Minneapolis-based ShiraTronics designed its neuromodulation system to address the debilitating symptoms of migraines. The company says it offers the first-ever fully implantable system for head location utilizing a minimally invasive approach.
The fully implantable, programmable device delivers precise electrical pulses tailored to disrupt migraine pain signals. ShiraTronics designed it to offer a new and potentially more effective treatment option. The device won FDA breakthrough device designation in 2021. The company completed the first six implants of the device in this RELIEV-CM pilot study in December 2023. It takes place in Australia in collaboration with leading neurology and pain management researchers.
ShiraTronics said that, in the pilot’s initial stages, data unveiled promising results indicating a substantial decrease in headache and migraine days. The company also reported notable reductions in headache duration and severity. Preliminary outcomes demonstrated meaningful headache day reduction after four weeks of therapy.
According to the company, these results set the stage for the next phase of research. ShiraTronics plans to conduct the RELIEV-CM2 pivotal clinical study in the U.S. and Australia later this year.
“We are grateful to our dedicated investigators and patients whose invaluable contributions have propelled our research forward,” said ShiraTronics VP of Global Clinical Affairs, Fred Ecklund. “As we embark on the next phase of clinical trials with our upcoming pivotal study, we eagerly anticipate continued partnerships that will help us make meaningful strides in advancing therapy options for these patients.”
