Search Results for: neurosigma

Los Angeles, CA-based NeuroSigma (NSIG) is set for its IPO of 3.6M shares of common stock at $13 - 15. The commercial stage life sciences firm develops bioelectric products based on external trigeminal nerve stimulation (TNS) to treat neurological and neuropsychiatric disorders such as epilepsy and depression. Its lead product is the Monarch eTNS system which is currently approved in the European Union as adjunctive treatment for epilepsy, in Canada for the treatment of drug-resistant epilepsy and in Australia for adjunctive treatment of drug-resistant epilepsy. A portion of the proceeds from the IPO will fund the Phase 3 trial to support a regulatory submission in the U.S. Financial results for 2013: Revenues: $35.8M; COGS: $47.9M; Gross Profit: ($12.1M); Operating Expenses: $6.2M (+8.6%); Net Loss: ($5.8M) (-11.9%); Loss Per Share: ($0.83) (-18.6%); Cash Burn Ops: ($2.6M) (-20.1%). Financial results for 1H 2014: Revenues: $23.9M (+195.1%); COGS: $12.1M) (+348.1%); Gross Profit: $11.8M (+118.5%); Operating Expenses: $6.9M (+153.9%); Net Loss: ($7.5M) (-205.4%); Loss Per Share: ($1.12) (-229.4%); Cash Burn Ops: ($2.1M) (-82.4%). S-1 ETFs: IBB, BIB, BIS Share this with a colleague See the original post: NeuroSigma on deck for IPO … Continue reading →

LOS ANGELES, July 29, 2013 /PRNewswire/ --NeuroSigma, Inc., today announced conditional approval by the U.S. Food and Drug Administration (FDA) of its Investigational Device Exemption (IDE) application to commence a Phase III pivotal trial of theMonarch eTNSSystem for treatment of drug resistant epilepsy. The Company is planning to conduct a multi-center trial at leading medical institutions in the U.S., Europe and Canada. The objective of the study is to evaluate the safety and effectiveness of the device and provide the basis for a PreMarket Approval (PMA) application to the FDA. In earlier Phase 1 and Phase 2 clinical trials of external Trigeminal Nerve Stimulation (eTNS), over 40% of patients treated showed a 50% or greater reduction in seizures. "We are eager to take this next key step in the regulatory approval process of eTNS in the United States," said Leon Ekchian, Ph.D., President and CEO of NeuroSigma. "We believe a safe, non-invasive and affordable alternative to pharmaceuticals and invasive treatments is urgently needed by the 50-million people with epilepsy worldwide." The Monarch eTNS System is currently available with a physician's prescription in the European Union and Canada as adjunctive treatment of epilepsy and depression, for adults and children 9 years … Continue reading →

LOS ANGELES, June 21, 2013 /PRNewswire/ --NeuroSigma, Inc., a Los Angeles based medical device company, today announced that its Monarch eTNS System for the adjunctive treatment of epilepsy and depression will make its Canadian debut at the 30th International Epilepsy Congress, taking place in Montreal, Canada from June 23 to June 27, 2013. The Monarch eTNS System will be on display at the NeuroSigma Booth #413 throughout the conference. "This conference represents the first opportunity for Canadian physicians, epilepsy specialists, and healthcare professionals to see the Monarch eTNS system up close, and to learn about the latest results from recent clinical trials. Our team looks forward to forging new relationships with physicians that desire a non-invasive, safe, and affordable neurostimulation therapy for the management of epilepsy and depression," said Leon Ekchian, Ph.D., NeuroSigma's President & CEO. NeuroSigma will host a Satellite Symposium on the safety and efficacy of eTNS for epilepsy and psychiatric disorders on Tuesday June 25, from 4:30 pm to 6:00 pm in Hall 4, Palais des Congres de Montreal. New results from acute and long-term trials in epilepsy will be presented by Christopher DeGiorgio, M.D., NeuroSigma's Vice President of Neurology and Professor of Neurology at UCLA. These … Continue reading →

LOS ANGELES, June 6, 2013 /PRNewswire/ --NeuroSigma, Inc., a California-based medical device company, today announced the launch of http://www.monarch-etns.com, its dedicated website for the Monarch eTNSTM System. The new site provides a comprehensive resource for those in the European Union and Canada who are considering use of the non-invasive Monarch system to treat their epilepsy and depression in conjunction with their existing drug treatment program. The therapeutic neuromodulation system is not yet approved for use in the United States. Visitors to the site will find information on: Patients and physicians who want more in-depth knowledge will find: "Those who visit the site to learn more about the Monarch will become not only informed but also empowered to take the next step in managing their condition with this safe, easy-to-use and non-invasive system," said Ian Cook, M.D., Director of the UCLA Depression Research & Clinic Program and Chief Medical Advisor to NeuroSigma. "Patients and physicians alike can ask questions of the NeuroSigma team, share insights, and make suggestions. In this way the site will become an online home to a growing population of patients whose lives have been transformed by the Monarch system, as well as an expanding number of physicians … Continue reading →

Non-Invasive Neurostimulation System, Well-Received in Europe , Now Available in Canada for Adults and Children 9 years and older LOS ANGELES , May 2, 2013 /CNW/ - NeuroSigma, Inc., a California-based medical device company, today announced that it has received a Class 2 medical device license for its Monarch eTNS (external trigeminal nerve stimulation) System from Health Canada . The license covers the use of the Monarch eTNS System for treatment of drug-resistant epilepsy (DRE), major depressive disorder (MDD), and treatment-resistant depression. (Photo: http://photos.prnewswire.com/prnh/20130502/LA06314) The Monarch, CE Mark approved in the European Union in 2012, but not yet approved in the United States (US), is now available to patients in Canada . Drug resistant epilepsy (DRE) is a serious medical disorder, and affects approximately 30% of all patients with epilepsy. Major depressive disorder is a prevalent condition, affecting up to 16% of the population at some point during their lives. The Health Canada approval was supported by years of safety and efficacy data generated in Phase I and Phase II clinical trials in the US, in which the therapy was shown to substantially reduce seizure frequency and significantly improve mood. Results from a Phase II Randomized Controlled Trial of eTNS … Continue reading →

LOS ANGELES, Feb. 11, 2013 /PRNewswire/ -- NeuroSigma, Inc., a California-based medical device company, today announced that 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 at NeuroSigma, will present in London, an overview of external trigeminal nerve stimulation (eTNS) for the treatment of epilepsy and depression at The Royal Society of Medicine's Sixth Medical Innovations Summit on February 16, 2013. Now available in the European Union, with a physician's prescription, the Monarch eTNS 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. A Phase II randomized controlled clinical trial, conducted at UCLA and the University of Southern California (USC), for the use of eTNS for the treatment of drug-resistant epilepsy showed a robust effect on seizure frequency and mood. At the end of the eighteen week treatment period, more than 40% of patients experienced a greater than 50% reduction … Continue reading →

LOS ANGELES, Jan. 30, 2013 /PRNewswire/ --NeuroSigma, Inc., a California-based medical device company, today announced the publication of a positive Phase II clinical study for the use of external Trigeminal Nerve Stimulation (eTNS) for the treatment of drug-resistant epilepsy. The study, led by Christopher M. DeGiorgio, M.D., Professor of Neurology at the University of California, Los Angeles (UCLA) and Vice President of Neurology at NeuroSigma, was published online in the January 30, 2013 issue of Neurology, the medical journal of the American Academy of Neurology. NeuroSigma is the exclusive worldwide licensee of UCLA's entire TNS intellectual property portfolio. Drug resistant epilepsy (DRE) is a serious medical disorder, and affects approximately 30% of the estimated 50 million people with epilepsy worldwide. Today's publication details the results of a double-blind randomized controlled trial of eTNS in 50 subjects with DRE. The trial demonstrated that among patients receiving eTNS there were significant reductions in seizure frequency over the course of the 18-week study. Patients receiving eTNS also demonstrated significant improvements in mood, making eTNS unique among epilepsy therapies. The clinical trial was conducted at UCLA and the University of Southern California (USC). "This randomized controlled trial provides Level II evidence that eTNS may … Continue reading →

LOS ANGELES, Sept. 25, 2012 /PRNewswire/ --NeuroSigma, Inc., a Los Angeles-based medical device company, announced today that its Monarch eTNS system for the adjunctive treatment of epilepsy and depression will make its debut at the 10th European Congress on Epileptology, which takes place in London, England from September 30 to October 4, 2012. "This conference represents an outstanding opportunity to put the Monarch in the hands of many healthcare professionals who will be future advocates of the system in the European Union. Our team looks forward to forming alliances and introducing a new paradigm for the management of epilepsy," said Leon Ekchian, Ph.D., NeuroSigma's President & CEO. NeuroSigma was invited by the conference organizers to lead a Satellite Symposium on September 30th, focused on trigeminal nerve stimulation (TNS) for the treatment of epilepsy and neuropsychiatric disorders. The presentations on eTNS will cover the following topics: The presenters will be Christopher DeGiorgio, M.D., NeuroSigma's Vice-President, Neurology, and Professor of Neurology at UCLA, Ian Cook, M.D., NeuroSigma Senior Medical Advisor and Professor of Psychiatry at UCLA and Colin Kealey, M.D., NeuroSigma's Manager of Business Development. The symposium will include the first public presentation of long-term data on the efficacy of eTNS for … Continue reading →

- Prepares for Fourth Quarter 2012 European launch of eTNS, its non-invasive treatment for epilepsy and depression LOS ANGELES, September 5, 2012 /PRNewswire/ -- NeuroSigma, Inc., a Los Angeles-based medical device company, announced today that it received CE Certification for its external Trigeminal Nerve Stimulation (eTNS) system, called the Monarch, for the adjunctive treatment of epilepsy and major depressive disorder, for adults and children 9 years and older. NeuroSigmas approval was supported by years of safety and compelling efficacy data generated in clinical trials conducted at the University of California, Los Angeles (UCLA) and the University of Southern California (USC). (Photo: http://photos.prnewswire.com/prnh/20120905/LA68181 [http://photos.prnewswire.com/prnh/20120905/LA68181]) The eTNS system will be sold under prescription from a physician in the European Union (EU). It is composed of an external pulse generator and disposable electric patches placed on the forehead that are replaced daily. The patches can be worn primarily in the evening while asleep. In clinical studies, eTNS was well tolerated and has been shown to substantially reduce seizures in patients with epilepsy and improve mood in patients with depression. Planning is underway for the introduction of this treatment at major EU epilepsy and depression centers. NeuroSigma is establishing a marketing, sales, and distribution … Continue reading →