FDA OKs StimRelieve chronic migraine trial

StimRelieve said today it won FDA investigational device exemption to launch a trial of its percutaneously implantable Halo CFNS device for treating chronic migraines.

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.

“To date, treatments for chronic migraines have had limited and inconsistent results. Chronic migraine headache pain is a crippling condition, disabling millions of Americans every year. If determined safe and effective, StimRelieve’s wireless neuromodulation device offers a promising option for alleviating and controlling this type of condition so that those living with this pain can better function and go on with their lives,” Dr. Konstantin Slavin of Chicago’s University of Illinois said in prepared remarks.

The clincial trial will compare the device to standard therapies such as treatment with NSAIDS, migraine specific drugs or combination therapy, the company said.

“We are delighted to be moving forward with this study to demonstrate the potential of our product platform to address a wide variety of chronic issues with minimally-invasive neuromodulation treatments. If this study demonstrates safety and effectiveness, StimRelieve can help millions of people in the U.S. who are suffering from chronic migraines, without the need for extensive surgery or bulky implants in their chest,” prez Laura Tyler Perryman said in a press release.

StimRelieve said the trial will assess safety and effectiveness of occipital and supraorbital nerve stimulation using its Halo Migraine system, based on wireless neuromodulation technology.

Earlier this month, StimRelieve said it won an investigational device exemption for a clinical trial of its neurostimulation treatment for treating refractory craniofacial neuropathic pain.

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.

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