Aclarion Launches Major US Trial to Test AI Tool That Could Improve Spine Surgery for Chronic Back Pain

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 the first patient enrollment in the CLARITY (Chronic Low bAck pain Randomized Independent Trial studY) trial evaluating Nociscan's clinical and economic value in spine surgery. The first patient was enrolled at the Texas Back Institute.

"Texas Back Institute has a long history of advancing spine care through clinical trial research," said Alexander Satin, MD, board-certified orthopedic spine surgeon and principal investigator for the CLARITY trial. "We have followed the advancements from Aclarion and their Nociscan platform. The CLARITY trial will allow us to observe patient-specific critical pain biomarker data and the relationship with surgical outcomes. Our physicians and research leaders have extensive experience treating patients with chronic low back pain and we are pleased to participate in this important trial, including enrollment of the first patient."

The CLARITY trial is a prospective, randomized multi-center study evaluating patients who are scheduled to undergo surgical treatment of 1- or 2- level discogenic low back pain. The study will enroll 300 patients at multiple high-volume sites across the US and all patients will receive a Nociscan prior to surgery. The study will be randomized at a 1:1 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 100mm VAS Back at 12 months compared to baseline, with several secondary endpoints collected. The principal investigator for the trial is Dr. Nicholas Theodore of Johns Hopkins Medicine. Other sites that have been activated include Northwestern Medicine, Advocate Aurora Research Institute, Keck Medicine at USC and UHealth - University of Miami Health System and University of Miami Miller School of Medicine.

Chronic low back pain is a global healthcare problem with approximately 266 million people worldwide suffering from degenerative spine disease and low back pain. 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 has the potential to drive better surgical outcomes.