Minneapolis-based ShiraTronics has officially commenced its pivotal FDA investigational device exemption (IDE) trial, aiming to assess its neuromodulation therapy for chronic migraines. The RELIEV-CM2 study marks the beginning of in-depth evaluation regarding the long-term safety and performance of this treatment. Initial implants have been successfully completed in both the U.S. and Australia. In a concerted effort to launch this trial, the company secured $66 million in funding this October.
The innovative, minimally invasive neuromodulation system developed by ShiraTronics is crafted to alleviate migraine symptoms. This innovative device, fully programmable and implantable, is positioned just beneath the scalp, where it precisely delivers electrical pulses to interrupt migraine pain pathways. The system offers a novel and potentially more effective therapeutic alternative for migraine sufferers.
ShiraTronics emphasizes the precision and round-the-clock capabilities of its neuromodulation device, asserting its ability to diminish both the frequency and intensity of migraine episodes. For patients, this could mean fewer interruptions to daily activities and reduced need for constant medication or more invasive treatments.
Since receiving the FDA’s breakthrough device designation in 2021, ShiraTronics has successfully completed the enrollment phase for its RELIEV-CM pilot study. According to company announcements, the extensive study aims to implant the device in up to 148 patients across the U.S. and Australia. In the U.S., Dr. Sandeep Vaid was among the first to perform an implant.
“Introducing this innovative treatment to patients is a significant advancement in addressing migrainous conditions,” remarked Dr. Vaid. “Chronic migraines drastically affect the daily lives and general health of those afflicted. This device offers a refreshed strategy that, according to preliminary findings, promises to enhance patients’ daily functionality.”