On 2 July, NeuroSigma 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 recognised 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.
The clinical development of trigeminal nerve stimulation for epilepsy was spearheaded by Christopher DeGiorgio, 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, 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 Cook.