NeuroSigma has obtained CE mark approval for its external Trigeminal Nerve Stimulation (eTNS) system, Monarch, designed for the treatment of epilepsy and major depressive disorder in adults and children of nine years and older.
The eTNS system comprises an external pulse generator and disposable electric patches to stimulate trigeminal nerve branches present on the forehead.
The approval is based on the safety and efficacy data generated in clinical trials, conducted at the University of California, Los Angeles (UCLA) and the University of Southern California.
The results demonstrated that eTNS was well tolerated and has shown to reduce seizures in patients with epilepsy and improve patients’ mood.
NeuroSigma senior medical advisor and UCLA School of Medicine psychiatry department professor-in-residence Ian Cook said; "As a non-invasive neuromodulation therapy, trigeminal nerve stimulation may represent a paradigm shift in the way we treat major depression and offers the potential to significantly improve the lives of millions of people without the side-effects common to medication treatment."
NeuroSigma president and CEO Dr Leon Ekchian said the company is begining the rollout of its commercialisation strategy for patients suffering from epilepsy and depression.
"Simultaneously, we will seek to obtain approvals in other parts of the world," Ekchian said.
"In the United States, we will be submitting a request to the FDA for an Investigational Device Exemption (IDE) to commence a multi-center eTNS pivotal trial in epilepsy.
"Over thirty major centers in the US and Europe have expressed interest in being part of this pivotal trial."
The eTNS system is currently limited by federal law to investigational use in the US.
Image: eTNS system delivers external pulses to stimulate trigeminal nerve in patients with epilepsy. Photo: Courtesy of PR Newswire.