ShiraTronics has commenced the pivotal RELIEV-CM2 CLINICAL Study of its implantable neuromodulation therapy, designed for chronic migraine treatment.
The US Food and Drug Administration (FDA)-approved investigation device exemption (IDE) trial is set to involve up to 148 subjects, evaluating the long-term safety and efficacy of the therapy. Subjects received the first implants of neuromodulation therapy in the US and Australia.
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The system is specifically designed to provide preventive, sustained relief for individuals experiencing 15 or more headache days per month and have not found success with other therapies.
ShiraTronics’ RELIEV-CM2 study comprises four phases, starting with an ‘assessment phase’ to determine candidate suitability, followed by a ‘trial phase’ to test the therapy temporarily.
During the ‘implant phase’, subjects undergo a minimally invasive surgical procedure to place two implantable stimulators and leads beneath the skin.
In the final ‘use and follow up phase’, subjects can use the therapy continuously and will charge the system weekly, maintaining regular appointments with their study doctor.
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By GlobalDataThe first implant in the US was carried out by Dr Sandeep Vaid, medical director of Clinical Research at Vista Clinical Research, Georgia.
Dr Vaid said: “Bringing this new therapy to patients represents an exciting step forward in migraine management. Chronic Migraine has a profound impact on people’s lives, limiting daily activities and affecting overall well-being.
“This device offers a fresh approach that, based on early results, holds promise for improving how patients function day-to-day. It’s a privilege to be part of this pivotal study and witness what this technology might mean for patients who have exhausted other options.”
The therapy works by delivering electrical impulses to nerve pathways, aiming to reduce migraine frequency and severity. This non-pharmacologic option could allow individuals to maintain daily activities with fewer disruptions and reliance on continuous medication or invasive therapies.
The earlier ‘RELIEV-CM Pilot Study’ conducted by the company showed positive outcomes, with a 50% reduction in migraine frequency observed in 80% of subjects after three months.
Additionally, 60% of the subjects observed less reliance on acute medications, with some discontinuing them within six months of receiving the therapy.
In October, the company raised $66m in Series B funding to advance the implantable migraine device.
