Disrupting Chronic Pain Treatment: Aclarion’s Nociscan Leads the Way in Identifying Painful Spinal Discs

We announced the completion of the first Nociscan exams for patients enrolled in the LIFEHAB Trial in Norway, where a clinical trial sponsor is paying Aclarion for the rights to use its breakthrough technology LIFEHAB is a randomized controlled trial studying 202 patients who have experienced LBP for more than a year, and it will compare treatment outcomes between lumbar interbody fusion surgery and multidisciplinary rehabilitation. Nociscan was selected for use in the study to help evaluate how magnetic resonance spectroscopy (MRS) biomarkers can be used in determine the best treatment option for patients.

While it’s difficult to speculate, we are very pleased to see the LIFEHAB Trial progressing on schedule and look forward to the results of this study. Specifically, regarding the role Nociscan could have, we are optimistic that the data our technology provides will not only help physicians determine which discs to treat but could also aid in potentially helping to predict which treatment option is optimal for a particular patient. While we talk frequently about driving Nociscan to become the standard of care for clinical use, we’re encouraged to see that the research market is proving to be an early adopter of our technology.

Absolutely – there have been several significant studies to date. Right now, we’re waiting to hear the results of a completed trial in Rome where Nociscan technology was used to evaluate regenerative technologies. In addition, the National Institutes of Health (NIH) funded two studies to examine the role of Nociscan in treating chronic low back pain and we’re looking forward to seeing those results shortly. At the same time, Aclarion is advancing its CLARITY trial, which will enroll up to 300 patients across eight sites, led by Dr. Nicholas Theodore from Johns Hopkins.

It’s very gratifying to see Nociscan moving at such an accelerated adoption rate among primary investigators and institutions committed to advancing medical research. We look forward to announcing more partnerships as we continue to drive Nociscan to what we expect to be the gold standard for determining which discs to treat in research protocols on low back pain.

We are confident that as this body of medical research expands—from important studies such as the LIFEHAB trial and the growing body of other compelling evidence—we’ll see successful reimbursement advances in more countries for MR Spectroscopy sequences and our augmented intelligence (AI) algorithms that enables Nociscan to generate the presurgical insights physicians need as well as endorsements from all the major spine societies. We anticipate more announcements about sponsor-supported research studies that generate additional revenue and insights in the near future.

We are also proud to have published persuasive peer-reviewed data in “The International Journal of Spine Surgery” highlighting Nociscan as a leading tool for noninvasive identification of painful lumbar discs. All of this momentum is driving Aclarion in our mission of optimizing clinical treatments to alleviate chronic low back pain.

In most cases, healthcare professionals rely on images from a magnetic resonance imaging or MRI machine to screen or diagnosis a particular structural issue in the body. Using an advanced form of MRI known as Magnetic Resonance Spectroscopy, we’re able to gauge the chemical makeup of tissue—specifically spinal disc tissue—which is captured as biomarker data and processed through Nociscan to produce insights surgeons use to distinguish the source of the spinal disc pain.

However, the cost of MRIs and our AI algorithm are expensive for many patients and require reimbursement approval or prior authorization from the various insurance providers before the procedure occurs. This can be a real financial obstacle for patients seeking relief from cLBP.

At the same time, it’s important to recognize potential savings inherent in using Nociscan within the U.S. spine surgery population based on the conclusions of a recent study commissioned by the Center for Disruptive Musculoskeletal Innovations. The study determined that Nociscan improves outcomes and reduces costs, conservatively saving the U.S. healthcare system nearly half a billion dollars annually and by more than $1,700 per patient.

Yes, that’s right. Within the market now, the only way to evaluate whether spinal discs are painful or not is through a procedure known as a discogram where the doctor takes a needle and pokes it into the outer layer of the suspected disc. The needle is further inserted and is the disc is pressurized.

The patient is awake during this entire time and asked whether the pressure is painful or not. While this had been the standard of care, it has fallen out of favor over the last decade, primarily because it’s invasive, it’s painful, it’s expensive, and it’s subjective.

Recently, several surgeons from The London Clinic, a large spine center in the UK, who were previously big believers in discography decided to conduct a study comparing about 20 patients of discogram to our technology.

The London Clinic surgeons were very impressed with our technology and went to the payers in the market to argue for payments so that they didn’t have to proceed with discograms anymore. The physicians were very successful in doing that, and they got three of the top four payers in the private market to provide payment coverage.

This is the model we’re taking to the United States as we continue to work with key opinion leaders and physicians to convey the benefits of Nociscan to the decisionmakers for payer coverage here.

Driving payer coverage by partnering with Key Opinion Leader (KOL) physicians who see the value of Nociscan in their practice helps us not only advocate for insurance coverage as we discussed but also enhance patient care. We have an esteemed panel of 10 of the top spine surgeon leaders in the world who strongly believe in the efficacy and clinical utility of adding Nociscan when evaluating patients who suffer from chronic low back pain. They help us collect clinical data, engage insurance companies and benefits management entities, and share the benefits of using the latest technology to address low back pain.

To expand access to more KOLs across the globe, we recently formed a strategic partnership with ATEC, a major spine implant company with a focus on leveraging pre-surgical data to drive better outcomes through its informatics platform. This will help us reach additional surgeons in key markets such as New York, New Jersey, Arizona, Colorado, and Michigan.

More than one million U.S. workers suffer back injuries on the job each year, according to Bureau of Labor Statistics data, and these injuries are the second most common reason people miss work – while costing billions of dollars per year in bills, disability payments, and productivity losses.

We know that low back pain is a major factor in workers’ comp and personal injury cases and believe that the right diagnosis—and the right treatment—can make a tremendous difference for individuals, companies, and the insurance market. We currently partner with an orthopedic spine surgeon in New Jersey to provide education on Nociscan’s potential benefits for this important population and will likely expand this approach in other locations.

We’re very excited and optimistic about the future. There are more than 500,000 lower back surgeries in the U.S. each year, and the estimated fusion and non-fusion surgical market—including diagnostic care—is estimated at $40 billion annually. There are 16 million people in the U.S. alone who suffer from cLBP, and 266 million patients with degenerative spine disease and lower back pain around the globe. We are confident we have the right technology at the right time to address a growing, unmet therapeutic need.