ShiraTronics’ migraine therapy system has demonstrated an 11.3-day mean reduction in monthly headache days (MHD) for chronic migraine (CM) patients in a pilot study evaluating the device, signalling strong efficacy for a patient population with limited treatment options.
The company’s system is a small device implanted beneath the skin to deliver electrical pulses to the occipital and super orbital nerves with the aim of disrupting pain signal to prevent or relieve migraines.
ShiraTronics RELIEV-CM study (NCT05700318) demonstrated a MHD reduction of 11.3 days at 12 weeks, with a 9.6-day average reduction in MHDs from baseline at 12 months.
Since closing a $66m Series B funding round in October 2024, ShiraTronics commenced enrolment in its pivotal trial.
ShiraTronics’ CEO Rob Binney told Medical Device Network: “To date, we've enrolled 205 patients in less than one year. Enrolling this number of patients in such a short period of time has been extremely validating for us and I think serves as testament to the fact a lot of patients are looking for a new solution for CM.”
Binney expects the pivotal study to complete by mid-2026. With ShiraTronics currently working up its pre-market application (PMA) to the US Food and Drug Administration (FDA), the company is looking at commercialisation of its system towards the “latter part” of 2027.
While treating head pain with neuromodulation has been around in various forms for around 20 years, companies’ success has been limited, either by not using non-purpose built systems, or for targeting the wrong primary endpoints.
Companies including Boston Scientific and St Jude (now part of Abbott) have run trials over the past decade using spinal cord stimulation (SCS) to treat CM by targeting the occipital nerve.
At the time, reduction in monthly migraine days (MMDs) was the gold standard primary endpoint promulgated by the US Food and Drug Administration (FDA).
Neither Boston Scientific’s OPTIMISE (NCT01775735) nor St Jude’s SUNBURST trials (NCT02091947) reached statistical significance for the primary endpoint.
Binney said: “However, when you look at some of the secondary endpoints of these trials, the therapies were generating some significant results.
“In the St. Jude study, if you look at the treatment of this patient population with their system, they actually achieved statistical significance with meaningful mean reduction in MHDs.”
In 2023, the FDA issued guidance advocating that reduction in MHDs was a better efficacy measure for CM patients and should become the primary endpoint in assessing treatments for the condition.
Binney concluded: “The most interesting piece in this whole thing is that had they used mean reduction in MHDs as a primary endpoint, they would have had successful studies.”
According to the Migraine Research Foundation, chronic migraine affects over four million adults daily in the US.
