ICI Conference II by Jonathan Goldstein

MEDICAL DEVICE DAILY

THE DAILY MEDICAL TECHNOLOGY NEWS SOURCE

MONDAY, DECEMBER 23, 2013

VOLUME 17, NO. 246

ASIA IN THE SPOTLIGHT

THE ISRAEL CONNECTION

CFDA streamlines domestic medical Israel’s ICI Conference describes device re-registration requirements major Digital Health ‘Apportunity’ Kristine Yang, Staff Writer Looking to help the domestic device industry continue to grow, China’s regulator has issued new regulations for the registration of new products from the beginning of 2014. The China Food and Drug Administration (CFDA) issued a notice on Dec. 17 announcing its plans to implement a simplified medical device registration renewal process. The new regulation will take effect from the Jan. 1. Assuming products are safe and effective and no major changes are made to the devices, manufacturers will face easier documentation requirements and faster approvals for certification renewals.

Jonathan Goldstein, Israel editor The Interventional Cardiologist (IC) has advanced from being a proceduralist - a service-provider who was the callpoint for other clinicians when the need arose - to being a subspecialty of its own, with a long-term relationship with patients. Many proceduralist subspecialties have not achieved this goal of ‘owning the patient’; the IC community is right to be proud of its achievements, and has no plans to slow down in the coming decade. The forward-looking IC community is now reviewing the next set of frontiers facing the patient. Stephen Oesterle, MD, Senior Vice President for Medicine and Technology at

See Asia, page 4

See Israel, page 5

Tryton Medical launches its Bifurcation Institute

WASHINGTON ROUNDUP

Omar Ford, Staff Writer In a bid to push the envelope on innovation, Tryton Medical (Durham, North Carolina), the developer of the Tryton Side Branch Stent, has unveiled plans to launch the Bifurcation Institute. The measure is a comprehensive resource put in place by the company to advance the standard of care for bifurcated coronary artery disease. Membership in the Bifurcation Institute is free and provides physicians access to e-newsletters summarizing recent clinical data and news, links to timely web casts and a Case Library that highlights the latest techniques and tips when treating bifurcation disease. Clinical symposia and educational workshops will be offered through the Bifurcation Institute. See Tryton, page 6

Staff Report The FDA and the Centers for Medicare and Medicaid Services (CMS) have decided to extend the pilot program for parallel review of medical products. The agencies say the program will continue as currently designed for two more years. The program was designed to allow companies to pursue regulatory and reimbursement approval at the same time. In October 2011, FDA and CMS announced the procedures and guiding nominations for the pilot. To date, there has been “significant interest” in the program, according to the agencies, and the agencies are working through the parallel review process See Washington, page 7

NEUROLOGY EXTRA

INSIDE BAXTER RECEIVES CE MARK FOR VIVA HD SYSTEM OIM TO PURCHASE 12.1M SHARES OF VERMILLION

FDA/CMS extend parallel review program for two more years

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Staff Writer Robert Kimball on one of med-tech’s key sectors Read this week’s Monday Special

MONDAY, DECEMBER 23 , 2013

MEDICAL DEVICE DAILY™

REPORT FROM EUROPE

Baxter receives CE mark for VIVIA HD System Staff Report Baxter International (Deerfield, Illinois) reported the completion of CE marking in Europe for the VIVIA hemodialysis (HD) system, designed to deliver more frequent, extended duration, short daily or nocturnal home HD therapy, known as High Dose HD therapy. “Globally, less than 1 percent of the estimated 1.9 million patients requiring hemodialysis currently perform High Dose HD therapy,” said Bruce Culleton, MD, senior medical director, Baxter. “VIVIA will allow a greater number of hemodialysis patients access to High Dose HD therapy in their home environment.” VIVIA is designed with the patient as the primary operator. Its touch screen and graphic user interface displays large, easy-to-comprehend graphics and animations that help guide patients through setup, treatment and cleanup. VIVIA’s Access Disconnect Sensor causes the system to stop pumping if the needle dislodges. The system also has one-button fluid infusion to help minimize user error and promote additional safety for the patient1. To support the important interface between patients and their healthcare practitioners, VIVIA includes the fully integrated Sharesource wireless connectivity platform that allows physicians and nurses to comprehensively monitor home therapy remotely. Baxter will introduce VIVIA in a limited number of European dialysis clinics in 2014 to allow patients and healthcare providers to become familiar with the system and its patient-friendly features. Baxter plans to expand the launch to other European countries in 2015. Data from clinical trials conducted in the U.S. and Canada

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evaluating the safety and effectiveness of VIVIA in more than 1,000 treatments were submitted as part of the filing for CE marking. “At Baxter, we are committed to providing physicians and their patients with product and therapy options for the best clinical outcomes possible,” said Brik Eyre, president of Baxter’s Renal business. “The VIVIA system was developed to support renal patients’ unmet need for an innovative home-based hemodialysis option.”

MAGFORCE INSTALLS NANOACTIVATOR AT THE KIEL UNIVERSITY HOSPITAL

MagForce (Berlin), a company that focuses on the field of oncology and is a leader in the nanotechnology sector, reported the installation of the third NanoActivator. The NanoActivator was installed as part of the preparations for the new glioblastoma study at the Kiel University Hospital in Germany. The company’s proprietary, NanoTherm therapy, enables the targeted treatment of solid tumors through the intratumoral generation of heat via activation of superparamagnetic nanoparticles. NanoTherm, NanoPlan, and NanoActivator are components of the therapy and have received EU-wide regulatory approval as medical devices for the treatment of brain tumors.

FIRST ULTRASOUND WITH CABLE FREE TRANSDUCERS INSTALLED IN UK

The University of Dundee Institute for Medical Science and Technology (Dundee, Scotland) has become the first site in the UK to install an Acuson Freestyle from Siemens Healthcare (Erlangen, Germany). The Freestyle is the world’s first ultrasound system that has wireless, cable free transducers that provide unique infection control benefits. The system is being used See Europe, page 3 PRACTICAL INFORMATION

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MONDAY, DECEMBER 23 , 2013

MEDICAL DEVICE DAILY™

FINANCINGS ROUNDUP

Oracle Investment Management to purchase 12.1M shares of Vermillion Staff Report Vermillion (Austin, Texas), a multivariate diagnostics company focused on gynecologic cancers and women’s health, reported that Oracle Investment Management, Jack Schuler, Matthew Strobeck and certain other investors have exercised warrants to purchase 12.1 million shares of Vermillion common stock at an exercise price of $1.46 per share. The warrants were issued in conjunction with an equity financing transaction that closed on May 13, 2013. With the exercise of the warrants, Vermillion received $17.6 million in proceeds, bringing the total investment by investors in the May 2013 equity financing transaction to approximately $30.9 million, before transaction costs. Emerging Growth Equities, Ltd. advised Vermillion on the equity financing transaction. Proceeds from the warrant exercise will be used to increase test sales and improve reimbursement for OVA1, expand commercial opportunities in the U.S. and new markets and advance one or more next-generation ovarian cancer diagnostic tests. In other financings; CSA Medical (Lutherville, Maryland), a provider of advanced spray cryotherapy technology that flash freezes unwanted tissue inside the body, said it has closed a $16 million Series C financing led by Ascension Ventures (AV). The financing round was oversubscribed with all existing investors participating, including SV Life Sciences, Intersouth Partners, First Analysis, Blue Heron Capital, Rose Park and Guide Medical Ventures. Tara Butler, MD, Managing Director at AV, will join the CSA Medical board. The truFreeze System is currently being used by physicians to ablate a variety of unwanted tissue inside the body such as in the esophagus and airway. The device delivers extremely cold liquid nitrogen spray through a small catheter to enable physicians to flash-freeze targeted tissue. This process has been shown to destroy the frozen cells without disturbing the underlying connective tissue, thereby providing a framework for healthy cells to regenerate over time. “The truFreeze technology has the potential to advance the treatment of multiple disease states and improve the quality of life for patients while reducing the cost of care,” said Butler. “We are impressed with the unique mechanism of action behind liquid nitrogen spray cryotherapy and the extensive work that CSA Medical has underway to develop new applications. The strength of the technology and management team, combined with our limited partners’ expertise as leading healthcare providers, make this a highly attractive investment opportunity for us.” //

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Europe Continued from page 2 for a mixture of research and clinical use and is located in the Multipurpose Interventional Suite alongside a Biograph mCT PET-CT and a Magnetom Skyra MR also from Siemens. The University of Dundee selected the system for its unique wireless technology and the sterile benefits of a cable-free design. Three different types of wireless transducers have been developed for the system, covering a wide range of imaging procedures. The system is being used in a clinical environment for interventional and vascular procedures in conjunction with Ninewells Hospital. It is also being used by the University for clinical research projects including the use of ultrasound within an MR system, along with robotics to provide precise placement of probes and ultrasound guided needle placement. The ACUSON Freestyle provides maximum freedom and ease-of-use with wireless transducers that can be used up to 3 meters from the system, helping to improve departmental workflow and streamline clinical research. Real-time imaging parameters are integrated into the transducers, freeing staff that would otherwise be needed to operate controls. The system also achieves excellent image quality due to multiple antennas and Pixelformer image processing which automatically focuses the image. // PEOPLE IN PLACES • Natera (San Carlos, California) reported the addition of Susan Gross, MD, as the company’s first chief medical officer. Gross is a professor of clinical obstetrics & gynecology and women’s health, pediatrics and genetics at the Albert Einstein College of Medicine (New York), where she has served as a member of the faculty since 1994. She is also the founding director of Einstein’s Program for Jewish Genetic Health and the founder of the Human Genetics Laboratory at Jacobi Medical Center, which was developed to provide the underserved with equal access to prenatal genetic services. The company said the addition of Gross reflects its focus on solidifying its technology leadership position and advancing a strong R&D pipeline for future innovation. Natera is a genetic testing company that has developed a bioinformatics-based technology (NATUS) to deliver accurate and comprehensive high-throughput testing for reproductive indications from tiny quantities of DNA.

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MONDAY, DECEMBER 23 , 2013

MEDICAL DEVICE DAILY™

Asia Continued from page 1 “The notice is one of the important steps of the CFDA to push forward the reform of the medical device registration process. Simplifying the medical device registration renewal process can relieve some paper work for manufacturers while shifting the focus on the technical changes of the applications can enhance the efficiency of the approval work,” said the CFDA in the announcement. “This update helps devices companies prevent (impact on) sales due to expired certification or changes that cannot be updated in time,” said Jonathan Zhong, Senior Medical Device Registration Specialist at Osmunda Medical Device Service Group, a Guangzhou-based medical device clinical trial contract research organization (CRO). “It also relieves the workload of approval authorities so they can focus on new product approvals and post-marketing surveillance,” he told Medical Device Daily. The notice identified different registration situations and eliminated some documentation requirements for devices without major changes. For products in which basic standards or manuals have not changed, manufacturers won’t need to re-submit the product standard, inspection reports and manuals to the CFDA. However, they still have to submit a declaration stating no changes have been made and that the products still comply with the current standards. Similarly, for applications in which only the location of manufacturing changes, the manufacturers have to submit a declaration stating the change along with new inspection reports to ensure quality system compliance and self-test reports on devices manufactured at the new site. Product standards, inspection reports and user manuals are no longer required in these cases. To speed the process up, these applications will go directly to the Department of Medical Device Registration and Administration under CFDA for approval after the Administration Service Center accepts the application. Products with changes in the scope of use, model, standard, structure or components will require a declaration of the change and technical information relative to the change rather than a whole new application with product standards, inspection reports and user manuals. But the new and streamlined processes do not apply for the registration of in-vitro diagnostic reagents. Earlier, in October, the CFDA issued a set of opinion on how to improve the capacity of provincial and municipal FDAs on the approval of medical devices and post-marketing surveillance over the next two or three years. Provincial FDAs are responsible for the approval and evaluation of Class II devices manufactured in China while the CFDA still controls the approval for imported and Class III devices. The new processes could help the industry in China.

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“The medical device industry is very welcoming of such a policy,” said Zhong. “Meanwhile, it is expected that there will be more regulatory updates in areas such as simplifying the first–time registration process, shortening approval times, strengthening post-marketing surveillance and current-use supervision. Most importantly, the industry is looking forward to the coming revised Regulation on Medical Device Supervision and Administration, which was (last) introduced in 2002.” “The new Regulation on Medical Device Supervision and Administration is coming soon, of which many (rules) will be changed,” Food and Drug Safety Director of the CFDA Jiao Hong said on Dec 11. “Regulatory authorities should prepare for the upcoming changes.” The CFDA has taken incremental steps to both streamline and strengthen regulations. Another recent move was to strengthen the supervision on medical device manufacturing. On Dec. 11, the CFDA circulated a draft Assessment Standard for Quality Management of Medical Device Manufacture and sought opinions from local FDAs by Jan. 10, 2014. The draft introduces a set 179 items that FDAs need to evaluate to grant manufacturing certificates. The CFDA issued assessment standards for sterile medical devices and implant medical devices in 2009 and for In vitro diagnostic reagents in 2007. These standards consist of the Regulation on Quality Management of Medical Device Manufacture, which required all Class III medical devices companies to meet the requirements by 2015 and all medical devices companies to meet them by 2017. // PRODUCT BRIEFS • Endologix (Irvine, California), a developer and marketer of innovative treatments for aortic disorders, reported that it has received Investigational Device Exemption approval from the FDA to begin a pivotal clinical trial to evaluate the safety and effectiveness of the Nellix EndoVascular Aneurysm Sealing System (“EVAS”) for the endovascular repair of infrarenal abdominal aortic aneurysms. The study, EVAS FORWARD-IDE, is one of a number of clinical studies that make up the broader EVAS FORWARD Clinical Program aimed at establishing clinical and economic evidence for EVAS using Nellix. The EVAS FORWARD-IDE study is approved to enroll 180 patients at up to 30 sites in the U.S., Canada and Europe. The Nellix EVAS system is a new generation of abdominal aortic aneurysm (AAA) therapy designed to seal the entire aneurysm with a biocompatible polymer. Nellix is the first and only EVAS product and was developed to simplify procedures, reduce re-interventions and expand the treatable patient population. • Regenesis Biomedical (Scottsdale, Arizona) reported FDA approval for the removal of the contraindication for use of the company’s Provant Therapy System in patients with metallic implants in the area of treatment. The decision was made after the FDA reviewed additional data and research demonstrating that the use of Provant’s Pulsed Electromagnetic Therapy (PEMT) did not put such patients at risk.

MONDAY, DECEMBER 23 , 2013

MEDICAL DEVICE DAILY™

Israel Continued from page 1 Medtronic (Minneapolis) explained to the audience that the next step is not merely the next IC device – the types described in our previous note – but rather something more associated with major convergence of IT technologies into healthcare. The IC (and general clinician) of tomorrow needs to generate an improved standard-of-care by empowering the patient by utilizing IT advances for the patient’s personal advantage, and society’s financial benefit. Professor Raphael Beyar, MD, CEO and Director General of the Rambam Health Care Campus (Haifa), and co-counder of the Innovations in Cardiologic Interventions (ICI), a mini-TCT three-day symposium that recently place in Tel Aviv, described Israel as a ‘Medical Startup Nation’. This should include taking Israel’s hi-tech strength, and integrating healthcare applications into this continuum – not solely developing technology-based device breakthroughs per se. It is probably this element – the opportunity of Israel medtech community integrating some of the local hi-tech skillset - that caused Oesterle to suggest to the audience that “Israel is the ideal place to generate this next version of innovationproducts. Israel has all of the right ingredients to lead this revolution, both in application R&D, and as a pilot test site,” he insisted.

NOT A NEW TECHNOLOGY, BUT A NEW APPLICATION

The immense value that the ‘connected’ digital world will offer medicine could be as revolutionary as Percutaneous Coronary Intervention (PCI) or the unraveling of the human genome. So stated Daniel Kraft, MD, a Stanford-trained hemo/oncologist, Executive Director of Futuremed, a Singularity University (Moffett Field, California) project, in his animated keynote speech. The availability of highpowered computing power and communication systems in the form of today’s smartphones is a key societal element that will affect a change in the world of healthcare, Kraft explained. With the smartphone already available to more than 1 billion of the 5 billion handset owners worldwide, the means of data collection, monitoring and transmission may be – literally and figuratively – in the hands of the patient. The greater level of awareness that today’s patients exhibit to both disease management and prevention makes the patient a willing partner in their own health management. Today’s patients have a far greater level of information available to them externally, and tend to receive a more open communication with their practitioners. In addition, there is an understanding that more healthcare management needs to be personalized to, and co-managed by, the patient. The Personal Smartphone revolution could not be coming at a more opportune time.

THE DEVICE IS READY FOR THE PATIENT

Eighty percent of U.S. doctor visits do not require handson physician involvement, one speaker explained, leaving much

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room for process efficiencies in utilizing remote management, offline support and self-assessment programs. The hardware technology needed to convert the smartphone into a measurement tool – e.g. a stethoscope, ECG or blood pressure monitor – is either available today, or is often attainable with limited development. Similarly from a software perspective, Kraft described that there has been explosive growth to approximately 40,000 different health-related apps, with some of them very likely to become world leaders in personal health management. These tools can lead to the ubiquitous, powerful handset identifying anything untoward in the patient’s ‘healthfootprint’, leading to earlier detection, earlier intervention, and improvements for both patients and the healthcare provider. One company that addresses this personalized approach to data-trolling is VGBio (Naperville, Illinois), whose Adviser Susan Alpert, MD, PhD, presented a number of sessions at the Conference. Alpert was previously Senior Vice President, Chief Regulatory Officer of Medtronic (Minneapolis), and prior to that Director, Office of Device Evaluation of the FDA. By adapting a predictive analytics approach first commercialized to monitor the health of mission critical industrial assets in aerospace (jet engines), VGBio is analyzing aberrant physiological data points and trends from individual people’s cardio-related parameters. Rather than accept demographic averages as baselines for personal irregularities, VGBio believes that the optimal personalized predictive method would be to assess the patient against their own baseline. “Billions of dollars can be saved, with improved quality of life by identifying very subtle changes in a person’s health before they are aware of it,” Gary Conkright, CEO of VGBio, explained to MDD, “and being able to intervene before the patient needs to be addressed in a more acute manner.” The company has already been collecting prospective datasets in partnership with the U.S. Department of Veteran Affairs and the University of Chicago Medical Center. This will lead to using the VitaLinkTM - currently consisting of sensors and a dedicated Android telephone, but eventually an App on the patient’s phone, and VGBio’s cloud-based analytics – as an early warning tool to prevent a patient’s (re)entry into the hospital setting.

SOCIETY IS READY FOR THE APP

“The trend of using Apps for both health maintenance and disease support is clearly underway”, Alpert shared with MDD. “While not currently requiring FDA approval for systems that support your wellness activities, the use of the App as a method of improving an individual’s disease related activities is on its way and is being regulated. Apps that claim to diagnose diseases or provide disease intervention are already clearly regulated medical devices.” This App-based approach has been validated at the regulatory level by many companies: the FDA has shared many Mobile Apps that have received clearance on its website. One company, Welldoc (Baltimore) attained FDA 510K clearance in 2010 for its Diabetes compliance system, a software tool for Type II Diabetes patients. But the company attained a first-ever See Israel, page 6

MONDAY, DECEMBER 23 , 2013

MEDICAL DEVICE DAILY™

Tryton Continued from page 1 “It’s really part of a three pronged effort,” Shawn McCarthy, CEO told Medical Device Daily. “Those efforts are innovation, clinical evidence and then professional education. The third leg is the launch of the Institute. As a leader of this space, we believe we have a great responsibility to our physicians to make sure that we are supporting those physicians with the right tools, the right evidence and the right level of innovation so that they can take care of their patients more effectively in the future.” He added, “it’s open to all professionals that are trying to advance the treatment of bifurcation so with that there are case reviews; there’s online procedural training; we provide clinical data in the form of publications and clinical outcomes from IDE’s like ours. We’re also conducting workshops and symposiums. The first workshop that has been announced will be March 5-16 with Maciej Lesiak, MD.” Lesiak is the chief of the catherization laboratory at the Karol Marcinkowski University of Medical Sciences (Poznan, Poland). “There is a significant unmet need for education and training regarding bifurcations. In patients undergoing PCIstenting, approximately one-third has a bifurcation lesion. Left main disease, an accumulation of plaque that narrows the base of the coronary tree, is a persistent challenge in interventional cardiology, as more than 75% of left main lesions are bifurcation lesions. The Bifurcation Institute aims to evolve treatment patterns and current procedural guidance to incorporate safe and effective treatment of bifurcations in daily practice,” Lesiak said. The firm will also be doing some sponsored research with organizations as part of the Institute. Steps for this were already put into place. Back in May, the company announced that the Nordic Baltic Bifurcation Study Group will investigate the Tryton Side Branch Stent in a prospective, controlled, randomized, multi center clinical study examining the role of final kissing balloon inflations in patient outcomes. “They will be evaluating Tryton in both arms of the study and it will be starting early next year,” McCarthy said. The firm has CE mark for the Tryton Side Branch stent, but is still vying for FDA approval of the device. The Bifurcation Institute features the results of the landmark Tryton IDE trial presented in a late-breaking clinical trial session at TCT 2013. The company said that the study,is the first randomized FDA IDE pivotal clinical trial to evaluate a dedicated bifurcation stent. Nearly 704 patients at 67 centers in North America and 11 countries throughout Europe and Israel were enrolled in the study.. Results of the trial show that both the Tryton strategy and the provisional strategy appear to be safe, with rare clinical post procedure myocardial infarctions, low rates of stent thrombosis, and no cardiac death. Both study arms had low 9-month clinically

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driven target vessel revascularization. Results also show that Tryton, compared to the provisional arm of the study, did not meet the non- inferiority clinical endpoint of target vessel failure (TVF), driven in large part by peri- procedural CK- MB elevations (Tryton 17.4%; Provisional 12.8%). Sixty percent of the side branch vessels treated were smaller than the intended study population of sidebranch vessels of 2.25 mm diameter or greater by QCA. Tryton joins several firms that have initiated programs and learning centers to push innovation. Earlier this year, Elekta (Stockholm, Sweden) launched its very own Learning and Innovation Center (LINC). The center was developed in part to help train healthcare personnel on how to effectively learn how to use the technology. “Not only do technologies need to be safe and effective, but they also need to be reasonable and necessary, so to be adopted they need to make sense for folks in the healthcare landscape and the healthcare economic landscape,” McCarthy. “So I think we have a responsibility to go with the grain.” //

Israel Continued from page 5 accomplishment when, armed with sufficient clinical data, it received a CMS coding in mid 2013, and is reimbursed by certain insurers. The physician can now offer Welldoc’s BlueStar product by prescription, ensure its loading onto the smartphone or laptop, in order to better manage the patient’s chronic condition, and advise on actions to stabilize blood sugar levels. Many insurers and employers who are currently incentivizing the individual to maintain a healthy lifestyle are likely to include the use of phone apps in order to guide, monitor and/or advise on healthy lifestyle in the coming years. “It’s not long,” said Kraft, “Before clinicians will be routinely prescribing an App to patients, either for wellness (health management) or compliance (disease management) and the partnership between patient and physician will be further enhanced.”

BIG DATA FROM THE PERSONAL DEVICE - A NEW RESERCH PLATFORM.

As these patient-setting apps proliferate, the opportunity will also arise to consolidate the data from large bodies of similar patient subpopulations. Today’s (and tomorrow’s) patient is becoming more willing to forego elements of privacy in exchange for being an integrated part of a community. Communities within a patient subgroup might enable data analytics to be performed over subpopulations, creating valuable sources of Big Data, which may be of great advantage to clinical studies moving forward. “What the public bodies have a duty to protect regarding the individual, that same individual has a right to share, which can teach us even more about optimal personal regimes”, one analyst shared with MDD. The future is on its way, and we have that to look forward to. //

MONDAY, DECEMBER 23 , 2013

MEDICAL DEVICE DAILY™

Washington Continued from page 1 with the approved pilot program participants. “We believe that interest in the pilot has also facilitated mutually informative discussions between additional sponsors and the agencies,” FDA and CMS said in a Federal Register notice. The agencies said that once a representative group of participants have completed the pilot process, the agencies will formally evaluate the program for best practices and will report any future revisions and/or enhancements in a future Federal Register notice. Among the participants in the pilot program, Edwards Lifesciences (Irvine, California), which invoked parallel review in its Sapien application.

PCORI APPROVES $97.3M TO FUND CER STUDIES

The Patient-Centered Outcomes Research Institute (PCORI; Washington) has approved a total of $97.3 million in new funding for 53 comparative effectiveness research (CER) studies designed to answer questions of most importance to patients and those who care for them. It has also approved $93.5 million to build and expand the individual research data networks that will form PCORnet, an ambitious new national patient-centered clinical research network to facilitate CER. The awards, approved during a recent PCORI board of governors webinar/teleconference, will support research aimed at providing patients, their families, and other healthcare stakeholders more information about the effectiveness of various healthcare options so they can make better-informed decisions about their care. Studies approved include efforts to improve care for heart disease, cancer, obesity, chronic pain, diabetes, respiratory disorders, and mental health disorders among other conditions. Several projects will explore ways to support patient and family caregiver decision-making, reduce health disparities, and improve healthcare delivery systems. Eight of the awards for CER studies will fund studies of multipronged strategies to reduce persistent disparities in uncontrolled asthma among African Americans and Hispanics/Latinos, the population groups at greatest risk for developing this common respiratory disease. These awards were made through PCORI’s first call for applications on a specific high-priority research topic. PCORI specifically called for proposals on this topic because not all treatment options work well for all populations and asthma has many triggers including environmental and social factors not typically addressed by medical providers. The eight projects were chosen from a pool of 74 applications to this targeted announcement. PCORI selected the other 45 CER studies for funding from a total of 461 submissions to broad funding announcements

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issued under its five National Priorities for Research in August. “We are very pleased to add this latest round of projects to our growing portfolio of patient-centered comparative effectiveness research, which will contribute much-needed insights about the benefits and risks of a range of medical interventions and approaches to healthcare delivery,” said PCORI executive director Joe Selby, MD. “Each project will engage patients and other stakeholders in meaningful ways with researchers to tackle critical health problems. We look forward to following and learning from the studies’ progress.” Since it began funding patient-centered outcomes research in 2012, PCORI has awarded $464.4 million in research support for a total of 279 projects.

CMS DENIES MDT NEW HCPCS CODE

Medtronic (Minneapolis) said that the Centers for Medicare and Medicaid Services (CMS) recently denied its request for a new HCPCS code for sensor augmented insulin pumps and that the company’s insulin pumps will now be exposed to competitive bidding starting on Jan. 1. The impact on the company should be minimal in CY 2014, according to Larry Biegelsen, an analyst for Wells Fargo, because Medicare accounts for only about 10% of total U.S. pump sales; the competitive bidding program is being piloted in only nine metropolitan areas in 2014 that account for only about 10% of total U.S.; and the reimbursement cut in 2014 is only about 11% to 13%. “However, we think competitive bidding for insulin pumps bears monitoring,” Biegelsen said. That’s because CMS could expand the program beyond the initial nine metropolitan areas in the next year or two; the amount of the reimbursement cut could get worse over time; and commercial payers could follow CMS’s lead, he noted. Earlier this year, Medtronic requested that CMS establish a new Level II HCPCS code for sensor augmented external insulin pumps in order to differentiate sensor augmented insulin pumps with continuous glucose monitoring (CGM) such as the company’s 530G from nonsensor augmented pumps such as those from Johnson and Johnson’s (New Brunswick, New Jersey) Animas. A Level II HCPCS code is a standardized coding system that is used by CMS primarily to identify products, supplies, and services such as ambulance services and durable medical equipment, prosthetics, orthotics, and supplies when used outside a physician’s office. According to Biegelsen, Medtronic confirmed that CMS denied its request for a new HCPCS code because the agency believes the existing code adequately describes the product. He noted that if CMS would have granted the request, the company’s insulin pumps would not have been exposed to competitive bidding which starts for insulin pumps in January. Also, a new code would have resulted in CMS paying for CGM, which it currently does not, he added. //

NEUROLOGY EXTRA Keeping you up to date on recent developments in neurology By Robert Kimball, Staff Writer

NIH: six funding opportunities for the BRAIN initiative in ‘14 . . . The National Institutes of Health is

releasing funding opportunities to build a new arsenal of tools and technologies for unlocking the mysteries of the brain. The NIH action is in support of President Obama’s Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative. The six opportunities announced today were developed in response to high priority areas identified by the NIH Advisory Committee to the Director’s BRAIN Working Group in September 2013. Awards are expected to be announced in September 2014 and will constitute NIH’s initial investment of $40 million in the initiative. “The human brain is one of the most complicated structures in the known universe,” said NIH Director Francis Collins, MD, PhD. “We have an unprecedented opportunity to develop new technologies that will allow us to map the circuits of the brain, measure activity within those circuits, and understand how their interactions maintain health and modulate human behavior.” The President’s BRAIN Initiative is a large-scale inter-agency federal effort that the President described as “giving scientists the tools they need to get a dynamic picture of the brain in action and better understand how we think, how we learn, and how we remember.” Three federal agencies – NIH, National Science Foundation, and Defense Advanced Research Projects Agency, or DARPA – expect to contribute a total of $110 million in the 2014 fiscal year. NIH’s $40 million contribution in fiscal 2014 is in addition to the roughly $5.5 billion slated in the NIH fiscal 2014 budget for neuroscience research. Private organizations have also signed on to bolster this bold, interdisciplinary effort. The first wave of NIH investments in the BRAIN initiative will focus largely on technology development that will advance basic science. Two of the funding announcements call for developing methods for classifying and accessing the diverse cells and circuits of the brain. Three focus on developing and optimizing technologies for recording and modulating collections of cells that function together as a circuit. One supports the formation of interdisciplinary teams of scientists to develop the next generation of non-invasive imaging technologies for human research. “Scientists need new tools to be able to dissect the roles of particular neurons in the circuits underlying how we think and behave, and to learn which brain cells are disrupted by neurological disorders. These initiatives should provide them,” said Story Landis, PhD, director of the NIH’s National Institute of Neurological Disorders and Stroke. “These grant opportunities are a down payment for the promise on what the President calls ‘the next great American project,’ said Thomas R. Insel, MD, director of the National Institute of Mental Health. The Brain Initiative and Brain Research Through Advancing Innovative MONDAY, DECFMBER 23 , 2013

Neurotechnologies are service marks of the U.S. Department of Health & Human Services.

Discovery of mechanism controlling Tourette Syndrome tics . . . A mechanism in the brain which

controls tics in children with Tourette Syndrome (TS) has been discovered by scientists at The University of Nottingham, UK. The study, which has been published in the British Psychological Society’s Journal of Neuropsychology, could herald new non-drug therapies to help young people with TS overcome the repetitive physical movements and vocal sounds which characterize their condition. The work was funded with a £150,000 grant from the James Tudor Foundation and was carried out by PhD student Amelia Draper. Professor Stephen Jackson, in the University’s School of Psychology, said: “This new study is very important as it indicates that motor and vocal tics in children may be controlled by brain changes that alter the excitability of brain cells ahead of voluntary movements. You can think of this as a bit like turning the volume down on an over-loud motor system. This is important as it suggests a mechanism that might lead to an effective non-pharmacological therapy for Tourette Syndrome.” The neurological condition TS affects around one child in every 100 and usually starts during early childhood. Scientists believe that the tics that affect children with TS are caused by faulty wiring in the brain that leads to hyper excitability in the brain regions controlling motor function. In adolescence, there is a period of ‘pruning back’ in which redundant brain connections are removed and other structural and functional brain changes occur. During this time, around one-third of children with TS will find that their tics disappear and another third are able to more effectively control their tics. Unfortunately, the remaining third of individuals will see little or no change in their tics and are likely to remain troubled by their TS symptoms into adulthood. This clinical observation suggests that there are mechanisms in the brain that are involved in controlling tics and undergo development or re-organization during the teenage years. Draper added: “The research is based on the general hypothesis that an area in the brain called the striatum is overactive as a result of alterations in the early development of the brain. As a result, the signals that are relayed to the brain’s cortex region lead to hyper-excitability and cause tics to occur. We have looked at how that hyperactivity and the resultant tics might be controlled by finding a way to ‘turn down the volume’ on that ‘cortical excitability’. This is potentially extremely important as the parents of children with tics are desperate to find a safe and effective therapy that is an alternative to drug

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Self control via electrical brain stimulation . . . Some people lack self-control. A habit of saying

the wrong thing at the wrong time is one example. But now, scientists have developed a way of improving a person’s self-control through electrical brain stimulation. This is according to a study published in The Journal of Neuroscience. Researchers from the University of Texas Health Science Center (UTHealth) at Houston and the University of California, San Diego, say their findings could be useful for future treatments of attention deficit hyperactivity disorder (ADHD) and Tourette’s syndrome, among other self-control disorders. To reach their findings, the investigators analyzed four study participants with epilepsy who were required to perform a series of behavioral tasks that involved the “braking” of brain activity. Using brief electrical stimulation through electrodes implanted directly on the brain surface, a computer increased activity in the prefrontal cortex brain of each patient at the point when their behavioral brain activity slowed. The researchers note that this was a double-blind study, so both the participants and investigators did not know when or where the electrical charges were triggered. They found that the electrical stimulation in the prefrontal cortex of the brain enhanced the slowing of behavioral activity, leading to an enhanced form of self-control. However, when electrical stimulation was administered outside the prefrontal cortex, the participants showed no change in behavior. The researchers say this suggests that the effects of electrical stimulation are specific to the prefrontal cortex. Commenting on the findings, Nitin Tandon, of the Vivian L. Smith Department of Neurosurgery at the UTHealth Medical School and senior author of study, said: “Our daily life is full of occasions when one must inhibit responses. For example, one must stop speaking when it’s inappropriate to the social context and stop oneself from reaching for extra candy. There is a circuit in the brain for inhibiting or braking responses. We believe we are the first to show that we can enhance this braking system with brain stimulation.” The investigators point out that although their findings are promising, they do not yet provide evidence that direct electrical stimulation is effective for treating self-control disorders, such as borderline personality disorder, obsessive-compulsive disorder (OCD), and Tourette’s syndrome. But they say their proof-of-principle study may be useful one day when it comes to treating these types of disorders.

MONDAY, DECEMBER 23 , 2013

Brain area attacked by Alzheimer’s links learning and rewards . . . One of the first areas

of the brain to be attacked by Alzheimer’s disease is more active when the brain isn’t working very hard, and quiets down during the brain’s peak performance. The question that Duke University (Durham, North Carolina) graduate student Sarah Heilbronner wanted to resolve was whether this brain region, called the posterior cingulate cortex, or PCC, actively dampens cognitive performance, say by allowing the mind to wander, or is instead monitoring performance and trying to improve it when needed. If the PCC were monitoring and improving performance, increased activity there would be the result of poor performance, not the cause of it. The PCC connects to both learning and reward systems, Heilbronner said, and is a part of the “default mode network.” It lies along a mid-line between the ears, where many structures related to rewards can be found. “It’s kind of a nexus for multiple systems,” said Heilbronner, who is currently a postdoctoral researcher in neuroanatomy at the University of Rochester in New York. “As this area begins to deteriorate, people begin to show the early signs of cognitive decline— problems learning and remembering things, getting lost, trouble planning – that ultimately manifest as outright dementia,” said Michael Platt, director of the Duke Institute for Brain Sciences, who supervised Heilbronner’s 2012 dissertation. Their findings appear Dec. 18 in the journal Neuron. Heilbronner concludes that the PCC summons more resources for a challenging cognitive task. So rather than being the cause of poor performance on a task, PCC actually steps in during a challenge to improve the situation. “This study tells us that a healthy PCC is required for monitoring performance and keeping motivated during learning, particularly when problems are challenging,” Platt said.

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