NeuroSigma’s Monarch eTNS System for Epilepsy, Depression Cleared in Europe

NeuroSigma’s Monarch eTNS System for Epilepsy, Depression Cleared in Europe

LOS ANGELES, Sept. 5, 2012 /PRNewswire/ — NeuroSigma, Inc., a Los Angeles-based medical device company, announced today that it received CE Certification for its external Trigeminal Nerve Stimulation (eTNS™) system, called the Monarch™, for the adjunctive treatment of epilepsy and major depressive disorder, for adults and children 9 years and older. NeuroSigma’s approval was supported by years of safety and compelling efficacy data generated in clinical trials conducted at the University of California, Los Angeles (UCLA) and the University of Southern California (USC).

The eTNS system will be sold under prescription from a physician in the European Union (EU). It is composed of an external pulse generator and disposable electric patches placed on the forehead that are replaced daily. The patches can be worn primarily in the evening while asleep. In clinical studies, eTNS was well tolerated and has been shown to substantially reduce seizures in patients with epilepsy and improve mood in patients with depression.

Planning is underway for the introduction of this treatment at major EU epilepsy and depression centers. NeuroSigma is establishing a marketing, sales, and distribution infrastructure for a fourth quarter 2012 product launch in the EU.

Epilepsy and depression are major health concerns in the EU, with approximately 4 million people suffering epilepsy and 20 million experiencing clinical depression.

“We are proud to successfully complete the CE marking process. It is a major milestone for NeuroSigma and will enhance our efforts to transform the way epilepsy and depression are managed. I would like to thank all of our employees, suppliers, clinical trial sites and consultants for their hard work and all our investors for their support,” said Lodwrick Cook, Chairman of NeuroSigma.

“As a company, we are committed to making eTNS affordable and widely available in the EU,” added Leon Ekchian, Ph.D., President and CEO of NeuroSigma. “We are excited to begin the rollout of our commercialization strategy for patients suffering from epilepsy and depression. Simultaneously, we will seek to obtain approvals in other parts of the world. 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.”

Trigeminal nerve stimulation was invented at UCLA and is exclusively licensed to NeuroSigma.

Dr. Christopher DeGiorgio, Vice-President of Neurology at NeuroSigma and Professor of Neurology at the UCLA School of Medicine, spearheaded clinical development of eTNS for epilepsy. “CE Certification of eTNS is one of the greatest moments of my life, marking the culmination of over 10 years of research. I wish to thank all of my colleagues at UCLA and USC, without whom this achievement would not have been possible, and recognize each and every patient in our clinical trials, who helped pioneer this breakthrough treatment. I am especially grateful to NeuroSigma’s management team for their faith in this technology and for their vision and commitment to patients suffering epilepsy and depression,” said Dr. DeGiorgio.

Clinical and human mechanism of action studies of eTNS in major depression were led by Ian A. Cook M.D., a Senior Medical Advisor to NeuroSigma and a Professor-in-Residence at the UCLA School of Medicine’s Department of Psychiatry, where he serves as Director of the UCLA Depression Research and Clinic Program. “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,” said Dr. Cook.

Background – TNS

There are two embodiments of trigeminal nerve stimulation: eTNS™ (external electrodes and an external pulse generator, currently being commercialized) and sTNS™ (subcutaneous electrodes and implantable pulse generator, currently being developed). The eTNS system utilizes a customized self-adhesive conductive patch applied to the forehead to stimulate 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.

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. 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. eTNS is a stand-alone therapy, but once approved by regulatory agencies, patients who respond well to eTNS may opt for the implantable sTNS system, which NeuroSigma is currently developing.

CAUTION: In the United States, both eTNS™ and sTNS™ are investigational devices and are limited by Federal (or United States) law to investigational use.

About NeuroSigma, Inc.

NeuroSigma is a Los Angeles-based medical technology company established to develop early stage technologies with the potential to transform medical practice. Currently, NeuroSigma is focused on a number of neuromodulation therapies and through its majority-owned subsidiary, NSVascular, Inc., on Thin-Film Nitinol covered stents for endovascular applications. NeuroSigma employs two neuromodulation therapy platforms: Trigeminal Nerve Stimulation (TNS) and Deep Brain Stimulation (DBS). NeuroSigma has amassed significant intellectual property licensed on an exclusive basis from the University of California, Los Angeles (UCLA), including potential therapies for epilepsy, depression, post-traumatic stress disorder (PTSD) and attention-deficit hyperactivity disorder (ADHD) via TNS, and for PTSD and obesity via DBS. For more information about NeuroSigma, please visit www.neurosigma.com.

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™ and sTNS™ 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.

Trigeminal Nerve Stimulation (TNS) is a novel medical treatment in which mild electrical signals stimulate branches of the trigeminal nerve (the largest cranial nerve) in order to modulate the activity of targeted brain regions. NeuroSigma is developing two embodiments of TNS: eTNSTM (TNS with external electrodes and an external pulse generator) and sTNSTM (subcutaneous electrodes and implantable pulse generator).

The trigeminal nerve conveys information to important structures in the brain, including the nucleus solitarius, the locus coeruleus, the vagus nerve and the cerebral cortex. These areas are known to play key roles in seizure inhibition and initiation. The trigeminal nerve also specifically sends signals to the anterior cingulate cortex, which is involved in mood, attention and decision-making.

Clinical trials are currently in progress for epilepsy, depression and post-traumatic stress disorder (PTSD). A clinical trial in attention-deficit hyperactivity disorder (ADHD) will soon be starting.

Positron Emission Tomography (PET) imaging studies in humans have identified a potential mechanism of action for the treatment of epilepsy, depression and other brain disorders. eTNSTM activates or inhibits key regions implicated in these disorders and changes in blood flow were observed with minutes of therapy.

Epilepsy

Epilepsy affects over three million Americans. Over one million of these people have drug-resistant epilepsy (DRE), which frequently leads to unemployment, injuries and carries a significantly increased risk of death.

There is growing interest in neuromodulation therapies for epilepsy. Trigeminal nerve stimulation is an emerging and promising therapy with unique advantages relative to other current therapies: it can be delivered externally, bilaterally, at competitive costs and with potentially lower risks.

Stimulation of the trigeminal nerve and its related structures have been shown to inhibit seizures in animal models. Human trials have been conducted at UCLA for nearly ten years. A randomized, active-controlled, double-blind, dual-center study at UCLA and USC was completed in April, 2011. Phase III clinical trials are currently in the planning stages.

Depression

Eighteen million adults in the United States suffer from depression and at least half of these people do not seek the necessary treatment.

Major depression is a severe form of depression. People with major depression usually experience a sad or depression mood and/or a loss of interest or pleasure in life’s joyful activities. Often the experience also includes physical symptoms, such as sleep disturbances, low energy, changes in appetite, and fatigue. These symptoms, plus difficulties with concentration, memory, and decision-making, can cause depression to interfere with a person’s normal functioning in life, whether in the workplace, in school, or with family and friends.

A person may experience only one episode of major depression, but often there are repeated episodes over an individual’s lifetime. About one in six people will experience at least one major depressive episode during their life. Depression affects people of all races, incomes, ages, and ethnic and religious backgrounds.

Trigeminal nerve stimulation for depression has been studied at UCLA for several years, with positive research findings published in 2011. A Phase II, double-blind clinical trial is in progress with expected completion in late 2011.

Post-Traumatic Stress Disorder (PTSD)

Post-traumatic stress disorder is an anxiety disorder that can develop after exposure to a traumatic or terrifying event in which serious physical harm occurred or was threatened.

Patients with this illness commonly report difficulty sleeping, persistent frightening recollections of the traumatic event, sudden outbursts of anger or anxiety, feeling detached or numb, avoidance of people or places that are reminders of the experience, as well as many other debilitating reactions. PTSD is a highly prevalent lifetime disorder that can often persist for years.

The Veterans Administration (VA) reports that 400,000 veterans are currently receiving compensation for PTSD and they expect the number to grow higher as long as the U.S. still has troops deployed in combat around the world.

A Phase I, open-label clinical trial of trigeminal nerve stimulation for PTSD is currently recruiting at UCLA.

CAUTION: Trigeminal Nerve Stimulation (TNS) is an investigational therapy and limited by United States law for investigational use.

893fjjj Trigeminal Nerve Stimulation for Epilepsy Management Proving Itself in Latest TrialA group of investigators under Dr. Christopher DeGiorgio, a neurology professor at UCLA, has reported promising results of a phase 2 clinical trial of trigeminal nerve stimulation (TNS) for controlling drug resistant epilepsy. DeGiorgio, a lead inventor of the technology that is being co-developed with California-based NeuroSigma, Inc., has been investigating its benefits for patients at least since 2006 when we first reported on it. The latest trial has shown that 40% of patients treated with the system had a significant reduction in seizure frequency.

The external stimulator, which is about the size of a large cell phone, attaches to a belt or can slip into a pocket. Wires from the stimulator are passed under the clothing and connected to conductive pads attached to the forehead. The electrodes, which can be covered by a cap or scarf, transmit a signal to the trigeminal nerve, which extends into the brain from the face and forehead and is known to play a role in seizure inhibition.

“TNS offers potential benefits — it can be delivered bilaterally (to both sides of the brain) and at high frequencies,” DeGiorgio said. “Since the electrical energy does not travel directly into the brain, TNS provides a safe method of brain modulation.”

The clinical trial showed that at the end of the 18-week study, 40 percent of patients receiving TNS experienced a significant improvement in seizure reduction, which is defined as a 50 percent or greater decrease in the frequency of seizures.

In addition, the researchers found that the TNS treatment also improved the mood of the participants. Since depression is a common problem in people with epilepsy, this finding could have significant impact on the quality of life of people who suffer from the disorder.

Source : http://www.neurosigma.com/tns.html

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