FDA OKs trial for StimRelieve’s facial pain device

StimRelieve said today that it won an investigational device exemption for a clinical trial of its neurostimulation treatment for treating refractory craniofacial neuropathic pain.

Ft. Lauderdale, Fla.-based StimRelieve said its Halo CFNS device, using wirelessly-powered, nanotech neurostimulators, is 95% smaller than other implantable treatment options. The wireless device, powered by an external transmitter in the ear, is implanted with a standard-gauge needle, the company said.

The trial is designed to evaluate the Halo CFNS device’s safety and effectiveness in comparison with no active treatment, the company said. The endpoint is sustained pain reduction at 3 months of more than 50%, as measured by visual analog pain scale measurement, with no increase in medication.

“Our goal is to evolve our core product platform and services to become the default solution for neuromodulation treatments, increasing the accessibility for patients worldwide while reducing the economic impact of treatment,” chairman & president Laura Tyler Perryman said in prepared remarks. “Should the study show positive results for safety and effectiveness, StimRelieve hopes to be able to treat an underserved patient population with a solution that is simple and not intimidating. We look forward to success from the study on the path to bringing this technology to market to provide a practical solution for undertreated patients suffering from craniofacial pain throughout the world.”

“Treatments for chronic craniofacial pain conditions remain inadequate for a significant number of suffering patients whose lives have been severely disrupted despite the best efforts of physicians and other caregivers to reduce pain and discomfort,” added Dr. Richard Weiner of Dallas Neurosurgical Associates. “The minimally-invasive neuromodulation technique utilized by the StimRelieve device offers an exciting approach to controlling these intractable conditions thereby greatly improving the lives of those suffering from these very difficult pain conditions.”

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