Aclarion Expands Clinical Trial for AI-Powered Low Back Pain Diagnostic Tool to New Jersey

Aclarion, Inc., a healthcare technology company specializing in chronic low back pain diagnosis, has announced the expansion of its Clinical Utility and Economic (CLUE) trial to New Jersey. This multi-center study aims to assess how frequently Nociscan, Aclarion's AI-powered diagnostic tool, influences treatment plans for patients suffering from chronic low back pain. Dr. Justin Kubeck, an orthopedic spine surgeon and founder of Ocean Pain and Spine in Toms River, NJ, has joined the CLUE trial as the second participating surgeon. This expansion follows the recent addition of Dr. John Keller, a neurosurgical spine surgeon in Michigan, to the study. Aclarion anticipates more spine surgeons will join the trial in the coming months, rapidly building a comprehensive dataset to demonstrate Nociscan's impact on clinical decision-making to payers.

The CLUE trial's expansion is significant for several reasons. Chronic low back pain affects approximately 266 million people globally, making it a major health concern. Nociscan, as the first evidence-supported SaaS platform to noninvasively help physicians distinguish between painful and nonpainful discs in the lumbar spine, has the potential to revolutionize diagnosis and treatment planning for this widespread condition. Dr. Kubeck emphasized the importance of individualized treatment plans and the potential role of Nociscan in this process. "Nociscan will be an invaluable decision support tool when evaluating diagnosis and treatment," he stated, highlighting the technology's potential to enhance the existing diagnostic protocol.

Nociscan's approach is unique in its use of chemical biomarkers associated with disc pain. The platform objectively quantifies these biomarkers and employs proprietary algorithms to identify potential pain sources. When used in conjunction with other diagnostic tools, Nociscan provides critical insights into the location of a patient's low back pain, potentially leading to more targeted and effective treatments. Ryan Bond, Chief Strategy Officer at Aclarion, underscored the importance of real-world evidence in driving early payer coverage decisions for emerging diagnostic tools. The CLUE trial's rapid expansion and the involvement of experienced surgeons like Dr. Kubeck are expected to accelerate the gathering of this crucial data.

For the healthcare industry, the CLUE trial and Nociscan's development represent a significant step forward in the diagnosis and treatment of chronic low back pain. By providing more accurate information about pain sources, this technology could lead to more precise treatments, potentially reducing unnecessary procedures and improving patient outcomes. As the trial progresses, its results could have far-reaching implications for both patients and healthcare providers. If Nociscan proves to consistently influence treatment decisions, it could become a standard tool in spine care, potentially transforming the approach to chronic low back pain management. The expansion of the CLUE trial to New Jersey marks an important milestone in Aclarion's efforts to validate Nociscan's clinical utility and economic impact. As more sites join the study, the healthcare community will be watching closely to see how this AI-driven approach might reshape the landscape of chronic low back pain diagnosis and treatment.