Medical Device Daily - April 8, 2013


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- Lensar’s laser system cleared by FDA for arcuate incisions

- InVivo Therapeutics gains IDE for biopolymer product study

- Hologic gets Health Canada approval for Aptima assays

- House inks doc fix proposal, may crowd device tax repeal

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Medical Device Daily - April 8, 2013

  1. 1. MONDAY, APRIL 8, 201 3 VOL. 17, NO. 67 PAGE 1 OF 9Lensar’s laser system cleared InVivo Therapeutics gains IDEby FDA for arcuate incisions for biopolymer product studyBy AMANDA PEDERSEN By OMAR FORDMedical Device Daily Senior Staff Writer Medical Device Daily Staff Writer Lensar (Orlando, Florida) reported that the FDA InVivo Therapeutics Holdings (Cambridge,has cleared its laser system for the execution of arcuate Massachusetts), a developer of groundbreakingincisions during cataract surgery. Arcuate incisions are technologies for the treatment of spinal cord injuriesprecise incisions made on the periphery of the cornea in the (SCI) and other neurotrauma conditions, reported FDA hascontext of cataract surgery. approved the company’s Investigational Device Exemption With this latest regulatory milestone, Lensar says its (IDE) to begin human studies to test its biopolymer scaffoldsystem is now cleared to perform both corneal and arcuate product, a technology developed to treat patients withincisions, as well as lens fragmentation and anterior acute, traumatic SCI.capsulotomy (with or without phacofragmentation), during With this approval, InVivo intends to commence a first-cataract surgery. The system is already available for sale in-man clinical study in the next few months that will testto cataract surgeons in the U.S., Europe and several other safety and performance of its biopolymer scaffold in fivecountries, the company noted. patients. Featuring the company’s Augmented Reality technology, “This is going to be an open label study,” Sean Moranthe Lensar laser system is designed to enable cataract Director of Finance for InVivo told Medical Device Daily. See Lensar, Page 4 See InVivo, Page 5International report Washington roundupHologic gets Health Canada House inks doc fix proposal,approval for Aptima assays may crowd device tax repealA Medical Device Daily Staff Report By MARK McCARTY Hologic (Bedford, Massachusetts) said that Health Medical Device Daily Washington EditorCanada has granted medical device licenses for Hologic’s There are a lot of theories about why Congress doesAptima HPV and Aptima HPV 16 18/45 genotype assays. or does not pass legislation, but two committees of theBoth assays are in vitro nucleic acid amplification tests House of Representatives have published a framework for(NAATs) that are designed to detect high-risk strains of the repeal of the sustainable growth rate (SGR) contrivance,the human papillomavirus (HPV) that are associated with a proposal the April 3 statement describes as “fiscallycervical cancer and precancerous lesions. HPV is among responsible and free of politics.” As one might expect, thethe most common sexually-transmitted infections (STIs) in sticking point is the question of how to pay for the doc fix,Canada and worldwide. The tests have been approved to and one long-term observer thinks one approach Congressrun on Hologic’s fully automated, high-throughput Tigris could resort to is to throw the device tax repeal under theinstrument system. bus. The Aptima HPV assay is designed to detect 14 high- The April 3 framework published in a joint statement byrisk HPV types associated with cervical cancer and the House Ways and Means and the Energy and Commerce See International, Page 6 See Washington, Page 7 Don’t miss today’s MDD Extra: NeurologyINSIDE: CANCER GENETICS LOOKING TO RAISEGROSS PROCEEDS OF $6 MILLION IN IPO ....................... 2 TCS IN MULTI-YEAR DISTRIBUTION DEAL WITH NONIN MEDICAL .......................... 3 To subscribe, please call MEDICAL DEVICE DAILY™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (404) 262-5476. Copyright © 2013 AHC Media. Reproduction is strictly prohibited. Visit our web site at
  2. 2. MONDAY, APRIL 8, 2013 MEDICAL DEVICE DAILY™ PAGE 2 OF 9Financings roundup conversion adjustments and conditions. The company also reported that in view of the proposedCancer Genetics looking to raise financing, the NYSE MKT, which is the company’s currentgross proceeds of $6 million in IPO listing exchange, has granted an additional quarterly extension of the company’s listing exchange complianceA Medical Device Daily Staff Report plan from March 30 to June 30 of this year, although as is Cancer Genetics (Rutherford, New Jersey), a normal course the company’s exchange compliance woulddiagnostics company that develops genomic-based continue to be evaluated on an ongoing basis.oncology tests and services, reported the pricing of its The initial closing covering the sale of 2,356initial public offering of 600,000 shares of its common shares of Series A preferred stock, of about $2.35stock at $10 a share. The gross proceeds are expected to be million in gross proceeds, which is subject to the$6 million before underwriting discounts and commissions satisfaction of customary closing conditions, isand other offering expenses. expected to be completed this week. The second The company has granted the representative of the closing, covering the sale of 1,656 shares of Series Aunderwriters a 45-day option to purchase up to 90,000 preferred stock, for an additional amount of roughlyadditional shares of common stock to cover over- $1.65 million in gross proceeds, is contingent uponallotments, if any. The offering is expected to close April 10. stockholder approval. As of Friday shares of Cancer Genetics’ common stock Cardium said it has also agreed to seek stockholderwere being quoted on the OTCQB Marketplace, operated by approval for the company to effect a reverse stock split ofOTC Markets Group, under the symbol “CGIX”. its issued and outstanding common stock. The Company Aegis Capital is acting as sole book-running manager plans to submit proposals to approve the sale of thefor the offering. Feltl and Company is acting as co-manager second tranche of 1,656 shares of Series A Preferred Stockfor the offering. and authorization for the proposed reverse stock split of In other financing activity: its issued and outstanding common stock at Cardium’s • Cardium Therapeutics (San Diego) said it upcoming annual meeting of stockholders.has entered into a definitive agreement with a single • PeriGen (Princeton, New Jersey), a provider of real-institutional healthcare fund managed by Sabby time clinical decision support to perinatal systems, saidManagement, the company’s largest shareholder, it received significant industry recognition, raised $6.4for a financing of up to $4 million in gross proceeds. million in funding, achieved record bookings and expandedLadenburg Thalmann & Co., a subsidiary of Ladenburg its senior management team in the first quarter of 2013.Thalmann Financial Services, served as the exclusive “Our first quarter results illustrate the industry’splacement agent on the transaction. recognition that PeriGen solutions are best positioned to Cardium will issue up to 4,012 shares of zero coupon enable superior perinatal care and reduce hospital liabilitySeries A convertible preferred stock, which are non-voting. risk,” said CEO Matthew Sappern. “Hospitals increasinglyEach share of Series A Preferred Stock has a purchase select us as their preferred perinatal vendor because ourprice and liquidation preference of $1,000 a share while solutions provide so much more clinically relevant andheld as preferred stock, or they may be converted into See Financings, Page 810,989 shares of voting common stock, subject to certain MEDICAL DEVICE DAILY™ (ISSN# 1541-0617) is published every business day by AHC Media, 3525 SUBSCRIBER INFORMATION Please call (800) 477-6307 to subscribe Piedmont Road, Building Six, Suite 400, Atlanta, GA 30305, U.S.A. Opinions expressed are not or if you have fax transmission problems. necessarily those of this publication. Mention of products or services does not constitute endorse- Outside U.S. and Canada, call (404) 262- ment. MEDICAL DEVICE DAILY™ is a trademark of AHC Media, a Thompson Media Group, LLC com- 5476. Our customer service hours are pany. Copyright © 2013 AHC Media. All Rights Reserved. No part of this publication may be 8:30 a.m. to 6:00 p.m. EST. reproduced without the written consent of AHC Media. (GST Registration Number R128870672) EDITORIAL Holland Johnson, (404) 262-5540 ATLANTA NEWSROOM: Executive Editor: Holland Johnson. Amanda Pedersen, (912) 660-2282 Omar Ford, (404) 262-5546 Washington Editor: Mark McCarty. Mark McCarty, (703) 268-5690 Staff Writers: Omar Ford, Amanda Pedersen. Rob Kimball, (404) 262-5451 Senior Production Editor: Robert Kimball. SVP/GROUP PUBLISHER BUSINESS OFFICE: Senior Vice President/Group Publisher: Donald R. Johnston. Donald R. Johnston, (404) 262-5439 Director of Brand Management: Beth Schilling. Product Marketing Manager: Sarah Cross. INTERNET Marketing Coordinator: Tessa Turner. Account Representatives: Matt Hertzog, Greg Rouse, Chris Wiley. REPRINTS: For photocopy rights or reprints, please call Stephen Vance at (404) 262-5511 or e-mail him at To subscribe, please call MEDICAL DEVICE DAILY™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (404) 262-5476. Copyright © 2013 AHC Media. Reproduction is strictly prohibited. Visit our web site at
  3. 3. MONDAY, APRIL 8, 2013 MEDICAL DEVICE DAILY™ PAGE 3 OF 9Agreements/contractsTerumo in accord People in the Newswith Nonin MedicalA Medical Device Daily Staff Report • Cognoptix (Acton, Massachusetts), an emerging Terumo Cardiovascular Systems (Ann Arbor, medical device company, said it has expanded its clinicalMichigan) reported that it has entered into a multi- advisory board, appointing two new members from theyear distribution agreement with Nonin Medical Alzheimer’s Disease-focused clinician community: Carl(Plymouth, Minnesota), a company that specializes in Sadowsky, MD, director of research at Premiere Researchnoninvasive medical monitoring. Institute (West Palm Beach, Florida); and Pierre Tariot, MD, Beginning May 1, Terumo CVS will distribute Nonin’s director of the Banner Alzheimer’s Institute (Phoenix).EQUANOX Model 7600 Regional Oximetry System to Cognoptix is developing a method to aid in early-detectionadult and pediatric cardiovascular hospitals in the U.S.; diagnosis of Alzheimer’s to allow treatment beforeNonin’s direct sales force will focus on certain non- significant neuronal loss and irreversible brain damagecardiovascular applications in those hospitals, and occurs.applications in all other U.S. hospitals. • Hooper Holmes (Basking Ridge, New Jersey) Terumo CVS manufactures and markets medical devices reported that Gus Halas has been appointed to its boardfor the global cardiac surgery market. Nonin Medical and of directors, effective April 2. Halas is currently president/Terumo CVS will make the announcement at the Society of CEO of the Central Operating Companies at Central GardenCardiovascular Anesthesiologists (SCA) Annual Meeting in & Pet Company. Hooper Holmes services include collectingMiami. personal health data and transforming it into useful The Nonin EQUANOX Model 7600 Regional Oximetry information.System is a noninvasive medical monitoring systemthat continuously detects oxygen saturation status inthe brain and tissue beneath the sensor during surgicalprocedures and in intensive care environments such aspediatric and neonatal intensive care units. The system allows anesthesiologists, perfusionists,cardiovascular surgeons, and other clinicians toquickly react to reverse tissue ischemia events beforethey become critical. “We are confident that Terumo’s extensivecardiovascular relationships in heart hospitals,combined with the clinical benefits and technologyadvancements of the EQUANOX System, will drive furtheradoption of Nonin’s regional oximetry solution acrossthe hospital as a cost-effective, standard-of-care toolthat helps prevent brain and organ injury in patients,”said Chris Holland , VP of business development forNonin Medical. ADVERTISE HERE ...and reach high-level med-tech professionals every day! For advertising opportunities in Medical Device Daily, please contact Stephen Vance at (404) 262-5511 or To subscribe, please call MEDICAL DEVICE DAILY™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (404) 262-5476. Copyright © 2013 AHC Media. Reproduction is strictly prohibited. Visit our web site at
  4. 4. MONDAY, APRIL 8, 2013 MEDICAL DEVICE DAILY™ PAGE 4 OF 9Lensar from FDA, Lensar is once again reaffirming its commitmentContinued from Page 1 to meeting all of the rapidly evolving needs of the cataract surgeon community.”surgeons to execute arcuate incisions with precision and Furthermore, the company noted, the laser system’srepeatability. Previously, these incisions were made as part sophisticated phacofragmentation techniques provide cataractof manual, highly variable procedures. With its several FDA surgeons with advantages in more efficient removal of all gradescleared indications supporting the capabilities of the laser of cataracts and a major reduction or complete eliminationsystem, the company says it is “providing physicians the of the use of the ultrasound energy required in conventionalmost advanced platform for conducting bladeless cataract cataract surgery. The mobile design of the Lensar laser systemsurgery and achieving consistent, predictable outcomes.” easily adapts to existing surgical facilities, allowing the system The company’s next-generation differentiating to be placed in the operating room or in a separate room.Augmented Reality technology consists of high-resolution For the company’s existing install base, using the Lensarimaging and measurement technology providing precise laser system for the new indication is simply a matter of abiometric information and 3-D reconstruction of the anterior software upgrade, Curtis said.anatomy of the eye. Lensar says its system provides precise “What it really does is opens up an additional market forcapsulotomy incision size, shape, and location, thereby us because there are a lot of doctors that have been looking atenhancing effective intraocular lens (IOL) lens positioning this technology,” he said. The additional indication for use mightand fitting for each individual patient, leading to optimized help sway doctors who had been sitting on the fence more inpatient outcomes. Lensar’s direction, Curtis added. “Lensar is deeply committed to providing cataract So far the Lensar system has been “really well received”surgeons with the most advanced and sophisticated tools in the marketplace and the latest regulatory milestone inthat support their delivery of optimal clinical outcomes to the U.S. is one more validation of the technology, Curtis toldtheir patients,” said Lensar CEO Nick Curtis. “By adding arcuate MDD. “We’re looking forward to the effect of this on potentialincisions to our growing list of FDA cleared indications for new customers and certainly our existing customer base.”the Lensar laser system, we have further strengthened ourposition as the provider of the industry’s most advanced, Amanda Pedersen, 912-660-2282;versatile, surgeon- and patient-centric laser cataract system.” Last year was a memorable one for Lensar as thecompany achieved two FDA clearances, raised $24 millionin private financing, installed about 30 of its laser systemsin 11 countries, and was profiled on the popular televisionshow “The Doctors” (Medical Device Daily, Dec. 11, 2012). “Milestones of this type underpin the significant tractionthat we have experienced in rapidly accelerating the adoptionof the Lensar platform among cataract surgeons around theworld,” Curtis said. “We expect this latest development will onlyserve to further increase the growing demand for our system.” Curtis told Medical Device Daily that the latest FDAclearance for the Lensar system is significant for the company,particularly in the U.S. rather than the rest of the world. Thereare fewer Toric options on the IOL side in the U.S. comparedto other parts of the world, he explained, which emphasizesthe importance of allowing doctors to use the Lensar systemfor making arcuate incisions during cataract surgery. “The execution of the arcuate incision with Lensar’sproprietary Augmented Reality imaging system andadvanced laser technology is one of the key recentadvances in the area of cataract surgery. Until recently, thesesmall and challenging incisions in the cornea were mademanually, leading to variability in predictable outcomes,”said Louis “Skip” Nichamin, MD, member of Lensar’s medicaladvisory board. “Lensar’s advanced technology platformwill help cataract surgeons achieve consistent, predictablearcuate incision outcomes, regardless of the challengesand complexity of the procedure. With this latest clearance To subscribe, please call MEDICAL DEVICE DAILY™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (404) 262-5476. Copyright © 2013 AHC Media. Reproduction is strictly prohibited. Visit our web site at
  5. 5. MONDAY, APRIL 8, 2013 MEDICAL DEVICE DAILY™ PAGE 5 OF 9InVivo study, it is imperative to take the time to get it right, becauseContinued from Page 1 any mistakes can lead to years of lost time for the scientists and patients that follow,” said Frank Reynolds, InVivo CEO.“The study has a one year-follow-up. Our expectation is that Reynolds added, “Everyone knows my obsession withby the end of 2014 we would have data to give to the FDA.” safe FDA studies. Over the next month or so, we plan to The company said that there are currently no treatment finalize the details of our study, and we expect to have alloptions approved by the FDA, or in clinical trials, to data to the FDA by the end of 2014. We will be conductingintervene directly in the spinal cord following SCI. The trial an open label study, and so we look forward to keepingwill be conducted at multiple U.S. hospitals, and work to gain the public aware of its progress. As a historical first-in-Institutional Review Board (IRB) approval at Massachusetts man study, this trial marks the next phase in our corporateGeneral Hospital in Boston is already underway. growth and begins our mission to maintain a collaborative “This is a biopolymer scaffolding that’s designed for relationship with the FDA. We’ve built a framework toneuro protection. What happens when you have a spinal optimize speed-to-market for our pipeline of technologies,chord injury is that you have a penetration within the and we’ll be working to commercialize over fifteen productsspinal cord and then an internal lesion forms,” Moran said. in the next five years while remaining focused on mitigating“You get this scarring process that occurs over 21 days. patient risk and maximizing patient safety and benefit.”That scarring process is what puts people in wheelchairsbecause the signal from the brain can’t go below the point Omar Ford, 404-262-5546;of where the scar is. The biopolymer scaffolding works to structural support and provides what we call pro-generation and allows for tissue ingrowth. So at the endof the day you get much better healing and less scarring.We’ve demonstrated that in primate studies. When we took Patent watchhistological samples we’ve got much better healing andless scarring.” Antares Pharma gains patent He added, “so if you have just 10% of a spinal cord left ina human remarkably through the process of neuroplasticity for Vibex Quickshot device A Medical Device Daily Staff Reportsignals can be rerouted through the healthy tissue. So whatthis product does is it protects the healthy tissue and allows Antares Pharma (Ewing, New Jersey) reported thatfor functional recovery to occur.” it has received a Notice of Allowance from the U.S. Patent The company said that although the technology has Trade Office (USPTO) on a patent application for the VIBEXyet to gain approval, it has already generated a significant QuickShot (QS) device, the latest advancement in itsamount of attention from the neurosurgical community. proprietary line of Vibex auto-injector systems. “Today there is no treatment for the spinal cord itself,” Paul Wotton, PhD, president/CEO, said, “The size andMoran said. “When you come in with a spinal cord injury scope of our intellectual property portfolio continues tothey decompress the cord, they do a laminectomy to relieve grow as we develop device technologies that will enhancepressure and then what will happen is that screws and rods the product performance of established drugs as well aswill be put in to stabilize the spine, but no neurosurgeon new drugs in development.”today actually treats the underlying spinal cord lesion so Wotton continued, “We believe that many injectablethis product would be the first of its class to do so.” drugs currently under development will be administered The company was also recently granted approval from by self-injection once they reach the market. Our advancingthe FDA on its Humanitarian Use Device (HUD) designation technology will therefore be important for the growingrequest. HUD designation is reserved for devices designed number of chronic care products that can only be given byto treat rare diseases or conditions. InVivo has received this injection.”designation for the treatment of recent complete spinal cord The VIBEX QS device offers a dose capacity up to 1injury (no motor or sensory function) that does not involve mL and the design can be scaled for larger volumes. Thepenetrating injury or complete severing of the spinal cord. device design emphasizes enhanced performance on theThe HUD designation and clinical trial data are required to attributes most critical to patient success – speed, comfortsupport a Humanitarian Device Exemption application to and discretion. The new design also accommodates fastthe FDA with the goal of commercializing the scaffold in the injection of highly-viscous drug products that stall less-United States sooner than a PMA approval would allow. powerful conventional auto-injectors. Many self-injectable “It’s heartbreaking for all of us for it to take even a biological agents currently marketed and in clinicalminute longer than necessary to begin human studies, and development are formulated to be administered in a 1 mLwe’ve all heard of, or experienced, treatments that have dose volume and tend to be of higher viscosity than non-proven to be unsafe, but when conducting a first-in-man biologic injectable products. To subscribe, please call MEDICAL DEVICE DAILY™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (404) 262-5476. Copyright © 2013 AHC Media. Reproduction is strictly prohibited. Visit our web site at
  6. 6. MONDAY, APRIL 8, 2013 MEDICAL DEVICE DAILY™ PAGE 6 OF 9International from Leksell Gamma Knife Perfexion equipped with Extend. Continued from Page 1 “We are delighted that Extend is now available in Japan,”precancerous lesions. The Aptima HPV 16 18/45 genotype said Tim Rooney, president and managing director ofassay is approved for genotyping HPV types 16, 18 and/ Elekta K.K. “Clinicians here will now be able to expand theor 45, which are associated with approximately 80% of versatility of their Leksell Gamma Knife Perfexion systemall invasive cervical cancers worldwide. Detecting the through multi-session radiosurgery. This technology willspecific HPV types 16, 18 and/or 45 provides healthcare enable treatment of lesions immediately adjacent to criticalprofessionals with additional information regarding a structures, such as the eye, in addition to targets that arepatient’s risk of subsequently developing cervical cancer. simply too large for just one radiosurgery session.”Both assays can be performed using Hologic’s ThinPrep Since its introduction in Japan in 1991, until the end of 2011,liquid cytology specimens collected for routine pap tests as Leksell Gamma Knife has been used to treat approximatelywell as Hologic’s Aptima cervical specimen collection and 173,000 patients. Through Leksell Gamma Knife Perfexiontransport kit. and its product line, Elekta intends to provide a wide “Most HPV infections clear up on their own, so it’s range of high-quality treatment options and to continue toimportant to identify those persistent, high-risk infections contribute to the field of radiotherapy.that are most likely to lead to cervical cancer,” said Tom Elekta is a human care company specializing inWright, MD, professor of pathology and cell biology at the solutions for treating cancer and brain disorders. TheColumbia University Medical Center. “In numerous clinical company makes tools and treatment planning systemsstudies involving approximately 45,000 women, the Aptima for radiation therapy, radiosurgery and brachytherapy, asHPV assay has consistently shown similar sensitivity and well as workflow enhancing software systems across thebetter specificity than the most frequently used DNA-based spectrum of cancer care.test. This means the Aptima HPV assay is highly accuratein detecting cervical disease, but is less likely to raise false Aerocrine passes regulatory milestone in Japanalarms that can result in unnecessary medical procedures.” Aerocrine (Solna, Sweden) said the Japanese authority The Hologic Aptima HPV assay has been approved for (PMDA) has approved its FeNO (fractional exhaled nitrictwo uses: oxide)-measuring device, Niox Mino as a tool for assessing • To screen patients with atypical squamous cells of patients with airway inflammation such as asthma.undetermined significance (ASC-US) cervical cytology The Japanese Pharmaceuticals and Medical Devicesresults in order to determine the need for referral to Agency (PMDA), decided, after a thorough review, to grantcolposcopy. the 2008 version of the Niox Mino marketing approval in • To be used adjunctively with cervical cytology to Japan. As Aerocrine introduced a new version in 2010 ofscreen women 30 years and older to assess the presence or Niox Mino, the approval will have limited impact on theabsence of high-risk HPV types. company’s sales in Japan in the near future. The Aptima HPV 16 18/45 genotype assay is intended “We look upon this approval as a positive regulatoryto test specimens from women with Aptima HPV assay milestone. We are very proud of being the first company topositive results and is approved for two uses: receive approval for the FeNO-method in Japan,” said Tobias • To be used adjunctively with the Aptima HPV assay Bergenblad, commercial director Aerocrine for women aged 30 years and older in combination with Aerocrine is a medical products company focusedcervical cytology to assess the presence or absence of on improved management and care of patients withspecific highrisk genotypes 16, 18 and/or 45. inflammatory airway diseases such as Asthma. • To be used adjunctively with the Aptima HPV assay inwomen aged 21 years or older with ASCUS cervical cytology Monteris gets Health Canada OK for AutoLITTresults to assess the presence or absence of specific high Monteris Medical (Plymouth, Minnesota) saidrisk HPV genotypes 16, 18 and/or 45. The results of this test Health Canada has approved the AutoLITT (now knownare not intended to prevent women from proceeding to as NeuroBlate) system, an MRI-guided ablation therapy forcolposcopy. brain lesions, for commercialization in Canada. The NeuroBlate System provides focal ablation (lethalElekta’s Extend approved in Japan heat therapy) for tumors and has been commercially available Elekta’s Japanese office, Elekta K.K. (Toyko), said in the U.S. since 2010. “We are excited that the NeuroBlatethat Elekta’s Extend system for multi-session stereotactic System will now be available for neurosurgeons and theirradiosurgery has been approved by the Japanese Health patients in Canada,” said John Schellhorn, president/CEOAuthority. Extend makes it possible to treat indications that of Monteris. “This approval is especially gratifying givenwere previously untreatable with Gamma Knife surgery. that the company was founded in Winnipeg, Manitoba andThe ability to treat a broader range of targets and morechallenging cases allows even more patients to benefit See International, Page 8 To subscribe, please call MEDICAL DEVICE DAILY™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (404) 262-5476. Copyright © 2013 AHC Media. Reproduction is strictly prohibited. Visit our web site at
  7. 7. MONDAY, APRIL 8, 2013 MEDICAL DEVICE DAILY™ PAGE 7 OF 9Washington that was assumed in the [budget] baseline” because of theContinued from Page 1 presumption that armed conflicts would not necessarilyCommittees indicates an interest in a “period of stable come to a halt. “It’s as fake as savings come because if wepayments,” to allow providers to brace for long-term changes had a shooting war somewhere, we’d have appropriations”to the payment system, with the more distant objective being to cover the cost, Antos continued, adding that a budgetarya series of payment options providers can choose from as clawback of OCO is a case of “projecting peace in the Middlesuits their practice models. The joint statement describes East.”the SGR hangnail as “a top priority” for the two committees, Still, the OCO is a possible if somewhat unlikely toolciting the perennial doc fix drama as a source of uncertainty in paying for the doc fix, Antos said. “Two years from nowthat makes it difficult “for [physician] practices to plan for if something happens” in terms of military conflict, “we’rethe future.” There is support for an SGR repeal on Capitol Hill going to spend the money.” He said that when it comes tobecause the cost of a repeal is nearly at an all-time low, but “solving a political problem like fixing the SGR, rememberpolicymakers and their advisors believe the price tag will rise that nobody goes back and” inquires where the offset cameagain after 2013 (Medical Device Daily, March 18, 2013). from. Should a war break out two years later, members of Joe Antos, PhD, of the American Enterprise Institute Congress would say “that’s something you couldn’t have(AEI; Washington) told Medical Device Daily anticipated.” are a couple of options Congress could avail itself ofin order to eliminate the SGR offset problem, including just FDA seeks feedback on sterilization, exportignoring the offset altogether. Antos, a healthcare scholar FDA apparently has its eye on two practices importantat AEI, seemed less than dazzled by the latest proposal, to device makers, namely non-sterile conveyance of deviceshowever. required to be sterile, and certificates of export for devices The current proposal is “a little more detailed than other not cleared or approved in the U.S.general statements, but it’s not much more” than prior drafts The agency announced both declarations for collectionaddressing this topic, Antos noted, pointing out that the 10-year, of information in the April 5 edition of the Federal Register,$138 billion cost of an SGR overwrite in the statute will not be but the explanations do little to tip FDA’s hand. Theeasy to cover. Still, Antos said, Congress has on one occasion announcement regarding exports is especially terse, statingdealt with this kind of dilemma without providing a pay-for. little more than that the statute “provides for the exportation “It hasn’t happened very often, but once in a while of an unapproved device under certain circumstances,”Congress will direct CBO to not score something” Antos including that the exportation “is not contrary to the publicremarked, stating that the Congressional Budget Office on health and safety and it has the approval of the foreignone occasion had included a footnote in a legislative report country to which it is intended for export.”estimating the cost, but that the cost of the offset did not One of the potential corollary issues here is that deviceappear anywhere else in the agency’s report. makers sometimes file 510(k) applications with FDA despite “What this says is Congress can do whatever it wants if having no intent to market the device in the U.S., a moveit has the votes and the gumption,” Antos quipped, adding, often undertaken to deal with nation-of-origin laws.“I think this is the year that something like that could As for the sterilization issue, the FR notice points out that FDAhappen. They’re having a fire sale on SGR and next year the has allowed device makers to ship products intended to be sterileprices are going to go back up, so they better take it.” Before for the purpose of sterilization, a practice FDA acknowledges islegislators get to that point, however, “they’re more likely an economic necessity for many device makers. The rest of theto look for the offsets, and the offsets are likely to be in the statement consists of federal government boilerplate or factsMedicare program.” such as are already appreciated by device makers. “If it looks like there’s an agreement on the Hill . . . to Both announcements set the response deadline at June 4.repeal the [device] tax, then people would say that leaves uswith another X billion dollars of hole to fill,” Antos pointed Mark McCarty, 703-361-2519out. “If you were of a suspicious mind, you might say that mark.mccarty@ahcmedia.comthis [device tax repeal] resolution is setting up that scenario,so that someone thinks they can offer to give up the repealof the device tax” in negotiations for the SGR repeal, “andthat will be their contribution to the payment for SGR,” he Sign up for our free, weeklyspeculated, although he pointed out that more would haveto be done to completely blank out the cost of the doc fix. e-mail blog, Perspectives, comment- Antos said the overseas contingency fund (OCO) as ing on today’s offset could happen in the congressional can-if-they-want scenario, but he said “the fuzziness of OCO is that Go to and sign is giving back money from the Department of Defense To subscribe, please call MEDICAL DEVICE DAILY™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (404) 262-5476. Copyright © 2013 AHC Media. Reproduction is strictly prohibited. Visit our web site at
  8. 8. MONDAY, APRIL 8, 2013 MEDICAL DEVICE DAILY™ PAGE 8 OF 9Court report International Continued from Page 6MAKO Surgical wins injunction a significant portion of our people and operations remain inagainst Blue Belt Technologies Canada. We are expanding our sales and marketing effortsA Medical Device Daily Staff Report to support Canadian neurosurgical centers offering brain tumor patients new therapies and technologies.” MAKO Surgical (Fort Lauderdale, Florida) reported that it Monteris Medical is a medical device companyhas obtained an order granting permanent injunction enjoining dedicated to the development of innovative MRI-guided,Blue Belt Technologies (Pittsburgh) from engaging a former laser-based brain lesion therapy.MAKO employee and requiring the destruction of all proprietaryMAKO business information in Blue Belt’s possession. MAKO Surgical is a device company that markets its RIO Bioelectronics to distribute in South KoreaRobotic-Arm Interactive Orthopedic system, with specific BioElectronics (Frederick, Maryland) has begunapplications for partial knee resurfacing and total hip product distribution of its ActiPatch Musculoskeletalreplacement, and proprietary Restoris Family of Implants Pain Relief, Allay Menstrual Pain Therapy andfor orthopedic procedures called MAKOplasty. RecoveryRx Chronic and Postoperative wound therapy On Jan. 30, Blue Belt reported that former MAKO brands with Herapharm (Seoul, South Korea).sales manager Jeff Gellman had been hired as West Area “South Korea has a population of more than 48 millionVice President of Sales. MAKO brought an action against with a world leading economy and personal incomes. It isBlue Belt and Gellman in the U.S. District Court of the an excellent introductory Asian market for BIEL’s awardSouthern District of Florida to enforce the non-competition winning products,” said Erin Sanders, BioElectronics Salesagreement between MAKO and Gellman and to prohibit the Manager.use or disclosure of MAKO’s proprietary information. BioElectronics is a medical device maker of By court order dated April 4, Gellman is prohibited from advanced medical devices. Its products are ActiPatchworking for Blue Belt in any capacity until August 2013, and Therapy, for over-the-counter treatment of back painmay only work in a limited capacity thereafter until 2014. and other musculoskeletal complaints, the AllayFurthermore, both Blue Belt and Gellman have been ordered menstrual cycle pain therapy, and RecoveryRx forto certify under penalty of perjury that all MAKO proprietary chronic and post-operative wound care.information in their possession has been permanentlypurged. The U.S. District Court retained jurisdiction of thematter to ensure compliance with its order. “MAKO is pleased with the sweeping and substantialinjunctive relief we obtained on an expedited basis,” said Financings Continued from Page 2Maurice Ferre, MD, president/CEO of MAKO. “We will remain actionable information than other solutions on the market.”vigilant in protecting the substantial investments made PeriGen says its suite of fetal surveillance solutions targetsin becoming the leader in the field of robotically assisted the most common underlying causes of preventable medicalorthopedic surgery.” errors to help clinicians improve clinical outcomes. Equipped The injunction was entered contemporaneous to a with evidence-based methods, these solutions deliver real-separate settlement agreement among Blue Belt, Gellman time decision support in a timely and visually intuitive way toand MAKO, which provided MAKO with the described nurses and physicians throughout the OB continuum.stipulated order, along with additional relief and future In the first quarter of 2013, PeriGen was recognizedprotections. for its innovative contributions to perinatal care when Blue Belt, which makes the the NavioPFS orthopedic experts from the National Institutes of Health (NIH)surgical system with precision robotics for unicondylar validated the company’s electronic fetal monitoringknee replacement (UKR), said in a statement sttributed (EFM) pattern recognition software, PeriCALM its president/CEO, Eric Timko that it believes “that this The company also expanded its clinical leadership inlawsuit was without merit and Mako failed to prove that Q1 by appointing Thomas Garite, MD, as chief clinicalBlue Belt engaged in any wrongdoing. In fact, Mako failed substantiate many of the allegations it made in its PeriGen secured $6.4 million from private investorscomplaint and we are confident that Blue Belt would have for further product development and marketingprevailed had the litigation continued. At the same time, initiatives. At the same time, PeriGen expanded itshowever, Blue Belt determined that it is in our best interest market reach through a distribution agreement withto compete with Mako by selling our new robotic technology leading international system integrator Helix Healthin the marketplace, instead of competing in the courtroom, Solutions (Dubai).where no surgeon or patient can benefit.” To subscribe, please call MEDICAL DEVICE DAILY™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (404) 262-5476. Copyright © 2013 AHC Media. Reproduction is strictly prohibited. Visit our web site at
  9. 9. MONDAY, APRIL 8, 2013 MEDICAL DEVICE DAILY™ PAGE 9 OF 9 Based Proteomic Mass Spectrometry Test on Treatment Recommendations in Advanced Non Small Cell Lung Med-Tech Notes Cancer,” shows that VeriStrat significantly influences therapy recommendations.Thermo Fisher gets ISO certification Thermo Fisher Scientific (San Jose, California) saidits facility in San Jose and its Franklin, Massachusetts site Product Briefshave achieved ISO 13485 certification, an internationallyrecognized standard of quality management for the designand manufacture of medical devices. The sites in Franklin and San Jose are the first of Thermo • Promega (Madison, Wisconsin) reported the launchFisher’s liquid chromatography and mass spectrometry of GenePrint 10 System for human cell line authenticationsites to achieve ISO 13485 certification. and sample identification. GenePrint 10 includes the eight Thermo Scientific TLX multiplexed HPLC (high loci recommended by the ANSI Standard (ASN-0002)performance liquid chromatography) platforms and a Authentication of Human Cell Lines: Standardization of STRnumber of Thermo Scientific mass spectrometry systems Profiling, plus Amelogenin for gender identification andwill be designed and manufactured under this standard, the highly polymorphic D21S11 locus for additional power ofpaving the way for CE-IVD device registration in Europe discrimination. Short Tandem Repeat (STR) analysis beginsand Class-1 medical device listing in the United States, the with amplification, and the GenePrint 10 System contains allcompany said. materials necessary to co-amplify human STR loci, using a “This is a critical step in our ongoing initiative to develop hot-start thermostable DNA polymerase and a robust bufferLC-MS (liquid chromatography-mass spectrometry)-based compatible with fast cycling and direct amplification fromdevices for the clinical market,” said Dan Shine, president of substrates. Tissue culture cells, important tools in manyThermo Fisher’s chromatography and mass spectrometry laboratories, are often misidentified or contaminated withbusiness. “The medical community is expressing great other cells, wasting substantial time, effort and laboratoryinterest in utilizing LC-MS technology, and we’re aggressively resources and potentially invalidating published data. Todeveloping tools to address this growing demand.” remedy this issue, the National Institute of Health and many journals now recommend or require cell line authenticationBiodesix releases VeriStrat study results before grant approval or acceptance for publication, Biodesix (Boulder, Colorado), a molecular diagnostic making cell line authentication a very important concerncompany dedicated to personalizing medicine, reported the for release of a peer-reviewed study demonstrating that • Syneron Medical (Yokneam, Israel) will beginphysicians are using the company’s VeriStrat test to help the market launch of its Sublative technology for theguide treatment decisions for patients with advanced non- removal or modification of the appearance of acne scars.small lung cell cancer (NSCLC). Details of the study and its The acne scar treatment is available on all of the Syneronresults appeared online ahead of print in Current Medical Sublative compatible systems, which includes els Plus,Research & Opinion. eTwo and eMatrix. Syneron’s Sublative technology is a “The results of this study show that when physicians bi-polar fractional radiofrequency (RF) energy deviceincorporated the VeriStrat test into their clinical practice, proven to effectively treat acne scars. Due to its design,it had a significant impact on their treatment decisions,” energy can now be delivered beneath the surface of thesaid David Brunel, CEO of Biodesix. “This data confirms skin to maximize collagen production while preservingthat VeriStrat provides valuable information to physicians the top layer of the skin intact, the company said. Thisas they recommend a therapy for individual patients— means patients benefit from significant results without theparticularly patients with advanced NSCLC who may not down time or potential complications of more aggressivebe receiving personalized therapy due to lack of a genetic treatments.mutation or squamous histology.” VeriStrat is a novel, multivariate, serum protein testdesigned to provide oncologists with information to Access Medical Device Daily Archives Online!help them choose between erlotinib and single-agent You have FREE access to articles dating back to 2005chemotherapy when treating advanced lung cancer — perfect for company research or for finding sup-patients. The test, which requires only a simple blood draw, porting data for presentations and reports.provides results in less than 72 hours, allowing physiciansto make quick treatment decisions. Go to for access. The published study, titled “The Impact of Serum To subscribe, please call MEDICAL DEVICE DAILY™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (404) 262-5476. Copyright © 2013 AHC Media. Reproduction is strictly prohibited. Visit our web site at
  10. 10. MDD’s Neurology ExtraADDITIONAL DEVELOPMENTS IN ONE OF MED-TECH’S KEY SECTORS MONDAY, APRIL 05, 2013 PAGE 1 OF 2Keeping you up to date on recent developments in neurologyCABG generally not associated with long-term cognitive dysfunction .. . The cognitive dysfunction observed in patients who undergo coronary artery bypass grafting (CABG) surgeryusually disappears within 8 weeks following surgery, according to a study published in the April 2013 issue ofThe Annals of Thoracic Surgery. Previously published estimates of the incidence of post-operative cognitivedysfunction vary widely, with some studies reporting lasting impairment in as many as 50% of patients. Research-ers from Monash University and RMIT University (both Victoria, Australia), periodically tested cognitivefunction in three sets of patients: 16 patients who underwent elective CABG surgery, 15 patients who underwentelective chest surgery for lung biopsies or lobectomies, and 15 non-surgical patients. “Our study carefully con-trolled for a wide range of factors that can influence cognition, such as the residual effect of general anesthesia,familiarity with testing procedures during retesting (practice effects), general intelligence, age, education levels,emotional state, and levels of pre-existing impairment,” said Kathryn Bruce, the primary author of the study. Theresearchers found that CABG patients performed worse on every subtest prior to surgery, and these disparitiescontinued following surgery. Anxiety, depression, and stress were associated with impaired cognitive perfor-mance in patients in the two surgical groups 1 week after surgery. At 1-week post-operation, 44% of CABG patientsand 33% of surgical control patients were significantly impaired; however, by 8-weeks post-operation nearly allpatients had recovered to pre-operation levels with 25% of CABG patients and 13% of surgical control patientsimproving beyond their pre-operative performance. The researchers also found that even though the surgicalgroups showed impairment, when individual performance within these groups was examined, more than half ofthe patients were unaffected by the surgery. The results also showed that the strongest predictor of worse cog-nitive performance after surgery was the emotional state of the patient, and patients who were anxious orstressed prior to undergoing surgery generally performed worse afterwards. “Previous research may have over-estimated the effects of cardiac surgery on cognition. Our data indicate that cardiac bypass surgery has a lowlikelihood of causing permanent cognitive deficits,” said senior author Stephen Robinson, PhD. “Cognitivechanges that occur immediately after surgery are likely due to confounding factors and will generally resolvewithin a few months.”Preventing sports-related brain injury in youngsters . . . Ice hockey accountsfor nearly half of all traumatic brain injuries among children and youth participating in organized sports whorequired a trip to an emergency department in Canada, according to a new study out of St. Michael’s Hospital(Toronto). The results are part of a first-of-its-kind study led by Michael Cusimano, MD, that looked at causes ofsports-related brain injuries in Canadian youth and also uncovered some prevention tactics that could be imme-diately implemented to make sports safer for kids. “Unless we understand how children are getting hurt in sport,we can’t develop ways to prevent these serious injuries from happening,” said Cusimano, a neurosurgeon andthe lead author of the study. “One would think that we know the reasons why kids are having brain injuries insports, but until know, it was based mainly on anecdotes.” The study used data from The Canadian HospitalsInjury Reporting and Prevention Program to look at the almost 13,000 children and youth aged 5-19 who had asports-related brain injury between 1990 and 2009. The results appeared in the journal PLOS ONE. The research-ers categorized injuries by players’ ages, what sport they occurred in and what mechanisms had caused them –“struck by player,” “struck by object” (such as net or post), “struck by sport implement” (such as ball or stick),“struck by playing surface” and “other.” Hockey accounted for 44.3% of all injuries and almost 70% of themoccurred in children over 10 as a result of player-to-player contact or being hit into the boards. Cusimano saidthey expected to see high numbers in hockey because it’s Canada’s national sport.Combined physical and mental activities good for older adults . . . Inac-tive, older adults, suffering from cognitive complaints, who completed 12 weeks of physical plus mental activity,experienced significant improvements in their cognitive function, a new study published in JAMA revealed. How-ever, there was little difference between the control and intervention group. Within the next 40 years, public To subscribe, please call MEDICAL DEVICE DAILY™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (404) 262-5476. Copyright © 2013 AHC Media. Reproduction is strictly prohibited. Visit our web site at
  11. 11. MONDAY, APRIL 05, 2013 MDD’S NEUROLOGY EXTRA PAGE 2 OF 2 health authorities expect an explosion of dementia cases as people live longer. Some potential strategies to pre- vent or delay dementia among asymptomatic individuals include a variety of behavioral interventions. Lifelong exercise can significantly improve cognitive functioning in later life, a previous study in Psychological Medicine revealed. However, according to the authors of this latest article, not many studies have observed the effects of physical and mental activity together. “We found that cognitive scores improved significantly over the course of 12 weeks, but there were no significant differences between the intervention and active control groups. These results may suggest that in this study population, the amount of activity is more important than the type of activity, because all groups participated in both mental activity and exercise for [60 minutes/per day, three days/per week] for 12 weeks. The researchers found that the overall cognitive scores improved greatly but didn’t differ between the different groups. “The prevalence of cognitive impairment and dementia are projected to rise dramatically dur- ing the next 40 years, and strategies for maintaining cognitive function with age are critically needed. Physical or mental activity alone result in small, domain-specific improvements in cognitive function in older adults; combined interventions may have more global effects,” the authors concluded. Obama unveils BRAIN Initiative . . . President Obama unveiled a decades-long project last week designed to map the inner workings of the brain, seeking answers to such challenges as epilepsy, autism and Alzheimer’s disease. “There’s this enormous mystery, awaiting to be unlocked,” Obama said during remarks at the White House. The initial cost: $100 million in Obama’s fiscal year 2014 budget to be proposed next week; Congress must approve the sum. The “BRAIN Initiative” – the acronym stands for “Brain Research through Advancing Innova- tive Neurotechnologies” – will look into ways people think, learn and remember, Obama said. Its goal is developing new technologies that can record the activities of individual cells and neurons within the brain. Obama cast the brain project as an example of how scientific research can generate economic growth, and he took the time to criticize the sequester – an ongoing series of $85 billion in automatic budget cuts that he said are damaging all sorts of research efforts. “Ideas are what power our economy,” he said. The brain project is “a bold new research effort to revolutionize our understanding of the human mind and advance the president’s vision for creating jobs and building a thriving middle class by investing in research and development,” said a White House statement. Obama made the brain project a part of his State of the Union Address in February. “Every dollar we invested to map the human genome returned $140 to our economy — every dollar,” Obama said on Feb. 12. “Today, our scien- tists are mapping the human brain to unlock the answers to Alzheimer’s.” Scientists will build on the sequencing of the human genome and other previous discoveries in determining how to address brain disorders. “Significant breakthroughs in how we treat neurological and psychiatric disease will require a new generation of tools to enable researchers to record signals from brain cells in much greater numbers and at even faster speeds,” the White House statement said. It added: “This cannot currently be achieved, but great promise for developing such technologies lies at the intersections of nanoscience, imaging, engineering, informatics, and other rapidly emerg- ing fields of science and engineering.” Resetting the addicted brain with laser light . . . By stimulating one part of the brain with laser light, researchers at the National Institutes of Health (NIH) and the Ernest Gallo Clinic and Research Center at UC San Francisco (UCSF) have shown that they can wipe away addictive behavior in rats – or conversely turn non-addicted rats into compulsive cocaine seekers. “When we turn on a laser light in the prelimbic region of the pre- frontal cortex, the compulsive cocaine seeking is gone,” said Antonello Bonci, MD, scientific director of the intramural research program at the NIH’s National Institute of Drug Abuse (NIDA), where the work was done. Bonci is also an adjunct professor of neurology at UCSF and an adjunct professor at Johns Hopkins University (Baltimore). Described last week in the journal Nature, the new study demonstrates the central role the prefrontal cortex plays in compulsive cocaine addiction. It also suggests a new therapy that could be tested immediately in humans, Bonci said. Any new human therapy would not be based on using lasers, but would most likely rely on electromagnetic stimula- tion outside the scalp, in particular a technique called transcranial magnetic stimulation (TMS). Clinical trials are now being designed to test whether this approach works, Bonci added. What makes the new work so promising, said Bonci, is that Billy Chen of NIDA, the lead author of the study, and his colleagues were working with an animal model that mimics this sort of compulsive cocaine addiction. The animals, like human addicts, are more likely to make bad decisions and take cocaine even when they are conditioned to expect self-harm associated with it. — Compiled by Robert Kimball, MDD Staff Writer To subscribe, please call MEDICAL DEVICE DAILY™ Customer Service at (800) 477-6307; outside the U.S. and Canada, call (404) 262-5476. Copyright © 2013 AHC Media. Reproduction is strictly prohibited. Visit our web site at