Industry News Briefs from the International Neuromodulation Society


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    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. (

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: (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. (

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. 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 expected to gross $126 million. (

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. (

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. (

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 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. (

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. (

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,, 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 Monday, March 02, 2015 04:00 PM
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