Aclarion Enrolls First Patient in CLARITY Trial for Chronic Low Back Pain

Aclarion, a healthcare technology company, has enrolled its first patient in the CLARITY trial to demonstrate the efficacy of Nociscan in improving surgical outcomes for chronic low back pain. The trial aims to establish Nociscan as the gold standard for identifying sources of low back pain using MRI spectroscopy and AI. The company reaffirms its internal interim results expected in Q2 2026.

Aclarion, Inc., a healthcare technology company leveraging biomarkers and AI algorithms, has enrolled its first patient in the CLARITY trial. This randomized clinical trial aims to evaluate the clinical and economic value of Nociscan, a SaaS platform designed to improve surgical outcomes for chronic low back pain. The trial, initiated at the Texas Back Institute, marks a significant milestone in the validation process for Nociscan.

The CLARITY trial is a prospective, randomized multi-center study enrolling 300 patients scheduled for surgical treatment of 1- or 2-level discogenic low back pain. Patients will receive a Nociscan evaluation prior to surgery. The study will compare outcomes between surgeons with and without access to Nociscan data, with the primary endpoint measuring changes in back pain at 12 months post-surgery [1].

Nociscan utilizes MRI spectroscopy (MRS) and AI technology to analyze chemical biomarkers associated with disc pain, offering an objective and non-invasive approach to identify the source of chronic low back pain. This technology has the potential to drive better surgical outcomes and establish a new standard of care in spine surgery patient selection [2].

Aclarion reaffirms its internal interim results expected in Q2 2026, indicating that the company anticipates significant advancements in the field of spine care. The trial's methodology, which includes a 1:1 randomization ratio, ensures a robust evaluation of Nociscan's effectiveness. The substantial market for chronic low back pain, with approximately 266 million people worldwide suffering from degenerative spine disease and low back pain, highlights the potential impact of successful trial outcomes [3].

The enrollment of the first patient in the CLARITY trial represents a significant step forward in the clinical validation of Nociscan. While the trial's results are expected in approximately a year, this milestone underscores Aclarion's commitment to advancing spine care technology and its potential to become the gold standard in identifying sources of low back pain.

References:
[1] https://www.globenewswire.com/news-release/2025/06/25/3104893/0/en/First-Patient-Enrolled-in-Aclarion-s-Groundbreaking-CLARITY-Trial.html
[2] https://www.stocktitan.net/news/ACON/first-patient-enrolled-in-aclarion-s-groundbreaking-clarity-fn7befvrglpa.html
[3] https://www.barchart.com/story/news/33018635/aclarion-to-present-nociscan-technology-at-leading-spine-innovation-forum