Aclarion Inc. (Nasdaq: ACON, ACONW) has secured nearly $20 million in gross proceeds since Jan. 1, 2025, which fully funds its pivotal CLARITY trial. The trial is designed to demonstrate the clinical and economic value of Nociscan in spine surgery.
Ryan Bond, chief strategy officer of Broomfield-based Aclarion, said, “This milestone ensures we reach the study’s conclusion, potentially unlocking broad payer coverage and redefining chronic low back pain treatment.”
The CLARITY trial is a prospective, randomized, multicenter study led by Dr. Nicholas Theodore of Johns Hopkins as principal investigator. It aims to validate Nociscan’s ability to improve surgical outcomes for patients suffering from chronic low back pain. The trial plans to enroll 300 patients across multiple sites, building on peer-reviewed data that supports Nociscan’s potential to enhance surgical outcomes by aligning surgical interventions with specific discs identified as pain sources by Nociscan.
Chronic low back pain is a global health issue affecting approximately 266 million people worldwide with degenerative spine disease and low back pain. Aclarion’s Nociscan solution is an evidence-supported SaaS platform that noninvasively aids physicians in distinguishing between painful and nonpainful discs in the lumbar spine. Nociscan quantifies chemical biomarkers linked to disc pain and, when combined with other diagnostic tools, offers insights into the location of back pain. It demonstrates a 97% surgical success rate at one-year follow-up when all Nociscan-identified pain positive discs are treated.
