Neuros Medical Altius System
Neuros Medical is a medical device company harnessing neurostimulation to treat the chronic pain that lingers after limbs have been amputated. The Cleveland, Ohio-based business has closed a $20 million funding round to complete clinical trials for its pain management technology and submit an application for Premarket Approval from the U.S. Food and Drug Administration in the next two years.
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U.S. Venture Partners led the round with participation from Boston Scientific, Aperture Venture Partners, and Osage University Partners. JumpStart Inc., which also took part in the round, had previously invested in the business.
Jon Snyder, CEO of Neuros Medical, said in a phone interview that the funds would be used to finish the company’s initial pivotal IDE clinical study and to secure pre-market approval. The trial is evaluating the use of nerve blocking technology to manage post-amputation pain. The randomized controlled pivotal trial will include up to 130 patients across 15 institutions to assess the safety and efficacy of Neuros Medical’s Altius System.
The majority of patients targeted for the product have lost limbs due to diabetes, peripheral vascular disease, and trauma. Amputations associated with diabetes and peripheral vascular disease have continued to climb every year, Snyder observed.
Despite what it sounds like, post-amputation pain has a physical cause — neuromas or ball-like tumors that grow at the end of severed nerves. By using neurostimulation, the company’s electrical nerve block therapy is intended to block the pain signal at a location proximal to the neuroma in a nerve. The goal is to provide a more effective, long lasting treatment for chronic pain than the options currently available such as opioids and other surgical interventions.
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The company developed an implantable device with electrodes placed on the previously severed nerve. The target nerves are exposed proximal to the neuroma formation at the tip of the severed nerve, according to a description of the treatment from an article on the pilot study. A cuff electrode is wrapped around the target nerve. The lead from each electrode is connected to a pacemaker-sized generator. The generator is implanted in the abdomen just below the rib cage. An external remote controller lets the user initiate a treatment session as needed.
Seven participants in the pilot study of 10 received the implant and their pain was reduced by up to 75 percent by the end of a three-month period. The original expectations were for a 50 percent pain reduction. The participants included men and women who had a leg amputated either from trauma or vascular disease.
Snyder noted that the company has received grant funding from the Department of Defense and the Veterans Administration is involved in the pivotal clinical trial.
Neuromodulation is an area that has seen steady growth in the past few years as more companies get FDA approval with diverse applications spanning from sleep apnea to obesity. Other applications in development include autonomic nervous systems, rheumatoid arthritis, Crohn’s disease and irritable bowel disease.
“It’s been great for this industry. We’re seeing more companies getting FDA approval.” Snyder said in the future, Neuros Medical plans to add indications for other types of chronic pain.
