Aclarion Adds USC's Keck Medical Center to Spine Pain Study, Joining Johns Hopkins, Northwestern

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 addition of Keck Medical Center of USC as a CLARITY (Chronic Low bAck pain Randomized Independent Trial studY) trial site. The pivotal CLARITY study is designed to demonstrate Nociscan's clinical and economic value in spine surgery.

"Keck Medicine of USC strives to offer patients access to new treatments and procedures, and tailored treatment options for all types of spine conditions – from simple to complex," says Patrick Hsieh, MD, neurological spine surgeon with Keck Medicine of USC. "The USC Spine Center's participation in the CLARITY trial demonstrates our commitment to deepening our understanding of spinal conditions to best serve patients' specific care needs."

Keck Medicine of USC is the latest CLARITY trial site, joining Johns Hopkins Medicine, Northwestern Medicine, Advocate Aurora Research Institute and Texas Back Institute. The principal investigator for the trial is Dr. Nicholas Theodore of Johns Hopkins Medicine.

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.