|By PR Newswire||
|January 27, 2014 06:00 AM EST||
LOS ANGELES, Jan. 27, 2014 /PRNewswire/ -- NeuroSigma, Inc. (NeuroSigma), a California-based life sciences company focused on commercialization of its non-invasive Monarch™ eTNS™ System for the treatment of neurologic and neuropsychiatric disorders, today announced the appointment of Gregory F. Brooks as Senior Vice President and Chief Commercial Officer.
Mr. Brooks brings more than 30 years of experience in the pharmaceutical, biologic and medical device industries to NeuroSigma. In his three decades at Allergan, he held roles of increasing responsibility, serving most recently as the VP Global Strategic Marketing. During his tenure there, he was responsible for global product line launches including BOTOX® for neurologic, cosmetic, and urologic conditions, as well as both pharmaceuticals and medical devices for ophthalmic and dermatologic conditions. Most recently, he oversaw Allergan's BOTOX franchise, where his leadership efforts resulted in successful launches of BOTOX for the treatment of idiopathic and neurogenic overactive bladder. Mr. Brooks also established Allergan's Health Economics organization responsible for creating and developing the data required to support global reimbursement policies, and identified new business opportunities for specialty pipeline products and indications. Prior to his position as Allergan's VP Global Strategic Marketing, he served in various senior strategic and commercial roles across the company's multiple product lines. Mr. Brooks received a Bachelor of Science in Marketing from Rider University.
"I am extremely pleased that Greg is joining NeuroSigma's management team and am confident that he will make valuable contributions," said Lodwrick M. Cook, Chairman of NeuroSigma.
"Greg's depth of experience in the pharmaceutical and medical device industries, his proven leadership in successful global product launches and marketing strategy, and his vision make him ideally suited to spearhead NeuroSigma's global commercialization initiatives and to build a pipeline of new indications with the Monarch eTNS System," added Leon Ekchian, Ph.D., NeuroSigma's President and CEO.
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 and a single-use patch that is applied to the forehead. Signals are transmitted through lead wires to the patch in order to stimulate the trigeminal nerve in the skin of the forehead; triggering these nerve fibers sends signals to targeted brain regions and changes the activity there. 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 3 clinical trial of eTNS in drug resistant epilepsy. Completion of that Phase 3 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.
BOTOX® is a registered trademark of Allergan, Inc.
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 and www.monarch-etns.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.
SOURCE NeuroSigma, Inc.
In the midst of the widespread popularity and adoption of cloud computing, it seems like everything is being offered “as a Service” these days: Infrastructure? Check. Platform? You bet. Software? Absolutely. Toaster? It’s only a matter of time. With service providers positioning vastly differing offerings under a generic “cloud” umbrella, it’s all too easy to get confused about what’s actually being offered. In his session at 16th Cloud Expo, Kevin Hazard, Director of Digital Content for SoftL...
Jun. 30, 2015 05:00 PM EDT Reads: 2,077
Agile, which started in the development organization, has gradually expanded into other areas downstream - namely IT and Operations. Teams – then teams of teams – have streamlined processes, improved feedback loops and driven a much faster pace into IT departments which have had profound effects on the entire organization. In his session at DevOps Summit, Anders Wallgren, Chief Technology Officer of Electric Cloud, will discuss how DevOps and Continuous Delivery have emerged to help connect dev...
Jun. 30, 2015 04:39 PM EDT Reads: 537
Today air travel is a minefield of delays, hassles and customer disappointment. Airlines struggle to revitalize the experience. GE and M2Mi will demonstrate practical examples of how IoT solutions are helping airlines bring back personalization, reduce trip time and improve reliability. In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect with GE, and Dr. Sarah Cooper, M2Mi’s VP Business Development and Engineering, will explore the IoT cloud-based platform technologies drivi...
Jun. 30, 2015 04:21 PM EDT Reads: 568
Containers are changing the security landscape for software development and deployment. As with any security solutions, security approaches that work for developers, operations personnel and security professionals is a requirement. In his session at DevOps Summit, Kevin Gilpin, CTO and Co-Founder of Conjur, will discuss various security considerations for container-based infrastructure and related DevOps workflows.
Jun. 30, 2015 03:59 PM EDT Reads: 515
It is one thing to build single industrial IoT applications, but what will it take to build the Smart Cities and truly society-changing applications of the future? The technology won’t be the problem, it will be the number of parties that need to work together and be aligned in their motivation to succeed. In his session at @ThingsExpo, Jason Mondanaro, Director, Product Management at Metanga, discussed how you can plan to cooperate, partner, and form lasting all-star teams to change the world...
Jun. 30, 2015 02:15 PM EDT Reads: 2,146
Overgrown applications have given way to modular applications, driven by the need to break larger problems into smaller problems. Similarly large monolithic development processes have been forced to be broken into smaller agile development cycles. Looking at trends in software development, microservices architectures meet the same demands. Additional benefits of microservices architectures are compartmentalization and a limited impact of service failure versus a complete software malfunction. ...
Jun. 30, 2015 01:56 PM EDT Reads: 645
Internet of Things is moving from being a hype to a reality. Experts estimate that internet connected cars will grow to 152 million, while over 100 million internet connected wireless light bulbs and lamps will be operational by 2020. These and many other intriguing statistics highlight the importance of Internet powered devices and how market penetration is going to multiply many times over in the next few years.
Jun. 30, 2015 01:45 PM EDT Reads: 1,990
Internet of Things (IoT) will be a hybrid ecosystem of diverse devices and sensors collaborating with operational and enterprise systems to create the next big application. In their session at @ThingsExpo, Bramh Gupta, founder and CEO of robomq.io, and Fred Yatzeck, principal architect leading product development at robomq.io, discussed how choosing the right middleware and integration strategy from the get-go will enable IoT solution developers to adapt and grow with the industry, while at th...
Jun. 30, 2015 01:45 PM EDT Reads: 1,859
Containers have changed the mind of IT in DevOps. They enable developers to work with dev, test, stage and production environments identically. Containers provide the right abstraction for microservices and many cloud platforms have integrated them into deployment pipelines. DevOps and Containers together help companies to achieve their business goals faster and more effectively. In his session at DevOps Summit, Ruslan Synytsky, CEO and Co-founder of Jelastic, reviewed the current landscape of...
Jun. 30, 2015 01:30 PM EDT Reads: 2,106
Malicious agents are moving faster than the speed of business. Even more worrisome, most companies are relying on legacy approaches to security that are no longer capable of meeting current threats. In the modern cloud, threat diversity is rapidly expanding, necessitating more sophisticated security protocols than those used in the past or in desktop environments. Yet companies are falling for cloud security myths that were truths at one time but have evolved out of existence.
Jun. 30, 2015 01:15 PM EDT Reads: 2,047
The cloud has transformed how we think about software quality. Instead of preventing failures, we must focus on automatic recovery from failure. In other words, resilience trumps traditional quality measures. Continuous delivery models further squeeze traditional notions of quality. Remember the venerable project management Iron Triangle? Among time, scope, and cost, you can only fix two or quality will suffer. Only in today's DevOps world, continuous testing, integration, and deployment upend...
Jun. 30, 2015 12:30 PM EDT Reads: 1,840
The time is ripe for high speed resilient software defined storage solutions with unlimited scalability. ISS has been working with the leading open source projects and developed a commercial high performance solution that is able to grow forever without performance limitations. In his session at Cloud Expo, Alex Gorbachev, President of Intelligent Systems Services Inc., shared foundation principles of Ceph architecture, as well as the design to deliver this storage to traditional SAN storage co...
Jun. 30, 2015 10:30 AM EDT Reads: 1,887
To many people, IoT is a buzzword whose value is not understood. Many people think IoT is all about wearables and home automation. In his session at @ThingsExpo, Mike Kavis, Vice President & Principal Cloud Architect at Cloud Technology Partners, discussed some incredible game-changing use cases and how they are transforming industries like agriculture, manufacturing, health care, and smart cities. He will discuss cool technologies like smart dust, robotics, smart labels, and much more. Prepare...
Jun. 30, 2015 10:20 AM EDT Reads: 546
"We provide a web application framework for building really sophisticated web applications that run on a browser without any installation need so we get used for biotech, defense, and banking applications," noted Charles Kendrick, CTO and Chief Architect at Isomorphic Software, in this SYS-CON.tv interview at @DevOpsSummit (http://DevOpsSummit.SYS-CON.com), held June 9-11, 2015, at the Javits Center in New York
Jun. 30, 2015 10:15 AM EDT Reads: 840
The Internet of Things is not only adding billions of sensors and billions of terabytes to the Internet. It is also forcing a fundamental change in the way we envision Information Technology. For the first time, more data is being created by devices at the edge of the Internet rather than from centralized systems. What does this mean for today's IT professional? In this Power Panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, panelists addressed this very serious issue of pro...
Jun. 30, 2015 09:45 AM EDT Reads: 892