INSIDE: - Medical Device Daily

TUESDAY, JANUARY 31, 2006 VOL. 10, NO. 20 PAGE 1 OF 10Misonix gets clearance forSonatherm tissue ablation useBy HOLLAND JOHNSONMedical Device Daily Associate Managing EditorMisonix (Farmingdale, New York), a developer of ultrasonicmedical device technology for the treatment of cancerand other conditions, reported that the FDA hasgranted it 510(k) clearance to market and sell theSonatherm 600 Ultrasonic Lesion Generating System in theU.S. for ablation of certain soft-tissue lesions in general surgeryprocedures.The Sonatherm 600 is based on the company's highintensity focused ultrasound (HIFU) technology, licensedfrom Focus Surgery (Indianapolis), a company in whichMisonix holds a minority equity position.The treatment entails placing the Sonatherm 600transducer on the surface of the organ to be treated andengaging the HIFU energy. The concentrated acousticReport from EuropeBiosensors reports win inNetherlands court on AxxionFirst approved inhaled insulinboosts device maker NektarBy KAREN YOUNGMedical Device Daily Staff WriterWhile those with diabetes will be the biggest beneficiariesof the inhaled insulin just approved by the FDA,another large benefactor – but unlikely to receive muchpublicity for the achievement – is Nektar Therapeutics(San Carlos, California).Late last week the FDA reported market approval ofExubera, a recombinant human insulin, from Pfizer (NewYork), with the drug delivered via an inhaler device developedby Nektar, for the treatment of both Type 1 and Type2 diabetes.As the first inhaled insulin on the market, Exubera ispredicted to produce sales of up to $10 billion annually. AndNektar, which in partnership with Pfizer also developed thepowdered, inhaleable form of the drug in addition to thewaves quickly ablate the targeted tissue without punctur- delivery device – could reap 10% to 20% of sales and royal-See Misonix, Page 4 See Nektar, Page 6Study backs ‘preemptive strike’by HALO 360 to battle Barrett’sBy DON LONGA Medical Device Daily Staff ReportMedical Device Daily Managing EditorBiosensors International Group (Singapore) said it Medical device companies looking for case studyhas successfully defended against legal claims and defeated examples of how devices can penetrate the drug market,a request for an injunction request brought against it in the and at the same time save lives, might well consider theNetherlands by Angiotech Pharmaceuticals (Vancouver, progress of Barrx Medical (Sunnyvale, California).British Columbia) and Boston Scientific (Natick, Massachusetts).Barrx is the developer of the Halo 360 System offering atreatment of Barrett’s esophagus, a preemptive approachThe company said the result of the court’s decision to targeting a condition identified as a precursor to esophagealdeny the claims and injunction allows it to continue thecancer (adenocarcinoma). And too often Barrett’s isproduction of the Axxion drug-eluting stent (DES) in the poorly served - sometimes fatally so – by drug regimens.Netherlands, with distribution throughout Europe and Barrett’s begins as gastrointestinal reflux diseaseother parts of the world where regulatory approval for the (GERD) – that is, heartburn – a nagging problem that individualsdevice has been secured.tend to treat primarily with over-the-counter med-The legal action, which commenced on Dec. 9 in The ications such as the purple pill and other proton pumpHague, the Netherlands, claimed that the Axxion stent medications.infringes on European patent No. 0706376, which is jointly Over an extended period of time, however, GERDowned by Angiotech and the University of British segues into a breakdown of esophageal tissues that is aSee Europe, Page 7See Barrx, Page 8INSIDE:ADVANCED MAGNETICS DENIES CLAIMS OF SUIT FILED BY CYTOGEN ..........2BAYER GETS ABBOTT LICENSES; INFORMEDIX CLOSES FIRST TRANCHE.........3To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 688-2421; outside the U.S. and Canada, call (404) 262-5476.Copyright © 2006 Thomson BioWorld ® . Reproduction is strictly prohibited. Visit our web site at www.medicaldevicedaily.com.

TUESDAY, JANUARY 31, 2006 MEDICAL DEVICE DAILY PAGE 3 OF 10Financings roundupBayer gets Abbott licenses;InforMedix closes 1st trancheA Medical Device Daily Staff ReportBayer HealthCare Diagnostics (Tarrytown, New York)said it has been granted licenses under patent rights relatingto free prostate specific antigen (PSA) and tacrolimustests from Abbott Laboratories (Abbott Park, Illinois).Financial details were not disclosed.Bayer said it intends to develop these two new tests forits Advia Centaur and Advia Centaur CP immunoassay systemsimmediately.“By adding free PSA to the oncology portfolio, BayerHealthCare Diagnostics will have a very comprehensivediagnostic menu for prostate cancer markers,” said SamirTaneja, MD, director of urologic oncology, NYU CancerInstitute and School of Medicine (New York).The company said the flexibility will allow physiciansto select the tests they feel most appropriate to differentiatemalignant and benign prostate disease within the individualpatient.“The addition of fPSA and tacrolimus to our assay offeringwill enhance the laboratories ability to increase theirtest offering while optimizing their overall efficiency,” saidTom Warekois, senior vice president global strategic marketing,Bayer Diagnostics.“This is another example of [our] commitment toexpanding the test offering for immunosuppression drugs.Tacrolimus is complementary to cyclosporine, which is currentlyalso in development and scheduled to release in2006,” he said.The free PSA test is primarily ordered when a patienthas a moderately elevated total PSA that does not appearto be caused by a non-cancer-related condition. Theresults give the doctor additional information aboutwhether a patient is at an increased risk of having prostatecancer and helps with the decision of whether to biopsythe prostate.The tacrolimus test is designed to determine theamount of immunosuppressant drug in the patient’s system.Primarily, the drug tacrolimus is used as an immunosuppressantin liver transplant patients.InforMedix Holdings (Rockville, Maryland) reportedthat it closed on the first tranche of a private placementfinancing of $1,380,000, which is a private investment in apublic entity (PIPE) offering that will enable the company toexpand its sales and marketing efforts nationally of itsMed-eMonitor System, and general working capital purposes.The offering will continue until an aggregate of $4.8million of securities are sold or the offering is terminated.“The Med-eMonitor System, InforMedix’ patentedsolution for improving medication and plan adherenceand reducing costs, has consistently achieved medicationadherence rates of greater than 90% in a variety ofclinical settings, as documented in peer-reviewed medicaljournals,” said Dr. Bruce Kehr, chairman and CEO.“Average patient medication adherence rates of 50% costthe U.S healthcare system $100 billion annually in hospitalexpenses alone, and $300 billion in total annualcosts.”Company officials said each $10,000 investment unitconsisted of 1 share of Series A preferred stock, convertibleinto 62,500 shares of the company’s common stock at 16cents a share, Series A-1 warrants to purchase 31,250shares of common stock of InforMedix exercisable at 24cents per share, and Series A-2 warrants to purchase31,250 shares of common stock of InforMedix at 32 centsa share.InforMedix said it has developed the Med-eMonitorSystem as the medication adherence solution for diseasemanagement and clinical drug trial markets.Fresenius Medical Care North America (Lexington,Massachusetts) reported that, in connection with a previouslydisclosed tender offer and consent solicitation byFlorence Acquisition, an indirect subsidiary of FreseniusMedical Care (Bad Homburg, Germany), for any and allof the $159,685,000 in outstanding principal amount of 9%senior subordinated notes due 2011 of Renal Care Group(Nashville, Tennessee), Florence Acquisition is furtherextending the tender offer expiration date to 5 p.m., EST, onFeb. 27.As of Jan. 27, 99.87% of the outstanding aggregate principalamount of the notes had been tendered.Renal Care shareholders approved in August the agreementunder which Fresenius will acquire that company for$48 per share of Renal Care Group common stock.Renal Care serves some 31,900 patients at more than450 outpatient dialysis facilities, and provides acute dialysisservices at more than 210 hospitals. In all, it providesservices in 34 states.Fresenius has a network of about 1,670 dialysis clinicsin North America, Europe, Latin America, Asia-Pacific andAfrica, providing treatment to some 130,400 patients. Italso is the leading global provider of dialysis products,including hemodialysis machines, dialyzers and relateddisposable products. ■B RIEFLYN OTEDTLC opens LASIK center in Des MoinesTLC Vision (St. Louis), an eye care services company,reported the opening of a LASIK Select center in DesMoines, Iowa. This is the third of five new centers the companyexpects to open in the first quarter, and 10 LASIKSelect centers total for 2006.To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 688-2421; outside the U.S. and Canada, call (404) 262-5476.Copyright © 2006 Thomson BioWorld ® . Reproduction is strictly prohibited. Visit our web site at www.medicaldevicedaily.com.

TUESDAY, JANUARY 31, 2006 MEDICAL DEVICE DAILY PAGE 4 OF 10MisonixContinued from Page 1ing or cutting the organ itself. The company said the treatmentmay be performed in either laparoscopic or intraoperativeprocedures.Michael McManus Jr., president and CEO of Misonix,said, "We are excited by the news from the FDA. This resultis an important milestone for our HIFU technology. Webelieve this technology will be used to the benefit of a largesurgical marketplace and related healthcare constituentsthat are constantly looking for innovative therapies."McManus said the latest approval helps to validate thecompany's decision last July to spin off its Laboratory andScientific Division in order to focus exclusively on thedevelopment of medical devices (Medical Device Daily, July26, 2005). “This milestone provides further validation of ourstrategic investments in developing our platform technologies,”he said. “We have carefully selected opportunities thathave significant growth potential and can also be deliveredto the market in efficient and fast development timeframes.For our shareholders, that means seeing our ultrasoundtherapeutic products in the market in the near term."”McManus noted that medical devices with marketpotential that are similar to those in Misonix’s productpipeline would typically take about “$5 million and fiveyears each to bring to market. We are demonstrating theability to significantly reduce the time to market for ourproducts.”The company said it expects the Sonatherm 600 to belaunched in markets outside the U.S. sooner than in the U.S.,Deals roundupUnited Surgical Partners adds24 centers with buy of SurgisA Medical Device Daily Staff ReportUnited Surgical Partners International (Dallas) reportedsigning an agreement to acquire Surgis (Nashville,Tennessee), a private surgery center company. Financialterms were not disclosed.Surgis operates 24 surgery centers and has an additionalseven facilities under development. Of the 31 totalfacilities, 20 are in markets currently served by UnitedSurgical Partners or its healthcare system partner. Surgisalso manages the endoscopy service in 42 acute-care hospitals.Surgis had revenues under management of $118 millionin 2005 and currently consolidates 13 of the 24 operationalfacilities.William Wilcox, CEO of United Surgical Partners, said,“This is a strategically attractive acquisition for the company.”United Surgical Partners has ownership interests in oroperates 104 surgical facilities. Of the company’s 101 domesticfacilities, 68 are jointly owned with not-for-profit healthcaresystems. The company also operates three facilities inLondon.The purchase is expected to be completed in March orApril, United Surgical said.In other dealmaking activity, IPC-The HospitalistCompany (North Hollywood, California) reported that ithas expanded into the Detroit area with the acquisition ofMichigan Hospitalists, a practice of about 70 providers.Already this year, IPC has announced expansions intoSalt Lake City and Ocala, Florida, and now has practice locationsin 19 markets nationwide.Michigan Hospitalists has been serving patients in thegreater Detroit area since 1997. The vast majority of its physicians,including President/Founder Gary Salem, DO, and partnersMichael Davis, MD; Paul Ragatzki, MD; Alan White, MD;and David Vandenberg, MD, have joined the IPC team.“We were at a critical juncture in our growth, and weknew that we would be able to achieve more by availingourselves of the vast resources offered by IPC,” said Salem.Hospitalists are acute-care specialists who focus on apatient’s hospital care from time of admission to discharge.IPC provides inpatient care in 20 markets nationwide,employing about 500 physicians and managing more than$1 billion in healthcare expenditures annually. ■where it will be ready for market in the 2007-2008 timeframe.“We will continue to invest in our already clearedproducts for wound debridement and bone cutting,”McManus said. “These investments will enable us to bringthese products to market in the short term and representsubstantial benefit to our shareholders.”He said the company is making progress in buildingout its present platform in laparoscopic surgery, neurosurgery,cosmetic surgery and the development of diagnosticproducts. “We will continue this record of growthinto the development of our European market for theSonoblate 500 for the treatment of prostate cancer and ournew products in the treatment of kidney tissue, wounddebridement and bone cutting,” McManus said. “The trueindicator of the success of our growth strategy is that eachof these new products is in a market segment considerablylarger than any of the present markets that we sell into.”In an interview on the Laboratory and Scientific Divisionspin-off, McManus also pointed to Misonix’s HearingInnovations (Tucson, Arizona) unit as offering growthopportunities. “We continue to believe in [Hearing Innovations']technology and are encouraged by recent studiesand articles on the benefits of ultrasonic bone conductionfor hearing loss. We will proceed with limited expense toconduct additional clinical work on the application for thistechnology.”On news of the FDA’s approval of the Sonatherm 600,shares of the company’s stock surged $2.14, or roughly47% to $6.70 at the close of Monday trading on theNasdaq. ■To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 688-2421; outside the U.S. and Canada, call (404) 262-5476.Copyright © 2006 Thomson BioWorld ® . Reproduction is strictly prohibited. Visit our web site at www.medicaldevicedaily.com.

TUESDAY, JANUARY 31, 2006 MEDICAL DEVICE DAILY PAGE 5 OF 10Grants/contractsClearant in accord with CTSfor the Clearant ProcessA Medical Device Daily Staff ReportClearant (Los Angeles), developer of the Clearant Process,reported that Community Tissue Services (CTS; Dayton,Ohio), a distributor accounting for about 10% of the $1 billionU.S. tissue market, has signed an agreement to adopt theClearant Process. CTS, with 10 locations throughout the countryin addition to its headquarters in Dayton, is one of thelarger non-profit tissue banks in the U.S., the company said.Investment firm Piper Jaffray has estimated the 2005U.S. tissue market to be approximately $1 billion andEmerging Grow-th Equities has forecasted a 15% to 20%annual growth rate for the market.The new agreement allows CTS to use the ClearantSterilization Service for a variety of human-sourced soft-tissueand bone allograft implants. CTS will initially begin toconvert its soft-tissue operations to the Clearant Process andthen migrate the technology to its hard-tissue processing.CTS can outsource the irradiation of hard- and soft-tissueallografts to Clearant. Clearant will then process theallografts using their proprietary technology.The Clearant Process is designed to substantiallyreduce all types of pathogens in biological products whilemaintaining a high degree of the underlying protein.Biophan Technologies (West Henrietta, New York), adeveloper of “next-generation” biomedical technology, saidthat it has joined as a senior member of the BiomimeticMicro-Electronic Systems Engineering Research Center atthe University of Southern California (USC/BMES ERC;Los Angeles), in a collaboration to revolutionize biomedicaldev- ices, including through development and integrationof Biophan’s proprietary innovations.The partnership gives Biophan access to the USC/BMESERC’s “world-class” research facilities, the company said.Biophan will contribute its expertise in advanced medicaldevice enhancement technologies to collaborate with theUSC center. Research will focus on the development of newmedical device solutions, including the application ofBiophan’s technologies to make medical devices MRI-safeand/or image compatible. Many implantable medicaldevices are currently contraindicated for use with MRI.Through an initial $17 million grant awarded by theNational Science Foundation (NSF; Arlington, Virginia),the USC/BMES ERC has been established to advance theeducation, research, and commercialization of biomedicaldevices that can dramatically improve the quality of life forpatients with debilitating diseases.Expanding into a new market segment, Bluegate(Houston) said it has signed an outsourced healthcare ITservices agreement with Northwest Oral and MaxillofacialSurgery (NWOMS; Woodlands, Texas). Bluegate is aprovider of outsourced healthcare IT solutions, professionaltechnology consulting services and the BluegateMedical Grade Network.In January Bluegate began to provide all IT outsourcingfor NWOMS’s six practices throughout Texas, including fullenterprise management for servers, storage equipment,backup equipment, desktops, notebooks, printers, switches,routers and firewalls; anti-virus services managementand removal of spyware, viruses and harmful software;quarterly network health check-ups; custom programming;IT policy and procedure planning; mandating and enforcingIT standards; and proactive enterprise monitoring servicesmanaged 24/7.These services are designed for healthcare organizationsthat want to adhere to best IT practices of HIPAA,technology and business relating to operating systempatches, locking down of desktops, roaming profiles andauditing. In addition, Bluegate will be assisting NWOMS indeploying Kodak’s PenCharts electronic medical record(EMR) system in all of its practices.NWOMS is a comprehensive, practice that uses extensiveimaging applications and is a national reference sitefor the Kodak PracticeWorks system. ■B RIEFLYN OTEDMedicare rate boosted for PlicatorNDO Surgical (Mansfield, Massachusetts) said Medicarehas increased the reimbursement rate for the Plicatorprocedure for the treatment of gastroesophageal refluxdisease (GERD). Effective Jan. 1, the hospital outpatient facilityreimbursement for the Plicator procedure increased byabout 7.5%.The Plicator procedure was first recognized for paymentunder Medicare’s hospital outpatient payment systemon April 1, 2005.NDO Surgical’s Full-Thickness Plicator is an endoscopicGERD treatment based on the principles of anti-reflux surgery.In an outpatient procedure, the Plicator is used tograsp, fold and fixate tissue at the junction between theesophagus and the stomach, thus tightening the valve thatacts as a barrier to gastric reflux.The company said the Plicator is the only endoscopicGERD treatment that mimics tissue restructuring performedduring anti-reflux surgery. It added that studieshave shown the Plicator procedure to be effective in reducingboth symptoms and medication use associated withGERD.More than 15 million Americans suffer from daily heartburn,the most common symptom of GERD. Until recently,treatment options for GERD have been limited to chronicdrug therapy or anti-reflux surgery, which requires generalanesthesia, multiple incisions and a recovery period lastingseveral days.To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 688-2421; outside the U.S. and Canada, call (404) 262-5476.Copyright © 2006 Thomson BioWorld ® . Reproduction is strictly prohibited. Visit our web site at www.medicaldevicedaily.com.

TUESDAY, JANUARY 31, 2006 MEDICAL DEVICE DAILY PAGE 6 OF 10NektarContinued from Page 1ties, Joyce Strand, director of corporate communicationsfor Nektar, told Medical Device Daily in September (MDD,Sept. 12, 2005).In approving the drug, the FDA followed the advice ofthe Endocrinologic and Metabolic Drugs Advisory Committee,which last September voted to recommend its approval.Strand at the time described the Nektar inhaler deviceas “like a thin soda pop can that extends like a telescope.The extended part is a clear chamber so you can seewhether you’ve take a dose or not in a simple manner.”Pulling a handle on the device, she said, “compressesthe air, forces the air through the powder and makes it intoa fine powder.”Nektar said in a statement following the announcementof the FDA approval that it would “receive royalties onall marketed products, as well as revenue for the manufactureof the powders and the inhalation devices.” It did notproject what these amounts will be.Pfizer is responsible for marketing, manufacturing andthe clinical development of Exubera. Nektar provides supportin the manufacturing process for Exubera insulin andmanufactures the inhalers.In its announcement of the approval, the FDA describedExubera as a “potential alternative for many of the morethan 5 million Americans who take insulin injections.”“Until today, patients with diabetes who need insulin tomanage their disease had only one way to treat their condition,”said Steven Galson, director of the FDA’s Center forDrug Evaluation and Research. “It is our hope that the availabilityof inhaled insulin will offer patients more op-tions tobetter control their blood sugars.”Larry Deeb, MD, president-elect, science and medicine,of the American Diabetes Association (ADA; Alexandria,Virginia), said patients have to remember that Exuberais “just insulin.”“It really is just insulin, and I think that’s an importantstatement to make, and so in a sense it can be expected todo no more and no less than insulin does,” Deeb told MDD.“The question really to me will be, are there people whowon’t take injections who might take inhaled insulin andthat might be appropriate.”Deeb said there clearly are certain groups of those withdiabetes who will be most likely to benefit from inhaledinsulin potentially: primarily those patients who do not currentlytake injections and those who intermittently takeinsulin and would be willing to take inhaled insulin andwant to switch. However, he doesn’t expect those withType 1 diabetes who are on strict diets and regimens ofinsulin injections to switch. “You can’t get that kind of vigor[for these patients] with inhaled insulin,” he said.The FDA said that the safety and efficacy of Exuberahave been studied in about 2,500 adult patients with Type1 and Type 2 diabetes. “In clinical studies Exubera reachedpeak insulin concentration more quickly than some insulin,called regular insulin, administered by an injection,” theagency said.Peak insulin levels were achieved at 49 minutes withExubera inhaled insulin compared to 105 minutes with regularinsulin, respectively.However, Exubera prescriptions will be accompaniedby a medication guide that the agency urges patients toadhere to for instructions on who is and who is not recommendedto take Exubera.The FDA specifically said that Exubera is “not to beused if you smoke or if you recently quit smoking,” withinthe past six months. Exubera is also not recommended inpatients with asthma, bronchitis or emphysema. Baselinetests for lung function are recommended to be repeatedevery six to 12 months thereafter, the FDA said.“Like any insulin product, low blood sugar is a sideeffect of Exubera and patients should carefully monitortheir blood sugars regularly,” the FDA said. “Other sideeffects associated with Exubera therapy seen in clinical trialsincluded cough, shortness of breath, sore throat and drymouth.”The agency also said it would continue to performlong-term studies on the insulin device “to confirm the continuedsafety of Exubera after it is marketed and to examinemore thoroughly the issue of the efficacy and safety ofExubera in patients with underlying lung disease.”The FDA approval followed an announcement the previousday that the European Union had approved Exuberafor the treatment of adults with Type 2 diabetes older than18 not adequately controlled with oral antidiabetic agentsand requiring insulin therapy (MDD, Jan. 27, 2006). Exuberaalso was approved in Europe for the treatment of adultswith Type 1 diabetes mellitus, in addition to long or intermediateacting injectable insulin, for whom the potentialbenefits of adding inhaled insulin outweigh the potentialsafety concerns.Originally, Exubera was developed jointly by Pfizer andSanofi-Aventis (Le Plessis Robinson, France). But Pfizerreached an agreement with Sanofi-Aventis earlier thismonth to obtain the worldwide rights to the inhaled insulinproduct. ■Applied Imaging retains Aquilo PartnersApplied Imaging (San Jose, California) reported thatthe company has retained investment bank Aquilo Partners(San Francisco) to assist management in exploring strategicalternatives to maximize shareholder value.The company said it believes that now is an “opportunetime” to launch such an initiative, given the resolution in2005 of outstanding legacy corporate issues, enhancementof the financial and operating performance of its corebusinesses, and further development of its CTC Inc. subsidiary.■To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 688-2421; outside the U.S. and Canada, call (404) 262-5476.Copyright © 2006 Thomson BioWorld ® . Reproduction is strictly prohibited. Visit our web site at www.medicaldevicedaily.com.

TUESDAY, JANUARY 31, 2006 MEDICAL DEVICE DAILY PAGE 7 OF 10EuropeContinued from Page 1Columbia (also Vancouver).Boston Scientific is the exclusive licensee of the patentfor cardiovascular medicine, which encompasses, amongother things, claims describing a stent that uses a compositionof paclitaxel and a polymeric coating as a drug carrier.Biosensors said the judge in the case ruled that itsAxxion DES does not infringe the European patent.Yoh-Chie Lu, chairman and CEO of Biosensors, said,“The decision of the Dutch court enables us to continue tosell the Axxion DES and to pursue our business model.” Hesaid the introduction and rollout of Axxion in Europe “hasbeen an important step for Biosensors as it has allowed usto build our sales and marketing infrastructure, initiatemarket share and develop the necessary systems for theeventual launch of our flagship BioMatrix DES.”Biosensors’ European subsidiary, Occam International(Eindhoven, the Netherlands), received European marketingapproval for the Axxion stent last summer (Medical DeviceDaily, July 13, 2005). The Axxion DES is a polymer-free systemthat incorporates Biosensors’ Calix stent delivery systemand the drug paclitaxel, which is directly coated on thestent over a layer of glycocalix, a substrate designed toimprove biocompatibility of the metal stent surface after thedrug is released.The technology is licensed exclusively by Occam froma privately held company in Germany that is a manufacturerof ultra-thin coatings that according to Biosensors,“set unsurpassed standards of efficiency, hemocompatibilityand biocompatibility.”Lu noted that the legal action only involved the Axxionproduct and does not relate to the company’s BioMatrixDES, which is expected to receive CE-mark approval in thefirst half of 2006. He said the BioMatrix “features a fullybiodegradable polymer and our own proprietary drug, andwe plan for it to drive our growth in the coming years.”The BioMatrix DES system incorporates the company’sproprietary anti-restenotic drug, Biolimus A9, bioresorbablepolymer, S-Stent and stent delivery catheter, all ofwhich have been developed in-house.Askion to produce device for EOSElectro-Optical Sciences (EOS; Irvington, New York),a company focused on designing and developing a noninvasive,point-of-care instrument to assist in the earlydiagnosis of melanoma, said it has entered into an agreementwith Askion (Gera, Germany) for the production ofEOS’s MelaFind hand-held imaging device.The agreement calls for Aakion to produce MelaFindimaging devices for EOS to be used in the company’s pivotaltrial, which is expected to be conducted at more than20 clinical study sites in the U.S. The purpose of the pivotaltrial is to establish the safety and efficacy of MelaFind in theimaging of suspicious skin lesions.Financial terms of the agreement were not disclosed.“This agreement is an important milestone for EOS andis a significant step in our pre-commercialization process,”said Joseph Gulfo, president and CEO of EOS. “2006 will bean exciting year for EOS as we conduct our clinical trialsand anticipate PMA approval and commercialization ofMelaFind in 2007.”Gerald Wagner, PhD, acting chief operating officer andmember of EOS’s board of directors, said, “I have had first-handdealings with Askion management and personnel for 15 yearssince my days at Bayer Diagnostics and Agfa. Askion has a solidreputation for top-quality production and manufacturing.”EOS started as a part of Agfa-Gevaert AG in 1991,mostly with employees from the former Carl Zeiss Jena.The MelaFind product features a hand-held imagingdevice that emits multiple wavelengths of light to captureimages of suspicious pigmented skin lesions and extractdata. The data are then analyzed against EOS’s database ofmelanomas and benign lesions in order to provide informationto the physician and produce a recommendation ofwhether the lesion should be biopsied.AMRI agrees to buy Hungarian firmAlbany Molecular Research (AMRI; Albany, New York)said it has signed a stock purchase agreement to acquireprivately held drug discovery service company ComGenex(Budapest, Hungary).Founded in 1992, ComGenex provides contract chemistryservices to the pharmaceutical and biotechnologyindustries, and possesses what AMRI termed “unique technologiesfor the rational design of chemical libraries forlead generation.”Specifically, the company integrates parallel synthesiswith computational chemistry to create unique small moleculeswith drug-like characteristics. It also has developednovel applications in the areas of chemical genomics andtarget identification.In 2005, ComGenex generated about $8.5 million in contractrevenue. The company and its subsidiaries currently have119 employees, including 88 scientific and technical staff.Thomas D’Ambra, PhD, chairman, president and CEO ofAMRI, said, “The acquisition of ComGenex further expandsAMRI’s global chemistry services platform. This combinationcreates an immediate presence in Europe in a EU memberstate with a significantly lower cost structure thanWestern European countries, while maintaining access to acomparable talent pool not only in Hungary, but all ofEurope and neighboring regions.”D’Ambra said, “Along with [our] offerings in the U.S.,Singapore and India, this move represents another step inthe diversification and globalization of AMRI’s brand amongtechnologies, geographic access and a range of differentcost structures.”Subject to customary closing conditions, the transactionis expected to be completed by the end of 1Q06. ■To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 688-2421; outside the U.S. and Canada, call (404) 262-5476.Copyright © 2006 Thomson BioWorld ® . Reproduction is strictly prohibited. Visit our web site at www.medicaldevicedaily.com.

TUESDAY, JANUARY 31, 2006 MEDICAL DEVICE DAILY PAGE 8 OF 10BarrxContinued from Page 1precursor to cancer. And when Barrett’s is not controlled, itcan then become a cancer that has a discouraging 90%fatality rate, and the interventions are highly invasive.Targeting the treatment of Barrett's, the Halo 360 Systemprovides increasing evidence of successful treatmentof this condition, and Barrx recently hailed publication of anew study, "Thin Layer Ablation of Human EsophagealEpithelium Using a Bipolar Radiofrequency Balloon Device,"as demonstrating the safety and efficacy of the system.Specifically, the study, appearing in the January issueof Surgical Endoscopy, the journal of the Society of AmericanGastrointestinal and Endoscopic Surgeons (SAGES;Chicago) demonstrated the ability of Halo to kill the precancerouscells without damaging healthy tissue. Significantly,this allowed the re-growth of normal cells.Thirteen male patients aged 49-85, all diagnosed withesophageal adenocarcinoma, were enrolled in this studyintended to determine the optimal energy density andtreatment parameters to achieve the complete removal ofhuman esophageal epithelium. The study was designed asa pilot trial leading up to the use of this device in patientswith Barrett’s.Patients underwent randomization into three groups,with each group receiving slightly different energy doseswhen treated with the HALO 360 System. Endoscopy wasperformed, followed by positioning of the HALO 360 ablationcatheter within the esophagus.The procedure is performed without incisions, underconscious sedation, and requires an average of less than30 minutes to complete. The physician first uses a HALO 360sizing balloon catheter to dilate the esophagus and determineits inner diameter. An ablation catheter is theninflated within the diseased area and the system’s energygenerator then delivers to the area a less than one secondburst – which the company has described as a “flash burn”not producing a great deal of heat – to the area, removingless than a 1 mm layer of diseased tissue.New healthy tissue replaces the ablated Barrett’s tissuein three to four weeks for most patients, according to thetrial results.In this particular study, the treatment was followed bya total esophagectomy (removal of the esophagus) as indicatedby the cancer diagnosis – a part of the stomachpulled up and used as a substitute esophagus in a highlyinvasive procedure (but necessary without any other treatmentavailable). Pathological evaluation was performed onthe ablated segments to determine the ablation depth andcompleteness of epithelial removal.Results confirm that the HALO 360 System is capable ofremoving the esophageal epithelium without causinguntoward injury to the underlying structures. Somepatients have minor discomfort which is managed withmedication, and following treatment patients may resumeacid suppression therapy.Brian Dunkin, MD, associate professor of surgery andchief of the division of laparoendoscopic surgery at theUniversity of Miami Miller School of Medicine, and hiscolleagues did most of the procedures and provided oversightof all of the pathology.He told Medical Device Daily that the HALO 360 systemoffers the opportunity of a “preemptive strike” vs. esophagealcancer that is "extremely easy to use, [the effects]extremely reproducible and very well controlled.“The data basically allowed us to choose the properenergy setting,” with 10 joules and 12 joules being the mostefficient, Dunkin said.He noted that other systems tend to offer “point andshoot” approaches. Rather than “pointing and cooking,”HALO 360 treatment is extremely uniform, he said. And someof these systems produce “strictures” within the esophagus,a loss of elasticity and difficulty in swallowing, he added.The HALO 360 System was FDA-approved in 2001 butnot commercialized until late 2004, with 2005 sales ofabout $1 million, according to the president of Barrx, GregBarrett, whose name, of course, resonates rather ironicallyin this context.“What we have been doing is pursuing a number ofclinical studies to validate the technology as to both safetyand efficacy, and we really wanted to understand betterhow the technology works,” Barrett said, with the sale of asecond-generation device now in full ramp-up.“What we are trying to do is ablate this condition at avery early stage, and even at the late stage, to avoid anesophageal cancer. We have gone through exhaustive studiesto demonstrate that we can successfully remove Barrett’sesophagus and these studies are really a culmination.”This most recent study, he said, “specifically was intendedto validate the depth of penetration of the tissue asa result of applying the energy to the esophagus. It furthervalidated [that] the energy penetrated the tissue tobetween 700 microns and 100 microns and did not penetratethe sub-mucosal tissue. “In the largest study conducted (AIM-II Trial), 70% ofpatients were Barrett’s-free at one year follow-up. Clearly,key to the success for Barrx will be the more rapid diagnosisof Barrett’s esophagus and the awareness of cliniciansthat they can avoid prescribing a drug-only solution.The opportunity to take share from a pharmaceuticalregimen is huge. Barrett’s is estimated to affect about 3.3million adults in the U.S. with about 86,000 cases newlydiagnosed each year. “Boomers” especially may be at risksince the condition increases with age until a plateau isreached in the 60s, according to Barrx.The company last presented three studies demonstratingthe technology at Digestive Disease Week 2005 (MDD,May 19, 2005), and Barrett promised an increased numberof HALO 360 studies at Digestive Disease Week 2006, scheduledfor May 20-25 in Los Angeles. ■To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 688-2421; outside the U.S. and Canada, call (404) 262-5476.Copyright © 2006 Thomson BioWorld ® . Reproduction is strictly prohibited. Visit our web site at www.medicaldevicedaily.com.

TUESDAY, JANUARY 31, 2006 MEDICAL DEVICE DAILY PAGE 9 OF 10P EOPLE IN P LACES• Stephen T.D. Dixon, executive vice president and CFOof Clarient (San Juan Capistrano, California), will resignthose posts effective Feb. 3 to pursue a new professionalopportunity. He has served in those positions for Clarientsince December 2002. Clarient, a majority owned subsidiaryof Safeguard Scientifics, provides technologies, services andsupport for the characterization, assessment and treatmentof cancer via its Automated Cellular Imaging System.• Indira Pottathil, PhD, has been appointed the first directorof international marketing for Grant Life Sciences (LosAngeles). Since 1996, Pottathil has served as vice president ofR&D at AccuDx, where she managed compliance efforts aswell as development and production of in vitro diagnosticproducts. Grant Life Sciences develops products to detect anddiagnose cervical cancer, including a non-invasive, point-ofcaretest. It also markets rapid tests for malaria, Dengue fever,HIV-1 and HIV-2 that were acquired from AccuDx.• Rob Burrows, vice president and CFO of LightPathTechnologies (Orlando, Florida), has been named CFO ofFDN Communications, a provider of communications servicesin the Southeast, and has resigned his positions withLightPath effective Feb. 8. The company said Kenneth Brizel,president and CEO, would serve as acting CFO and actingprincipal financial and accounting officer while a search for areplacement for Burrows takes place. LightPath manufacturesoptical products including precision molded asphericoptics, Gradium glass products, collimator assemblies, lasercomponents, higher-level assemblies and packing solutions.• McKesson (San Francisco) has reported a series of managementchanges in its Pharmaceutical Solutions and Medical-Surgical Solutions segments, effective April 1. John Figueroa,president of retail national accounts for U.S. PharmaceuticalDistribution, becomes president, U.S. pharmaceutical distribution.Gary Muensterman, president, McKesson Medical-Surgical, becomes senior vice president, corporate strategyand business development. Brian Tyler, president, McKessonSpecialty Pharmaceutical, becomes president, McKessonMedical-Surgical. Patrick Blake, president, customer operationsfor U.S. Pharmaceutical Distribution, becomes president,McKesson Specialty Pharmaceutical, McKesson PharmacySystems and Automated Prescription Systems. McKesson is ahealthcare services and information technology company.• Christopher Wagner has been named senior vicepresidentof sales and marketing at MDS Nordion (Ottawa,Ontario). Wagner has nearly 30 years of global sales andmarketing experience, most recently with Tyco Healthcare/Mallinckrodt. MDS Nordion’s product lines include medicalisotopes for molecular imaging, development and manufacturingof radiotherapeutics, and sterilization productsand services for the diagnosis, prevention and treatment ofdisease.Medical Alley/MNBIO addstwo vice presidents to staffA Medical Device Daily Staff ReportMedical Alley/MNBIO (St. Louis Park, Minnesota), alife sciences trade association serving Minnesota andsurrounding areas, has added two new vice presidents toits staff. Dana Boyle will serve as vice president for businessdevelopment, with a focus on bioscience, and LarryKuusisto, PhD, is the new vice president of education andexecutive director of Alley Institute.Boyle has served for the past 20 years as a tradecommissioner at the Consulate General of Canada inMinneapolis, where she built relationships betweenthe business and scientific communities, bridgingCanada to the Upper Midwest and Rocky Mountainstates.She has focused on the biosciences and environmentalsectors to grow what Medical Alley/MNBIO characterizedas “a strong network of contacts including smallcompanies, large corporations, research institutions,industry associations, universities and government tradeand investment offices on both sides of the border —with an objective to help create a solid and well-roundedcorridor throughout Minnesota and the surroundingregion.”Kuusisto has served Medical Alley for 12 years onthe organization’s Government Committee and threeyears on its board of directors. In 2004, he designedand implemented a community decision-makingprocess determining consumer healthcare coveragestemming from Alley Institute’s “Town Hall” convenerinitiative.He recently completed a postdoctoral fellowship inhealth services research and policy in the School ofPublic Health at the University of Minnesota, and previouslyserved in a number of roles at Northwestern HealthSciences University. Kuusisto directs the MinnesotaPalliative Care Partnership and will continue in that rolethrough Alley Institute.Medical Alley/MNBIO President and CEO Don Gerhardtsaid the two additions “bring the expertise andexperience that will greatly enhance the programs webring to our members and the life sciences communitythat benefit from this organization’s services.”He added: “We believe the surrounding states andCanadian provinces possess common attributes, challengesand great potential — and with closer collaboration,including how we inform and educate, this regionwill be highly successful in addressing key health andenvironmental issues.”Medical Alley/MNBIO is comprised of more than 500life science member organizations employing about250,000.To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 688-2421; outside the U.S. and Canada, call (404) 262-5476.Copyright © 2006 Thomson BioWorld ® . Reproduction is strictly prohibited. Visit our web site at www.medicaldevicedaily.com.

TUESDAY, JANUARY 31, 2006 MEDICAL DEVICE DAILY PAGE 10 OF 10P RODUCTB RIEFSBiopure reports initial sale ofHemopure in South Africa• Abbott Point of Care (East Windsor, New Jersey)reported that it has received FDA 510(k) clearance to marketits i-Stat Chem 8+ cartridge, a new point-of-care diagnostictest used to quickly assess basic metabolic status ofpatients in emergency rooms and other critical care settings.The Chem 8+ cartridge is designed for use with the i-Stat, an automated hand-held blood analyzer that performsa comprehensive panel of critical tests at the patient’s bedsidein only a few minutes, producing lab-quality resultsthat allow healthcare professionals to make on-the-spotdiagnosis and treatment decisions for their patients. TheChem 8+ cartridge is a single-use, in vitro diagnostic testthat combines a battery of basic metabolic tests withmeasurements for hematocrit and hemoglobin into a singletest. The i-Stat Chem 8+ cartridge provides a rapid snapshotof the most critical homeostatic processes: glycemiccontrol, electrolyte balance and renal function, right at thepatient’s side and using just a few drops of blood.• Advanced Medical Optics (Santa Ana, California)said that its Tecnis foldable intraocular lens (IOL) has beendesignated as a New Technology Intraocular Lens (NTIOL)by the Centers for Medicare & Medicaid Services (Baltimore).The designation follows labeling claims approvedby FDA in April 2004 that the Tecnis foldable IOL reducedpostoperative spherical aberrations compared to lenseswith spherical optics and improved night driving simulatorperformance. The NTIOL designation goes into effect Feb.27 and includes both the acrylic and silicone platformTecnis lenses. The company said the Tecnis IOL is the onlylens approved for NTIOL reimbursement status, which providesfor additional Medicare reimbursement of $50 perlens for ambulatory surgical centers, which perform morethan half of all cataract surgeries in the U.S.• BrainStorm Cell Therapeutics (Tel Aviv, Israel),developer of NurOwn bone marrow-derived stem cell therapeuticproducts for the treatment of neurodegenerativediseases, said a patent application has been filed with theU.S. Patent and Trademark Office for a new procedure toderive oligodendrocyte-like cells. The invention involvesinducing oligodendrocyte-like cells using the company’sbone marrow-derived human mesenchymal stem cell technology.The patent application was filed by Ramot, the technologytransfer company of Tel Aviv University, on thebasis of research funded by Brainstorm . Worldwide rightsto the development and commercialization of the newtechnology are exclusively licensed to BrainStorm.• CardiArc (Lubbock, Texas) said it has received 510(k)clearance from the FDA to market its new cardiac singlephoton emission computed tomography (SPECT) imagingdevice, which the company said could lead to better cardiacdiagnosis and fewer hospitalizations to rule out heartA Medical Device Daily Staff ReportBiopure (Cambridge, Massachusetts) yesterdayreported that it has made the first commercial sale of itsoxygen therapeutic Hemopure (hemoglobin glutamer —250 (bovine)), with that sale coming in South Africa.The product is approved in South Africa for the treatmentof adult surgical patients who are acutely anemicand for the purpose of eliminating, delaying or reducingthe need for allogenic red blood cell transfusions in thesepatients.“This first-ever commercial sale of a hemoglobinbasedoxygen therapeutic for human use is a milestonein the field of oxygen therapeutics and representsdecades of research and development by the company,”said Zafiris Zafirelis, Biopure CEO and chairman. “It is alsoan important step in understanding how doctors perceiveand use the product outside of clinical trials.”Biopure said its initial sales targets are providers thathave used or been trained to use Hemopure as part of apost-approval medical education program. In April 2001,South Africa’s Medicines Control Council granted marketingclearance for the product (Medical Device Daily,April 2001). However, it said that issues between Biopureand the original product registration holder and distributordelayed marketing and sales.In 2005, Biopure acquired control of the product registration,selected a warehousing and shipping agent andappointed a sales agent. And in early January, the companyreported that it had complied with new import regulationsand shipped product to South Africa to supportthe initiation of sales and marketing activities.The company said it plans to apply in Europe, in mid-2006, for approval of an acute anemia indication inorthopedic surgery patients.Hemopure has not been approved for sale in otherjurisdictions, including the U.S. or the European Union.attacks. It said physicians soon would have sharper imagesof blood flow and function of their patients’ hearts, in halfthe time previously required. CardiArc has developed andpatented a new, smaller and faster technology for SPECTwith twice the resolution of existing devices. The CardiArcsystem is the size of an executive chair, runs on 110 volts ACcurrent and fits easily in a 6-foot by 7-foot exam room withoutremodeling. The device has no visible moving parts anduses solid-state cadmium zinc telluride (CZT) technology.Patients sit upright, without rotating or holding their armsover their heads. Scan times range from 2 minutes to 6 minutesat physician discretion. The company said theCardiArc SPECT device has been designed for use in outpatientsettings and emergency rooms.To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 688-2421; outside the U.S. and Canada, call (404) 262-5476.Copyright © 2006 Thomson BioWorld ® . Reproduction is strictly prohibited. Visit our web site at www.medicaldevicedaily.com.