Neuromodulation Industry News Archive
Industry News 2014
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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 clearance for its Cerena transcranial magnetic stimulator for migraine relief. The device is designed to be held to the back of the head to stimulate the occipital cortex when a patient senses a pre-migraine aura. (Mass Device)
Industry News 2013
Company Seeks PMA for Newly Developed Spinal Cord Stimulation System
Dec. 19, 2013 - Greatbatch has filed for pre-market approval of its spinal cord stimulation system that was designed by its subsidiary, QiG Group. Offering a complete medical system is part of a strategy to increase growth and profitability, the company said. (Mass Device)
First U.S. Patients Receive Deep Brain Stimulation Systems That Are Capable of Sensing and Recording
Dec. 5, 2013 - Medtronic, Inc. announced that the first U.S. patients have received implants of the company's Activa PC+S deep brain stimulation system (DBS) that senses and records brain activity. The system could be subject to research at up to 20 centers, and the brain-mapping data will be made available to physicians worldwide for clinical studies. The system is investigational in the U.S., and received CE Mark in January in the European Union. The first U.S. patients were treated at Stanford Movement Disorders Center and the University of California San Francisco’s Bachmann-Strauss Dystonia and Parkinson Foundation Center of Excellence. (Star Tribune)
Electroceutical Startup Chooses Developer for Programmable Interface
Dec. 5, 2013 - Product developer Sangentia announced it will work on a programming interface with SetPoint Medical to develop an iPad App and advise on radio frequency and Bluetooth Low Energy interfaces for SetPoint's bioelectronics platform. The platform is being developed to treat inflammation-mediated autoimmune diseases as a lower-risk, lower-cost alternative to immunosuppressive drugs for chronic inflammatory diseases. (Business Wire)
Company Expects a Growing Number of Patients to be Covered for Percutaneous Tibial Nerve Stimulation Treatment
Dec. 4, 2013 - Minnesota-based Uroplasty, Inc. expects to end calendar year 2013 with an increasing number of patients receiving insurance reimbursement for its percutaneous tibial nerve stimulation system, Urgent® PC, for overactive bladder and relate symptoms. This includes approximately 40 million Medicare recipients, an increase from 37 million a year ago, and approximately 106 million patients with private insurance, up from 87 million a year ago. The Health Care Service Corporation (HCSC), the largest customer-owned health insurance company in the United States, recently announced that in Illinois, Montana, New Mexico, Oklahoma and Texas, as of Dec. 15, 2013, coverage will be extended for up to three years for patients showing continued improvement after the first year of treatment.
(Benzinga)
Company Releases Interim Results of Weight-Loss Study; Shares Rise
Dec. 3, 2013 - EnteroMedics said its vagus nerve stimulation implant, the Maestro Rechargeable system, showed in the first 18 months of a pivotal five-year study that 117 patients in the active treatment group achieved 25% loss of excess weight compared to 12% weight loss in the 42 patients in the sham treatment group. With the news, shares rose 81 cents Tuesday to $2.24. (TwinCities.com)
Burst Stimulation Spinal Cord Stimulation Clinical Trial Announced
Dec. 3, 2013 - St. Jude Medical, Inc. has initiated a U.S. clinical trial of spinal cord stimulation with its Prodigy™ neurostimulator that uses a proprietary burst mode of stimulation. Up to 442 chronic pain patients will be enrolled at up to 50 sites in the safety and efficacy trial, SUNBURST™ (Success Using Neuromodulation with BURST). The new investigational device has an expected 10-year battery life and requires recharging approximately once a week. It is designed to deliver both tonic and burst stimulation. International Neuromodulation Society President Elect Tim Deer, MD commented that the comprehensive approach may help manage pain in patients whose pain is not adequately managed by tonic spinal cord stimulation alone, or who lose therapeutic benefit over time. Also, the prospect of burst stimulation providing paresthesia-free pain relief means it could suit patients who cannot tolerate traditional stimulation. (Mass Device)
Mobile Platform for Transcranial Direct Current Stimulation Announced
Dec. 2, 2013 - Soterix Medical Inc. of New York, N.Y., Rogue Resolutions Ltd of Cardiff, UK, and neuroConn GmbH of Ilmenau, Germany announced a transcranial direct current stimulation (tDCS) platform with a headgear designed for clinical trial or home use. The MOBILE neuromodulation device kits are designed to deliver Limited Total Energy (LTE) tDCS, using a proprietary technology developed at The City College of New York. The kits include cloud-based compliance monitoring and are explicated to enter clinical trials in 2014. (PR Newswire)
External Stimulation System for Shoulder Pain Approved in Australia
Nov. 22, 2013 - The Australian Therapeutic Goods Administration has approved use of SPR Therapeutics' Smartpatch percutaneous peripheral nerve stimulation system for shoulder pain. The device is manufactured by NDI Medical of Cleveland, Ohio. International Neuromodulation Society Secretary Marc Russo, MBBS, commented that the minimally invasive system fills a gap in the pain treatment continuum, between narcotics or more invasive surgery. (Digital Journal)
Gastroesophageal Reflux Disease Treatment System Approved in Argentina
Oct. 30, 2013 - St. Louis-based EndoStim announced it has received approval in Argentina for sale of its neurostimulation system to treat gastroesophageal reflux disease, GERD. The Lower Esophageal Sphincter Stimulation System strengthens the muscle that prevents stomach acid from rising into the esophagus, which lacks a protective lining to protect against tissue damage. The system uses bipolar leads that are implanted laparoscopically and powered by an impulse pulse generator. (PR Newswire via EndoStim)
Vagus Nerve Stimulator Manufacturer Posts Gains in Second Quarter
Nov. 22, 2013 - Cyberonics Inc. of Houston, TX announced second-quarter 2013 gains with net income up to $13.8 million from $13.5 million during the same quarter one year ago. Sales of its vagus nerve stimulation system grew internationally by almost 10% and overall sales were at a record high. Product development includes submission of the vagus nerve stimulation generator AspireSR for approval in Europe for use in epileptics in whom the device could automatically deliver stimulation in response to a change in heart rhythm. (Fierce Medical Devices)
Canada Approves Electrical Stimulation System to Assist Breathing
Nov. 21, 2013 - Oberlin, Ohio-based Synpase Biomedical received Health Canada approval for its diaphragm pacing system, NeuRx. The system electrically stimulates the muscles to allow spinal cord injury patients to breathe longer without the need of a mechanical ventilator forcing air into the lungs. (Today's Medical Developments)
Early Stage Functional Electrical Stimulation Company Appoints New Director
Nov. 19, 2013 - Medtronic Inc.'s former vice president and general manager of neuromodulation, Karl Schweitzer, was appointed to the board of EBS Technologies GmbH, an emerging device company developing a noninvasive electrical brain stimulation platform to expand the visual field in patients whose vision is impaired following stroke or other nerve damage. The NEXT WAVE(TM) platform stimulates firing along optic pathways. (Market Watch)
Neurostimulation Developer Collaborates with Designer of Power-Efficient Circuits
Nov. 13, 2013 - For the past 12 months, Rosellini Scientific, LLC of Dallas, Texas has been collaborating with NanoWattICs SRL of Montevideo, Uruguay to develop a suite of implantable, wireless and non-invasive neurostimulation technologies for applications including migraines and neuropathic pain. Montevideo, Uruguay- based NanoWattICs received a grant to partially fund this work from the Agencia Nacional de Investigación e Innovación in Uruguay. The company focuses on custom circuits that maximize battery life in portable applications. (PR Web)
U.S. Insurer to Cover Percutaneous Tibial Nerve Stimulation Treatment for Overactive Bladder
Oct. 29, 2013 - Humana, Inc. -- the sixth-largest private health insurer in the U.S. and administrator of Tricare South and several Medicare Advantage plans -- will begin covering treatment with percutaneous tibial nerve stimulation of overactive bladder and associated symptoms, announced Uroplasty, Inc., manufacturer of the Urgent PC Neuromodulation System. (Wall Street Journal)
Column Ponders Market Performance of One Medical Device Company
Oct. 29, 2013 - While shares of Boston Scientific have risen 120% in the past year and exceeded expectations, its adjusted earnings per share growth is less than competitors St. Jude Medical and Medtronic, notes a financial columnist, who adds that the company announced changes ahead with resignation of its CFO, new approvals in China and Europe, and layoffs for 2014. The columnist says moves to stabilize costs and margins would be positive catalysts and, since the stock is trading at a premium (based on its forward profit/earnings ratio) compared to its competitors, the price could be impacted more than its peers during a market pullback. (Motley Fool)
Neuromodulation Implants in the U.S. Burgeoned in the Past Decade
Oct. 27, 2013 - A Star Tribune analysis of data from the U.S. Department of Health and Human Services indicates that there were more than 19,000 neurostimulation implants in the U.S. in 2010, with most of the implants being performed on patients younger than 65 years of age for pain and other indications, such as movement disorder or bladder dysfunction. The total number of neurostimulation implants in 2010 is 80% more than the number performed in the year 2000. The article includes comments from patients industry leaders and states that, according to Transparency Market Research of Albany, N.Y., the global market for neuromodulation devices is expected to grow to more than $6 billion by 2018, at a rate of 14% a year. (Minneapolis Star Tribune)
Device Maker That Targets Voiding Dysfunction Sees More Revenue, Plus an Operating Loss
Oct. 24, 2013 - Uroplasty, Inc. announced a 5% increase in revenues the second fiscal quarter of 2014 compared to the same quarter a year ago. The Minneapolis, MN-based maker of devices to treat voiding dysfunctions took in $6 million in the quarter ended Sept. 30, with $4.5 million of that from U.S. sales. The company booked a one-time expense of $1.2 million due to changes in executive management and internal reviews, and overall had an operating loss of $1.9 million. (PR Newswire)
Neuromodulation Firm Recognized as a Top Private Medical Technology Company of the Year
Oct. 15, 2013 - During FierceMedical's second annual selection of the top 15 device and diagnostic companies of the year, SetPoint Medical was named one of the most promising private med-tech companies. Companies on the list are evaluated based on factors including technology strength, partnerships, venture backers and a competitive market position. SetPoint is developing vagus nerve stimulation of the autonomic nervous system to combat inflammation in autoimmune disease. (EON)
Company Plans to Start Pivotal Clinical Trial of High-Frequency Nerve Block Technology in Amputation Pain
Oct. 10, 2013 - With Investigational Device Exemption from the FDA for its Altius™ System to deliver high-frequency stimulation to sensory nerves in the peripheral nervous system to block chronic pain, Neuros Medical, Inc. can start its pivotal clinical trial of the high-frequency nerve block for management of intractable limb pain in amputees, the company said in a press release. Neuros Medical plans to enroll 130 patients at 15 U.S. institutions for a prospective, randomized controlled clinical trial to evaluate the system's safety and efficacy. (Business Wire)
A $14 Million Deal to Develop Wirelessly Powered Vagus Nerve Stimulation
Oct. 9, 2013 - The company electroCore has entered a deal with waveCore -- a company owned by the founding shareholders of electroCore -- to develop a system to wirelessly power and control an implanted vagus nerve stimulator. New Jersey-based electroCore has developed external vagus nerve stimulation (VNS) to address symptoms of headache and potentially other disorders, such as bronchoconstriction, epilepsy, gastric motility disorders, depression and anxiety. The implanted VNS system would include a receiver that is powered by a transmitter worn on the body or placed up to four feet away at night. With the deal, waveCore will pay electroCore $2 million to fund the first-in-man pilot study, with additional milestone payments of $12 million during the U.S. regulatory process. (Enhanced Online News)
Retinal Prosthesis User Describes Its Advantages as Company Poises for a U.S. Market Launch
Oct. 7, 2013 - A man who has been using the Argus II visual prosthesis that will soon be marketed in the U.S. by Second Sight describes in an interview how it aids his coping with retinitis pigmentosa. The eyeglass-mounted device contributes to quality of life, says ophthalmology professor Jacque Duncan of the University of California, San Francisco, because its video camera link to a retinal implant allows users to distinguish edges and moving objects through enhancing their perception of light and dark. (CBS News)
Israeli Company Raises Funds from Japanese Distributor, Tel Aviv Stock Exchange
Oct. 6, 2013 - Deep Transcranial Magnetic Stimulation (TMS) system manufacturer Brainsway Ltd. of Jerusalem, Israel has raised NIS 24 million on the Tel Aviv Stock Exchange, and also received $1 million over the weekend in the first of two payments from the distributor Century Medical, Inc. of the Japanese ITOCHU Group for exclusive distribution rights in Japan. The company uses technology licensed from the National Institutes of Health to penetrate TMS stimulation to structures deep within the brain. The therapy has initially been focused on major depressive disorder, with other indications under investigation. (Globes)
Company Raises Funds for Vagus Nerve Stimulation Trials in Stroke Recovery, Tinnitus
Sept. 20, 2013 - MicroTransponder, Inc. of Dalla, TX has raised $3.4 million to carry out clinical trials of vagus nerve stimulation -- two trials that would use the company's Vivistim System to restore functionality in the upper limbs of stroke patients, and one using its Serenity System that is designed to "rewire" the auditory cortex of tinnitus patients. The company intends to secure a CE mark for both systems next year, and then raise more funds to support a clinical trial for a pre-market approval in the U.S. (BioNews Texas)
Hand-held Vagus Nerve Stimulation Device Undergoing Development in U.S.
Sept. 13, 2013 - New Jersey-based GammaCore's handheld external vagus nerve stimulation device to minimize effects of chronic migraine is expected to be submitted for FDA approval early next year, after completion of clinical studies, according to a business profile. The prescription device has received approval in Europe, India, Brazil, Canada and Australia, but has not launched commercially. (NJ.com)
Patient Receives MRI While Implanted with Spinal Cord Stimulation Device Designed to Allow Full-Body Scans
Sept. 12, 2013 - An MRI center in South Bend, IN announced it performed the first MRI in the U.S. on a patient who had a neurostimulator that was recently approved for conditional use in full-body MRI scans. (Market Watch)
New Head of Strategic Planning Announced at Firm Marketing Vagus Nerve Stimulation Systems
Sept. 12, 2013 - Rohan J. Hoare, Ph.D., previously president of St. Jude Neuromodulation Division, has been named senior vice president of strategic planning at Cyberonics, Inc. With core expertise in neuromodulation, Cyberonics developed and markets an implanted vagus nerve stimulation system that is FDA-approved for the treatment of refractory epilepsy and treatment-resistant depression. (Market Watch)
Company's Non-Invasive Approach to Vagus Nerve Stimulation Described
Sept. 1, 2013 - Addressing the issue of the inherent challenges involved in surgically accessing the vagus nerve to implant cuff electrodes prior to a lengthy recovery period, ElectroCore Medical of Bernards Township, New Jersey is developing non-invasive vagus nerve stimulation therapies. The devices are being developed to treat or prevent symptoms of serious headache conditions, including migraines and cluster headaches, and bronchoconstriction including asthma and chronic obstructive pulmonary disorder. (Implantable Devices)
Medical Device Industry Investment Options Analyzed in Financial Column
Aug. 28, 2013 - Medtronic, Inc. is noted as being worthy of consideration for income investors due to its stable history of dividend increases and diversification into such divisions as neuromodulation, which has future growth potential. (Motley Fool via Daily Finance)
South Korea Approves Transcranial Magnetic Stimulation for Major Depressive Disorder
Aug. 23, 2013 - A transcranial magnetic stimulation technology developed by NeuroStar for major depressive disorder was approved by the South Korea Ministry of Food and Drug Safety. Neuronetics will work with distribution partner BR Holdings of Seoul for entry into the market, which is considered to represent the world's 15th largest economy. (BioSpectrum Asia)
Vagus Nerve Stimulation System Maker Reports Strong First-Quarter 2014 Earnings
Aug. 22, 2013 - Net product sales increased 12.4% to $67.4 million in the first fiscal quarter ended July 26 for Cyberonics, Inc. of Houston, TX. Including license revenue, sales were up 14.2% overall, with Europe in particular contributing a strong performance. Diluted earnings per share were adjusted by $0.17 cents due to a litigation settlement. (PR Newswire)
Neurostimulation Industry, Investment and Research Puts Ohio on the Map
Aug. 22, 2013 - Ohio's neurostimulation industry is described as being "on the brink of a breakout" due to its economic climate, investments, advances and talent. (hiVelocity)
New Bioelectronic Medicines Fund Joins $27 Million Financing Round for Start-Up Neuromodulation Company
Aug. 8, 2013 - A year after starting a Bioelectronics R&D division, GlaxoSmithKline launched Action Potential Venture Capital (APVC) Limited in Cambridge, Mass., a $50 million venture capital fund targeting development of bioelectronic medicines and technologies with the potential to normalize signaling between the peripheral nervous system and organs in some chronic disease states. Along with Covidien and Boston Scientific Incorporated, APVC joined existing investors to participate in a $27 million round of financing for neuromodulation start-up SetPoint Medical, a Valencia, CA company creating vagus nerve stimulation devices to treat inflammatory diseases. (Fierce Medical Devices)
Voiding Dysfunction Treatment Drives Sales Growth
Aug. 1, 2013 - Uroplasty, Inc. reported its first sequential growth for three quarters in its quarterly results for the first quarter of fiscal 2014, ended June 30, 2013. Sales of its devices to treat voiding dysfunctions grew 11% from the fourth quarter of fiscal 2013. Overall, the company's global sales increased 5% to $5.8 million in the first quarter of fiscal 2014, compared to $5.6 million in the fiscal first quarter a year ago. (MSNMoney)
Neuromodulation Sales Add to Company's Bottom Line
July 25, 2013 - Boston Scientific Corporation's neuromodulation sales in the second quarter of 2013 ending June 30th were up 21% over the same period the previous year, according to quarterly results the company announced Thursday. Overall, analysts noted the device maker showed organic sales growth, from an operational standpoint, for the first time since 2009. This 2% growth on a constant currency basis, excluding divested businesses, was largely due to its neuromodulation and cardiovascular business segments. Neuromodulation sales were $14 million ahead of analysts' consensus forecast, at $111 million for the second quarter of 2013. (Medical Device and Diagnostic Industry)
Retinal Prosthesis Company Prepares to Raise Capital
July 24, 2013 - Second Sight Medical Products is seeking to raise $10.5 million, according to a regulatory filing. The Sylmar, Calif.-based company received FDA approval earlier this year to market its Argus II retinal prosthesis -- already sold in Europe -- in the U.S. to assist patients who have late-stage retinitis pigmentosa. (Medical Device and Diagnostic Industry)
Closed-Loop Spinal Cord Stimulator Developer Receives Startup Grant
July 22, 2013 - NICTA spin-out Saluda Medical received a $5M grant from an inaugural round of funding from the New South Wales, Australia Government’s Medical Devices Fund. Through the Ministry of Health, the fund is intended to promote innovative new medical technologies that may have a global benefit. NICTA is Australia’s largest publicly-funded information and communications technology research organization. Sydney-based Saluda is developing closed-loop spinal cord stimulation that adjusts stimulation levels based on detecting neural response. (WhaTech)
Medical Device Company Charts Growth Plans
July 11, 2013 - Greatbatch, Inc. is looking for a partner to bring its spinal cord stimulation system Algostim to the end market, and believes the spinal cord stimulation market is $1.4 billion, growing at more than 10% a year, according to an interview in a business column. The company is combining the sales, marketing and operations groups of its Greatbatch Medical and Electrochem Solutions, the article says, in a realignment that is meant to help achieve growth of 5% or more annually. (Dallas Business Journal)
Company Developing Responsive Stimulation for Epilepsy Raises $18 Million
July 9, 2013 - NeuroPace of Mt. View, California reported in a U.S. Securities and Exchange Commission filing that it has raised about $18 million of a planned $50 million round of funding. The 20 investors who provided the new capital were not named. Since its founding in 1997, NeuroPace has raised about $180 million. (Silicon Valley Business Journal)
Company Seeks Premarket Approval from FDA for Vagus Nerve Stimulation Device to Treat Obesity
June 26, 2013 - Minnesota-based EnteroMedics submitted its premarket approval application to the FDA for review of the Maestro VBLOC system that stimulates the vagus nerve to reduce food cravings to treat obesity, metabolic disease and other gastrointestinal disorders. (Mass Device)
U.S. Clinical Trial of Deep Brain Stimulation System Starts
June 17, 2013 - Boston Scientific Corporation announced the first U.S. patient has been implanted with the Vercise deep brain stimulation system for the treatment of Parkinson's disease at Cedars-Sinai Medical Center in a prospective, multi-center, double-blinded, randomized, controlled study, INTREPID, to evaluate the safety and effectiveness of motor function and overall quality of life.
Developing Neurostimulation Technology Receives $3 Million Commercialization Grant
June 18, 2013 - The Ohio Third Frontier Commission has awarded a $3 million grant to Case Western Reserve University to commercialize a neurostimulation technology in collaboration with NDI Medical LLC, SPR Therapeutics and Valtronic. Developed over the past decade, the platform is designed to treat indications ranging from pain to muscle paralysis. (Healio)
Heart Failure Neuromodulation Startup Receives Venture Capital Funding
June 13, 2013 - NeuroTronik of Chapel Hill, N.C. received $13.1 million from a venture capital syndicate led by Hatteras Venture Partners to develop its neuromodulation system to treat heart failure by improving pumping effectiveness. (News & Observer)
Company Launches Integrated Lead-to-Pulse-Generator Interconnect for Implantable Neurostimulators at INS 11th World Congress
June 4, 2013 - The first pretested integrated lead-interconnect system designed for implantable neurostimulator pulse generator devices will be featured at the International Neuromodulation Society's 11th World Congress in Berlin June 8-13 at the Evergreen Medical Technology booth. The system, Encompass, is versatile and enables rapid product development; it has a port-entry screw-anchor mechanism and three lead strain relief seal options for transition from the header port. A slot is molded into the header for the placement of a radiopaque identifier and a suture hole is included. The header has been designed with a set of two anchors to firmly attach the header to the hermetic enclosure. (Business Wire)
U.S. Shipments of Transcranial Magnetic Stimulation Systems Are Set to Start
June 3, 2013 - Brainsway is poised to begin shipping its Deep TMS (transcranial magnetic stimulation) system to the U.S. where the company received clearance for marketing it for drug-resistant major depressive disorder. The system is also approved in Europe for addressing neuropathic chronic pain, bipolar disorder, and schizophrenia. Using a special helmet to target specific regions of the brain, treatment is conducted in an outpatient setting during 20-minute sessions over a four week period. (MedGadget)
Texas Man Finds relief From 32-Contact Spinal Cord Stimulator
May 30, 2013 - A man who suffered from chronic pain despite repeat surgery and painkillers found relief through spinal cord stimulation, according to a newspaper account that profiles the patient, a U.S. Navy veteran. His procedure was one of the first in the Dallas-Ft. Worth area with Boston Scientific's 32-contact Precision Spectra™ system. (Star-Telegram)
Deep Brain Stimulation Visualization System Receives CE Mark Approval
May 27, 2013 - Boston Scientific Corporation has received CE Mark approval for use of its deep brain stimulation visualization system, Guide DBS, in Parkinson's disease. The tool allows physicians to visualize the relative position of the lead and model stimulation fields and output. Designed to help reduce programming time and tailor stimulation therapy, the system is the first commercial product resulting from the company's acquisition of Intelect Medical in 2011. (PR Newswire)
Deep Brain Stimulation Technology Platform is the Basis of a Newly Launched Company
May 23, 2013 - Venture and commercialization firm NDI Medical launched a new portfolio company, Deep Brain Innovations, LLC, to commercialize its Temporally Optimized Patterned Stimulation (TOPS™) technology that delivers novel, more efficient, patterns of stimulation, allowing smaller and longer-lasting devices. (Digital Journal)
North American is Estimated to Account for Largest Share of Neuromodulation Market
April 28, 2013 - North America is estimated to account for the maximum share of the neuromodulation market in 2012, followed by Europe, and Asia-Pacific countries like Japan, India, and China, according to a report by Markets and Markets that looks at 2012 - 2017. (Digital Journal)
Neuromodulation Growth Reported in Company Earnings Report
April 25, 2013 - Boston Scientific announced global year-over-year revenue growth of 6 percent in neuromodulation and combined revenue in the countries of Brazil, Russia, India and China 35 percent year-over-year, while taking a write down of $422 million related to the 2006 acquisition of Guidant Corp. for $28 billion. Overall adjusted earnings per share were $0.16 for the first quarter ended March 31, 2013, on revenue of $1.761 billion. (Sacramento Bee)
2013 Directory of Neuromodulation Products Being Published and Will Be Free to INS World Congress Attendees
April 2013 - Neurotech Reports, the publisher of Neurotech Business Report, will publish the 2013 Directory of Neuromodulation Products later this year. The print directory will be given to each attendee at the 11th World Congress of the International Neuromodulation Society (INS), which takes place June 8-13, in Berlin, Germany, and attracts more than 1,500 clinicians, engineers, researchers and entrepreneurs to hear an internationally renowned faculty address the most comprehensive breadth of all neuromodulation therapies. For more information, contact Neurotech Reports at 415 546 1259 or visit this link. (Neurotech Reports)
INS Accepts Record Number of Abstracts for Biennial Congress
April 19, 2013 - The International Neuromodulation has accepted a record number of abstracts for its 11th World Congress June 8 - 13 in Berlin. Diverse highlights are previewed in a news announcement issued today. INS also announced a pre-conference innovation-and-investment summit. (Newswise)
Company Plans Presentation on External Trigeminal Nerve Stimulation in Children with ADHD
April 18, 2013 - Results of external trigeminal nerve stimulation in children aged 7 - 14 who have attention deficit hyperactivity disorder will be presented on May 20 in San Francisco by Los Angeles-based NeuroSigma, Inc. The open-label Phase I study was prompted by observations in PET scans of the stimulation's effect on attention centers. (San Francisco Business Times)
Report Foresees Double-Digit Growth in Neuromodulation
April 18, 2013 - TechNavio predicts a compound annual growth rate of 15.3 percent from 2012 - 2016 for neuromodulation across the globe, partly due to an increase in neurological disease. (PR Web)
Company Sees First-Quarter Earnings Dip, But Strong Year-Ahead Prospects
April 17, 2013 - St. Jude Medical sales of neuromodulation products were $99 million in the first quarter of 2013, down 4 percent from the prior year. Overall, partly due to unfavorable currency translations, the company reported net sales of $1.338 billion in the first quarter of 2013, a decline of approximately 4 percent compared with the first quarter of 2012. With more than 20 diverse products due to launch in 2013, the company expects full-year 2013 consolidated net earnings to be in the range of $3.68 to $3.73. (Wall Street Journal)
Deep Brain Stimulation Service Comes to Bangalore
April 17, 2013 - Commenting on a new deep brain stimulation service for Parkinson's disease patients in Bangalore, a neurologist calls the procedure a good option in carefully selected patients. The Columbia Asia Referral Hospital in Yeshwanthpur is one of more than 20 medical facilities in India and Southeast Asia operated by Columbia Asia Group, which entered the country with 100 percent foreign investment. (Moneylife)
Company to Launch Anchoring Technology for Spinal Cord Stimulation Leads and Pain Pump Catheters
April 15, 2013 - Boston Scientific Corporation announced it has acquired and is launching the Fixate Tissue Band for spinal cord stimulator leads and pain pump catheters. Anulex Technologies of Minnetonka, MN developed the device to secure leads to the fascia or inter-spinous/supra-spinous ligament, and received expanded FDA approval last year for the catheter application. International Neuromodulation Society member Richard Bowman, MD, commented that the device permits quick and efficient lead anchoring. (Implantable Medical Devices)
Peripheral Nerve Stimulation Trial for Back Pain Begins Enrolling Patients
April 11, 2013 - Patient enrollment has begun in the SubQStim II pivotal clinical trial of peripheral nerve stimulation for chronic back pain. Medtronic, Inc. plans for up to 323 patients at up to 30 U.S. centers in the trial, in which patients will be randomized into control or treatment groups for the first three months, then participate in open-label follow-up for up to five years. (Mass Device)
Company Announces Research Funding, Prize to Develop "Electroceuticals"
April 10, 2013 - The global pharmaceutical company GlaxoSmithKline (GSK) announced plans to foster development of "electroceuticals" that were compared to a cross between a device and molecular medicine. The investment might initially target using an electric stimulus to regulate cytokine production involved in inflammatory diseases such as rheumatoid arthritis. The unveiling includes a $1 million research prize, and initial funding of work by 40 scientists in 20 labs at such institutions as MIT, the University of Pennsylvania, and Feinstein Institute of Medical Research. Heading the effort, GSK Vice President of Bioelectronics Research and Development Kristoffer Famm was lead co-author of a commentary in Nature. (Fierce Biotech)
Future Growth Will be a Key Topic of the INS 11th World Congress Pre-Conference, Innovations in Neuromodulation
April 10, 2013 - The International Neuromodulation Society expects more than 200 entrepreneurs, thought leaders, innovators and investors at Innovations in Neuromodulation on June 9th in Berlin, a pre-conference of the INS 11th World Congress. The day-long session draws industry strategists and investment managers by focusing on business, technical, and regulatory developments in this rapidly changing field. (BusinessWire)
Spinal Cord Stimulation Featured in Business Column
March 29, 2013 - International Neuromodulation Society member Anthony Berg, MD, was interviewed by a business columnist about using the new 32-contact Precision Spectra spinal cord stimulator by Boston Scientific. In the three cases he has implanted so far, patients have all seen a significant drop in use of pain medication and an improvement in quality of life, he said. (Dallas Business Journal)
Maker of High-Frequency Stimulation Device Garners $48 Million in Series C Financing
March 7, 2013 - Nevro Corp. has completed a $48 million Series C round of financing led by new investor Novo Ventures, with New Enterprise Associates and Coviden Ventures. Existing investors participating in this financing round included Accuitive Medical Ventures, Bay City Capital, Johnson & Johnson Development Corporation, Mayo Clinic, MPM Capital, and Three Arch Partners. Based in Menlo Park, Calif., Nevro is commercializing the Senza® high-frequency spinal cord stimulation system for chronic pain, such as low back pain, and other conditions. The system is available in Europe and Australia. The funds will be used to sponsor an ongoing U.S. clinical trial, explore new indications, and support commercialization. (Nevro)
Neuromodulation Market Report Predicts $12.45 Billion Market by 2023
March 4, 2013 - In a market report that spans 2013 - 2023, Visiongain projects a value of $12.45B for the global neuromodulation devices market in 2023. Among other factors, the report describes expanding disease indications. (PR Newswire)
Heart Failure Neuromodulation Developer Receives Additional Startup Funding
Feb. 28, 2013 - Sorin Group announced a $5 million investment in Israel-based Enopace Biomedical, which is developing an endovascular neurostimulation system for heart failure. Sorin Group, a global medical device company based in Milan, has invested in Enopace in 2011 and anticipates further investments based upon completion of development milestones. (BusinessWire)
Device Supplier Posts Strong Profits in Fourth Quarter
Feb. 26, 2013 - Greatbatch, Inc. posted a fourth-quarter 2012 adjusted earnings per share of 53 cents significantly exceeded the year-ago adjusted earnings of 39 cents (up 36% year over year). Within the neuromodulation and cardiac rhythm management area, sales decreased 5% year over year to $73.7 million due to market competition, strong shipments in the prior quarter and tough year-over-year comparables. In this sector, management anticipated short-term headwinds from key original equipment manufacturer customers. (NASDAQ.com)
Deep Brain Stimulation Developer Receives Additional Funding
Feb. 25, 2013 - Sapiens Steering Brain Stimulation B.V. of Eindhoven, the Netherlands and Munich, Germany, has added €7.5 m to its €16.5 m round of Series A financing. The investment supports development of a deep brain stimulation with the capacity to steer the electrical pulses away from areas which may produce side-effects. The most recent financing comes from the Dutch investment group INKEF Capital, whose founder Frank R. Landsberger, PhD, was appointed to the company's advisory board. Sapiens was spun out in 2011 from Royal Philips Electronics to commercialize a steering brain stimulation probe, implant and image-guided programming. (News-Medical.Net)
Vagus Nerve Stimulation Device Company Sees Shares Climb
Feb. 22, 2013 - Cyberonics Inc. said Friday that its net income climbed 39 percent in the fiscal third quarter as it sold more of its nerve stimulation devices designed to treat epilepsy and depression by delivering electrical stimulation to the vagus nerve. Net income in the November-January quarter rose to $13.2 million, or 47 cents per share, from $9.5 million, or 34 cents per share. Revenue rose grew 15 percent, to $62.7 million from $54.5 million. (Yahoo News)
Agreement Reached to Distribute Neuromodulation Products in Japan
Feb. 20, 2013 - The Boston Scientific subsidiary Boston Scientific Japan K.K. has reached an agreement with Fukuda Denshi Co., Ltd. to market and sell the Boston Scientific Spinal Cord Precision Plus System and accessories throughout Japan. Fukuda Denshi will begin distributing Boston Scientific neuromodulation products April 1, 2013. (Boston Scientific)
Clinic Created to Streamline Process for Potential Deep Brain Stimulation Candidates
Feb. 20, 2013 - A new clinic aimed at streamlining the evaluation and approval process for the growing number of patients who are potential candidates for deep brain stimulation has opened at the Muhammad Ali Parkinson Center of the Barrow Neurological Institute. The process should now be completed in six weeks or less, rather than up to one year, and includes comprehensive treatment education. (PR Newswire)
New Rates for INS Pre-Conference Sessions
February 2013 - The pre-conference sessions on June 8 and 9 for the 11th World Congress, Technology Transforming Chronic Illness Management, are now $360.53 each day, or $600 for both days. Register for one or two pre-conference days and the main congress and receive a 10% discount on the pre-conference fee. (International Neuromodulation Society)
Brazilian Chapter of the International Neuromodulation Society Launches Website
February 2013 - The Brazilian chapter of the INS (Sociedade Brasileira Neuromodulação - SBNM) has published its website listing articles, conferences, and members and their specialties, which include interventional pain treatment, movement disorders, spasticity, and neurosurgery.
A Social Media Presence for the 11th World Congress
Feb. 1, 2013 - The International Neuromodulation Society has added an 11th World Congress "event" area to its Facebook page about the June 2013 meeting in Berlin that features a map of the meeting location at the Estrel Hotel, and provides an opportunity to share information, post a photo, video, or link, and network with upcoming attendees. (Facebook)
Magnetic Resonance Imaging Compatible Spinal Cord Stimulation Systems Released in Europe
Jan. 30, 2013 - Medtronic, Inc. released in Europe the first spinal cord stimulation systems for use in treating chronic back and/or leg pain that are designed for compatibility with full-body magnetic resonance imaging (MRI) scans under specific conditions. The devices recently received CE Mark approval. They include special leads that can withstand MRI scanning and a proprietary programming option, SureScan, which sets an appropriate mode for an MRI environment. International Neuromodulation Society member J.P. Van Buyten, MD, from the AZ Niklaas Hospital in Belgium, was quoted as calling the development an important advancement. (National Pain Report)
Retinal Implant Maker Eyes Raising More Capital
Jan. 29, 2013 - Second Sight Medical of Sylmar, Calif. registered with the Securities and Exchange Commission on Monday to raise $25 million while waiting for the FDA to decide whether to approve its retinal implant, Argus II, which has been sold in Europe since 2011. (MassDevice)
Chronic Pain is Called a Poorly Recognized Silent Epidemic
Jan. 29, 2013 - International Neuromodulation Society president Simon Thomson, MBBS, FRCA, FIPP, FFPMRCA, commented in conjunction with release of a survey of more than 1,000 chronic pain sufferers across Europe, "The Painful Truth Survey: The State of Pain Management in Europe," sponsored by Boston Scientific and supported by a number of regional pain associations. He noted that healthcare systems throughout the world have not really produced specific answers to the needs of patients who suffer chronic pain that is not resolved by addressing any identifiable underlying condition. Some 17% of Europeans, he continued, will have significant chronic pain affecting daily living, with about 1/3 of those having pain that is really quite severe. About half suffer from neuropathic pain that arises spontaneously from damage to the nervous system. Of the patients whose neuropathic pain does not respond to pharmacological treatment, he said, spinal cord stimulation becomes an option, and has been advancing technologically since he first began using it slightly more than 20 years ago. (Boston Scientific)
Global Randomized Clinical Trial to Compare Medical Management With Or Without Spinal Cord Stimulation for Lower Back Pain
Jan. 28, 2013 - International Neuromodulation Society member Philippe Rigoard, M.D., is principal investigator of a global randomized clinical trial of patients with predominant low back pain due to failed back surgery syndrome. The study, sponsored by Medtronic, Inc., compares optimal medical management combined with use of a multicolumn, implantable lead for neurostimulation treatment and optimal medical management alone. The first of up to 300 patients in the PROMISE trial began treatment in the U.S. earlier this month, and Dr. Rigoard started enrolling patients January 14 at Poitiers University Hospital in France. The study is designed to assess the value of spinal cord stimulation (SCS) for predominant low back pain with leg pain. Previous studies focused on predominant leg pain. Health care utilization data will be collected to develop cost analysis models to potentially evaluate the long-term economic impact of SCS. (Yahoo Finance)
INS Website's List of Terminology Descriptions Grows
Jan. 24, 2013 - The latest addition to the International Neuromodulation Society's list of descriptions of terminology for use by patients or the general public is a brief overview about neuromodulation therapy. Since its inception one year ago -- through the efforts of the website's editorial contributors, the list of short explanations for treatment and condition terms has been viewed some 30,000 times by INS website visitors. (International Neuromodulation Society)
Neuromodulation Startup Adds Board Member
Jan. 22, 2013 - Functional Neuromodulation, founded in Toronto in 2010, has added Vince Owens, former CEO and director of Intelect Medical, to its board of directors. Other board members are company co-founder and CEO Dan O’Connell; founding scientist Andres Lozano, MD, PhD; Kelly Holman, managing director of Genesys Capital; and Andrew D. Firlik, MD, managing partner at Foundation Medical Partners. Lothar Krinke, PhD, vice president and general manager of Medtronic’s Deep Brain Stimulation business serves as an active board observer. Dedicated to applying deep brain stimulation (DBS) to memory and other cognitive disorders, the company is conducting the ADvance Study in North America to evaluate DBS of the fornix, a major pathway in the brain’s memory circuit, for patients with mild Alzheimer’s disease. (BioSpace)
Small-Business Grant Announced to Aid Deep Brain Stimulation System Programming for Parkinson's Disease
Jan. 22, 2013 - The National Institutes of Health, National Institute of Neurological Disorders and Stroke is funding a clinical feasibility study at the University of Alabama at Birmingham through a $283,828 Phase I Small Business Innovation Research grant to Cleveland, OH-based Great Lakes NeuroTechnologies to explore using intelligent algorithms to aid programming deep brain stimulation in Parkinson’s disease. The system will leverage existing technology to quantify Parkinson’s motor symptoms such as tremor, bradykinesia, and dyskinesia into a functional map. Intelligent algorithms will determine optimal parameters for symptom relief while minimizing side effects and battery consumption. (News-Medical.Net)
Functional Neuromodulation System for Foot Drop Cleared for Use by Minors
Jan. 22, 2013 - Valencia, Calif.-based Bioness Inc. announced it has received FDA clearance to market to pediatric patients and their caregivers its L300 system to treat foot drop, a condition which causes walking difficulty in adults and children who have motor-impairment conditions such as cerebral palsy, stroke or traumatic brain injury. The system consists of a small wireless sensor in the shoe, a sport brace-like leg cuff worn just below the knee, and a hand-held remote control. In addition to being used to assist walking, it can also be used for rehabilitation purposes. (Business Wire)
Israel-Based Company Eyes an Expanded Presence in U.S. Trading and Distribution
Jan. 21, 2013 - Brainsway Inc. of Israel expects to name a U.S. partner this quarter to distribute its noninvasive transcranial magnetic stimulation system for treatment-resistant depression, a technology it licensed from the National Institutes of Health. This step would precede seeking listing on the Nasdaq exchange, according to an article in Bloomberg BusinessWeek. (Bloomberg)
Analysis Estimates a $6.8 Billion Market for Neuromodulation in 2017
Jan. 14, 2013 - The U.S.-based firm Marketsandmarkets forecasts the global neuromodulation market will reach $6.8 billion by 2017. Vagus nerve stimulation is expected to see the most growth due to being less invasive and with more development of applications anticipated. The key factors that drive the neuromodulation market are higher incidences of endemic diseases, rise in aging population, technological advancement, devices under approval, and presence of several niche players. Reimbursement in certain geographies and cost of devices are major challenges. North America is estimated to account for the maximum share of the neuromodulation market in 2012, followed by Europe, and Asia-Pacific countries like Japan, India, and China. (PR Newswire)
New Device Rules Reported to Take Effect This Month in Russia
Jan. 11, 2013 - Revised regulations regarding medical device clearances in Russia reportedly took effect Jan. 1, 2013. It was previously reported that some of the anticipated changes were that final approval decisions will be made by “expert reviewers” rather than the regulator (Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation, or Roszdravnadzor); there was an apparent lack of timelines for medical testing, meaning they could last for years; and medical device registration fees would be written into law. One anticipated change could mean expert reviewers would determine whether additional clinical testing of a device is necessary and provide a list of hospitals where that should occur. A registration certificate would be issued to an applicant based on a positive expert review, or a refusal would be based on a negative expert review. (Mass Device)
Israel Company Announces Its Noninvasive Depression Treatment Device is Cleared by FDA Jan. 9, 2013 - Brainsway Ltd. announced it has obtained FDA approval for its deep transcranial magnetic stimulation device to treat depression in patients who fail to respond to therapeutics during a depression cycle. (Globes)
Smart Phone Interface Technology Presented for Controlling TENS
Jan. 9, 2013 - The Consumer Electronics Show included what was presented as a certified transcutaneous electrical nerve stimulation medical product by China-based E-Tek that uses an iPhone interface, according to a blog covering the event. (9to5Mac)
External Peripheral Nerve Stimulator to Initially Target Post-Stroke Shoulder Pain
Jan. 8, 2013 - SPR Therapeutics expects CE mark certification for its Smartpatch peripheral nerve stimulator to be announced shortly, according to published comments by the chief executive officer of the Cleveland-based company. Also, the company plans clinical trials at six U.S. centers in the next few months, initially targeting post-stroke shoulder pain. Finally, the company was reported to have raised an additional $2.8 million in financing, bringing the total to $5 million from NDI Healthcare Fund, Public Square Partners and individual investors. (MedCity News)
Market Study Projects Neuromodulation Growth to $12.45 billion by 2023
Jan. 8, 2013 - London-based Visiongain predicts a $12.45 billion global market for neuromodulation devices by 2023, with sales of $3.03 billion in 2011. Hemant Mistry, healthcare industry analyst, says, "The neuromodulation device market has experienced substantial growth in recent years, as their benefits in cost saving particularly have become more evident. Such devices can not only provide long-term relief to patients, but can also offer an effective alternative to the use of drugs that are well-known to have side effects . . . (although the initial cost of the device and surgery to implant the device is high, their prescription is cost-effective in the long-term). With future developments in the pipeline such as phrenic nerve and gastric stimulators . . . the market for neuromodulation devices has significant potential to grow in the future". (PR Newswire)
Vagus Nerve Stimulation Therapy Developer Adds Industry Veteran to Its Board
Jan. 4, 2013 - The co-founder and former CEO of Cyberonics, Inc., Reese Terry, has joined the board of directors of ElectroCore, which is developing non-invasive vagus nerve stimulation therapies for serious headache conditions and bronchoconstriction. (PR Newswire)
Upcoming Neuromodulation Market Report Predicts Continued Growth
Jan. 3, 2013 - The growth in emerging markets such as India and China will be driven by an aging population that will increase demand for newer treatment options for age-related diseases, such as deep brain stimulation (DBS) for motor disorders, according to a market report being published next month by Visiongain. The report, for instance, anticipates the DBS market will almost
double in value, reaching $0.85 billion in 2017, with a compound annual growth rate of 11.2%. (Visiongain)
Industry News 2012 
Company's Device Reaches 100,000th Implant
Dec. 24, 2012 - Cyberonics, Inc. announced the 100,000th patient implant of its vagus nerve stimulation (VNS) system for epilepsy. This is the 15th year of VNS approval for the treatment of epilepsy in the U.S. and 25th anniversary of Cyberonics' founding. (NASDAQ)
Neuromodulation Market Report Released
Dec. 5, 2012 - Reportlinker.com announced a new analysis of global neurostimulation markets from 2010 - 2018. The report analyses markets for spinal cord stimulation, deep brain stimulation, sacral nerve stimulation, vagus nerve stimulation, and gastric electric stimulation; and profiles 21 companies, including Boston Scientific Corp., Cyberonics, Inc., Medtronic, Inc., St. Jude Medical, Inc., Synapse Biomedical, Inc., and SPR Therapeutics, LLC. (The Street)
Device Maker of Vagus Nerve Stimulation Systems for Epilepsy is Ranked "Outperform"
Nov. 30, 2012 - Cyberonics, Inc. maintained an "outperform" rating by Zacks Equity Research due to strong continued growth in its vagus nerve stimulation products to treat epilepsy in the U.S. and abroad. The last-reported quarter saw a 17% increase in sales to $63 million compared to the same quarter last year, and an increase in earnings per share of 37.5% to 44 cents. The results surpassed Zacks consensus estimates of $60 million in sales and 39 cents in earnings per share. (Zacks Equity Research)
Patent Issues for Method to Treat Obesity Through Sympathetic Nerve Stimulation
Nov. 27, 2012 - The U.S. Patent Office issued a patent Nov. 27, 2012 assigned to Advanced Neuromodulation Systems, Inc. (now part of St. Jude Medical) for treating obesity by electrically stimulating the sympathetic nervous system to induce feelings of satiety and increase energy expenditure. Stimulation would be applied on or near sympathetic nerves such as the sympathetic chain ganglia, the splanchnic nerves (greater, lesser, least), or the peripheral ganglia (e.g., celiac, mesenteric). (Equities.com)
Patent Issued to Improve Reliability of Neuromodulation Lead Connection
Nov. 6, 2012 - A U.S. patent issued Nov. 6, 2012 and assigned to Medtronic, Inc. covers an implantable lead with coplanar contract coupling to reduce conductor bending moments where the contact connects to the lead, reducing chances of stress affecting the conductor that can interfere with reliability of the connection. (NewsRx.com)
Patent Issued to Limit Patient-Initiated Neurostimulation
Nov. 6, 2012 - A U.S. patent issued Nov. 6, 2012 and assigned to Cyberonics, Inc. would provide the capability to set a variety of limits or alternative modes, which may include reduced repeat on-demand dosing, on patient-initiated stimulation doses for an implantable neurostimulator, such as a vagus nerve stimulator used to treat epilepsy. (equities.com)
Company Acquires Vagus Nerve Stimulation Developer to Enhance Heart Failure Portfolio
Nov. 12, 2012 - Milan-based Sorin Group announced acquisition of Neurotech SA, of Belgium, which developed an implantable vagus nerve stimulator that uses a rechargeable battery and records neural activity of the target. Sorin said the acquisition will accelerate the time to market of its neuromodulation therapies to treat heart failure. Neurotech SA was spun out of the Université catholique de Louvain with funding by SOPARTEC, the technology transfer company of Université catholique de Louvain, Vives Louvain Technology Fund SA and SRIW Techno SA (Société Régionale d'Investissement de Wallonie). (Business Wire)
Neuromodulation Market Predicted to Grow to More Than $7 billion by 2018
Oct. 30, 2012 - The market for neuromodulation devices is expected to grow at a compound annual growth rate of 14.4 percent from 2012, reaching $7.07 billion in 2018, according to a report by Transparency Market Research. North America accounted for 65% of the market in 2011, while the Asia-Pacific region represents the fastest growth at a compound annual growth rate of 14%. Contributing to that growth is the aging population, coupled with the increase in chronic diseases, increasing demand for minimally invasive surgeries, and availability of external funding to conduct clinical studies to help come up with new and technologically advanced products. (PR Newswire)
Cleveland-Based Firm Receives Most Promising Startup AwardOct. 29, 2012 - Cleveland-based Neuros Medical, Inc. received Neurotech Reports' 2012 Gold Electrode Award for Most Promising Startup at the Neurotech Leaders Forum in San Francisco on Oct. 22. Publisher James Cavuoto said the company has a strong, focused market and is executing development of its technology in a sound and effective manner. The company is carrying out a pilot clinical trial to evaluate its patented high-frequency Electrical Nerve Block™ technology for acute treatment of pain in the residual limb of amputees. The company has also identified potential applications in chronic post-surgical pain, chronic migraine, and trigeminal neuralgia. (Neuros Medical)
Supplier Reports Increased Income from Neuromodulation
Oct. 26, 2012 - Greatbatch, Inc.'s neuromodulation and cardiac rhythm management sales increased 13% from the previous year, to $80.3 million, the company reported in a quarterly earnings statement. Overall, third-quarter adjusted earnings of 46 cents per share exceeded the year-ago adjusted earnings of 41 cents per share and were above an analyst consensus estimate of 44 cents per share. The company reported a net loss of $7.6 million, compared to a net gain in the third quarter of 2011 of $7 million. The cause of the loss was reported to come from operational hazards at its Swiss orthopedic facilities.
Low-Profile Neurostimulation Device Earns Patent
Oct. 25, 2012 - International Neuromodulation Society member Carl Wahlstrand and Robert Skime are inventors on a U.S. patent issued Oct. 23, 2012, and assigned to Medtronic, Inc. for a neurostimulation device with a low profile so it may be implanted directly beside a neuralgic region at the back of the neck, for instance, to relieve symptoms of occipital neuralgia. (equities.com)
Paralympic Athlete Releases Her Biography Next Week at Neurotechnology Conference
Oct. 15, 2012 - Jennifer French, a quadriplegic and competitive sailing athlete who recently medaled at the 2012 Paralympics Games in London , will release her new book, On My Feet Again: My Journey Out of the Wheelchair Using Neurotechnology, October 23, 2012 at the Neurotech Leaders Forum in San Francisco. She uses a functional electrical stimulation (FES) system that was designed and developed at the Cleveland FES Center, a consortium of Case Western Reserve University, Veterans Administration and MetroHealth Medical Center. (Neurotech Reports)
Market Research Report Examines Neuromodulation Devices Forecast through 2018
Oct. 17, 2012 - Transparency Market Research offers a report on the neuromodulation devices market, including global industry size, market share, trends, analysis, and forecasts from 2012 - 2018. The announcement lists major device companies as including Medtronic, St. Jude Medical, Boston Scientific, Cyberonics, IntraPace, Nevro, Johnson & Johnson, Codman, and Integra. (SBWire)
Follow-up Study Reviews Safety and Durability of Bladder Incontinence Device
Oct. 15, 2012 - Three of seven patients who were implanted with a tibial nerve stimulation device in 2003 continued to use the Urgent PC product by Uroplasty, Inc. regularly over nine years and sustained improvement in symptoms of overactive bladder, according to results to be presented at the annual meeting of the International Continence Society (ICS) in Beijing. (PR Newswire)
Israeli Device Company Enters Second Phase of Global Trials of Vagus Nerve Stimulation for Heart Disease
Oct. 14, 2012 BioControl Medical, Inc. has entered a second phase of its multi-center, global clinical trials of the CardioFit vagus nerve stimulation system. The trials in 650 heart failure patients should take about three more years, funded in part by a 2010 investment of $70 million by Medtronic. (Israel 21c)
Closed-Loop Deep Brain Stimulation Anticipated to be Ready for Clinical Trials in One Year
Oct. 12, 2012 - A closed-loop deep brain stimulation system designed to only deliver stimulation when needed to patients with Parkinson's disease or epilepsy should be ready for human clinical trials next year, according to an interview with Medtronic. (Technology Review)
Patent Issued for Powering Medical Implants Passively from an External Source
Oct. 11, 2012 - Medtronic has received a new U.S. patent for a passive method of powering implanted medical devices wirelessly from an external source, including possibly having the source be located in chairs, blankets or clothing. (MassDevice)
China, India Launch New Medical Regulatory Guidelines
Oct. 9, 2012 - China's State Food & Drug Administration released instructions that will require Chinese labels or packaging marks on foreign medical devices as of April 1, 2013. Meanwhile, India's Drug Controller General of India has begun a special effort scrutinizing manufacturing processes for discrepancies, and is considering introducing a bill this winter on drugs, cosmetics and medical devices, due to a growing consensus that a separate governing law is needed for medical devices. (HealthpointCapital)
Market Report Predicts the Neuromodulation Market Size May Rival That of Cardiac Devices
October 2012 - A new market report segments the neuromodulation sphere into deep brain stimulation, transcranial magnetic stimulation, spinal cord stimulation, vagus nerve stimulation and peripheral nerve stimulation. It claims the market from 2012-2018 will benefit from growing demand for non-invasive treatment options and by addressing large patient populations in epilepsy, anxiety disorders, stroke, depression, Parkinson's disease and others. Overall, it predicts the neuromodulation market to become as big as the cardiac devices market. (Transparency Market Research)
Israeli Exoskeleton Maker Plans a U.S. Headquarters in Massachusetts
Oct. 2, 2012 - Argo Medical Technologies Ltd. announced it will open U.S. headquarters in Marlborough, Mass, as part of its entry into the U.S. market for its exoskeleton that allows paraplegics to walk. The ReWalk device is currently available for use at rehabilitation centers by multiple users, according to news reports. CE Mark approval was received in 2010 for the Israel company's system. (Boston.com)
Hand Prosthesis Maker Creates Version Appropriate for Smaller and Younger Amputees
Oct. 1, 2012 - Touch Bionics of Livingston, Scotland, has announced release of a compact version of its hand prosthesis that includes individual artificial fingers whose action is powered by batteries in a wristband. This version allows the i-Limb Digit to be fitted to smaller persons, as well as young teen-agers or possibly younger people, the company said. (The Scotsman)
News Feature Article Explores Neurostimulator Company's Status and Market Prospects
Oct. 1, 2012 - Cyberonics' vagus nerve stimulators have been implanted in 55,000 U.S. patients with treatment-resistant depression since 1997; business in Europe is growing in double digits, and approval was received in Japan for the treatment of refractory epilepsy two years ago, where about 350,000 potential patients have treatment-resistant epilepsy. The $24,500 device's generator is about 3/4 of the total cost, and must be periodically replaced. Possible future markets may include depression and chronic heart failure. (Investor's Business Daily)
CE Mark Approval Announced for Selective Deep Brain Stimulation System
Sept. 29, 2012 - Boston Scientific Corp. announced receiving CE Mark approval for the Vercise deep brain stimulation system for the treatment of Parkinson's disease. The system allows selective stimulation through multiple independent current control. (Implantable-Device.com)
Analyst Firm Forecasts a $6.9 Billion Market by 2018, Examines Driving Factors
Sept. 28, 2012 - Global Industry Analysts, Inc. reports the release of its comprehensive global report on neurostimulation markets. The firm identified more than 140 products in the development pipeline, and vagus nerve stimulation seems to be the fastest-growing intervention, at a projected 23%. The market is anticipated to reach $6.9 billion by 2018. (PR Web)
Minneapolis Back-Pain Neuromodulation Therapy Start-Up Secures $20 Million, Will Move to Ireland
Sept. 27, 2012 - Mainstay Medical, which targets chronic non-specific lower back pain, has obtained $20 million in financing and will relocate to Ireland from Minneapolis. Chief Executive Peter Crosby, a member of the International Neuromodulation Society, is quoted as saying the therapy is based on recent science, and that one societal benefit of improved therapy is returning people to work. (Irish Times)
Insurance Group in New England Will Cover Overactive Bladder Neuromodulation Treatment
Sept. 26, 2012 - ConnectiCare of the Emblem Health family of insurers has begun coverage of percutaneous tibial nerve stimulation (PTNS) using Uroplasty Inc.'s Urgent PC system for overactive bladder. With the insurance coverage, the therapy is available to 240,000 ConnectiCare members. Also, the California Technology Assessment Forum has concluded that PTNS meets short-term benefit criteria. (PR Newswire)
Minnesota Company Receives Additional Financing for Obstructive Sleep Apnea Trial
Sept. 24, 2012 - Apnex Medical of St. Paul, Minn. has raised an additional $10 million to support its randomized clinical trial of its hypoglossal nerve stimulation system to treat obstructive sleep apnea. (MedCity News)
External Trigeminal Nerve Stimulation System to be Offered by the National Health Service
Sept. 22, 2012 - An external trigeminal nerve stimulation device approved for use in Europe for severe epilepsy and major depression is described in an overview of Neurosigma Inc.'s Monarch system. (Daily Mail)
Israel Company Eyes U.S. Clinical Trials Using Transcranial Magnetic Stimulation in Alzheimer's Disease
Sept. 21, 2012 - A therapy being developed for mild to moderate Alzheimer's disease combines memory exercises and focused transcranial magnetic stimulation. Developed by Neuronix of Israel, the NeuroAD system has marketing approval in Europe and Asia, and is set to undergo multi-site U.S. trials to expand upon studies undertaken by a professor of neurology at Harvard Medical School. (News-Medical.net)
Patent Materials Describe Spinal Cord Stimulation Epidural Needle Invention
Sept. 20, 2012 - An epidural needle for spinal cord stimulation undergoing patent review has been assigned to Greatbatch Ltd. (Equities.com)
CE Mark Approval Announced for Family of Neurostimulators to Treat Intractable Chronic Migraine
Sept. 20, 2012 - St. Jude Medical Inc. has received CE Mark approval for its Eon family of neurostimulators for patients with intractable chronic migraine. The company previously received CE Mark approval for European marketing of the industry's first-approved implanted neurostimulation device for this indication, the Genesis system. The new approvals include the rechargeable Eon mini and Eon systems and EonC (a non-chargeable option). (St. Jude Medical)
U.S. Firm Partners with German Company to Fund Trial of Vagus Nerve Stimulation in Epilepsy
Sept. 20, 2012 - Cyberonics, Inc. has invested EUR 2 million in cerbomed GmbH, becoming a minority shareholder and financing a current clinical trial in Germany of cerbomed's transcutaneous vagus nerve stimulation device, Nemos, for the treatment of epilepsy. Commercially available in Germany and Austria, the system received CE Mark approval for the treatment of epilepsy and depression in 20120, and pain in 2012. Houston-based Cyberonics developed and markets an FDA-approved vagus nerve stimulation system for the treatment of medically refractory epilepsy and treatment-resistant depression. Under the agreement, Cyberonics may invest up to EUR 5.5 million and optionally conduct a Nemos clinical trial in the U.S. (4-traders.com)
FDA Permits Clinical Trial of Externally Powered Peripheral Nerve Stimulation Device for Post-Stroke Shoulder Pain
Sept. 20, 2012 - Cleveland-based SPR Therapeutics has received clearance from the FDA to begin a randomized, controlled clinical trial of a minimally invasive peripheral nerve stimulation system for treating post-stroke shoulder pain. The system, Smartpatch, uses an external battery that snaps onto an adhesive patch to stimulate a lead placed on the deltoid muscle during an office procedure. About 60 patients will be enrolled in the safety and efficacy trial set to begin by the end of the year. (MedCity News)
Company Says FDA Clearance Obtained for Urinary Incontinence Device
Aug. 30, 2012 - Colorado-based Zynex, Inc. announced FDA 510(k) clearance of its InWave medical device, primarily used for treating female urinary incontinence. The company manufactures and markets diagnostic and electrotherapy devices, and recently opened a European subsidiary. (Reuters)
Vagus Nerve Stimulation Company Investors Anticipated to Seek Profits Following Positive First-Quarter Results
Aug. 28, 2012 - Cyberonics Inc. shares opened trading on Tuesday about 10% up after the company released first-quarter results that beat analyst expectations, then dropped to about 5% up near mid-day. Prices may decline slightly during the week as investors take profits, predicted the information service PropThink. The vagus nerve stimulation device company reported sales growth of 15% and income growth of 35% over the same quarter a year ago. (PropThink via Reuters)
Wireless Transcutaneous Electrical Nerve Stimulation Device Receives FDA Marketing Approval for Back Pain
Aug. 28, 2012 - The CNET blog "Crave" reported on the WiTouch wireless transcutantous electrical nerve stimulation device (TENS), recently cleared by the FDA for marketing for back pain in the U.S. In addition to this over-the-counter version, the device maker Hollywog of Chattanooga, TN, was also cleared to market the WiTouch Pro, a programmable version that can be used on the upper back and is available by prescription. (CNET)
Vagus Nerve Stimulation Company Due to Release Quarterly Earnings Report
Aug. 24, 2012 - Cyberonics, Inc., which markets a vagus nerve stimulation system, was reported to be expected to release results for the first quarter of fiscal 2013, with an anticipated earnings per share of 36 cents on revenues of $58 million for the quarter. (Zack's Investment Research)
Market Report Places Size of Neurostimulation Market at $16.3 billion in 2011
Aug. 17, 2012 - The "Markets for Electrostimulation Devices" report from notes that the neurostimulation market reached $16.3 billion in 2011 and has a moderate growth projection for the next few years. The report was recently issued by the life sciences research publisher Kalorama Information. (Healthcare Finance News)
Weight-Loss Neurostimulation Device Maker Seeks to Raise Additional Capital
Aug. 15, 2012 - EnteroMedics, a weight-loss neurostimulation device maker, filed regulatory documents with the U.S. Securities and Exchange Commission to sell up to $75 million in stock, securities and warrants. Through exercising warrants, the device maker may issue more than 1.7 shares of common stock. (MassDevice)
New Ohio-Based Medical Commercialization Network Will Focus on Neuromodulation and Other Emerging Technologies
July 24, 2012 - In what is described as the creation of the largest medical commercialization network in Ohio, neuromodulation will be one of the first areas of innovation to be targeted for commercialization under a new regional partnership, the Cleveland Plain Dealer reported. International Neuromodulation Society member Ali Rezai, president of the INS North American Chapter and director of the Ohio State University's Center for Neuromodulation, was quoted about the new partnership between Ohio State University and the Cleveland Clinic. The development was also reported by Med City News http://bit.ly/MmzBo6. (Plain Dealer)
Neuromodulation Product Pipeline Volume is Described
July 13, 2012 - Coverage of a market report by GBI Research indicates there are 144 products in the neurostimulation pipeline. Deep brain stimulators are reportedly the largest component, comprising almost 17%, then vagus nerve stimulators, with 21 pipeline products, and spinal cord stimulators have just seven products expected on the horizon. (NeuroNews)
Analysts Initiate Coverage of Medtronic, Estimate a Stock Price 5% Ahead of Market
July 6, 2012 - Trefis Analysts initiated coverage of the medical device company Medtronic, with a stock price estimate of $41, which is about 5% ahead of the current market price for this leading medical device supplier. The analysis firm said neuromodulation accounts for about 11% of the company's stock price. (Trefis)
Market Research Firm Estimates that Neurostimulation Market May Double by 2018
July 3, 2012 - The global neurostimulation market, estimated at $2.3 billion in 2011, is expected to almost double by 2018 to $4.4 billion, with a compound annual growth rate of 10%. Market share of the three main manufacturers was reported to be 62% for Medtronic, 15% for St. Jude, and 13% for Boston Scientific. Electrical neurostimulation devices are becoming more common as the world's elderly population increases, Global Data reports. (PHARMABIZ.com)
Medicare Changes to Only Covering Transcutaneous Electrical Nerve Stimulation for Clinical Trials
June 11, 2012 -- The Centers for Medicare and Medicaid Services will no longer cover most uses of transcutaneous electrical nerve stimulation (TENS) for chronic low back pain, based a on a review prompted by a 2010 report by an American Academy of Neurology panel that found published reports presented conflicting evidence of effectiveness. The agency will cover randomized clinical trials of TENS for three years. (MedPage Today)
Licensing Agreement Targets MRI-Compatible Leads for Vagus Nerve Stimulation System
June 11, 2012 - Cyberonics, Inc. has entered into an exclusive technology license agreement with Imricor Medical Systems, Inc. to develop magnetic resonance imaging-compatible leads for use with its vagus nerve stimulation system. (PR Newswire)
CE Mark Granted for Vagus Nerve Stimulator to Treat Refractory Epilepsy
June 8, 2012 - Belgium-based Neurotech has received CE mark approval for its vagus nerve stimulation system to treat epilepsy patients who are refractory to anti-epileptic drugs and not eligible for surgery. The company's ADNS-300 uses a cuff electrode to record vagus nerve activity, which can be used to personalize the treatment. (Medical Device Network)
Vagal Nerve Stimulation Device Company Reports Increased Earnings on Par with Estimates
June 6, 2012 - For the quarter that ended April 27, 2012, Cyberonics reported U.S. net sales increased 10% in the period, while international net sales grew 33%, on a constant currency basis. Net income and diluted earnings per share were both up, at $10.7 million and 38 cents per share respectively, compared to last year's $7.4 million and 26 cents diluted earnings per share. The company markets an FDA-approved vagus nerve stimulation (VNS) system for epilepsy and treatment-resistant depression, and said further growth is expected based on global replacement activity of VNS in epilepsy. The company repurchased $50 million in shares for the year, had $97 million in cash at the year's end, and met analysts' earnings estimates for the quarter. (Cyberonics)
Company: Transcranial Magnetic Stimulation Device for Depressive Disorders Receives European Marketing Approval
June 4, 2012 Pennsylvania-based Neuronetics announced it has received CE mark approval for its transcranial magnetic stimulation device, Neurostar, so that it can be marketed in Europe now for treatment of depressive disorders. It has been approved since 2008 in the U.S. to treat major depressive disorders in patients who have not received satisfactory results with antidepressant medication. (MedCity News)
Company Expected to Seek FDA Approval to Market Its Device to Treat Depression with Deep Transcranial Magnetic Stimulation
May 30, 2012 - Following a multicenter trial http://on.msnbc.com/LGskwE of deep transcranial magnetic stimulation in 233 patients suffering from treatment-resistant depression, Brainsway is expected to seek FDA approval to market its device in the U.S. in June. The initial trial results showed that after five weeks of treatment with the helmet-shaped device, some 30% of patients in the treatment group went into remission and 36.7% of patients showed more than 50% decrease in symptoms. The device delivers magnetic stimulation in a wider area of the brain than the more focused stimulation delivered by repetitive transcranial magnetic stimulation. (IEEE Spectrum)
Company Receives Commercialization Loan for Shoulder-Pain Device
May 24, 2012 - The Ohio Department of Development will loan SPR Therapeutics $900,000 to commercialize the company’s neurostimulation pain-relief system, designed to relieve post-stroke shoulder pain through peripheral nerve stimulation. (MedCity)
Device Component Supplier Will Move Corporate Headquarters to Texas
May 22, 2012 - Medical device supplier Greatbatch Inc. announced it will move its corporate headquarters from outside Buffalo, N.Y. to Frisco, Texas, to be near medical technology firms, academic research centers, and an international airport. The company will maintain offices, manufacturing and research and development operations in western New York. (Dallas News)
Investment Firm Increases Stake in St. Jude Medical
May 7, 2012 - St. Jude Medical Inc.'s largest investor, Boston-based MFS Investment Management, reported in a regulatory filing it has increased its stake from owning about 8% of the medical device maker's stock to about 10%, a stake worth about $1.03 billion at the recent share price. (Mass Device)
Analyst Discusses Funding for Obesity Trial
April 20, 2012 - EnteroMedics' recent round of financing should allow it to complete its Recharge trial that examines its vagus nerve stimulation device in control and treatment groups, and probably also continue to a product launch, comments an analyst who follows the company. (MedCity News)
Small Business Receives Grants for Motor Symptom Monitoring and High School Curriculum
April 20, 2012 - Great Lakes NeuroTechnologies, which was spun out of Cleveland Medical Devices, has received a grant of about $3 million from the National Institute on Aging to enhance its technology that monitors Parkinson's disease symptoms at home, Kinesia HomeView. The platform uses a ring-like sensor worn on a finger to measure motor symptoms and transmit data about tremor. With the new funding, the platform will be enhanced to evaluate gait and balance. The company received an additional grant from the National Institute of Neurological Disorders and Stroke for a wireless physiological monitor and Web-based curriculum to teach neuroscience to high school students. (MedCity News)
St. Jude Medical Neuromodulation Sales Grow by 12 Percent
April 18, 2012 - In the first quarter of 2012, sales of neuromodulation products at St. Jude Medical, Inc. were $103 million, up 12 percent from the comparable quarter of 2011. (Seeking Alpha)
Deep Brain Stimulation Device Maker Closes Financing Round
April 10, 2012 - Aleva Neurotherapeutics, a company developing next-generation implants for deep brain stimulation, announced the closing of a Series B financing round totaling 4.0 million in Swiss francs. (Open PR.com)
First Commercially Available Vagal Blocking Systems for Obesity Shipped to Australia
April 5, 2012 - EnteroMedics announced it has shipped its first commercially available MaestroRechargeable System for vagus nerve blocking therapy, VBLOC, designed to control both hunger and the feeling of fullness, to Australia. The company also said it has signed a multiyear distribution agreement to sell the system to countries in the Persian Gulf. (MedCity News)
Tissue-Securing System Now Permitted for Intrathecal Catheter Applications, Company Says
April 4, 2012 - Anulex Technologies announced it has received FDA approval to expand indications for its fiXate™ Tissue Band. The product was previously approved for securing Spinal Cord Stimulation (SCS) lead anchors to fascia or interspinous/supraspinous ligaments in patients with chronic, intractable pain of the trunk and/or limbs. The new indication allows for securing intrathecal pain pump catheters in the same tissue. (Enhanced Online News)
Early-stage Medical Device Company Announces New Vice President for Neurology
April 2, 2012 - NeuroSigma, an early-stage medical device company exploring new systems of trigeminal nerve stimulation for neurological disorders, has appointed its recent senior medical advisor, Christopher M. DeGiorgio, MD, to the new post of vice president, neurology. A professor of neurology at the University of California, Los Angeles, he was first to study TNS in patients with epilepsy, and collaborated with in developing TNS as a potential treatment for depression, PTSD and ADHD, the company said. (PR Newswire)
With an Approved Neurostimulation System for Overactive Bladder, is Small Company a Valuable Investment?
March 23, 2012 - Minnesota-based Uroplasty has had FDA clearance since 2005 for its system to treat urge incontinence, Urgent PC, which uses percutaneous tibial nerve stimulation. An investment column explores the market being pursued by this small company, and its stock's investment value. (Seeking Alpha)
How Mature is the Market for Transcranial Direct-Current Stimulation?
March 16, 2012 - A NeuroTech Zone blog looks at one company's intent to provide $99 mail-order devices for the non-invasive cortical stimulation approach transcranial direct-current stimulation. (NeuroTech Zone)
Neuromodulation Sales Increase in Medtronic's Third Quarter
February 21, 2012 - Medtronic's neuromodulation business reported a 4 percent increase to $419 million in the third quarter of a fiscal year ending April 30. The growth was driven by strong InterStim Therapy sales. Also, the company received FDA clearance in the third quarter for the RestoreSensor spinal cord stimulator with the proprietary AdaptiveStim technology. (Becker's Orthopedic, Spine & Pain Management)
Device-maker Greatbach Pays $12 million for Neural Interface Developer NeuroNexus
February 17, 2012 - Reuters reports that Greatbach, a leading pulse-generator component maker, acquired NeuroNexus for about $12 million. NeuroNexus develops neural interface devices across a wide range of functions including neuromodulation, sensing, optical stimulation and targeted drug delivery applications. Key NeuroNexus technologies, high-density silicon-based electrodes and interconnects, are more suited to neuroprosthetic rather than neuromodulation therapies, points out NeuroTech Zone, adding that the acquisition "brings us one step closer to a long-awaited clinical trial of probes developed using the semiconductor microfabrication technologies." (NeuroTech Zone, Reuters)
St. Jude Fourth-Quarter Report Shows Neuromodulation Growth
February 3, 2012 - St. Jude's quarterly earnings report shows growth of the neuromodulation segment was up 12%. Overall revenues were up although that was offset somewhat by special charges. (Zack's)
Boston Scientific Announces CE Mark Approval and European Launch for Rechargeable Spinal Cord Stimulator InfinionTM 16 Percutaneous Lead
February 3, 2012 - At the World Institute of Pain Conference, Boston Scientific announced it has received regulatory approval to begin marketing its Infinion 16 Lead in European CE Mark countries. Already marketed in the U.S., it is designed for use with the company's rechargeable Precision PlusTM Spinal Cord Stimulator System. The first patient implant in Europe using the InfinionTM 16 Lead was performed at the Sahlgrenska University Hospital in Guldheden, Sweden by by Kliment Gatzinsky, MD, Ph.D., and David Revesz, MD - both members of the International Neuromodulation Society. (PR Newswire)
Hybrid Imaging and Emerging Markets are Growth Areas for Medical Devices
January 27, 2012 - The use of hybrid imaging technologies such as PET/CT and PET/MRI will see growth in the diagnostic imaging industry and will likely be a mainstay in future imaging, according to a report from GBI Research. The report also anticipates that the increasing demand for imaging in emerging markets, including China, India and Brazil, will balance the lower demand in developed countries, particularly the U.S., because of reimbursement cuts. (MolecularImaging.net)
EnterioMedics, Inc. Receives Australian Approval for Vagal Stimulator Targeting Digestive Functions, Reports Ongoing Medical Trial Spending
January 26, 2012 - EnteroMedics Inc., which develops vagal neuroregulation devices to treat obesity, metabolic diseases and other gastrointestinal disorders by affecting the perception of hunger and fullness, announced final approval to commercialize its Maestro System in Australia. For the full year ended December 31, 2011, the company reported a net loss of $26.0 million, or $0.86 per share, and $29.7 million in cash and equivalents. Main operating expenses are for ongoing clinical trials, including the ReCharge Pivotal Trial, due to be unblinded by the end of 2012. In it, 233 patients are being evaluated at 10 sites to test effectiveness and safety of a second-generation Maestro System powered by a rechargeable integrated battery. All patients in the randomized, double-blind, parallel-group study are expected to participate in a weight management counseling program and receive an implanted device, with one-third of patients, in a control group, receiving a non-functional device for the duration of the study. (Newswire)
 Industry News 2011
Obstructive Sleep Apnea Therapy Receives European Approval
October 26, 2011 - Apnex Medical, Inc., has received CE Mark approval in Europe to market and sell its neurostimulation device for the treatment of obstructive sleep apnea. The company presently is pursuing FDA clearance for the device.(Star Tribune)
Enopace Biomedical Receives Funding for Neuromodulation Therapy to Treat Patients with Congestive Heart Failure
October 20, 2011 - Sorin Group has invested $7 million in Enopace Biomedical for the development and study of an implantable neurostimulator to increase heart efficiency in patients suffering congestive heart failure. (Mass Device)
Penta™ Surgical Lead Receives Regulatory Approval in Japan
October 7, 2011 - The Japanese Ministry of Health, Labor and Welfare (MHLW) has granted regulatory approval of St. Jude Medical's Penta™ surgical Lead for neurostimulation for the treatment of chronic pain. The Penta lead is also available in the U.S., Europe, Australia and Canada. (MassDevice)
Cyberonics Invests in ImThera's Neurostimulator for Obstructive Sleep Apnea
October 5, 2011 - Cyberonics, which produces a vagus nerve stimulator for epilepsy, has invested $4 million to fund research on ImThera's hypoglossal nerve stimulator for the treatment of obstructive sleep apnea. ImThera is pursuing CE Mark approval in Europe and plans are underway for a pivotal clinical trial. (Xconomy)
Nevromatrix Receives $3.5M in Funding to Further Research on its Neurostimulator
September 27, 2011 - Everett Partners has invested $3.5 million in Nevromatrix in support of further research on its Auto-Targeting Neurostimulation therapy, a device designed to non-invasively pinpoint the source of pain. Nevromatrix obtained FDA approval for the device last year. (Globes)
Anulex Technologies, Inc, Receives FDA Approval of its Spinal Cord Stimulation Lead Anchors
September 20, 2011 - The FDA has given clearance to Anulex Technologies' fiXate™ Tissue Band, which secures Spinal Cord Stimulation (SCS) lead anchors to the fascia or interspinous/supraspinous ligament in patients with chronic, intractable pain in the limbs and/or trunk. (Enhanced Online News)
NeuroSigma Receives STTR Phase I Grant from NINDS to Further Research on eTNS Therapy for Intractable Epilepsy
September 6, 2011 - National Institute of Neurological Disorders and Stroke (NINDS) has awarded NeuroSigma an NIH Small Business Technology Transfer (STTR) Phase I Grant to further development of its external trigeminal nerve stimulator (eTNS™) for the treatment of intractable epilepsy. The grant will be applied toward the animal and human clinical trials of a new pulse generator and electrodes. (NewsMedical)
NINDS Grants MicroTransponder $2.5 Million to Continue Development of its Neurostimulator
August 16, 2011 - The National Institutes of Neurological Disorders and Stroke (NINDS) has awarded a Phase II U44 SBIR grant of $2.5 million to MicroTransponder to further develop its SAINT™ wireless neurostimulator for the treatment of chronic pain and other neurological disorders, after the company successfully reached its Phase I endpoints. MicroTransponder has collaborated with the NINDS staff to "develop milestones designed to efficiently translate this technology for clinical use." (PRWeb)
Cyberonics Stops Shipment of Aspire Generators (Models 105 and 106)
August 15, 2011 - Cyberonics, Inc., has stopped shipping and is recalling field inventory of its Aspire generators (models 105 and 106) due to a hardware-related design issue. The company does not believe the generator will put patients at risk, but it is suspending its E-36 clinical trial until inconsistencies in the output current have been resolved. (Street Insider)
Nevro Corp. Secures $58 Million to Fund U.S. Pivotal Trial and International Commercialization of Spinal Cord Stimulator to Treat Chronic Pain
July 19, 2011 - Johnson and Johnson Development Corporation, as well as Nevro's existing investors, Aberdare Ventures, Accuitive Medical Ventures, Bay City Capital, Mayo Clinic, MPM Capital, and Three Arch Partners have invested in Nevro's neurostimulator for the treatment of chronic back and leg pain. (Mass Device)
Spinal Modulation Raises $30 Million in Series D Financing
June 15, 2011 - Investors include DeNovo Ventures, ePlanet/DFJ, InCube Ventures, Johnson & Johnson Development Corporation (JJDC), Kleiner Perkins Caufield & Byers, Medtronic, MedVenture Associates, and Raffles Venture Partners. The funding will be applied toward international clinical trials, with the hope of commercializing its spinal cord stimulation system outside of the US in the near future. (Enhanced Online News)
Medtronic Receives CE Mark Approval for Peripheral Nerve Stimulator
May 23, 2011 - The peripheral nerve stimulator, which is not yet available in the US, is being used to treat chronic back pain. (Mass Device)
FDA Approves Neurostimulator to Treat Chronic Fecal Incontinence
April 4, 2011 - The FDA has approved Medtronic's InterStim device, a sacral nerve stimulator used to improve or restore bowel control. The device previously had gained FDA approval for treatment of bladder dysfunction. (Bloomberg Businessweek)
Gastric Stimulator Receives CE Mark Approval
March 29, 2011 - EnteroMedics' Maestro RC System, which uses electrical stimulation to suppress hunger, has received CE Mark approval in Europe. The company is conducting more clinical trials and is hoping to gain FDA approval for the device in 2012. (MedCity News)
St. Jude Medical Receives Approval to Sell its DBS in Australia
January 24, 2011 - The Australian Therapeutic Goods Administration has approved the Athena Programmer, which enables physicians to adjust deep brain stimulation parameters, and collect patient data for export and analysis. (MedCity News)
Boston Scientific Purchases Intelect Medical
January 5, 2011 - Boston Scientific is acquiring Intelect Medical, a start-up company that is developing a visual programming system and direnal leads for deep brain stimulators, to enable clinicians to visualize the anatomical structures and target stimulation in patients. Boston Scientific is planning to use the programming technology with its Vercise deep brain stimulator, which is in clinical trials for the treatment of Parkinson's Disease. (Star Tribune)
2010 & Earlier
Boston Scientific Abandons Plans to Sell its Neurostimulation Business
December 13, 2010 - Boston Scientific ceased its efforts to sell its Neuromodulation Division a few weeks ago and has no further plans to pursue the sale. Analysts speculate that the company is reevaluating the potential for its neuromodulation business. (Bloomberg)
Tibial Nerve Stimulator Gains Coverage from Regional Medicare Carrier
November 26, 2010 - Uroplasty Inc.'s posterior tibial nerve stimulator, used for the treatment of overactive bladder, is now covered by Palmetto GBA for California, Nevada and Hawaii. (Mass Device)
Boston Scientific Begins Deep Brain Stimulation Trial in Europe
November 9, 2010 - Boston Scientific has announced the multi-center, prospective clinical trial of its Vercise deep brain stimulator for the treatment of Parkinson's disease. The study will examine motor function in approximately 40 European patients in whom the device will be implanted. The neurostimulator is not available for sale. (Mass High Tech)
The European Union Approves St. Jude Medical's New Deep Brain Stimulator Programmer
September 20, 2010 – St. Jude Medical, Inc. has announced European CE Mark approval of its new Athena™ programmer, a deep brain stimulation (DBS) therapy management system. The programmer is a notebook-based PC that clinicians can adjust either through a touch screen or keyboard.
Stryker Purported to Be in Talks with Boston Scientific's Neuromodulation Division
August 17, 2010 - Bloomberg has reported that Stryker Corp., a maker of artificial hips and knees, is in advanced talks to buy Boston Scientific's Neuromodulation division for about $1.5 billion. If an agreement is reached, the announcement may be made next week. (Bloomberg)
FDA Approves Boston Scientific Leads
August 2, 2010 - Boston Scientific Corp. was granted U.S. Food & Drug Administration approval for leads designed for use in its Precision Plus spinal cord stimulator system. (MedCity News)
EndoStim raises $6M in Venture Capital
July 19, 2010 - EndoStim Inc., a start-up company that is making microstimulators to treat gastrointestinal and urological neuro-muscular disorders, has reported that it had raised $6 million in Series B equity financing. EndoStim would invest the money to continue clinical trials and pursue FDA approval for gastroesophageal reflux disease and urinary urge incontinence. (St. Louis Business Journal)
Neuros Medical Receives U.S. Government Funding for Stimulator to Treat Amputees' Pain
July 2, 2010 - The U.S. Department of Defense has awarded $1.5 Million for the development of its neurostimulator to treat the chronic pain suffered by amputees, known as stump or phantom limb pain. The award's purpose is to “advance state-of-the-art solutions for world-class medical care with an emphasis on post-traumatic stress disorder, traumatic brain injury, prosthetics, restoration of eyesight and advancing eye care, and other conditions directly relevant to the injuries our service members are currently receiving on the battlefield”. (MedCity News)
Boston Scientific Corp. Has Released Two New Spinal Cord Stimulation Lead Splitters
June 24, 2010 - The new design enables multi-site placement of up to four spinal cord leads, which will enable a greater range of lead configurations and treatment options. (MedCity News)
St. Jude Medical's Epiducer lead delivery system for neurostimulation therapy receives CE Mark approval
May 27, 2010 – St. Jude Medical, Inc., today announced European CE Mark approval of its new Epiducer™ lead delivery system for neurostimulation therapy. Unveiled at the Neurosurgery 2010 Congress in Lyon, France, the Epiducer lead delivery system allows the introduction of S-Series perc-paddle leads as well as multiple lead arrays through a single percutaneous entry point, thus obviating the need to perform a laminotomy. (Med City News)
Spin-Off Device Companies Draw Venture Capital
May 26, 2010 - Some of the larger device companies have accumulated more technology than they can fully pursue and, rather than abandoning potentially beneficial therapies, they are spinning off these low-priority products into new start-ups. Biotech venture firms have been known to back pharmaceutical spin-offs and now they are looking to do the same with device technology. (Wall Street Journal)
Medtronic to Invest $70M in BioControl
May 24, 2010 - Globes in Israel reports that Medtronic Inc. (NYSE: MDT) will invest $70 million in a start-up company, BioControl Medical Ltd., which has developed a vagal nerve stimulator to treat heart failure. (Globes)
Dysphagia Wins a $25,000 Grant from the Innovation Fund of the Lorain County Community College Foundation
May 24, 2010 - Dysphagia will use this grant to develop a prototype of its neurostimulator for clinical trials. The device, which uses a sensor in the mouth to detect a "swallow event", stimulates the trachea to close off the airway when food is being swallowed. (Massachusetts Medical Devices Journal)
Medtronic begins new spinal cord stimulator trials
May 6, 2010 - Medtronic has announced a U.S. clinical trail for its RestorSensor Neurostimulator for the treatment of Chronic pain. The device automatically adjusts the stimulation strength, based on the patient's body position and activity. Ten U.S. medical centers will enroll patients in the study. The device already has received European approval. (Minneapolis St. Paul Business Journal)
Boston Scientific begins ‘Evidence’ clinical trial for Precision Plus spinal device
May 3, 2010 - Boston Scientific has enrolled the first patient in the 132-patient trial, in which researchers will compare its spinal cord stimulator system with revision surgery for the treatment of failed back surgery syndrome. (Med City News)
Boston Scientific Eyes Selling its Neuromodulation Division
April 9, 2010 - Reuters reported that Boston Scientific, in the aftermath of a costly recall of certain heart defibrillators and debt following its 2006 acquisition of Guidant Corp., is considering selling its neuromodulation and neurovascular intervention businesses. Abbott Laboratories and Johnson & Johnson have been identified as potential bidders for the neuromodulation business. (Reuters)
St. Jude Medical Receives Australian TGA Regulatory and Reimbursement Approval for its Rechargeable Deep Brain Stimulator for Parkinson’s Disease
March 23, 2010 - St. Jude Medical, Inc. reported that its Brio deep brain stimulation system to treat Parkinson's disease symptoms received the Australian Therapeutic Goods Administration's regulatory and reimbursement approval. (RTTNews)
The Cleveland Clinic partners with Irish companies to develop new devices
March 23, 2010 - The Cleveland Clinic has partnered with Irish start-up companies to support the development of new medical devices. The Clinic also has teamed with The Royal College of Surgeons of Ireland and the Centre of Innovation in Surgical Technology. (Irish Times)
Neurotech Reports Teams with International Neuromodulation Society for Online Database
March 4, 2010 - The new Online Database of Neuromodulation Products offers comprehensive information on existing and forthcoming products to treat neurological disorders and diseases. (Neurotech Business Report)
Epilepsy Market Poised for New Device Competition
March 4, 2010 - NeuroPace and Medtronic will soon join Cyberonics in the epilepsy device market. (Neurotech Business Report)
EnteroMedics CEO Offers Explanation for Failed Obesity Trial
March 4, 2010 - The failure may stem from an unexpected therapeutic effect in the control arm of the study. (Neurotech Business Report)
Commentary: Focus on Epilepsy
March 4, 2010 - Editor James Cavuoto comments on the market opportunity for neurosensing systems and neurosurgical tools created by neurosurgical treatment for epilepsy. (Neurotech Business Report)
OrbiMed Advisors raises $550M for health venture fund
February 22, 2010 - OrbiMed Advisors, which has invested in Ohio companies Athersys Inc. and ViewRay, has raised $550 million for its latest health venture capital fund. OrbiMed plans to invest 60 percent of the fund in biotechnology, 30 percent in medical devices and 10 percent in diagnostics, and will back a total of 25 to 30 companies, according to VentureWire. (Med City News)
MicroTransponder Inc. raises $7M
February 24, 2010 - The Austin company is testing a wireless neurostimulation platform that will treat chronic pain and other neurological indications. MicroTransponder did not name the investors, but said the latest contribution came from existing funders and angel investors. (Austin Business Journal)
Case Western Reserve University licenses neuromodulation technology to Pennsylvania company
February 17, 2010 - Case Western Reserve University has licensed to a Pennsylvania company the right to make and sell three types of electrodes and a control unit used by researchers to do their neuromodulation work. (Med City News)
Medical Device Entrepreneurs Converge on Wings, a New Angel Investing Network
February 16, 2010 - People who make a living creating medical devices, like ultrasound machines or stents to prop open clogged arteries, have lived through a crummy 18 months. But that’s not discouraging a group of prominent medical device entrepreneurs from Seattle who are building the region’s first dedicated network of angel investors who have the money and expertise to bankroll new med-tech startups. (Xconomy News)
Medtronic launches 2 brain stimulation products
February 16, 2010 - Medtronic Inc. said Tuesday it began marketing two surgically implanted devices that are intended to help relieve symptoms for patients with neurodegenerative diseases. (AP / Seattle Times)
Chip maker Zarlink puts big bet on medical sector
February 12, 2010 - Five years after Kirk Mandy's return to resurrect Zarlink Semiconductor ZL.TO, the chief executive says the "heavy lifting" is done and it is time to see if strategic wagers will pay off for the one-time Canadian high-tech leader. (Reuters Canada)
Celebrating 30 Years Of Innovation In Neuromodulation, St. Jude Medical Unveils Latest Product At American Academy Of Pain Medicine Annual Meeting
February 4, 2010 - St. Jude Medical, Inc. today announced the U.S. Food and Drug Administration (FDA) clearance of the Swift-Lock(TM) anchor, a new product designed to help physicians efficiently secure neurostimulation leads utilized in spinal cord stimulation (SCS) therapy for the management of chronic pain. (Medical News Today)
St. Jude Medical Announces Approval And Launch Of Neurostimulation System In Japan
January 19, 2010 - St. Jude Medical, Inc. announced regulatory approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for the Genesis(TM) spinal cord stimulation system for the management of chronic pain. (Medical News Today)
St. Jude Medical Receives FDA Approval for Industry-First Five-Column Neurostimulation Lead to Manage Chronic Pain
December 4, 2009 - St. Jude Medical, Inc. (NYSE:STJ) today announced the U.S. Food and Drug Administration (FDA) approval and U.S. market introduction of its new Penta™ surgical lead for neurostimulation therapy. Unveiled at the annual North American Neuromodulation Society meeting... (Genetic Engineering and Biotechnology News)
Medtronic's Reclaim Deep Brain Stim Approved for Some OCD Sufferers
February 20, 2009 - Medtronic's Reclaim deep brain stimulation system has received a humanitarian device exemption (HDE) from the FDA for treatment of severe cases of obsessive-compulsive disorder (OCD). (medGadget)
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