Aclarion Broadens CLARITY Trial Enrollment Criteria to Accelerate Enrollment
Local review-board approval remains pending at two active sites, while the company expects the overall trial duration to remain unchanged.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Aclarion (ACON) broadened enrollment criteria for its pivotal CLARITY clinical trial after enrollment failed to support an initial Q4 2026 readout. Institutional Review Boards, which oversee clinical research, have fully approved the revised criteria at 9 of 11 active sites. The other two sites are using them for screening before local approval. Newly added sites, including NYU and the most recently activated center, will also use the revised criteria.
The approval process temporarily slowed enrollment while sites paused screening under the prior criteria. Aclarion expects the changes to expand patient eligibility and accelerate enrollment without extending the overall trial duration. Based on current enrollment and the required three-month postoperative follow-up, the company plans to update enrollment levels and anticipated initial-readout timing by year-end. Operational measures implemented over the past nine months had not increased enrollment sufficiently.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate point. Forward-looking: it has not happened yet and may not happen.Broader criteria are expected to expand eligibility and accelerate enrollment, Aclarion says.
- Moderate point. Forward-looking: it has not happened yet and may not happen.Overall CLARITY completion remains within the originally anticipated timeline, Aclarion expects.
- Minor pointRevised CLARITY criteria have full review-board approval at 9 of 11 active sites.
- Minor point. Forward-looking: it has not happened yet and may not happen.Revised criteria are expected to improve study-population representativeness, Aclarion says.
Negative
- Moderate pointEnrollment did not increase enough to support a Q4 2026 initial readout.
- Minor pointLocal review-board approval remains pending at two active sites already using revised criteria for screening.
- Minor pointReview-board approval temporarily slowed enrollment as sites paused screening under prior criteria.
Key Figures
- Sites with revised-criteria approval
- 9 of 11 active sites
- CLARITY enrollment criteria approved by Institutional Review Boards
- Sites screening before local approval
- 2 active sites
- Using revised criteria for screening prior to local IRB approval
- Prior initial-readout target
- Q4 2026
- Enrollment did not increase at the pace required to support this timing
- Timeline update
- By year-end
- Update on enrollment levels and anticipated initial-readout timing
- Postoperative follow-up
- Three months
- Required follow-up period cited in assessing initial-readout timing
Historical Context
-
Added a CLARITY site and anticipated an initial readout in Q4 2026.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
institutional review boards regulatory
saas technical
biomarkers medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
- New criteria fully approved at nine of eleven active sites expected to significantly accelerate enrollment pace
- Initial readout timing to be updated by year-end based on demonstrated Q4 enrollment increases
- Overall trial duration remains on track
BROOMFIELD, Colo., Oct. 08, 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 an update to the enrollment criteria and expected timing of the initial readout from its pivotal CLARITY clinical trial. Based on current enrollment levels and the required three-month postoperative follow-up period, Aclarion will provide an update on enrollment levels and anticipated timeline for the initial readout by year-end.
The Company emphasizes that this timing update does not change the overall expected duration of the CLARITY trial at this time.
Enrollment and Inclusion/Exclusion Criteria
CLARITY was intentionally designed with highly optimized inclusion and exclusion criteria to remove confounding factors that have historically complicated chronic low back pain studies. These criteria strengthened the scientific rigor of the trial but significantly narrowed the pool of eligible patients at participating sites.
Over the past nine months, Aclarion implemented multiple operational measures to accelerate enrollment without altering the criteria, including:
- Increasing site level engagement and training
- Enhancing patient identification workflows
- Adding dedicated internal study coordination resources
- Expanding outreach to referring physicians
- Improving communication pathways between radiology and surgical teams
Despite these efforts, enrollment did not increase at the pace required to support a Q4 2026 initial readout.
Revised Criteria to Reflect Real World Chronic Low Back Pain
Recognizing that the optimized criteria were excluding a substantial portion of real world chronic low back pain patients, Aclarion undertook a comprehensive review of the inclusion/exclusion framework in partnership with the primary investigator and lead surgeon researchers at each enrollment site. The Company subsequently implemented revised criteria that:
- Maintain scientific rigor
- Better reflect the clinical reality of chronic low back pain
- Expand the pool of eligible patients
- Improve alignment with how Nociscan is used in everyday practice
These revised criteria have now been fully approved by the Institutional Review Boards (IRBs) at 9 of 11 active CLARITY sites, with the other 2 active sites using revised criteria for screening prior to local IRB approval. The revised criteria will be used at all newly added sites, including NYU and the most recent center activated for enrollment.
Overall Length of the CLARITY Trial Remains on Track
The IRB approval process temporarily slowed enrollment as sites paused screening under the prior criteria. With approvals now complete, Aclarion expects meaningful acceleration in enrollment going forward.
Importantly, the Company does not anticipate that this adjustment will extend the overall length of the CLARITY trial. The revised criteria are expected to:
- Increase the number of eligible patients
- Improve enrollment consistency across sites
- Enhance the representativeness of the study population
- Strengthen the real-world applicability of the eventual study results
With the pace of enrollment expected to increase under the revised criteria, Aclarion believes the trial remains on track to complete within its originally anticipated timeline.
Brent Ness, Aclarion CEO said, “CLARITY is designed to deliver the highest level of scientific rigor, and that required us to begin the study with very narrow inclusion criteria. As we gained real-world insight into patient flow across our sites, we needed to adjust those criteria to better reflect the chronic low back pain population surgeons actually treat. With IRB approvals now complete at nearly all active sites, we expect enrollment to accelerate meaningfully. We remain focused on enrollment and look forward to providing an update by year end with timing for the initial readout. Importantly, our confidence in the overall timeline remains on track with the importance of CLARITY demonstrating Nociscan’s clinical value.”
Chronic low back pain is a global healthcare problem with approximately 266 million people worldwide suffering from degenerative spine disease and low back pain. 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. When used with other diagnostic tools, Nociscan provides critical insights into the location of a patient’s low back pain and demonstrates a
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 that we will provide an update on enrollment levels and anticipated timeline for the initial readout by year-end, the expectation that we will significantly accelerate enrollment of patients in our ongoing clinical trial, that the overall duration of the CLARITY Trial Remains on Track and that the Company does not anticipate that this initial readout adjustment will extend the overall length of the CLARITY trial, that the revised criteria are expected to: increase the number of eligible patients; improve enrollment consistency across sites; enhance the representativeness of the study population and; strengthen the real-world applicability of the eventual study results; with the pace of enrollment expected to increase under the revised criteria, and, the continued expansion of the CLARITY trial to generate the high-quality evidence needed to advance Nociscan. 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
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