Core Viewpoint - Aclarion, Inc. has announced the Texas Back Institute as a new site for its pivotal CLARITY trial, which aims to demonstrate the clinical and economic value of its Nociscan technology in spine surgery [1][4]. 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]. - The company's Nociscan platform is the first evidence-supported SaaS solution designed to noninvasively differentiate between painful and nonpainful lumbar discs [4][7]. 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, guiding surgical treatment decisions [3]. - The primary endpoint is the change in back pain measured on a 100mm Visual Analog Scale (VAS) at 12 months compared to baseline [3]. Texas Back Institute's Role - Texas Back Institute is recognized for its excellence in research and has participated in various studies related to spine treatments [2][4]. - The institute's involvement in the CLARITY trial is expected to enhance the study's credibility and align with its patient population [2][4]. Market Context - Chronic low back pain affects approximately 266 million people globally, highlighting the significant healthcare challenge it presents [4]. - Aclarion's Nociscan aims to improve surgical outcomes by providing critical insights into the sources of low back pain through advanced diagnostic techniques [4][7].
Aclarion Announces Texas Back Institute as New CLARITY Trial Site