Aclarion Adds UHealth, University of Miami Miller School of Medicine as CLARITY Trial Site

Core Viewpoint - Aclarion, Inc. announced the addition of UHealth — University of Miami Health System as a trial site for the CLARITY study, which aims to demonstrate the clinical and economic value of its Nociscan technology in spine surgery [1][2]. 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][6]. - Nociscan is the first evidence-supported SaaS platform designed to noninvasively differentiate between painful and nonpainful discs in the lumbar spine [4][6]. CLARITY Trial Details - The CLARITY trial is a prospective, randomized multi-center study involving 300 patients scheduled for surgical treatment of 1- or 2-level discogenic low back pain [3]. - The trial will randomize patients in a 1:1 ratio between surgeons blinded to Nociscan results and those unblinded, with the primary endpoint being the change in back pain measured on a 100mm VAS at 12 months [3]. - UHealth joins other prestigious institutions like Johns Hopkins Medicine and Northwestern Medicine as a trial site [2][3]. Clinical Significance - Chronic low back pain affects approximately 266 million people globally, highlighting the need for effective diagnostic and treatment solutions [4]. - Nociscan aims to improve surgical outcomes by providing critical insights into the location of low back pain through the analysis of chemical biomarkers [4][8]. Research and Development - The CLARITY trial represents a unique opportunity to advance the spine industry and showcase the research capabilities of the University of Miami [2][7]. - Aclarion's technology leverages Magnetic Resonance Spectroscopy (MRS) to optimize clinical treatments for chronic low back pain [6][7].