Aclarion Announces First Patient Enrollments at Two Additional CLARITY Trial Sites and Provides Guidance on Expected Availability of Initial Data

Rhea-AI Summary

Aclarion (Nasdaq: ACON) announced first patient enrollments at two additional CLARITY trial sites (Northwestern Medicine and Scripps Health), bringing the number of sites that completed regulatory setup to seven and sites that have enrolled patients to four.

The multi-site pivotal CLARITY trial will randomize up to 300 patients to evaluate Nociscan-guided surgical planning versus blinded care. The company expects an initial interim readout after the first cohort reaches a 3-month follow-up, projected in 3Q 2026, and aims to enroll ~25% of patients by end of Q2 2026. Full enrollment target is mid-2027, with possible early termination if significance is reached earlier.

Positive

• 300-patient pivotal CLARITY trial established
• Seven sites completed regulatory and operational setup
• Initial interim data expected in 3Q 2026 after 3-month follow-up
• Target to enroll ~25% of patients by end of Q2 2026

Negative

• Only four sites have enrolled one or more patients so far
• Full enrollment not expected until mid-2027, extending time to definitive results
• Enrollment pace may force prolonged rolling readouts or trial continuation

Key Figures

Planned enrollment up to 300 patients CLARITY pivotal trial design

Industry benchmark ~54% Current outcomes benchmark for chronic low back pain surgery

Enrollment target 25% of patients by end of Q2 2026 CLARITY enrollment goal for initial cohort

Disease prevalence 266 million people Estimated global population with chronic low back pain

Q3 2025 revenue $18,942 Quarterly revenue, up from $14,407 a year ago

Q3 2025 net loss $1.71 million Quarterly net loss vs $1.37 million a year earlier

Cash and equivalents $11.34 million Balance sheet cash as of Q3 2025, funding operations through Q1 2027

Registered direct gross proceeds $2,507,997.64 Capital raised via common stock and pre-funded warrants on Oct 14, 2025

Market Reality Check

$5.37 Last Close

Volume Volume 30,212 is below the 106,139 20-day average, suggesting limited pre-news participation. low

Technical Shares at $5.18 are trading below the $7.70 200-day MA, reflecting a weak longer-term trend.

Peers on Argus

ACON gained 4.02% while peers were mixed: WORX (-0.52%), BFRG (-2.87%), VSEE (-5.85%), DRIO (+17.51%), and POAI (flat), indicating stock-specific factors rather than a broad sector move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 04	Clinical publication	Positive	+5.0%	Nociscan featured in IJSS pain issue with successful clinical case example.
Dec 02	Commercial hire	Positive	+10.3%	Appointment of Eastern U.S. Commercial Director to drive Nociscan adoption.
Nov 05	Market expansion	Positive	+0.0%	UK Commercial Director hire and reimbursement by major UK private insurers.
Oct 22	Industry award	Positive	-4.7%	Rising Star award recognition for Nociscan digital health platform.
Oct 14	Corporate update	Positive	-7.6%	Q3 update on CLARITY enrollment, record scan volumes, and cash position.

Pattern Detected

Recent announcements have generally been positive but produced mixed price reactions, with several instances of divergence where upbeat clinical or corporate news coincided with flat or negative moves.

Recent Company History

Over the last few months, Aclarion highlighted commercial expansion, clinical validation, and financial strengthening. On Oct 14, 2025, a corporate update with CLARITY progress and rising Nociscan volumes saw a -7.64% move. Subsequent awards and commercial hires, including UK and Eastern U.S. directors, produced both gains and declines. In Dec 2025, publication of Nociscan data and a commercial appointment led to positive moves. Today’s CLARITY enrollment update extends this clinical and commercial execution narrative.

Market Pulse Summary

This announcement highlights continued operational progress in the CLARITY pivotal trial, with first patient enrollments at two additional sites and a plan to enroll up to 300 patients. It builds on earlier commercial and clinical milestones for Nociscan. Investors may watch upcoming interim data timing, enrollment versus the 25% target, and how outcomes compare to the current ~54% surgical benchmark, alongside the company’s net loss and cash runway disclosed in recent filings.

Key Terms

biomarkers medical

"Nociscan objectively quantifies chemical biomarkers demonstrated to be associated with disc pain"

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.

augmented intelligence technical

"leveraging biomarkers and proprietary augmented intelligence (AI) algorithms to help physicians"

Augmented intelligence combines human skills with advanced technology to enhance decision-making and problem-solving. It acts like a helpful partner that provides insights and suggestions, allowing people to make better choices more quickly. For investors, this means smarter analysis, improved efficiency, and the ability to respond to market changes with greater confidence.

visual analog scale (vas) medical

"patient-reported pain outcomes using the Visual Analog Scale (VAS), the trial’s primary endpoint"

A visual analog scale (VAS) is a simple measurement tool patients use to rate the intensity of symptoms—often pain—by marking a point along a straight line between two extremes (for example, 'no pain' and 'worst pain'). It acts like a thermometer for a subjective feeling, turning personal experience into a single number researchers and regulators can track. Investors care because VAS results frequently influence clinical trial success, product labeling, approval decisions and market acceptance, which affect a healthcare product’s commercial value.

saas platform technical

"Nociscan solution is the first evidence-supported SaaS platform to noninvasively help physicians"

A SaaS platform is software delivered over the internet that customers access through a subscription instead of installing and running it on their own computers; the provider hosts, updates, and secures the application remotely. Investors care because SaaS businesses often generate predictable, recurring revenue and can scale quickly as more customers sign up, making them easier to value and potentially more profitable over time—similar to a utility that collects steady fees as its user base grows.

AI-generated analysis. Not financial advice.

• Northwestern and Scripps Health join two previously announced sites in achieving this critical patient enrollment milestone
• Seven leading U.S. spine centers have now completed the regulatory and operational requirements to screen and enroll patients in CLARITY
• First readout on interim data expected after initial cohort of patients achieves 3-month follow up visit in 3Q 2026
  
  

BROOMFIELD, Colo., Jan. 06, 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, today announced that Northwestern Medicine and Scripps Health have enrolled their first patients in the company’s pivotal CLARITY (Chronic Low bAck pain Randomized Independent Trial studY) trial, advancing enrollment progress in the trial.

The trial represents a key clinical and commercial catalyst for the company and is intended to support future reimbursement discussions in the U.S. With the latest enrollments by Northwestern and Scripps, four sites have enrolled one or more patients. Seven clinical sites have completed the required regulatory approvals, contracting, training, and study setup, enabling them to begin enrolling patients. These CLARITY sites include Texas Back Institute, University of Miami Health, Advocate Health, Northwestern Medicine, Scripps Health, Keck Medicine of USC, and Johns Hopkins University.

The company recently hired Jason Brosniak as Commercial Director for the Eastern U.S. and Andy Murillo as Director of Market Access to focus on driving CLARITY trial enrollment and adding more sites to accelerate enrollment progress. The company continues to actively evaluate additional sites to ensure it meets enrollment targets.

The CLARITY trial is a multi-site trial designed to evaluate whether incorporating Nociscan into standard surgical planning can improve outcomes that significantly exceed the current ~54% industry benchmarks for patients undergoing surgery for chronic low back pain. The study will enroll up to 300 patients, randomized between surgeons who are blinded-to-Nociscan results and unblinded-to-Nociscan results to guide surgical planning for Fusion/TDR.

The Company aims to enroll approximately 25% of patients by the end of Q2 2026. An initial readout on the results of this first cohort of patients will be internally available 90 days later upon the last patient completing their 3-month follow up visit. Additional patient data will be added to the initial readout on a rolling basis until enrollment is completed. Although Aclarion targets full enrollment of 300 patients by mid-2027, if statistically significant improvements are seen in the Nociscan group prior to reaching 300 patients, the trial may be terminated prior to full enrollment. The analysis will evaluate patient-reported pain outcomes using the Visual Analog Scale (VAS), the trial’s primary endpoint, with comparisons to pre-surgical pain levels.

“The CLARITY trial is a foundational value-creation initiative for Aclarion, and we are encouraged by the pace of site activation, early enrollment, and completed surgeries,” said Brent Ness, Chief Executive Officer of Aclarion. “Each patient enrolled and treated moves us one step closer to generating high-quality clinical evidence while reinforcing the commercial momentum we are building across the business.”

Aclarion believes the continued expansion of high-quality clinical sites, combined with early surgical throughput, positions CLARITY to progress with increasing efficiency and predictability, supporting the Company’s strategy to generate Level 1 evidence and drive long-term shareholder value.

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.

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 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. 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

FAQ

What is Aclarion's CLARITY trial design and size (ACON)?

CLARITY is a randomized multi-site pivotal trial enrolling up to 300 patients to compare Nociscan-guided surgical planning versus blinded care.

When does ACON expect initial CLARITY interim data?

An initial internal readout is expected in 3Q 2026 after the first cohort completes their 3-month follow-up visits.

How many CLARITY sites are activated and enrolling as of Jan 6, 2026 for ACON?

Seven sites have completed approvals and setup; four sites have enrolled one or more patients.

What enrollment milestones has Aclarion set for CLARITY (ACON)?

The company aims to enroll approximately 25% of patients by end Q2 2026 and targets full enrollment by mid-2027.

Can the CLARITY trial end before 300 patients for ACON?

Yes; the trial may be terminated early if statistically significant improvements are observed in the Nociscan group before full enrollment.