First Patients Enrolled at UHealth – University of Miami in Aclarion’s Pivotal CLARITY Trial

Core Insights - Aclarion, Inc. has initiated the CLARITY trial to evaluate the clinical and economic value of its Nociscan technology in spine surgery for chronic low back pain [1][3] Company Overview - Aclarion is a healthcare technology company focused on chronic low back pain, utilizing biomarkers and proprietary AI algorithms to assist physicians in identifying pain sources [1][4] - Nociscan is the first evidence-supported SaaS platform designed to noninvasively differentiate between painful and nonpainful lumbar discs [3][4] CLARITY Trial Details - The CLARITY trial is a prospective, randomized multi-center study involving 300 patients scheduled for surgical treatment of discogenic back pain [2][5] - The trial will randomize patients in a 1:1 ratio between surgeons blinded and unblinded to Nociscan results, with the primary endpoint being the change in back pain measured on a 100mm VAS scale at 12 months [2][5] - Initial patient enrollment has begun at the University of Miami Health System, with additional sites including Northwestern Medicine and Texas Back Institute [2][3] Market Context - Chronic low back pain affects an estimated 266 million people globally, representing a significant health challenge [3] - Aclarion aims for Nociscan to become the gold standard in identifying sources of low back pain through advanced diagnostic techniques [5][6]