Aclarion Broadens CLARITY Trial Enrollment Criteria to Accelerate Enrollment
Key Highlights
- ➤CLARITY criteria broadened, with IRB approval at nine of 11 active sites
- ➤Enrollment pace expected to accelerate after prior criteria slowed screening
- ➤Initial readout timing update deferred to year-end based on Q4 enrollment
- ➤Overall CLARITY trial duration remains on track despite readout timing update
- ➤Revised criteria expand eligibility and improve real-world chronic pain representation
Expert Statements
Brent Ness, CEO of Aclarion
“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.”
* 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.
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