LOS ANGELES, July 2, 2012 /PRNewswire/ -- Today NeuroSigma, Inc., a Los Angeles-based medical device company, announced that it received ISO 13485: 2003 certification, indicating that it operates a Quality Management System for the design, manufacturing and distribution of its external Trigeminal Nerve Stimulation (eTNS™) system for the treatment of neurological and neuropsychiatric disorders. This certification is an important first step in a two-step process towards CE Mark approval in the European Union.
ISO 13485: 2003, published by the International Organization for Standards (ISO), is the globally recognized standard of medical device quality control. This standard calls for a risk management approach to product development, validation of processes, effective product traceability and recall systems.
NeuroSigma anticipates submitting the Technical File in pursuit of European regulatory approval for its first generation eTNS system, called theMonarch™, in July 2012. The company is preparing to commence marketing and distribution of this new therapy for epilepsy and depression in Europe after CE Mark certification.
"We are proud to have achieved ISO certification, which will serve to provide assurance that our systems meet the stringent standards established for medical device manufacturers. We are very grateful to our suppliers, consultants and employees, particularly our Manager of Operations, Patrick Miller, who have all worked hard to make this happen," said Lodwrick M. Cook, Chairman of NeuroSigma.
The clinical development of trigeminal nerve stimulation for epilepsy was spearheaded by Christopher DeGiorgio, M.D., NeuroSigma's Vice-President of Neurology and Professor at the UCLA School of Medicine. Pioneering clinical and human mechanism of action studies in major depression were led by Ian 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 novel and non-invasive therapy, trigeminal nerve stimulation may represent a paradigm shift in the way we treat major depression, post-traumatic stress disorder (PTSD), and epilepsy, and offers the potential to significantly improve the lives of millions of people without the side-effects common to drug treatment," said Dr. Ian Cook.
"All of us at NeuroSigma are excited that the groundbreaking research of these eminent physicians is coming closer to becoming commercially available to doctors and their patients as an external and drug-free alternative to current therapies," said Leon Ekchian, Ph.D., President and CEO of NeuroSigma. "We have received an increasing number of inquiries from the public as they become aware of eTNS via sources such as the recent article in the Daily Mail in the United Kingdom."
Background - TNS
NeuroSigma 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 confirm 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 (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.
|SOURCE NeuroSigma, Inc.|
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