Aclarion, Inc. (Nasdaq: ACON, ACONW) has announced Northwestern Medicine as the inaugural site for its pivotal CLARITY trial, marking a significant step forward in chronic low back pain diagnosis and treatment. The study will evaluate Nociscan, a pioneering technology that combines biomarkers and artificial intelligence to identify pain sources in the lumbar spine.
Trial Design and Objectives
The CLARITY trial is designed as a prospective, randomized multi-center study focusing on patients scheduled for surgical treatment of one- or two-level discogenic low back pain. The study will enroll 300 patients across multiple high-volume U.S. centers, with all participants receiving a Nociscan evaluation before surgery. Surgeons will be randomized in a 1:1 ratio between those with and without access to Nociscan data to guide surgical treatment decisions.
Dr. Alpesh Patel, Professor and Co-Director of the Northwestern Center for Spine Health, emphasized the institution's research prominence: "Northwestern Medicine led over 6,900 clinical studies with 372,561 study participants in 2024. The CLARITY trial represents a groundbreaking investigation into Nociscan's potential impact on surgical outcomes for discogenic low back pain."
Technology and Clinical Impact
Nociscan stands as the first evidence-supported SaaS platform that noninvasively helps physicians differentiate between painful and nonpainful discs in the lumbar spine. The technology utilizes Magnetic Resonance Spectroscopy (MRS) and proprietary signal processing techniques to quantify chemical biomarkers associated with disc pain.
"When compared to traditional testing options, these technologies improved diagnostic accuracy, reduced unnecessary procedures, and ultimately saved the health system significant costs," stated Brent Ness, CEO of Aclarion, drawing parallels to his experience with algorithm commercialization in cardiology.
Global Health Impact and Market Potential
The trial addresses a significant global health challenge, with approximately 266 million people worldwide affected by degenerative spine disease and low back pain. The primary endpoint will measure changes in back pain using a 100mm VAS Back assessment at 12 months compared to baseline, along with various secondary endpoints.
Dr. Nicholas Theodore of Johns Hopkins will serve as the principal investigator for this fully-funded study. The trial's design reflects Aclarion's commitment to generating robust clinical evidence supporting Nociscan's adoption as a standard tool in chronic low back pain management.
Clinical Implementation
Through cloud connectivity, Nociscan processes MRS data from MRI machines for each evaluated lumbar disc. The platform's proprietary algorithms analyze biomarker data to indicate potential pain sources, providing physicians with critical insights for treatment optimization when used alongside other diagnostic tools.
