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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 that the UHealth – University of Miami Health System and the Miller School of Medicine enrolled its first two patients in the CLARITY (Chronic Low bAck pain Randomized Independent Trial studY) trial. The pivotal CLARITY 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 who are scheduled to undergo surgical treatment for discogenic back pain in up to two lumbar levels. 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 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," said Ryan Bond, Chief Strategy Officer of Aclarion. "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 across the globe 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 has the potential to drive better surgical outcomes for patients suffering from degenerative spine disease and low back pain worldwide.
Posted In: ACON
