First Patients Enroll in Neuro Medical Nerve Block Trial

Cleveland, Ohio-based Neuros Medical Inc., a neuromodulation medical device company, has enrolled the first patients in its pivotal clinical trial to evaluate the company’s patented Altius system high frequency nerve block technology for the management of intractable limb pain of amputees.

The prospective, randomized, controlled pivotal clinical trial will consist of up to 130 patients at 15 institutions to evaluate the safety and efficacy of Neuros Medical’s Altius system. When completed, the results will support a premarket approval application to the U.S. Food and Drug Administration in order to market the device. The pivotal study builds off their long-term pilot study, which reported significant pain reduction, up to 30 months. In addition, more than half of the responders discontinued their pain medication use during the study.

“The Neuros high frequency nerve block has the opportunity to be a paradigm shift in treating chronic pain, especially post-amputation pain, due to its on-demand blocking effect, versus traditional stimulation,” said Leonardo Kapural, M.D., the study’s principal investigator, from the Carolinas Pain Institute in Winston-Salem, N.C.

Cleveland Clinic will be one of the initial implanting sites.

“We are excited to have our first implants underway as we execute our pivotal study, with our wave of sites commencing recruitment and enrollment,” said Jon J. Snyder, president and CEO of Neuros Medical.