Industry News Briefs from the International Neuromodulation Society

 

Industry News Feed

 

Emerging Neuromodulation Company Files for Initial Public Offering

Aug. 26, 2014 - Los Angeles-based NeuroSigma, Inc. has registered to undergo an initial public offering. The proceeds would help to fund a pivotal trial of is external trigeminal nerve stimulation system as an adjunctive treatment for drug-resistant epilepsy, develop a second-generation system, and advance clinical studies for neuropsychiatric indications. The company also plans retire $2.4 million of debt with the proceeds. (PR Newswire)

Device Maker Acquires Developer of Deep Brain Stimulation System

Aug. 26, 2014 - Medtronic, Inc. acquired Sapiens Steering Brain Stimulation for approximately $200 million in an all-cash transaction. Sapiens is developing a deep brain stimulation system with 40 individual stimulation points that may be more precise and require a shorter procedure time. Medtronic will keep Sapiens' site in Eindhoven, The Netherlands as a research and development center for its Neuromodulation business unit. Sapiens was spun out of Philips Healthcare in 2011 as a privately held enterprise. (NASDAQ)

Europe, Australia Issue Patents for High-Frequency Spinal Cord Stimulation

Aug. 25, 2014 - Nevro Corp. announced it has received patents in Europe and Australia related to spinal cord stimulation with its proprietary high-frequency system that delivers electrical pulses at a rate of up to 10,000 per second (10 kHz). The stimulation differs from lower-frequency spinal cord stimulation for back and leg pain by not causing tingling from paresthesia. More patents are pending the company said. (PR Newswire)

France to Fund Initial Implants of Retinal Prostheses

Aug. 22, 2014 - The French Ministry of Health will fund the first wave of patients to receive the Argus II retinal prosthesis, according to the device-maker, Second Sight Medical. The company said that 36 patients will receive the devices for vision loss from retinitis pigmentosa in a contract through France's Forfait Innovation program meant to support the emergence of medical innovation. (Mass Device)

Neuromodulation Revenues Add to Company's Quarterly Earnings

Aug. 19, 2014 - Medtronic Inc. reported first-quarter 2015 earnings with Neuromodulation and Surgical Technologies businesses offsetting declines in its Spine business, with the Restorative Therapies Group overall showing an increase of 3% on a constant currency and reported basis. The group's overall sales for the quarter were $1.603 billion. Neuromodulation revenue was up 11% on a constant currency basis or 12% as reported, totaling $479 million for the quarter. The drivers included pain stimulation, deep brain stimulation and gastroenterology/urology. The company's overall revenue was $4.273 billion, up 4% from the same quarter a year ago on a constant currency adjusted basis, or 5% as reported. (MarketWatch)

Private Vagus Nerve Stimulation Firm Selects Investment Banking Company

Aug. 18, 2014 - Saying it is fully funded until 2016, electroCore reports increasing interest in its non-invasive vagus nerve stimulation therapy over the last six months from Medical device companies and pharmaceutical and technology companies as well. The New Jersey-based privately held company has appointed the investment banking firm Piper Jaffray to assist in partnering discussions with pharmaceutical companies regarding commercialization of the technology. (Market Watch)

Visual Prosthesis Company Plans a Public Stock Offering

Aug. 13, 2014 - Second Sight Medical plans a $32 million public offering, on NASDAQ under the ticker symbol EYES, while it considers trying to expand the market the its Argus II visual prosthetic beyond the relatively few sufferers of retinitis pigmentosa to the wider group of people who have age-related macular degeneration. Meanwhile, it is at work on a next-generation device, the Orion I, that its leadership believes could address nearly all forms of blindness, and that could be developed two to three years after the stock offering. (Mass Device)

German Health System Will Cover Retinal Implant

Aug. 11, 2014 - Retina Implant AG announced the German health system will cover its implant to partially restore vision in late-stage retinitis pigmentosa, Alpha IMS. The microchip-based device is implanted behind the retina, to stimulate healthy nerve cells there. The device received CE mark approval in 2013 and this is its first reimbursement coverage announcement. (Mass Device)

Medicare Administrator in New England and the Midwest Will Reimburse Posterior Tibial Nerve Stimulation for Overactive Bladder

Aug. 11, 2014 - Uroplasty, Inc. announced a positive coverage decision for its device that delivers posterior tibial nerve stimulation to treat symptoms of overactive bladder. The decision from National Government Services, a Medicare administrative contractor, applies to approximately 10 million Medicare beneficiaries in the states of New York, Illinois, Massachusetts, Wisconsin, Minnesota, Connecticut, Maine, New Hampshire, Rhode Island and Vermont. The company said it will increase its marketing to those areas. (Wall Street Journal)

Neuromodulation Recipients Are Among Long-Distance Runners for Company Race

Aug. 11, 2014 - Three patients who have deep brain stimulation implants and another who has a spinal cord stimulator are among the 25 runners who have medical technology implants and will compete as a team sponsored by Medtronic, Inc. in the Twin Cities, MN in October. Running as "Medtronic Global Heroes" the international team will compete in the Medtronic Twin Cities Marathon or TC 10 Mile on Oct. 5, 2014. (3BL Media)

Neuromodulation Company Completes Its Acquisition of a Private Manufacturer of Pain Interventions

Aug. 7, 2014 - St. Jude Medical, Inc. announced it has completed its acquisition of privately held NeuroTherm, Inc., a manufacturer of interventional pain management therapies. The acquisition for approximately $200 million was announced initially in July. (Fierce Medical Devices)

Add-on Payment for Medicare Coverage Approved for Closed-Loop Device for Epilepsy

Aug. 6, 2014 - NeuroPace, Inc. received approval from the Centers for Medicare & Medicaid Services for a New Technology Add-on Payment (NTAP) for its RNS® System, a responsive neurostimulation system that uses closed-loop feedback as an adjunctive control for some types of medically refractory epilepsy. The NTAP program is designed to support timely access to innovative technologies for Medicare beneficiaries. (Biospace)

Startup Seeks Partnerships to Develop Clinical Data

July 28, 2014 - Soft, thin, stretchable leads that can be more affordably manufactured are under development by the Milan- and Berlin-based start-up WISE Srl (Wiringless Implantable Stretchable Electronics), which, in preparation for seeking CE mark approval, is looking for new partnerships with neurosurgeons focused on spinal cord stimulation and neurophysiologists focused on cortical grids recording. (Daily Buzz)

Company Announces Device Approval in China

July 14, 2014 - Advanced Bionics said its waterproof cochlear implant, which allows users to go swimming, the Neptune, has been approved for use in China. (Mass Device)

Company Broadens Its Stake in the Chronic Pain Intervention Market

July 14, 2014 - Adding to its chronic pain management portfolio, St. Jude Medical, Inc. agreed to acquire radiofrequency device-maker NeuroTherm, Inc. for approximately $200 million. St. Jude Medical described the acquisition as strengthening its position in chronic pain therapies, by becoming the only medical device manufacturer to offer radio frequency ablation products as well as spinal cord stimulation systems. The transaction is being structured so that it is expected to be complete before the fourth quarter, with some $10 - 15 million in revenue from NeuroTherm adding to St. Jude Medical's 2014 sales. (Seeking Alpha)

External Trigeminal Nerve Stimulation Studies Presented at European Epileptology Meeting

July 8, 2014 - NeuroSigma, Inc. recapped a number of presentations made last week at the 11th European Congress on Epileptology in Stockholm, Sweden about external trigeminal nerve stimulation, which the company plans to evaluate for drug-resistant epilepsy in a pivotal clinical trial. (PR Newswire)

Vagus Nerve Stimulation Company's Funding Round is Oversubscribed

July 1, 2014 - A funding initiative started last April by electroCore, a New Jersey-based electroceutical company, has been oversubscribed by $10 million, bringing the total investment to $50 million upon agreement of all the parties, including Merck's Global Healthcare Innovation Fund. The company's non-invasive vagus nerve stimulation device is currently in four randomized studies focused on cluster and migraine headache. The gammaCore device is CE marked in Europe for primary headache, bronchoconstriction epilepsy, gastric motility disorders, depression and anxiety. (MarketWatch)

Neurostimulation Company Joins Canadian Securities Exchange

June 24, 2014 - Intellectual property developed 20 years ago at the University of Wisconsin to deliver neurostimulation non-invasively under the tongue has been transferred to Helius Medical Technologies, which acquired NeuroHabitation Corporation and began trading on the Canadian Securities Exchange under the ticker symbol HSM. The new company is capitalized at $127 million. A Cooperative Research and Development Agreement with NeuroHabitation and the University of Wisconsin and the U.S. Army Medical Research and Materiel Command in 2013 focused on exploring the portable system for treating balance and gait issues from causes such as traumatic brain injury, multiple sclerosis and vestibular disorders. (Wall Street Journal)

Developer of Transcranial Magnetic Stimulation Therapy Raises Capital

June 9, 2014 - The medical device-maker Cervel Neurotech of Redwood City, CA has raised $11.1 million and is near the close of a $11.9 million round of financing, through the sale of equity, rights, and securities. The company is developing repetitive transcranial magnetic stimulation for neurological and psychiatric disorders, in an approach that involves multiple magnetic coils to steer the magnetic field to targeted regions of the brain. (Mass Device)

Trade Association Will Establish an Office in Shanghai

June 3, 2014 - The medical technology trade association AdvaMed plans to open a China office where it will work on efforts to streamline China's medtech regulation, boost reimbursement and harmonize ethical standards with those in place elsewhere. AdvaMed also established a council of China representatives from several member companies. The association received official approval to open this new office in Shanghai. (Mass Device)

Interview Focuses on the Head of a Firm That Developed Non-invasive Vagus Nerve Stimulation

May 24, 2014 - ElectroCore Medical's CEO, J.P. Errico, discussed the company's external, non-invasive vagus nerve stimulation system and evolution from an acute, self-administered therapy for bronchoconstriction during an asthma attack to other uses, such as cluster headache, migraine, and potentially also pain, sleep disorders, and depression and anxiety. (Medgadget)

U.S. Patent Issued for Nerve-Blocking Technology

May 22, 2014 - Neuros Medical, Inc. announced it received a new U.S. patent for application of high-frequency electrical nerve block technology in nerves from 3mm - 12mm wide, with broad claims for treating pain, spasticity, and bladder dysfunction. Neuros now has three issued patents in its portfolio, with others pending. (Business Wire)

Neurostimulation System for Treatment-Resistant Depression Receives Marketing Approval in Europe

May 20, 2014 - BioControl Medical of Israel announced CE mark approval in Europe for its FitNeS™ vagus nerve stimulation system for adjunctive use in treatment-resistant depression. The system applies low-amplitude stimulation to the vagus nerve to preferentially activate nerve fibers leading to the brain. (Business Wire)

Voiding Dysfunction Company Reports Quarterly and Fiscal 2014 Results

May 15, 2014 - Uroplasty, Inc. reported increased revenues for the fourth quarter ending March 31, as well as the full fiscal year. The Minnesota-based company said sales of its Urgent® PC Neuromodulation System for voiding dysfunction were up 27% in the fourth quarter in the U.S. and 74% globally. An expansion of the marketing team led to operating expenses that contributed to a loss of $1.1 million in the fourth quarter of 2014, compared to $1 million in the fourth quarter of 2013, on total revenue of $24.6 million for the full year. (Market Watch)

Retinal Implant Company Plans an Initial Public Offering in Paris

May 13, 2014 - Pixium Vision of Paris is planning an initial public offering on Euronext Paris, a development covered in the French media, including L'Express. The company is targeting a 2015 market launch and is seeking CE mark approval for its retinal implant system, IRIS. (BioCentury)

China's Medical Device Market Continues to Expand

May 3, 2014 - A news feature describes how the medical device market in China is growing despite fears of intellectual property piracy. The country has shown double-digit growth in this sector, although its current market is just one-tenth the size of that in the U.S. As an example of the changes, Medtronic, Inc. began doing business in China in 1970 and opened an Innovation Center in Shanghai in 2012. Medtronic’s China revenues have grown from $50 million a decade ago to $800 million today. (Star Tribune)

Company Developing Back-Pain Implant Raises €18 million

April 30, 2014 - Mainstay Medical raised €18 million in an initial public offering that is said to be the first by a medical technology company to be simultaneously held in Dublin and Paris. The company makes a novel implanted device designed to stimulate muscles that stabilize the lower back, in order to treat chronic back pain. (Irish Times)

Neuromodulation Sales Contribute to Company's Quarterly Earnings

April 29, 2014 - Boston Scientific Corporation reported a higher adjusted profit in the first quarter of 2014 that ended March 31, partly due to higher sales of neuromodulation and heart rhythm management devices. Net earnings for the quarter were $133 million, or 10 cents a share. (Reuters)

Neuromodulation Company Appoints Chief Commercialization Officer

April 28, 2014 - Autonomic Technologies, Inc. (ATI) has appointed Karl Schweitzer chief commercialization officer. Previously, as a vice president at Medtronic, Inc. he served on the global leadership team for Medtronic's neuromodulation business. At ATI, he will lead global sales and marketing. The company received CE marking in Europe for its treatment for cluster headache, the ATI™ Neurostimulation System. The system is now being investigated in a multi-center, randomized study for the treatment of high frequency, high disability migraine. (Market Watch)

Two Executive Roles Announced for Vagus Nerve Stimulation Firm

April 28, 2014 - Cyberonics, Inc. has named its former senior vice president of strategic planning, Rohan Hoare, PhD, to the newly created role of chief operating officer for the company's epilepsy franchise. Cyberonics announced it has also recently names O'Neill F. D'Cruz, MD as Chief Medical Officer. The announcement described technology in its pipeline of vagus nerve stimulation products that focus on epilepsy: AspireSR™ pulse generator, with seizure detection and response technology, that has been CE marked in Europe; and the Centro™ and ProGuardian™ products that are anticipated to be nearing regulatory submissions. (Market Watch)

Consortium to Study Patient Preferences in Medical Devices

April 28, 2014 - The U.S. FDA announced http://us7.campaign-archive1.com/?u=cff97b5f3bf8acc54721b83b1&id=4e3f86eea4 it has awarded the public-private Medical Device Consortium $500,000 for a 12-month study of patient preferences regarding medical devices. The consortium formed in Minneapolic in 2012 as a partnership between the FDA and the medical device industry with the intent to improve how medical device safety is regulated. (Star Tribune)

Company Offers Advanced Implantable Pulse Generator for Future Neuromodulation Devices

April 23, 2014 - A new implantable pulse generator (IPG) for next-generation neuromodulation devices is now available from Massachusetts-based AdvaStim, Inc., where developers say it provides tools to explore issues of neural adaptation. The IPG has a modular platform with embedded software that allows customization of output parameters for advanced waveform modes, such as modulating current amplitude and pulse duration, and allowing for multi-channel delivery of simultaneous, sequential or independent pulse rates. The architecture enables multi-channel switching, electrode programming, response to external sensor data, and suitability for shrinking form factors. (Businesswire)

Device Maker's Earnings Report Anticipates Neuromodulation Growth

April 16, 2014 - In its first quarter 2014 earnings report, St. Jude Medical Inc. announced net sales increased 4% over 2013. Neuromodulation product sales were flat at $99 million compared to the same quarter one year ago, but CE mark approval and European launch of the Prodigy spinal cord stimulation system was explicated to be a future driver of growth. (Medical Product Outsourcing)

Irish Neuromodulation Device Company Plans Initial Public Offering

April 9, 2014 - To fund ongoing development of its chronic back pain device to stabilize muscles of the lower spine, the Irish medical device company Mainstay Medical announced it plans an initial public offered on the Euronext market in Paris and Dublin’s junior Enterprise Securities Market to raise up to €26.4 million through sale of 851,175 shares. (Irish Times)

Patient Enrollment Starts in Deep Brain Stimulation Clinical Registry

April 10, 2014 - Boston Scientific Corporation announced enrollment of the first patient in a new registry of the Vercise(TM) Deep Brain Stimulation (DBS) System in patients with Parkinson's disease. Approved  for sale in Europe, Israel, Australia and select countries in Latin America, the system offers multiple independent current control and a Zero Volt(TM) battery designed for longevity. The registry will evaluate the system's clinical outcomes and the economic value. (Wall Street Journal)

 

Neuromodulation Company With Noninvasive Investigational Approach to Depression Expands Its Leadership Team

April 10, 2014 - In preparation for pivotal clinical trials of its low-field magnetic stimulation therapy for depression, Tal Medical, Inc. of Boston added Jan Skvarka as president, CEO and member of the board of directors, as well as Ben Shapiro, MD, also on the board of directors. The National Institute of Mental Health selected the technology for its RAPID treatment program evaluating novel rapidly acting antidepressant treatments. The company is preparing for multi-site clinical trials led by psychiatric researcher Maurizio Fava, MD, director of the Clinical Research Program at Massachusetts General Hospital. The trial will examine the efficacy and durability of the treatment over an extended period of time in patients with major depressive disorder. (Market Watch)

U.S. Neurostimulation Market Projected to Approach $4 Billion by 2022

April 9, 2014 - The value of the U.S. neurostimulation device market will approach $4 billion by 2022, according to the Decision Resources Group, due in part to first-time demand for replacement of implantable pulse generators in new patients -- as well as anticipated growth in chronic heart failure, obesity, and epilepsy. However, market penetration is still thought to be low generally "because many referring physicians are not exposed to neurostimulation in medical school." (Digital Journal)

Business Column Expresses Optimism for Industry Due to News of Neurostimulation Aiding Spine-Injury Patients

April 9, 2014 - A column by the Motley Fool says now that three paralyzed patients were able to move limbs through a combination of spinal cord stimulation and physical therapy, there should be potential optimism for investors and patients who could anticipate growth in the neuromodulation sector. The column points out that the implanted systems were manufactured by Medtronic, Inc. and mentions the latest business developments from St. Jude Medical and Boston Scientific Corporation. (Motley Fool)

FDA Approves First Spinal Cord Stimulation Implantable Pulse Generator Fashioned for Noninvasive Software Upgrades

April 4, 2014 - The FDA has approved St. Jude Medical's Protégé™ implantable pulse generator for spinal cord stimulation, the first such device to allow future technology upgrades through software updates. New stimulation modes -- such as the currently investigated burst mode -- diagnostic capabilities, or other features could be accessed noninvasively, without needing surgery. The device has a seven-year warranty and 10-year projected battery life. International Neuromodulation Society member Tim Deer, MD, was the first to implant the device, the smallest in its class. “In the first 40 years of SCS we’ve seen advances in hardware but limited progress in software and programming. This new device evolves with promising therapies,” he commented. (Enhanced Online News)

Company's Progress Reflects Northern Ohio's Growing Neurostimulation Industry

April 1, 2014 - Ohio-based Neuros Medical, Inc. was featured in an article about the regional industry for electrical stimulation technology to address "spinal cord injury, stroke, bladder incontinence and chronic pain." International Neuromodulation Society member Amol Soin, MD, was quoted about a pilot study of the company's Altius high-frequency nerve block device for limiting amputation pain. He anticipated the device might be commercially available within two years. (Cleveland.com)

Noninvasive Brain Stimulation Platform Allowed Further Patent Claims

March 31, 2014 - Soterix Medical Inc. of New York City announced an allowance of patent claims for controlling the targeting of high-definition transcranial direct current stimulation. The company says its technology combines the advantages of transcranial direct current stimulation and transcranial magnetic stimulation. The non-invasive system is being trialled in applications spanning depression, pain, epilepsy and stroke rehabilitation. The company uses individualized brain current-flow modeling and patented algorithms for placing and energizing high-definition electrodes on the scalp. (Digital Journal)

Growth-Stage Company Adds Chief Medical Officer

March 31, 2014 - Nevro Corp. announced appointment of David Caraway, MD, PhD as its chief medical officer. A member of the International Neuromodulation Society, Dr. Caraway is a pain management physician who has been active in developing the field of neuromodulation. Nevro's high-frequency spinal cord stimulation system, Senza, is authorized for sale in Europe and Australia. (Digital Journal)

Neuromodulation Device Early Stage Company Expands Its Financial Management Team

March 28, 2014 - Los Angeles-based NeuroSigma, Inc. has expanded its management team with two former Amgen finance executives. Carl Adams, who was briefly the company's controller and vice president, was promoted to chief financial officer.Craig Rostamian was appointed vice president of Finance, where he will oversee financial planning and analysis. NeuroSigma has Health Canada and CE Mark approval to market its external trigeminal nerve stimulation system, the Monarch™ eTNS™ System, for the adjunctive treatment of drug-resistant epilepsy and major depressive disorder for adults and children 9 years and older. (Wall Street Journal)

France Issues Neurostimulation Health Technology Assessment
March 27, 2014 - Chronic neuropathic pain, complex regional pain syndrome, and ischemic pain are considered indications in which neurostimulation can play a treatment role, according to a health technology assessment just published by the French commission for evaluation of medical devices and health technologies. (Vidal)

Vision-Restoration Startup Names New Chief Executive Officer and Director

March 25, 2014 - Khalid Ishaque, most recently general manager of Boston Scientific's international neuromodulation business, has been named chief executive officer and director of a Paris company that works on retinal implants to restore sight, Pixium Vision. Pixium has a surface-retinal-implant system, IRIS®, that entered a clinical trial in 2013 with initial patient data expected in 2014 to form the basis of a CE Mark application. The company is also developing a sub-retinal implant system, PRIMA™. Formed in 2011 based on research from the Vision Institute and Université Pierre et Marie Curie, the company incorporates academic research from the U.S. and Europe, and has raised €24.5m from venture capital and investment firms including Sofinnova Partners, Omnes Capital, Abingworth, Global Life Sciences Ventures, Bpifrance, Seventure and Polytechnos. (Pixium Vision)

Neuromodulation Startup Raises $32.6 Million in Series A Funding

March 25, 2014 - Axonics Modulation Technologies of Irvine, Calif. has raised $32.6 million in a Series A preferred stock financing led by Edmond de Rothschild Investment Partners of Paris, with participation by NeoMed Management of Genveva, and Legend Capital of Beijing as well as a number of private investors. The company is developing novel implantable neuromodulation technology licensed from The Alfred Mann Foundation. Initially the company will focus on chronic pain and overactive bladder. Among the company's leaders is co-founder and medical advisor Timothy Deer, MD, a member of the International Neuromodulation Society. (Fierce Medical Devices)

Technology Assessment Forum Seeks Comment on Migraine Treatment Options

March 25, 2014 - The California Technology Assessment Forum will take written comments prior to a public meeting July 11, 2014 in Los Angeles to examine treatment options for migraine headaches, including a newly approved, hand-held device that provides transcranial magnetic stimulation. The forum is intended to provide guidance to clinicians, insurers and patients. (Institute for Clinical and Economic Review)

Firm Announces First Use of Its Technology for Asleep Deep Brain Stimulation Surgery

March 25, 2014 - Mazor Robotics Ltd. announced the first deep brain stimulation surgery using its Renaissance® Guidance System with the patient asleep. The surgeon in charge of the operation said the system allows the patient to have less anxiety and the procedure to be performed more quickly with fewer probes into the brain. The operation in Littleton, CO took place on a 65-year-old man who was recently diagnosed with Parkinson's disease. (Mazor Robotics)

Business Column Explores Positive News of CE Mark Approval for Neuromodulation Device

March 21, 2014 - Recent CE Mark approval for St. Jude Medical's Prodigy neuromodulation device should help the company in light of declining sales of pacemakers and ICDs and competition from Medtronic, Inc. and Boston Scientific Corporation, a column in the Motley Fool says. The column mentions that the company estimates more than 1.5 billion people worldwide suffer from chronic pain, so the market for devices like the Prodigy is potentially huge. Also, the column calls neuromodulation "an up-and-coming field" in medical technology. (Motley Fool)


Company Ships Next-Generation Device for Diabetic Pain
March 18, 2014 - A transcutanteous electrical stimulation system designed to relieve neuropathic pain during sleep has been released in its second-generation form by NeuroMetrix, Inc. The company's Sensus (TM) pain management system is intended for diabetics who have chronic pain, such as from painful diabetic neuropathy. In its second iteration, the device is thinner than the previous device released in 2013, and has several hardware improvements. (Wall Street Journal)

 

Vagus Nerve Stimulation System Company Receives Positive Investment Analysis
March 10, 2014 - An investment analyst issues a positive report on the company Cyberonics, Inc., explaining that up to one-third of epileptic patients do not respond to medication, and that the Houston, TX company's implantable vagus nerve stimulation (VNS) system for treatment-resistant epilepsy has been implanted in more than 75,000 patients since 1997. The company recently released a VNS device that activates in response to abnormal heart rhythms associated with seizures. The analyst said one study showed that in about 62 percent of activations seizures were diminished or halted, adding that the cost of the device and Medicare reimbursements are climbing, while VNS saves an estimated $60,000 in treatment-related expenses. (Investing Daily)


Transcranial Magnetic Stimulation Company Raises Private Capital in Israel

March 9, 2014 - Brainsway Ltd. has raised NIS 41 million (US $11.9 million) in a private-equity placement. The investment house Yelin Lapidot received 772,585 of the company's shares (5.48%) in the exchange. Brainsway will apply the proceeds to market expansion for its Deep TMS (transcranial magnetic stimulation) system for neurological/neuropsychiatric disorders. (Globes)


India Starts Fellowship for Affordable Medical Technology Innovation

March 8, 2014 - A technology accelerator in India, InnAccel, has started a six-month fellowship program on Affordable Innovation in Medical Technology to train engineers and product designers in medtech invention and entrepreneurship. The first three fellows are undergoing two months of clinical observation at the trauma and emergency care unit at St. Johns National Academy of Health Sciences in Bengaluru, which already has a number of med-tech start-ups and venture capitalists, as well as a presence by multinational companies like GE Healthcare, Phillips and Siemens. (Pharmabiz.com)


Company Formed to Commercialize Implantable System Conducive to Infusion of Biologic Agents
March 6, 2014 - The Alfred Mann Foundation announced creation of a Minnesota-based life sciences company to commercialize an implantable infusion pump that provides capability for delivery of large molecules associated with emerging biologic therapies for neurodegenerative diseases. The new company, Medallion Therapeutics, is conducting a pivotal clinical evaluation for pre-market approval of the device in the United States, and is pursuing CE Mark certification in Europe. The foundation said in a news release that the technology is the result of more than 10 years of development, and could address unmet need and expand indications for implantable drug delivery. International Neuromodulation Society member Don Deyo, a seasoned industry executive, is chief executive officer, and Eric S. Harris, also an industry veteran, is chief commercial officer. (Jewish Business News)

Special Report Focuses on Four Global Neuromodulation Companies

Feb. 25, 2014 - Saying neuromodulation is poised for major growth in the coming years, Fierce Medical Devices provides an overview of the four main global competitors -- Medtronic, Inc., Boston Scientific Corporation, St. Jude Medical, and Cyberonics, Inc. Part of the anticipated growth, the article says, would come from wider and long-term use of neuromodulation therapies. (Fierce Medical Devicesl)

Vagus Nerve Stimulation in Response to Seizure Detection Receives CE Mark

Feb. 20, 2014 - Cyberonics, Inc. has received CE Mark approval for its 6th-generation generator for vagus nerve stimulation, the AspireSR generator, which provides automatic stimulation in response to detection of a seizure as indicated by an increase in heart rate. (Wall Street Journal)

External Vagus Nerve Stimulation Company Featured in Business Column

Feb. 20, 2014 - A columnist calls electroCore's external vagus nerve stimulation system "digital health's big secret" and adds that the company is working on a screening tool to predict responders. (Forbes)

Vagus Nerve Stimulation Company Plans Business Presentations

Feb. 19, 2014 - Cyberonics, Inc.'s Chief Financial Officer Greg Browne will meet individually with investors and participate in a neuromodulation panel discussion in New York City next week. The panel takes place Feb. 26 at the Citi 2014 Global Healthcare Conference. On March 11, the company's president and chief executive officer, Dan Moore, will present at the Barclays Global Healthcare Conference in Miami, with a live audio webcast available from the company's website, http://www.cyberonics.com, at 2:30 PM Eastern Time. (Market Watch)

Developers Announce Low-Power Circuit for Body-Area Networks

Feb. 18, 2014 - A power-efficient wireless transceiver circuit for use in body area networks for medical applications that adheres to the 400MHz-band international standard has been developed by Fujitsu Laboratories Ltd. and imec Holst Centre. Rather than require more than 12 milliwatts to monitor brainwaves or other vital signs as typically is needed, the circuit power requirements are reduced by more than a factor of 10 to 1.6mW for receiving data and 1.8mW for transmitting. (Today's Medical Developments)

Transcranial Direct Current Stimulation Product Manufacturer Opens Boston-Area Office

Feb. 13, 2014 - Neuroelectrics, a Spanish spinoff of Starlab Neuroscience Research, has opened its first U.S. office, which is based at the Cambridge Innovation Center in Massachusetts, where it will be near research laboratories that may use its non-invasive brain stimulation research products, a transcranial direct current stimulation device, Starstim, and a wireless EEG brain monitoring device, Enobio. (BioFlash)

Noninvasive Brain Stimulation System Company's System is Installed in Sweden

Feb. 17, 2014 - Brainsway Ltd. announced it has installed deep transcranial magnetic stimulation systems at Karolinska University Hospital for depression treatment. The Swedish health system is public, the company noted, enabling more access to this mode of treatment than in the U.S. (Globes)

Neurostimulation Company Executive Questions Patent Infringement Proposed Bill

Feb. 11, 2014 - The CEO of Autonomic Technologies, Inc. and a patent attorney write in an opinion piece that proposed anti-patent-infringement legislation is unnecessarily too broad and could harm companies that assemble goods with components sourced from many manufacturers. The article describes the benefits of the startup company's ATI Neurostimulation System, a small implant designed to halt headache. (San Jose Mercury News)

Medical Device Companies Eyed as Leading Health Care Sector Growth

Feb. 6, 2014 - A 32% growth in neuromodulation in the last three months of 2013 for Boston Scientific Corporation and a 6% growth in Medtronic Inc.'s most recent quarter were mentioned in a column that asks if the medical device industry is the biggest player in health care. (Motley Fool)

Pennsylvania Insurer Will Cover Percutaneous Tibial Nerve Stimulation for Urinary Symptoms

Feb. 6, 2014 - Independence Blue Cross of southeastern Pennsylvania will cover percutaneous tibial nerve stimulation for treatment of overactive bladder, device maker Uroplasty, Inc. announced. The addition of 2.2 million people covered by the carrier brings to some 150 million people who are covered by private insurance or Medicare who now have access to the therapy. (Wall Street Journal)

Analyst Examines Market Penetration of Vagus Nerve Stimulation System Device Maker

Feb. 5, 2014 - Depression is called the likely biggest incremental driver for value of shares of Cyberonics, Inc., whose vagus nerve stimulation systems are FDA-approved for treatment of epilepsy and depression. (Seeking Alpha)

Device Maker's Neuromodulation Revenue Tops 30% at the End of 2013

Feb. 4, 2014 - Boston Scientific Corporation's fourth quarter results for the three months ending Dec. 31, 2013 showed a 33% increase in the neuromodulation sector of its medical-surgerical division -- the second quarter in a row that neuromodulation revenue topped 30% -- and overall 5% operational revenue growth and 1% revenue growth on a reported basis compared to the prior year period. (Yahoo! Finance)

Medical Device Component Vendor Announces Flexible Neurostimulation Platform

Feb. 4, 2014 - Los Gatos, Calif.-based CIRTEC Medical Systems has released a development platform for neuromodulation devices, VeraSTIM, that offers 4 channels, 32 electrodes, up to 10,000 HZ frequency, remote transcutaneous charging, and multiple pulse modes (burst, ramp up, ramp down, etc.). The flexibility enables testing multiple parameters during device development. (PR Newswire)

Dubai Becomes New Regional Base for Medical Device Firm

Jan. 29, 2014 - Medtronic has moved its regional Middle East and Africa headquarters from Beirut, Lebanon to a Dubai freezone-based complex, the DuBiotech Research Park, citing its "infrastructure, accessibility, and strategic location." (Mass Device)

Patients Start Receiving Commercial Implants of Recently Approved Visual Prosthetic

Jan. 29, 2014 - The first commercial implants of the Argus II visual prosthetic took place at the University of Michigan's Kellogg Eye Center. The device maker, Second Sight Medical, plans to provide updates during a press conference at the American Society of Cataract and Refractive Surgery conference in April, after the patients complete about three months of rehabilitation and training. The retinal implant, approved by the FDA in 2013, is designed to enhance vision in patients who have been progressively blinded by the condition retinitis pigmentosa. (Mass Device)

Voiding Dysfunction Medical Device Company Reports Quarterly Earnings

Jan. 23, 2014 - Uroplasty, Inc. reported a strong fiscal 2014 third quarter ending Dec. 31, 2013. Total revenues grew 14% over the same quarter the previous year to $6.4 million. The company forecasts 25-30% revenue growth for its Urgent PC neuromodulation system in the U.S. during the fourth quarter of fiscal 2014. Operating expenses were up, $6.3 million compared to $5.5 million the same quarter last year, reflecting investment in ongoing sales training, expansion and reorganization of the sales and marketing team and programs, and the medical device tax. The company booked a non-GAAP operating loss of $0.3 million compared with $0.1 million in the third quarter a year ago. (Market Watch)

Neuromodulation Devices Count Heavily in Publications' Top-Ranked New Medical Technologies

Jan. 22, 2014 - Three of Fierce Medical Devices' list of the top eight FDA medical technology approvals in 2013 are neuromodulation devices -- Second Sight's Argus II Retinal Prosthesis System, NeuroPace's antiepilepsy neurostimulation implant, and eNeura's antimigraine device. (Fierce Medical Devices)

Company Seeks CE Mark for Spinal Cord Stimulation System

Jan. 20, 2014 - After filing for pre-market approval of its spinal cord stimulation system last month, Greatbatch filed a CE Mark application for the system with the German notified body TÜV SÜD America. (Mass Device)

Chief Medical Officer Will Oversee Development of Sphenopalatine Ganglion Stimulation for Chronic Headache

Jan. 20, 2014 - Autonomic Technologies, Inc. has appointed as chief medical officer Shashidhar Kori, MD. With a background in establishing and running large academic training programs in pain management, he was previously vice president of Clinical Development and Medical Affairs at Allergan and MAP Pharmaceuticals, and senior director of Clinical Development and senior medical advisor on the pain/migraine team at GlaxoSmithKline before that. He will oversee clinical trials of the ATI™ Neurostimulation System for cluster headache and migraine in the United States and in Europe. (Business Wire)

Neurostimulation Devices Called a Technology to Watch

Jan. 14, 2014 - Many recent developments have borne out a prediction from 2010 that technological advancements would improve neurostimulation device efficacy and potential to disrupt the market, according to a "technologies to watch" news report. The report also mentions neuroprosthetic development and sensors. (Medical Device and Diagnostic Industry)

Migraine Therapy Device Maker Receives $2.2 Million Investment

Jan. 6, 2014 - Sunnyvale, Calif.-based eNeura Therapeutics received a $2.2 million investment in late December in an equity transaction with an unnamed investor, on the heels of FDA clearancefor its Cerena transcranial magnetic stimulator for migraine relief. The device is designed to be held to the back of the head to stimulate the occipital cortex when a patient senses a pre-migraine aura. (Mass Device)

Industry News 2013

Company Seeks PMA for Newly Developed Spinal Cord Stimulation System
Dec. 19, 2013 - Greatbatch has filed for pre-market approval of its spinal cord stimulation system that was designed by its subsidiary, QiG Group. Offering a complete medical system is part of a strategy to increase growth and profitability, the company said. (Mass Device)

 

First U.S. Patients Receive Deep Brain Stimulation Systems That Are Capable of Sensing and Recording
Dec. 5, 2013 - Medtronic, Inc. announced that the first U.S. patients have received implants of the company's Activa PC+S deep brain stimulation system (DBS) that senses and records brain activity. The system could be subject to research at up to 20 centers, and the brain-mapping data will be made available to physicians worldwide for clinical studies. The system is investigational in the U.S., and received CE Mark in January in the European Union. The first U.S. patients were treated at Stanford Movement Disorders Center and the University of California San Francisco’s Bachmann-Strauss Dystonia and Parkinson Foundation Center of Excellence. (Star Tribune)

Electroceutical Startup Chooses Developer for Programmable Interface
Dec. 5, 2013 - Product developer Sangentia announced it will work on a programming interface with SetPoint Medical to develop an iPad App and advise on radio frequency and Bluetooth Low Energy interfaces for SetPoint's bioelectronics platform. The platform is being developed to treat inflammation-mediated autoimmune diseases as a lower-risk, lower-cost alternative to immunosuppressive drugs for chronic inflammatory diseases. (Business Wire)

 

Company Expects a Growing Number of Patients to be Covered for Percutaneous Tibial Nerve Stimulation Treatment
Dec. 4, 2013 - Minnesota-based Uroplasty, Inc. expects to end calendar year 2013 with an increasing number of patients receiving insurance reimbursement for its percutaneous tibial nerve stimulation system, Urgent® PC, for overactive bladder and relate symptoms. This includes approximately 40 million Medicare recipients, an increase from 37 million a year ago, and approximately 106 million patients with private insurance, up from 87 million a year ago. The Health Care Service Corporation (HCSC), the largest customer-owned health insurance company in the United States, recently announced that in Illinois, Montana, New Mexico, Oklahoma and Texas, as of Dec. 15, 2013, coverage will be extended for up to three years for patients showing continued improvement after the first year of treatment.
(Benzinga)

Company Releases Interim Results of Weight-Loss Study; Shares Rise
Dec. 3, 2013 - EnteroMedics said its vagus nerve stimulation implant, the Maestro Rechargeable system, showed in the first 18 months of a pivotal five-year study that 117 patients in the active treatment group achieved 25% loss of excess weight compared to 12% weight loss in the 42 patients in the sham treatment group. With the news, shares rose 81 cents Tuesday to $2.24. (TwinCities.com)

 

Burst Stimulation Spinal Cord Stimulation Clinical Trial Announced
Dec. 3, 2013 - St. Jude Medical, Inc. has initiated a U.S. clinical trial of spinal cord stimulation with its Prodigy™ neurostimulator that uses a proprietary burst mode of stimulation. Up to 442 chronic pain patients will be enrolled at up to 50 sites in the safety and efficacy trial,  SUNBURST™ (Success Using Neuromodulation with BURST). The new investigational device has an expected 10-year battery life and requires recharging approximately once a week. It is designed to deliver both tonic and burst stimulation. International Neuromodulation Society President Elect Tim Deer, MD commented that the comprehensive approach may help manage pain in patients whose pain is not adequately managed by tonic spinal cord stimulation alone, or who lose therapeutic benefit over time. Also, the prospect of burst stimulation providing paresthesia-free pain relief means it could suit patients who cannot tolerate traditional stimulation. (Mass Device)

Mobile Platform for Transcranial Direct Current Stimulation Announced
Dec. 2, 2013 - Soterix Medical Inc. of New York, N.Y., Rogue Resolutions Ltd of Cardiff, UK, and neuroConn GmbH of Ilmenau, Germany announced a transcranial direct current stimulation (tDCS) platform with a headgear designed for clinical trial or home use. The MOBILE neuromodulation device kits are designed to deliver Limited Total Energy (LTE) tDCS, using a proprietary technology developed at The City College of New York. The kits include cloud-based compliance monitoring and are explicated to enter clinical trials in 2014. (PR Newswire)

 

External Stimulation System for Shoulder Pain Approved in Australia
Nov. 22, 2013 - The Australian Therapeutic Goods Administration has approved use of SPR Therapeutics' Smartpatch percutaneous peripheral nerve stimulation system for shoulder pain. The device is manufactured by NDI Medical of Cleveland, Ohio. International Neuromodulation Society Secretary Marc Russo, MBBS, commented that the minimally invasive system fills a gap in the pain treatment continuum, between narcotics or more invasive surgery. (Digital Journal)

Gastroesophageal Reflux Disease Treatment System Approved in Argentina
Oct. 30, 2013 - St. Louis-based EndoStim announced it has received approval in Argentina for sale of its neurostimulation system to treat gastroesophageal reflux disease, GERD. The Lower Esophageal Sphincter Stimulation System strengthens the muscle that prevents stomach acid from rising into the esophagus, which lacks a protective lining to protect against tissue damage. The system uses bipolar leads that are implanted laparoscopically and powered by an impulse pulse generator. (PR Newswire via EndoStim)

 

Vagus Nerve Stimulator Manufacturer Posts Gains in Second Quarter
Nov. 22, 2013 - Cyberonics Inc. of Houston, TX announced second-quarter 2013 gains with net income up to $13.8 million from $13.5 million during the same quarter one year ago. Sales of its vagus nerve stimulation system grew internationally by almost 10% and overall sales were at a record high. Product development includes submission of the vagus nerve stimulation generator AspireSR for approval in Europe for use in epileptics in whom the device could automatically deliver stimulation in response to a change in heart rhythm. (Fierce Medical Devices)

 

Canada Approves Electrical Stimulation System to Assist Breathing
Nov. 21, 2013 - Oberlin, Ohio-based Synpase Biomedical received Health Canada approval for its diaphragm pacing system, NeuRx. The system electrically stimulates the muscles to allow spinal cord injury patients to breathe longer without the need of a mechanical ventilator forcing air into the lungs. (Today's Medical Developments)

 

Early Stage Functional Electrical Stimulation Company Appoints New Director
Nov. 19, 2013 - Medtronic Inc.'s former vice president and general manager of neuromodulation, Karl Schweitzer, was appointed to the board of EBS Technologies GmbH, an emerging device company developing a noninvasive electrical brain stimulation platform to expand the visual field in patients whose vision is impaired following stroke or other nerve damage. The NEXT WAVE(TM) platform stimulates firing along optic pathways. (Market Watch)

 

Neurostimulation Developer Collaborates with Designer of Power-Efficient Circuits
Nov. 13, 2013 - For the past 12 months, Rosellini Scientific, LLC of Dallas, Texas has been collaborating with NanoWattICs SRL of Montevideo, Uruguay to develop a suite of implantable, wireless and non-invasive neurostimulation technologies for applications including migraines and neuropathic pain. Montevideo, Uruguay- based NanoWattICs received a grant to partially fund this work from the Agencia Nacional de Investigación e Innovación in Uruguay. The company focuses on custom circuits that maximize battery life in portable applications. (PR Web)

 

U.S. Insurer to Cover Percutaneous Tibial Nerve Stimulation Treatment for Overactive Bladder
Oct. 29, 2013 - Humana, Inc. -- the sixth-largest private health insurer in the U.S. and administrator of Tricare South and several Medicare Advantage plans -- will begin covering treatment with percutaneous tibial nerve stimulation of overactive bladder and associated symptoms, announced Uroplasty, Inc., manufacturer of the Urgent PC Neuromodulation System. (Wall Street Journal)

Column Ponders Market Performance of One Medical Device Company
Oct. 29, 2013 - While shares of Boston Scientific have risen 120% in the past year and exceeded expectations, its adjusted earnings per share growth is less than competitors St. Jude Medical and Medtronic, notes a financial columnist, who adds that the company announced changes ahead with resignation of its CFO, new approvals in China and Europe, and layoffs for 2014. The columnist says moves to stabilize costs and margins would be positive catalysts and, since the stock is trading at a premium (based on its forward profit/earnings ratio) compared to its competitors, the price could be impacted more than its peers during a market pullback. (Motley Fool)

Neuromodulation Implants in the U.S. Burgeoned in the Past Decade
Oct. 27, 2013 - A Star Tribune analysis of data from the U.S. Department of Health and Human Services indicates that there were more than 19,000 neurostimulation implants in the U.S. in 2010, with most of the implants being performed on patients younger than 65 years of age for pain and other indications, such as movement disorder or bladder dysfunction. The total number of neurostimulation implants in 2010 is 80% more than the number performed in the year 2000. The article includes comments from patients industry leaders and states that, according to Transparency Market Research of Albany, N.Y., the global market for neuromodulation devices is expected to grow to more than $6 billion by 2018, at a rate of 14% a year. (Minneapolis Star Tribune)

Device Maker That Targets Voiding Dysfunction Sees More Revenue, Plus an Operating Loss
Oct. 24, 2013 - Uroplasty, Inc. announced a 5% increase in revenues the second fiscal quarter of 2014 compared to the same quarter a year ago. The Minneapolis, MN-based maker of devices to treat voiding dysfunctions took in $6 million in the quarter ended Sept. 30, with $4.5 million of that from U.S. sales. The company booked a one-time expense of $1.2 million due to changes in executive management and internal reviews, and overall had an operating loss of $1.9 million. (PR Newswire)

Neuromodulation Contributes to Company's Bottom Line
Oct. 24, 2013 - Boston Scientific Corporation announced revenue growth in neuromodulation of 32% compared to one year ago, with $115 million in sales in neuromodulation in the third quarter of 2013. The company announced restructuring in 2014 should increase operational efficiencies by reducing headcount between 1,100 - 1,300 worldwide through attrition and reductions in force. Overall the company generated $1.735 billion in sales and adjusted earnings per share of $0.17 in the quarter ending Sept. 30, 2013, and reported a GAAP loss of $5 million. After neuromodulation, the next highest area of revenue growth was in MedSurg, which was up 9% (12% on a constant currency basis). Interventional cardiology, meanwhile, had the most depressed earnings, down 4% or 2% on a constant currency basis. (Yahoo Finance!)

Neuromodulation Firm Recognized as a Top Private Medical Technology Company of the Year
Oct. 15, 2013 - During FierceMedical's second annual selection of the top 15 device and diagnostic companies of the year, SetPoint Medical was named one of the most promising private med-tech companies. Companies on the list are evaluated based on factors including technology strength, partnerships, venture backers and a competitive market position. SetPoint is developing vagus nerve stimulation of the autonomic nervous system to combat inflammation in autoimmune disease. (EON)

Company Plans to Start Pivotal Clinical Trial of High-Frequency Nerve Block Technology in Amputation Pain
Oct. 10, 2013 - With Investigational Device Exemption from the FDA for its Altius™ System to deliver high-frequency stimulation to sensory nerves in the peripheral nervous system to block chronic pain, Neuros Medical, Inc. can start its pivotal clinical trial of the high-frequency nerve block for management of intractable limb pain in amputees, the company said in a press release. Neuros Medical plans to enroll 130 patients at 15 U.S. institutions for a prospective, randomized controlled clinical trial to evaluate the system's safety and efficacy. (Business Wire)

A $14 Million Deal to Develop Wirelessly Powered Vagus Nerve Stimulation
Oct. 9, 2013 - The company electroCore has entered a deal with waveCore -- a company owned by the founding shareholders of electroCore -- to develop a system to wirelessly power and control an implanted vagus nerve stimulator. New Jersey-based electroCore has developed external vagus nerve stimulation (VNS) to address symptoms of headache and potentially other disorders, such as bronchoconstriction, epilepsy, gastric motility disorders, depression and anxiety.  The implanted VNS system would include a receiver that is powered by a transmitter worn on the body or placed up to four feet away at night. With the deal, waveCore will pay electroCore $2 million to fund the first-in-man pilot study, with additional milestone payments of $12 million during the U.S. regulatory process. (Enhanced Online News)

Retinal Prosthesis User Describes Its Advantages as Company Poises for a U.S. Market Launch
Oct. 7, 2013 - A man who has been using the Argus II visual prosthesis that will soon be marketed in the U.S. by Second Sight describes in an interview how it aids his coping with retinitis pigmentosa. The eyeglass-mounted device contributes to quality of life, says ophthalmology professor Jacque Duncan of the University of California, San Francisco, because its video camera link to a retinal implant allows users to distinguish edges and moving objects through enhancing their perception of light and dark. (CBS News)

Israeli Company Raises Funds from Japanese Distributor, Tel Aviv Stock Exchange
Oct. 6, 2013 - Deep Transcranial Magnetic Stimulation (TMS) system manufacturer Brainsway Ltd. of Jerusalem, Israel has raised NIS 24 million on the Tel Aviv Stock Exchange, and also received $1 million over the weekend in the first of two payments from the distributor Century Medical, Inc. of the Japanese ITOCHU Group for exclusive distribution rights in Japan. The company uses technology licensed from the National Institutes of Health to penetrate TMS stimulation to structures deep within the brain. The therapy has initially been focused on major depressive disorder, with other indications under investigation. (Globes)

Company Raises Funds for Vagus Nerve Stimulation Trials in Stroke Recovery, Tinnitus
Sept. 20, 2013 - MicroTransponder, Inc. of Dalla, TX has raised $3.4 million to carry out clinical trials of vagus nerve stimulation -- two trials that would use the company's Vivistim System to restore functionality in the upper limbs of stroke patients, and one using its Serenity System that is designed to "rewire" the auditory cortex of tinnitus patients. The company intends to secure a CE mark for both systems next year, and then raise more funds to support a clinical trial for a pre-market approval in the U.S. (BioNews Texas)

Hand-held Vagus Nerve Stimulation Device Undergoing Development in U.S.
Sept. 13, 2013 - New Jersey-based GammaCore's handheld external vagus nerve stimulation device to minimize effects of chronic migraine is expected to be submitted for FDA approval early next year, after completion of clinical studies, according to a business profile. The prescription device has received approval in Europe, India, Brazil, Canada and Australia, but has not launched commercially. (NJ.com)

Patient Receives MRI While Implanted with Spinal Cord Stimulation Device Designed to Allow Full-Body Scans
Sept. 12, 2013 - An MRI center in South Bend, IN announced it performed the first MRI in the U.S. on a patient who had a neurostimulator that was recently approved for conditional use in full-body MRI scans. (Market Watch)

New Head of Strategic Planning Announced at Firm Marketing Vagus Nerve Stimulation Systems
Sept. 12, 2013 - Rohan J. Hoare, Ph.D., previously president of St. Jude Neuromodulation Division, has been named senior vice president of strategic planning at Cyberonics, Inc. With core expertise in neuromodulation, Cyberonics developed and markets an implanted vagus nerve stimulation system that is FDA-approved for the treatment of refractory epilepsy and treatment-resistant depression. (Market Watch)

Company's Non-Invasive Approach to Vagus Nerve Stimulation Described
Sept. 1, 2013 -  Addressing the issue of the inherent challenges involved in surgically accessing the vagus nerve to implant cuff electrodes prior to a lengthy recovery period, ElectroCore Medical of Bernards Township, New Jersey is developing non-invasive vagus nerve stimulation therapies. The devices are being developed to treat or prevent symptoms of serious headache conditions, including migraines and cluster headaches, and bronchoconstriction including asthma and chronic obstructive pulmonary disorder. (Implantable Devices)

Medical Device Industry Investment Options Analyzed in Financial Column
Aug. 28, 2013 - Medtronic, Inc. is noted as being worthy of consideration for income investors due to its stable history of dividend increases and diversification into such divisions as neuromodulation, which has future growth potential. (Motley Fool via Daily Finance)

South Korea Approves Transcranial Magnetic Stimulation for Major Depressive Disorder
Aug. 23, 2013 - A transcranial magnetic stimulation technology developed by NeuroStar for major depressive disorder was approved by the South Korea Ministry of Food and Drug Safety. Neuronetics will work with distribution partner BR Holdings of Seoul for entry into the market, which is considered to represent the world's 15th largest economy. (BioSpectrum Asia)

Vagus Nerve Stimulation System Maker Reports Strong First-Quarter 2014 Earnings
Aug. 22, 2013 - Net product sales increased 12.4% to $67.4 million in the first fiscal quarter ended July 26 for Cyberonics, Inc. of Houston, TX.  Including license revenue, sales were up 14.2% overall, with Europe in particular contributing a strong performance. Diluted earnings per share were adjusted by $0.17 cents due to a litigation settlement. (PR Newswire)

Neurostimulation Industry, Investment and Research Puts Ohio on the Map
Aug. 22, 2013 - Ohio's neurostimulation industry is described as being "on the brink of a breakout" due to its economic climate, investments, advances and talent. (hiVelocity)

New Bioelectronic Medicines Fund Joins $27 Million Financing Round for Start-Up Neuromodulation Company
Aug. 8, 2013 - A year after starting a Bioelectronics R&D division, GlaxoSmithKline launched Action Potential Venture Capital (APVC) Limited in Cambridge, Mass., a $50 million venture capital fund targeting development of bioelectronic medicines and technologies with the potential to normalize signaling between the peripheral nervous system and organs in some chronic disease states. Along with Covidien and Boston Scientific Incorporated, APVC joined existing investors to participate in a $27 million round of financing for neuromodulation start-up SetPoint Medical, a Valencia, CA company creating vagus nerve stimulation devices to treat inflammatory diseases. (Fierce Medical Devices)

Voiding Dysfunction Treatment Drives Sales Growth
Aug. 1, 2013 - Uroplasty, Inc. reported its first sequential growth for three quarters in its quarterly results for the first quarter of fiscal 2014, ended June 30, 2013. Sales of its devices to treat voiding dysfunctions grew 11% from the fourth quarter of fiscal 2013. Overall, the company's global sales increased 5% to $5.8 million in the first quarter of fiscal 2014, compared to $5.6 million in the fiscal first quarter a year ago. (MSNMoney)

Neuromodulation Sales Add to Company's Bottom Line
July 25, 2013 - Boston Scientific Corporation's neuromodulation sales in the second quarter of 2013 ending June 30th were up 21% over the same period the previous year, according to quarterly results the company announced Thursday. Overall, analysts noted the device maker showed organic sales growth, from an operational standpoint, for the first time since 2009. This 2% growth on a constant currency basis, excluding divested businesses, was largely due to its neuromodulation and cardiovascular business segments. Neuromodulation sales were $14 million ahead of analysts' consensus forecast, at $111 million for the second quarter of 2013. (Medical Device and Diagnostic Industry)

Retinal Prosthesis Company Prepares to Raise Capital
July 24, 2013 - Second Sight Medical Products is seeking to raise $10.5 million, according to a regulatory filing. The Sylmar, Calif.-based company received FDA approval earlier this year to market its Argus II retinal prosthesis -- already sold in Europe -- in the U.S. to assist patients who have late-stage retinitis pigmentosa. (Medical Device and Diagnostic Industry)

Closed-Loop Spinal Cord Stimulator Developer Receives Startup Grant
July 22, 2013 - NICTA spin-out Saluda Medical received a $5M grant from an inaugural round of funding from the New South Wales, Australia Government’s Medical Devices Fund. Through the Ministry of Health, the fund is intended to promote innovative new medical technologies that may have a global benefit. NICTA is Australia’s largest publicly-funded information and communications technology research organization. Sydney-based Saluda is developing closed-loop spinal cord stimulation that adjusts stimulation levels based on detecting neural response. (WhaTech)

Medical Device Company Charts Growth Plans
July 11, 2013 - Greatbatch, Inc. is looking for a partner to bring its spinal cord stimulation system Algostim to the end market, and believes the spinal cord stimulation market is $1.4 billion, growing at more than 10% a year, according to an interview in a business column. The company is combining the sales, marketing and operations groups of its Greatbatch Medical and Electrochem Solutions, the article says, in a realignment that is meant to help achieve growth of 5% or more annually. (Dallas Business Journal)

Company Developing Responsive Stimulation for Epilepsy Raises $18 Million
July 9, 2013 - NeuroPace of Mt. View, California reported in a U.S. Securities and Exchange Commission filing that it has raised about $18 million of a planned $50 million round of funding. The 20 investors who provided the new capital were not named. Since its founding in 1997, NeuroPace has raised about $180 million. (Silicon Valley Business Journal)

Company Seeks Premarket Approval from FDA for Vagus Nerve Stimulation Device to Treat Obesity
June 26, 2013 - Minnesota-based EnteroMedics submitted its premarket approval application to the FDA for review of the Maestro VBLOC system that stimulates the vagus nerve to reduce food cravings to treat obesity, metabolic disease and other gastrointestinal disorders. (Mass Device)

U.S. Clinical Trial of Deep Brain Stimulation System Starts
June 17, 2013 - Boston Scientific Corporation announced the first U.S. patient has been implanted with the Vercise deep brain stimulation system for the treatment of Parkinson's disease at Cedars-Sinai Medical Center in a prospective, multi-center, double-blinded, randomized, controlled study, INTREPID, to evaluate the safety and effectiveness of motor function and overall quality of life.

Developing Neurostimulation Technology Receives $3 Million Commercialization Grant
June 18, 2013 - The Ohio Third Frontier Commission has awarded a $3 million grant to Case Western Reserve University to commercialize a neurostimulation technology in collaboration with NDI Medical LLC, SPR Therapeutics and Valtronic. Developed over the past decade, the platform is designed to treat indications ranging from pain to muscle paralysis. (Healio)

Heart Failure Neuromodulation Startup Receives Venture Capital Funding
June 13, 2013 - NeuroTronik of Chapel Hill, N.C. received $13.1 million from a venture capital syndicate led by Hatteras Venture Partners to develop its neuromodulation system to treat heart failure by improving pumping effectiveness. (News & Observer)

Company Launches Integrated Lead-to-Pulse-Generator Interconnect for Implantable Neurostimulators at INS 11th World Congress
June 4, 2013 - The first pretested integrated lead-interconnect system designed for implantable neurostimulator pulse generator devices will be featured at the International Neuromodulation Society's 11th World Congress in Berlin June 8-13 at the Evergreen Medical Technology booth. The system, Encompass, is versatile and enables rapid product development; it has a port-entry screw-anchor mechanism and three lead strain relief seal options for transition from the header port. A slot is molded into the header for the placement of a radiopaque identifier and a suture hole is included. The header has been designed with a set of two anchors to firmly attach the header to the hermetic enclosure. (Business Wire)

U.S. Shipments of Transcranial Magnetic Stimulation Systems Are Set to Start
June 3, 2013 - Brainsway is poised to begin shipping its Deep TMS (transcranial magnetic stimulation) system to the U.S. where the company received clearance for marketing it for drug-resistant major depressive disorder. The system is also approved in Europe for addressing neuropathic chronic pain, bipolar disorder, and schizophrenia. Using a special helmet to target specific regions of the brain, treatment is conducted in an outpatient setting during 20-minute sessions over a four week period. (MedGadget)

Texas Man Finds relief From 32-Contact Spinal Cord Stimulator
May 30, 2013 - A man who suffered from chronic pain despite repeat surgery and painkillers found relief through spinal cord stimulation, according to a newspaper account that profiles the patient, a U.S. Navy veteran. His procedure was one of the first in the Dallas-Ft. Worth area with Boston Scientific's 32-contact Precision Spectra™ system. (Star-Telegram)

Deep Brain Stimulation Visualization System Receives CE Mark Approval
May 27, 2013 - Boston Scientific Corporation has received CE Mark approval for use of its deep brain stimulation visualization system, Guide DBS, in Parkinson's disease. The tool allows physicians to visualize the relative position of the lead and model stimulation fields and output. Designed to help reduce programming time and tailor stimulation therapy, the system is the first commercial product resulting from the company's acquisition of Intelect Medical in 2011. (PR Newswire)

Deep Brain Stimulation Technology Platform is the Basis of a Newly Launched Company
May 23, 2013 - Venture and commercialization firm NDI Medical launched a new portfolio company, Deep Brain Innovations, LLC, to commercialize its Temporally Optimized Patterned Stimulation (TOPS™) technology that delivers novel, more efficient, patterns of stimulation, allowing smaller and longer-lasting devices. (Digital Journal)

North American is Estimated to Account for Largest Share of Neuromodulation Market
April 28, 2013 - North America is estimated to account for the maximum share of the neuromodulation market in 2012, followed by Europe, and Asia-Pacific countries like Japan, India, and China, according to a report by Markets and Markets that looks at 2012 - 2017. (Digital Journal)

Neuromodulation Growth Reported in Company Earnings Report
April 25, 2013 - Boston Scientific announced global year-over-year revenue growth of 6 percent in neuromodulation and combined revenue in the countries of Brazil, Russia, India and China 35 percent year-over-year, while taking a write down of $422 million related to the 2006 acquisition of Guidant Corp. for $28 billion. Overall adjusted earnings per share were $0.16 for the first quarter ended March 31, 2013, on revenue of $1.761 billion. (Sacramento Bee)

2013 Directory of Neuromodulation Products Being Published and Will Be Free to INS World Congress Attendees
April 2013 - Neurotech Reports, the publisher of Neurotech Business Report, will publish the 2013 Directory of Neuromodulation Products later this year. The print directory will be given to each attendee at the 11th World Congress of the International Neuromodulation Society (INS), which takes place June 8-13, in Berlin, Germany, and attracts more than 1,500 clinicians, engineers, researchers and entrepreneurs to hear an internationally renowned faculty address the most comprehensive breadth of all neuromodulation therapies. For more information, contact Neurotech Reports at 415 546 1259 or visit this link: http://www.neurotechreports.com/pages/2013_Directory_Neuromodulation_Products.html (Neurotech Reports)

INS Accepts Record Number of Abstracts for Biennial Congress
April 19, 2013 - The International Neuromodulation has accepted a record number of abstracts for its 11th World Congress June 8 - 13 in Berlin. Diverse highlights are previewed in a news announcement issued today. INS also announced a pre-conference innovation-and-investment summit. (Newswise)

Company Plans Presentation on External Trigeminal Nerve Stimulation in Children with ADHD
April 18, 2013 - Results of external trigeminal nerve stimulation in children aged 7 - 14 who have attention deficit hyperactivity disorder will be presented on May 20 in San Francisco by Los Angeles-based NeuroSigma, Inc. The open-label Phase I study was prompted by observations in PET scans of the stimulation's effect on attention centers. (San Francisco Business Times)

Report Foresees Double-Digit Growth in Neuromodulation
April 18, 2013 - TechNavio predicts a compound annual growth rate of 15.3 percent from 2012 - 2016 for neuromodulation across the globe, partly due to an increase in neurological disease. (PR Web)

Company Sees First-Quarter Earnings Dip, But Strong Year-Ahead Prospects
April 17, 2013 - St. Jude Medical sales of neuromodulation products were $99 million in the first quarter of 2013, down 4 percent from the prior year. Overall, partly due to unfavorable currency translations, the company reported net sales of $1.338 billion in the first quarter of 2013, a decline of approximately 4 percent compared with the first quarter of 2012. With more than 20 diverse products due to launch in 2013, the company expects full-year 2013 consolidated net earnings to be in the range of $3.68 to $3.73. (Wall Street Journal)

Deep Brain Stimulation Service Comes to Bangalore
April 17, 2013 - Commenting on a new deep brain stimulation service for Parkinson's disease patients in Bangalore, a neurologist calls the procedure a good option in carefully selected patients. The Columbia Asia Referral Hospital in Yeshwanthpur is one of more than 20 medical facilities in India and Southeast Asia operated by Columbia Asia Group, which entered the country with 100 percent foreign investment. (Moneylife)

Company to Launch Anchoring Technology for Spinal Cord Stimulation Leads and Pain Pump Catheters
April 15, 2013 - Boston Scientific Corporation announced it has acquired and is launching the Fixate Tissue Band for spinal cord stimulator leads and pain pump catheters. Anulex Technologies of Minnetonka, MN developed the device to secure leads to the fascia or inter-spinous/supra-spinous ligament, and received expanded FDA approval last year for the catheter application. International Neuromodulation Society member Richard Bowman, MD, commented that the device permits quick and efficient lead anchoring. (Implantable Medical Devices)

Peripheral Nerve Stimulation Trial for Back Pain Begins Enrolling Patients
April 11, 2013 - Patient enrollment has begun in the SubQStim II pivotal clinical trial of peripheral nerve stimulation for chronic back pain. Medtronic, Inc. plans for up to 323 patients at up to 30 U.S. centers in the trial, in which patients will be randomized into control or treatment groups for the first three months, then participate in open-label follow-up for up to five years. (Mass Device)

Company Announces Research Funding, Prize to Develop "Electroceuticals"
April 10, 2013 - The global pharmaceutical company GlaxoSmithKline (GSK) announced plans to foster development of "electroceuticals" that were compared to a cross between a device and molecular medicine. The investment might initially target using an electric stimulus to regulate cytokine production involved in inflammatory diseases such as rheumatoid arthritis. The unveiling includes a $1 million research prize, and initial funding of work by 40 scientists in 20 labs at such institutions as MIT, the University of Pennsylvania, and Feinstein Institute of Medical Research. Heading the effort, GSK Vice President of Bioelectronics Research and Development Kristoffer Famm was lead co-author of a commentary in Nature. (Fierce Biotech)

Future Growth Will be a Key Topic of the INS 11th World Congress Pre-Conference, Innovations in Neuromodulation
April 10, 2013 - The International Neuromodulation Society expects more than  200 entrepreneurs, thought leaders, innovators and investors at Innovations in Neuromodulation on June 9th in Berlin, a pre-conference of the INS 11th World Congress. The day-long session draws industry strategists and investment managers by focusing on business, technical, and regulatory developments in this rapidly changing field. (BusinessWire)

Regulatory Agency Issues First Approval for Deep Brain Stimulation for Both Primary and Secondary Dystonia
April 10, 2013 - St. Jude Medical, Inc. announced it is the first to receive CE Mark approval for use of deep brain stimulation to manage both primary and secondary dystonia. Dystonia is considered secondary when its cause can be attributed to a toxin, injury, or another disease or condition. In the announcement, International Neuromodulation Society Member Elena Moro, Ph.D., professor of neurology at the University Hospital Center of Grenoble, France noted that the involuntary muscle contraction and spasms of dystonia strike people of all ages. (St. Jude Medical)

Spinal Cord Stimulation Featured in Business Column
March 29, 2013 - International Neuromodulation Society member Anthony Berg, MD, was interviewed by a business columnist about using the new 32-contact Precision Spectra spinal cord stimulator by Boston Scientific. In the three cases he has implanted so far, patients have all seen a significant drop in use of pain medication and an improvement in quality of life, he said. (Dallas Business Journal)

Maker of High-Frequency Stimulation Device Garners $48 Million in Series C Financing
March 7, 2013 - Nevro Corp. has completed a $48 million Series C round of financing led by new investor Novo Ventures, with New Enterprise Associates and Coviden Ventures. Existing investors participating in this financing round included Accuitive Medical Ventures, Bay City Capital, Johnson & Johnson Development Corporation, Mayo Clinic, MPM Capital, and Three Arch Partners. Based in Menlo Park, Calif., Nevro is commercializing the Senza® high-frequency spinal cord stimulation system for chronic pain, such as low back pain, and other conditions. The system is available in Europe and Australia. The funds will be used to sponsor an ongoing U.S. clinical trial, explore new indications, and support commercialization. (Nevro)

Neuromodulation Market Report Predicts $12.45 Billion Market by 2023
March 4, 2013 - In a market report that spans 2013 - 2023, Visiongain projects a value of $12.45B for the global neuromodulation devices market in 2023. Among other factors, the report describes expanding disease indications. (PR Newswire)

Heart Failure Neuromodulation Developer Receives Additional Startup Funding
Feb. 28, 2013 - Sorin Group announced a $5 million investment in Israel-based Enopace Biomedical, which is developing an endovascular neurostimulation system for heart failure. Sorin Group, a global medical device company based in Milan, has invested in Enopace in 2011 and anticipates further investments based upon completion of development milestones. (BusinessWire)

Device Supplier Posts Strong Profits in Fourth Quarter
Feb. 26, 2013 - Greatbatch, Inc. posted a fourth-quarter 2012 adjusted earnings per share of 53 cents significantly exceeded the year-ago adjusted earnings of 39 cents (up 36% year over year).  Within the neuromodulation and cardiac rhythm management area, sales decreased 5% year over year to $73.7 million due to market competition, strong shipments in the prior quarter and tough year-over-year comparables. In this sector, management anticipated short-term headwinds from key original equipment manufacturer customers. (NASDAQ.com)

Deep Brain Stimulation Developer Receives Additional Funding
Feb. 25, 2013 - Sapiens Steering Brain Stimulation B.V. of Eindhoven, the Netherlands and Munich, Germany, has added €7.5 m to its €16.5 m round of Series A financing. The investment supports development of a deep brain stimulation with the capacity to steer the electrical pulses away from areas which may produce side-effects. The most recent financing comes from the Dutch investment group INKEF Capital, whose founder Frank R. Landsberger, PhD, was appointed to the company's advisory board. Sapiens was spun out in 2011 from Royal Philips Electronics to commercialize a steering brain stimulation probe, implant and image-guided programming. (News-Medical.Net)

Vagus Nerve Stimulation Device Company Sees Shares Climb
Feb. 22, 2013 - Cyberonics Inc. said Friday that its net income climbed 39 percent in the fiscal third quarter as it sold more of its nerve stimulation devices designed to treat epilepsy and depression by delivering electrical stimulation to the vagus nerve. Net income in the November-January quarter rose to $13.2 million, or 47 cents per share, from $9.5 million, or 34 cents per share. Revenue rose grew 15 percent, to $62.7 million from $54.5 million. (Yahoo News)

Agreement Reached to Distribute Neuromodulation Products in Japan
Feb. 20, 2013 - The Boston Scientific subsidiary Boston Scientific Japan K.K. has reached an agreement with Fukuda Denshi Co., Ltd. to market and sell the Boston Scientific Spinal Cord Precision Plus System and accessories throughout Japan. Fukuda Denshi will begin distributing Boston Scientific neuromodulation products April 1, 2013. (Boston Scientific)

Clinic Created to Streamline Process for Potential Deep Brain Stimulation Candidates
Feb. 20, 2013 -  A new clinic aimed at streamlining the evaluation and approval process for the growing number of patients who are potential candidates for deep brain stimulation has opened at the Muhammad Ali Parkinson Center of the Barrow Neurological Institute. The process should now be completed in six weeks or less, rather than up to one year, and includes comprehensive treatment education. (PR Newswire)

New Rates for INS Pre-Conference Sessions
February 2013 - The pre-conference sessions on June 8 and 9 for the 11th World Congress, Technology Transforming Chronic Illness Management, are now $360.53 each day, or $600 for both days. Register for one or two pre-conference days and the main congress and receive a 10% discount on the pre-conference fee. (International Neuromodulation Society)

Brazilian Chapter of the International Neuromodulation Society Launches Website
February 2013 - The Brazilian chapter of the INS (Sociedade Brasileira Neuromodulação - SBNM) has published its website listing articles, conferences, and members and their specialties, which include interventional pain treatment, movement disorders, spasticity, and neurosurgery.

Australia, Colombia Approve Non-Invasive Vagus Nerve Stimulation for Primary Headache
Feb. 19, 2013 - New Jersey-based ElectroCore announced approval from Australia and Colombia for its non-invasive vagus nerve stimulation (nVNS) therapies for the acute and/or prophylactic treatment of primary headache (migraine, cluster headache and hemicrania continua) and medication-overuse headache in adults. The GammaCore therapy is available in Australia with physician authorization, and is expected to be available in Colombia in the first half of 2013. (MarketWatch)

A Social Media Presence for the 11th World Congress  
Feb. 1, 2013 - The International Neuromodulation Society has added an 11th World Congress "event" area to its Facebook page about the June 2013 meeting in Berlin that features a map of the meeting location at the Estrel Hotel, and provides an opportunity to share information, post a photo, video, or link, and network with upcoming attendees. (Facebook)

Magnetic Resonance Imaging Compatible Spinal Cord Stimulation Systems Released in Europe
Jan. 30, 2013 - Medtronic, Inc. released in Europe the first spinal cord stimulation systems for use in treating chronic back and/or leg pain that are designed for compatibility with full-body magnetic resonance imaging (MRI) scans under specific conditions. The devices recently received CE Mark approval. They include special leads that can withstand MRI scanning and a proprietary programming option, SureScan, which sets an appropriate mode for an MRI environment. International Neuromodulation Society member J.P. Van Buyten, MD, from the AZ Niklaas Hospital in Belgium, was quoted as calling the development an important advancement. (National Pain Report)

Retinal Implant Maker Eyes Raising More Capital
Jan. 29, 2013 - Second Sight Medical of Sylmar, Calif. registered with the Securities and Exchange Commission on Monday to raise $25 million while waiting for the FDA to decide whether to approve its retinal implant, Argus II, which has been sold in Europe since 2011. (MassDevice)

Chronic Pain is Called a Poorly Recognized Silent Epidemic
Jan. 29, 2013 - International Neuromodulation Society president Simon Thomson, MBBS, FRCA, FIPP, FFPMRCA, commented in conjunction with release of a survey of more than 1,000 chronic pain sufferers across Europe, "The Painful Truth Survey: The State of Pain Management in Europe," sponsored by Boston Scientific and supported by a number of regional pain associations. He noted that healthcare systems throughout the world have not really produced specific answers to the needs of patients who suffer chronic pain that is not resolved by addressing any identifiable underlying condition. Some 17% of Europeans, he continued, will have significant chronic pain affecting daily living, with about 1/3 of those having pain that is really quite severe. About half suffer from neuropathic pain that arises spontaneously from damage to the nervous system. Of the patients whose neuropathic pain does not respond to pharmacological treatment, he said, spinal cord stimulation becomes an option, and has been advancing technologically since he first began using it slightly more than 20 years ago. (Boston Scientific)

Global Randomized Clinical Trial to Compare Medical Management With Or Without Spinal Cord Stimulation for Lower Back Pain
Jan. 28, 2013 - International Neuromodulation Society member Philippe Rigoard, M.D., is principal investigator of a global randomized clinical trial of patients with predominant low back pain due to failed back surgery syndrome. The study, sponsored by Medtronic, Inc., compares optimal medical management combined with use of a multicolumn, implantable lead for neurostimulation treatment  and optimal medical management alone. The first of up to 300 patients in the PROMISE trial began treatment in the U.S. earlier this month, and Dr. Rigoard started enrolling patients January 14 at Poitiers University Hospital in France. The study is designed to assess the value of spinal cord stimulation (SCS) for predominant low back pain with leg pain. Previous studies focused on predominant leg pain. Health care utilization data will be collected to develop cost analysis models to potentially evaluate the long-term economic impact of SCS. (Yahoo Finance)

INS Website's List of Terminology Descriptions Grows
Jan. 24, 2013 - The latest addition to the International Neuromodulation Society's list of descriptions of terminology for use by patients or the general public is a brief overview about neuromodulation therapy. Since its inception one year ago -- through the efforts of the website's editorial contributors, the list of short explanations for treatment and condition terms has been viewed some 30,000 times by INS website visitors. (International Neuromodulation Society) 

Neuromodulation Startup Adds Board Member
Jan. 22, 2013 - Functional Neuromodulation, founded in Toronto in 2010, has added Vince Owens, former CEO and director of Intelect Medical, to its board of directors. Other board members are company co-founder and CEO Dan O’Connell; founding scientist Andres Lozano, MD, PhD; Kelly Holman, managing director of Genesys Capital; and Andrew D. Firlik, MD, managing partner at Foundation Medical Partners. Lothar Krinke, PhD, vice president and general manager of Medtronic’s Deep Brain Stimulation business serves as an active board observer. Dedicated to applying deep brain stimulation (DBS) to memory and other cognitive disorders, the company is conducting the ADvance Study in North America to evaluate DBS of the fornix, a major pathway in the brain’s memory circuit, for patients with mild Alzheimer’s disease. (BioSpace)

Small-Business Grant Announced to Aid Deep Brain Stimulation System Programming for Parkinson's Disease
Jan. 22, 2013 - The National Institutes of Health, National Institute of Neurological Disorders and Stroke is funding a clinical feasibility study at the University of Alabama at Birmingham through a $283,828 Phase I Small Business Innovation Research grant to Cleveland, OH-based Great Lakes NeuroTechnologies to explore using intelligent algorithms to aid programming deep brain stimulation in Parkinson’s disease. The system will leverage existing technology to quantify Parkinson’s motor symptoms such as tremor, bradykinesia, and dyskinesia into a functional map. Intelligent algorithms will determine optimal parameters for symptom relief while minimizing side effects and battery consumption. (News-Medical.Net)

Functional Neuromodulation System for Foot Drop Cleared for Use by Minors
Jan. 22, 2013 - Valencia, Calif.-based Bioness Inc. announced it has received FDA clearance to market to pediatric patients and their caregivers its L300 system to treat foot drop, a condition which causes walking difficulty in adults and children who have motor-impairment conditions such as cerebral palsy, stroke or traumatic brain injury. The system consists of a small wireless sensor in the shoe, a sport brace-like leg cuff worn just below the knee, and a hand-held remote control. In addition to being used to assist walking, it can also be used for rehabilitation purposes. (Business Wire)

Israel-Based Company Eyes an Expanded Presence in U.S. Trading and Distribution
Jan. 21, 2013 - Brainsway Inc. of Israel expects to name a U.S. partner this quarter to distribute its noninvasive transcranial magnetic stimulation system for treatment-resistant depression, a technology it licensed from the National Institutes of Health. This step would precede seeking listing on the Nasdaq exchange, according to an article in Bloomberg BusinessWeek. (Bloomberg)

Analysis Estimates a $6.8 Billion Market for Neuromodulation in 2017
Jan. 14, 2013 - The U.S.-based firm Marketsandmarkets forecasts the global neuromodulation market will reach  $6.8 billion by 2017. Vagus nerve stimulation is expected to see the most growth due to being less invasive and with more development of applications anticipated. The key factors that drive the neuromodulation market are higher incidences of endemic diseases, rise in aging population, technological advancement, devices under approval, and presence of several niche players. Reimbursement in certain geographies and cost of devices are major challenges. North America is estimated to account for the maximum share of the neuromodulation market in 2012, followed by Europe, and Asia-Pacific countries like Japan, India, and China. (PR Newswire)

New Device Rules Reported to Take Effect This Month in Russia
Jan. 11, 2013 - Revised regulations regarding medical device clearances in Russia reportedly took effect Jan. 1, 2013. It was previously reported that some of the anticipated changes were that final approval decisions will be made by “expert reviewers” rather than the regulator (Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation, or Roszdravnadzor); there was an apparent lack of timelines for medical testing, meaning they could last for years; and medical device registration fees would be written into law. One anticipated change could mean expert reviewers would determine whether additional clinical testing of a device is necessary and provide a list of hospitals where that should occur. A registration certificate would be issued to an applicant based on a positive expert review, or a refusal would be based on a negative expert review. (Mass Device)

Israel Company Announces Its Noninvasive Depression Treatment Device is Cleared by FDA Jan. 9, 2013 - Brainsway Ltd. announced it has obtained FDA approval for its deep transcranial magnetic stimulation device to treat depression in patients who fail to respond to therapeutics during a depression cycle. (Globes)

Smart Phone Interface Technology Presented for Controlling TENS
Jan. 9, 2013 - The Consumer Electronics Show included what was presented as a certified transcutaneous electrical nerve stimulation medical product by China-based E-Tek that uses an iPhone interface, according to a blog covering the event. (9to5Mac)

External Peripheral Nerve Stimulator to Initially Target Post-Stroke Shoulder Pain
Jan. 8, 2013 - SPR Therapeutics expects CE mark certification for its Smartpatch peripheral nerve stimulator to be announced shortly, according to published comments by the chief executive officer of the Cleveland-based company. Also, the company plans clinical trials at six U.S. centers in the next few months, initially targeting post-stroke shoulder pain. Finally, the company was reported to have raised an additional $2.8 million in financing, bringing the total to $5 million from NDI Healthcare Fund, Public Square Partners and individual investors. (MedCity News)

Market Study Projects Neuromodulation Growth to $12.45 billion by 2023
Jan. 8, 2013 - London-based Visiongain predicts a $12.45 billion global market for neuromodulation devices by 2023, with sales of $3.03 billion in 2011. Hemant Mistry, healthcare industry analyst, says, "The neuromodulation device market has experienced substantial growth in recent years, as their benefits in cost saving particularly have become more evident. Such devices can not only provide long-term relief to patients, but can also offer an effective alternative to the use of drugs that are well-known to have side effects . . . (although the initial cost of the device and surgery to implant the device is high, their prescription is cost-effective in the long-term). With future developments in the pipeline such as phrenic nerve and gastric stimulators . . . the market for neuromodulation devices has significant potential to grow in the future". (PR Newswire)

Vagus Nerve Stimulation Therapy Developer Adds Industry Veteran to Its Board
Jan. 4, 2013 - The co-founder and former CEO of Cyberonics, Inc., Reese Terry, has joined the board of directors of ElectroCore, which is developing non-invasive vagus nerve stimulation therapies for serious headache conditions and bronchoconstriction. (PR Newswire)

Upcoming Neuromodulation Market Report Predicts Continued Growth
Jan. 3, 2013 - The growth in emerging markets such as India and China will be driven by an aging population that will increase demand for newer treatment options for age-related diseases, such as deep brain stimulation (DBS) for motor disorders, according to a market report being published next month by Visiongain. The report, for instance, anticipates the DBS market will almost
double in value, reaching $0.85 billion in 2017, with a compound annual growth rate of 11.2%. (Visiongain)

 
 
     
Last Updated on Wednesday, August 27, 2014 01:25 PM
 
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