The ShiraTronics migraine therapy system is designed to alleviate the symptoms of migraine sufferers through electrical pulse delivery. Credit: SurfsUp via Shutterstock.

ShiraTronics has shared data showing that its implantable neurostimulation system reduces the frequency of migraines and improves quality of life.

The data from the RELIEV-CM Australian pilot study was presented at the American Society of Pain and Neuroscience (ASPN) conference, which took place in Miami, Florida, from 11 to 14 July.

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New 12-week data shows a significant reduction in migraine frequency and severity. Participants noted enhancements in daily activities and overall well-being, demonstrating that the device improves quality of life.

The ShiraTronics migraine therapy system is designed to alleviate the symptoms of migraine sufferers through electrical pulse delivery. The device is implanted into the head to administer continuous targeted electrical pulses that disrupt migraine pain signals.

The company announced the conclusion of the study in February 2024, sharing four-week interim data that indicated a meaningful decrease in headache days. ShiraTronics now plans to initiate the expanded RELIEV-CM2 study in sites in the US and Australia later this year.

One of the first physicians to implant the system, Matthew Green of Pain Med SA, said: “Our experience in this Australian pilot study has highlighted the positive health impacts of the innovative ShiraTronics Migraine Therapy System for chronic migraine suffers who have tried and failed standard treatment options.  

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“Excitingly, our participants have shown significant improvements in pain levels, migraine days, and quality of life indicators.”

ShiraTronics raised $5m in an August 2023 funding round. Spun off from the accelerator NuXcel, the Brooklyn Park-based company raised $33m in Series A financing in 2019.

There are several neuromodulation devices on the market to treat migraine. Theranica Bioelectronics’s smartphone-controlled wearable neuromodulation device, Nerivio, was granted de novo approval by the US Food and Drug Administration (FDA) in 2019. The device is available in the US by prescription only, for both adolescent and adult populations. Additionally, Neurolief’s neuromodulation device, Relivion, was approved by the FDA in March 2021.  

Neuromodulation devices are also being used to treat other conditions, including sleep apnoea, depression, and cerebral palsy. According to a GlobalData market model, the neuromodulation device market in the US will be worth $6.9bn in 2030.