The Ft. Lauderdale, Fla.-based company’s device is designed to be implanted near inflicted painful nerves to modulate nerve activity and provide therapeutic relief, the company said. The device is powered wirelessly by an external transmitter.
“The development of a minimally invasive implantable neuromodulation system targeting craniofacial nerves has the potential to help patients suffering from facial pain without the added complexity associated with extension cables and implantable pulse generators. StimRelieve’s technology has the potential to be that innovation,” Dr. Ashwin Viswanathan of Houston, Texas’ Baylor College of Medicine said in a press release.
Dr. Viswanthan is the principal investigator for the trial at Baylor, and enrolled the 1st patient in the trial, StimRelieve said.
The study, which is slated to enroll 50 patients, will examine the safety and efficacy of the device in delivering pulsed electrical energy to the targeted craniofacial nerve for treating chronic pain. The trial will focus on patients with neuropathic pain of the face, head or neck, which can be the result of a variety of modalities, the company said.
“Why no other product was ever really practical for placement in the head was due to the need for extensive tunneling down the neck with connection to an implanted pulse generator system. Now, for the first time ever, patients in this trial have an option for wireless stimulation for potential pain relief from various modalities that are impacting their quality of life,” ONS stim developer Dr. Richard Weiner of the Dallas Neurosurgical and Spine Associates said in a prepared statement.
“If the safety and effectiveness of the device is successfully trialed, the StimRelieve technology would allow neuromodulation to be offered to an underserved population living with chronic refractory craniofacial pain as a viable alternative to drug based therapy. The StimRelieve solution proposes a treatment option that is simple and not intimidating for patients. We look forward to the potential of positive results from the study on the path to bring this technology to market,” StimRelieve co-founder & managing director Laura Perryman said in a prepared release.