NeuroSigma Receives Health Canada Approval for Its Monarch eTNS System for the Treatment of Drug-Resistant Epilepsy and Major Depressive Disorder
Non-Invasive Neurostimulation System, Well-Received in Europe, Now Available in Canada for Adults and Children 9 years and older
The Monarch, CE Mark approved in the European Union in 2012, but not yet approved in
The Health Canada approval was supported by years of safety and efficacy data generated in Phase I and Phase II clinical trials in the US, in which the therapy was shown to substantially reduce seizure frequency and significantly improve mood. Results from a Phase II Randomized Controlled Trial of eTNS for epilepsy were published online in the
The Monarch eTNS System will be sold by prescription in
“We are very pleased to have received the license from Health Canada,” said Leon Ekchian, Ph.D., President and CEO of NeuroSigma. “It is another major milestone for NeuroSigma in the commercialization of trigeminal nerve stimulation and enables us to work with a new physician population and their patients. We are committed to making eTNS affordable and available worldwide.”
“I am delighted as an inventor that this therapy is now available to physicians and patients in
“As a psychiatrist, I’m excited to see that this new treatment paradigm will be available to physicians in
Background – TNS
The trigeminal nerve is the largest cranial nerve, offering a high-bandwidth pathway for signals to enter the brain. The trigeminal nerve projects to specific areas of the brain, such as the locus coeruleus, nucleus tractus solitarius, thalamus and the cerebral cortex, which are involved in epilepsy, depression, PTSD, ADHD and other disorders.
Trigeminal Nerve Stimulation (TNS) is the electrical stimulation of branches of the trigeminal nerve, which are located very close to the surface of the skin in the forehead. The low-energy stimulus is confined to the soft tissues of the forehead without direct penetration into the brain. PET imaging studies in humans confirm that eTNS activates or inhibits key regions implicated in these disorders and the changes were observed within minutes of therapy.
NeuroSigma is the exclusive worldwide licensee of
eTNS, sTNS, Monarch, and the Monarch eTNS are trademarks of NeuroSigma, Inc.
About NeuroSigma, Inc.
NeuroSigma is a
NeuroSigma’s first TNS product, the Monarch(TM) eTNS(TM) System, is currently being marketed to patients in the European Union (EU), with a physician’s prescription. In
Forward-Looking Safe Harbor Statement:
This press release contains forward-looking statements, including but not limited to, research and development outcomes, efficacy, adverse reactions, market and product potential, product availability and other statements regarding our eTNS(TM) and sTNS(TM) systems. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Company’s expectations and projections. Risks and uncertainties include, among other things, general industry and medical device market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to new product marketing, such as the unpredictability of market acceptance for new medical device products; inconsistency of treatment results among patients; potential difficulties in manufacturing a new product; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations.
SOURCE NeuroSigma, Inc.