Medtronic plc announced it has acquired Stimgenics, LLC, a privately-held company based in Bloomington, Illinois, that has pioneered a novel spinal cord stimulation (SCS) waveform known as Differential Target Multiplexed (DTM) Spinal Cord Stimulation. The therapy, which is delivered via the Medtronic Intellis platform, is a new and unique programming option to treat patients with chronic pain. Three month results from a randomized control trial (RCT) evaluating DTM versus conventional SCS will be presented at the upcoming North American Neuromodulation Society (NANS) 23rd Annual Meeting on January 23-26 in Las Vegas. The RCT will continue to evaluate outcomes through 12 months follow-up.
The DTM waveform may engage a novel mechanism that modulates both neurons and glial cells, expanding the understanding of SCS mechanisms of action. The DTM waveform has been studied in animal models, showing statistically significant reversal of pain behaviors compared to either low frequency or high frequency alone. In addition, preclinical studies investigating the genome of nerve-injured animals suggests that the DTM waveform has a greater impact in the neural-glial interaction than other frequencies alone. Decades of basic science research have expanded the understanding of the role of glial cells in the nervous system, which outnumber neurons 12:1 in the spinal cord. Glial cells are no longer thought to be only “glue” in the brain and spinal cord, but active contributors to neural processing and various disease states including chronic pain.
“Stimgenics’ research is deeply rooted in clinical science that began with animal work more than a decade ago. Our preclinical data demonstrated that the modulation of both neurons and glial cells may return glial cells to their normal state and modify how they interact with neurons, which could normalize biological processes and break the pain cascade,” said Dr. Ricardo Vallejo, co-founder and director of research at Millennium Pain Center in Bloomington, Illinois, and founder and lead investigator of Stimgenics, LLC. “I’m thrilled that Medtronic has acquired a therapy that has the potential to significantly improve outcomes for chronic pain patients.”
Stimgenics’ preclinical research on the neuronal-glial mechanism of action has been recognized at various medical society meetings. Over the course of the past two years, the team has received six “best of” awards for their research, three of which were specific to research investigating the DTM mechanism of action. NANS awarded the “Best Basic Science Research Award” to Stimgenics at their annual meeting in both 2018 and 2019.
“Medtronic is committed to providing clinically-proven therapeutic options for millions of patients suffering from chronic pain around the world,” said Marshall Stanton, M.D., president of the Pain Therapies business, which is part of the Restorative Therapies Group at Medtronic. “We believe that DTM therapy will advance the treatment of chronic pain, supported by clinical evidence and preclinical research on a neuronal-glial mechanism of action. It’s an exciting, new proprietary SCS waveform that will be available on the Intellis platform, and we are looking forward to seeing the results of the randomized control trial data later this month at NANS.”
This transaction is expected to be neutral to fiscal year 2020 earnings per share and meet Medtronic’s long-term financial metrics for acquisitions. Additional terms of the transaction were not disclosed.