Industry News Briefs from the International Neuromodulation Society


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Company Targeting Low-Back Pain Issues Half-Year Report

Sept. 22, 2017 - Mainstay Medical International plc announced publication of its half-year report for the period ended June 30, 20176. The company had $42.8 million cash on hand and operating expenses of $8.0 million. This increase reflected expansion of the team, preparation for its clinical trial of its neurostimulator for chronic low back pain, and preparation for commercial launch. The launch is being concentrated for now in Germany, where a direct sales force has been recruited and initial customers have been trained. (Business Wire)

Israeli Startup Raises Money for Its Migraine Patch

Sept. 20, 2016 - Theranica Bio-Electronics closed a round of seed financing for an undisclosed amount. The Israeli company is developing wearable electrical stimulation patches to treat migraine. (Pharmweb)

Device Company Announces European Patent for Its Vagal Nerve Stimulator

Sept. 20, 2016 - EnteroMedics Inc. announced issuance of a European patent for its implantable vagus nerve stimulation system that was developed to treat obesity and metabolic diseases. (Scibility Media)

Back Pain Neurostimulator One-Year Results Announced

Sept. 20, 2016 - Mainstay Medical International plc announced positive one-year follow-up results for 41 patients who completed 12 months in its single-arm clinical trial of a neurostimulation device for chronic low back pain. The device received CE mark in May 2016 and the clinical trial continues to enroll patients for a post-market clinical follow-up for safety and performance data. (Business Wire)

Company Plans Brain Stimulation Clinical Trial for Stroke, Announces Financing Deal

Sept. 15, 2016 - Nexstim Plc announced it is finalizing plans with the FDA for a multicenter pivotal clinical trial of repetitive transcranial magnetic stimulation following stroke. The company expects the clinical trial, which is being designed to include a sham comparator, will start in 2017. Nextstim also announced a financing agreement with Bracknor Investment to convert €20,000 of its convertible loan into 51,633 shares at €0.387345 each. (Globe Newswire)

First Patient is Enrolled for Clinical Trial of Neurostimulator for Chronic Lower Back Pain

Sept. 14, 2016 - Mainstay Medical International plc announced the first subject with chronic lower back pain has been enrolled in Australia for its clinical trial of a neurostimulator that is designed to electrically stimulate the nerves responsible for contracting muscles which stabilize the lumbar spine. (Business Wire)

Medical Device Portfolio Company with Deep Brain Stimulation Technology Files for Public Offering

Sept. 12, 2016 - Nexeon MedSystems Inc. of Lexington, KY recently filed a registration statement to become publicly traded. The company is seeking FDA approval for a rechargeable deep brain stimulation system for Parkinson's disease. (Med City News)

Peripheral Nerve Stimulator Receives CE Mark

Sept. 7, 2016 - BlueWind Medical announced its has received CE mark approval for its neurostimulator to treat peripheral neuropathic pain. The device is implanted on the tibial nerve and powered by a control unit worn on the ankle. The company said patients select stimulation for up to eight hour a day, with pain reduction typically lasting for 30 minutes to a few hours afterwards. (PR Newswire)

Company Announces Peripheral Neuralgia Treatments

Sept. 7, 2016 - Bioness, Inc. announced a series of implantations of its peripheral nerve stimulation system to treat peripheral neuralgias. The company said there is a specific focus on these areas or conditions: axillary nerve (e.g. post-stroke shoulder pain); ulnar nerve (e.g. cubital tunnel syndrome); ilioinguinal (e.g. post-surgical hernia complication); superior cluneal nerve (e.g. lower back neuralgia). (PR Newswire)

Long-Term Results Published in Prospective, Randomized Clinical Trial That Compares Spinal Cord Stimulation Therapies

Sept. 6, 2016 - Nevro Corp. announced that long-term data were published in Neurosurgery from its prospective, randomized clinical trial that compares high-frequency and traditional spinal cord stimulation in patients with chronic back and leg pain. Based on data from 156 subjects who were assessed at 24 months, secondary outcomes were reported that included the percentage of subjects who responded for leg pain, the percent of pain relief for back and leg pain, and the disability level over the follow-up period. (Street Insider)

Study: Phrenic Nerve Stimulation Improved Central Sleep Apnea

Sept. 1, 2016 - A study of 151 patients with central sleep apnea showed benefits from a transvenous phrenic nerve stimulator, according to a news release about the publication in The Lancet. The device was developed by Respicardia, Mass Device reported. (Mass Device)

Company Announces Success Among Neurostimulator's "Early Adapters"

Aug. 29, 2016 - Stimwave LLC announced it has "achieved long-term success" in the early adapter rollout of its neurostimulator to address chronic pain. The first patients were treated in 2015 for back and leg pain. In March 2016 the FDA approved uses for peripheral neuropathic pain as well. (Business Wire)

Robotic Surgical Assistant to be Exhibited at September Neurosurgical Events

Aug. 29, 2016 - Medtech announced it will exhibit its surgical assistance robot at three meetings for stereotactic neurosurgeons during September. The robot was developed for use in deep brain stimulation implantation procedures and other brain and spine surgeries. (Globe Newswire)

News Outlet Offers Overview of One Medical Device Company's Activities  

Aug. 25, 2016 - A news feature about the Alfred Mann Foundation describes its work in neurostimulation for functional restoration and other research programs. (Globes)

Drug Company's Venture Arm Sees Promise in Neuromodulation

Aug. 18, 2016 - A question-and-answer column about neuromodulation investments by the venture arm of Johnson & Johnson discusses potential indications in heart failure. In it, an executive describes the company's anticipation that neuromodulation therapies could address unmet needs in the company's areas of interest, such as "epilepsy, pain, Parkinson’s disease, sleep apnea, as well as many other chronic disease and conditions not well managed by drugs or that are drug resistant." (Med City News)

Article Says Neuromodulation is a Growth Area for Company

Aug. 18, 2016 - An article says Boston Scientific Corporation registered 12% growth in the second quarter of 2016, compared to the same quarter one year ago, which was up from its growth of about 8% in the first quarter of 2016. The article calls spinal cord stimulators a key growth area for the company's neuromodulation business, and deep brain stimulation a potential market. (Market Realist)

Peripheral Nerve Stimulation System to Be Presented at Military Health Symposium

Aug. 16, 2016 - SPR® Therapeutics planned to present recent clinical findings concerning its peripheral nerve stimulation system for acute and chronic pain control at the 2016 Military Health System Research Symposium in Florida. (Market Wired)

Company to Seek Approval for Its Device to Treat Dry Eye

July 18, 2016 - Allergan announced it is applying for FDA approval of a handheld intranasal neuromodulation device to stimulate tear production in people who have dry eye disease due to decreased tear production. (MPR)

Company Releases Second Version of Its External Neurostimulator for Episodic Migraine

July 18, 2016 - Cefaly Technology is releasing the next version of its external trigeminal nerve stimulation device for the prevention of frequent episodic migraine attacks. The Cefaly® II device is available in the U.S. and will be available next in Europe in September. (PR Newswire)

Company Eyes $21.5 Million Acquisition of Non-invasive Neurostimulation Development Firm

July 11, 2016 - Endonovo Therapeutics, Inc. announced it intends to acquire Rio Grande Neurosciences, Inc. for $21.5 million following execution of a definitive purchase agreement, shareholder approvals, and raising more capital. Privately held Rio Grande Neurosciences develops non-invasive technology for the treatment of neuro-inflammation and central nervous system diseases and disorders. The company's devices include an FDA-cleared device for treating pain and edema, a proprietary multi-coil repetitive transcranial magnetic stimulation system with pending 510(k) application, which is currently being adapted for the treatment of neuro-inflammatory conditions, including traumatic brain injury, acute concussion, post concussion syndrome and multiple sclerosis; and targeted pulsed electromagnetic field therapy for the treatment of post surgical neuroinflammation. The deal is expected to be completed by Sept. 30 and entails $15 million in Endonovo common stock, $5 million in Endonovo warrants and $1.5 million in cash. (Fierce Biotech)

Company Raises Funds for Commercialization of Sleep Apnea Neurostimulator

July 7, 2016 - Nyxoah, of Israel and Belgium, raised €18 million ($20 million) for development of its neurostimulation system for obstructive sleep apnea. Its implant is powered by a disposable patch placed on the patient's skin. (Fierce Biotech)

Neurostimulation Company to Be Tracked in a Fund Index

June 28, 2016 - The neurostimulation company Nuvectra Corporation was added June 24 to the Russell Microcap® Index. Membership in the index lasts for one year. Indexes are used for investment or benchmarking purposes by fund managers. (Nasdaq)

Developer of Noninvasive Brain Stimulation Technology Announces a Patent

June 28, 2016 - Nexstim Plc announced it received a U.S. patent for its way of estimating motor threshold when delivering transcranial magnetic stimulation to targets below the cortex. The method involves a scan of 60 - 90 seconds combined with an electromyography measurement. (Nasdaq)

Company Announces Presentation of Small Study of Neurostimulator to Augment Gait Therapy in Multiple Sclerosis

June 24, 2016 - A six-person study presented at the 2016 Annual Meeting of the Consortium of Multiple Sclerosis Centers was subject to a news release by Helius Medical Technologies. The study involved use of the company's noninvasive portable nerve stimulation system, PoNS, in combination with physical training. At the end of the trial, the company said, all patients could be considered improved, with those who had better functional status at the start making the most gains. (Mass Device)

Researchers Present Studies of Vagus Nerve Stimulation in Headache

June 24, 2016 - New Jersey-based electroCore LLC issued a news release summarizing three clinical studies and two preclinical studies regarding the mode of action of noninvasive vagus nerve stimulation in primary headache. The studies were presented at the annual meeting of the American Headache Society. (BioSpace)

Clinicians Launch Study of Rechargeable Neurostimulator for Overactive Bladder

June 20, 2016 - Axonics Modulation Technologies, Inc. announced its small, rechargeable sacral nerve stimulation system has been implanted in the first patients as part of a post-market follow-up study in overactive bladder. The study is being conducted in England, Belgium, the Netherlands and France. (Business Wire)

Concerns Raised About U.S. Insurers' Classification of High Frequency Spinal Cord Stimulation

June 20, 2016 - International Neuromodulation Society (INS) member David Provenzano, MD mentions a randomized controlled clinical trial by INS member Leonardo Kapural, MD, PhD and colleagues in remarks published in an article about letters written by the American Society of Regional Anesthesia (ASRA) to Blue Cross Blue Shield of Tennessee and Highmark Blue Cross Blue Shield of Pennsylvania regarding classification of  high-frequency spinal cord stimulation (SCS) for chronic pain. In an April 2016 medical policy, the insurers classified this type of SCS, which is approved by the FDA, to be experimental and investigational. The letters say beneficiaries should be provided access to this "evidence-based therapy when deemed medically necessary." ASRA pointed out the importance of patient access to non-drug options for chronic pain in light of the U.S. opioid epidemic. (News-medical.net)

Company Targeting Heart Failure Raises Funds

June 18, 2016 - CVRx has raised $46 million for development of its potential heart-failure intervention, an implantable neurostimulator that targets the baroreflex to restore autonomic balance through lowering sympathetic activity and raising parasympathetic activity. A pivotal clinical trial involving 310 patients is expected to conclude in September 2017. (Med City News)

Company Developing Neurostimulator for Low Back Pain Raises Funds

June 17, 2016 - Mainstay Medical has raised €30 million through placing shares that represent roughly one-third of all the company's shares. As part of the placement, KCK, a family investment group, is taking ownership of half the shares. The company is addressing certain types of lower back pain through commercialization of an implantable device that stimulates nerves to strengthen muscles that stabilize the lower back. (Irish Times)

Company Launches a Deep Brain Stimulation System in Europe

June 16, 2016 - St. Jude Medical has launched a deep brain stimulation system in Europe that has stimulation leads designed to steer current. The system also allows commercial handheld wireless devices to be used as controllers by patients and physicians. (Mass Device)

Startup's Tibial Nerve Stimulator Receives CE Mark

June 15, 2016 - BlueWind Medical received CE mark approval for a wirelessly powered tibial nerve stimulator to treat overactive bladder. (Fierce Medical Devices)

Grant Will Help Support Clinical Trial of Brain Stimulation to Augment Stroke Recovery

June 15, 2016 - Soterix Medical, Inc. announced the company has received a $2.5 million grant from the National Institute of Neurological Disorders and Stroke to support a Phase II clinical trial of non-invasive brain stimulation for post-stroke aphasia. The company plans to test transcranial direct current nerve stimulation as an adjunctive treatment for aphasia patients. Stimulation will be individualized based on functional MRI results. (Business Wire)

Startup Raises Funds for Development of Closed-Loop Deep Brain Stimulation

June 15, 2016 - The Italian startup Newronika has raised €1.7 million in venture financing to help support development of an adaptive, closed-loop, deep brain stimulation system for Parkinson's disease. The company spun out of the Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico in Milan and Università degli Studi di Milano. (FINSMES)

Article Profiles Drugmaker's Bioelectronics Push

June 10, 2016 - An article summarizing an interview by Bloomberg says GlaxoSmithKline plans three clinical trials that combine drugs and other companies' electrical stimulation devices, and aims to develop an implant of its own in 2019. The article said the company's overall investment would be "on par" with the amount that is often seen quoted for "molecular" medicines, that is, in the billions of dollars. It adds that determining how to modulate individual neurons will be a challenge, but it is hoped that ensuing generations of devices can be modified slightly to treat other diseases, making those versions less costly to produce than a medication. The company is limiting its focus to systems that treat the peripheral nervous system. (Mass Device)

Article Features Company's Work on a Neurostimulator for Post-Amputation Pain

May 26, 2016 - An article profiles development by Neuros Medical of emerging electrical devices to block post-amputation pain. (Tech Ohio)

Company Prices Public Offering of Convertible Senior Notes

June 8, 2016 - Nevro Corp. announced its public offering of convertible senior notes will pay an interest rate of 1.75% a year. In addition, the company revised the amount it expected to raise from $125 million to $150 million. (Mass Device)

TV Segment Features Transcranial Magnetic Stimulation Treatment for Depression

June 1, 2016 - News coverage of transcranial magnetic stimulation for depression calls the therapy "a sort of depression fighting helmet" and features one patient describing how she has benefited from the treatment. (KING5)

Device Company Announces Upcoming Financing Round

June 7, 2016 - Nevro Corp. announced it plans to offer $125 million in convertible senior notes to support repayment of a term loan agreement, general corporate purposes, and continued commercialization of its high-frequency spinal cord stimulation system. (Mass Device)

Rechargeable Sacral Nerve Stimulation System Receives CE Mark

June 6, 2016 - Axonics Modulation Technologies, Inc. announced it has received CE mark approval for its rechargeable sacral nerve stimulation (SNS) system. The system is designed to treat overactive bladder, urinary retention, and fecal incontinence. The company also announced publication of a study in Neurology and Urodynamics in April that modeled comparative costs of a rechargeable SNS system versus a non-rechargeable one. (Mass Device)

Visual Prosthetics Company Raises $19.4 Million

June 1, 2016 - Second Sight Medical Products, Inc. said it netted about $19.4 million in a rights offering that was oversubscribed. The company will use the proceeds on the research and development of its visual prosthetics. (Business Wire)

Company Plans Reorganization of Unit That Includes Neuromodulation

June 1, 2016 - Medtronic said its restorative therapies group, which includes neuromodulation, posted a 1% gain over the previous year. This was the smallest growth margin of the company's four divisions. The restorative therapies group will be reorganized into a general-manager model and the focus will shift to diseases and conditions over technology. The company will focus its pain stimulation strategies toward the opioid epidemic. (Twin Cities Business)

Company Receives CE Mark Approval for Neurostimulation Device Targeting Back Pain

May 25, 2016 - Mainstay Medical International plc announced it has received CE mark approval for its implantable neurostimulation system to treat disabling chronic low back pain. The company plans a commercial launch in Germany. These plans include conducting a post-market clinical data follow up. A clinical trial in the U.S. may follow. (Business Wire)

Texas Company to Work With Pittsburgh Researchers on A Bladder-Control Implant for Spine-Injured Patients

May 24, 2016 - InCube Labs of San Antonio, TX has been awarded a $10 million subcontract, part of a U.S. Department of Defense contract, to work with the University of Pittsburgh on developing an implant that could improve or restore bladder function in patients who have suffered spinal cord injuries. (My SA)

Device Company Announces Launch of MRI-Compatible Spinal Cord Stimulation System

May 19, 2016 - Boston Scientific Corporation announced it received FDA approval of its MRI-safe spinal cord stimulation system, which it will launch during the World Institute of Pain annual meeting, taking place May 20 - 23, 2016. The company said the FDA cleared the system for full-body, 1.5 Tesla MRI scans, and that it is designed to deliver multiple waveforms. (Mass Device)

Researchers Model Effectiveness and Costs of Non-invasive Vagus Nerve Stimulation for Cluster Headache

May 16, 2016 - The company electroCore has issued a press release about research published last month showing that non-invasive vagus nerve stimulation for cluster headache is effective and cost-effective, according to scenarios modeled from a German health economy perspective. (PRLog)

Electroceutical Startup Raises $8 Million

May 12, 2016 - An article reports that Silicon Valley startup NeuSpera Medical has raised $8 million in Series A financing for its injectable neuromodulation technology. The company was founded in 2014 as Vivonda Medical, and is targeting applications in electroceuticals, which the article calls "a futuristic field that already has substantial strategic interest." (Fierce Medical Devices)

Company Targeting Gastro-esophogeal Reflux Disease Raises $25 Million

May 12, 2016 - EndoStim, Inc. completed a Series D financing round of $25 million that will go in part toward clinical trials of its neurostimulation therapy for acid reflux. (PE Hub Network)

Company Announces Fast-Track Designation from the FDA

May 11, 2016 - Lungpacer Medical received approval to use the FDA expedited access pathway for its diaphragm pacing system. The system provides temporary transcatheter stimulation of the phrenic nerve to aid weaning patients from mechanical ventilation. (Mass Device)

Device Maker Releases First-Quarter Financial Report

May 11, 2016 - Nuvectra Corporation announced first-quarter financial results. The company's total revenue was $2.1 million, up 76% from the same quarter one year ago. Operating expenses were $8.1 million, a 42% increase from one year ago. The company completed its spin-out March 14. The company established a term loan agreement in March. Overall its net loss for the quarter was $0.70 per share, compared to $0.54 per share in the first quarter of 2015. The first commercial implants began in April for its first product, a spinal cord stimulation system. (Nasdaq)

Company's Pain-Relief Device Sales Were Higher Than Anticipated

May 10, 2016 - First-quarter sales for Nevro Corp. were higher than analysts' forecasts and the company raised its guidance about 2016 anticipated earnings. The company's spinal cord stimulation system received FDA approval last May. (Fierce Medical Devices)

Columnist: Are Non-drug Therapies Gaining Favor?

May 10, 2016 - A column discusses the total lifetime costs of drug therapies compared to neuromodulation therapy and mentions a recent article http://onlinelibrary.wiley.com/doi/10.1111/ner.12389/abstract in Neuromodulation: Technology at the Neural Interface. (Neurotech Business Report)

Company Plans a Stock Offering to Shareholders

May 9, 2016 - Second Sight Medical Products, Inc. is offering its shareholders subscription rights to purchase a proportionate amount of additional stock at $4.25 per share or 85% of the Nasdaq closing price by May 31, 2016. The proceeds will be used to fund operations and research, such as development of a cortical visual prosthesis as well as continuing a post-market clinical study of the company's retinal prosthetic for age-related macular degeneration. (Yahoo Finance)

Company Targeting Urogenital Indications Announces Patents

May 9, 2016 - Axonics Modulation Technologies, Inc. announced it received six U.S. patents relating to implantable neuromodulation technology and recharging systems in the past 12 months. The company said its initial clinical application is sacral neuromodulation to treat urinary and fecal dysfunction, which it said affects more than 100 million adults in the U.S. and Europe. (Yahoo Finance)

Neurostimulator Company Raises More Money in an Over-allotment Offering

May 3, 2016 - Helius Medical Technologies raised an additional $857,083 in an over-allotment to its latest offering, bringing the total to $8.1 million. The company said the proceeds will help fund completion of a clinical registry trial of its portable neuromodulation stimulator to evaluate treating traumatic brain injury, prior to seeking 510(k) clearance from the FDA. The company plans to also pursue indications in multiple sclerosis and stroke. (Mass Device)

Company Raises Capital to Commercialize Obesity-Treatment Neurostimulator

May 3, 2016 - EnteroMedics closed a third tranche in a $25 million offering, bringing in $6.3 million. The company is commercializing an implantable vagus nerve stimulator for obesity treatment. (Mass Device)

Device to Potentially Address Peripheral Nerve Pain Moves Forward in Competition

May 3, 2016 - Bioness, Inc. announced its implantable neurostimulator for peripheral neuropathic pain is a finalist for the 2016 Medical Device Excellence Awards. Results of the competition will be announced in June. (PR Newswire)

Columnist Sees Promise in April Developments in the Neurotechnology Industry

April 2016 - A column by an industry observer says that following St. Jude Medical's acquisition by Abott, other large healthcare firms may take greater interest in entering the neurotech arena. The column adds that proposed U.S. legislation, if passed, would require Medicare to automatically cover newly approved medical devices. Finally, the column notes the FDA is moving toward expediting access to market by considering lowering classification, from class III to class II, of cranial electrical stimulation systems for some indications. (Neurotech Business Reports)

Neuromodulation Company is Acquired by Healthcare Giant

April 28, 2016 - Abbott is acquiring St. Jude Medical, Inc. for $25 billion. The deal provides a broader cardiovascular portfolio and also confers "a leading position in the high-growth neuromodulation market," it was reported today. Abbott, which has product lines in cardiovascular, diabetes, and vision care, will assume or refinance St. Jude's net debt of approximately $5.7 billion. (Street Insider)

New Neurostimulation Company Receives up to $45 Million in Debt Financing

April 22, 2016 - Nuvectra's first disclosed financing is a $40 million loan and $5 million line of credit from Oxford Finance and Silicon Valley Bank. The newly spun-out neurostimulation company's overall market capitalization is about $90 million. (Fierce Medical Devices)

Company Acquires Startup's Neurostimulation Patents

April 22, 2016 - Nexeon MedSystems Inc. has acquired neuromodulation patents from NeuroTek Medical, Inc. related to electrode design and occipital nerve stimulation for migraine headache. NeuroTek created a device that delivers transcutaneous occipital nerve electrical stimulation as an investigational treatment for migraine pain. Nexeon anticipates using this intellectual property in its research into similar technology for cardiovascular disease, cognitive enhancement, and sepsis. (Biospace)

CE Mark Approved for Migraine Prevention Labeling

April 22, 2016 - The company eNeura has received an expanded CE mark for its single-pulse transcranial magnetic stimulation device to prevent migraine, as well as for acute treatment of migraine. (FDA News)

Transcranial Magnetic Stimulation System Maker Announces New European Patent

April 20, 2016 - Nexstim Plc announced the European Patent Office has issued a patent for the company's technology that displays where an electric field is generated on the brain during transcranial magnetic stimulation. (Globe Newswire)

Device Maker Cites Neuromodulation Revenue in Quarterly Earnings

April 20, 2016 - Neuromodulation sales at St. Jude Medical grew 8% in the first quarter and contributed to earnings and revenues the company said were above forecast. (Market Watch)

Neurostimulation Spin-off Completes Private Financing Round

April 19, 2016 - A spinoff from the Swiss Federal Institute of Technology in Lausanne, G-Therapeutics, raised $41 million in a Series A round and debt. The company plans to use the proceeds on clinical trials for an implantable neurostimulation system to restore lower limb function spinal cord injury patients. (Fierce Medical Devices)

Non-invasive Stimulation Startup Raises Capital

April 18, 2016 - Helius Medical Technologies has raised $7.2 million in a Canadian short-form offering and a concurrent private placement in the U.S. The company is completing a clinical trial of non-invasive nerve stimulation for treatment of traumatic brain injury, in preparation for a request for FDA 510(k) clearance and an envisioned U.S. commercial launch. (Med City News)

Spinal Cord Stimulation Leads Receive Pre-Market Approval

April 18, 2016 - Nevro Corp. announced FDA pre-market approval of its spinal cord stimulation leads for use with its high-frequency spinal cord stimulation device, which was FDA-approved in May 2015. (Mass Device)

Company Releases Dorsal Root Ganglion Neurostimulator in the U.S.

April 11, 2016 - St. Jude Medical announced the U.S. launch of its dorsal root ganglion (DRG) neurostimulator, following FDA approval in February. Providers are being trained in use of the device to treat people with chronic pain from complex regional pain syndrome I and II for whom traditional neurostimulation is not sufficiently effective. The company announced the first two procedures in a news release and said it has partnered with implanting chronic pain specialists who will conduct more than 100 procedures in 59 centers nationwide in the first month after launch. (MedGadget)

Clinical Trial of Neurostimulation in Post-Amputation Pain Will Continue Following Interim Analysis of Early Results

April 7, 2016 - Neuros Medical, Inc. announced positive feedback from an analysis of interim results in the company's pivotal clinical study of high-frequency nerve stimulation for post-amputation pain. An independent data monitoring committee analyzed safety and efficacy outcomes for the first 20 patients in the study. Based on that analysis, the clinical trial will continue. The study seeks to ultimately enroll up to 130 patients at 15 institutions. (Business Wire)

Public Body Says National Health Service Can Use Noninvasive Vagus Nerve Stimulation for Chronic Headache

April 1, 2016 - In a news release, electroCore LLC reports that the National Institute for Health and Care Excellence (NICE) has issued guidance on transcutaneous stimulation of the cervical branch of the vagus nerve for cluster headache and migraine. NICE reviewed and summarized results of five clinical trials that documented the degree of benefit experienced by enrollees. The guidance to physicians encourages them to inform patients that evidence of efficacy is uncertain due to the extent and nature of the data published to date, but adds that further research is encouraged and "current evidence raises no major concerns". Based on the guidance issued by NICE, the intervention can now be used in the National Health Service. (PR Newswire)

Company Evaluates Response of Stroke Patients to Different Forms of Noninvasive Stimulation

March 31, 2016 - Nexstim Plc of Finland plans to file for FDA 510(k) clearance for its navigated repetitive transcranial magnetic stimulation system in the second quarter of 2016, the company announced. The system is CE marked, and was undergoing a clinical trial at 12 centers in the U.S. to augment post-stroke arm and hand motor rehabilitation. The sham group received a different stimulation than the patients in the active-treatment arm. After 138 patients were treated, the study reached a futility criterion because both the sham and treatment groups showed clinically meaningful gains, with more than two-thirds of patients in each group responding. The company is filing a patent application on the sham stimulation method, based on this unexpected response. The company is halting the clinical trial and will unblind the data for further analysis. (Globe Newswire)

Retinal Prosthesis Maker Gets CE Mark Approval

March 31, 2016 - Retina Implant of Germany received CE Mark approval for its neuroprosthetic device designed to restore some vision in patients who have retinitis pigmentosa. (FDA News)

Pilot Trial of a Wearable Pain-Relief Device Will Gather Data on Sleep Impact Through a Mobile App

March 31, 2016 - NeuroMetrix will offer its FDA-cleared wearable pain-relief device to people with chronic pain who work for Premera Blue Cross in the Pacific Northwest in a pilot trial in which data on device utilization and sleep quality will be gathered by a mobile app. (FDA News)

Company Launches a Minimally Invasive Neurostimulation Treatment for Overactive Bladder

March 30, 2016 - Medtronic plc has launched a percutaneous tibial nerve stimulation system to treat symptoms of overactive bladder. (Yahoo Finance)

Company Starts to Market Peripheral Nerve Stimulator

March 23, 2016 - Stimwave, LLC said it has begun to market its peripheral nerve stimulator that received 510K approval from the FDA earlier this month. Its indications include upper and lower extremity neuropathies and some pain of the mid or lower back, chest well, abdomen, or pelvic region.The device is wirelessly powered by a wearable fabric patch unit. (Business Wire)

Neurostimlation Company Spinout Concludes With Stock Exchange Listing

March 14, 2016 - Nuvectra Corporation began trading under the symbol NVTR, completing its spinout from Greatbatch, Inc. Nuvectra's chief executive officer, Scott Drees, said the newly independent neurostimulation medical device company will begin focusing on launching its proprietary spinal cord system in the U.S.. (Yahoo Finance)

Company"s Robotic Surgery System to Assist in Deep Brain Stimulation Surgery

March 14, 2016 - Montpellier-based Medtech announced sale of its brain robotic surgery system to the Yale School of Medicine's Comprehensive Epilepsy Center, where its uses will include deep brain stimulation surgery. The company said two additional units were sold in China, bringing their total there to nine. (Nasdaq.com)

Company Says the FDA Has Approved Its Processor to Wirelessly Stream Audio to Hearing Prosthesis

March 14, 2016 - Cochlear announced the FDA approved the company's sound processor that uses wireless technology for users to stream audio directly to their device. The device is intended for people who have higher degrees of mixed-hearing loss. (FDA News)

Company Receives FDA Approval for MRI-Safe Stimulation Leads

March 3, 2016 - Medtronic plc announced it has received FDA approval of its spinal cord stimulation leads that are designed for MRI compatibility. The company expects to begin marketing them later this month. (Mass Device)

Visual Prosthetics Maker Garners $28.2 Million in Investment

March 2, 2016 - Retina Implant of Reutlingen, Germany said it has raised $28.2 million for further commercialization of its subretinal microchip to treat retinitis pigmentosa. The device received CE Mark in 2013 and won reimbursement in Germany in 2014. (Mass Device)  

Neuromodulation Activity Adds to Bottom Line for Company

March 1, 2016 - An analyst report says Greatbatch, Inc.'s cardiac/neuromodulation sales in the fourth quarter grew 44.5%, primarily driven by a neuromodulation product launch. Overall, the company reported adjusted gross earnings of 92 cents a share in the fourth quarter, and an 87.1% increase in sales from the previous year, totaling $317.6 million. (Zacks)

Earnings Report Shows Growth in Neuromodulation Revenue

Feb. 24, 2016 - LivaNova, PLC announced 2015 annual financial results and fourth-quarter results. For the twelve months ended December 31, 2015, worldwide sales were $1.2 billion. In neuromodulation, growth was primarily driven by launch of the company's vagus nerve stimulation system in the U.S. in June 2015, and continued sales in international markets. In the fourth quarter, neuromodulation sales were $92 million, an increase of 25.9% on a constant currency basis. The company said it expects growth in neuromodulation in 2016 to be between 9% and 11%. (Globe Newswire)

Startup Peripheral Nerve Stimulation Company Raises Capital

Feb. 18, 2016 - A startup company spun out of Stanford University has raised $18 million from Google Ventures, Johnson & Johnson Development Corporation, Lux Capital, Action Potential Venture Capital, DRX Capital and Lightstone Ventures, according to the Silicon Valley Business Journal. The company, Cala Health, has a 2014 patent application for a peripheral nerve stimulator to control tremor. (MobiHealthNews)

Overview Summarizes Ongoing Clinical Trials of Vagus Nerve Stimulation for Migraine

Feb. 22, 2016 - ElectroCore has expanded from studying noninvasive vagus nerve stimulation (VNS) in cluster headache. In Europe, the company is now conducting two randomized, double-blind, parallel-group, sham-controlled studies of noninvasive VNS in migraine. One multi-center study on the prevention of migraines attacks has enrolled more than 200 of up to 400 patients. A second study enrolled the first of up to 250 patients at 10 sites in Italy to investigate noninvasive VNS as an acute treatment to reduce pain in migraine attacks. (Life Scientist)

Dorsal Root Ganglion Stimulation is Approved in the U.S. for Complex Regional Pain Syndrome Therapy

Feb. 17, 2016 - St. Jude Medical received FDA premarket approval for its dorsal root ganglion neurostimulation system. The device is designed to treat chronic intractable lower-limb pain in adults who have complex regional pain syndrome. (Modern Healthcare)

Company Receives Broadened FDA Approval for Use of Its Deep Brain Stimulation System in Parkinson's Disease

Feb. 17, 2016 - Medtronic plc received a broader FDA approval for its deep brain stimulation (DBS) system. The system is now approved for patients who have had Parkinson's disease for at least four years, with recent onset of motor symptoms, or who have had longstanding motor complications not adequately controlled by medication. (Fierce Medical Devices)

Pharmaceutical Company Partners with Neurostimulation Device Maker

Feb. 16, 2016 - GlaxoSmithKline has partnered with Nuviant Medical to use its neurostimulation implant systems as a research platform for clinical applications of bioelectronics medicine. Bioelectronics, the company specified, seeks to develop miniaturized implants to interface with the peripheral nervous system to modulate organ function in order to treat chronic disease. (Fierce Medical Devices)

Company Raises Financing for "Neuropriming" Development

Feb. 10, 2016 - Halo Neuroscience announced it has raised $9 million in Series A financing and is pursuing both stroke rehabilitation and athletics with its headphones that are designed to provide brain stimulation to the motor cortex, an effect the company calls neuropriming. (Med City News)

Company Eyes Commercialization of Implantable Therapy for Chronic Low Back Pain.

Feb. 8, 2016 - Mainstay Medical International plc announced 2015 preliminary results and a business update. The Dublin-based company said it awaits CE marking and is preparing to commercialize its implantable device for chronic low back pain in Europe, with the first target market located in Germany. Meanwhile, the company received two more U.S. patents, bringing the total number to seven, and is currently preparing for an international prospective randomized sham-controlled blinded clinical trial, to include sites in the U.S. (Business Wire)

Companies Announce Plans for Directional Deep Brain Stimulation

Feb. 1, 2016 - Aleva Neurotherapeutics announced a strategic development, supply, and manufacturing relationship with the Greatbatch, Inc. subsidiary Greatbatch Ltd. Aleva will license a neurostimulation platform for the field of use of deep brain stimulation for treatment of Parkinson’s disease and essential tremor. Aleva will incorporate its own proprietary electrode technology for directional deep brain stimulation (DBS) along with the in-licensed technology for a 24-channel neurostimulator and related programmers. Aleva is raising a Series C round of financing, led by Greatbatch, for completing a chronic study in 60 Parkinson's disease patients, and to support seeking CE Mark approval for the directional DBS system. Additionally, Greatbatch said it expects to be renamed Integer Holdings Corporation later this year, following its October 2015 acquisition of Lake Region Medical. (GlobeNewswire)

Company Looks to Gain More Capital for Its Visual Prosthesis Pipeline

Jan. 25, 2016 - Second Sight Medical Products, Inc. filed a proposed rights offering with the Securities and Exchange Commission for its existing companies. The company would use the proceeds for an ongoing safety and efficacy trial of its Argus® II Retinal Prosthesis System for the treatment of age-related macular degeneration and development of a visual cortical prosthesis to potentially treat nearly all forms of blindness. (Business Wire)

Company Announces New Head of Neuromodulation Business Unit

Jan. 14, 20i6 - LivaNova, PLC has named former Cyberonics, Inc. executive Jason Richey president of LivaNova's neuromodulation business unit and a member of the executive team. He was previously vice president of global sales and marketing for neuromodulation. (Street Insider)

Device Maker Announces Sales Growth

Jan. 13, 2016 - St. Jude Medical, Inc. expected to report consolidated net sales of approximately $1.447 billion for the fourth quarter of 2015. That is an increase of 7% on a constant currency basis. Sales of its neuromodulation products in the fourth quarter amounted to approximately $128 million, an increase of 9% on a constant currency basis over the fourth quarter of 2014. (Business Wire)

Vagus Nerve Stimulation System Developer Raises $11 Million

Jan. 13, 2016 - Minnesota-based EnteroMedics Inc. brought in $11 million in the 2nd tranche of a $25 million offering, announced in November, of senior amortizing convertible notes. The company received $1.5 million at the initial offering in November 2015. In 45 days, a 3rd tranche of $12.5 million is scheduled. The company has developed a vagus nerve stimulation system to treat metabolic diseases and other gastrointestinal disorders. (Mass Device)

Neurostimulation Device Maker Receives Regional Government Grant in Belgium

Jan. 8, 2016 - Neurostimulation device maker Nuviant Medical received a research grant of €3.4 million from the Walloon Region government and plans to expand manufacturing operations there in a program that incorporates digital healthcare in collaboration with regional innovators. (Fierce Medical Devices)

Company Raises Capital to Support a Clinical Trial of a Neuromodulation Device for Overactive Bladder

Dec. 21, 2015 - Axonics Modulation Technologies announced $38.5 million in Series B financing that it intends to use to support a clinical trial next year of its rechargeable sacral nerve stimulation system in patients with overactive bladder. The company has raised $59 million since it formed in 2013 to commercialize technology licensed from the Alfred E. Mann Foundation. (PE Hub Network)

Forum Focuses on Emerging Neurotechnology

December 2015 - The 15th annual Neurotech Leaders Forum in San Francisco in November featured regulators, funders, and entrepreneurs who discussed emerging technologies and the path to market. Speakers included the FDA's director of Neurological and Physical Medicine Devices, Carlos Pena, who described how FDA intends to decide investigational device exemption requests within 30 days, and other ways the agency is endeavoring to make its processes timely and effective. Other sessions focused on considerations for device security. (Neurotech Business Report)

Company Says Cohort Group Comparison Demonstrates Improvements from Newest Spinal Cord Stimulator

Dec. 16, 2015 - Data presented at the North American Neuromodulation Society meeting in December updated initial results from the long-term LUMINA spinal cord stimulation (SCS) study, initially shown at the International Neuromodulation Society 12th World Congress in June. Boston Scientific Corporation announced the data from four patient groups who were followed for up to 24 months demonstrate that the company's most-recent SCS system provides a 70% improvement in lower back pain relief compared to the previous-generation device. The latest system has 32 contacts and four lead ports, along with programming software that is based on three-dimensional modeling of spinal cords. (Med Device Online)

Company Plans U.S. Clinical Trial of Percutaneous Stimulation in Chronic Migraine

Dec, 11, 2015 - StimRelieve LLC announced FDA investigational device exemption approval to begin a clinical trial of percutaneous, wirelessly powered neurostimulators to treat medically refractory chronic migraine. (Business Wire)

Long-Term Data Show Benefits of Dorsal Root Ganglion Stimulation for Pain Conditions

Dec. 11, 2015 - St. Jude Medical, Inc. announced long-term data presented in a plenary session at the North American Neuromodulation Society meeting show dorsal root ganglion stimulation provides sustained and superior pain relief over traditional spinal cord stimulation in patients with complex regional pain syndrome or peripheral causalgia.The data from the ACCURATE study confirm three-month primary endpoint data that was originally presented at the International Neuromodulation Society World Congress in June 2015. (Business Wire)

Study Results Presented Comparing Tonic and Burst Spinal Cord Stimulation

Dec. 11, 2015 - St. Jude Medical, Inc. announced the SUNBURST study has demonstrated that burst stimulation is superior to traditional tonic spinal cord stimulation in relieving chronic pain. The study results presented in a plenary session at the North American Neuromodulation Society meeting  showed patients preferred burst stimulation and most experienced less paresthesia or none. (Business Wire)

Company Announces Mobile Application Partnership

Dec. 11, 2015 - Medtronic plc is expanding a partnership with Samsung Electronics America that began in june with smart devices for diabetes to now also develop Android mobile applications for neuromodulation devices. (Fierce Medical Devices)

Company Anticipates Medicare New Device Payment Specifications in January

Dec. 10, 2015 - Nevro Corp. announced the Centers for Medicare & Medicaid Services approved a transitional pass-through payment, under a new device category, for high frequency stimulation under the Medicare hospital outpatient prospective payment system to begin Jan. 1, 2016. (Street Insider)

Equipment Manufacturer Expands Access to Implantable Pulse Generator Platform Technology

Dec. 10, 2015 - Evergreen Medical Technologies, Inc. announced it is expanding product development services through access to AdvaStim's customizable, modular core electronic components for implantable pulse generators, the ASICore platform. These components can be applied to various neurostimulation applications, from spinal cord stimulation and deep brain stimulation to prosthetic control. (Business Wire)

Company Says Injectable Spinal Cord Stimulation System Received Marketing Clearance in Europe

Dec. 10, 2015 - Medical device distributor Stimwave Neuro LP announced CE Mark approval for Stimwave Technologies Incorporated's Freedom spinal cord stimulation system for pain relief of the back or legs. The system incorporates up to eight electrode contacts and an embedded chip, that are introduced into the body through a needle. (Business Wire)

Company Announces Its Deep Brain Stimulation Systems Have Expanded Conditional Approval for MRIs

Dec. 9, 2015 - Medtronic plc announced that systems within its Activa® portfolio of deep brain stimulation devices have received FDA approval for full-body magnetic resonance imaging under specific conditions of use. (Street Insider)

Company Announces FDA Approval of Its Neuromodulation Device for Chronic Back and Leg Pain

Dec. 9, 2015 - Stimwave Technologies announced it has received FDA clearance to market its  wireless neuromodulation device for relief of chronic back and leg pain. (Digital Journal)

Results Published in Clinical Trial of Vagus Nerve Stimulation During Stroke Rehabilitation; Company Plans Further Research and Announces Additional Funding

Dec. 9, 2015 - International Neuromodulation Society member Jesse Dawson, MD was quoted in an article about a small controlled study he and colleagues published in Stroke that suggests pairing vagus nerve stimulation with upper-limb rehabilitation is safe and feasible after stroke. Based on those results, MicroTransponder, Inc. is conducting a 20-patient followup study in the U.S. and the U.K. The privately held company announced that it has closed a $5.5 million round of funding to support its activities. (Medgadget)

Company Anticipates Distributing Its Transcranial Magnetic Stimulation Systems in Mexico in 2016

Dec. 8, 2015 - Brainsway Ltd. announced an exclusive distribution agreement with moksha8 in Mexico, where the distributor plans to make Brainsway's deep transcranial magnetic stimulation system available in 2016 as a treatment for major depressive disorder. (Globes)

Company Receives Clearance to Test Implantable Device in Craniofacial Neuropathic Pain

Dec. 2, 2015 - StimRelieve LLC, announced it has received an FDA Investigational Device Exemption for a clinical trial of its injectable, wirelessly powered, stimulator to test the device for the treatment of refractory craniofacial neuropathic pain. Its Halo CFNS system is powered by an external transmitter placed on the ear. (Businesswire)

Stimulation Therapy for GERD Receives Approval in Brazil

Dec. 2, 2015 - EndoStim announced that ANVISA, the Brazilian health authority, approved its minimally-invasive therapy for gastroesophageal reflux disease (GERD) in Brazil. The EndoStim II LES Stimulation System is intended for patients who "may not be ideally treated with medication therapy," the company said. The stimulation targets the lower esophageal sphincter between the stomach and esophagus to improve or strengthen its function. (PR Newswire)

Projected Sacral Nerve Stimulation Costs to Be Presented at NANS

Dec. 2, 2015 - Axonics Modulation Technologies, Inc. announced that an abstract will be presented on Dec. 12 at the North American Neuromodulation Society (NANS) meeting that compares estimates of long-term treatment costs for overactive bladder using either rechargeable, or non-rechargeable, sacral nerve stimulators (SNS). The analysis is based on a model that uses a U.S. payer perspective. Results indicate a rechargeable system would have significantly lower costs per patient. Axonics is developing a rechargeable SNS system. (Businesswire)

Petition for Review Denied on U.S. Patent for High Frequency Spinal Cord Stimulation

Dec. 1, 2015 -  Despite two petitions challenging validity of some patent claims for high frequency spinal cord stimulation, the Patent Trial and Appeals Board (PTAB) at the U.S. Patent Office has decided to not conduct an inter partes review, the patent-holder, Nevro Corp., announced. http://www.prnewswire.com/news-releases/nevro-announces-the-us-patent-and-trademark-offices-denial-of-boston-scientific-petitions-for-inter-partes-review-of-us-patent-no-8359102-300185543.html The PTAB decided against holding a review after considering two petitions filed in May 2015 by Boston Scientific Corporation that challenged certain claims in Nevro's patent (U.S. Patent No. 8,359,102). (Fierce Medical Devices)

Company Announces FDA Approval for Spinal Cord Stimulation System

Nov. 30, 2015 - Greatbatch, Inc. announced FDA approval for its spinal cord stimulation system, Algovita®, which was developed by the company's subsidiary, QiG Group. The subsidiary is in the process of being spun out as Nuvectra Corporation, a process that is expected to be complete in the first quarter of 2016. (Nasdaq)

Company Opens an International Headquarters in Germany

Nov. 25, 2015 - Autonomic Technologies, Inc. is opening a new international headquarters in Munich, Germany. The company is commercializing sphenopalatine ganglion stimulation for cluster headache, and its device has received CE Mark in Europe. (Market Wired)

Deep Brain Stimulation Surgery Performed with Continuous MRI Guidance

Nov. 23, 2015 - MRI Interventions, Inc. announced the first MRI-guided electrode placement for deep brain stimulation surgery in Arizona, at the Banner - University Medical Center in Tucson. (CNN Money)

Group Eyes Commercialization of Neuromodulation to Control Bleeding

Nov. 22, 2015 - A nerve-stimulation device under development to control bleeding is expected to be subject to a new spin-out company in three months, as a step toward preparation for clinical trials. (Innovate Long Island)

Company Announces FDA Approval of Spinal Cord Stimulation System

Nov. 19, 2015 - St. Jude Medical announced FDA approval of its Proclaim Elite Spinal Cord Stimulation System, a non-rechargeable device that is upgradable to allow for new simulation waveforms and software updates. The patient controller and physician programmer use wireless and mobile technology for use during a trial phase and for tailoring stimulation parameters, respectively. (Fierce Medical Devices)

Company Says Its Device to Address Heart Failure Will Have Expedited FDA Review

Nov. 19, 2015 - Minneapolis-based CVRx announced that its neuromodulator to treat heart failure is the fifth device to enter the six-month-old FDA Expedited Access Pathway. The device is designed to reduce the workload of the heart through modulating the baroreflex system that helps control blood flow. The device activates the baroflex through the afferent (sensory) pathway, helping to restore autonomic balance between the sympathetic and parasympathetic systems. (Fierce Medical Devices)

Company Receives Clearance to Market Non-Invasive Stimulation System in Europe

Nov. 16, 2015 - NeuroSigma Systems announced CE Mark approval for its external trigeminal nerve stimulation system to treat attention-deficit hyperactivity disorder in people aged 7 years or older. (Mass Device)

Another Partner is Announced for Diaphragm-Pacing System

November 2015 - Oberlin, Ohio-based Valtronic is partnering with Synapse Biomedical to commercialize a third-generation, fully implantable diaphragm pacing technology. Valtronic and other partners plan to provide matching funds for the commercialization, which is being supported by a $3 million economic-development grant from Ohio Third Frontier. The device is also being commercialized in Asia with help from another partner, USCI Japan Ltd. (U.S. Tech)

Company Plans to Present Peripheral Nerve Stimulation Data Next Month

Nov. 12, 2015 - Israel-based BlueWind Medical plans to present details of its miniature leafless neurostimulator clinical trial in neuropathic pain patients during the North American Neuromodulation Society meeting in Las Vegas in December. The study was performed in four centers in Belgium and Poland, with up to six months' follow-up. (PR Businesswire)

Company Reports on Past Fourth Months of Activities

Nov. 9, 2015 - Mainstay Medical International plc issues an Interim Management Statement from July 1, 2015 to the present. The statement said that the company submitted an application for CE Mark for its neurostimulation system for chronic low back pain, closed a debt financing for up to $15 million, and announced issuance of three U.S. patents during that period. (Business Wire)

Patient Receives New Neurostimulator Device to Treat Heart Failure

Nov. 5, 2015 - A patient in Croatia is the first to begin using a catheter-based neurostimulator device to treat congestive heart failure, Enopace Biomedical, announced. The leadless, active miniature stimulator and is implanted in a 30-minute percutaneous procedure, and is designed to increase cardiac efficiency by reducing left ventricular workload. (PR Newswire)

Responsive Neurostimulation System Receives Recognition

Nov. 4, 2015 - NeuroPace, Inc. announced it received an award that recognizes its responsive neurostimulation system as the most promising new product of the year. The award was presented at the 2015 Phoenix Medical Device CEO Conference, which is comprised of medical device and diagnostic industry executives. (Business Wire)

Neuromodulation Company Announces New Investment

Oct. 26, 2015 - Helius Medical, which is commercializing a portable neuromodulation stimulator in several countries in Asia, raised $2 million in new financing from an anonymous donor, and intends to raise up to $12.3 million for the round. (Mass Device)

Company Acquires Technology for Multi-Coil Transcranial Magnetic Stimulation

Oct. 20, 2015 - Rio Grande Neurosciences announced it has acquired Cervel Neurotech’s multi-coil transcranial magnetic stimulation technology, including all related patent applications, issued patents, trademarks and equipment. (Business Wire)

Neuromodulation Company Undergoes Merger

Oct. 19, 2015 - The merger between neuromodulation company Cyberonics, Inc. and Sorin S.p.A. was completed and the new company, LivaNova PLC began trading on NASDAQ and the London Stock Exchange. Besides its existing portfolio in cardiac surgery and neuromodulation, LivaNova is pursuing therapies for heart failure, mitral valve repair, and sleep apnea. (Globe Newswire)

Company Receives Medical Coverage Decision in Germany

Oct. 13, 2015 - EndoStim announced that in 2016, approved treatment with its device for gastroesophageal reflux disease will be routinely reimbursed in Germany. (PR Newswire)

Neurostimulation Company Strikes Development Agreement in Asia

Oct. 13, 2015 - Helius Medical has entered into a $7 million agreement with the Hong Kong-based investment and development company A&B Company Limited. In the sales and licensing transaction, A&B will acquire certain Asian patents, patent applications, and product support material to develop and commercialize the Portable Neuromodulation Stimulator, PoNS™, in China, Hong Kong, Macao, Taiwan and Singapore. A news release mentions A&B's interest in its potential as a treatment for chronic neurological symptoms of traumatic brain injury. Helius said it will repay $2 million drawn down from A&B's provision of a $7 million credit facility by issuing 2.1 million shares of Helius at 96¢ per share and 1 million 3-year warrants at $1.44 per share. (Mass Device)

Device Maker Says Deep Brain Stimulation Patient is the First in the U.S. to Receive a New Anti-Infective Implant

Oct. 8, 2015 - Medtronic announced the first patient use of its Tyrx infection-fighting envelope, which it is launching for use with deep-brain stimulation devices in the U.S. The device releases two anti-microbial drugs, minocycline and rifampin, for seven days. The envelope then dissolves over roughly nine weeks. Medtronic acquired Tyrx for $160 million in January 2014 and received 510(k) clearance from the FDA for its use with neurostimulation implants, including sacral nerve stimulators, spinal cord stimulators and vagus nerve stimulators. Tyrx won CE Mark approval for cardiac devices in September 2014. (Mass Device)

Company Plans Clinical Trial of Injectable Tibial Nerve Stimulator

Oct. 8, 2015 - StimGuard announced FDA Investigational Device Exemption approval to launch a clinical trial this winter of its percutaneously implantable tibial nerve stimulation device to treat overactive bladder. (Sys-Con Media)

Bioelectronic Medicine Center Names a Managing Director

Oct. 7, 2015 - International Neuromodulation Society (INS) member Chad Bouton will leave his research leadership role at Battelle to become a managing director of the Feinstein Institute’s new Center for Bioelectronic Medicine. At Battelle, his work included a project to develop neural implants to bypass spinal cord damage and return some voluntary hand and arm movement to a patient with paralysis (described in an announcement of the 2015 INS abstract winners).  (Innovate LI)

Company's Trial Stimulation System Receives Expanded FDA Approval

Oct. 2, 2015 - Medtronic plc was reported to have received expanded FDA approval for its Verify Evaluation System that allows basic evaluations of patient benefit from sacral nerve stimulation for bladder or bowel control. The system has a wireless touchscreen and is used in conduction with trial stimulation of three to seven days. (FDA News)

Company Raises Funds to Pursue a Clinical Trial of a Noninvasive Device for Tinnitus

Sept. 29, 2015 - Neuromod Devices  Ltd. of Ireland as raised €5.5 million from Fountain Healthcare Partners to fund clinical trials in the U.S. for its bi-modal system to treat some forms of tinnitus. The system uses simultaneous auditory stimulation in the ear and sensory stimulation on the tongue. The device received CE Mark approval in Europe in October 2014 and a U.S. patent September 2015. (Irish Times)

Company Halts Plans for Initial Public Offering

Sept. 28, 2015 - According to an SEC filing, NeuroSigma Systems has decided to not pursue an initial public offering at this time. The Los Angeles-based company had registered for an initial public offering on the NASDAQ last August. The company is marketing its external trigeminal nerve stimulation system in Canada and Europe as an adjunctive treatment of drug-resistant epilepsy and major depressive disorder. The FDA also has permitted an investigational device exemption for clinical trials in the U.S. (MedCity News)

Companies Receive Clearance for Merger

Sept. 23, 2015 - The High Court of England and Wales approved the $2.7 billion merger of Cyberonics and the Sorin Group, now known as LivaNova. The merger will go into effect October 19, according to the companies. (Mass Device)

Company Announces European Approval for Deep Brain Stimulation Technology

Sept. 22, 2015 - St. Jude Medical announced it has received European CE Mark approval for its Infinity deep brain stimulation (DBS) device, and a directional lead that permits physicians to "steer" current to different targets. The DBS device incorporates Bluetooth connectivity that allows patients and physicians to use some Apple™ mobile devices as wireless controllers. (Mass Device)

Company Receives Funding to Develop Wearable Sensors for Deep Brain Stimulation Programming

Sept. 21, 2015 - The National Institute of Neurological Disorders and Stroke is providing $1.9 million in Phase II Small Business Innovation Research funding to Cleveland-based Great Lakes NeuroTechnologies to integrate their wearable sensors into a platform for programming deep brain stimulation (DBS) systems. The company's wearable sensors were initially used for assessing Parkinson's disease. The integrated system should provide real time, closed-loop feedback to adjust DBS programming. (PR Newswire)

Company Reports Use of Its Peripheral Nerve Stimulator

Sept. 16, 2015 - Bioness, Inc.'s StimRouter™ peripheral nerve stimulator has FDA clearance for adjunctive use to treat chronic, intractable pain of peripheral nerve origin. The company announced its first commercial use occurred in Cleveland. The system is a minimally invasive prescription device with an implanted lead, external pulse transmitter, and conductive electrode that is powered transdermally. (BioPortfolio)

Non-rechargeable Deep Brain Stimulation System Receives European Marketing Approval

Sept. 14, 2015 - Boston Scientific Corporation announced CE Mark designation for its Vercise non-rechargeable, primary cell, deep brain stimulation (DBS) system for patients with Parkinson's disease, primary and secondary dystonia, and essential tremor. The system has an eight-contact directional lead with multiple independent current control. The non-rechargeable Vercise primary cell system is not available in the U.S., although its counterpart, the rechargeable Vercise DBS system, is cleared in the U.S. for investigational use to evaluate its effectiveness in Parkinson's disease in the INTREPID study. (Med Device Online)

Company Extends Equity Financing Round

Sept. 8, 2015 - SetPoint Medical, Inc., which is developing bioelectronic therapy for inflammatory disease, has raised an additional $25 million in an extension of its Series C equity financing, bringing the total raised to $43 million. Current investors in the Valencia, CA-based company include Morgenthaler Ventures, Foundation Medical Partners, Topspin Partners, Covidien Ventures, Action Potential Venture Capital Limited and Boston Scientific. (PE HUB)

Company Releases Data in Clinical Trial of Neurostimulation Device for Back Pain

Aug. 31, 2015 - Mainstay Medical International plc announced positive results from the international clinical trial of its neurostimulation device to treat chronic disabling back pain by stimulating nerves for the muscles that stabilize the lumbar spine. In 47 patients who had at least 90 days of follow-up, the company said, 63% had clinically important improvement in back pain and 72% of patients improved who had no financial compensation related to back pain. The clinical trial is being conducted prior to application for CE Mark approval. (Business Wire)

Transcranial Magnetic Stimulation System Cleared for U.S. Use in Certain Cases of Depression

Aug. 28, 2015 - Denmark-based MagVenture, Inc. announced its MagVita transcranial magnetic therapy (TMS) system has received FDA clearance for the treatment of major depressive disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode. The company said it is the fourth to receive clearance for this technique. Its system was CE marked in the European Union in 2011. (PR Newswire)

U.S. Patent Issued for an Approach Under Development to Address Low Back Pain

Aug. 26, 2015 - Mainstay Medical International plc announced issuance of a new U.S. patent, “Apparatus and Methods for Rehabilitating a Muscle And Assessing Progress of Rehabilitation.” The company is developing a new implantable neurostimulation system to treat chronic low back pain. (Business Wire)

Device Maker Announces CE Mark for MRI-Conditional Implantable Pulse Generator

Aug. 24, 2015 - St. Jude Medical Inc. announced receiving CE Mark approval for magnetic resonance imaging-conditional labeling of its soon-to-be-launched implantable pulse generator, the Prodigy MRI chronic pain system, saying the approval applies with select leads. (Business Wire)

Device Developer Announces New Financing

Aug. 24, 2015 - Mainstay Medical International plc has secured $15 million in debt financing for commercialization of its neurostimulation device that is designed to address low back pain by contracting the muscles that provide stability. The funding from IPF Partners includes milestone payments for progress toward CE Mark approval of the device for the Dublin-based company. (Business Wire)

Non-invasive Neurostimulation Company Raises Capital

Aug. 19, 2015 - A company that is developing a therapy for loss of the visual field that involves 10 daily sessions of non-invasive electrical brain stimulation, EBS Technologies of Berlin, has raised 1.1 million Euros. The external device, operated by a technician, delivers alternating current to the retina. The stimulation is intended to activate the optic nerve and visual cortex, with the stimulation adjusted in response to monitoring of the patient's EEG. (Market Watch)

Consultants Foresee Broader Role for Neuromodulation

Aug. 13, 2015 - A product design innovator in the U.K., Cambridge Consultants, is publicizing its vision of future neuromodulation devices that it says might address what a news column terms  "lifestyle" issues -- such as migraine, obesity and incontinence. (Business Weekly)

Executive Changes Take Place at Company that Develops Neuromodulation Systems to Address Vision Problems

Aug. 13, 2015 - Second Sight Medical will get a new CEO this month when Robert Greenberg, MD, PhD steps down from that position and becomes chairman of the board, replacing Alfred Mann who will become chairman emeritus. The new CEO, Will McGuire, was an executive at medical-device-industry companies Volcano, Covidien and AtheroMed. An article notes that Greenberg had said the company intends to treat most types of blindness, such as glaucoma and diabetic retinopathy. The company's next-generation device "would bypass the retina with an electrode array implanted directly on the portion of the brain that deals with signals from the retina." (Mass Device)

Neuromodulation Device Developer Acquired by Pharmaceutical Firm

Aug. 11, 2015 - Dublin-based Allergan announced it has closed its purchase of dry-eye disease, neuromodulation-device developer Oculeve for $125 million in up-front payments plus commercialization milestone payments. (Mass Device)

Company Names Two Business Leaders for Its Proposed Spin-out

July 30, 2015 - Greatbatch Inc., proposes a tax-free spin-off of its subsidiary, the QiG Group, into a medical device company, Nuvectra Corporation. In a Form 10 registration statement filed with the U.S. Securities and Exchange Commission, Greatbatch said neuromodulation industry veteran Scott Drees will be chief executive officer of Nuvectra; and Joseph A. Miller, Jr., PhD, its director and chairman of the board. (Globe Newswire)

Wirelessly Controlled Spinal Cord Stimulation System Receives FDA Approval

July 16, 2015 - The FDA has approved St. Jude Medical's Invisible Trial System, which patients can control with an iPod Touch and clinicians can program and track with an iPad Mini. The wirelessly controlled trial spinal cord stimulation system includes a small external pulse generator. (Fierce Medical Devices)

Device Company Targeting Low-Back Pain Announces Two U.S. Patents

July 15, 2015 - Mainstay Medical International plc announced issuance of two U.S. patents concerning its neurostimulation therapy for chronic low back pain. The company's device stimulates muscles in the lower spine to provide more control over these stabilizing muscles. (Business Wire)

Article Describes Prototype Device Intended to Guide Placement of Neurostimulators

July 15, 2015 - An article about a prototype neurostimulator-delivery tool in development by Cambridge Consultants says the Chimaera hand-held instrument is designed to be used in conjunction with a wearable optical device such as Google glass to provide the operator a visual overlay of the target area. It combines pre-operative 3D imaging and real-time sensing of nerves. (Reuters)

Company Announces Patent Allowance for High-Frequency Peripheral Nerve Stimulation

July 14, 2015 - Bioness, Inc. received clearance from the U.S. Patent Office for a patent claiming use of high-frequency stimulation with its implantable peripheral nerve stimulation device, StimRouter. The device is FDA-approved to treat chronic, intractable pain of peripheral nerve origin as an adjunct to other modes of therapy. (Business Wire)

Contract Finalized to Support Clinical Trial of Neuromodulation Device to Address Balance Issues Arising from Traumatic Brain Injury

July 7, 2015 - Helius Medical Technologies, Inc.'s  NeuroHabilitation Corporation division has entered into a cost-sharing contract with the U.S. Army Medical Research and Materiel Command to support a clinical trial investigating the safety and effectiveness of the company's non-invasive Portable Neuromodulation Stimulator (PoNS™) for the treatment of balance disorder in patients with mild-to-moderate traumatic brain injury. The (PoNS™) device is placed on the tongue to stimulate cranial nerves that innervate muscles there. (Business Wire)

Firm Acquires Developer of Dry-Eye Neurostimulation Therapy

July 6, 2015 - Allergan of Dublin, Ireland will pay $125 million acquire South San Francisco-based Oculeve, a development-stage company that is developing a nasal neurostimulation device designed to increase tear production in patients with dry eye disease. The deal includes milestone payments for development of Oculeve's OD-01 neurostimulation therapy. Two pivotal trials are planned, with commercialization potentially occurring in 2017 after FDA approval, the company said. (Mass Device)

Future Name of Newly Merged Company Announced

June 25, 2015 - Sorin Group and Cyberonics said when their merger is complete the new company will be named LivaNova. Its three business units in cardiac surgery, cardiac rhythm management and neuromodulation will have headquarters in Mirandola, Italy; Clamart, France; and Houston, Texas, respectively. (Mass Device)

FDA Approves Deep Brain Stimulation System

June 12, 2015 - The U.S. FDA approved St. Jude Medical Inc.'s rechargeable Brio deep brain stimulation (DBS) system for management of medication-resistant motor symptoms of Parkinson's disease and essential tremor. The DBS system is the second to receive FDA approval, with Medtronic's Activa system approved in the U.S. in 1997 for essential tremor and in 2002 for Parkinson's disease. (FDA)

Device Company Announces Financing Round

June 9, 2015 - WISE Srl, which is developing next-generation neurostimulation leads, announced the closing of a EUR 3 million series A financing round, led by Principia SGR, an Italian Venture Capital firm. Existing investors High-Tech Gründerfonds, Atlante Seed and b-to-v Partners joined the round alongside with three new investors Atlante Ventures, F3F and Antares. (WISE Srl)

Company Announces Name Change as Commercialization Starts for Spinal Cord Stimulation System

June 5, 2015 - Algostim, LLC, a subsidiary of Greatbatch, Inc.'s QiG Group, announced it will now do business as Nuvectra. The medical device company will commerciallze the Algovita spinal cord stimulation system to treat chronic intractable pain of the trunk and/or limbs. (NASDAQ)

Company Announces Launch of Compact Spinal Cord Stimulator System

June 5, 2015 - Boston Scientific announced the European launch of the Precision Novi™ spinal cord stimulation system at the 12th World Congress of the International Neuromodulation Society. The 16-contact primary cell (non-rechargeable) device has CE Mark approval for the treatment of chronic pain. (Newsmedical.net)

Company Announces App-Based, Wireless Neuromodulation Trialling System

June 4, 2015 - St. Jude Medical, Inc. announced CE Mark approval and the European launch of its Invisible Trial System, an app-based and wireless neuromodulation programming system that uses Apple™ iPod touch™ and iPad mini™ technology. The system consists of an external pulse controller, a patient iPod touch controller, and Bluetooth communication function that eliminates the programming trial cable. (Med Device Online)

FDA Approves Vagus Nerve Stimulation System That Responds to Heart Rate Change in Epilepsy Patients

June 2, 2015 - Cyberonics announced FDA approval for its AspireSR generator designed for vagus nerve stimulation to treat drug-resistant epilepsy. It uses a proprietary, customizable cardiac algorithm to detect relative heart-rate increases and deliver automatic stimulation. (Mass Device)

Results Announced for Two Overactive Bladder Patients Receiving Wirelessly Powered Tibial Nerve Stimulation Since August 2014

May 28, 2015 - StimGuard LLC announced two patients who received injectable tibial stimulator in August 2014 for overactive bladder have ongoing reduction of voiding episodes and more than 80% relief. The treatment is carried out at night using a sock to cover the stimulation area. The wirelessly powered implant delivers stimulation that the company said enables the brain to remap specific urge signals in a fashion similar to acupuncture, but permanent. The company plans to complete regulatory studies for CE Mark in 2015 and seek FDA approval in 2016. (Business Wire)

Company Launches a Next-Generation Device for GERD in Europe

May 18, 2015 - EndoStim announced CE Mark approval and European launch of its second generation system, EndoStim II, to treat gastroesophageal reflux disease (GERD). (PR Newswire)

Sacral Neuromodulation Device Company to Present at Meeting

May 20, 2015 - Axonics Modulation Technologies, Inc. announced that it has been selected to present its technology advancements during the Innovations in Neuromodulation session at the International Neuromodulation Society's 12th World Congress on June 6th in Montreal. The company makes an implantable sacral neuromodulation system to manage chronic intractable urinary and fecal dysfunction. The system has a rechargeable implantable pulse generator designed to be small and long-lasting. (Business Wire)

Enrollment is Completed in a Pilot Clinical Trial Addressing Balance Issues in Multiple Sclerosis

May 20, 2015 - Helius Medical Technologies has completed enrollment for its pilot clinical trial at the Montreal Neurological Institute in which 14 patients with multiple sclerosis will be treated for balance and gait symptoms over the course of 14 weeks, undergoing a physiotherapy protocol combined with noninvasive stimulation of cranial nerves using the Portable Neuromodulation Stimulator (PoNS™). (Business Wire)

First Patient in Canada Receives Burst-Mode Spinal Cord Stimulator Implant

May 19, 2015 - Health Canada approved St. Jude Medical's Prodigy™ spinal cord stimulation system with burst technology, the company announced. The first Canadian patient was implanted with the system earlier this month by Ivar Mendez, M.D., Ph.D, FRCSC, FACS at Saskatoon Health Region’s Royal University Hospital. (Market Watch)

Company Receives Permission to Start a U.S. Clinical Trial of a Needle-Implanted, Wirelessly Powered Device in Overactive Bladder Patients

May 11, 2015 - Privately held StimGuard announced the FDA has approved the start of a clinical trial to evaluate a micro-sized device for overactive bladder (OAB) that can be placed completely through a needle. The announcement says the implant is wirelessly powered by an external, "electroceutical" microchip from Stimwave, a company founded by StimGuard's co-founder, which delivers small pulses of energy to electrodes near surrounding nerves. The StimGuard-device clinical trial is due to start in the U.S. in the summer of 2015. (Business Wire)

Device Maker Raises $38 Million in Financing

May 12, 2015 - Autonomic Technologies, Inc. announced it has received a series D round of financing that raised $38 million. The company said it will use the money to expand its marketing in Europe of Pulsante™, its microstimulator to treat severe headaches, and to fund an ongoing clinical study of the device in the U.S. to treat chronic cluster headache. Pulsante™ has received CE mark approval in Europe for treatment of cluster headache. (Military Technologies)

Company Faces Patent-Claims Challenge

May 11, 2015 - Nevro Corp. said Boston Scientific Corporation has filed two petitions at the U.S. Patent Office for inter partes review of claims that were previously granted to Nevro. A inter partes  petition challenges patent claims based on prior art and publication. (CNN Money)

FDA Approves Paresthesia-Free Spinal Cord Stimulation System

May 8, 2015 - The FDA has approved the Senza system, Nevro Corp.'s spinal cord stimulation device that relieves trunk or limb pain without paresthesia. The company said in announcing the approval that the FDA is not restricting patients receiving the therapy from operating motor vehicles, that the system has 3T-conditional MRI compatibility, and received "superiority" labeling from the FDA. The FDA based its approval on a clinical study that showed 75% of patients treated had their chronic pain reduced by 50% within three months. Implant site pain and device lead dislocation were among the adverse events reported. (PR Newswire)

Device Company Completes Acquisition of Developer of Dorsal Root Ganglion Spinal Cord Stimulator

May 4, 2015 - St. Jude Medical announced it has completed acquisition of Spinal Modulation, Inc. The acquisition was completed on May 1. Spinal Modulation developed the Axium™ spinal cord stimulation system. That system has approval in the European Union and Australia. Results of a U.S. clinical trial, ACCURATE, will be presented at the International Neuromodulation Society 12th World Congress in June in Montreal, according to the company's announcement. (Business Wire)

Manufacturer Announces Plans to Spin Out Device Company

April 30, 2015 - Greatbatch, Inc. said it expects to spin off its QiG Group subsidiary, Algostim LLC, by the end of 2015, in order to create a new publicly traded company focused on commercializing the Algovita spinal cord stimulation system, which Greatbatch would continue to manufacture. (GlobeNewswire)

Company Announces FDA Approval of Spinal Cord Simulation System and Leads

April 30, 2015 - St. Jude Medial, Inc. said it has received FDA approval of its Protégé MRI™ spinal cord stimulation system, as well as approval for MRI compatibility of the company’s 60cm Octrode™ percutaneous leads. The leads received MR-conditional labeling for use with the Protégé MRI system. (Market Watch)

Sacral Neuromodulation Developer Raises Capital

April 30, 2015 - Axonics Modulation Technologies of Irvine, Calif. was reported to have raised $17.3 million, according to a regulatory filing. The company is developing sacral neuromodulation (SNM) technology to address bladder and fecal incontinence. A news article said the financing, on top of $32.6 million last year, is "proof that this neuromodulation trend [SNM] is really taking off." (Med City News)

Company Whose Stimulator Addresses Restless Leg Syndrome Announces U.S. Patent

April 30, 2015 - Sensory NeuroStimulation Inc., which produces a non-pharmacological stimulator for Restless Leg Syndrome, announced issuance of a U.S. patent covering technologies noninvasive treatment device, Relaxis (TM). (Business Wire)

Device Company Strikes Strategic Agreement With Maker of Surgical Navigation Software

April 27, 2015 - Boston Scientific, Inc. announced that in select countries, along with its Vercise™ deep brain stimulation system, it will begin distributing Brainlab AG's surgical planning and navigation portfolio. The Vercise system is available to treat Parkinson's disease, tremor and dystonia in Europe, Israel, and Australia as well as in some parts of Latin America and Asia Pacific. A U.S. clinical trial, INTREPID, is currently enrolling patients to evaluate the system's safety and effectiveness for the treatment of Parkinson's disease. (PR Newswire)

Poster: No Serious Cardiovascular Effects from Noninvasive Vagus Nerve Stimulation

April 27, 2015 - A poster at the American Academy of Neurology annual meeting showed no meaningful cardiovascular adverse effects in 29 patients who use electroCore’s non-invasive vagus nerve stimulation as a home treatment for asthma. (Business Wire)

Deep Brain Stimulation System Receives European Approval for Full-Body MRI Scanning

April 22, 2015 - Medtronic announced that European regulators have approved the use of full-body MRI scans in patients who have one of their Activa deep brain stimulation systems. (Mass Device)

Company Raises Series B Financing for System to Treat Depression

April 21, 2015 - Boston-based Tal Medical has raised $14 million in Series B financing, led by PureTech Ventures, to further develop its low-field magnetic stimulation system for use in depression and bipolar disorder. (Med City News)

Device Maker Exercises an Acquisition Option for $175 million, adding Dorsal Root Ganglion Stimulation to Its Portfolio

April 20, 2015 - St. Jude Medical, Inc. announced that, for $175 million and sales-based milestone payments, it will exercise its option to acquire Spinal Modulation, Inc., which has submitted a PMA application for marketing approval of its Axium™ system for stimulation of the dorsal root ganglion to manage intractable chronic pain. The system has received a CE Mark and is subject to a U.S. clinical trial, ACCURATE. The company said in its acquisition announcement that results from the clinical trial will be presented at the International Neuromodulation Society's 12th World Congress in June in Montreal. St. Jude Medical made an initial $40 million equity investment in Spinal Modulation in 2013.  (Business Wire)

U.S. Regulators Approve Merger Involving Vagus Nerve Stimulation Device Maker

April 14, 2015 - Cyberonics and Sorin Group announced approval from U.S. anti-trust regulators of their all-stock merger, which is expected to close by the end of the 3rd quarter. (Mass Device)

Privately Held Company Appoints Medical Advisory Board Chair

April 3, 2015 - Stimwave Technologies Incorporated announced it has appointed Gabor Racz, MD, as chair of its medical advisory board. The privately held company is developing wirelessly powered, injectable, microtechnology neurostimulators. Widely acknowledged for his leadership in pain medicine, Dr. Racz is emeritus chairman of the Department of Anesthesiology at Texas Tech University Health Science Center, and belongs to the International Neuromodulation Society. Other INS members on the Stimwave board are David Kloth, MD, and Ralph Rashbaum, MD. (Business Wire)

Privately Held Firm Announces Patent Allowing "Beat Technology" Spinal Cord Stimulation Claims

March 20, 2015 - Privately held Meagan Medical, Inc., a research arm of RS Medical based in Vancouver, WA announced issuance of a U.S. patent for delivering high frequency stimulation to the spinal cord with the ability to direct a higher beat output toward the spinal column. The patent includes claims for delivering stimulation with base frequencies between 500 Hz to 20 kHz while generating a directionally controllable beat frequency between 0-250 Hz. (Megan Medical, Inc.)

Blog Describes Obstructive Sleep Apnea Device Under Development

March 27, 2015 - A Belgium-based business pursuing neuromodulation applications, Nyxoah, was featured in a blog by the Health Cluster of Wallonia. The 20-person, clinical-stage company has R&D facilities in Israel and is developing an implant to treat obstructive sleep apnea that is wirelessly powered by an adhesive patch and activation chip worn at night. (Win Health)

Company With Novel Implanted Stimulator for Pain Plans to Add Staff

March 18, 2015 - Stimwave Technologies of Miami Beach, FL announced plans to double in size by hiring 20 staff members, primarily for clinical support, over the coming year, and plans to move to Fort Lauderdale in May. The company relocated to Florida about a year ago from Arizona in order to be in a location that is central to customers in the U.S., Central America and Europe. The company has a 12-cm Freedom Stimulator for spinal cord stimulation to treat chronic pain, and plans to release a peripheral nerve stimulator later this year. (South Florida Business Journal)

Company Eyes Overactive Bladder Application, and Is Expanding to Germany

Feb. 27, 2015 - nUro, Inc. is adapting its CE Marked Synapse™ system to a wireless neurostimulation system for the treatment of overactive bladder. The company plans to begin trading on the US OTC Markets QB Stock Exchange by Aug. 1, 2015. It is opening a German subsidiary in the Erlangen Medical Valley Center, and plans to also begin trading in 2015 on a German stock exchange. (PR Web)

Company Receives CE Mark for Vagus Nerve Stimulation System in Heart Failure

Feb. 26, 2015 - Cyberonics, Inc. announced it has received CE mark approval of its vagus nerve stimulation for use as adjunctive therapy in treatment-resistant patients with heart failure with left ventricular dysfunction. The company's Vitaria system delivers autonomic regulation therapy, which was shown in the open-label ANTHEM-HF clinical study to improve a number of symptoms at six months of treatment. (Pharmabiz.com)

Neuromodulation Company to Merge with Global Device Company

Feb. 26, 2015 - Cyberonics Inc. plans to merge with create a new company domiciled in the UK by buying* Italian medical device company Sorin SpA in an all-stock deal to create a new company with a combined equity of $2.7 billion. The new company will apply for dual-listing on the Nasdaq and the London Stock Exchange, the companies said in a statement. The newly formed company will include a portfolio addressing heart failure and sleep apnea, according to a news release by Sorin Group. *Note: Reuters later ran an updated story to clarify that this is a merger: http://www.reuters.com/article/2015/02/26/us-sorin-m-a-cyberonics-idUSKBN0LU0QE20150226 (Reuters)

Neuromodulation Supplier Reports Increased Earnings

Feb. 25, 2015 - Greatbatch Inc. reported adjusted earnings per share of 65 cents in the fourth quarter of 2014, up 18.2% from one year ago. Revenues from QiG Group, which includes sales from the recently acquired implantable-pulse-generator-maker CCC Medical Devices, rose to $5.5 million from $0.9 million the previous year. (Nasdaq)

Insurer Adds Coverage of Overactive Bladder Treatment

Feb. 24, 2015 - Uroplasty, Inc. announced its percutaneous tibial nerve stimulation therapy for overactive bladder is now covered by Cigna, which wrote a positive coverage policy that applies to some 14 million people and became effective Feb. 15, 2015. (CNN Money)

Peripheral Nerve Stimulation Device Receives FDA Clearance

Feb. 24, 2015 - Bioness, Inc. announced FDA clearance of its minimally invasive neuromodulation device for peripheral nerve pain, StimRouter®, which consists of an implanted lead, external pulse transmitter and conductive electrode, and is controlled by a small hand-held wireless control unit. Electrical signals travel from the pulse generator to the electrode and down the lead to the origin of pain. (Business Wire)

Obesity Device Startup Announces Fourth Quarter Earnings

Feb. 23, 2015 - An earnings report for EnteroMedics, Inc., whose vagus nerve stimulation therapy for certain types of obesity received FDA approval in January, shows that as the company completed U.S. regulatory approval and geared up for commercialization, its losses totaled nearly $6.2 million in the fourth quarter of 2014. The loss of $0.09 per basic and diluted share was a slight improvement losses in the same quarter a year ago of $0.11 per basic/diluted share. For the year, EnteroMedics lost $26.1 million, and had $11.6 million on hand. (Mass Device)

Company Developing Closed-Loop Spinal Cord Stimulation Announces $10 Million Investment

Feb. 23, 2015 - Saluda Medical announced it received $10 million in Series B financing in a funding round led by new investor Biosciences Managers, in which existing investors also participated. The Australian-based company plans to use the funds to support clinical trials and commercialization plans for its Evoke™ closed-loop spinal cord stimulation system that is intended to treat chronic pain of the trunk and limbs, automatically adjusting stimulation levels for optimal pain relief. (Send2Press Newswire)

Company Acquires Developer of Overactive Bladder Treatment

Feb. 23, 2015 - Medtronic plc has acquired Advanced Uro-Solutions, a Tennessee-based developer of a percutaneous tibial nerve stimulation system, which consists of a small external stimulator and a single, reusable lead to provide temporary stimulation to the tibial nerve, NURO(TM). The device has FDA clearance for patients with overactive bladder and associated symptoms, and Medtronic plans U.S. commercialization within the next 12 months. (Fierce Medical Devices)

Business Profile Features Borough's Neuromodulation Center

Feb. 8, 2015 - A business feature profiles the Greenville Neuromodulation Center, which opened 10 years ago in Greenville, a borough of about 5,000 people, 80 miles from Pittsburgh and Cleveland, which is home to Thiel College. Eighteen months ago the center added a neurologist experienced in deep brain stimulation. (Sharon Herald)

Spinal Cord Stimulation System Receives Expanded Labeling for MRI Scans

Feb. 4, 2015 -  Nevro Corp. announced its Senza® spinal cord stimulation system has received approval for expanded labeling in Europe and Australia. The expanded labeling now permits scans of the head and extremities with both 1.5 and 3 Tesla MRI machines under specified conditions for existing and future patients. (Market Watch)

Company Plans a U.S. Clinical Trial of Its Neurostimulation Device to Treat Chronic Lower Back Pain

Jan. 26, 2015 - Mainstay Medical International plc has applied for an FDA Investigational Device Exemption to begin a clinical trial of its ReActiv8® implantable neurostimulation device to treat people with disabling chronic low back pain for whom conventional therapy has not been successful and for whom surgery is not indicated. (Mainstay Medical)

Company Announces FDA Allows Gastroparesis Device Therapy

Jan. 23, 2015 - Medtronic announced a Humanitarian Device Exemption for its Enterra II neurostimulation implant for treating gastroparesis. (Mass Device)

Price Index Tracks Hospital Costs for Spinal Cord Stimulators

Jan. 23, 2015 - According to the Modern Healthcare/ECRI Institute Technology Price Index, the average cost of spinal cord stimulators is now $16,957, up 8% from this time last year. The article mentions that advanced versions released in 2013 by Boston Scientific Corp. and Medtronic cost on average $19,000 while older models cost hospitals on average $13,000, although more hospitals are choosing to buy the newer devices. (Modern Healthcare)

Company Plans to Release Cochlear Implant on U.S. Market That Permits 3.0 Tesla Imaging

Jan. 23, 2015 - MED-EL USA says it will launch its Synchrony cochlear implant in the U.S. following FDA approval for this model, which the company says is the only U.S.-approved one that can be used with 3.0 Tesla magnetic resonance imaging devices without surgical removal of the internal magnet. (FDA News)

Company Announces FDA "Approvability" Letter for New Spinal Cord Stimulator

Jan. 22, 2015 - Nevro Corp. announced the FDA has written to say that, subject to check-off on a number of inspection, audit, labeling, and similar compliance issues, its Senza spinal cord stimulation system is approvable under the premarket approval application, based on the application's supporting data. (PR Newswire)

FDA Approves Intrathecal Device With Safety Valve to Facilitate MRI Procedures

Jan. 19, 2015 - Flownix Medical Inc. announced a PMA-Supplement approval from the FDA for is intrathecal Prometra® II system with a flow-activated safety valve that allows an MRI without the need to remove the drug from the reservoir in advance. (PR Newswire)

Shareholders Pave Way for Merger to Close

Jan. 7, 2015 - Medtronic, Inc. said shareholders who have more than 75% of the stock voted in favor of its merger with Ireland-based Covidien, whose shareholders approved the deal hours earlier. The $43 billion merger should close in two weeks, turning Medtronic into an Irish-based entity, Medtronic PLC. (Mass Device)

Cross-Continental Merger Faces Shareholder Vote Tomorrow

Jan. 4, 2015 - After a shareholder vote tomorrow on the $48 billion merger of Medtronic, Inc. and Covidien, an article in the Minneapolis Star Tribune says, Medtronic would become a new Irish-domiciled, multinational conglomerate called Medtronic PLC. Top executives will remain based in Fridley, MN. The New York Stock Exchange ticker will remain MDT, with the new shares expected to begin trading at the same price as the closing price from the day before. (Star Tribune)

Company Opens U.S. Entity for Distribution of Deep Transcranial Magnetic Stimulation Systems

Dec. 30, 2014 - Beginning Jan. 1, 2015, Brainsway Ltd. will use its new entity, Brainsway USA Inc. for sales, marketing and customer support in the U.S. of its deep transcranial magnetic stimulation systems. Headquartered in the northeast, Brainsway USA also opened two U.S. regional service centers. (Globe Newswire)

Company Outlines Settlement for Shareholder Lawsuit

Dec. 29, 2014 - Covidien said it has proposed a settlement for a consolidated derivatives lawsuit blocking its pending merger with Medtronic, Inc. The $43 billion merger values its shares at $93.22 each, and the three shareholder lawsuits, first filed in July 2014, alleged a breach of fiduciary duty in agreeing to the merger. The company said that it created a memorandum of understanding in which it agrees to make certain additional disclosures related to the proposed transaction, as part of a stipulation of settlement. (Mass Device)

Company Receives Small-Business Funding for Home-Use Neurostimulation to Treat Overactive Bladder

Dec. 21, 2014 - Rosellini Scientific has launched nUro Inc. to develop a percutaneous tibial nerve stimulator for overactive bladder that can be operated at home. It involves an implanted neurostimulator and an unobtrusive external controller, which is only worn during therapy sessions. The company announced that to help fund the development, it has received a Phase I Small Business Innovation Research grant from the NIH's National Institute of Diabetes and Digestive and Kidney Diseases. (Virtual-Strategy Magazine)

Engineering Organization Receives R&D Funding to Work on a Micro-Stimulator

Dec. 18, 2014 - Draper Laboratory received $200,000 in Phase 1 funding from GlaxoSmithKline as part of its Innovation Challenge to develop micro-stimulators that may address one or more chronic health conditions - including cardiovascular disease, diabetes, arthritis, asthma, or cancer. Draper Laboratories previously developed an interface for the GSK Bioelectronics R&D group that can record the communication between individual populations of nerve fibers within the whole nerve bundle and deliver precision therapy when these electrical signals operate abnormally. The current funding will be applied to development of a hermetically sealed device that offers wireless processing and can be injected or inserted through a catheter. (PR Web)

Heart Failure, Hypertension Therapy Granted MRI-Conditional Status in Europe

Dec. 16, 2014 - CVRx Barostim neo is now cleared for MRI use in Europe under certain conditions, according to a company announcement. This second-generation carotid artery pulse stimulator is being developed as a therapy for some types of heart failure and drug resistant hypertension. (MedGadget)

Company Prepares for Shareholder Vote on Merger

Dec. 16, 2014 - Medtronic, Inc. announced it is ready for a shareholder vote Jan. 6, 2015, on the proposed merger with Covidien, now that the way has been cleared by anti-trust regulators from the U.S., European Union, China, South Korea and Canada. (Mass Device)

Company Says Patent Issued on Treatment for Balance Problems

Dec. 16, 2014 - Helius Medical Technologies, Inc. said it has received a U.S. patent "generally directed to a non-invasive neuromodulation therapy that includes stimulating the cranial nerves found in the mouth while the patient is engaged simultaneously in physical movement." The company's Portable Neuromodulation Stimulator (PoNS™) device induces neuromodulation by stimulating the cranial nerves found in the tongue, and is being studied for the treatment of balance disorder symptoms caused by traumatic brain injury and multiple sclerosis. (Business Wire)

Company's Pain Portfolio to be Presented

Dec. 8, 2014 - St. Jude Medical, Inc. will present data from 16 research abstracts about its product portfolio to provide spinal cord stimulation for chronic pain during the North American Neuromodulation Society annual meeting Dec. 11 - 14, 2014 in Las Vegas, NV. (Business Wire)

Merger Plans Receive Antitrust Clearance from China and Korea

Dec. 4, 2014 - The Chinese Ministry of Commerce and the South Korean Fair Trade Commission have accepted plans for Medtronic, Inc. to merge with Covidien Plc, according to Medtronic. With all antitrust clearances in hand, the companies now need sanction by the High Court of Ireland and shareholder approval. Covidien is based in Ireland and the combined company would have its tax domicile in Ireland, with operational headquarters in the U.S. (Mass Device)

Company Reports Record Revenues, Plans to Present at International Neuromodulation Society Chapter Annual Scientific Meeting

Dec. 2, 2014 - Nevro Corp. booked its biggest revenue gain in the quarter ended Sept. 30, 2014, the company announced, with $8.7 million in revenues marking a 40% increase over the same period the year before. The company added that results of its randomized controlled clinical trial, SENZA-RCT, will be presented Dec. 12 in Las Vegas at the annual meeting of the North American Neuromodulation Society. The Senza spinal cord stimulation system is marketed outside the U.S. Combined with that revenue, the company also raised approximately $131 million in an initial public offering and secured a $50 million credit facility. (BusinessWire)

FDA Approves Injectable Wireless Spinal Cord Stimulator

Dec. 2, 2014 - Stimwave Technologies Incorporated announced it has received FDA clearance to begin marketing its wireless microtechnology device, the Stimwave Freedom Spinal Cord Stimulation (SCS) System (TM), which is expected to be available in January 2015. Bearing electrode contacts and a microchip, the device is 2-11cm in size, and can be implanted through a standard needle. The permanent implant is designed to allow a patient to have a whole-body MRI of up to 3 Tesla, greater than is currently available. David Kloth, MD, president of the International Neuromodulation Society's North American chapter, hailed the arrival of this new option for chronic pain patients. (Yahoo News)

Company Completes $17 Billion Debt Offering

Dec. 1, 2014 - Medtronic, Inc. raised $17 billion in a corporate-debt bond sale to finance its acquisition of Covidien Plc. The deal was the largest corporate debt offering in more than a year. The investment-grade bonds were given a provisional rating of A3 by Moody's Investors, and had maturities of three to 30 years, with a 10-year bond offering a total yield of 3.613. The offering reportedly attracted $45 billion in orders. (Wall Street Journal)

European Regulators Clear Way for Companies to Merge

Nov. 28, 2014 - Medtronic, Inc. gained European regulatory approval for its $34 billion takeover of Covidien Plc on the condition it sells Covidien's Stellarex catheter business, which will be acquired by Spectranetics. The deal was cleared by US. authorities a few days earlier with the same condition. (Reuters)

Speaker Describes Influencing the Adoption of Neurostimulation Therapy

Nov. 28, 2014 - At the FT Global Pharmaceutical and Biotechnology Conference in London, JP Errico, founder and CEO of electroCore, explained its effort to reach coalitions of medical experts, patient advocacy groups, and payors in the U.S. and Europe to understand the benefits of their non-invasive neurostimulation technology and determine the placement of new therapies in the continuum of care through reimbursement approval processes. (PR.com)

Analyst Plans Webinar Regarding Factors Involved in the Evolution of Neuromodulation Technology

Nov. 25, 2014 - Innovations in neuromodulation technology are anticipated from advances in sensing, wireless communication, mircoprocessing, and mobile health approaches. Collaborative opportunities and trends in medical and non-medical applications will be addressed for registered participants in a webinar on Dec. 4, 2014 that touches upon the field's "technology and adoption roadmap" by a research analyst for the firm Frost & Sullivarn. (PR Newswire)

Company Announces Patent Allowances For Its Neurostimulation Power-Conditioning Technology

Nov. 20, 2014 - Solterix Medical Inc. of New York City announced the U.S. Patent Office has allowed claims for its technology, Limited Total Energy. Described as akin to gears on a car, it received a patent allowance to be applied to invasive neuromodulation devices as well as non-invasive, such as transcranial direct current stimulation. The company said their technology essentially reduces the power demand of electrical stimulation and makes it more energy-efficient. (Businesswire)

Vagus Nerve Stimulation Supplier Eyes New Neurostimulator Release Next Year

Nov. 20, 2014 - Cyberonics, Inc. may be offering a new version of its vagus nerve stimulation system for epilepsy as early as 2015 in the U.S., pending approval. The Houston, TX-area company recently opened its premises to a media tour. (Houston Chronicle)

Custom Provider of Skull Implants Acquires Neurostimulation Technology Supplier

Nov. 19, 2014 - Kelyniam Global, Inc. has supplied cranial and facial implants made-to-order to fill bony voids due to defects or disease. Now the Canton, CT-based business has acquired the custom neuromodulation active-implantable supplier MED-ALLY, LLC to diversify its product line. (Businesswire)

Company Surpasses Goal in Opening Day of Trading

Nov. 19, 2014 - Second Sight Medical Products Inc. began trading 3.5 million shares on the Nasdaq exchange under the symbol EYES, opening at $9 each and more than doubling to $22.45. The company, which has the world's only approved retinal implant, reached a market valuation of $777.3 million. (Reuters)

Start-Up With Pain-Relief Spine Implant Receives Funding

Nov. 17, 2014 - New funding was announced for a medical device start-up in Iowa that has a prototype spinal cord stimulator designed for direct implantation on the spinal cord. Direct Spinal Therapeutics, whose prototype was spun out of the University of Iowa Neurosurgery Clinic, received $140,000 from the Iowa Growth Fund and $1 million in funding from a private investor. The company calls its device the I (Iowa) Patch System. The concept was described in the spring in a presentation to the university regents. Developers say they anticipate more responders due to the direct spinal contact, and believe the implant below the dura would be safe. (University of Iowa)

Proxy Vote Schedule Set for Acquisition by Device Maker

Nov. 17, 2014 - Device maker Medtronic Inc. will hold a shareholders vote on Jan. 6, 2015 regarding its acquisition of Covidien. The same day, Covidien will hold shareholder meetings in Ireland, where it is based. (Minneapolis-St. Paul Business Journal)

Spinal Cord Stimulation Device Maker Raises $145 Million in an Initial Public Offering

Nov. 12, 2014 - Nevro Corp. raised $144.9 million in its initial public offering. The Menlo Park, CA-based company said it hopes to market its high-frequency spinal cord stimulation device, Senza, by early 2016 if approved by the FDA. The company is conducting a prospective, randomized controlled pivotal trial comparing the treatment to low-frequency stimulation. (Mass Device)

Transcranial Magnetic Stimulation Device-Maker Raises More Than 15 Million Euros

Nov. 10, 2014 - Nexstim Oy raised EUR 15.3M in an initial public offering and expects to begin trading Nov. 14 on Nasdaq First North Finland and Nasdaq First North Sweden exchanges. The company sells navigated transcranial magnetic stimulation for pre-surgical mapping of motor and speech cortices. The company is investigating repetitive transcranial magnetic stimulation as part of post-acute stroke treatment in a clinical trial at 12 U.S. rehabilitation centers that participate in the NICHE study (Navigated Inhibitory rTMS in Contralesional Hemisphere Evaluation). (Reuters)

Device Company Obtains External Debt to Finalize Acquisition

Nov. 10, 2014 - Medtronic, Inc. announced finalizing $16.3B in loans as part of its preparations to complete acquisition of Covidien. The financing includes a $11.3B bridge loan of 364 days, and an unsecured loan of $5B for a three-year-term. Two investment rating firms planned to lower the credit rating for Medtronic based on its approach to financing the deal, but the company hopes to maintain an investment-grade credit rating once the deal is final. (Mass Device)

Initial Public Offering Opens Trading Above Expected Range

Nov. 6, 2014 - Nevro Corp. launched its initial public offering Thursday. The company priced 7 million shares at $18 a share (above the expected range of $15-17), and trading opened at $23.40. The company granted underwriters a 30-day option to purchase up to an additional 1,050,000 shares at the same price to cover any over-allotments. http://www.prnewswire.com/news-releases/nevro-corp-announces-pricing-of-initial-public-offering-281730441.html The company has developed a high-frequency spinal cord stimulator, and is trading on the New York Stock Exchange under the symbol NVRO. The offering was initially http://www.massdevice.com/news/nevro-boosts-ipo-126m?page=show expected to gross $126 million. (thestreetinsider.com)

Retinal Prosthesis Maker Seeks $31.5 million in Initial Public Offering

Nov. 6, 2014 - Second Sight Medical plans to raise $31.5 million in an initial public offering that may take place next week. The company makes the Argus II, the first retinal prosthesis approved for sale by the FDA. Second Sight plans to issue 3.5 million shares at $9 each on the NASDAQ exchange under the symbol EYES. (Mass Device)

Device Company Reports Progress in Seeking and Gathering Clinical Trial Data in Chronic Back Pain

Nov. 6, 2014 - Mainstay Medical International plc issued an update saying that more than 25 patients have been implanted with its investigational ReActiv8 device that addresses chronic back pain through helping to restore control of muscles that stabilize the lower spine. The company anticipates that data from 40 patients in its single-arm, prospective clinical trial should be sufficient to apply for CE mark approval. Meanwhile, the company met with the US. FDA regarding a proposed U.S. clinical trial under an investigational device exemption. Mainstay Medical anticipates making a submission to start s U.S. trial in the first quarter of 2015. (Mainstay Medical)

Company Adds a Chief Commercial Officer

Oct. 30, 2014 - EnteroMedics Inc. will have industry veteran Brad Hancock join as chief commercial officer in mid-November. The company is launching vagal blocking therapy, VBLOC, for obesity in the U.S. The company's new incoming executive was most recently vice president of sales and marketing at Flowonix Medical, and has worked more than 30 years in the medical device field. (CNN Money)

Spinal Cord Stimulation Developer Eyes Initial Public Offering in Early November

Oct. 27, 2014 - Nevro Corp., developer of a high-frequency Senza spinal cord stimulation device that is marketed in Europe and Australia, plans an initial public offering on the New York Stock Exchange, which is expected to price the week of Nov. 3. The Menlo Park, CA-based company seeks to raise $100 million by offering 6.3 million shares at a range of $15 - 17 per share. If its device receives FDA approval, the company would initiate a U.S. launch as early as 2016. (Nasdaq)

Conference: Neurotechnology Industry Appears Young, But Promising, and May Benefit from a Roadmap

Oct. 22, 2014 - A blog post about the Neurotech Leaders Forum in San Francisco says the conference presented a fairly sunny outlook for the neuromodulation industry, although the overall industry is still young. Some presenters discussed the possibility of hastening and optimizing development of the field through creation of an industry roadmap and technology standards. (Cirtec)

Acquisition Debt-Financing Plans Unveiled

Oct. 24, 2014 - Medtronic, Inc. plans to assume $16 billion in U.S. debt to help pay its $43 billion acquisition of Covidien, rather than using some $13.5 billion in overseas cash for the merger. The interest rate on the debt is expected to range from 4 - 4.5%. Standard & Poor's announced it would lower its short-term rating on Medtronic to A-1 if the deal goes through as described. Medtronic said the acquisition would be neutral to earnings by fiscal 2019, and that its overall tax rate will lower by 2%. (Mass Device)

Initial Public Offering Postponed Due to Market Conditions

Oct. 23, 2014 - Citing market conditions, EndoStim has postponed its initial public offering. The company markets a neurostimulation device for gastroesophageal reflux, with $1 million in sales for the year ending June 30, 2014. The company planned to raise some $35 million, trading under the symbol STIM. (Renaissance Capital)

Regulatory Filing Provides Companies' Merger Details

Oct. 22, 2014 - More details emerged in a regulatory filing Monday from Medtronic, Inc. regarding its merger with Covidien, which is based in Ireland and operated from Massachusetts. The deal is expected to close late in the fourth quarter or early in 2015, using external debt rather than Medtronic's offshore cash to finalize the transaction. Both companies' shares rose, and two asset-management firms were said to approve the financing structure. The filing said that structure was already approved by Japan, Russia, Israel and Turkey. (Mass Device)

Initial Public Offering Planned for Company Targeting Gastroesophageal Reflux

Oct. 22, 2014 - St. Louis-based EndoStim was scheduled for an initial public offering on Nasdaq of $35 million. The company's implantable system to address severe, medication-resistant gastroesophageal reflux disease has CE Mark approval, an investigative device exemption in the U.S., and is also marketed in South America and Asia. (equities.com)

Neurostimulation Lead with 32 Contacts Introduced at a Meeting in Boston

Oct. 21, 2014 - Boston Scientific Corporation introduced its 32-contact CoverEdge™ 32 and CoverEdge™ X 32 neurostimulation leads this week at the Congress of Neurological Surgeons meeting in Boston. The leads received CE Mark and FDA approval in 2012 and 2013, respectively. While the CoverEdge™ 32 contacts are closely spaced, the CoverEdge™ X 32 provides a wider and longer contact area. International Neuromodulation Society member Giancarlo Barolat, MD, said he believes the ability to cover a larger area of the spinal cord "will give patients, especially those with low back pain or pain in multiple areas, a better opportunity for relief." (PR Newswire)

Subcutaneous Trigeminal Nerve Stimulation Patent Allowed

Oct. 21, 2014 - NeuroSigma, Inc. announced it has received a U.S. patent allowance for the use of  subcutaneously implanted electrodes and pulse generator for trigeminal nerve stimulation (TNS) for the treatment of neuropsychiatric disorders, including depression, ADHD, post-traumatic stress disorder and traumatic brain injury. The company markets an external system TNS system, the Monarch™ eTNS system, and anticipates using that to screen for responders who might then receive a fully implantable system, said International Neuromodulation Society member Ian Cook, MD, senior vice president and chief medical officer of the company, who led TNS development as a professor of psychiatry at the University of California, Los Angeles. The patent is co-owned by NeuroSigma and the University of California Regents, and exclusively licensed to NeuroSigma. (PR Newswire)

Transcranial Magnetic Stimulation System to be Distributed in France, Reimbursed by Insurers in the United States

Oct. 20, 2014 - Brainsway Ltd. announced insurance coverage decisions in the U.S. representing about 17 million people, in addition to a distribution agreement in France for its deep transcranial magnetic stimulation system. Blue Cross Blue Shield will provide reimbursement for the use of the system in Florida, Kansas and Missouri, and Tufts provide reimbursement in Massachusetts. (Globes)

Article Describes Cooperative Research Development Agreement Involving External Trigeminal Nerve Stimulation

Oct. 16, 2014 - An article about the cooperative research and development agreement between Neurosigma, Inc. and U.S. Veteran's Administration offers details about regulatory approvals for the company's external trigeminal nerve stimulation system and its mode of action. The U.S. combat veterans in the Phase I trial will undergo eight weeks of stimulation at home at night, followed by assessment of changes in cognitive function and regional brain activity. The trigeminal nerve, near the surface of the forehead, was selected for bilateral stimulation since it is considered to offer a high-bandwidth pathway linked directly or indirectly to areas of the brain, such as the locus coeruleus, nucleus tractus solitarius, thalamus, and cerebral cortex, that are involved in conditions such as epilepsy, depression, post-traumatic stress disorder, attention-deficit hyperactivity disorder. (PBR Drug Research)

Transcranial Direct Current Stimulation for Consumer Market Draws Investment and Media Interest

Oct. 8, 2014 - An ethics professor quoted in an article about a company that is pursuing transcranial direct current stimulation (tDCS) for the consumer market compares the state of the field's development to the Wild West of brain stimulation. The startup, Thync, raised $13 million in capital. Meanwhile, a writer for the BBC traveled to Boston to experience tDCS as an aid in concentration, describing some of the circuits and neurotransmitters involved in productive and unstressed attention-to-task. (Bloomberg Businessweek)

Neurostimulator to Be Tested in Traumatic Brain Injury; Initial Public Offering Postponed

Oct. 15, 2014 - NeuroSigma, Inc. is postponing its $50 million initial public offering due to poor market conditions. The company announced it has entered a cooperative research and development agreement with the Veteran's Administration to test its external trigeminal nerve stimulation device on veterans with traumatic brain injury. (Los Angeles Business Journal)

European Antitrust Regulators to Decide on Proposed Company Merger by Mid-November

Oct. 13, 2014 -  Medtronic, Inc.'s $43 billion purchase of Ireland-based Covidien Plc would put it on the same footing as Johnson & Johnson, according to Reuters, and will reduce the company's overall tax burden. The company said the goal was to boost its medical technology strategy rather than to acquire an overseas company to relocate its headquarters for tax purposes (a corporate "inversion"). European Union antitrust regulators plan to issue a decision on the deal by Nov. 14. The regulators' options are to approve, request concessions, or investigate. Analysts said since the companies are not competitors it is unlikely there will be significant regulatory worries. (Reuters)

More Details Emerge on Proposed Merger of Device and Medical Supply Companies

Oct. 11, 2014 - Medtronic, Inc. announced that post-merger, it will operate Covidien PLC as a separate unit and overall will restructure around four international bases. The merger would be finalized upon approval by shareholders of each company, and is not anticipated until after Nov. 15, 2014. In addition to the Covidien medical supply group, the structure calls for a cardiac and vascular group, a diabetes group, and a restorative therapies group. (Minneapolis Star Tribune)

Neuromodulation Company Plans Initial Public Offering

Oct. 3, 2014 - Nevro Corp. has filed for an initial public offering under the symbol NVRO on the New York Stock Exchange. The company is reportedly seeking $125 million and intends to launch its Senza spinal cord stimulation (SCS) device by early 2016. The high-frequency stimulation device does not cause paresthesia. It would enter an SCS pain-relief market the company values at $1.5 billion overall. (San Francisco Business Times)

Retinal Prosthesis Maker Secures Additional Financing

Oct. 3, 2014 - Second Sight Medical, which filed for a $132 million initial public offering in August, is entering a bridge loan agreement with the Mann Group to provide operating capital through the end of November. The company developed the first retinal prosthesis approved for sale by the FDA, the Argus II implant. (Mass Device)

Device-Company Merger Will Not Involve Foreign Cash

Oct. 3, 2014 - Medtronic, Inc. announced that its previously announced merger with Covidien will use $16 billion in external financing rather than foreign cash, in the face of moves by the U.S. Treasury Department to tighten tax rules involving mergers or acquisitions of overseas companies. (Mass Device)

Interview Looks at Neurostimulation Development for the Coming Decade

Sept. 24, 2014 - A product leader at the UK-based Cambridge Consultants discusses a recent panel report forecasting neurostimulation market factors, saying clinical appetite will need to be enhanced and a vision of the future established for developers to align with that. (Medgadget)

Low-Back-Pain Device Company Details Plans

Sept. 18, 2014 - In an interview in the Irish Independent, Mainstay Medical CEO Peter Crosby, a member of the International Neuromodulation Society, said their strategy is to build a successful global company out of the Dublin-based business whose ReActiv8 muscle-stimulating device targets low back pain. The article said that at this phase, the company is not planning to be acquired or merged as smaller companies might. (Fierce Medical Devices)

Company Says Study Confirms Potential of Nerve-Stimulation to Improve Some Vision Loss

Sept. 18, 2014 - EBS Technologies, which offers a non-invasive brain stimulation for restoring partial vision to an impaired eye, issued a news release about a study by the company's co-founder, published in Neurology, that he said "confirms that repetitive transorbital alternating current stimulation (rtACS), otherwise known as electrical brain stimulation, can reactivate residual capabilities of brain function." The study said vision loss is not only caused by primary tissue damage, but also by a breakdown of synchronization in brain networks. The stimulation aims to bring about resynchronization of alpha band coherence. (Business Wire)

Company Offering Neurostimulation Therapy for Reflux Files for Initial Public Offering

Sept. 5, 2014 - St. Louis, MO-based Endostim Inc. has filed for an initial public offering in an offer valued at up to $40.25 million. The company plans  to trade on NASDAQ under the symbol STIM. Endostim previously received approval in Europe, Asia and South America of its LES Stimulation System for the treatment of gastro-esophageal reflux disease (GERD). The company plans a U.S. clinical trial. (247wallst.com)

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)

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)

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)

 
     
Last Updated on Thursday, September 22, 2016 04:38 PM
 
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