NeuroSigma has received approval from the Australian Therapeutic Goods Administration (TGA) to market its Monarch eTNS (external trigeminal nerve stimulation) system in the country for the adjunctive treatment of drug-resistant epilepsy (DRE) in patients aged nine years and older.
DRE reportedly affects approximately 30-37% of all patients with epilepsy. The Monarch eTNS system is a non-invasive adjunctive therapy for DRE that delivers low-intensity electrical current through a single-use adhesive patch to stimulate branches of the trigeminal nerve near the surface of the forehead. Patients may self-administer the therapy at home and typically use the device while sleeping. The system will be sold in Australia by prescription under a physician's supervision.
TGA approval was supported by data generated in Phase I and II clinical trials in the US, which measured the device's safety and efficacy. Results from a Phase II randomised, controlled trial of eTNS for epilepsy were published in the February 26 2013 issue of Neurology, the medical journal of the American Academy of Neurology (2013;80:786-791).
In August 2012, NeuroSigma received CE mark approval to market the Monarch eTNS system in the EU, for the adjunctive treatment of DRE and major depressive disorder (MDD) for adults and children aged nine years and older. In addition, the system received a Class II medical device licence from Health Canada in April 2013 for the same indications. NeuroSigma is currently offering the Monarch eTNS system to patients in the EU and Canada with a physician's prescription.