Aclarion, Inc. Advances Chronic Low Back Pain Management with Nociscan Platform

As healthcare technology rapidly evolves, significant advancements are being made in addressing chronic low back pain (cLBP), a condition that affects approximately 266 million people worldwide. Aclarion, Inc. (NASDAQ: ACON) is at the forefront of this innovation with its Nociscan platform, an advanced diagnostic tool designed to noninvasively differentiate between painful and nonpainful discs in the lumbar spine.

Nociscan utilizes Magnetic Resonance spectroscopy (MRS), proprietary signal processing techniques, and augmented intelligence algorithms to process MRI data, quantifying chemical biomarkers associated with disc pain. This data provides physicians with crucial insights for more precise diagnostics and enhanced treatment planning, ultimately improving patient care.

Aclarion recently announced the completion of the first Nociscan exams in the LIFEHAB trial, a pivotal study in Norway comparing lumbar interbody fusion surgery with multidisciplinary rehabilitation for cLBP. This trial, involving 202 patients, aims to correlate MRS biomarkers with treatment responses. As of late August, six patients have completed their Nociscan exams, marking a significant milestone in the trial's progress.

Further emphasizing Aclarion's commitment to advancing cLBP management, the company has expanded its presence in the U.S. market. On August 14, 2024, Aclarion announced a commercial agreement with Sheridan Community Hospital in Michigan, partnering with neurosurgeon Dr. John Keller to validate Nociscan’s clinical effectiveness. This agreement signifies Aclarion's entry into central Michigan and its potential to advance noninvasive, cost-effective diagnostics for disc pain.

Building on its success in the UK, where Aclarion has secured insurance coverage, the company is now focused on achieving similar coverage in the U.S. This step is critical to increasing Nociscan’s accessibility and adoption within the American healthcare system.

Aclarion is also making inroads into the personal injury and workers’ compensation markets in New Jersey. On August 29, 2024, the company announced a collaboration with orthopedic spine surgeon Dr. Justin Kubeck to enhance the evaluation of cLBP in these complex legal and insurance settings. This initiative aims to provide objective data to support treatment decisions and compensation claims.

Moreover, Aclarion has launched two major clinical trials to substantiate Nociscan’s benefits. The Clinical Utility and Economic (CLUE) Trial, announced on August 21, 2024, assesses how Nociscan’s AI-generated biomarker data impacts surgical treatment decisions. Complementing this, the CLARITY trial—a multicenter, prospective randomized study—aims to provide definitive evidence on the advantages of incorporating Nociscan data into surgical decision-making processes.

Industry recognition of Aclarion’s innovative approach came on September 5, 2024, when the company was added to the PRISM Emerging Medical Devices Index. This inclusion underscores Aclarion’s position as a leading innovator in the medtech sector and can enhance its market visibility and attractiveness to investors.

With the U.S. medical devices market projected to grow to nearly $315 billion by 2032, Aclarion’s Nociscan is well-positioned to capture a portion of the $40 billion lumbar spine diagnostics and treatment market. Aclarion’s efforts to address chronic low back pain through innovative, noninvasive technology underscore its potential to make a significant impact in the healthcare sector.