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 9 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 improvements in patients’ mood.
NeuroSigma president and CEO Leon Ekchian said the company is planning to begin the rollout of its commercialization strategy for patients suffering from epilepsy and depression.
"Simultaneously, we will seek to obtain approvals in other parts of the world," Ekchian added.
"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."