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NeuroSigma Receives Global Quality Control Certification
Date:7/2/2012

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-Residen
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SOURCE NeuroSigma, Inc.
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