Aclarion Inc. announced the expansion of its multi-center Clinical Utility and Economic (CLUE) Trial to New Jersey. Dr. Justin Kubeck, an orthopedic spine surgeon and founder of Ocean Pain and Spine in Toms River, will initiate the trial in the state.
The CLUE Trial aims to assess how often Nociscan’s AI-generated data alters the treatment plans for patients with chronic low back pain. Kubeck is the second surgeon to join the trial since its announcement in early August, following Dr. John Keller, a neurosurgical spine surgeon in Michigan. Aclarion anticipates that more spine surgeons will participate in the trial in the coming months to gather data on the impact of Nociscan during critical decision-making stages for patient treatment.
Kubeck emphasized the importance of personalized treatment plans, stating, “I always tell new patients that we need to see what makes sense for their individual circumstances – whether it’s medication, or therapy, or ultimately, surgery.” He added, “Nociscan will be an invaluable decision support tool when evaluating diagnosis and treatment.”
The global prevalence of degenerative spine disease and low back pain affects 266 million people. Aclarion’s Nociscan solution is designed to noninvasively assist physicians in distinguishing between painful and nonpainful discs in the lumbar spine by quantifying associated chemical biomarkers. This information, used alongside other diagnostic tools, can offer insights into the location of a patient’s pain.
Ryan Bond, chief strategy officer at Aclarion, noted the significance of real-world evidence obtained through the trial, stating, “Real world evidence is incredibly valuable when evaluating the influence and utility of an emerging diagnostic tool… it becomes a critical tool for driving early payer coverage decisions.”