Aclarion Provides Corporate Update Highlighting Market Expansion as CLARITY Trial Advances Toward Key Data Catalyst

Rhea-AI Summary

Aclarion (Nasdaq: ACON) issued a Q3 2025 corporate update highlighting accelerating commercial adoption, a strong cash position, and progress in its pivotal CLARITY trial.

Key facts: Nociscan scan volumes +89% YoY in Q3 with three consecutive record quarters; debt-free balance sheet with $13.3 million cash (≈$15.11/share) as of Oct 14, 2025; CLARITY enrolling with first patients at University of Miami and full enrollment targeted by Q4 2026; early 3-month interim readouts expected Q2 2026. Company appointed Greg Gould as CFO and will present at LD Micro on Oct 20, 2025.

Positive

• Cash $13.3M on hand as of Oct 14, 2025 ($15.11/share)
• Nociscan scan volumes +89% YoY in Q3 2025
• Three consecutive quarters of record utilization across U.S., U.K., E.U.
• CLARITY pivotal trial progressing on schedule; first patients enrolled
• Early 3-month interim readout expected Q2 2026
• Seven leading Phase I sites actively engaged in CLARITY trial

Negative

• Full CLARITY enrollment delayed until Q4 2026, deferring final pivotal readout
• Cash balance of $13.3M may require further financing to fund full commercial scale-up

Insights

Commercial-clinical strategist

Aclarion shows commercial traction, a funded runway, and a scheduled CLARITY interim readout that could be a visible catalyst.

Aclarion reports an accelerating commercial uptake with Nociscan volumes up +89% year‑over‑year and three consecutive quarters of record utilization across the U.S., U.K., and E.U., which indicates growing clinical adoption. The company states a debt‑free balance sheet with $13.3 million in cash ($15.11 per share fully diluted) and recent net proceeds of $2.5 million from a registered direct offering, providing near‑term liquidity to fund commercial and clinical activities.

The pivotal CLARITY trial is described as progressing on schedule with first site enrollments at named academic centres and full enrollment targeted by Q4 2026. An early internal interim three‑month readout is expected in Q2 2026, which the company positions as a high‑visibility catalyst tied to validation of its AI biomarker integration. Key dependencies and risks are explicit in the update: enrollment pace to hit the Q4 2026 target, the internal nature of the interim readout, and continued physician adoption outside the listed sites.

Watchable items and near‑term horizons include the Q2 2026 early three‑month data readout, progress toward full enrollment by Q4 2026, and continued quarterly utilization trends for Nociscan. The appointment of Greg Gould as CFO and the stated cash position are concrete operational items supporting execution through these milestones.

Debt-free balance sheet with $13.3 million in cash as of today ($15.11 per share fully diluted) providing strategic flexibility for continued commercial growth

Nociscan scan volumes increase +89% year-over-year with third consecutive quarter of record utilization across U.S., U.K., and E.U. markets

CLARITY pivotal trial progressing on schedule and early 3-month readouts expected Q2 2026 as AI-driven disc pain biomarker validation continues

Webcast scheduled for October 20^th at 12:00 pm PT at the LD Micro Main Event

BROOMFIELD, Colo., Oct. 14, 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 issued its Q3 2025 corporate update highlighting its strong financial position, accelerating market adoption, and continued progress in the pivotal CLARITY trial.

Market Adoption & Growth Momentum

• Nociscan scan volumes increased +89% year-over-year in Q3 – marking the third consecutive quarter of accelerating growth across U.S., U.K., and E.U. sites.
• Three straight quarters of record utilization underscore growing physician adoption and commercial traction.
• MR Spectroscopy and biomarker technology featured at the International Society of Pain and Neuroscience (ISPN) annual meeting in London validating the importance of disc chemistry as a key biomarker for chronic low back pain diagnosis.
• Aclarion named a finalist in the Rising Star – Clinical Diagnostic Device category at the 2025 Digital Health Awards (HLTH) – furthering industry validation of Nociscan’s innovation and clinical impact.
• Commercial expansion strategy on track to drive new revenue channels and strengthen global brand visibility in 2026.
  
  

Key Value Catalyst: CLARITY Trial Progress & AI Algorithm Validation

• CLARITY pivotal trial advancing on schedule – first patients enrolled at UHealth-University of Miami Health System and the Miller School of Medicine, advancing progression towards full enrollment of CLARITY patients by Q4 2026.
• Trial designed to quantify the clinical value of integrating Nociscan data into surgical planning, targeting outcomes that significantly exceed current ~54% industry benchmarks.
• Seven leading Phase I sites are now actively engaged:
  • Texas Back Institute
  • University of Miami Health
  • Advocate Health
  • Northwestern Medicine
  • Scripps Health
  • Keck Medicine of USC
  • Johns Hopkins University
• Early internal interim data readout expected Q2 2026, offering high-visibility catalyst as three-month patient data accumulates.
• Positive momentum reinforces Nociscan’s position as the first AI-enabled platform to objectively identify discogenic pain biomarkers.
  
  

Leadership & Financial Strength Catalyst

• Appointed Greg Gould as Chief Financial Officer, adding deep public-company, capital markets, and operating experience to drive the next phase of growth.
• Debt-free balance sheet with $13.3 million in cash ($15.11/share) as of October 14, 2025– providing strong liquidity and strategic flexibility to fund commercial expansion and clinical execution.
• Cash position includes net proceeds from recent $2.5 million registered direct offering of common stock only at market as per NASDAQ rules.
• Financial discipline remains a core priority, with capital allocation tightly aligned to high-return milestones across commercial and clinical initiatives.
• Focused on operational leverage, strategic partnerships, and scalable revenue models to unlock long-term shareholder value.
  
  

“We are executing on our key milestones– expanding adoption, accelerating Nociscan growth, and advancing the CLARITY trial on time,” said Brent Ness, Chief Executive Officer of Aclarion. “Greg’s addition as CFO strengthens our leadership team at a pivotal inflection point. With a debt-free balance sheet, expanding data pipeline, and growing commercial traction, Aclarion is positioned to create meaningful long-term value for patients and shareholders alike.”

An estimated 266 million people across the globe live with chronic low back pain, making it one of the most widespread health challenges. 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 patients suffering from degenerative spine disease and low back pain worldwide.

Upcoming Webcast:

The Company will be presenting at the 19th Annual LD Micro Main Event on Monday, October 20, 2025 at 12:00 PM PT at the Hotel del Coronado in San Diego, CA. Brent Ness, Chief Executive Officer will be giving the presentation.

Register to watch the virtual presentation https://ldmicrocasts.com/#register

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: 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 potential benefits of our Nociscan technology, the CLARITY Trial yielding early 3-month follow-up results in Q2 2026 and the Company’s plans for future regulatory and commercialization activities. 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 Contact:

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

Media Contact:

Jessica Starman
media@elev8newmedia.com

FAQ

What did Aclarion (ACON) report for cash on Oct 14, 2025?

Aclarion reported a debt-free balance sheet with $13.3 million cash (≈$15.11 per share) as of Oct 14, 2025.

How much did Nociscan scan volumes grow in Q3 2025 for ACON?

Nociscan scan volumes increased +89% year-over-year in Q3 2025, marking the third straight quarter of record utilization.

When are early CLARITY trial readouts expected for ACON?

Aclarion expects early internal 3-month interim readouts in Q2 2026 as patient data accumulates.

Which sites have enrolled patients in Aclarion’s CLARITY trial (ACON)?

First patients enrolled at UHealth–University of Miami and other Phase I sites include Texas Back Institute, Northwestern Medicine, Johns Hopkins, and more.

What is the timeline to complete CLARITY enrollment for Aclarion (ACON)?

The company targets full enrollment by Q4 2026 for the CLARITY pivotal trial.

When will Aclarion present at LD Micro and who will speak?

Aclarion will present on October 20, 2025 at 12:00 PM PT at the LD Micro Main Event; CEO Brent Ness will present.