|By PR Newswire||
|January 21, 2014 05:00 AM EST||
LOS ANGELES, Jan. 21, 2014 /PRNewswire/ -- NeuroSigma, Inc. (NeuroSigma), a California-based life sciences company, today announced that two presentations were made last month at the annual American Epilepsy Society meeting held in Washington, DC, which reported positive results using external Trigeminal Nerve Stimulation (eTNS™) for the adjunctive treatment of epilepsy.
In the first presentation, Lina Nashef, M.D., Consultant Neurologist and Honorary Reader at King's College London (KCL) presented a summary of their initial results in the clinical use of NeuroSigma's non-invasive Monarch™ eTNS™ System. Dr. Nashef reported that the treatment was well-tolerated and that there were no serious adverse events. Of the initial 16 patients, 2 patients dropped out early, and in 4 patients it was not possible to evaluate efficacy due to other medication changes or absence seizures that were difficult to count. Of the remaining 10 patients, 6 patients had a 30% or more reduction in seizure frequency and 4 patients had a 50% or more reduction in seizures at the 12-week assessment. In addition, Dr. Nashef reported statistically significant improvements in mood and quality of life. Eight patients chose to continue receiving treatment using the Monarch system beyond the first 18 weeks. These findings were in line with results obtained in the Phase II clinical trial of eTNS for epilepsy at the University of California, Los Angeles (UCLA) and the University of Southern California (USC).
"I am encouraged by these early results and am looking forward to longer follow-up and more patients being offered the device, which we found generally very easy to use. A major advantage is that it is non-invasive," said Dr. Nashef.
"I'm very excited by the results presented by Dr. Nashef and her team in London," commented Christopher DeGiorgio, M.D., Vice President of Neurology at NeuroSigma, Professor of Neurology at UCLA and a co-inventor of eTNS. "These findings are consistent with the clinical trial work we've done in Los Angeles, and further suggest that the benefits of eTNS include not only a reduction in seizures but also an improvement in mood. People with epilepsy have a higher rate of clinically significant depression than the general population, so an easy-to-use treatment that is delivered at home could make a positive impact on the lives of people with epilepsy. Because eTNS is completely non-invasive, one no longer needs to think of neuromodulation as an option only after everything else has failed – eTNS could become the first adjunctive treatment offered," added Dr. DeGiorgio.
In the second presentation, Dr. DeGiorgio reported a summary of the results of a sub-analysis of a previously reported 50-subject Phase II double-blind randomized controlled trial of eTNS in drug resistant epilepsy conducted at UCLA and USC. The sub-analysis included the 26 subjects who met modified inclusion criteria of having between 4 and 60 seizures per month. This is the same inclusion criteria recently approved by the FDA for NeuroSigma's upcoming pivotal trial of eTNS for epilepsy. Using these inclusion criteria, Dr. DeGiorgio reported a statistically significant mean percent change in seizure frequency of ‑34.4% in the eTNS treatment group vs. +6.6% in the control group (p = 0.03).
Background – The Monarch eTNS System from NeuroSigma
In August 2012, NeuroSigma received CE Mark approval to market NeuroSigma's first TNS product, the Monarch™ eTNS™ System in the European Union for the adjunctive treatment of drug-resistant epilepsy (DRE) and major depressive disorder (MDD) for adults and children 9 years and older. In addition, the Monarch™ eTNS™ System also received a Class II medical device license from Health Canada in April of 2013 allowing NeuroSigma to market the system for treatment of DRE and MDD for adults and children 9 years and older. NeuroSigma is currently offering the Monarch™ eTNS™ System to patients in the European Union and Canada with a physician's prescription.
The Monarch™ eTNS™ System is composed of a cell-phone sized pulse generator that delivers electrical signals to the trigeminal nerve, which are transmitted through lead wires to a single-use patch that is applied to the forehead, thereby non-invasively modulating activity in targeted brain regions. Patients may conveniently self-administer the Monarch™ eTNS™ System at home and typically use the device while sleeping.
Background – TNS
The trigeminal nerve is the largest cranial nerve, offering a high-bandwidth pathway for signals to enter the brain, bilaterally and at high frequency. 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 near the surface of the forehead. Functional neuroimaging data suggests the mechanism of action of TNS is related to its ability to modulate activity in targeted brain regions.
CAUTION: In the United States, eTNS™ is an investigational device and is limited by Federal (or United States) law to investigational use. The U.S. Food and Drug Administration has given NeuroSigma approval to proceed with a pivotal Phase III clinical trial of eTNS in drug resistant epilepsy. Completion of that Phase III study is necessary before the FDA will consider permitting the marketing and sale of eTNS in the United States.
eTNS, Monarch, and Monarch eTNS are trademarks of NeuroSigma, Inc.
About King's College London
King's College London is one of the oldest and largest colleges of the University of London. King's College Hospital is a large acute-care teaching hospital serving the local diverse community of Lambeth, Southwark, and Lewisham in South London, and features 840 inpatient beds along with a large outpatient program. It also offers tertiary services the clinical neurosciences and other fields to people from a wider catchment area nationally and internationally. Patients come to King's from all over the world – for the skill and compassion of its people and its reputation as pioneers in medical research.
About NeuroSigma, Inc.
NeuroSigma is a Los Angeles-based life sciences company established to develop TNS technologies with the potential to transform medical practice and patients' lives. NeuroSigma is focused on TNS neuromodulation therapies based on 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™ system. 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.
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