatment is working or whether a disease is developing, helping to assess the potential success or risks of healthcare companies or innovations. Think of biomarkers as biological signals that provide clues about a person’s health status.

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• 85% year-over-year scan volume growth in Q3 2026, contributing to 117% growth for the nine months ended September 30, 2026
• European Spine Journal publishes peer-reviewed data supporting MRS as a potential viable alternative to provocative discography
• CLARITY trial expanded to eleven clinical sites with updated enrollment criteria to accelerate recruitment
• Overall CLARITY trial duration remains on track, with an update on enrollment progress and anticipated initial readout timing by year-end
• $14.2 million in cash, providing anticipated runway into the second half of 2027 and resources to fully fund the 300-patient CLARITY trial
  
  

BROOMFIELD, Colo., Oct. 20, 2026 (GLOBE NEWSWIRE) -- 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, announced today the publication of a Shareholder Letter from Chief Executive Officer Brent Ness providing an update on the Company’s momentum and value-creating priorities for the quarter ended September 30, 2026.

“The third quarter was a strong one for Aclarion, reflecting the growing interest among physicians in what Nociscan can offer their patients with chronic low back pain,” said Brent Ness, Chief Executive Officer of Aclarion. “Scan volumes grew 85% year-over-year and 117% for the first nine months of 2026, and our clinical program is advancing on multiple fronts. The European Spine Journal publication adds to our growing evidence base, and CLARITY is now enrolling at eleven sites under revised criteria designed to accelerate recruitment and strengthen the study's real-world applicability.”

The letter highlights Aclarion’s continued commercial traction and an expanding clinical evidence base which will be instrumental in supporting reimbursement initiatives in both the United Kingdom and the United States. The CEO update also highlights the Company’s ongoing commitment to the CLARITY clinical trial with updated inclusion/exclusion criteria to accelerate recruitment. In addition, the Company maintained a strong balance sheet with disciplined capital allocation and investments to create sustainable shareholder value.

The full CEO Shareholder Letter is available on the company’s website.

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, statements regarding the $14.2 million in cash, providing anticipated runway into the second half of 2027 and resources to fully fund the 300-patient CLARITY trial, our continued commercial traction and an expanding clinical evidence base which will be instrumental in supporting reimbursement initiatives in both the United Kingdom and the United States, our expectation that these changes to the CLARITY enrollment criteria will meaningfully improve recruitment, the plan to update shareholders on enrollment progress and anticipated initial readout timing by year-end, and that the overall CLARITY trial duration remains on track. 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.

Investor Contacts:

Kirin M. Smith
PCG Advisory, Inc.
ksmith@pcgadvisory.com

Media Contacts:

Jennie Kim
SPRIG Consulting
jennie@sprigconsulting.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

How much did Aclarion's scan volume grow in Q3 2026?

Aclarion's scan volume grew 85% year-over-year in Q3 2026. Growth for the nine months ended September 30, 2026 was 117%.

When will Aclarion update investors on CLARITY enrollment and initial readout timing?

Aclarion plans to provide an update on enrollment progress and anticipated initial readout timing by year-end. This is the timing for an update, not a stated date for the initial readout itself.