FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--StimRelieve LLC, a privately held medical device company, today announced that it has received FDA Investigational Device Exemption (IDE) approval to launch a clinical trial of the world’s smallest percutaneously implantable device for the treatment of refractory craniofacial neuropathic pain. StimRelieve uses wirelessly-powered, miniature neurostimulators leveraging nanotechnology for the treatment of refractory craniofacial pain ailments, including, but not limited to, TMJ disorders, chronic, intractable trigeminal and other neuralgias, persistent idiopathic facial pain (atypical facial pain) conditions, and a variety of other cranial or facial pain syndromes.
“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,” said Richard L. Weiner, MD, FACS, inventor of occipital stimulation, leading neurosurgeon, and partner at 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.”
This clinical trial will assess the safety and effectiveness of craniofacial nerve stimulation using the StimRelieve Halo CFNS System for the treatment of refractory neuropathic craniofacial pain. The Halo CFNS System is based on wireless neuromodulation technology that includes a minimally-invasive procedure of an implantable stimulator with an embedded receiver through a standard gauge needle, without the need for extensive surgery. Unlike other devices, there is no implanted battery pack placed in the patient’s chest. Instead, a discreetly-worn external transmitter placed on the ear provides energy and therapy to the implanted device. The goal of the study is to achieve sustained pain reduction of more than 50 percent as measured by VAS at three months with no increase in medication, as compared to the control group that will have no active treatment during the same period.
The StimRelieve Halo CFNS System is an innovative implantable neurostimulator with four or eight electrodes and includes the ability to provide stimulation parameter frequencies to 10,000 Hz. It is among the world’s smallest devices – 95 percent smaller than other implanted options – and eliminates extensive surgery to the face and neck.
“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,” said Laura Tyler Perryman, StimRelieve Chairman and President. “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.”
StimRelieve products are not approved for sale or commercial distribution, and are limited to investigational use only. For more information about the StimRelieve clinical trials for the treatment of refractory craniofacial neuropathic pain, please visit www.clinicaltrials.gov.
About StimRelieve
StimRelieve LLC is a privately held medical device company engaged in the development, manufacture and commercialization of wirelessly-powered, implantable neurostimulators leveraging nanotechnology for the treatment of chronic migraines and other craniofacial pain modalities. StimRelieve provides patients with a convenient, safe, minimally-invasive, and highly cost-effective solution for pain management that is easily incorporated into daily routines. StimRelieve’s goal is to evolve its patented, cutting-edge platform into the default for neuromodulation, increasing the accessibility for patients worldwide, while lowering the economic impact of the treatment. www.stimrelieve.com
