Clinical-stage medical device company ShiraTronics has completed its pilot study in Australia for its implantable migraine therapy system.
The device is designed to alleviate the debilitating symptoms of migraine sufferers through electrical pulse delivery.
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The fully implantable, programmable device administers targeted electrical pulses to disrupt migraine pain signals.
In a collaborative effort with Australian neurology and pain management researchers, the RELIEV-CM pilot study, undertaken in five centres, is assessing the ShiraTronics System’s performance.
The pilot study’s initial stages showed data with a significant reduction in headache and migraine frequency, duration, and severity in participants.
Preliminary results indicate a meaningful decrease in headaches days after four weeks of treatment using the ShiraTronics System and completion of a 28-day headache diary.
ShiraTronics global clinical affairs vice-president Fred Ecklund said: “We are grateful to our dedicated investigators and patients whose invaluable contributions have propelled our research forward.
“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.”
The pilot study’s success paves the way for the next phase of research, the RELIEV-CM2 pivotal clinical study, which will expand to include sites in the US and Australia, later this year.
The RELIEV-CM2 study will be spearheaded by co-principal investigators, University of Connecticut School of Medicine neurology professor Brian Grosberg, and Western Reserve Hospital’s Center for Pain Medicine chairman Dr Narouze.
Grosberg said: “The positive results from the Australian pilot study indicate the potential impact of ShiraTronics’ treatment on chronic migraine sufferers. I am excited to co-lead the pivotal clinical study advancing migraine treatment options and further explore the benefits this technology could offer to patients dealing with chronic migraine.”
In December 2023, ShiraTronics implanted its Chronic Migraine System in six patients, a significant advancement in migraine treatment.
