NeuroSigma Receives CE Certification

September 4, 2012

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(TM)) system, called the Monarch(TM), 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).


 
(Photo: http://photos.prnewswire.com/prnh/20120905/LA68181)

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(TM) (external electrodes and an external pulse generator, currently being commercialized) and sTNS(TM) (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(TM) and sTNS(TM) 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(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.
NeuroSigma Contacts:

Dr. Leon Ekchian, President & CEO
Tel: +1-310-479-3100
Email: lekchian@neurosigma.com
NeuroSigma, Inc.
Website: http://www.neurosigma.com

Mr. Mark Collinson, Partner
Tel: +1-310-954-1343
Email: mark.collinson@ccgir.com
CCG Investor Relations
Website: http://www.ccgir.com
SOURCE NeuroSigma

Source: PR Newswire

redOrbit (http://s.tt/1mwI6)

Effects of eTNS™ on Post-Traumatic Stress Disorder (PTSD) and Major Depressive Disorder (MDD) examined as an adjunct to pharmacotherapy

Interim Results Reported for Phase I Open-Label Clinical Trial for the Treatment of PTSD and MDD Using External Trigeminal Nerve Stimulation (eTNS™) - The USB Port to the Brain™

Effects of eTNS™ on Post-Traumatic Stress Disorder (PTSD) and Major Depressive Disorder (MDD) examined as an adjunct to pharmacotherapy

Average decreases in PTSD measures of 36% recorded

LOS ANGELES, May 30, 2012 /PRNewswire/ -- Today, at the 52nd annual New Clinical Drug Evaluation Unit (NCDEU) Conference in Arizona, Ian Cook, M.D., Professor of Psychiatry at the University of California, Los Angeles (UCLA) and a Senior Medical Advisor to NeuroSigma, Inc., presented the results from the first 6-subject cohort of a 10-subject Phase I open-label clinical trial studying the effects of external trigeminal nerve stimulation (eTNS™) on Post-Traumatic Stress Disorder (PTSD) and depressive symptoms in Major Depressive Disorder (MDD) as an adjunct to pharmacotherapy. The trial is being conducted at UCLA and is funded by NeuroSigma. Mean decreases in PTSD measures of 36% and depression measures of over 50% were reported.

The study was conducted over an 8-week period and followed similarly designed eTNS trials conducted at UCLA, in which promising results were generated in treating both major depression and epilepsy. Subjects had a mean age of 54 with a median of 28 years since traumatic exposure and suffered from both PTSD and MDD. Current episodes were required to be of at least four months in duration, with non-response to at least one antidepressant. In this outpatient trial, subjects placed stimulating eTNS electrodes on their foreheads for approximately eight hours each night while asleep, and the severity of PTSD and depression symptoms was measured every two weeks using standard recognized rating scales.

"These findings are very encouraging," said Dr. Cook. "The combination of depression and an anxiety disorder, like PTSD, is usually difficult to treat effectively. The participants in the study told us that eTNS was easy to use at home and led, in some instances, to the best mental health they had experienced in years. We expect these results, along with results from the remaining subjects in this Phase I trial, to form the basis for an upcoming Phase II clinical trial that will examine efficacy, tolerability, and safety in a larger sample with a double-blind, controlled trial design."

Lodwrick Cook, Chairman of NeuroSigma, added, "PTSD is a serious global disorder drastically in need of promising new therapies. As Americans we have an obligation to do our utmost to help the thousands of fellow citizens who are stricken by PTSD as a result of both military and non-military related traumatic events. We are very pleased by the preliminary results and applaud the efforts of the clinical team at UCLA."

PTSD, commonly associated with the effects of warfare, arises after exposure to a traumatic event; such as train bombings and terrorist attacks as experienced on September 11th, or natural disasters such as Hurricane Katrina and the massive Fukushima earthquake and tsunami in Japan, or personal tragedies affecting those involved in traffic accidents, domestic violence or sexual assault. It is marked by symptoms in three groups: those of re-experiencing (nightmares, flashbacks), those of avoidance and numbing (isolation from others, avoiding reminders), and increased arousal (being on edge, hyper-alert, subject to explosive responses when startled). PTSD is often accompanied by depression, and many of the medications used to treat PTSD were first developed as antidepressants. However, recent studies suggest that having an anxiety disorder, such as PTSD, significantly reduces the likelihood that antidepressants will work, making the treatment of PTSD very challenging. The August 2011 issue of the Journal of the American Medical Association reported that a widely prescribed antipsychotic medication may be no more effective than placebo in treating PTSD.

NeuroSigma, Inc., a Los Angeles-based medical technology company established to in-license and develop early stage technologies with the potential to transform medical practice, is the exclusive worldwide licensee of UCLA's TNS intellectual property, including eTNS for PTSD and depression.

Dr. Ian Cook added, "I'm confident that the transfer of the technology from academia to the next phase of trials will go smoothly and that, with replication, this treatment has the opportunity to be made available to help many of those who suffer with PTSD and major depression. Given the external, non-invasive nature of this therapy, it might be useful in the battlefield or in an emergency room immediately after a traumatic event, with the theoretical potential to impact the development of full-blown PTSD."

Background - TNSNeuroSigma is commercializing two embodiments of trigeminal nerve stimulation (TNS): eTNS™ (external electrodes and an external pulse generator) and sTNS™ (subcutaneous electrodes and implantable pulse generator). The eTNS system utilizes a self-adhesive conductive pad 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 trigeminal nerve is the largest cranial nerve, offering a high-bandwidth pathway for signals to enter the brain. In clinical studies, eTNS is well tolerated and the low-energy stimulus is confined to the soft tissues of the face without direct penetration into the brain – hence the term "USB Port to 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 and other disorders. PET imaging studies in humans confirms that eTNS activates or inhibits key regions implicated in these disorders and the changes were observed within minutes of therapy. Once approved by regulatory agencies, patients who respond well to eTNS can opt to switch to the implantable sTNS system. NeuroSigma has completed development of its eTNS system and is seeking CE Mark approval in Europe for the treatment of epilepsy and depression. NeuroSigma is concurrently developing its implantable sTNS system.

CAUTION: Both eTNS™ and sTNS™ systems are investigational devices and at this time are limited by Federal (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 http://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.

Source: PR Newswire (http://s.tt/1d2gI)

http://www.prnewswire.com/news-releases/interim-results-reported-for-phase-i-open-label-clinical-trial-for-the-treatment-of-ptsd-and-mdd-using-external-trigeminal-nerve-stimulation-etns---the-usb-port-to-the-brain-155820115.html