ShiraTronics announced it initiated its FDA investigational device exemption (IDE) pivotal trial for its neuromodulation therapy. The RELIEV-CM2 clinical study evaluates the company’s neuromodulation therapy for chronic migraine. Investigators completed the first implants in the US and Australia, kicking off the evaluation of the system’s long-term safety and efficacy. In October, the company raised $66 million to support the launch of this trial.
Minneapolis-based ShiraTronics designed its minimally invasive implantable neuromodulation system to address the symptoms of migraines. The fully implantable, programmable device goes just beneath the skin in the head. It delivers precise electrical pulses tailored to disrupt migraine pain signals. ShiraTronics designed it to offer a new and potentially more effective treatment option.
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ShiraTronics said its device offers precise, 24/7 electrical neuromodulation to reduce the frequency and intensity of migraine attacks. It could allow patients to maintain their daily activities with fewer disruptions and less dependence on continuous medication or invasive treatments.
The device won FDA breakthrough device designation in 2021. ShiraTronics completed enrollment for its RELIEV-CM pilot study for the device in February.
According to a news release, the company expects the study to implant up to 148 patients in the U.S. and Australia. Dr. Sandeep Vaid completed the first implant in the U.S.
“Bringing this new therapy to patients represents an exciting step forward in migraine management,” Vaid said. “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.”
