External Trigeminal Nerve Stimulation (eTNS) For Refractory Status Epilepticus
UCLA Case Study Results To Be Presented At Major International Status Epilepticus Conference In Salzburg, Austria
LOS ANGELES, March 25, 2013 /PRNewswire/ — NeuroSigma, Inc., a California-based medical device company, today announced that it will exhibit its CE Mark approved, non-invasive Monarch(TM) eTNS(TM) System for the adjunctive treatment of epilepsy and depression, at the 4th London-Innsbruck Colloquium on Status Epilepticus and Acute Seizures to be held in Salzburg, Austria from April 4-6, 2013.
NeuroSigma’s exhibit will feature the Monarch neuromodulation system. Conference attendees will be able to learn about the device and its safety and efficacy for patients whose epilepsy remains poorly controlled with drug therapy. NeuroSigma will be represented at the conference by Leon Ekchian, Ph.D., President and CEO, Christopher DeGiorgio, M.D., Vice President of Neurology at NeuroSigma and Professor of Neurology at the University of California Los Angeles (UCLA), and Colin Kealey, M.D., Manager of Business Development.
Case Study of the Use of eTNS for Status Epilepticus in the ICU
Status epilepticus is a life-threatening neurological emergency characterized by multiple or continuous seizures lasting longer than 5-10 minutes. Approximately 30-40% of patients with status epilepticus may develop refractory status epilepticus, where seizures continue longer than 1-hour after failing to respond to two or more antiepileptic drugs. Refractory status epilepticus is very lethal, with a mortality of 30-40%, and serious risk of neurological impairment. In the United States approximately 152,000 cases of status epilepticus occur annually, resulting in about 42,000 deaths and an inpatient cost of $3.8 to $7 billion per year.
Brian Moseley, M.D., a Fellow in the UCLA Department of Neurology, will present a case study in which external Trigeminal Nerve Stimulation (eTNS) was used successfully at UCLA as an adjunctive treatment of refractory status epilepticus on a patient who had failed multiple drug therapies prior to eTNS and was in a medication-induced coma. Subsequent to treatment with eTNS, the patient regained consciousness and was eventually discharged. This will be the first report of the potential clinical utility of eTNS as adjunctive treatment in refractory status epilepticus.
Given the portability of the Monarch eTNS System and its non-invasive nature, the case study suggests applicability of the Monarch as adjunctive treatment of refractory status epilepticus in an Intensive Care Unit (ICU) or emergency setting.
eTNS in the European Union
NeuroSigma’s first TNS product, the Monarch(TM) eTNS(TM) System, is currently being marketed to patients in the European Union (EU), with a physician’s prescription. In September 2012, NeuroSigma received CE Mark approval for the adjunctive treatment of epilepsy and major depressive disorder, for adults and children 9 years and older in the EU. The Monarch was recently unveiled in London at the 10th European Congress on Epileptology. The Monarch(TM) eTNS(TM) System consists of a small stimulator that can be placed in a pocket or worn at the waist, and an electric patch that is placed on the forehead. The patch stimulates the trigeminal nerve through the surface of the skin, and is used primarily while the patient is asleep.
Background – TNS
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. Trigeminal Nerve Stimulation (TNS) is the electrical stimulation of 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. 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.
NeuroSigma is the exclusive worldwide licensee of UCLA’s entire TNS intellectual property portfolio and continues to develop additional technologies and target additional indications.
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.
eTNS, sTNS, Monarch, and the Monarch eTNS are trademarks of NeuroSigma, Inc.
About NeuroSigma, Inc.
NeuroSigma is a Los Angeles-based medical device company established to develop early stage technologies with the potential to transform medical practice and patients’ lives. Currently, NeuroSigma is focused on neuromodulation therapies and has amassed significant intellectual property licensed on an exclusive basis from the University of California, Los Angeles (UCLA), including TNS therapies for epilepsy, depression, post-traumatic stress disorder (PTSD) and attention-deficit hyperactivity disorder (ADHD). 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.
SOURCE NeuroSigma, Inc.