By Elizabeth Hofheinz, M.P.H., M.Ed., October 4, 2019
If one of the most defining human traits is a need for certainty, you can double that for surgeons. Hence the frustration for spine surgeons when it comes to treating low back pain, arguably one of the most elusive orthopedic conditions to diagnose and treat.
But Nocimed, Inc. is making a dent in that problem. This San Mateo, California-based spine business is the only company in the world that is exploring the role of chemical biomarkers in helping to diagnose lumbar disc pain. Based on MR Spectroscopy, Nocimed puts more and better decision-making power in the hands of surgeons.
CEO Brett Lanuti notes: “Drs. Jeff Lotz and David Bradford, along with Jim Peacock, founded Nocimed in 2008 essentially because of the unpredictability of surgical outcomes for low back pain patients. They could see that a better option was necessary as a traditional MRI was unable to provide sufficient information.”
Thus, the founders went on a scientific quest for quantifiable information that would shed light on the chemical cocktail that might be responsible for low back pain.
Brett Lanuti: “Conventional thinking says that a dark disc in MRI indicates pain while a light disc is void of pain because it is hydrated. The early research at the University of California at San Francisco (UCSF) looked at tissue samples under a high field MRI and found that in a scoliotic disc there were high levels of glycogens and low acids. Then they examined tissue samples from patients undergoing lumbar surgery for back pain and saw low proteoglycan and high acids.”
Going beyond the noise…
Licensing this technology that was invented at the UCSF, Nocimed knew it was onto something. Lanuti stated, “We knew that this had never been done for the spine before and that spectroscopy can be difficult to interpret unless you can increase the signal to noise ratio. The solution took several years to develop, but ultimately is now one of many patents Nocimed holds as part of our software portfolio.”
And their work paid off. “Using spectroscopy, we were able to find the ‘fingerprint’ of a disc much more easily as we were able to capture the signal spikes of individual biomarkers We are taking raw biomarkers and post processing them with an algorithm to create a report which provides a valuable adjunctive piece of information in order to assess acids and collagen in the disc.”
So what do patients undergo? It starts with a conventional lumbar MRI, with spectroscopy added within the same session. The resulting data is then uploaded to a cloud-based system for analysis that is processed into a readable report, i.e., a “Nocigram.”
A resounding ‘thank you’ from surgeons…
Matt Gornet, M.D., a spine surgeon at the Orthopedic Center of St. Louis, states, “Nociscan has changed my practice. For years we’ve had to use a variety of limited tools in diagnosing discogenic low back pain. Now, with Nociscan, I have a tool that scientifically enables me to identify and then treat the source of patients’ low back pain.”
Roger Sung, M.D., with Colorado Springs Orthopedics Group, noted, “I find that Nociscan can be most beneficial in the setting of a patient with very clear pathology at one level (spondy and stenosis) with radicular symptoms. These patients often have significant low back pain as well. I know that this level needs to be fused. Nociscan can help to identify whether an adjacent segment with mild age-related wear is a significant component of this patient’s low back pain. If it is, including it in the fusion can help significantly with low back pain. If it’s negative, leaving it alone is better for the patient and cheaper for the insurance company in terms of time of surgery, complications, implant costs, etc. If this adjacent disc level is painful and included in the surgery and the patient has a better result, the insurance costs are less as there is less long-term treatment, less chance of a second surgery soon, etc. In either scenario, the information and the correct treatment based on the Nociscan information combined with the conventional diagnostic information can save significant costs.”
The technology, which functions on the Siemens platform, is in high demand, says Lanuti. “Imaging centers are quickly adopting this technology as it clearly addresses an unmet need.”
Brett Lanuti: “We now know that it is possible to monitor interdiscal health over a period of time as long as there has been no fusion. So patient X had painful discs, underwent conservative therapy, and six months later showed a reduction in acids within the disc. Clinicians are telling us that they are relieved to finally see an adjunctive tool in this market that can better address the gap in diagnosing chronic back pain.”
An orthopedic business for the greater good…
“The number two consumers of opioids are chronic back pain patients,” says Lanuti. “The Nocimed technology can be used for the greater good as it can help patients get the right treatment at the right time, thus obviating or lessening the need for opioids.”
“Using a large payor database, we were able to demonstrate well over $200 million in savings over four years through the reduction of adjacent segment surgery. It is a fact that 9% of all patients who undergo lumbar spine surgery go on to need an adjacent level surgery at some point. Information from the Nocimed report can help reduce that number, and in doing so, reduce suffering, and unnecessary surgery.”
Douglas Beall, M.D. of the Center of Radiology of Oklahoma states, “Nociscan is filling a major and long-standing gap in the diagnostics of low back pain. It’s not an exaggeration to believe that years from now, Nociscan will be as commonly used as the flu vaccine in an effort to address this significant gap.”
But in the meantime, Nocimed is proceeding in a methodic manner and establishing the validity of its product. Brett Lanuti notes, “We expect to have 10 imaging centers utilizing the Nocimed technology by the end of this year. In addition, we have just launched a Post Market Study where we will enroll 240 patients at 8-10 of the leading Spine Centers in the US to support our previously published data which had been published in the European Spine Journal earlier this year. We are expecting to see similar results validating the NOCISCAN-LS as an adjunctive diagnosis tool helping in the improvement of surgical and non-surgical patient outcomes.”