US-based Neurolief’s neuromodulation device, Relivion has been approved by the Japanese Ministry of Health, Labor and Welfare (MHLW) for at-home use in the acute treatment of migraine.
Relivion is a non-invasive multi-channel brain neuromodulation technology. The device simulates both the occipital and trigeminal nerve branches, which are the neural pathways responsible for debilitating migraine headaches.
The device connects with a mobile app and a physician interface equipped with AI integration and remote monitoring capabilities. Sawai Pharmaceutical has exclusive development and commercialisation rights to the device for migraine and depression indications in Japan.
Relivion has two versions - RelivionMG for the treatment of migraine and RelivionDP for major depressive disorder (MDD). RelivionMG device has been cleared for the treatment of acute migraine by multiple regulatory bodies, including the US Food and Drug Administration (FDA). Neurolief is currently seeking FDA clearance and a European CE mark for RelivionDP as a treatment for MDD, as per a 9 January press release.
Migraine treatment through neuromodulation is a relatively new treatment, with only a few devices currently on the market. Theranica Bioelectronics’s smartphone-controlled wearable neuromodulation device, Nerivio, was granted De Novo approval by the FDA in 2019. The device is available in the US by prescription only, for both adolescent and adult populations.
In August 2023, Salvia BioElectronics implanted the first patient with its paper-thin neuromodulation device for the treatment of severe migraine and cluster headaches. The Dutch start-up’s implantable neurostimulation system was granted breakthrough device designation by the FDA in 2020.
Neuromodulation devices are also being developed as a treatment for a variety of central nervous system disorders. The market for neuromodulation devices is forecasted to grow from being worth approximately $7bn in 2023 to more than $10.7bn last year, as per GlobalData analysis.
In September 2023, PathMaker Neurosystems started an early feasibility study investigating its non-invasive neuromodulation device, MyoRegulator, in patients with amyotrophic lateral sclerosis (ALS). The MyoRegulator device has received breakthrough device designation by the FDA.
NeuroPace is investigating its neuromodulation therapy for the treatment of idiopathic generalised epilepsy. To that end, the company completed enrolment in a clinical trial evaluating the device last month.
