Enrollment Begins in Aclarion’s Pivotal CLARITY Trial

UHealth – University of Miami Health System and the Miller School of Medicine has enrolled its first two patients in Aclarion Inc.’s CLARITY (Chronic Low bAck pain Randomized Independent Trial studY) trial. The pivotal study is designed to demonstrate Nociscan’s clinical and economic value in spine surgery.

“We are pleased to have enrolled our initial patients at the University of Miami Health System,” commented Gregory Basil, M.D., director of endoscopic spine surgery and assistant professor at UHealth and the Miller School. “CLARITY is an important trial for spine surgeons and their patients with low back pain. The additional information provided by Nociscan is challenging pre-conceived notions about the sources of low back pain and we look forward to understanding the correlation between surgical outcomes and the patient-specific biomarkers provided in the unblinded cohort.”  

The CLARITY trial is a prospective, randomized multi-center study evaluating patients scheduled to undergo surgical treatment for discogenic back pain in up to two lumbar levels. The study will enroll 300 patients at multiple U.S. high-volume sites, and all patients will receive a Nociscan prior to surgery. The study will be randomized at a one-to-one ratio of surgeons blinded-to-Nociscan and unblinded-to-Nociscan to guide the surgical treatment (fusion/TDR). The primary endpoint is change in back pain as measured on a 100 mm VAS Back at 12 months compared to baseline, with several secondary endpoints collected. The trial’s principal investigator is Dr. Nicholas Theodore of Johns Hopkins Medicine. Other enrolling sites include Northwestern Medicine, Advocate Health, Texas Back Institute, and USC.

“The CLARITY trial is a major catalyst for driving long-term value as we believe these results will be an important milestone in securing broad payer coverage for Nociscan,” Aclarion Chief Strategy Officer Ryan Bond said. “Our timelines for the CLARITY trial remain on track due to the commitment of our trial investigators and their teams to help us generate the evidence needed to advance Nociscan and expand access to patients in need.”

An estimated 266 million people worldwide live with chronic low back pain, making it one of the most widespread health challenges. 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 and can potentially drive better surgical outcomes for patients suffering from degenerative spine disease and low back pain worldwide.

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. Through a cloud connection, Nociscan receives MRS data from an MRI machine for each lumbar disc being evaluated. In the cloud, proprietary signal processing techniques extract and quantify chemical biomarkers 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.