LOS ANGELES , Nov. 29, 2011 /PRNewswire/ — NeuroSigma, Inc., a Los Angeles -based medical technology company, today announced it will introduce its External Trigeminal Nerve Stimulation (eTNS™) system as an exhibitor at the 65th Annual American Epilepsy Society (AES) Meeting being held December 2-6, 2011 at the Baltimore Convention Center. NeuroSigma is the exclusive worldwide licensee of trigeminal nerve stimulation (TNS), which is a proprietary therapy originally developed at the University of California, Los Angeles ( UCLA ).
In previously reported results of a Phase II double-blind clinical trial, conducted at UCLA and the University of Southern California ( USC ), led by Christopher DeGiorgio , M.D., a neurologist at UCLA and scientific advisor to NeuroSigma, subjects receiving NeuroSigma’s active eTNS™ treatment experienced a 40.5% responder rate (responder defined as a subject with a 50% or greater reduction in seizures), while those receiving the control condition (“sham” or “placebo”) experienced a 15.6% responder rate. A Positron Emission Tomography (PET) study revealed significant decreases in regional cerebral blood flow in several regions of the cerebral cortex, which is where seizures originate. These findings provide a potential mechanism of action, supporting the seizure reducing effects of eTNS observed to date, and confirm the results of a Phase I clinical trial published in 2009 in the journal Neurology.
NeuroSigma is currently developing its next generation eTNS™ system and in 2012 anticipates filing a CE Mark application for approval to commence marketing its new eTNS system for the treatment of epilepsy in Europe . In 2012, the company anticipates filing an IDE for an upcoming multi-center Phase III pivotal trial in the United States .
NeuroSigma’s eTNS system is a non-invasive therapy and 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 above the forehead. The trigeminal nerve, the largest cranial nerve, offers 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 forehead without penetration into the brain. NeuroSigma is developing eTNS for other applications, including Major Depression, Attention Deficit Hyperactivity Disorder, and Post Traumatic Stress Disorder, for which clinical trials are already underway. An implantable version of TNS, called sTNS™ is also in early development.
To learn more about NeuroSigma and the eTNS™ system, please visit Exhibit Booth #202 at the AES Meeting from December 3-5 .
CAUTION: The eTNS™ system is an investigational device and at this time is limited by United States law for investigational use only in approved research protocols. NeuroSigma does not recommend the off-label use of nerve or muscle electrical stimulation units for any purpose not approved by the FDA because of the potential risk of injury or death.
About NeuroSigma, Inc.
NeuroSigma is a Los Angeles -based medical technology company established to in-license and develop early stage technologies with the potential to transform medical practice. Currently we have a specific focus on neuromodulation and through our majority-owned subsidiary, NSVascular, on Thin-Film Nitinol covered stents for endovascular applications. NeuroSigma employs two 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, Attention Deficit Hyperactivity Disorder (ADHD) and post-traumatic stress disorder (PTSD) via TNS and for PTSD, obesity and cachexia via DBS. For more information about NeuroSigma, visit our website at http://www.neurosigma.com.
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