Aclarion (NASDAQ:ACON) reached a significant clinical milestone on Tuesday, January 6, 2026, announcing the first patient enrollments at two prestigious new sites: Northwestern Medicine and Scripps Health.
This expansion brings the total number of active enrollment sites to four, with seven leading U.S. spine centers having completed full regulatory and operational setup.
The CLARITY trial is a randomized, multi-center study designed to evaluate Nociscan, Aclarion’s proprietary AI-driven software that uses Magnetic Resonance Spectroscopy (MRS) to non-invasively identify the specific spinal discs causing chronic low back pain.
The trial will randomize up to 300 patients to compare surgical outcomes between surgeons who have access to Nociscan data and those who are "blinded" to the results.
By objectively identifying pain-positive discs, Nociscan aims to move beyond current diagnostic limitations, which lead to a roughly 54% industry benchmark for surgical success.
Aclarion management confirmed that the trial remains a "foundational value-creation initiative" intended to secure broad insurance reimbursement.
The company is targeting an enrollment milestone of 25% by the end of Q2 2026.
This pace sets the stage for a highly anticipated interim data readout in Q3 2026, which will analyze the initial patient cohort following their three-month post-operative visits.