Groundbreaking Clinical Trial Yields Impressive 2-Year Outcomes – Aclarion Reports!

Aclarion Inc., a healthcare technology company, has just released two-year durability data showing improved surgical outcomes for discogenic low back pain (DLBP) surgeries at painful lumbar discs identified by its own proprietary Nociscan technology. The data is a major breakthrough in the fight against chronic low back pain, providing physicians with a greater degree of accuracy and precision in their treatments.

The multi-year, single site clinical trial studied 78 patients who underwent surgery for DLBP, following standard clinical work-up including MRI and provocative discography. All patients underwent Nociscan, yet the results were not used in the surgical decision-making process. The patient outcomes were evaluated using the Oswestry Disability Index (ODI) scoring scale (100 points), with a 15-point improvement as the industry-standard for surgical success.

Remarkably, the results showed a 22 percentage point improvement (p = 0.07) between the two groups in terms of surgical success rates at 2 years. These findings suggest that Nociscan is an invaluable tool that can help physicians effectively treat DLBP.

Dr. Matthew Gornet, a fellowship-trained spine surgeon and national leader in treating chronic low back pain, believes Nociscan is a game-changer for those in the medical field. According to the two-year surgical outcomes of the clinical trial, Nociscan is significantly effective in the primary (ODI) endpoint.

Dr. Gornet states, “I feel uncomfortable now moving forward in treatment of low back pain patients without the information Nociscan provides, like a cardiologist who does not have an echocardiogram.” Nociscan has the potential to revolutionize the standard of care for those suffering from chronic low back pain.

Low back pain is a global health concern, affecting millions of people around the world. The source of pain has long been difficult to pinpoint – until now. Nociscan, an innovative diagnostic tool developed by Aclarion, offers an objective measure of pain biomarkers in an MRI-like experience.

Unlike invasive, painful and expensive discography, Nociscan is accurate, non-invasive, and painless. This allows medical professionals to accurately differentiate between discs that are merely aging and those that are painful, providing a more comprehensive and effective diagnosis.

Aclarion is proud to report that its clinical trial has achieved a hallmark achievement: two-year outcomes that are incredibly durable. This impressive foundational evidence, compiled by Dr. Gornet and his team, serves as the cornerstone of Aclarion’s commitment to leading with clinical evidence and changing the standard of care for low back pain.

Moreover, the Economic Value Analysis of Low back pain (EVAL) abstract, a healthcare economics study conducted by CDMI, has been submitted for presentation at upcoming spine society meetings, highlighting the economic and clinical benefits of Nociscan. As Aclarion continues to push forward with additional clinical trials, the possibilities for improving standards of care are endless.

The groundbreaking Gornet Trial, published in the esteemed European Spine Journal, has provided two year’s worth of evidence that pinpointing the source of pain is essential for successful treatment planning and outcomes. This surgical outcome trial has cemented Robert Eastlack, MD, Head of the Division of Spine Surgery at Scripps Clinic in San Diego, CA’s confidence in using Nociscan in his practice.

About Aclarion, Inc.

Aclarion is revolutionizing healthcare with its use of Magnetic Resonance Spectroscopy (MRS), proprietary signal processing techniques, biomarkers, and augmented intelligence algorithms. Through the cloud-connected Nociscan, their first SaaS platform, physicians now have a non-invasive way of discerning between painful and non-painful discs in the lumbar spine.

Nociscan extracts and quantifies chemical biomarkers from MRI machine data for each lumbar disc being evaluated. The combination of biomarkers and proprietary algorithms give physicians greater clarity on the source of a patient’s low back pain and enable them to provide more effective treatment strategies.

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