MEDICAL DEVICE DAILY STATE THE INDUSTRY OF … · Medical Device Daily ... succeed and thus we must continue to evolve ... , medical device companies have launched products in Europe

STATE INDUSTRY REPORT 2 0 1 3

OF THE

INSIGHTS AND INNOVATIONS FROM INDUSTRY LEADERS

M E D I C A L D E V I C E D A I L Y

2013 State of the induStry report

inSightS and innovationS from induStry leaderS

Medical device daily™

MedicalDeviceDaily™StateoftheIndustry v

TableofContents

IntroductionMed-tech innovation continues, but may be heading overseas . . . . . . . . . . . . . . . . . . . . . . .3Industry Expert Panel Innovators see both obstacles and opportunities as they assess the condition of medical innovation in the U .S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9NewCos on the GoAirXpanders gets IDE to study AeroForm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19Apollo Endosurgery raises $47 .6M in Series B round . . . . . . . . . . . . . . . . . . . . . . . . . . . .21New device may offer hope for ‘suicide headache’ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23Auxogyn aims to improve IVF outcomes with Eeva . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25Avinger enrolls first U .S . patient in CONNECT II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26Bluegrass Vascular focuses on Surfacer ‘inside out’ catheter . . . . . . . . . . . . . . . . . . . . . . . .28New combat clamp device stops groin area bleeding . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30CardioComm earns FDA clearance for OTC heart monitoring system . . . . . . . . . . . . . . .32Case Medical study uses fMRI to investigate dystonia . . . . . . . . . . . . . . . . . . . . . . . . . . . .34HeartLight EAS lights the way for catheter ablation of AF . . . . . . . . . . . . . . . . . . . . . . . .36CellScope develops ear infection detection device via smart phone . . . . . . . . . . . . . . . . . .38CerebralRx enters market with vagus nerve stimulation device . . . . . . . . . . . . . . . . . . . . .40CerviLenz offers screening tool for preterm birth risk . . . . . . . . . . . . . . . . . . . . . . . . . . . .42ChromaGen’s lenses help aid color blind patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43Clarimedix gains traction despite rough VC landscape . . . . . . . . . . . . . . . . . . . . . . . . . . .45CytoPherx gets $34 million in funding for kidney therapy . . . . . . . . . . . . . . . . . . . . . . . . .46Dune to provide realtime analysis of cancer margin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47Ellipse uses ‘MAGEC’ for treatment of scoliosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49Haldor launches ORLocate in U .S ., for instrument tracking . . . . . . . . . . . . . . . . . . . . . . .51ImageIQ’s partnership with NASA could boost profile . . . . . . . . . . . . . . . . . . . . . . . . . . .53Ivantis enrolls first patient in Hydrus Microstent study . . . . . . . . . . . . . . . . . . . . . . . . . . .55IVDiagnostics to monitor cancer treatment results with platform . . . . . . . . . . . . . . . . . . .57iWalk robotic prosthetics to have ‘profound’ impact . . . . . . . . . . . . . . . . . . . . . . . . . . . . .59Kelyniam switches to med-tech industry, with skull implants . . . . . . . . . . . . . . . . . . . . . .61Simple device could solve complex problem of acid reflux . . . . . . . . . . . . . . . . . . . . . . . .63MindFrame ischemic stroke device successful in human procedure . . . . . . . . . . . . . . . . . . . . . .65Neuronetics seeks to corner market on treating depression . . . . . . . . . . . . . . . . . . . . . . . .66NeuroSigma licenses UCLA patents to form NSVascular . . . . . . . . . . . . . . . . . . . . . . . . .68Novasyte answers common device industry dilemma . . . . . . . . . . . . . . . . . . . . . . . . . . . .70OvaScience secures $37M Series B funding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .72PhysioSonics sees nICP device as game-changer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .74PreviMed thrives while avoiding the traditional VC funding route . . . . . . . . . . . . . . . . . . . .75ReCor reports six month data for Paradise system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .77Researchers fuse vessels together without sutures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .79Heart tissue stimulation could lead to light-guided pacemakers . . . . . . . . . . . . . . . . . . . . .81TSI set to launch Phantom MIS hip retractor system . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83TransEnterix develops laparoscopic vessel sealer, stapler for Spider . . . . . . . . . . . . . . . . .84UCLA researchers develop hologram microscope device . . . . . . . . . . . . . . . . . . . . . . . . .85

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Fear of unknown, not money, slows technology adoption . . . . . . . . . . . . . . . . . . . . . . . . .87InterVapor vows ‘no implant left behind’ in emphysema patients . . . . . . . . . . . . . . . . . . . . .89VasoStitch set to solve PCI access/closure challenge . . . . . . . . . . . . . . . . . . . . . . . . . . . . .91Velomedix gets IDE to evaluate rapid cooling system for AMI . . . . . . . . . . . . . . . . . . . . .93World Micro sets sights on medical device market . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .94By the NumbersMed-Tech Financings: Aug . 2011 – Aug . 2012 (commencing at $40M) . . . . . . . . . . . . . .99Top 25 Med-Tech Deals: Aug . 2011 – Aug . 2012 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .100All Med-Tech Deals: Aug . 2011 – Aug . 2012 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .100Top 25 Med-Tech Financings: Aug . 2011 – Aug . 2012 . . . . . . . . . . . . . . . . . . . . . . . . . . .101Top 25 Med-Tech Financings: Aug . 2011 – Aug . 2012 . . . . . . . . . . . . . . . . . . . . . . . . . . .102All Med-Tech Financings: Aug . 2011 – Aug . 2012 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .102Med-Tech Deals: Aug . 2011 – Aug . 2012 (commencing at $100M) . . . . . . . . . . . . . . . .103Med-Tech Financings: Aug . 2011 – Aug . 2012 (commencing at $40M) . . . . . . . . . . . . .106Conference CoverageMedtronic CEO: ‘business model has to be adjusted’ . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115Private companies make their pitches to receptive audience . . . . . . . . . . . . . . . . . . . . . 117Modified mosquitoes, robotic limbs, make Clinic’s Top 10 list for 2012 . . . . . . . . . . . . .120Changing partnership models reflect new paths to business . . . . . . . . . . . . . . . . . . . . . . .122Leahey: Stakes for med-tech sector have never been higher . . . . . . . . . . . . . . . . . . . . . .124Mexico streamlining its drug/device registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .126Shuren promises to screen out ad hoc bar raising . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .128Regulatory Patent reform may prompt more filings, does little for pendency . . . . . . . . . . . . . . . . . . .133Kerry’s message: Not ‘a choice between innovation and safety’ . . . . . . . . . . . . . . . . . . .135Foster; ‘little incentive for cost-reducing technology’ . . . . . . . . . . . . . . . . . . . . . . . . . . .136Mobile application guidance a preliminary effort, says FDA . . . . . . . . . . . . . . . . . . . . . .137FDA’s de novo tweak allows firms a parallel 510(k) filing . . . . . . . . . . . . . . . . . . . . . . . .138FDA’s innovation blueprint relies on existing programs . . . . . . . . . . . . . . . . . . . . . . . . . .140Patent reform will drive more global searches for prior art . . . . . . . . . . . . . . . . . . . . . . .141FDA inks IDE guidance for early feasibility studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . .143FDA spells out new staged IDE approval in new draft guidance . . . . . . . . . . . . . . . . . . .144CMS holds on pass-through payments for CY 2012 OPPS . . . . . . . . . . . . . . . . . . . . . . .145FDA formally adds a step to the device exemption process . . . . . . . . . . . . . . . . . . . . . . .147FDA updates 1988 guidance on substantial equivalence . . . . . . . . . . . . . . . . . . . . . . . . .148$595M user fee agreement will measure by total review times . . . . . . . . . . . . . . . . . . . .149Court rejects Prometheus patent citing danger to innovation . . . . . . . . . . . . . . . . . . . . . .150Supreme Court vacates Myriad decision, remands case to CAFC . . . . . . . . . . . . . . . . . .152ESRD devices first entries to Innovation Pathway 2 .0 . . . . . . . . . . . . . . . . . . . . . . . . . . .154CMS to cover TAVR via CED minus mandate for superiority . . . . . . . . . . . . . . . . . . . . .156Device tax repeal bill clears House via vote of 270-146 . . . . . . . . . . . . . . . . . . . . . . . . . .157Senate passed FDA user fee bill via a 92-4 vote . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .159Roberts casts deciding vote to uphold Affordable Care Act . . . . . . . . . . . . . . . . . . . . . . .161CAFC judges exhibit no drift in respective views of Myriad . . . . . . . . . . . . . . . . . . . . . .163

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Industry InterviewsAspinall says diagnostics assure effective treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . .167Ideas abound, but Belson follows a set of rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .171Coppola sees NovaSom, ASAA goal the same: serve patients . . . . . . . . . . . . . . . . . . . . .175Erdman optimistic about changing device industry . . . . . . . . . . . . . . . . . . . . . . . . . . . . .179‘Nasty disease states’ creates opportunities for EKOS . . . . . . . . . . . . . . . . . . . . . . . . . . .183Former pharma company Endo knee-deep in ‘health solutions’ . . . . . . . . . . . . . . . . . . . . .186Meyers heads up physician entrepreneurs group, SoPE . . . . . . . . . . . . . . . . . . . . . . . . . .189Nash sees healthcare mission as: improve care, cut costs . . . . . . . . . . . . . . . . . . . . . . . . .193Avantis has ‘exciting oportunity’ in colon cancer detection . . . . . . . . . . . . . . . . . . . . . . . .197Founding values added to appeal of CEO post for Shimer . . . . . . . . . . . . . . . . . . . . . . . .200Topol urges patients to take control of their health data . . . . . . . . . . . . . . . . . . . . . . . . . .204GE healthymagination Fund invests on ‘mega-trends’ . . . . . . . . . . . . . . . . . . . . . . . . . . .208PwC report: major opps eyed in healthcare sector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .210Yadav sees benefits of wireless sensing tech for HF patients . . . . . . . . . . . . . . . . . . . . . .217Company Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .223

IndustryExpertPanel

MedicalDeviceDaily™StateoftheIndustry 9

The MDD Interview

Innovators see both obstacles and opportunities as they assess the condition of medical innovation in the U.S.Interview by JIM STOMMEN, MDD Contributing Writer

AspartofMed-Tech on a Mission: Strategies to Drive Innovation,aspecialeditionoftheMDDInterviewwasputtogether,withthefocusonthestateofmedicalinnovationintheU.S.

Apanelofentrepreneursandinnovatorsinthemedicalfieldsharedtheirthoughtsonawidevariety of issues related to where innovation is in this country today and where it seems to beheadedinthefuture.

Theparticipantsinclude:ThomasFogarty,MD,PhD,presidentofFogarty Research & Development(PortolaValley,

California). A renowned cardiovascular surgeon, successful entrepreneur and investor, and anaward-winning vintner, he is perhaps best known for inventingand patenting the Fogarty Balloon Catheter, a device which hasrevolutionizednotonlyvascularsurgerybutthemedicalfieldoverall.He has been the founder/co-founder and chairman of the board ofmore than 33 business and research companies, all of which arebased on devices designed and developed by Fogarty EngineeringInc. In 1993,Fogarty foundedThreeArchPartners,aventurecapitalfirmthatinvestsinnewhealthcarecompanies.

Perry Genova, PhD, founder and CEO of medical device start-up firm Oncoscope (Durham, North Carolina), a maker of opticalimagingsystemsfortissuesampling.Abiomedicalprofessionalwithexpertise in medical and pharmaceutical product innovation anddevelopment.Previously,hepreviouslyservedwithGlaxoSmithKlineand Kos Pharmaceuticals, and has also been involved in a numberofsuccessfulstart-upventures,includingQuillMedical(acquiredbyAngiotechin2006)andIEPPharmaceuticalDevices(acquiredbyKos

Pharmaceuticalsin1999).JoshMakower,MD,founderandCEOofExploraMed Development(MountainView,California),

amedicaldeviceincubator.HealsoisaventurepartnerwithNewEnterpriseAssociates,wherehesupportstheinvestingactivityinthemedicaldevicearena,andisaconsultingassociateprofessorofmedicineatStanford,whereheco-foundedtheuniversity’sBiodesignInnovationProgram.

ArlenMeyers,MD,president/CEOoftheSociety of Physician Entrepreneurs(SoPE;Denver).Healsoisprofessorofotolaryngology,dentistryandengineeringattheUniversityofColoradoDenver.Thefounderorco-founderofseveralcompanies,heisaconsultanttolifescience,ITandinvestmentfirms.

Kevin Schulman, MD, professor of medicine in the Duke University School of Medicine (Durham,NorthCarolina),wherehealsoservesasthedirectoroftheCenterforClinicalandGeneticEconomicsandasanassociatedirectoroftheDukeClinicalResearchInstitute. He holds a joint appointment as a professor of businessadministrationinDukeUniversity’sFuquaSchoolofBusiness,whereheisthedirectoroftheHealthSectorManagementProgram.

They chatted with MDD Contributing Writer Jim Stommen on

Fogerty

Genova

IndustryExpertPanel

10 MedicalDeviceDaily™StateoftheIndustry

issuesimpactingthepresentandfutureofmedicalinnovation.

MDD: What’s the state of medical device innovation in the U.S. today, and where do you see it headed?

Makower: I fundamentally believe that regardless of thedownwardpressureonhealthcarecost,thatAmericanswillcontinueto value their health above other needs and thus there is a futureformedical innovation intheU.S.Thatsaid, thehurdlesassociatedwithreimbursement,certaingovernmentpolicies/taxes,regulatorychallenges and access to capital will limit which projects cansucceed and thus we must continue to evolve our thinking aboutwhichbusinessmodelsandtechnologieswecanandshouldpursue.In all likelihood there will be a redistribution of focused effort asentrepreneursadapttothesechanges.Certainlygovernmentpolicieswithrespecttohownewtechnologiesarepaidforandtaxedcoulddramaticallypropelordepressinnovationinoursector.

Schulman: That’s a really challenging question. I think we’re in transition between models.Theneedfornewtechnology,fornewmedicaldevices,isgreat,butthecustomerintermsofthepayer or the hospital is becoming increasingly challenging and that’s putting a lot of pressureon thebusinessmodel,at least in theU.S.And thenwehaveanexplosionofwhatweconsidermedicaldevices,fromimplantabledevicestoinformationtechnologysystemstoallkindsofnewopportunitiesforsensorsforremotemonitoring.SoIthinkthetechnologythatenablesustodonewthingsandexcitingthingsisthereandincreasingindevelopment,butthepayermakesthereimbursementmodelandthebusinessmodelarounddevices,andthat’sreallychallenging.

Genova:Personally,IbelievetheU.S.isstillextremelyinnovativeandcreativeasanationand,more specifically, within the medical device sector. We have an abundance of people who arecreativeandunderstandtheentrepreneurialmodelandtherisksandrewardsthatareassociatedwithit,andarewillingandabletotaketheserisks.However,Iamconcernedaboutthesignificantchallengesaheadofus.Theproblemisn’tfundamentallywithourcreativegenius,but,rather,withthe lack of a receptive environment on the back-end for that creativity. For innovation to thrivewemustwarmlyembrace,onanational level,medicaldeviceinnovationandrewardinnovationand innovators rather than hobbling them through regulatory complexity or by associatinginnovationwith increasedcosts. I fearthatthemedicaldevice innovationmodel intheU.S.mayfollowtheoutsourcedmanufacturingmodelforconsumerproductswherewesetupmanufacturingsomewhereelseintheworldandsubsequentlyestablishedengineeringservicestobeproximalto the manufacturing centers. In a way, it’s already begun. For some time now, medical devicecompanieshavelaunchedproductsinEuropeorAsiafirstandleveragedsomeoftherevenuefromthoseexercisestofundU.S.regulatoryfilingsandcommercialization.So,liketheaforementionedoutsourcingmodel,ifwearefocusingoncommercializingoutsideoftheU.S.,itwouldn’tbeunusualtoconsiderthatinnovationcentersmayfollow.

Meyers:Overregulated,overtaxedandstillmostlyrunbythecombinationofpayers,industryandthegovernment.Doctorsandpatients,thetwomostimportantingredientsintheinnovationformula,arestillonthemargins.

Fogarty:It’sanimportantissue,probablymoreimportantinthisdayandagethanithaseverbeen. It’s introubletoday,andrightnowit’snotheadedinaverygooddirection.Anevenmoreunfortunatethingisthatmanyphysiciansreallydon’tknowthat,andevenfewerpatientsknowthat.Butifyoulookatthefacts,ifyoulookatthereportsbeingmadeatmajormedicalmeetings,probablyathirdoftheinformationbeingpresentedisbeingpresentedbypeoplefromoffshore.When I first entered this field 40 years ago, probably 90% of what was presented in the way ofvaluablenew informationcamefromtheUnitedStates.Notanymore,and Idon’t think that isawelcomedirectionbyanymeans.Ithinkpatientsarenotgettingthecaretheyshouldget,arenotgettingthecareatthepricetheyshouldget.Itsmulti-factorial,butamajorreasonisthatmedicine

Makower

NEW COs ON THE GO

NewCosontheGo


AirXpanders gets IDE to study AeroFormBy AMANDA PEDERSENMedical Device Daily Senior Staff Writer

Therehastobeabetterway.That sentiment is what inspired the development of a new breast tissue expansion device

for mastectomy patients undergoing breast reconstruction. The device, called AeroForm, wasdeveloped by AirXpanders (Palo Alto, California), which recently received an investigationaldeviceexemptionfromFDAtomoveforwardwithaclinicaltrialevaluatingthetechnology.

The prospective, randomized, controlled, open-label pivotal study, XPAND (AirXpandersPatientActivatedControlledTissueExpanderSystemforBreastReconstruction),willbeconductedat multiple centers across the U.S. AirXpanders said the results will be used as the basis for itsAeroForm510(k)filingwiththeFDA.

ScottDodson,president/CEOofAirXpanders,toldMedical Device Dailythatthecurrentmethodfor undergoing breast reconstruction following a mastectomy is a procedure during which thesurgeoncreatesaspaceforapermanentimplant.Todothis,thesurgeonmakesasmallincisioninto the woman’s pectoral muscle, inserts a silicone bag. Then, during weekly office visits, thesurgeoninsertsaneedlethroughtheskinintothetissueexpander’sporttoinjectsalineintothetemporaryimplant.Theseweeklyinjectionscontinueforupwardsoffourmonths,Dodsonsaid.

SoDanielJacobs,MD,apracticingplasticsurgeonandoneoftheco-foundersofAirXpanders,decidedtherehadtobeabetterway.

WhatAirXpandersendedupcomingupwithwasabreasttissueexpansiondevicethatwouldaddress the limitations of traditional saline expanders. The AeroForm tissue expander consistsof a technologically advanced self-contained tissue expander and a small hand-held wirelessremotecontrol.Dodsonsaidthesystemusescompressedcarbondioxidethatisgraduallyreleasedthroughasmall internalvalve, inplaceof invasivesaline injections, tofill theexpander.Afterastandardproceduretoimplanttheexpander,thepatientisabletoinflatetheexpanderherselfathomeusingtheremotecontrol,eliminatingtheneedforweeklydoctorvisitsandneedle-basedsalineinjections.

Thepatientcaninflatetheexpanderuptothreetimesadaywithathree-hourlock-outbetweendoses.“Wethoughtifwecouldexpandthepatientonagradualdailybasiswecouldgethertherequicker,”DodsontoldMDD.

The way the remote control part of the system works is that the patient waves it over theimplantareatoallowittocommunicatewiththeimplant.

“It’slikeusingastudfinderonthewalltofindoutwhereastudis,”Dodsonsaid.“Thisdosecontrollercommunicateswhenitisovertheimplant...onceyou’reinthesweetspotyousimplypressthebuttonandimmediatelya10ccdoseisdelivered.”

HesaidthecompanyrecentlycompleteditsfeasibilitytrialinAustraliawhichshowedthattheimplantwasabletoreachfullexpansioninabouttwoweeksusingthenewdevice.

“Thisisasignificanteventinthefactthatwomenwanttogetontotherecoveryphaseafterthey’vegonethroughthishorribleordealwithcancer...wevalidatedthatwecanhelpgetthemthere quicker,” Dodson said. AirXpanders noted that the randomized, controlled clinical trialis designed to directly compare the outcomes of tissue expansion using the traditional salineexpansionmethodtotheinvestigationalAeroForm,remote-controlled,needle-freetissueexpander.Enrollmentwillcontinueuntilatotalof92AeroFormdeviceshavebeenimplantedand46salineexpandershavebeenimplanted.Dodsonsaidthecompanyexpectsthetrialtotakesixtoeightmonthstocomplete.

ParticipatingsitesincludehospitalsinAtlanta,Boston,NewYork,St.Louis,SanDiegoandothercitiesacrosstheU.S.,thecompanynoted.

“We’reveryblessedtohavesomegreatsitesonboardwiththisstudy,wehavenotbeentoldnobyanyone,therehasbeengreatphysicianreceptivitytothistrial,whichinmy25yearsofworking

NewCosontheGo


Apollo Endosurgery raises $47.6M in Series B roundBy AMANDA PEDERSENMedical Device Daily Senior Staff Writer

Apollo Endosurgery (Austin,Texas) raised$47.6million in itsSeriesBfinancinground inFebruary2012.NewinvestorsNovoA/S,RemeditexVentures,andCPMGjoinedexistinginvestorsPTVSciencesandH.I.G.BioVenturesintheround.Proceedsweretargetedforthecommerciallaunchof thesecondgenerationOverStitchendoscopicsuturingsystemandotherApolloendosurgeryflexible surgical tools designed to allow surgeons and interventional endoscopists to performnumerousprocedureswithoutmakingincisionsintothepatient’sskin.

Aspartofthefinancing,JackNielsenofNovoA/S,JohnCreecyofRemeditexandKentMcGaughyofCPMGwilljoinApollo’sboard.

“Wearepleasedtohavethisstrongfinancialsupportfrombothournewandexistinginvestors,whichwillenableasuccessfullaunchoftheOverStitchplatformandthebroaderadoptionofflexiblesurgical approaches for numerous medical conditions,” said President/CEO Dennis McWilliams.“ThisnewfinancingwillenhanceApollo’sleadershippositionasaninnovatorandadrivingforceinadvancingthisnewclassoflessinvasivetherapies.”

McWilliamstoldMedical Device DailythatbeingabletoraisesuchasignificantroundoffundsinthecurrentfinancialenvironmentisatestamenttoApollo’stechnology,theOverStitch,aswellasthesizeoftheopportunitythecompanyistargeting.Thecompanyhasbeenfortunatetohavethecontinuedsupportithasreceivedfromitsexistinginvestors,henoted.

“Thepastthreeyearshavebeenverychallenginginthefundraisingenvironment...andthat’sconstrainedalotofcompaniestobuildtheirbusinessesandgrow,”McWilliamssaid.“Weputourheads down and focused on preserving our cash and continuing to hit the milestones, but wemaintainedourvisiontodeveloptheOverstitch.”Headdedthatthecurrentfinancingisatestamenttothesizeofmarketthecompanyisgoingafter.

“Therearehugeopportunitiesthathavenotbeenverywelltapped,”hesaid.Thislatestround,combinedwithApollo’searlierroundof$11.7million,addsuptoatotalraisedof$59.3million.

Apollo’s OverStitch platform combines the flexibility of endoscopy with the precision ofsurgical suturing, allowing physicians to access, manipulate and suture internal tissue withoutmakingincisionsthroughtheskin,thecompanysays.Theplatformthereforeallowsphysicianstodeveloplessinvasiveoptionsforthepatient.

Ted Stephens, global marketing director at Apollo, told MDD that the second generationOverStitch isclinicallyverysimilar tothefirstgenerationof thedevice. “Thesecondgenerationdevice was really designed to allow much easier, improved experience from the clinician’sperspective,”

Stephenssaid.“It’smucheasiertouse,itallowsformoreprecisioninplacingsuturesthanthefirstgenerationdevice.”McWilliamsaddedthatApollobuilttheOverStitchdevicetocommercialscale,whichisuniquethesedaysamongmedicaldevicecompanies,hesaid.“Notmanycompaniestakethatapproachoutofthegate,whichisatestamenttonewtimesinmedicaldevices,”McWilliamssaid.

Withexitmarginsnotbeingverysolidintheindustryoverthelastfewyears,McWilliamssayscompaniesneedtobuildtheirbusinessestohaveproductsbuilttoscalefromthestart.Withthatinmind,hesaidApollohasbeenbuilttobeaselfsustainingcompanybecausethetraditionalmodelofbuildingaprototypedevice,runningaclinicaltrial,andgettingacquiredisnolongeraseasyasitoncewas.“Theyreallywanttoseetractioninthemarketplaceandyoureallyhavetobuildyourcompanylikethatfromthestart,”hesaid,referringtocompanieslookingatacquiringsmallerstart-ups.

ApolloalsorecentlyreceivedFDAclearanceforitsSuMOplatformdesignedtohelpsurgeonsremove large, flat pre-cancerous gastrointestinal lesions and polyps. The company now has 11productsclearedbyFDA,McWilliamssaid.Ingeneral,thisnewclassofflexiblesurgeryprocedures

NewCosontheGo


Auxogyn aims to improve IVF outcomes with EevaBy AMANDA PEDERSENMedical Device Daily Senior Staff Writer

Thefieldofassistedreproductionisonethatishighlysubjectiveusingtoday’stechnology.Thechallengeembryologistsarefacedwithduring in vitrofertilization(IVF)proceduresistolookatembryosunderamicroscopeanddecide,basedonlimitedinformation,whatthechancesarethattheembryoisviableenoughtoresultinasuccessfulpregnancyanddecidethefateofthatembryo.

“The ultimate objective of IVF procedures is to transfer one embryo that will result in onehealthybaby,”LissaGoldenstein,president/CEOofAuxogyn(MenloPark,California),toldMedical Device Daily.

The company’s first product, the Early Embryo Viability Assessment System (Eeva), wasdeveloped based on science and technology that started at Stanford University (California).EevabringstheIVFfieldclosertoitsgoalbyprovidingsoliddatafortheselectionofembryo(s)totransfer,Goldensteinsaid.ThenoninvasivesystemisdesignedtoprovideIVFclinicsandpatientswithobjectiveinformationregardingembryoviability.

“Webelieve itwillrevolutionizethefieldofassistedreproductionbecauseofthefactthat itbringsscientificrigorandobjectivitytotheselectionofembryos,”Goldensteinsaid.“WebelievethatEeva’spredictivecapabilitieswillhelpguidethetreatmentpathdecisionsforwomenpursuingIVF.”

Eeva’ssoftwareisdesignedtoautomaticallyanalyzeembryodevelopmentagainstscientificallyandclinicallyvalidatedcell-divisionparameters.WithEeva’squantitativedataforeachembryo’spotentialdevelopment,accordingtoAuxogyn.

ThecompanywasinitiallyfundedinMay2010byKleinerPerkinsCaufield&Byers,TPGBiotechandMerckSeronoVentures.

LastweekAuxogynreportedraising$18millioninaSeriesBfinancinground,whichincludednewinvestorSROne.

“Webelievethatwe’vebeenabletoattractanewhighqualityinvestorandsecureparticipationfromallexistinginvestorsduetothefactthatEevabringsscientificrigorandobjectivitytothefieldofassistedreproduction,afieldthatislargelysubjectivetoday,”GoldensteintoldMDD.“WebelievetheadditionofSROneisavalidationoftheimportanceofourtechnology,thestrongsciencebehindEeva,andalsoourabilitytomovethistestquicklytowardcommercialization.”

Thecompanyhasalsorecentlycompletedamulticenter,160-patientstudytovalidatethesafetyandefficacyofEeva,andplanstointroducethesystemtotheEuropeanmarketlaterthisyear.TheresultsofitsclinicalstudyareexpectedtosupportregulatoryfilingsbothinEuropeandintheU.S.

“WeareveryexcitedtobringEevatothemarket,andweareabsolutelycommittedtofurtheringresearchforwomenandtheirfamiliespursuingassistedreproduction,”Goldensteinsaid.

InadditiontoEeva,Auxogynsaysitintendstodevelopotherproductstoaddressinfertility.The company joins several others working on medical technology to address this need,

includingOvaScience (Cambridge,Massachusetts), INVO Bioscience (Beverly,Massachusetts),Incept BioSystems(AnnArbor,Michigan),andIntimate Bridge to Conception(Ib2c;Pittsburgh),amongothers.

OvaScience,whichwaslaunchedin2011,recentlycompleteda$37millionSeriesBfinancing.That company is developing a method of capturing mitochondria from a mother’s own ovarianstemcellsandinjectingthemalongwithspermintoeggsforIVF.

Incept BioSystems has developed a device with the intention of enabling a continuous,refreshableculturemicroenvironmentwhileusingindustry-standardIVFculturemedium.

BytheNumbers


Top 25 Med-Tech Deals: Aug. 2011 - Aug. 2012

All Med-Tech Deals: Aug. 2011 - Aug. 2012

$400M - $699M40%

$700M - $999M12%

$1B - 2.9B20%

more than $3B28%

$400M - $699M

$700M - $999M

$1B - 2.9B

more than $3B

greater than $800M

13% $400M - $800M9%

$100M-$399M57%

less than $100M21%

greater than $800M

$400M - $800M

$100M-$399M

less than $100M

BytheNumbers


Top 25 Med-Tech Financings: Aug. 2011 - Aug. 2012Rank Company Value Notes Date

1 Bristol-Myers Squibb

$3.000B increaseditsrepurchaseauthorization 6/28/12

2 Baxter $2.000B authorizedsharerepurchaseprogramforupto2billion

7/26/12

3 Community Health Systems

$1.200B aggregateprincipalamount 7/20/12

4 Health Care REIT $1.100B 20.7millionsharesinpublicoffering 2/29/12

5 Cowen Healthcare Royalty Partners

$1.000B CowenHealthcareRoyaltyPartnersII 1/6/12

6 Quest Diagnostics

$1.000B increasedsharerepurchaseauthorization

1/25/12


$1.000B Seniornotesdue2019 3/9/12

8 Hologic $1.000B privateplacementof6.25%seniornotes 7/20/12

9 Biomet $1.000B completedpreviouslyreportedofferingofseniornotesdue2020

8/9/12

10 DaVita $1.000B offeringtohelpwithHealthCarePartnersbuy

8/15/12

11 LabCorp $1.000B pricedofferingofnotesintwotranches 8/22/12

12 Healthcare REIT $963M 2/23/12


$850M 4/6/12

14 Health Care REIT $811M totalproceedsofstocksale 8/14/12

15 Stryker $750M offeringofseniorunsecurednotes 9/15/11

16 Medtronic $650M offeringofseniornotes 3/15/12

17 Health Care REIT $632.5M publicofferingofstock 11/11/12

18 OrbiMed $600M creationofanewInvestmentFund 9/1/11

19 Canaan Partners $600M mostlygoestotechinvestments 1/11/12

20 Health Care REIT $600M notesdue2019 3/29/12

21 Ventas $600M publicofferingofnotes 4/16/12

22 Covidien $600M seniornotes 5/23/12

23 Riverside Partners

$561M committedcapital 5/15/12

24 Biomet $550M aggregateprincipalamount 7/26/12

25 Perkin Elmer $500M offeringofaggregateprincipalamountof5%seniornotes

10/24/11

CoNfERENCE CovERaGE

ConferenceCoverage


Medtronic CEO: ‘business model has to be adjusted’By AMANDA PEDERSENMedical Device Daily Senior Staff Writer

Inaneconomywherepeoplearemorecarefulwiththeirmoneythaneverbefore,eventhebigguysintheindustryhavetotakeadisciplinedapproachwiththeirbusinessmodel.Thatwasthetake-homemessagefromMedtronic(Minneapolis)CEOOmarIshrakMondayatthe30thannualJ.P.MorganHealthcareConferenceinSanFrancisco.

“Thebusinessmodelhastobeadjustedwithoutcompromisingtheneedfor,andthedesirefor,higherstandardofcare,”Ishraktoldhisaudienceduringapresentationthatwasalsowebcast.

IshraksaidMedtronichas identifiedthreekey imperatives to improve itsgrowth: improvedexecution;optimizinginnovation;andglobalization.

“Wewantabusinessthatmovesquicklyandisagile,”hesaidinexplainingthefirstofthesethreeimperatives,improvedexecution.

Doingsorequiresabusinessalignment“sothateveryoneismovinginthesamedirection,”headded.Thingslikequarterlyassessmentsandconstantmarketconnectionareexamplesofthis,Ishraksaid,notingthathemakesapointtomeetinpersonwithcustomersintheU.S.afewdaysamonth.“Meandmymanagementteamwanttostayintouchwithcustomers,”hesaid.

Inordertooptimizeinnovation,IshraksaidthecompanywillaimtoimproveitsR&Dspendand“optimize”itscapability.“Thisisnotaboutgoingandgettingengineerstoworkharder,norisitaboutimprovingourtechnicalcapability,”hesaid.“Itreallyismoreaboutwhatweworkonandhowweworkonit...workingonthingsthatdon’thaveaneffectivevaluepropositionhastobede-focused.Ifthereisnovaluepropositiontheinnovationisnotgoingtosucceed.”

Doingthismeansprovidingeconomicvaluetocustomers,Ishraksaid,addingthatthecompanyaimstodevelopproductsthateitherimprovesthehospital’sstandardofcare,increasesprocedurevolumes,orimprovesqualityofcaresothatthehospital’squalitymetricsgoup.“Allofthiswillprovidemorerevenuetoahospital,”hesaid.

Productsthatimproveworkflowforhospitalsisanotherwaythecompanystrivestoaddvalueforitscustomers,Ishraknoted.“ReducingICUstays...movingtheshiftofcarefromonetypeofphysiciantoanotherormovingthecarefromthehospitaltohome,”areexamplesofinnovationthatimproveshospitalworkflow,hesaid.

Finally,Ishraknoted,Medtronicwilloptimizeproductpricesbyprovidingbettervalueforthesameprice.

“Customereconomicsissomethingthatisgoingtobeascreenforallofournewproducts,”Ishraksaid.

Ofcoursethecompanyalsorecognizestheneedtoreachemergingmarketsforfuturegrowth.“Contrarytopopularperception,ourmarginsinemergingmarketsareactuallyasgoodifnotbetterthan...othermarkets,”Ishraksaid.

Also,goingforward,IshraktoldtheaudiencethatMedtronicwillhavetobemoredisciplinedinitsapproachtoacquisitions–asitwillbefornewproductdevelopmentandexistingproducts–byfirstasking:Isitagrowthmarket?CanMedtronicwininthatmarket?Andfinally,canMedtronicaddvaluetothatmarket.

DuringanotherwebcastpresentationfromtheJ.P.Morganconference,theCEOofaconsiderablyyounger company, CareFusion (San Diego), offered his perspective on how companies likeCareFusioncanturnthecurrentchallengesinhelathcareintoopportunities.

“Asallofyouknow,thisiscertainlynotnewnewsinthisroomtoday,thisiscertainlyachallengingenvironmentinhealthcaremarketsinvariouspartsoftheglobe,”CareFusionCEOKieranGallahuesaid.Specifically,henotedthat“30%ofU.S.hospitalsarerunningatnegativeoperatingmargins. . . they understand that they need to make some fundamental changes” including capturingefficienciesintheirsupplychain,primarilyintheareasofpharmaceuticalsandmedicaldevices.

Sowhilethereisalotof“doomandgloom”outtherewherehealthcareisconcerned,Gallahue

REGulatoRy

Regulatory


Patent reform may prompt more filings, does little for pendencyBy MARK McCARTYMedical Device Daily Washington Editor

TheU.S.Senatepassedalong-awaitedpatentreformbillinSeptember2011,avoidingashowdownwiththeHouseoverthelowerchamber’sversionofH.R.1249(theAmericaInventsAct)bytakinganup-or-downvoteontheHouseversion.PresidentObamasignedthebillwithoutdelayasexpected,butopinionsdivergedfromthereastothevalueofthelegislationformed-techfirmsintheU.S.

TonyShaw,counselat the lawfirmofArent Fox (Washington)andanadjunctprofessoroflaw at the Georgetown University Law Center (Washington), told Medical Device Daily thatoncethelawgoesintoeffect,inventorsmayconcludethey“havetofilepreemptivelyevenif[they]haven’tquiteperfectedtheinvention”becauseoftheimpositionofthefirst-to-file(FTF)paradigmembodiedinthebill.ShawalsoremarkedthatinventorsinothernationsaremoresavvyabouttheFTFapproachandhence“wesortofputourselvesatacompetitivedisadvantagebyadoptingtheirsystem.”

On the other hand, JC Scott, senior executive VP for government affairs at the Advanced Medical Technology Association (AdvaMed; Washington), said in a statement e-mailed toMedical Device Dailythatmodernizingthepatentprocess“isanimportantelementofmakingsurethat America’s medical device companies continue to be the world leaders.” Scott said FTF will“promoteinternationalharmonizationandcreateefficienciesthroughoutthesystem.”

Notalltheassociationswereasoptimistic,however.TomNovelli,VPforgovernmentaffairsattheMedical Device Manufacturers Association (MDMA;Washington)said inastatemente-mailedtoMedical Device Dailythatthebill,“whilenotperfect,isapositivesteptowardsupdatingthecurrentpatentsystem,”althoughNovelliexpressedconcernthattheestablishmentofanewpost-grantreviewprocess“mayoverburdenPTOandprovideapotentialvehicleforabusebysomeparties.”

The debate over the America Invents Act covered several amendments addressing issuessuchasbusinessmethodpatents,butthemostimportantamendmentintermsoftheU.S.Patentand Trademark Office’s operations was offered by Sen. Tom Coburn (R-Oklahoma). Coburn’samendmentwouldhaveremovedthepatentfeediversionwrittenintoH.R.1249,afeaturethatwillsendsomepatentfeestothegeneraltreasuryfund,whichwouldthenberepatriatedtoPTOuponCongressionalapproval.TheSenatevoted50-48totableCoburn’samendment.

Despite reassurances from many on Capitol Hill, Shaw echoed some of the widespreadskepticism regarding Congress’s ability to keep its hands off PTO’s fees. “I don’t think anyonethinksCongresswillbehaveitself”onthisscore,hesaid.“Ithinkeveryonerecognizestheneedtostopfeediversion,anditdidn’thappen,”heshrugged.

Regardingthependency/patentbacklogproblem,Shawremarked,“youseearticlesbypeoplewhothinkthrowingmoremoneyatPTOwon’tsolvetheproblem,”buthenotedthattheBoardofPatentAppealsandInterferencesatPTOisalsoworkingunderabacklog.“There’snothinginthislegislationthat’sgoingtoaddressthat,”hesaid.

Shaw seemed appreciative of the efforts by PTO’s management to streamline operations attheagency,buthesaidPTOdirectorDavidKapposmayhave“usedallthetoolsinhistoolkittothispoint”toclearoutthebacklog.“I’mnotsurehowmuchmorehecandrivethosenumbersdown,”andthenewlawmayfuel“ahugesurgeofpatentapplications”18monthsafterpassage.

Asfortheprioruserrightsissue,Shawremarkedthattheintentis“toavoidsnaringpeoplewhodidn’tstealitfromtheinventor,”and“thereasonwedidn’thavethatbeforeisthatwewantedtoencouragepeopletofile”soastodisseminatetechnologicalandmethodologicaladvances.

Amongthethingsthebilldoesnotdo,Shawsaid,isitdoesnotaffecteligiblesubjectmatteralaPrometheus v. Mayo.“Theredidn’tseemtobemuchpushtodothat,”heobserved.Hedidnotforecastmuchofanimpactonlab-developedtests,however,atleastnotanegativeeffect.

“Thebigthingisthatyoudevelopsomeproprietarymethodofinterpretingtestresultsandyou

INdustRy INtERvIEws


IndustryInterviews

Aspinall says diagnostics assure effective treatmentBy JIM STOMMEN, MDD Contributing Writer

MaraAspinallispresidentofVentana Medical Systems (Tucson,Arizona),amakeroftissue-basedcancerdiagnosticsandamemberoftheRocheGroup.PriortojoiningVentanainSeptember2011, she was founder, president/CEO of On-Q-ity, a start-up diagnostics company focused oncirculating tumor cell technology. Prior to that, Aspinall spent 12 years with Genzyme, whereshe held senior leadership roles as president of Genzyme Genetics and president of GenzymePharmaceuticals.

A frequent industry speaker, she has spearheaded industry-wide outreach initiatives tobettereducatethehealthcarecommunityandpolicymakersabouttheimportanceofdiagnostics,genomics, and personalized medicine. Aspinall is a founder of DxInsights, a new organizationfocused on education regarding the importance of diagnostics in healthcare today and into thefuture.

MDD: What was the genesis of the DxInsights organization?Aspinall: It started three years ago when a number of political and healthcare-related events

occurredandthediagnosticscommunityeitherdidnotgetafullseatat thetableorthe industrywasnotfullyunderstoodbythekeystakeholders.Thediagnosticsindustryhasbecomeanorderofmagnitudemoreimportantoverthelastdecade.Thisincreasedsignificancehashappenedasaresultofnewtechnologiesthatallowustousediagnosticsmuchmoreeffectively,andthecombinationofdiagnosticswithspecifictherapeutics.

Asaresultofthecomingtogetheroftheincreasingimportanceofdiagnosticsandtheincreasingsophistication of diagnostics technology, we believed there was a need to set a foundationaleducationarounddiagnosticsacrossthebroadhealthcareindustry.Thatwaswhywebelieveditwas important tostartanon-profit, independent, technology-agnostic,businessmodel-agnosticorganizationthatcanprovidethatcoreeducationondiagnostics.

MDD: I would add as an outside observer, I too have thought that diagnostics has gotten short shrift from the policy perspective over the years, and I also agree with your view on how diagnostics has grown in importance over the past decade.

Aspinall:Itisagreattimetobeindiagnostics.Manypeoplebelievetheyunderstanddiagnosticstoday,butdiagnosticshastakenonaverydifferentpersonaoverthelastdecade.Diagnosticshasmoved from important but basic tests that analyze serum for single analytes to highly complexassays that identifyandanalyzegenes,proteinsandothermarkers fromthesmallestsamplesoftissue,bloodandsaliva.

Diagnosticsnowhastheabilitytodomuchmorethanjustdiagnose.It’snowaboutmonitoring.It’snowaboutprediction.It’snowaboutprognosis.Thedimensionsforwhichdiagnosticscanaddvaluehasincreasedconsistentwiththechangesandimprovementsinthetechnologiesavailable.

MDD: The two words that really jumped out at me from that comment were “monitoring” and “prediction” or “prognosis.” What a different role for diagnostics today. Personally I think those have moved ahead of pure diagnosis in terms of the importance.

Aspinall: Idon’tknowif theyhavemovedahead,buttheycertainlyhavebecomeat leastasimportant.

MDD: All right, co-equals then.Aspinall: Right. Many ask if diagnostics today is all about personalized medicine – I would

arguethatpersonalizedmedicineiscriticalandgrowing,butit’sstill justapieceofthebroaderdiagnostics industry.But ifwearetomakelife-threateningdiseasessuchascancer intochronicdiseases,itisnolongerpossibletosay,we’rediagnosingthemonDayOneandyou’redone–wemustcontinuetomonitorandassesspatientsthroughdiagnostics.

AIDSisthebestexample.Wedon’tmakeonesinglediagnosisofAIDSandthentreatthepatient.

ComPaNy INdEx

CompanyIndex


a

Abbott122AbbottMedicalOptics128AcuFocus109AdvancedMedicalTechnologyAssociation126,

128,133,149,157,160,162Aetna103Affymetrix104Agilent103AgileTherapeutics110AirXpanders19Alere104Allscripts108AmericanCivilLibertiesUnion163AmericanGlaucomaSocietyAnnualMeeting55AmericanHealthcareInvestors108AmericanHeartAssociation81AmericanIntellectualPropertyLawAssociation152AmericanMedicalSystems122Amerigroup103,109Amgen53AMSGroup40AmSurg105Amtek105AngioDynamics104ApolloEndosurgery21,110APSHealthcare105Ardian77ArentFox133AriaDiagnostics109ArkansasHeartHospital26AsahiKasei103AscendHealth103Aspen104AssociationfortheAdvancementofMedicalInstrumentation148AstuteMedical110AtriumMedical103AttendsHealthcare104AutonomicTechnologies23Auxogyn25AvantisMedical197Avinger26

B

BainCapital103BarrxMedical104Bausch+Lomb107,117Baxa104Baxter99,101,104,106BaxterInternational104

BaylorHealthSystem156BB&TCapitalMarket108BD103Bellevue79Biocartis109BioControlMedical40BioHorizons109Biomet99,101,104,106BiosenseWebster122BioServeSpaceTechnologies53BiotechnologyIndustryOrganization151BluegrassVascularTechnologies28BostonScientifi161BostonScientific105Bristol-MyersSquibb99,101,106ByrneMedical105

C

CaliperLifesciences103CameronHealth105CanaanPartners99,101,106CantelMedical105Cantor&Nissel43CapitalOneBank109CardinalHealth116CardioangiologischesCentrumBethanien36CardioCommSolutions32CardioFocus36CardioMEMS219CareFusion105,107,115CaseWesternReserveUniversitySchoolofMedicine34CastlightHealth109CellScope38CerebralRx40CerviLenz42ChineseUniversityofHongKong22ChromaGenVision43Cigna103Clarimedix45ClatterbridgeHospital44ClearCountMedicalSolutions52ClevelandClinic53Codman&ShurtleffInstrumentbusiness105CombatMedicalSystems30CommunityHealthSystems99,101,106ConcentricMedical105ConforMIS109CooperCompanies105Corning103CoventryHealth103Covidien70,77,84,99,101,104,105,106

CompanyIndex


CowenHealthcareRoyaltyPartners99,101,106C.R.Bard104,105,107CreatiVascMedical155Crescendo109Cynosure,InstrumentationLaboratory183CytoPherx46

d

Dako103DaVita99,101,103,106DePuy104DiscoveryLabs110DJOGlobal108Domtar104DukeUniversitySchoolofMedicine9DuneMedicalDevices47

e

EarlyStagePartners,ONSETVentures46eBioscience104EdisonPharmaceuticals42EdwardsLifesciences70,156,161EKOS183EllipseTechnologies49Emboline92EndoHealthSolutions186EndoPharmaceuticals122eReasearch104ErnestHealth104eScreen104EstillMedicalTechnologies31Evolution1108ExactSciences109ExcelVentureManagement108ExploraMedDevelopment9

f

Finnegan163FogartyResearch&Development9FreseniousMedicalCare103Fujifilm103

g

GECapital108,109GEHealthcare122,208,210GEMedicalSystems183Gen-Probe103GenstarCapital104Genzyme167GeorgetownUniversityLawCenter133

GermanMigraineandHeadacheSociety24Getinge104GIDynamics109GlobusMedical109

h

Haemonetics103HaldorAdvancedTechnologies51HealthCarePartners103HealthCareREIT99,101,106HealthcareTrustofAmerica105,108HealthSpring103HealthStream110HeartFlow109HenrySchein105,107Hill-Rom104Histogenics110Hologic99,101,103,106

i

IdahoTechnologies30Illumina109ImageIQ53InceptBioSystems25InspireMedicalSystems122InternationalBusinessForum123InternationalHeadacheSociety24InternationalSocietyforHeartandLungTransplantation88IntersectPartners65IntuitiveSurgical171Invibio61INVOBioscience25IPCTheHospitalistCompany109Ivantis55IVDiagnostics57iWalk59

J

JeffersonSchoolofPopulationHealth193JohnsHopkinsUniversity22Johnson&Johnson45,74,80,84,186JonesDay163

K

KatherinenHospital65Kelyniam61KenseyNash104KineticConcepts104

l

CompanyIndex


LabCorp99,101,105,106LemhiVentures108LernerResearchInstitute53Levitronix105LibertyDialysisHoldings103LifeScienceAlley123LMAInternational104Lutonix104

m

MannKind109MaquetCardiovascular103MayoClinic22MedicalCollegeofWisconsin63MedicalDeviceManufacturersAssociation124,

133,158,162MedicalPropertiesTrust104,108MedicalUniversityofSouthCarolina22Medivance105Mednax107Medrad105Medtox105Medtronic74,77,99,101,106,115,122,156MedtronicPhysio-Control103MemorialSloan-KetteringCancerCenter57MetropolitanHealthNetworks107Mevion110MidwestFund46MindFrame65M*Modal103ModularSurgical,RadGuardMedical92MolinaHealthcare108MyriadGenetics163

n

NationalHealthCare109NationalHealthInvestors107NationalSurgicalCare105NavilystMedical104NeoGuideSystems92,171Neuronetics66NeuroPace110NeuroSigma68NewportMedicalInstruments105NoraTherapeutics186NovaSom175Novasyte70NSVascular68

o

OakHill105

OmegaHealthcareInvestors107Oncoscope9OneEquityPartners103OneLambda103On-Q-ity167OpticalSociety85Optovue118OraSureTechnologies109OrbiMed101,107Oridion104Origo105Orthofix105OspedalediMirano26OvaScience25,72OxfordFinance107

p

Pall103PathwayMedicalTechnologies105Penumbra117PerkinElmer101,107PerkinElmer103PervasisTherapeutics105Phadia103PhotoMedex110Physio-Control103PhysioSonics74PreviMed75PricewaterhouseCoopers212PSSWorldServices107,108

Q

QuantumMedicalSystems183QuestDiagnostics99,101,106

r

RainbowMedical110RBCCapitalMarkets161ReCorMedical77ReichertTechnologies105RestorationRobotics110RiteAid107RiversidePartners101,107Rodman&Renshaw110RoperIndustries103Rowa105RoyalDSM104

S

Santé108

ScrippsClinic204SelectMedical107SeyfarthShaw141ShalgrenskaAcademy40Shire105Sientra109SightLinePartners109SmallBoneInnovations110Smith&Nephew70SocietyofPhysicianEntrepreneurs9,189Sonosite103StanfordUniversity25StanfordUniversitySchoolofMedicine55,79Stereotaxis108Steris105StewardHealthCareSystem105St.JudeMedical77,122St.Luke’sMidAmericaHeartandVascularInstitute87StonyBrookUniversity81Stryker99,101,105,106SunquestInformationSystems103SunriseSeniorLiving104superDimension104SurModics109SymetryMedical105SynovisLifeTechnologies104

t

TeDanSurgicalInnovations83Teleflex104TenetHealthcare107TheCooperCompanies108TherixMedical28Thermocure92ThermoFisherScientific103Thoratec105Thoraxklinik89TranS1197TransEnterix84TriVascular109,117TuftsUniversitySchoolofMedicine175

u

UCBerkeley38UnitedSurgicalPartnersInternationa107UniversalAmerican105UniversalHealthServices103UniversalHospitalServices107UniversityHospitalHamburg-Eppendorf24UniversityHospitalofSchleswig-Holstein48UniversityHospitals(UH)CaseMedicalCenter’sNeurologicalInstitute34UniversityofCaliforniaatLosAngeles68,85UniversityofCaliforniaatSanDiego49UniversityofCaliforniaatSanFrancisco48,155UniversityofCaliforniaHastingsCollegeoftheLaw150UniversityofColorado45UniversityofColoradoDenver189UniversityofKentuckyAlbertB.ChandlerHospital28

UniversityofLiege24UniversityofMichigan46UniversityofMinnesota179UniversityofSouthernCaliforniaMedicalCenter83UniversityofTexasMedicalBranch22UniversityofUtah30UniversityofUtahSchoolofMedicine87UptakeMedical89USEndoscopy105

v

Valeritas108VanguardHealth107VarianMedicalSystems108VascularPathways92VasoStitch91Velomedix93VentanaMedicalSystems167Ventas101,104,107VerinataHealth107VessixVascular77ViewRay110VoceraCommunications200

W

WarburgPincus117WelchAllyn200WellPoint103WestPharmaceuticalServices108WHSP105WorldMicro94

X

XDx87

Z

ZeltiqAesthetics108ZiplineMedical171ZipLineMedical92ZocDoc109ZollMedical30,103

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