BIOMEDICAL BUSINESS New The BBI sletter && ECHNOLOGYECHNOLOGY

POC testing, new monitoringstrategies on fast growth pathsin European healthcare arenasBy MICHAEL SIMONSEN, PhDBB&T Contributing Editor

DÜSSELDORF, Germany — The worldwide markets for products used inpoint-of-care (POC) testing and for monitoring of vital signs in patients outside thetraditional hospital setting have been growing at rates in excess of those for theoverall medical device and diagnostics market. Among the segments of the mar-ket exhibiting the most rapid growth are products for whole blood glucose testing,POC coagulation testing products, POC cardiac markers, and patient monitoring

products used for home and ambulatory monitoring. The European market is no exception, although POC test-

ing and remote patient monitoring have advanced less rapidlyin Europe than in the U.S. The 2006 MEDICA exhibition, heldhere in mid-November, provided an opportunity to view thelatest developments in POC testing and patient monitoring, aswell as advances in many other segments of the medical devicemarket, including diagnostic imaging, surgical navigation,

endoscopy, drug delivery and electrostimulation therapy. Although held in Europe, the MEDICA exhibition attracts vendors from all

the major world markets, including suppliers from emerging markets such asChina, India, and Latin America, which represent some of the most rapidly grow-ing segments of the global market. In addition, suppliers from emerging marketsare having an impact on markets in the developed regions by offering productswith competitive features at low prices. Chinese companies in particular arebeginning to expand outside of their domestic market to target penetration of theEuropean and U.S. markets, with product offerings that in some cases offer fea-tures equivalent to those provided by established suppliers.

POC testing expanding in EuropeThe market for in vitro diagnostic POC testing products in Europe is one seg-

ment that is attracting growing interest among suppliers, from both from devel-

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❏❏ BB&T — 29, and counting.Page 2.

❏❏ Few surprises, little new FDAaction seen for addressingDES. Page 8.

❏❏ Americans too often on losingside of risk/benefit ratio.Commentary, page 10.

❏❏ Drug delivery less dominatedby pills, capsules. 1.

❏❏ Microneedles offering mini-mally invasive tool. Page 14.

❏❏ Reviewing newest in-officestrategies for fibroid treat-ment. Page 14.

❏❏ Preserving fertility whileattacking problem fibroids.Page 17.

❏❏ What’s holding back realfocus on safety? Page 18.

❏❏ JCAHO in authority toaccredit DMEPOS. Page 18.

❏❏ International report. Page 19.

❏❏ Acquisitions. Page 22.

❏❏ Business developments. Page 23.

❏❏ Agreements. Page 26.

❏❏ Markets/technology. Page 27.

❏❏ Product briefs. Page 31.

BIOMEDICAL

BUSINESSBIOMEDICAL

BUSINESSFormerlyThe BBI

Newsletter

TECHNOLOGYTECHNOLOGY&&January 2007 Vol. 30, No. 1

TheInsideStory

Our 30th year of providing

med-tech news & analysis

Now available online: Go to www.medicaldevicedaily.com for details

BB&Tat

Medica

oped as well as emerging countries. As shown inTable 1, the total market for POC testing products inEurope is estimated at more than $3.3 billion for 2005,and the market is forecast to more than double by2011, approaching $6.9 billion.

Products for home and self-testing, primarilywhole blood glucose monitoring products, areexpected to exhibit the most rapid growth, followedby hospital POC testing products and physician’s

office laboratory products. Other important prod-ucts within the home and self-testing segmentinclude coagulation self-testing products, as well ashome pregnancy and fertility test kits.

Testing whole blood glucoseThe market for whole blood glucose testing

products, estimated at almost $2.9 billion in Europein 2006, is being driven by continued increases in

Biomedical Business & Technology JANUARY 2007


The name of the publication was changed toBBI Newsletter in 1994 and then, last year, to Bio-medical Business & Technology, to emphasize theintrinsic connection between medical technologiesand business development. And over the past 12years, this publication has been the foundation fornumerous spin-off products: Cardiovascular DeviceUpdate in 1995, Medical Device Daily (first launchedas Medical Device Week in 1997), Diagnostics & Imag-ing Week in 1998, Medical Technology & Devices Weekin 2003 and numerous sourcebooks convering vari-ous sectors of med-tech.

The Jan. 4, 1982, issue is a loose-leaf product,rather than bound, and just 16 pages. The layout isn'tparticularly wonderful, the type style and organiza-tion generally reflecting a pre-desktop publishing era,but some of the main categories then are the same asthose in this issue (though with different names):“International Scene,” “Acquisitions, Divestments,Agreements,” “Business Briefs,” “New Products &Techniques” — the word “Techniques” seeming nowrather antiquated as compared to the current ubiqui-tous “technologies.” As with this issue of BB&T inyour hand, the 1982 issue is replete with the names ofcompanies and organizations (more than 200), manystill with us but most now gone or merged into othercompanies.

We promise that BB&T under its new ownershipwill maintain the tradition that the publication haspursued so well over the past 29 years, bringing youan overview and understanding of key med-tech andbiomedical sectors as these areas continue to changeand develop — some companies and technologies ris-ing in importance, some fading away, both develop-mental and mature technologies bringing importanttherapies to the world.

A promise, of course, is just words. But words,and conversations with the med-tech community, arewhat we do best. And we ask you and potential read-ers to share the important words that describe thisindustry now and into the future.

— Don Long, Managing Editor

“During a conference on 'Cardiac Monitoring in aComplex Patient Care Environment’ . . . A slowincrease in the use of the relatively expensiveimplantable defibrillators was predicted. MED-TRONIC, which has such a device under develop-ment, is expected to enter the market in 1984 and maystir more interest.”

“BIOSONICS (Philadelphia) is finally coming outwith a delayed offering totaling 20 mln shares (maxi-mum) at $0.05 each. If the maximum number ofshares are sold, the company will have raised $1 mln($0.9 mln in net proceeds) for 11.4% of its outstandingcommon stock . . .” BIOSONICS’ “claim to fame willbe the male electronic genital stimulator, a self-con-tained, electronic device inserted rectally and con-trolled by the user to initiate the physiological processculminating in an erection.”

“NATIONAL MEDICAL CARE (Boston), whopioneered free-standing dialysis centers in the 1970's,is focusing on diabetic self-management. It hasopened two self-care centers (New York and Dallas)where insulin-using patients are taught to bring andkeep their blood glucose within normal range.”

These items, taken from the Jan. 4, 1982, issue ofBIOMEDICAL BUSINESS INTERNATIONAL (thispublication’s predecssor) suggest how many thingshave changed in the med-tech environment over thepast 25 years — and have stayed the same: Medtron-ic remains strong in implantable defibrillators andnew ventures keep being developed; companies areraising money via stock sales and innovative ideasare being tested to reach specific disease states andpatient groups (though drugs, not devices, now dom-inate the erectile dysfunction market).

BIOMEDICAL BUSINESS INTERNATIONAL waslaunched in 1977 (though we don’t have the first fiveyears of issues in our archives) and then was pur-chased by the Thomson Corp. in 1994. Thus, 2007marks this publication’s 30th year in covering med-ical technology (with the newsletter group purchasedby Thompson Publishing Group of Washington D. C.last year).

BB&T — 29, and counting

diabetes prevalence worldwide as well as by growingappreciation of the benefits of improved managementof blood glucose levels on long-term outcome. Tightglucose control (TGC) programs in hospitals are animportant factor, with some suppliers of hospital bed-side whole blood glucose testing systems reportingthat 78% of the hospitals in their U.S. customer basehave adopted TGC protocols, and estimating thatsimilar trends are prevailing in Europe.

A new concept for whole blood glucose self-testingwas introduced at the MEDICA exhibition by GlucoTelScientific (Reno, Nevada/Lichtenfels, Germany). Glu-coTel is the medical division of the IT security companySafe-com GmbH & Co. (also Lichtefels), and in addi-tion to glucose monitoring technology is also focusedon telemedical applications for monitoring of bloodpressure, body weight, and other parameters.

The company has developed a new glucose meterthat communicates via Bluetooth to any enabled cellphone, as well as Java-based software that runs on thephone and provides a wireless link to the Internet andthence to a disease management website running on adedicated server.

The system provides automatic archiving of glu-cose readings as well as of patient-entered data onexercise level, food intake, drug dosage, and otherfactors relevant to diabetes management such asintake of nutritional supplements. The web site pro-vides a graphic representation of the archived data,and allows review via the Internet by the patient andhis or her doctor or diabetes educator.

GlucoTel has already received FDA clearance andCE-marking for the test strips used with the system,which will represent the primary revenue source forthe product line, and it is applying for clearances forthe meter and software, with a target worldwidelaunch in Q107. The company may enter into a part-nership with a telecommunications provider to obtaina source for the cell phone used with its system.

GlucoTel also is drawing upon the resources of itsparent to provide highly secure, encrypted, HIPAA-compliant data communications and archiving, whichis a particularly important requirement in the Euro-pean market. The company plans to price its metercompetitively, and believes the test strips will bepriced at below the market average.

Glucose meters — and moreSimilar products that combine a glucose meter

with a cellular phone to transmit glucose readings toa server are manufactured by Infopia (Anyang,Korea), Hahn & Hahn (Waiblingen, Germany), eHIT(Kuopio, Finland). Cardiocom (Chanhassen, Min-nesota), through its newly formed GlucoCom divi-sion, has also introduced a telemedicine product forglucose monitoring as a new component of its Aut-lolink Diabetes Telemonitoring System.

Hahn & Hahn’s MWD Diabetes ManagementSystem consists of a highly compact meter, the MWDPen Sensor, and a handheld wireless communicationdevice, the Medwatchdog. Up to 10 glucose readingscan be stored in the Pen Sensor. Stored glucose testdata is uploaded by placing the Pen Sensor in contactwith the Medwatchdog. The user can then transmitthe archived glucose readings along with data enteredmanually into the Medwatchdog on physical activity,food and drug consumption, and parameters such asblood pressure readings to a web site for review by aphysician.

eHIT is developing the Health Gateway, consist-ing of a handheld mobile telemedicine unit that canacquire data from a variety of testing devices includ-ing glucose meters, weight scales, pulmonary func-tion testing devices, respiration rate monitors, andECG monitors, and transmit the data to a server viathe cellular network using GPRS/3G technology.Data is transmitted in a secure format and can betransferred to an electronic patient record or hospital

JANUARY 2007 Biomedical Business & Technology


Table 1European Point-of-Care Testing Products Market

Year Hospital POC Home/Self-Testing Physician’s Office Total Market GrowthProducts Products Lab Products ($millions) (%)($millions) ($millions) ($millions)

2005 273 2,636 438 3,346 —2006 297 3,025 468 3,790 13.32007 327 3,470 504 4,300 13.52008 360 3,976 545 4,881 13.52009 396 4,523 591 5,510 12.92010 435 5,099 641 6,176 12.12011 478 5,724 694 6,896 11.7CAGR2006-11 10.0% 13.6% 8.2% 12.7% —

Source: Supplier reports, Biomedical Business & Technology

information system, allowing physician review. Wire-less data links to measurement devices are estab-lished automatically using the eHIT intelligent Blue-tooth adapter, which mates to the measurementdevice.

In addition to monitoring of blood glucose data,the system has also been configured to monitor coag-ulation (PT/INR) self-testing data measured usingthe CoaguChek meter and test strips from RocheDiagnostics (Basel, Switzerland). The software for thesystem is priced at €140.

National Diagnostic Products (Sydney, Aus-tralia) introduced a new 60-second personal diabetesscreening test that does not require a meter for read-out and costs 30% less than a conventional diabetestest strip. The Betachek Diabetes Test, designed forhome use, was launched in Australia earlier this year.The product complements National Diagnostic’sBetachek Visual Kit, which provides a semi-quantita-tive visual readout of blood glucose levels using astrip format similar to that used in urine test strips.The latter product is sold in 50 countries worldwide.

The new personal diabetes test is designed for useat home by individuals who have not been diagnosedwith diabetes but who are at risk based on age, bodymass index, family history, or other factors, andexhibit symptoms of the disease. It is intended toaddress the issue of undiagnosed diabetes, a signifi-cant public health issue because up to 50% of peoplewho have diabetes are unaware of their disease.

HbA1c testingAnother segment of the POC testing market

focused on diabetes management is point-of-care gly-cated hemoglobin/HbA1c testing products. A num-ber of products are already on the market, includingthe DCA 2000 from Siemens/Bayer Diagnostics (Tar-rytown, New York); the Micromat II from Bio-RadLaboratories (Hercules, California); the A1CNow+single-use OTC device from Metrika, now a unit ofBayer Diagnostics; the GDX System from Cholestech(Hayward, California); the Nycocard and CLIA-waived Afinion HbA1c tests from Axis-Shield PoCAS (Oslo, Norway); and the €6 Smart/700 HbA1c testfrom Diazyme Laboratories (San Diego, California).

Another POC system providing HbA1c testingcapability, the in2it from Provalis (Flintshire, UK), isno longer actively marketed following the acquisitionof Provalis’ diagnostics business, PB Diagnostics, byBio-Rad. A new entrant in the POC HbA1c market,Quotient Diagnostics (Surrey, UK), introduced theQuo-Test A1C hemoglobin A1c testing system at theMEDICA exhibition.

The Quo-Test technology was developed at St.Bartholomew’s Hospital (London) and licensed byQuotient Diagnostics. The Quo-Test analyzeremploys fluorescence quenching in concert with

boronic acid affinity chromatography, creating ahomogenous assay technology well-suited to POCtesting. Test time is under three minutes not includ-ing sample preparation. The test requires a wholeblood sample of less than 5 uL.

Two versions of the instrument are in develop-ment, including Quo-Test A1C LAB, a compact, dedi-cated HbA1c reader suitable for low-volume testingin small labs, and the Quo-Test instrument, a $3,000unit that combines a photometer and a fluorimeter inone unit and is designed for either POC testing or cen-tral lab testing.

The latter instrument is intended to serve as aplatform that will eventually allow a range of assaysto be performed using individual test cartridges. TheA1C cartridge will be the first test to be introduced,and feasibility studies have been performed for a totalcholesterol assay.

Quotient is targeting a selling price for the HbA1ccartridge of $4 to $5 in the U.S., making the productcompetitive with existing tests such as the DCA 2000HbA1c assay that typically is priced at $8-$9. Thereader will be priced at $3,000. Quotient is now initi-ating clinical studies to generate data for a 510(k) sub-mission in the U.S. and CE mark submission inEurope.

The company is targeting product launch duringthe first half of 200 and is projecting that the systemwill have CLIA-waived status by July 2007. Quotientbelieves there is a significant opportunity for expan-sion of the POC HbA1c testing market.

At present, only around 5 million of the 100 mil-lion HbA1c tests performed annually in the U.S. aredone POC. In Europe, the company believes that atleast one-third of HbA1c testing could migrate to thepoint of care. Quotient has been funded to date by acombination of venture capital, private investment,and an industry partner, BBI Holdings.

Other companies developing POC HbA1c testingproducts for the global market include Audit Diag-nostics (Cork, Ireland), Nano-Ditech (MonmouthJunction, New Jersey), and Sand County Biotechnol-ogy (Taiwan).

Audit Diagnostics exhibited the Liqui-Stat, adevelopment-stage POC wet chemistry analyzer tar-geted for launch in April 2007. The Liqui-Stat requiresa serum or plasma sample, and requires a startingblood sample volume of 10-20 uL. Test time is veryrapid, at about one minute, although the initial cen-trifugation step required for all assays takes aboutfive minutes. Audit plans to offer a broad test menu ofclinical chemistry tests, in-cluding HbA1c, as well asimmunoassays, drugs of abuse tests, cancer markers,cardiac markers, and electrolytes.

Nano-Ditech has developed a new im-munoassaytechnology employing microfluidics and electro-immunochromatography (Electro-Immuno chro-



matography Lab On a Film Chip or EI LOFC). A U.S.patent application has been filed on the technology,which employs a microchannel and conductive parti-cles to provide rapid, quantitative detection using alow-cost chip.

The company has already introduced qualitativeimmunochromatography test cartridges for POCdrugs of abuse and cardiac marker testing. The newHbA1c test cartridge will employ the LOFC technolo-gy, providing a rapid quantitative readout. A targetlaunch date has not yet been set.

Nano-Ditech also is developing a troponin I car-diac marker assay employing LOFC technology. SandCounty Biotechnology plans to introduce an 8-minute, non-instrumented semi-quantitative test forglycated hemoglobin in whole blood in June 2007.The test cartridge will require application of twodrops of blood, one for measurement of total hemo-globin, the second for measurement of non-glycatedhemoglobin, with the glycated hemoglobin resultderived from the difference between the two meas-urements.

Highlighting cardiac markersAnother segment of the POC testing market

highlighted at the MEDICA exhibition was cardiacmarkers. The POC cardiac marker segment hasattracted considerable investment due to its highgrowth rate and is expected to total more than $300million worldwide in 2006, including markers suchas BNP and NT-proBNP as well as troponin, CK-MB and myoglobin.

Biosite dominates the market with an estimated60% share worldwide in 2005, followed by RocheDiagnostics with reported 2005 sales of its CardiacReader reaching CHF61 million (about $49 million).At MEDICA, Roche exhibited a new version of theCardiac Reader, the Cobas h232, that will be launchedin Spring 2007. The new reader is designed as a hand-held unit, and is slightly larger than the i-STAT ana-lyzer marketed by Abbott Diagnostics (Abbott Park,Illinois), another POC testing system that offers car-diac markers.

The reader features a touchscreen interface, aswell as enhanced connectivity. The menu will includeNT-proBNP, D-dimer, myoglobin, Troponin T, Tro-ponin T Sensitive, and CK-MB. Roche will targetusers in the hospital bedside, emergency department,and physician’s office segments.

AMIC (Uppsala, Sweden) exhibited the ForecastSystem, a development-stage POC analyzer slated forinitial market launch in late 2007 in Europe. The sys-tem is based on AMIC’s 4castchip technology, whichemploys a highly ordered array of micropillars thatdrive capillary flow of sample and reagents. Key fea-tures of the technology include high sensitivity andprecision.

The cardiac Troponin I assay under developmentfor the Forecast system has an analytical sensitivity of< 0.05 ng/mL, qualifying it as a high-sensitivity tro-ponin assay. Total test time is 10 minutes, which willallow users to meet the newest guidelines of the Euro-pean Society of Cardiology (Sophia Antipolis,France) and the American College of Cardiology(Washington) for management of acute myocardialinfarction.

Nanomedics Technology (Düsseldorf, Ger-many), another development-stage company target-ing the POC cardiac marker market and founded in2002, is a subsidiary of Diagenics (Woburn, Massa-chusetts). Diagenics has introduced the Diacordonlaboratory-based ELISA test for the cardiac markerGlycogen Phosphorylase isoenzyme BB (GPBB) inEurope, and its Nanomedics division is now devel-oping a POC version of the assay, as well as a tro-ponin I assay and other cardiac marker tests, basedon a biochip platform.

Preliminary studies indicate that GPBB is elevat-ed earlier in myocardial infarction than the troponinsand is more specific for MI than myoglobin.

Another POC cardiac marker system was exhibit-ed at MEDICA by Mitsubishi Kagaku Iatron (Tokyo).The Pathfast system is a compact desktop automatedimmunoassay analyzer which combines chemilumi-nesence with Mitsubishi’s Magtration magnetic parti-cle separation technology. Both whole blood and plas-ma samples can be used.

Turnaround time for analysis of six samples isless than 17 minutes, depending on the tests per-formed. The test menu includes Troponin I, myoglo-bin, CK-MB, D-Dimer, and a new NT-proBNP assay.A total of 80 analyzers have been placed in Japan,and 60 have been placed in Europe to date. Sales inthe U.S. are targeted for this month, pending FDAclearance. The Pathfast is sold through a worldwidenetwork of 20 distributors.

POC coagulationAnother growing segment of the POC testing

market is products for point-of-care coagulationtesting. This market is particularly strong inEurope, where a patient-driven movement origi-nating in Germany has created a high level ofawareness of the benefits of regular PT/INR moni-toring for patients undergoing anti-coagulant ther-apy, and many patients now perform coagulationself-testing.

A recent meta-analysis published in the Lancet byHeneghan et al. demonstrates that patient self-testingcan reduce thromboembolic events in patients under-going anticoagulation therapy by 55%, and canreduce mortality by one-third.

The global market leader, Roche Diagnostics,sells the CoaguChek S for professional use in



Europe and has recently launched the CoaguChekXS, a compact handheld meter with a 60-second testtime, a 10uL blood sample volume requirement, andoff-meter dosing. The Roche CoaguChek is alsoused for patient self-testing in Europe.

Inverness Medical (Bedford, UK), one of theleading suppliers of POC testing products world-wide, introduced a new entry in the market, theSmartCheck INR, designed for patient self-testing.The SmartCheck requires only a 3 uL blood sample,and fits easily in the hand. It is being launched first inGermany, and is priced at €800. Test strips cost €3each.

Personalized patient monitoringThe market for patient vital signs monitoring

technology is also expanding in areas outside of thetraditional hospital setting in Europe and worldwide.Wireless technology is playing a major role by allow-ing patients to be monitored at any location in thehospital as well as after dis-charge in the home. An impor-tant area of focus for new prod-uct development in hospital-based patient monitoring issystems to improve the integra-tion of the various aspects ofpatient management, includingboth monitoring and therapy,as the patient moves throughthe care process within the hos-pital.

At present, most hospitals have a complex anddiverse array of instruments in the various specialtydepartments with differing user interfaces and oper-ating standards.

Many medical errors are attributable to commu-nication problems between departments or differentmedical teams that manage the patient at varioustimes during a hospital stay. Hand-off of patientsbetween departments or different patient manage-ment teams is particularly error-prone.

A new system designed to address such issueswas introduced by Dräger Medical (Lübeck, Ger-many) at the MEDICA exhibition. Key components ofDräger’s Infinity Acute Care System include the Med-ical Cockpit, a standardized control unit, and a per-sonal vital signs monitor that travels with the patientthroughout the hospital stay. The monitor employswireless local area network technology to communi-cate with the hospital’s clinical information system aswell as with various fixed base monitors and thera-peutic devices such as ventilators, infusion pumps,and anesthesia machines.

In a typical scenario, the TeleSmart personal mon-itor would be attached to the patient upon initial pres-entation in the Emergency Department. When the

patient is subsequently admitted for treatment, suchas for emergency surgery in the OR, the monitor trav-els with the patient and can be interfaced to equip-ment such as an anesthesia machine.

To further simplify the transfer process, Dräger hasdeveloped a single-use ventilator tubing set that con-tains an integrated electronic chip which can automati-cally transfer ventilator settings used in the ED to theventilation/anesthesia equipment in the OR, eliminat-ing the need for time-consuming and error-prone datare-entry.

When the patient is subsequently transferred tothe recovery room, the personal monitor again travelswith the patient to ensure continuity of tracking ofphysiological status, and to automatically transferpatient information to fixed-base equipment such asventilators or drug delivery devices. If the patient isthen transferred to the intensive care unit, the person-al monitor continues to stay with the patient for trans-fer of data and continuous monitoring without the

need for manual informationexchange or data entry. TheInfinity System not only tracksclinical parameters, but canalso be used to monitor the costof care throughout the hospitalstay.

Dräger also exhibited aproduct under developmentfor non-invasive monitoring oflung respiratory volume that

allows ventilator parameters to be determined usingelectrical impedance tomography. Feasibility studieswith the device are nearly complete, and according tothe company physician feedback has been positive.The respiratory volume monitor is about two to threeyears away from market introduction. Out-of-hospital monitoring

A number of companies exhibited new devicesfor monitoring of patients outside of the hospital set-ting, in keeping with the growing trend to deliver carein the least expensive setting while maintaining thecapability to continuously track key patient data.

Biomedical Instruments (Shenzhen, China)exhibited the MOQI ambulatory wireless monitor,which allows tracking of ECG, non-invasive bloodpressure, oxygen saturation, respiration rate and tem-perature remotely via a link to the cellular telephonenetwork.

The monitor can also be configured to communi-cate via wireless LAN, or a memory card can beinserted to record patient data. At present, the device,which is priced at $3,500, is sold only in China for usein emergency departments and research hospitals, butthe company is seeking distributor partnerships tomarket the product worldwide.

Cardiomedix (Evanston, Illinois) has introduced



An important area of focus for newproduct development in hospital-

based patient monitoring is systemsto improve the various aspects of

patient management . . . as the patientmoves through the care process.

the Physio-Glove-ES/ET in Europe, used for remotemonitoring of 12-lead ECG data. The system consistsof a glove containing a network of ECG leads that isplaced over the patient’s chest, and a Bluetooth inter-face for transmission of ECG data to a cell phone,from which it can be uploaded to a monitoring center.The company has submitted to the FDA for 510(k)clearance. Cardiomedix provides a monitoring serv-ice and also sells a $2,000 software package allowinga monitoring center to be set up in a nursing center orclinic.

In addition, the company markets the Health-e-Chair, a specialized chair outfitted with monitorsfor body weight and blood pressure, with an inter-face that connects to the patient’s television tointeract with a care manager in the monitoring cen-ter. The complete monitoring service using boththe Health-e-Chair and the Physio-Glove has abase price of $250 per month, adjusted based onusage level.

Energy Lab Technologies (Hamburg, Germany)introduced the viport ECG event recorder at theMEDICA exhibition. The device is a further develop-ment of the viport mini-ECG device launched lastyear, which is a self-contained handheld unit that per-forms three-lead ECG measurements. The new modelwith event recording also includes a real-time colordisplay of the ECG trace, and can display a color-coded electrocardioportrait indicating heart functionand cardiac stress.

Cardiac stress is derived from measurement ofheart rate variability, and can indicate the presenceof diseases other than arrhythmias such as infec-tions and mental disorders. Two versions are avail-able, a €399 consumer model for home use bypatients, and a €599 professional model with addedsoftware capabilities. Physicians can use the viport

in the home or office to acquire ECG data on thespot in about two minutes. The data can be trans-ferred via Bluetooth link to a PC or cellular phonefor transmission to a monitoring center.

Home and alternate-site treatment advancesOther new developments were exhibited at MED-

ICA in the areas of respiratory disease managementand diabetes management.

A new instrument for rapid POC screening fortuberculosis infection was previewed at the MEDICAexhibition by Clement Clarke International (Essex,UK). The XTS Xpress TB Screen is a breath analyzerthat provides detection of patients infected withtuberculosis in under five minutes.

The system consists of a disposable breath collec-tion device that is coated with an antibody that specif-ically binds to tuberculosis mycobacteria, which areexpelled in the breath of individuals with active, con-tagious infections. After collection of a breath sample,the collection device is inserted into a handheld ana-lyzer that detects presence of tuberculosis bacteria viaa fluorescent labeling technique.

The product has already received 510(k) clearancein the U.S., and CE marking is pending. The targetdate for market introduction is April 2007. Cost forthe analyzer is about $8,000, with the consumable col-lection device priced at $10. In an initial trial conduct-ed in India, the device exhibited 100% sensitivity fordetection of tuberculosis infection. Potential applica-tions include screening in immigration control, pri-mary care diagnosis, containment of outbreaks inhigh risk areas, and screening of patients in clinicaltrials.

SeQual (San Diego, California) exhibited theEclipse oxygen concentrator, a portable device thatis about the size of a small carry-on suitcase andcan operate on a rechargeable internal battery toprovide oxygen therapy during short periods oftransport. It is approved for use aboard commer-cial airplanes.

The Eclipse was launched in the European mar-ket just prior to MEDICA, and was introduced inthe U.S. in August 2006, where it has already beendeployed by more than 200 providers serving inexcess of 60% of the 1.5 million existing home oxy-gen patients.

The product addresses the growing market foroxygen concentrators, which, as shown in Table 2,exceeded $450 million worldwide in 2005. In theU.S., changes in Medicare reimbursement for oxygentherapy allowing payment for therapy delivered byportable devices will drive expansion of the marketfor products such as the Eclipse. The Eclipse candeliver continuous oxygen at a 3-liter-per-minuterate, and can eliminate the need for oxygen cylindersfor most patients.



Table 2Global Market for Oxygen Concentrators

Year Worldwide Sales Growth($millions) (%)

2004 396 15.82005 451 14.02006 512 13.52007 575 12.32008 639 11.12009 697 9.2CAGR2004-09 12.0% —

Key market participants include Invacare (Elyria, OH),Airsep (Buffalo, NY), Sunrise Medical (Carlsbad, CA) andRespironics (Murrysville, PA).

Source: Biomedical Business & Technology

Delivering insulinA new development in insulin therapy for dia-

betes was announced by Wristop Technologies(Vantaa, Finland), which manufactures wirelesswrist computers and wearable and portable med-ical and leisure instruments. At the MEDICA exhi-bition, the company introduced the WRISTOPwireless insulin pump controller. The battery-powered device is the size of a typical wrist watch,and can be customized with different colors anddesigns for various user segments such as chil-dren. It internally measures energy consumptionof the wearer as well as heart rate, and can inter-face to a glucose meter via Bluetooth or aninfrared link.

In addition, the device can be connected tocontinuous glucose sensors manufactured byRoche and Medtronic (Minneapolis). Via a wirelessinterface to the user’s insulin pump, the device candisplay the level of insulin remaining in the pump,and allows the user to remotely set the insulin doseand activate the pump from the WRISTOP, avoid-ing the need to access the pump directly. That fac-tor is important, according to Wristop, because itallows the user to be less conspicuous when oper-ating the pump. Cost has not yet been set. Thecompany plans to establish partnerships withinsulin pump manufacturers to commercialize thedevice.

gbo Medizintechnik (Rimbach, Germany) exhib-ited the HiToP electrotherapy system for treatment ofdiabetic neuropathy. Existing therapies for diabeticneuropathy such as pain medications have limitedeffectiveness, as does transcutaneous electrical nervestimulation (TENS) therapy.

The HiToP system, which is available as both aprofessional-use model for physician’s offices as wellas a home-use model, employs higher frequency stim-ulation versus TENS.

According to the company, high frequenciesallow energy to be coupled into the body more effec-tively. A comparative study using the HiToP systemversus TENS demonstrated an 80% response rate indiabetics treated with HiToP compared to 30% forTENS. Therapy is applied daily and typically must becontinued indefinitely.

However, there is some evidence for improve-ment in microvascular perfusion in treatedpatients, presumably reflecting restoration ofmicrovascular endothelial cell function, as well asevidence for reduction in insulin requirements fordiabetics who take insulin. The HiToP system issold in Western Europe and some parts of EastEurope, as well as in Japan and Korea. gbo Mediz-intechnik is now in the process of applying forFDA clearance to allow marketing of the product inthe U.S.

In two-day meeting . . .

Few surprises, little new FDA action seenfor addressing DESBy MARK McCARTYBB&T Washington Editor

WASHINGTON — On the eve of the two-daymeeting held by the FDA in early December to dis-cuss drug-eluting stents (DES), the American HeartAssociation (Dallas) released a statement essentiallycalling for: more care in the applications of DES, morelonger-term hard data focused on the possibility ofadverse events, and longer, more-targeted and consis-tent use of drug therapies in follow-on care afterstenting.

Besides tending to put the onus on patients forfailing to comply with the prescribed drug regimenswith DES, the AHA noted a “second issue . . . lesswell-established at this time,” referring to the increas-ing number of concerns — both anecdotally fromphysicians and clinically from new studies — thatDES is associated with the risk of blood clotting andeven death.

In fact, these conservative conclusions — per-haps better described as tepid — were a foreshadow-ing of what came out of the meetings, the agencyindicating that it won’t do more than tweak the cur-rent guidelines for DES use. Both days were repletewith the pro and con views concerning broad DESuse, and that balance served to provide a foundationsupporting no large alterations in the agency’s con-cerns about DES or to support a broad roll-back oftheir use in U.S. hospitals.

Giving the panel an overview on behalf of the FDAwas Andrew Farb, a medical officer at the agency’sinterventional cardiology devices branch, focusing onthe BASKET-LATE study, which pointed to significantpatient non-compliance in using anti-platelet therapyand that these patients had higher rates of late majorcardiac events between seven and 18 months than thoseon bare-metal stents (BMS). These differences were notstatistically significant in the DES/BMS comparison,and he presented other data similarly equivocal. Farbconcluded that “the data available to FDA indicate thatthe currently approved drug eluting stents, whenimplanted in accordance with their labeled intendeduse, are associated with reduced repeat procedures totreat restenosis compared to bare-metal stents and arealso associated with a small but significant increase inlate stent thrombosis.”

But what of the longer term?He noted also, however, the lack of data beyond



three years. And Herman Gold, a professor of med-icine and an interventional cardiologist at Massa-chusetts General Hospital (Boston) said that“although earlier pivotal studies indicate that thesestents are safe, with longer follow-up, it has becomeclear that late stent thrombosis may impose signifi-cant risk for some patients.” Gold said that “healingis not uniform within a DES and strut coverage isnot uniform, either.” The coating toward the middleof the stent is more subject to depletion, and he saida 37% exposure of the stent is associated with anincrease in the risk of latent stent thrombosis (LST)of 11%. However, the most powerful predictor ofthrombosis, Gold said, is lack of endothelial cover-age on the inner lining of the blood vessel, whichDES suppress inadvertently while suppressingsmooth muscle proliferation.

One of the questions theagency tasked the panel toinvestigate was whether DESare associated with a dis-cernible increase in the rate ofLST compared to BMS.

Christopher White, MD,of the Ochsner Clinic (NewOrleans), said that he wasuncertain about whether the rate of thrombosis waselevated. “I’m worried, but not certain” about throm-bosis, but “I think death and MRI are not” conspicu-ous among the DES group, he said.

An ‘emotional issue’Norman Kato, MD, of the Cardiac Care Medical

Group (Encino, California), said that the evidence ofincreased thrombosis associated with DES had creat-ed “an emotional issue” and that the data seemed tobounce between a 1% and a one-half percent frequen-cy producing an emotion “yes,” but an “evidence-based no.”

The meeting’s second day produced a bit morecontroversy since there was considerable focus onthe large percentage of DES off-label use, withthose uses offering a large number of uncontrolledvariables not easily measured, including uses inpatients with more complex disease and more co-morbidities.

Addressing the wealth of contradictory dataand its interpretation, William Maisel, MD, chair-man of the panel and a staff member at Beth IsraelDeaconess Hospital (Boston), noted “significantuncertainties” and as a result said he found it “dif-ficult to make conclusive judgments regarding thisissue.But the panel appeared to find considerablecomfort in recommending that DES-implantedpatients stay on dual antiplatelet therapy for atleast a year, and suggested that stent labels informdoctors that high-risk patients do not seem to ben-

efit as much as patients who are covered by thecleared indications.More warnings, or no change in practice?

Steve Nissen, MD, of the Cleveland Clinic(Cleveland, Ohio), said, “I want to warn people a lit-tle more than we do now” about DES risks. On theother hand, Dr. White of the Ochsner Clinic, said hehad not “heard anything today that will change mypractice.”

Ralph Brindis, MD, interventional cardiologistwith Northern California Kaiser Permanente (SanFrancisco), said that his organization as a whole is“impressed with the marked reduction in clinicalrestenosis and improvement in quality of life” seenin patients who picked DES over bare-metal stents(BMS). Kaiser data for more than 4,200 patients

over three years, ending Oct.31, 2006, showed that morethan 95% of those whounderwent angioplastychose to have a stentinstalled, and in that group95% opted for DES.

Sanjay Kaul, director ofthe vascular physiology andthrombosis research lab at

Cedars Sinai Medical Center (Los Angeles), said thatDES devices offer “a quantum leap in interventionalcardiology,” but that they predispose patients tothrombosis. And he posed one of the key questions:Do the clinical trials reflect real-world practice indefining occurrence of restenosis?

He also asked what the duration of risk might befor various outcomes and insisted that the FDA’sleast-burdensome pathway would be improved byinsisting on trials that are larger, of longer durationand more inclusive of “real-world” populations.“Reducing restenosis is desirable if we have ways tomitigate the risk of stent thrombosis,” Kaul said, but“the optimal duration” of dual antiplatelet therapy isunknown, the data less than certain due to an infor-mation gap regarding compliance.

“With regard to the approval recommendations .. . we need larger and longer pre-approval random-ized clinical trials” and a broader cross-section ofpatients and trial designs that emphasize clinical out-comes over statistical measures, “ he said. “I think wewill all agree that the [resulting] approval process islikely to benefit from” a more stringent standard ofproof “than the current standard of least burdensomepathway.”He commended the FDA for “taking theinitiative” on setting up surveillance registries andinsisted that “the crux of the debate here is the over-utilization of revascularization,” adding that the DESvs. BMS debate can’t be adequately argued until the“the root cause” for the reported adverse events isfound.



The panel suggested that stent labelsinform doctors that high-risk patients donot seem to benefit as much as patients

who are covered by the clearedindications.

Americans too oftenon losing side of risk/benefit ratioBy DON LONGBB&T Managing Editor

American patients. American guinea pigs?No, not pleasant to think of oneself as a laborato-

ry animal, but that is pretty much what the Americanpatient is these days while continually told that med-ical technology is a game of high-stakes dice, butmedia-driven to the belief that he or she will mostalways end up on the “benefit” side of the risk/bene-

fit ratio.An American as

healthcare guinea pig iscounter-intuitive, ofcourse.

It is usually thoughtthat Europe and European patients bear the majorbrunt of U.S. med-tech experimentation since the CEmark is the primary staging area for new technolo-gies. But at least in Europe the adverse events of badproducts may become obvious early, so that the dam-age to patients from bad technologies, or bad uses ofthem, can be somewhat lim-ited.

In contrast, the damagedone by approved but high-ly equivocal technologiesmight be much more wide-spread, subtle and continu-ous in America. The reasonsfor this, of course, areembedded in this country’s robust healthcare eco-nomics.

Most commentators on these economics haveformed a chorus which claims that the main reasonfor sharply rising U.S. healthcare costs is a prolifera-tion of new medical technologies. But the blanketblame put on med-tech is simply a flimsy shorthand,with the real reason being a complicated and inter-twined series of circumstances permeating the cultureof U.S. med-tech.

Any new technology, healthcare or otherwise,usually is more costly. And if a new med-tech systemcan be shown in enough studies to be effective (stud-ies often de facto-rigged in favor of effectiveness), itattracts dollars from two sources: from those willingto pay out of pocket and from insurers, private andpublic. Those dollars are divvied up by manufactur-ers and providers, and together manufacturers andproviders collude in a variety of ways to attract themost possible, by tending to favor the technologiesthat bring them the most dollars (always of course

adding to this dollar-heavy cake tasty claims for supe-rior outcomes for patients).

Providers thus line their pockets, and the best inthe med-tech manufacturing put hefty dollars backinto research to keep pushing the cycle (all of theseinterconnected factors working piston-like to drivethe engine of innovation and more technology).

This is well case-study-demonstrated by therecent curious case of the drug-eluting stent, curiousbecause DES problems appeared to have escaped thenotice of the FDA until four years post-approval.

The recent information concerning DES technolo-gy is clearly tending to indicate that DES is no betterthan its basic first-generation bare-metal stent pro-genitors, when looked at in large populations andlonger terms of follow-on evidence.

Even more broadly, there seems to be a buildingtide of evidence suggesting that the angioplasty/stent-ing strategy isn’t all that superior to bypass surgery oreven well-directed drug therapy. In particular, angio-plasty/stenting has been revealed by new studies as notbeing particularly effective in the treatment of heartattack patients if not used rather quickly — the effectivewindow only about three weeks wide after the MI.

And the play-in of health insurance as a driver tothe more sophisticated DES over BMS is pretty clearas well. For instance, a study presented at the recent

American Heart Asso-ciation conferencedemonstrated rathercogently that the heartdisease patient on theramp for angioplas-ty/stenting is morelikely to get the DESdevice if he or she has

health insurance. The particular economics here aretwofold: the uninsured patient is less able to pay forthe DES and less likely to afford the necessary follow-on regimen of expensive anti-platelet therapy.

All of this is a fairly complex syllogism that leadsto the conclusion that a firm and rather powerfuldecider of therapeutic decision-making is, one, theability to pay, and, two, the ability to attract healthreimbursement.

Yes, medical technology has done wonderfulthings. This writer has experienced its benefits, asprobably have most readers of Biomedical Business &Technology. But many of us, or people we know, haveprobably experienced its down sides. And theumbrella fact is that the U.S., while having the best,most expensive healthcare technology in the worlddoes not have the best healthcare — or health. Anddespite all of the many, many benefits of med-tech,those benefits may be part of a system that puts toomany Americans too often on the risky side of therisk/benefit ratio.



Commentary

. . . the curious case of the drug-eluting stent,curious because DES problems appeared tohave escaped the notice of the FDA until four

years post-approval.

Rodman & Renshaw healthcare conference

Drug delivery lessdominated by onlypills and capsule By JEFFREY BERG, PhDBB&T Contributing Writer

NEW YORK — One of the most varied and inter-esting areas of medical technology is the recent prolif-eration of new device systems for the delivery ofdrugs, an area traditionally dominated by pills andcapsules. This variety is being augmented by the needto develop systems for the delivery of newly emerg-ing therapies such as biologics, stem cells and RNAi.

The range of these systems and strategies wasshowcased at the late-November Rodman & Renshawhealthcare conference, its 8th annual event. More than350 public and private companies were on hand totout their novel drug delivery technologies and drugdevelopment pipelines, including new developmentsin RNAi and stem cells. A distinguishing feature ofmany of the drugs being reviewed was their propri-etary delivery technologies, frequently presented asenhancing either product differentiation or improvedtherapeutic performance, or both.

Oral spray and inhalersSprays and inhalers have long been used for the

delivery of throat sprays, other over-the-counter med-ications and asthma drugs, and they are now beingmore frequently employed for more complex phar-maceuticals.

Pharma (Flemington, New Jersey) used the con-ference to report its recent FDA approval, via the505(b)(2) regulatory pathway, of NitroMist, a nitro-glycerine lingual aerosol for acute relief of an attackor acute prophylaxis of angina pectoris due to coro-nary artery disease. This is the company’s first prod-uct approval utilizing its oral spray technology. ParPharmaceutical (Newton, Massachusetts) haslicensed North American rights to NitroMist.

Other oral spray products in NovaDel Pharma’spipeline are Sumatriptan and Zolpiderm which targetpatients suffering from migraines and insomnia,respectively. The benefits of the oral spray system aremore rapid delivery of drugs to the bloodstreamresulting in a faster therapeutic effect, increasedbioavailability by avoiding metabolism by the liver,improved drug safety from a reduced dosage require-ment and obviating the need to swallow.

Generex Biotechnology (Toronto) uses its Rapid-Mist metered dose inhaler for oral delivery of its Ora-lyn insulin spray. The drug is absorbed through theinner walls of the check (buccal mucosa), thereby

entering directly into the bloodstream. The product issold only in Ecuador but is in various stages of clini-cal development throughout the world. GlucoseRapidSpray is used to treat minor symptoms of lowblood sugar and is sold in the U.S. and Canada. Met-formin medicinal chewing gum for treating Type IIdiabetes is in Phase II trials and spray formulations offentanyl and morphine for pain management are inPhase I trials.

Mannkind (Calencia, California) is enrollingpatients in three pivotal Phase III clinical trials in theU.S. and Europe for use of its inhaled dry powderinsulin Technospheres for the treatment of Type 1 andType 2 diabetes. A proprietary inhaler is used to deliv-er insulin deep into the lungs. Efficacy is being evalu-ated on the basis of changes in HbA1c levels and inblood glucose levels after a standardized mixed meal.An impassioned presentation was given by AlfredMann, the company’s CEO and chairman, who haspersonally invested $369 million in Mannkind.

Nastech Pharmaceutical (Bothell, Washington) isutilizing its proprietary technology for the intransaldelivery of compounds, ranging from small mole-cules to peptides, for treating a variety of disease con-ditions. It is in a Phase II trial of a morphine gluconatenasal spray for treating breakthrough pain, a Phase Itrial of a rapid-acting insulin nasal spray for diabetes,and a Phase II trial of Peptide YY for treating obesitythat was previously a collaborative program withMerck (Whitehouse Station, New Jersey). Nastechhas strategic alliances for several of its nasal deliveryprograms.

These include a Phase I trial using parathyroid hor-mone (PTH1-34) for osteoporosis with Procter & GamblePharmaceuticals (Cincinnati), a Phase I trial using exe-natide for Type 2 diabetes with Amylin (San Diego), anda calcitonin-salmon nasal spray for osteoporosis with ParPharmaceuticals that received a non-approvable letterfrom the FDA.

Nastech also is a new entrant in the emergingclass of therapeutics utilizing RNAi technology. TheRNAi mechanism provides researchers with the abili-ty to specifically silence the expression of individualgenes and prevent protein synthesis. Nastach recent-ly has licensed intellectual property rights from Cityof Hope (Duarte, California) for Dicer-Substrate RNAinterference technology. This effort is pursuing thehope of developing small interfering (si)RNAs thatcould have improved pharmacological propertiesimportant for drug development and delivery whencompared to conventional, first generation RNAitechnology.

The field of RNA interference received a majorboost with the announcement by Merck at the end ofOctober of its $1.1 billion acquisition of Sirna Thera-peutics (San Francisco), a leading company in this rap-idly growing area of research and drug development.



Anlylam Pharmaceuticals (Cambridge, Massa-chusetts) also has corporate alliances for RNAi thera-peutics with Merck, Novartis (Basel, Switzerland),Medtronic (Minneapolis) and Biogen Idec (Cam-bridge, Massachusetts), and CytRx (Los Angeles) ispursuing RNAi programs for treating obesity, Type 2diabetes, ALS and CMV which are based on a licenseand research ongoing at the University of Massachu-setts Medical School (Amherst) and Advanced Bio-Science Laboratories (Kensington, Maryland).

Electroporation and iontophoresisInovio Biomedical (San Diego) utilizes electropo-

ration technology for drug and gene delivery by local-ly applying electrical pulses to create permeability incell membranes. It has developed devices consisting ofpulse generators and needle electrode applicators thatare used together with a drug or a gene. Preclinicalstudies have shown that the company’s electropora-tion technology enhances the cellular uptake of DNAplasmids, increases expression 100-fold compared tonaked DNA, and generates immune responses withprophylactic or therapeutic benefits. Thus, it providesan alternative to viral and other gene delivery vectors.The company recently reported that Wyeth (Madison,New Jersey) will use Inovio’s delivery technologywith its DNA vaccines in development.

Transport Pharmaceuticals (Framingham, Mass-achusetts) is developing iontophoretic systems forenhancing the delivery of topically applied drugs. Itslead product, SoloVir, is for the treatment of herpeslabialis (cold sores). Positive results from a Phase IIbclinical trial were published in August 2006 in ClinicalInfectious Diseases. The device is reusable and consistsof a microprocessor-driven control unit and a unit-dose drug cartridge that contains a proprietary for-mulation of acyclovir. The therapy entails a singletreatment with the device (about the size of a nickel)held pressed against the cold sore for about 10 min-utes. Another product under development is an ion-tophoretic patch that releases terbinafine for the treat-ment of onychomycosis (nail fungus).

The FDA has approved two single-use ion-tophoretic products. One is the LidoSite patch devel-oped by Vyteris Holdings (Fair Lawn, New Jersey)that employs its Actyve transdermal drug deliverytechnology and is being sold by B. Braun Medical(Bethlehem, Pennsylvania), a subsidiary of B. Braun(Melsungen, Germany). The second is the Ionysisfentanyl delivery patch for treating acute postopera-tive pain on adult patients that utilizes the E-Transelectrotransport technology from ALZA (MountainView, California), a Johnson & Johnson (J&J; NewBrunswick, New Jersey) subsidiary. This product iscurrently in production scaleup for launch in 2007. Itwill be sold in the U.S. by Ortho-McNeil and inEurope by Janssen-Cilag, both J&J subsidiaries.

Microspheres for IV and catheter deliveryAcusphere (Watertown, Massachusetts) uses

porous microsphere technology for improved formu-lations of existing drugs. Its microparticles have con-trolled aerodynamic properties for quick or slow pul-monary delivery. Its lead product, Imagify, is in aPhase III trial. It employs gas-filled microparticles forintravenous delivery that act as tracers of blood flowfor improved ultrasound imaging used to detect coro-nary artery disease. Its technology can converthydrophobic drugs into tiny sponge-like micros-pheres for rapid dissolution. Acusphere has complet-ed a Phase I study with a currently marketed drugreformulated with its technology and has demon-strated sustained drug release in the lungs.

BioSphere Medical (Rockland, Massachusetts)markets an embolotherapy system for treating uterinefibroids. Uterine artery embolization (UAE) is animage-guided, minimally invasive procedure thatentails an injection through a small catheter ofEmbosphere microspheres that occlude arteries feed-ing the vascularized uterine fibroids. Symptomaticfibroids afflict 5 million women in the U.S. UAE isgaining acceptance as a fibroid treatment within theU.S. medical community.

BioSphere is using microspheres in combinationwith Avastin to treat liver cancer patients in a Phase IItrial underway at Johns Hopkins University Schoolof Medicine (Baltimore, Maryland). The companyhas just received notification from the FDA of 510(k)clearance of QuadraSphere microspheres for treatinguterine fibroids, hypervascularized tumors and vas-cular malformations. This product is sold in Europe.Biocompatibles (Farnham, UK) is also conductingPhase I/II chemoembolization trials at hospitals inBarcelona, Spain and Hong Kong on liver cancer(hepatocellular carcinoma) patients. It uses doxoru-bicin-loaded microspheres.

Drug/polymer combinationsColumbia Laboratories (Livingston, New Jersey)

markets products that utilize its patented bioadhe-sive system which consists of a mucoadhesive poly-mer, polycarbophil, and an active ingredient.Prochieve 4% progesterone gel is used for the treat-ment of secondary amenorrhea and Prochieve 8% forthe treatment of infertile women with progesteronedeficiency. A pivotal Phase III trial is being conduct-ed for use of Prochieve 8% to prevent preterm birth.This product would compete against Gestiva fromAdeza Biomedical (Sunnyvale, California), a long-acting synthetic progestin used to prevent recurrentpreterm birth which recently received an approvableletter from the FDA contingent on completion of anadditional animal study.

Columbia Laboratories also markets Striant, atestosterone buccal delivery system for the treat-



ment of male hypogonadism which it licensed forsale in Europe to Ardana (Edinburgh, UK) andMipharm (Milan, Italy). In a competing develop-ment, BioSante Pharmaceuticals (Lincolnshire, Illi-nois) is in clinical trials with a transdermal testos-terone gel for male hypogonadism. Columbia Labo-ratories has recently reported that it has initiated a42-patient clinical study of vaginally administeredlidocaine for use in preventing and treating dys-menorrhea.

Access Pharmaceuticals (Dallas) is using its poly-mer-drug delivery technology for the enhanced deliv-ery of chemotherapeutic agents to tumors. The com-pany’s lead product, ProLindac, is a polymer prodrugof oxaliplatin, currently in a Phase II clinical trial. Thecompany has a preclinical research program thatcombines its polymer expertise and vitamin-targetingtechnologies to enhance the tumor delivery of othercancer drugs. Its polymer know-how is also beingused in MuGard, an oral rinse that was developed fortreating oral mucositis. It forms an adhesive protec-tive film in the oral cavity but does not contain a bio-logically active agent.

The company recently submitted a 510(k) appli-cation to the FDA for MuGard. Access has R&D col-laborations with UCB-Celltech (Slough, UK) andHunter-Fleming (Bristol, UK) and with a U.S. compa-ny, undisclosed, for the development of oral drugdelivery formulations utilizing its vitamin B12 medi-ated oral drug delivery technology.

Oral controlled release of solid dosages Depomed (Menlo Park, California) uses its Acu-

Form drug delivery technology to develop noveloral products and extended-release formulation ofexisting oral drugs. This technology allows for pro-longed gastric retention and is designed for drugsthat are preferentially absorbed in the upper portionof the gastrointestinal tract. It is used in two prod-ucts marketed in the U.S. and Canada. ProQuin XRis a once-daily tablet of ciprofloxacin used for thetreatment of uncomplicated urinary tract infection.It is licensed for sale in the U.S. to Esprit Pharma(East Brunswick, New Jersey) and in Europe toMadaus (Cologne, Germany). Glumetza is extendedrelease metformin used for the treatment of adultType 2 diabetes. Gabapentin is in a Phase III trial forthe treatment of postherpetic neuralgia. It islicensed for co-promotion in the U.S. to King Phar-maceuticals (Bristol Tennnessee) and in Canada toBiovail (Mississauga, Canada).

Elite Pharmaceuticals (Northvale, New Jersey) isdeveloping oral controlled-release versions of genericdrugs with high barriers to entry. Its lead product,ELI-216, is a once-daily oxycodone that has complet-ed a Phase I bioavailability study and is formulated todiscourage illegal diversion and abuse of the drug.

This is accomplished by combining an opiod antago-nist with an agonist in such a way that when admin-istered as an intact product, only the agonist will beabsorbed in a sustained manner. When the product isphysically damaged with the intent of abusing it, theantagonist is also released and thereby antagonizesthe effect of the agonist.

Elite has a pipeline of six products under devel-opment in the therapeutic areas of cardiovascular,pain, allergy and infection. It has partnered with ECRPharmaceuticals (Richmond, Virginia) for the sale ofits allergy medications, Lodrane 24, a once-daily doseof an antihistamine formulation, and Lodrane 24Dwhich also contains a decongestant.

Light-activated and topical deliveryDUSA Pharmaceuticals (Toronto) markets Levu-

lan which uses photodynamic therapy for the treat-ment of pre-cancerous actinic keratoses. It also isbeing developed for the treatment of acne and photo-damaged skin. Additional marketed products thatcame with its acquisition in March 2006 of Sirius Lab-oratories (Vernon Hills, Illinois) are Nicomide, a vita-min-based oral supplement for treating acne, Nico-mide-T, a vitamin -based topical cream or gel for acne,and Avar a drug for rosacea.

Antares Pharma (Ewing, New Jersey) has a vari-ety of drug delivery platforms. These include itsAdvanced Transdermal Delivery (ATD) system andthe related TecTix system for topical and transmucos-al delivery, Easy Tec oral fast-melt technology, andMedi-Jector needle-free injection devices. Medi-JectorVision is currently marketed for delivering insulinand growth hormone.

The company has a development and licensingagreement with Eli Lilly (Indianapolis) for use of itsMedi-Jector Valeo device for delivery of drugs totreat diabetes and obesity. It also recently reportedan agreement with Teva Pharmaceutical Industries(Petach Tikvah, Israel) to provide its needle-freeinjection system for use with an unnamed product inthe U.S. and also has signed two other commercialdevelopment agreements with Teva for its dispos-able mini-needle injector.

Antares Pharma has completed a Phase II trial ofoxybutynin gel for treating an overactive bladder. Ithas licensed its ATD technology to BioSante Phar-maceuticals (Lincolnshire, Illinois) for use in its Bio-E-Gel transdermal estradiol gel for treating hot flash-es in menopausal women. Market clearance from theFDA is expected shortly. BioSante has just disclosedan exclusive license for Bio-E-Gel to Bradley Phar-maceuticals (Fairfield, New Jersey). BioSante usesthe ATD technology in its Libi-Gel low-dose testos-terone gel that has completed a Phase II trial for treat-ing female sexual dysfunction. The Intrinsa patchfrom Procter & Gamble Pharmaceuticals (Cincin-



nati, Ohio) also uses testosterone for this indicationand recently received marketing approval for thisproduct in Europe.

Injectable therapeutic, aesthetic materialsAnika Therapeutics (Woburn, Massachusetts)

has developed products based on hyaluronic acidaned licensed out. OrthoVisc a synovial fluidreplacement for the treatment of joint pain fromosteoarthritis, is sold in the U.S. by DePuy Mitek(Raynham, Massachusetts), a subsidiary of J&J, andAmvisc, a viscoelastic gel used in cataract surgery, issold worldwide by Bausch & Lomb (Rochester,New York).

In July of last year, Anika signed a worldwidemarketing and distribution agreement with Galder-ma Pharma (Fort Worth, Texas) for its cosmetic tissueaugmentation (dermal filler) product with expecta-tions of launching the product in mid-2007. It willcompete with other hyaluronic acid-based dermalfillers currently marketed by Medicis Pharmaceuti-cals (Scottsdale, Arizona) and Allergan Medical(Irvine, California).

Reviewing newestin-office strategies for fibroid treatmentBy Diana TuckerBB&T Contributing Writer

LAS VEGAS — More than 1,500 of the 3,200members of the American Association of Gyneco-logic Laparoscopists (AAGL; Cypress, California)attended the Global Congress of Minimally Inva-

sive Gynecology meeting herein November. Topics of inter-est spanned several areas thatwere once newly emergingtechnologies. For the most partthese technologies were pre-sented first at this conferenceonly a few years ago but nowhave gained traction in com-

munity-based practices. This is especially true forprocedures — such as treatment for fibroids andintrafallopian tubal occlusion for permanent sterili-zation — that were once performed in the hospitalbut can now be performed in an office setting.

In a postgraduate course Daniel Breitkopf, MD, ofthe University of Texas Medical Branch (Galveston,Texas) presented “An Overview of HysteroscopicTubal Occlusion Techniques — What is AvailableNow and What is Coming in the Future.” He beganwith a reminder of the brief failed histories of hys-teroscopic, as opposed to laparoscopic, tubal occlu-sion technologies, which began in 1934 with electro-coagulation of the tubes, followed by IUD insertion ofquinacrine pellets in 1970, and then silicone plugs in1983. Finally, in 2002, the Conceptus Essure devicewas cleared by the FDA.

By show of hands, about 40% of those attendingthe course indicated they had placed at least oneEssure device. The Essure device consists of two niti-nol micro-inserts containing a Dacron implant thatpromotes tissue ingrowth and is placed using a pro-prietary transcervical insertion instrument.

“The success of all intrafallopian tubal occlusiondevices is in the tissue ingrowth following placementof the device, not in the occlusion of the insert itself.It is the tissue in-growth that blocks the tubes,” Bre-itkopf said. He said that “the current Essure successrate of bilateral placement is 98%, the procedure takeson average 36 minutes total, 13 minutes for the place-ment itself, and boasts a 99.95% effectiveness rate. Theprocedure can be done in an office setting without IVsedation and is often cost-favorable to a laparoscopictubal ligation.

But he then asked: “Why, then, aren’t morepatients electing an intrafallopian tubal occlusion



BB&Tat

AAGL2006

Miocroneedles offeringminimally invasive tool

A new report, "Microneedles in Medicine:Technology, Markets, and Prospects," from con-sulting firm Greystone Associates (Amherst, NewHampshire), says that advances in materials pro-cessing are creating new devices and new oppor-tunities for minimally invasive medicine.

These advances have led to the developmentand introduction of devices that employ verysmall needles — microneedles — to deliver drugsor sample analyte by mechanically perforating theouter skin layer. The processing techniques incor-porate one or more technologies that enable theprecise machining, extrusion, casting, and/orforming of from one to an array or grid ofmicroneedles.

Evolving microneedle systems will be well-positioned to address a significant segment of thelarge-molecule biological drugs expected toemerge from the convergence of automated dis-covery and genome mapping. Microneedles willalso be a factor in continuous and remote patientmonitors and point-of-care diagnostics, accordingto the report

But before microneedles find widespread use,researchers must perfect the techniques for opti-mally inserting them into the skin, and completethe integration of microneedles into full diagnos-tic, monitoring or drug delivery systems.

over a laparoscopic tubal ligation?” He said one reason often given is that patients are

not willing to undergo the hysterosalpingogram(HSG) procedure that is required as a follow-up forthe Essure placement. As a way to remove that bias,Breitkopf referred to a survey performed in Britainwhere no follow-up HSG is required and where eligi-ble patients were given a choice between the two pro-cedures. Slightly more than 75% of the patients chosea laparoscopic tubal ligation.

Patient reasons for the choice of permanent steril-ization include the desire of immediate results, therapidity of the procedure, the lack of scars, quickerrecovery and the desire not to have something left inthe body.

Breitkopf then discussed the other intrafallopiandevices currently being developed, listed in Table 3.

With the market adoption of the Essure systemnow robust and annual revenues running at about$40 million, it appears that any major player in thegynecology space now needs to incorporate a tran-scervical sterilization product. Other than the womenhaving their last child and selecting same-time per-manent sterilization immediately following birth,many women are predicted to select an in-office per-manent sterilization procedure now that reimburse-

ment is in place, rather than a laparoscopic tubal liga-tion that entails hospitalization.

Dealing with fibroidsLess-invasive techniques for the removal of

fibroids — especially if they are designed to maintainthe woman’s fertility — continue to storm the mar-ketplace. The removal of fibroids, termed a myomec-tomy, can be a technically challenging surgical proce-dure. And because many of the patients presentingwith fibroids wish to maintain their fertility, itbecomes even more challenging to avoid adhesions orcompromise the uterus in any way. Table 4 outlinesthe many novel approaches discussed or exhibited atthe conference that provide for less invasive or non-invasive technologies to ablate fibroid tumor. Most ofthese also enable treating the patient in a less intensesetting than an operating room.

Robotic surgery by Intuitive Surgical (Santa Bar-bara, California) and MRI-Guided High FrequencyUltrasound (HIFU) from Insightec (Dallas) pepperedthe podium and poster presentations, as well asengaging a significant share of exhibit action.Insightec has developed and marketed an MRI-guid-ed HIFU system FDA-cleared for non-invasive abla-tion of fibroids. And the company was offering clini-



Table 3Intrafallopian Tubal Occlusion Devices in Development

(Listed in order of estimated next to market)

Name of Company Type of Technology CommentsAdiana/Boston Scientific RF energy applied Thermal lesion stimulates tissue

with silicone implant left behind ingrowth97% success placement

Ovion/American Off same patent as Conceptus Titanium mesh implant with Medical Systems tissue growth matrix

No trailing insert in uterusCan be used with flexible hysteroscopeSmaller than Essure In Phase II clinicals

Quinecrine pellets Malaria drug pellets inserted into In Phase III clinical trialsuterus using IUD inserter Tubal scarring from drug

No hysteroscope requiredHistory of toxicity in past

ZRO-Operculum Titanium insert remains on Removableuterus side of junction Early clinicals

Can use flexible or rigid scope for deliveryPossible reversal

Novomedicus/ Regulated thermal coagulation Early clinicalsUniversity of Texas Tubal closure in 2 weeksInvectus Flexible catheter used to Early clinicals

glue and ligate tubes Possible reversal

Source: Breitkopf, MD and BB&T Industry sources

cians the opportunity to witness live HIFU proce-dures for fibroid ablation at the local office that hadjust recently purchased the 36th system sold.

C.J. Ascher-Walsh, MD, of the Sinai School ofMedicine (New York), presented “Robot-AssistedLaparoscopic Myomectomy Represents anImprovement Over Standard Laparotomy forPatients with a Limited Number of Fibroids” inwhich she compared the effects of the robotic sur-gery versus standard laparoscopic surgery on pro-cedure time, length of stay, transfusions, charges,reimbursement, nursing, pharmacy, depreciation ofthe robot, and other pertinent factors. She foundthat “when everything was considered [formyomectomies] the robot became cost-effective andoffered an improvement to the care of women witha small number of myomas.”

Bryan D. Cowan, MD, professor and chair ofthe Department of OB/Gyn, Univer-sity of Mississippi (Jackson), pre-sented two clinical studies that hehad performed using a new cryoabla-tion device from Galil (Yokneam,Israel) for cryomyolysis, or freezingof the fibroids, with the intent toshrink them. In his series of 12patients in each study — one grouptreated using MRI guidance, theother a laparoscopic cryoprobe — heshowed a 50% reduction in fibroidvolume at three months and 87%reduction in fibroid volume at sixmonths, with 10 of the 12 patientshaving symptom improvement. Heacknowledged the higher cost of the

MRI but added that with laparoscopic or evenultrasound guidance he “anticipated a less-expen-sive price than many of the other emerging tech-nologies for fibroid removal or ablation.”

George Vilos, MD, professor of obstetrics andgynecology, The University of Western Ontario(London), presented “Transvaginal Doppler-Guid-ed Temporary Uterine Artery Occlusion for theTreatment of Symptomatic Fibroids” in which hestudied the feasibility, safety and efficacy of the Flo-stat system, now owned by Gynecare/Ethicon(New Brunswick, New Jersey). He studied 30women who had their uterine arteries clamped forsix to nine hours and found significant reduction inmenorrhagia and a reduction in uterine and fibroidvolume at six months. He concluded that “tempo-rary uterine artery occlusion provides the gynecol-ogist with an alternative to uterine artery emboliza-



Table 4Less Invasive Technologies for Fibroid Tumor Ablation

Technology Company FDA Status CommentsMRI Guided Insightec FDA cleared Non-invasive;

Performed in MRI suite;High Intensity/Focused Ultrasound

Robotic Assisted Intuitive Surgical FDA cleared Least invasive surgical method;Myomectomy Studies show less blood loss,

quicker recovery, less adhesions than other surgical techniques

Uterine Artery Boston Scientific FDA cleared Performed by interventional radiologistBiosphere in radiology suiteEmbolization Uterine Artery Vascular Control In clinical trials Transcervical;Temporary Systems/Gynecare Doppler guided outpatient procedureOcclusionCryomyolysis Galil In developmentLaparoscopic Gynasonics In development ApproachRF ablation

Table 5Average Use of Time for Typical Gynecologist in One Afternoon

Office HospitalNumber of Patients Seen 13 3Hysteroscopies Performed 2 2Endometrial Ablations 1 1Charts Updated 13 3Travel & Change Time 0 1 hourReimbursement $3000 $1000Hourly Rate $750 $250

Copyright 2006 Microsulis Americas, Inc.



tion. The system is simple and easy to apply withthe efficacy equivalent to UAE”

Although many of the emerging fibroid treatmentsare not yet out of the operating suite at this time, themovement is to a less-intense setting and some willeventually make it into an office based setting.

The No. 1 reason cited by gynecologists for theirdesire to move a procedure into an office setting wasthat the number of procedures accepted by patientsincreased significantly when the procedure could be

performed in an office setting rather than a hospital.The second reason for wanting to move a procedureinto the office was to generate greater revenue and max-imize efficiency.

Microsulis Americas (Waltham, Massachusetts),manufacturer of a microwave endometrial ablationsystem designed for office use, studied office prac-tices in the U.S. and found that the clinician couldmake better use of his time by performing proceduresin the office, as shown in Table 5.

Preserving fertilitywhile attacking

problem of fibroidsA BB&T staff report

Although fibroids — benign tumors that grow inthe uterus — can cause pelvic pain, abnormal vagi-nal bleeding and infertility, women of childbearingage frequently decide against treatment because theavailable procedure choices don’t guarantee contin-ued fertility.

In a study in the December issue of The FemalePatient, physicians at Thomas Jefferson UniversityHospital (Philadelphia) present the case history of a35-year-old woman whose numerous fibroidsformed a large mass in her pelvic area that was com-parable to a full-term pregnancy in size.

“Traditionally, treatment for such a largefibroid mass in the uterus has been limited tohysterectomy, because the patient would bleedextensively if an attempt was made to merelyremove the fibroids,” said Jay Goldberg, MD,lead author and director of the Jefferson FibroidCenter at Thomas Jefferson University. He saidthat in this case hysterectomy was not an option

“because the patient strongly desired future fer-tility and uterine preservation.”

To meet her wishes and remove the fibroids,the physicians performed two procedures amonth apart, the first a uterine fibroid emboliza-tion (UFE), a minimally invasive radiologic proce-dure that blocks the arteries that supply blood tothe fibroid tumors. This type of procedure reducesblood flow within the patient’s uterus and the riskof hemorrhaging at the time of surgery. Then, amonth later, the patient underwent an abdominalmyomectomy in which fibroids are removedthrough an abdominal skin incision.

After the UFE, her 38-week sized uterus haddecreased to a 34-week size, with decreased blood flow.The myomectomy procedure was successful in remov-ing removed 11 large fibroids with minimal blood loss.

The patient was discharged from the hospitalafter two days with no complications.

Goldberg, who is also director, Division ofGeneral Obstetrics at Thomas Jefferson University,and his colleagues recommend the combination ofprocedures for women who want to preserve theiruterus. They write: “We are noting a trend towardmore women requesting uterine-preserving treat-ment for fibroids — even with massively enlargeduteri, and even when future fertility may not be aconsideration.

BioWorld Report Looks At Biotechnology Executive Pay The editors of BioWorld Today, sister publication to Biomedical Business & Technology, have recently

completed the new BioWorld Executive Compensation Report, updated for 2007 and providing an in-depthlook at executive compensation by providing details on individual salary packages, as well as analysisand interpretation on compensation trends.

Using data from Salary.com's CompAnalyst, BioWorld's team examined the compensation records of269 biotech firms.

"Executives, investors, analysts, HR committees, recruiters and boards of directors will be especiallyinterested in these findings," said Managing Editor Brady Huggett. "The details on salaries, bonuses andstock-option packages for individual executives in the biotechnology industry provide a necessaryresource."

What’s holding backreal focus on safety?By Diana Tucker BB&T Contributing Writer

CHICAGO — Organizations can set goals, butwhat then? What if the goals are not to be reached bythe organization itself but by the audience the organ-ization addresses?

That is the constant dilemma of the Joint Com-mission on Accreditation of Health Care Organiza-tions (JCAHO; Oakbrook Terrace, Illinois), an organi-zation whose primary job is goal-setting for hospitals

and trying to encourage hospi-tals to do what they are sup-posed to do best: heal rather thanharm.

The organization most re-cently rolled out a set of fourgoals and requirements, in draftform, targeting patient safety.

They are:• To improve recognition

and response to changes in apatient’s condition;

• To reduce the risk of post-operative complica-tions for patients with obstructive sleep apnea;

• to prevent patient harm associated with health-care worker fatigue;

• and to prevent catheter misconnections.The organization has set Jan. 26 as the deadline

for receiving comment on the goals. But the JCAHO’s president, Dennis O’Leary, MD,

at the organization’s 20th annual national conference



on Patient Safety, in mid-November appeared toacknowledge that there are a whole host of humanelements that block hospitals for being truly safe, nomatter what persuasion is used by the JCAHO.

Using the results of the organization’s 2005 annu-al survey, O’Leary highlighted key items focused onpatient safety and asked: “What’s holding us backfrom improving on patient safety?”

Leary clarified the difference between patientquality and safety, saying, “safety operates on a riskreduction activity such as ‘Do this and you will havefewer problems’ while quality measures errors ofomission — things you should have done but didn’t.”The goal of patient safety is to prevent human errorfrom reaching the patient with a system for measur-ing this.

“One key barrier towards improved patient safe-ty is the absence of a national leadereship platform,”he said. “That is, there is no government leadershiprole to help make the goal of improved patient safetyhappen.” He added: “Currently, the system paysequally for good or bad patient care, and what thegovernment wants, which in itself underminespatient safety. . . . [I]f the government want sto accom-plish a standardized care, it needs to create a budgetand a leaer in order to achieve the goals they desire,such as performance measurements, quality improve-ment and sharing of information.

Leary concluded that given the extent and diffi-culty of these issues there are key factors for successthat individual hospitals should embrace for the bestin patient safety. Among these: an organizational cul-ture of safety and quality, systems for measuring ual-ity and safety, use of root cause analysis; engaging thepatient in reporting problems and problem solving,and apologizing sincerly for mistakes.

JCAHO in authority to accredit DMEPOS

The Centers for Medicare & Medicaid Servicesin late November granted the Joint Commission onAccreditation of Healthcare Organizations(JCAHO) authority to accredit durable medicalequipment, prosthetics, orthotics and supplies(DMEPOS). The designation means that DMEPOSsuppliers accredited by the JCAHO meet Medicarerequirements which include the recently publishedQuality Standards.

Maryanne Popovich, RN, executive director,Home Care Accreditation Program, JCAHO, saidthat its accreditation process “sharpens the focus oncontinuous improvement of a supplier’s opera-tional systems to provide safe, quality services and

prevent errors. The JCAHO’s longstanding experience in pro-

viding quality oversight is essential to DMEPOSproviders in meeting the healthcare needs of Ameri-ca’s citizens and, specifically, Medicare beneficiariesof durable medical equipment, orthotics, prostheticsand other supplies.”

JCAHO accredits nearly 3,500 organizationsunder its Home Care Program, which includesaround 1,400 home medical equipment suppliers.

The primary Home Medical Equipment servicesaccredited are:

• DME, hospital beds, wheelchairs, lift chairs • Oxygen delivery systems, CPAP, Bi-PAP, venti-

lators • Diabetic supplies • Ambulatory aids, canes, crutches, walkers • Orthotics and prosthetics

BB&Tat

JCAHOannualmeeting



International report

Series A $9.6 millionfinancings for CMIorthopedics spin-out

OrthoMimetics (OM; Cambridge, UK), the firsttechnology spin-out from the Cambridge-MIT Insti-tute (CMI), last month reported completing a Series Afunding round totaling $9.6 million (£5 million) net ofcosts last month.

Led by Andrew Lynn, founder and CEO, a teamof surgeons, scientists and engineers from the Uni-versity of Cambridge (Cambridge, England) and theMassachusetts Institute of Technology (Cambridge,Massachusetts) helped OM bring to market a medicaldevice technology that it says has the potential toreduce the need for joint-replacement surgery.

“Closure of this funding round providesOrthoMimetics with a sound financial basis to moveforward swiftly with its development program tobring the first of its products through clinical trials toCE-mark approval,” said Lynn.

The company said that completion of the fundinground would enable it to advance the first two prod-ucts derived from its orthobiologics scaffold platformtowards market approval. ChondroMimetic, the com-pany’s flagship product for cartilage repair, and Lig-aMimetic, OM’s pipeline product for ligament repair,address a combined yearly global market in excess of$1 billion, OrthoMimetics said.

Durect, Nycomed sign deal for PosidurDurect (Cupertino, California) has signed a col-

laboration agreement with Nycomed (Roskilde, Den-mark), a pharmaceutical company, to jointly developDurect’s Posidur post-operative pain relief depot.

Posidur is a long-acting local anesthetic underdevelopment for the treatment of post-surgical pain.It is meant to be injected during surgery to continu-ously release therapeutic levels of bupivacaine in acontrolled fashion, providing up to 72 hours of unin-terrupted local analgesia.

Durect’s Saber delivery system is an injectable,biodegradable drug-delivery technology that allowsfor less post-injection burst than is typical of polymer-based systems. Posidur is in Phase II clinical develop-ment and is expected to move into Phase III this year.

Nycomed will pay Durect an up-front license feeof $14 million, with additional payments of up to $188million upon achievement of certain milestones.

Nycomed will have exclusive commercializationrights in Europe and other select countries, andDurect will retain full ownership of Posidur in theU.S., Canada, Asia and other countries.

“We believe that Posidur has the potential to playa major role in addressing post-surgical pain,” saidHakan Bjorklund, CEO of Nycomed. “The strategy ofemploying local post-surgical pain management toreduce the need for systemic pain relief is consistentwith current trends to reduce the use of narcotics andassociated side effects, as well as hospital stays andassociated costs.”

The companies will jointly direct and equallyfund a development program for Posidur intended tosecure regulatory approval in the U.S. and the Euro-pean Union.

HPV DNA testing covered in FranceDigene (Gaithersburg, Maryland) reported that

as of December French insurer MAAF Sante(Niort)began paying for HPV DNA testing of allwomen in France age 30 to 65 who are most at risk ofdeveloping cervical cancer. The insurer also will fundHPV DNA testing for women of all ages whose Papresults are inconclusive or as a “test of cure” forwomen treated for cervical disease.

Digene said this marks the first time in Franceand the second time in Europe that reimbursementfor HPV testing for all uses — including routine, pri-mary screening to identify women at risk of cervicalcancer — is being offered by a major insurer.

The Digene HPV Test, which uses the company’sHybrid Capture II (hc2) technology, is the only clini-cally validated, FDA-approved and CE-marked testfor detecting the presence of high-risk types of thehuman papillomavirus (HPV), the cause of cervicalcancer, the company said.

“Only the combination of a negative (normal) Papand a negative HPV test can provide a full guaranteethat the risk of developing cervical cancer within thenext three years is equal to zero,” MAAF Sante said inreporting its new policy.

“This announcement in France — coming after aparallel decision by a major insurer in Germany earli-er [in 2006] — is an important milestone for cervicalcancer screening and prevention programs globallyand should trigger similar shifts in the standard ofcare elsewhere in France, Europe and around theworld,” said Rob Lilley, senior VP, global sales andmarketing at Digene.

The first HPV vaccine was approved recently bythe FDA for girls and young women age 9-26, butDigene said screening will continue to be important,since the vaccine protects against just two types of thevirus responsible for 70% of cervical cancers, and hasonly been shown to be effective in women not yetexposed to the targeted types of HPV.

CE mark for International Spine PDS System Interventional Spine (Irvine, California) report-

ed that its Percutaneous Dynamic Stabilization sys-

tem for early-age treatment of spinal disorders hasreceived CE mark approval.

The company said it believes the PDS system isthe only procedure available that can provide dynam-ic stabilization of the spine via a percutaneous accesspuncture. It said all other dynamic stabilization sys-tems and procedures require a major or minimallyinvasive surgical incision to provide pain relief topatients with degenerative spinal disc disease.

Dynamic stabilization is an alternative to medicalmanagement, corticosteroid injections and, whenindicated, invasive surgical fusion therapies, toroughly 500,000 patients worldwide who suffer fromdegenerative disc disease of the spine, according toInterventional Spine.

The procedure is intended to provide relief fromthe pain of degenerative disc disease while maintain-ing greater motion compared to patients of spinalfusion surgery.

In addition to providing the least-invasiveapproach to dynamic stabilization, the results fromthe company’s initial pilot clinical study indicate thatthe PDS system provides greater relief from pain forindividuals suffering from spinal disc disease thanany other dynamic stabilization product or proce-dure.

Interventional Spine said it intends to conduct aseries of extensive clinical trials and continue to provethe clinical value. Interventional Spine also has FDAclearance and CE-marking for its PLS system, whichallows the least-invasive method of providing fixa-tion of the vertebral structures following convention-al spinal fusion procedures. The PLS system canaccomplish fixation with one small percutaneous-access puncture.

Interventional Spine’s products for the treatmentof degenerative spinal disc disease as well as a rangeof orthopedic applications, are based upon its Claspand Teleport Access technologies.

Misonix in device distribution pact in ChinaMisonix (Farmingdale, New York), a developer

of ultrasonic device technology for the treatment ofcancer and other chronic health conditions, said itplans to bring the Sonatherm 600, used for high-inten-sity focused ultrasound (HIFU) treatment of soft tis-sue, including cancerous tissue in the kidney, intoChina. In its strategy to enter China, it formed anagreement with Acton Medical Device (Guangzhou,China), which has a sales team of 156 covering morethan 20 provinces.

Acton will be responsible for conducting clinicalstudies and acquiring all necessary governmentapprovals for the sale of the Sonatherm in China. Mis-onix will make the device at its facilities in Farming-dale and will ship it to Acton for use by its partners inthe Chinese medical community for satisfying regula-

tory requirements as well as establishing regionalbranding, the company said.

The Sonatherm has been developed by Misonix inconnection with the worldwide rights that it acquiredfrom Focus Surgery (Indianapolis), a HIFU develop-er. Based on clinical studies conducted for Misonix inother parts of the world, the Sonatherm has beendemonstrated as an advanced product for minimallyinvasive procedures that ablate cancerous tissue with-out the need to puncture the kidney organ.

VeriChip cites Italian study resultsVeriChip (Delray Beach, Florida) last month

reported the results of a clinical study on its VeriMedSystem for patient radio frequency identification(RFID) conducted by the Spallanzi National Institute(Rome) and sponsored by the Italian Ministry ofHealth. The two-year, 10-patient study was designedto evaluate the safety and efficacy of the VeriMedimplantable RFID microchip and the functionality ofthe VeriMed System in the management of patientswith chronic infectious diseases undergoing care atthe institute.

The study reported no complications or sideeffects related to the insertion procedure, flawlessaccess of the ID number using a hand-held reader,and universal acceptance within the patient studygroup. Based on the results of the study, VeriChip’sdistributor for Italy said it plans to petition the ItalianMinistry of Health for full availability of the VeriMedsystem through the Italian National Health Service.

VeriChip is a subsidiary of Applied Digital Solutions.

Asset 2 electronic ‘toolkit’ for stroke in UKA new electronic “toolkit” for the staff of the

National Health Service, launched by the UK Depart-ment of Health, is intended to help transform the livesof stroke sufferers, according to Health Minister RosieWinterton.

The computer-based program, called Asset 2, hasbeen developed to assist healthcare commissioners inmodernizing their services, preventing thousands ofstrokes in the process. Aimed at Primary Care Trustsand general practitioners, the web-based system iden-tifies levels of demand for services in an area, bench-marks current services against other organizations,identifies best practices and demonstrates the impactof changes.

The guide encourages four key changes:• Increasing stroke unit capacity.• Providing quicker access to transient ischemic

attack (minor stroke) services.• Rapid scanning to enable greater use of clot-

busting drugs.• Early supported discharge.If all services made these changes, then each year



840 strokes would be avoided, and 3,900 suffererswould regain their independence rather than facingthe prospect of death or long-term dependency, thedevelopers have said. Another 20,000 strokes could beavoided through preventive work on high blood pres-sure, irregular heartbeats, smoking cessation andwider statin use.

Johns Hopkins part of Egypt cardiac programJohns Hopkins Medicine International (Balti-

more) and Sanofi-Aventis Egypt have signed anagreement for educational and consultative servicesthrough the Johns Hopkins Division of Cardiology.The agreement calls for assistance with the develop-ment of new national guidelines on cardiovasculardisease prevention. Other services will include sup-port in training of primary care physicians and cardi-ologists.

In Egypt, this initiative is referred to as the Delta-C Project, a model for change. According to JohnsHopkins, Egypt has among the highest incidences inthe world of hypertension, obesity, smoking, Type 2diabetes and other risk factors leading to heart dis-ease.

The Delta concept was originated by Innovara(Hadley, Massachusetts), a healthcare consulting firmthat has facilitated the relationship between JohnsHopkins and the Egyptian cardiology community.

Last month a physician re-education event hostedby Sanofi-Aventis Egypt launched the guidelineswhile also training cardiologists to train primary carephysicians throughout the country. The two-dayevent included case studies, medical training in car-diovascular disease prevention, advances in the useof new cardiovascular medicines in disease preven-tion, and plans for a patient intervention study tomeasure the effect of prevention education on cardio-vascular disease outcomes.

Maha Ibrahim, professor of radiology at CairoUniversity, said that two complementary preventionstrategies are needed in Egypt, one directed to thewhole population to decrease the risk profile of thecommunity and another that approaches individualsin high risk of cardiovascular disease. The guidelinesalso call for complete smoking cessation and educa-tion on the hazards of an increasingly unhealthydietary style.

The Delta-C project is licensed from Innovara bySanofi-Aventis Egypt for use by the Egyptian Hyper-tension Society. Innovara also serves as advisor tothe project.

Talecris Biotherapeutics opens Europe officeTalecris Biotherapeutics (Research Triangle Park,

North Carolina) last month established Talecris Bio-therapeutics (Frankfurt, Germany) to serve as itsEuropean headquarters. The new European sub-

sidiary represented the second expansion in 2006 forthe biotherapeutics manufacturer, completing thenext phase in the company’s global expansion plan.

“Our expansion into Europe signifies another keymilestone demonstrating the strategic growth wehave planned for our company,” said president/CEOAlberto Martinez, MD. “We established TalecrisEurope to deliver tailored sales and support servicesto our European customers, and our European lead-ership team brings the knowledge, experience anddedication to do exactly that.”

With the new German offices, Talecris said it isnow positioned to work closely with physicians andtheir patients to improve clinical care of primaryimmune deficiency patients.

In business for just 20 months, Talecris alreadyhas achieved annual sales of more than $1 billion andhas grown to employ more than 3,000. The companysupplemented its business with the acquisition of Pre-cision Pharma Services, which provides additionalfractionation capacity, and by acquiring 58 plasmacollection centers from International BioResources tocomplete the vertical integration of the business.

England goes smoke-freeAll enclosed public places and workplaces in

England will become smoke-free beginning July 1,according to Health Secretary Patricia Hewitt, wholast month said, “This is a triumph for public healthand a huge step forward for health protection. Thou-sands of people’s lives will be saved and the health ofthousands more protected.”

“Smoke-free legislation will protect everyonefrom the harm of secondhand smoke when working,socializing and relaxing and will provide a more sup-portive environment for smokers who wish to giveup,” Hewitt said.

Hewitt said the scientific and medical evidence“is clear — second-hand smoke kills, causing a rangeof serious medical conditions including lung cancer,heart disease and sudden infant death syndrome.This legislation will help to prevent the unnecessarydeaths caused every year from second-hand smoke,and recognizes that there is absolutely no safe level ofexposure.”

She said that no other health issue has created asmuch debate in Parliament, across government,through the business and the voluntary sectors, andamong the general public. “And the more it has beendebated, the more people have responded andpushed the limits to ensure that enclosed publicplaces and workplaces in England will become whol-ly smoke-free,” she said.

The Health Secretary also launched a new Smoke-free England campaign intended to help the country’s3.7 million businesses prepare for the implementation ofthe legislation.





• American Medical Systems Holdings (AMS;Minnetonka, Minnesota) reported that it signed anagreement to sell the assets of its aesthetics divisionacquired via the Laserscope (San Jose, California)acquisition to Iridex (Mountain View, California) fortotal consideration of up to $37 million. The transac-tion is anticipated to close no later than Jan. 31. Thetransaction calls for $28 million in total considerationto be paid to AMS at closing, with up to an addition-al $9 million in cash to be paid for any remaininginventory at the end of a six to nine month manufac-turing transition period. AMS bought Laserscope inJuly 2006 for $715 million. Iridex is a worldwideprovider of therapeutic-based laser systems, dispos-able laser probes and delivery devices to treat eye dis-eases and skin diseases.

• ATS Medical (Minneapolis) has acquired cer-tain assets of EM Vascular (Shoreview, Minnesota). Itsaid the transaction will be completed by issuing ATScommon stock to EM Vascular and subsequently dis-tributed to EM Vascular stockholders. The projectedvalue of the deal was not disclosed. ATS said the “sig-nificant asset” acquired in the deal is intellectualproperty “that may lead to breakthroughs in thetreatment of common vascular and blood disorders.”It said the technology may allow for a “non-invasive,non-pharma therapy for the treatment of such disor-ders as atherosclerotic plaque and blood hypercho-lesterolemia.” The technology also provides opportu-nities for future angiogenesis applications, it said.

• Biomoda (Albuquerque, New Mexico), a devel-oper of early lung cancer detection testing and othercancer diagnostics, has signed an agreement to exclu-sively license cancer detection technology from LosAlamos National Laboratory. Financial terms werenot disclosed. Biomoda’s technology is based on aporphyrin application that preferentially binds tocancerous or aberrant cells, which are non-invasivelycollected from lung sputum samples. The porphyrinthen glows red under fluorescent light, easily identi-fying cancerous cells.

• Braun (Kronberg, Germany), part of Procterand Gamble (P&G; Cincinnati), and Kaz (New York),have formed a partnership under which Kaz hasacquired Braun’s thermometer and blood pressuremonitoring business. The partnership also includes alicensing agreement between the two companies, inwhich the products will be marketed by Kaz underthe Braun name. The business comprises Thermoscandigital thermometers and wrist blood pressure moni-tors and currently represents about 5% of Braun’s

global sales. Braun and its vendors will continuemanufacturing thermometers and blood pressuremonitors for a significant period of time after thetransaction.

• Gamma Medica-Ideas (GM-I; Los Angeles/Oslo,Norway), a developer of imaging devices for the pre-clinical and clinical markets, reported reaching agree-ment to acquire and merge operations withAdvanced Molecular Imaging (AMI; Quebec), whichbills itself as the only company in the world deliver-ing a fully digital APD positron emission tomogra-phy (PET) product for pre-clinical imaging. Financialterms of the deal were not disclosed. Gamma saidthat the combined company will be “the first andonly firm with a complete range of digital imagingtechnologies, including APD PET and GM-I’s recent-ly unveiled CZT SPECT detector technologies, as wellas the most advanced range of multiple modalityimaging systems for drug discovery and medicalresearch.”

• Micrus Endovascular (San Jose, California)reported that it has acquired certain assets and busi-ness of privately held VasCon (Doral, Florida), amaker of vascular access and delivery devices. Thesubsidiary of Micrus formed to acquire the assets willdevelop and manufacture neurovascular catheterproducts for Micrus, including Micrus’ steerablecatheter, the Enzo. VasCon’s cardiovascular productswill continue to be sold through non-Micrus distribu-tion channels. Micrus, through its subsidiary, acquiredassets of VasCon for an up-front payment of about $5million, paid in cash and Micrus stock, and perform-ance based earn-out payments over three years. Vas-Con has made diagnostic catheters, guiding catheters,PTCA catheters, catheter sheath introducers, neuro-logical stimulators, hydrophilic coating and stentdeployment systems under private label, as well as fora list of medical device customers.

• MIV Therapeutics (MIVT; Atlanta/Vancouver,British Columbia), heretofore focused primarily onthe development of a material to be used in a drug-eluting stent (DES), has acquired a key stent platformfor its technology with the purchase of Biosync Sci-entific (Gujarat, India), a developer of interventionalcardiology products, including stents. MIVT saidthat Biosync provides it a “highly competitive” baremetal stent (BMS) platform that compares favorablywith the best BMS devices available today. MIVTsaid it will use the Biosync stent platform as theunderlying BMS technology for its biocompatiblepolymer-free DES.

Table 6Acquisitions

Source: BioMedical Business & Technology

the system, though it is currently reimbursed for usein the treatment of epilepsy. The TRD application wasfinally approved by the FDA in July 2005 after a near-ly seven-year struggle.

But at least one critic — Public Citizen — hadlaunched a campaign to bash the company’s strategyas promoting a technology for a disease applicationthat it basically created. That criticism is certainlyvalid since any disease can be labeled “treatment-resistant” if there is no cure for its worst cases.

The outspoken Cummins did not leave the com-pany empty-handed; he will receive $1.7 million cashas part of a severance package that includes 75,000shares of unregistered stock, the company disclosedin a regulatory filing.

Reese Terry Jr., the company’s co-founder, formerCEO and a current director, has been named interimCEO. In addition, George Parker III has been namedinterim COO, and John Riccardi has been namedinterim CFO. The company’s board said it has alreadyinitiated a search for a permanent CEO and CFO withthe assistance of an executive search firm.

Westbrook, who was also vice president offinance and administration, will receive a payment of$300,000 in cash, along with the acceleration and vest-ing of any stock options and restricted stock thatwould have vested within the next 12 months if shehad remained employed by the company. Westbrookhas been retained by the company as a consultant andwill advise it with respect to financial matters, includ-ing the preparation and filing of the company’s annu-al report for the period ending April 28, and quarter-ly reports for the quarters ending July 28 and Sept. 29.The company will pay Westbrook $1,200 per day forthose services.

Besides the external pressures on the company,the criticisms were more recently from internalsources. A group of Cyberonics shareholders sinceSeptember had been clamoring for changes on thecompany’s board, including the nomination of threenew directors, and had cited a “series of bad deci-sions” by the company’s management and board.

The company also received several delistingnotices from the Nasdaq, citing non-compliance withstandards due to a failure to file financial results forthe quarter ended July 28. The delay in filing reportswith the Securities and Exchange Commission wasthe result of an investigation by the commission intothe company’s stock option practices, primarily relat-ed to Cummins’ options. Also, the U.S. Attorney’sOffice for the Southern District of New York has sub-poenaed the company.

Kyphon builds arsenal with big purchaseIn a bid to dramatically expand its already potent

minimally invasive spine product arsenal — andmarking one of the biggest deals of the year —

Stock option issuesknock out top-levelexecs at Cyberonics

While vagus nerve stimulation (VNS) developerCyberonics (Houston) has had to deal with multipleissues concerning its device systems and regulatorystrategies, it was accounting problems rather thantechnology issues that served to knock out its top-level executives in late November. The review by thecompany’s audit committee showed flaws in itsreporting of stock option grants between 1999 and2003, the company said. The errors mean Cyberonicsmust restate results for the fiscal years 2000 through2005.

As a result of the investigation of these problems,Robert “Skip” Cummins, company president/CEO,and Pamela Westbrook, company CFO, resigned.Cummins’ resignation serves to muffle one of themost vociferous and combative voices in the med-tech industry. He has been an aggressive promoter ofthe company’s VNS technology, in particular for thetreatment of treatment-resistant depression (TRD),and was not afraid to take on critics of that applica-tion at any level — from the national media, to ana-lysts to FDA regulators.

Perhaps one of the most interesting chapters inCummins’ tenure as head of the company was hiscalling out a device analyst who had managed to infil-trate one of the company’s stockholders meetings—apparently using a grad-student “mole.” While Cum-mins billed that strategy as an invasion of the compa-ny’s privacy, other analysts praised the move for ded-ication to getting “ground-zero” information out ofCyberonics.

Cummins also headed the charge in the compa-ny’s lengthy campaign to win FDA approval for theTRD application, a campaign that served to overturna panel recommendation against that approval andwell-publicized criticism of the company’s trial dataindicating that VNS for TRD was no better than place-bo. But Cummins apparently was able to overridethese criticisms often via rhetorical fireworks and fre-quent claims that VNS was the only option availablefor the severely depressed who had run out of otherpossibilities for treatment.

Even after winning FDA approval of VNS for thebroad application to treat TRD, the company hasstruggled to win private and CMS reimbursement of



Businessdevelopments

Kyphon (Sunnyvale, California) last month said itwould acquire privately held St. Francis MedicalTechnologies (Alameda, California) in a transactionvalued at $525 million in upfront cash payable uponclosing, plus additional revenue-based contingentpayments of up to $200 million, payable in either cashor a cash/stock combination.

St. Francis is the maker of the X Stop Inter-spinous Process Decompression (IPD) system, thefirst FDA-approved — in November 2005 — inter-spinous process device for treating lumbar spinalstenosis. The X Stop has been available in Europe andJapan since 2001. More than 15,000 X Stop deviceshave been sold worldwide, the companies said.

Kyphon noted that the transaction broadens itsfocus in minimally invasive surgery (MIS) for thespine by adding the X Stop platform to its existingKyphX balloon kyphoplasty technologies for repair-ing vertebral compression fractures and its recentlylaunched Functional Anaesthetic Discography proce-dure for diagnosing the source of low back pain.

“This acquisition directly supports our statedstrategy of bringing minimally invasive spine thera-pies to our markets and adds an innovative newproduct platform to benefit the large number ofpatients suffering from lumbar spinal stenosis,” saidRichard Mott, president/CEO of Kyphon during aconference call. “It gives us a new platform for futurerevenue and earnings growth in one of the fastest-growing segments of the spine industry.”

Mott noted that the X Stop “fills a gap in the con-tinuum of care,” between conservative therapies,such as analgesics and injections, and invasive sur-gery with a laminectomy. Laminectomy, a lumbardecompression surgery, is a more invasive procedureto widen the spinal canal and relieve pressure on thespinal cord or nerve. It involves removing part of thespine to relieve the pain associated with the spinalstenosis.

The less-invasive X Stop procedure can be per-formed under local anesthesia, taking less than anhour. Since the device is not fixed to any bony struc-tures, the procedure does not result in fusion and iscompletely reversible, thus allowing for future thera-peutic alternatives, if needed.

The company said its initial target market is the200,000 patients who undergo a laminectomy eachyear, translating to a $1 billion market opportunity.

The company anticipates closing of the deal in1Q07. Upon closing, Kyphon said it expects to incuran estimated one-time, pre-tax charge of about $35million to $50 million for in-process R&D.

GMD to provide device ‘generics’At a time when rising healthcare costs make

headlines almost daily, a new medical device compa-ny has set out to respond to the pending Medicare cri-

sis the same way the pharmaceuticals industry has:by offering generics. Generic Medical Devices(GMD; Gig Harbor, Washington) last month touteditself as the first to offer what it calls “commonly usedand efficacious surgical products at generic prices.”

Richard Kuntz, president/CEO of GMD, told Bio-medical Business & Technology that he got the ideawhile traveling and found a newspaper articleslipped under his hotel room door about Medicarepredicting bankruptcy by 2019, seven years earlierthan previously predicted. “I didn’t understand whythe medical device industry had not followed in thepharmaceutical industry’s path of when a productpatent expires offering a generic alternative,” Kuntzsaid. “It was sort of a ‘duh’ — as my kids say — anda ‘Why not?’”

GMD says it will leverage expired patents onstandard-of-care surgical devices and bring genericalternatives to market in the $80 billion-a-year indus-try. The devices chosen will all have existing 510(k)classification approvals, reimbursement by Medicareand third-party payors, established product safety,efficacy and outcomes, and a trained surgeon/physi-cian base, the company said. As with pharmaceuti-cals, generic medical devices would be developedbased on the specifications for existing FDA-approved products that are becoming a commodity inthe marketplace.

GMD reported that it has filed three 510(k) appli-cations and expects its first products to be available tohospitals, clinics and physician-owned surgical cen-ters worldwide in 2007. Kuntz declined to unveil theidentity of its first three products but said those cho-sen will save the healthcare system, Medicare andthird party payers, more than $360 million a year inthe U.S. alone. He did say that the company’s initialproduct focus is in the pelvic healthcare area.

“The pie is only so big — we can’t keep takingpieces,” Kuntz said. “But we can keep the pie in a con-stant state by reducing the cost of the devices thathave come off patent.”

Kuntz said the concept of GMD has been “verywell-received,” both in the U.S. and internationally.He said the company plans to open an office inEurope after the first of the year. The company hasreceived Series A funding, with Kuntz saying that atleast half has come from surgeons and physicians“which we didn’t expect or foresee,” Kuntz said.

End-of-year moves for several companiesDecember saw a variety of companies taking

actions to pull back, refine or abandon product lines.• Following the path taken by Bausch & Lomb

(B&L; Rochester, New York) earlier in the year,Advanced Medical Optics (AMO; Santa Ana, Califor-nia) recalled 18 lots of its 12-ounce Complete Mois-turePlus multipurpose contact lens care solution and



Active Packs in the U.S. after three lots sold in Japanwere found to have bacterial contamination whichcompromised sterility. The problem was traced to aproduction-line issue at AMO’s manufacturing plantin China.

Of the 2.9 million units being recalled, 183,000units were shipped to the U.S. and the remainder wasshipped to Asia Pacific and Japan. Products made inAMO’s facility in Spain, which produces the vastmajority of its contact lens solution products distrib-uted in the U.S. and Europe, are not affected by therecall, the company said.

Steve Chasterman, a spokesman for AMO, toldBiomedical Business & Technology: “This is an isolatedissue, not a formulation issue” and that the recall isbeing done as a precautionary measure “in the bestinterest of our consumers.”

“Because three lots of products we sold in Japanwere found to have sterility issues we decided wewould recall the lots in the U.S. that were producedon the same production lines in the same productionperiod,” Chasterman said.

AMO said it expected the recall to reduce its rev-enue for through the end of 2007 by $40 million to $45million.

• Medtronic (Minneapolis) disclosed a plan tospin off Physio-Control (Redmond, Washington), itsautomated external defibrillator (AED) unit, some-time in the first half of its 2008 fiscal year. The spin-off, said Art Collins, CEO and chairman, is beingmade because Physio-Control “is not central to ourlong-term strategic business.”

In a conference call, Collins said, “[w]e believethis transaction . . . will allow Physio to renew itsfocus, while allowing Medtronic to focus” on oppor-tunities that align better with its strategic aims. Thoseaims, he said, include pursuing growth in the mid-teens. The company, which operated as Medtronic’sEmergency Response Systems division, will continueoperations with its headquarters in Redmond, itslocation prior to the Medtronic buy-out.

Physio-Control was purchased for $538 million instock in June 1998, and it has built sales, but Medtron-ic said it had not found a marketing match —described as “tangible operating synergies” —between its emphasis on implantable cardioverterdefibrillators (ICDs) and AEDs. Even in hospitals, itsaid, AEDs are a capital equipment purchase whileICDs are purchased as therapeutic devices.

• Edwards Lifesciences (Irvine, California)reported two initiatives: the discontinuation of itsOptiwave 980 Cardiac Laser Ablation System and“realigning resources to better drive key strategicopportunities,” it said. In the realignment, the compa-ny said it will eliminate about 70 full-time positionsand target saving an estimated $16 million pre-taxcharge in the fourth quarter. Michael Mussallem, CEO

and chairman of Edwards, said, “At this time we areactively recruiting talent to fill many new roles as weincrease investments to drive growth.”

The announcement from Edwards came on theheels of its report that it will sell its angiogenesis pro-gram to Sangamo BioSciences (Richmond, Califor-nia) in a share transaction worth about $7.5 million.

Dropping the Optiwave program impacts PLCSystems (Franklin, Massachusetts), which manufac-tures the system under a supply agreement withEdwards signed in March 2006. In the first three quar-ters of 2006, PLC reported recording about $20,000 insales from Optiwave 980 laser systems, plus about$12,000 in royalty payments on sales of Optiwave 980disposables, or less than 5% of the company’s totalrevenues in the first nine months of 2006.

• Lifestream Technologies (Post Falls, Idaho), asupplier of cholesterol monitors, said it filed a petitionfor bankruptcy and entered into an asset purchaseagreement with Polymer Technology Systems (PTS;Indianapolis) to sell off its assets for $750,000.

HIT exec, Vanderbilt roll out IT firmBuilding on pilot implementation at Bassett

Healthcare (Cooperstown, New York), GaryZegiestowsky, a health information technology (HIT)executive, and Vanderbilt Medical Center (Vander-bilt; Nashville, Tennessee) unveiled a new clinicalsoftware and solutions company, Informatics Corpo-ration of America (ICA). ICA’s foundation was laidearly 2005 with informatics-based tools and processesdeveloped by physicians at Vanderbilt for improvedpatient information, along with better evidence andbest practice guidance

Bassett — a rural health system which compro-mises four hospitals, 23 community health centersand 14 school-based health systems — completedpilot implementation of ICA’s core aggregation solu-tion in November and said it will roll it out across itsdelivery network early next year. The first phase ofBassett’s implementation went live with the produc-tion pilot in November, and the expanded implemen-tation is already underway.

Zegiestowsky, CEO of ICA, said that ICA’s solu-tion “integrates the clinical systems and processesacross a delivery network to create a unified electronicmedical record solution. The core solution, typicallyimplemented in less than six months, involves aggre-gating all available patient information and making iteasily accessible to clinicians anytime, anywhere.”

ICA further provides communication and work-flow tools to improve communications, facilitate datacapture, track clinical metrics and incorporate evi-dence to help clinicians more effectively act on avail-able information.

ICA has the exclusive right to use the productsoutside of Vanderbilt.





• Accuray (Sunnyvale, California) and SiemensMedical Solutions (Malvern, Pennsylvania) reportedsigning an agreement to collaborate in the develop-ment of advanced imaging and software solutionstargeted for use in both radiosurgery and radiothera-py. The companies will jointly focus on the integra-tion of Siemens computed tomography (CT) imagingtechnology with Accuray’s CyberKnife robotic radio-surgery system. They will also work towards the inte-gration of Accuray’s advanced targeting techniquesinto Siemens radiotherapy product line.

• Acuo Technologies (St. Paul, Minnesota) andNU Design Medical Technologies (Minnetonka,Minnesota) reported that NU Design would incorpo-rate DICOM Services Grid technology from Acuo intoits Mammography Manager. The technology willallow NU Design’s Mammography Manager to auto-matically route, based on content, to a reading physi-cian without manual intervention, the company said.The system will enable content-aware DICOM rout-ing, JPEG, encryption and storage virtualization.Acuo was founded in 2000 to develop the first enter-prise-wide collaborative asset management solutionfor medical DICOM images residing in a PictureArchiving and Communications System. NU Design,a software and teleradiology company, specializes inwomen’s healthcare.

• Avitar (Canton, Massachusetts) has signed adistribution agreement with Dukal (Hauppauge,New York) for Avitar’s Hydrasorb polyurethanefoam wound dressing product line to replace thecompany’s existing distributor. The agreement coversthe U.S. and will be effective Jan. 1. Hydrasorb, whichuses Avitar’s polyurethane technology, is designed tobe a highly absorbent topical dressing for moderateto heavy exuding wounds. These dressings have aconstruction providing a moist wound-healing envi-ronment which promotes skin growth and closure.Dukal makes a variety of wound care and patient careproducts. Avitar makes products for the oral fluiddiagnostic market, the disease and clinical testingmarket and customized polyurethane applicationsused in the wound dressing industry.

• Clearant (Los Angeles) reported that it signedan agreement with O.R. Specialties (Milford, Michi-gan), a distributor of orthopedic surgical supplies, torepresent and distribute Clearant Process SterileImplants for allograft sport medicine surgeries. O.R.will utilize its team of 13 sales representatives to mar-ket the implants to sports medicine specialiststhrough hospitals and surgery centers throughoutNew York, northern New Jersey, Connecticut and

Rhode Island and western Massachusetts. The Clear-ant Process is designed to eliminate all types ofpathogens in tissue implant sterilized in its finalpackaging.

• iCAD (Nashua, New Hampshire), a provider ofcomputer-aided detection (CAD) solutions for theearly identification of cancer, reported entering aproduct integration and distribution agreement withViatronix (Stony Brook, New York), a developer ofdiagnostic 3-D imaging software. Viatronix willincorporate iCAD’s CAD solutions with its virtualcolonoscopy technology, to enhance early detectionand identification of polyps, potential precursors tocolon cancer. Viatronix will offer iCAD’s computedtomography (CT) colon CAD software for the identi-fication of potential polyps in CT Colonography(CTC) examinations in conjunction with its V3D Sys-tem for “virtual colonoscopy.” iCAD’s CT ColonCAD software is pending regulatory review andapproval by the FDA.

• Premier Purchasing Partners (Charlotte, NorthCarolina) reported new agreements for tracheostomytubes and related products have been awarded toSmiths Medical ASD (Keene, New Hampshire), andTyco Healthcare/Nellcor Puritan Bennett (Pleasan-ton, California). The 36-month agreements, effectiveJan. 1, are available to acute care and continuum ofcare markets. Purchasing Partners, which says it isthe nation’s largest healthcare purchasing network, ispart of Premier (San Diego), a healthcare alliance.

• Smiths Medical (Carlsbad, California), part ofthe global technology business Smiths Group andprovider of temperature management productsworldwide, recently signed an exclusive agreementwith Inditherm (Rotherham, UK), the provider ofheating solutions to the medical industry. The three-year distribution agreement stipulates U.S. marketsales of Inditherm heated mattresses and blanketsunder Smiths Medical’s Level 1 brand, adding toSmiths’ range of temperature management brands.

· Volcano (Rancho Cordova, California), Stan-ford University (Palo Alto, California), Cardialysis(Rotterdam, the Netherlands) and the Cardiovascu-lar Research Foundation (CRF; New York) reported acollaboration whereby Volcano has agreed to provideintravascular ultrasound (IVUS) catheters free ofcharge for use in drug-eluting stent (DES) trials. Theoffer will be made available to stent manufacturersusing the core lab services of Stanford, Cardialysis orCRF in trials where IVUS images and data areplanned to be collected in 100% of patients at enroll-ment and at pre-determined follow-up periods.

Table 7Agreements

Source: BioMedical Business & Technology

Policy promoting‘transparency’ isadopted byAdvaMed

Apparently sensing the directional winds, theAdvanced Medical Technology Association(AdvaMed; Washington) in early December adopteda statement of principles supporting increased trans-parency in healthcare cost and quality, positioningitself to be one of the key voices that may put togeth-er any comprehensive program to address the issue.AdvaMed said it supports building a “transparentvalue-driven” healthcare system to improve the qual-ity and reduce spending.

Stephen Ubl, AdvaMed president/CEO ofAdvaMed, said that support of the statement of prin-ciples by the organization board is based on theunderstanding that greater transparency will help toensure continued patient access to available technolo-gies. "Everyone is a healthcare consumer. Greatertransparency is a win for patients and the delivery ofhealth care overall. Transparency supports increasedconsumer and provider awareness about the qualityand costs associated with healthcare." He added:"Escalating healthcare costs have led employers toseek new ways to reduce costs in order to remaincompetitive in the global marketplace," Ubl added.

Adoption of the stand on transparency comes inresponse to an executive order from President GeorgeBush requiring four government agencies to imple-ment quality measurement programs awaits imple-mentation in January. Additionally, the initiativedovetails with the plan by Mike Leavitt, secretary ofU.S. Health and Human Services to connect thehealthcare system through better use of informationtechnology, including electronic health records; meas-uring and publishing information regarding the qual-ity of healthcare, with a focus on patient outcomesfrom care; measuring and publishing prices forepisodes of care; and creating positive incentives byimplementing contractual arrangements that rewardthose who offer and purchase high-quality, competi-tively-priced healthcare.

AdvaMed said its principles underscore the needto provide consumers with tools to make informeddecisions about their healthcare, based on "accurate,timely and robust measures which reflect the com-plexity of the procedures and services available." Thegroup said that such initiatives should incorporate

comprehensive definitions of the benefits and costs ofhealthcare services, including consideration of recov-ery times, lost productivity from days absent fromwork, and other factors contributing to the overallvalue of the healthcare provided.

The AdvaMed board recommended that qualityand cost measures should be tied to well-establishedclinical guidelines developed by appropriate physi-cian specialty societies. The organization did not sug-gest, however, that its members should have to pro-vide data on the cost of their products to the public.Indeed many medical device companies have jealous-ly guarded that information and it appears unlikelythat outside of a government mandate, that willchange any time soon. Rather, the board said that costmeasures should be based on the resources needed todeliver a group of services, or entire episode of care.The resources, it said, should be identified from "well-established clinical guidelines."

The group also stressed that greater transparencymust support technological innovation as well asinnovation in healthcare delivery. Any transparencyrequirements, they noted "should not discourage vig-orous competition within the healthcare system andshould also ensure continued patient access to the fullarray of available technologies."

Disability in elderly tailing offAs administrators at the Centers for Medicare &

Medicaid Services work to rein in spending, variousstakeholders continue to offer evidence that whilethere is no free lunch, the budget lunch sometimes isa worse deal than going with something pricier thanthe blue plate special. A recent report on the function-ing of Medicare enrollees by the Center for Demo-graphic Studies at Duke University (Durham, NorthCarolina) suggests that investments in long-term careeventually save the taxpayer a dollar or two, a notionthat echoes an earlier, privately funded study onpower wheelchair use (Medical Device Daily, Nov. 9,2006).

On the other hand, the growing numbers of the“older old” — and the impact that 79 million BabyBoomers will have on this population — demand thatimprovements in the status of the disabled be sus-tained to keep the federal ledger in balance.

Kenneth Manton, PhD, director of research at theCenter for Demographic Studies, and the rest of theteam reviewed data obtained in the National Long-Term Care Survey (NLTCS) documented that the per-centage of Medicare eligibles who were disabled fellto 19% in 2004/05 from 22.5% in 1982, the first year ofdata available for the analysis. Those with one dis-ability only dropped from 5.7% in that first year to2.4% in the final year, and those who were institu-tionalized due to their disabilities fell from 7.5% to 4%during that same time span.



Market &technology updates

The definition of disability is based on “the diffi-culty of performing both activities of daily living,”which includes basic personal care such as eating,grooming and bathing, and so-called instrumentalactivities of daily living, a list that includes mealpreparation and budget maintenance.

When broken down by age, the ratio of the dis-abled between the ages of 65 and 74 fell from 14.2% in1982 to 8.1% in 2004/05. For those aged 75-84, thosenumbers went from 20.7% to 11.9% and for thoseolder than 85, the disability drop was from 62.1% to49.7%.

The authors noted, however, that if federalhealthcare expenditures are to “decline at the project-ed rate because of a per annum decline of 1.5% inchronic disability, future disability declines will haveto occur at increasingly older ages.” This improve-ment in those above the age of 85 “must occur tomaintain the current rate of improvement in the fiscalstatus of Medicare and Medicaid to 2050, the year bywhich the last of the post-World War II” cohort hasreached that age.

The article noted that the “rate of decline inchronic disability prevalence accelerates from 1982 to2004/2005, starting at 0.6% per annum in 1982-1984and increasing to almost four times that level (2.2%)by 1999-2004/2005.” The authors stated a correlationwith “a change in the management of severely dis-abled persons, especially in long-term institutionalcare.” Prior to the 1980s, institutional long-term carewas “primarily conceived of as residential and hous-ing services and maintenance care, which was notwell developed medically or for rehabilitation.”Among subsequent institutional changes were thepush from acute-care hospitals to skilled nursingfacilities (SNFs) and the increased use of post-acutecare due to the 100-day limit on Medicare paymentfor SNFs.

While the authors are reluctant to project theimpact of the recent increases to the NIH budget,from slightly more than $10 billion in 2003 to a pro-jected $28 billion in 2007, on disabilities in those aged65 and older, they nonetheless comment that “invest-ments in biomedical research and the production ofinnovative and more effective therapeutic and pre-ventive medical care are possible explanations,” asare “behavioral risk factor changes such as smokingcessation and moderation of alcohol consumption.”

The impact of all this on the budget for Medicareand Medicaid is of no small consequence. The articleput the potential savings at $73 billion, “or 17% of allMedicare expenditures expected for the elderly . . . ifdeclines in chronic disability prevalence continue attheir 1982-1999 rate.”

Manto told Medical Device Daily that cardiovascu-lar and cerebrovascular diseases are most closely tiedto the observed drop in disability. “The biggest source

of the decline in cardiovascular disease is reductionsin disease risk and treatment after the event occurs,”he stated. On the other side of the coin sits a series ofneurological disorders, such as Alzheimer’s disease.However, the prevalence of Alzheimer’s and otherneurological condions is somewhat linked to otherelements of health status.

Alzheimer’s has “a lot of circulatory diseaseunderlying it,” Manto remarked, and by some projec-tions, the prevalence numbers “get huge.” However,he insisted that “[t]he numbers are not as over-whelming as they’re sometimes portrayed,” addingthat some Americans are fearful that they willinevitably succumb to Alzheimer’s. He said suchfears are somewhat overblown.

Getting after disabilities in the extremely elderlysounds particularly difficult, a notion Manto did notrefute. On the other hand, early intervention makes adifference here, too. “If you reduce disability in the“young old, it cuts down on disability in the olderold,” Manto said.

“The relative rate of improvement has been high-er in those 80 and older,” he observed, but Manto saidthat the link between disease and age-related declineis blurry. “A lot of what we see is identifiable as dis-ease syndromes that are separate from the other thingthat we call senescence,” but there is some interplay,often leading to a chicken-or-egg dilemma where dif-ferential diagnoses are concerned.

As for the Woodstock crowd that partied heartilywith substances that were much less popular or evenunavailable prior to the Sixties, Manto said that theeffects of drug abuse on the prevalence of cognitivedisability are difficult to pin down. “I don’t know thatit comes through in the numbers, but I’m sure that’s afactor in a small percentage of people,” he said.

“I have a feeling that recreational drug use is a bitlike alcohol consumption in that other problems goalong with it, and it’s not clear that your life expectan-cy will be as high.”

Too little ‘nano’ knowledge a big problem?Two recent polls of the public indicate a host of

positives in attitudes concerning nanotechnology butthis doesn’t translate to continued and guaranteedsuccess for this emerging sector, according to one ana-lyst and commentator on the field.

Neal Lane, a former science advisor to PresidentBill Clinton, has warned that the good public relationsnanotechnology is experiencing now may not last,since the “warm and fuzzy” public attitudes towardthe sector don’t eminate from a good understandingof the science. This, he says, could result in consider-able misunderstanding when critical questions andnegative headlines inevitably come along.

“Nanoscale science and engineering promise tobe as important as the steam engine, the transistor,



and the Internet, and have the potential to revolution-ize all other technologies” Lane said, in remarks madeat a Project on Emerging Nanotechnologies event atthe Woodrow Wilson International Center for Schol-ars. The program marked the release of an article inthe December 2006 issue of Nature Nanotechnology.

Lane cited a recent poll by the Project on Emerg-ing Nanotechnologies indicated awareness of nan-otechnology is increasing. But it also showed, he said,that 69% of Americans have heard little or nothingabout nanotechnology, said Lane and that “moreyoung people are seeing nanotechnology in adver-tisements for MP3 players than are learning aboutnanotechnology in schools.”

Another survey, called the largest and most com-prehensive survey on the subject, recently tested pub-lic perceptions of nanotechnology. It found that U.S.consumers are willing to use specific nano-containingproducts — even if there are health and safety risks —when the potential benefits are high. And it foundthat U.S. consumers rate nanotechnology as less riskythan everyday technologies like herbicides, chemicaldisinfectants, handguns and food preservatives. Thestudy was conducted by researchers at the Center forBiological and Environmental Nanotechnology(CBEN) at Rice University, University College Lon-don (UCL) and the London Business School.

Lane is a co-author of that study, and he said thepublic is likely to become more aware of nanotech-nology’s risks as environmental health and safetyresearch is completed and as nanomaterials find theirway into more products. But he said that the surveyalso appears to indicate that the public may not beable to discriminate between real nanotech and whatis misrepresented as nanotechnology.

“A major environmental, medical or safety prob-lem — real or bogus-with a product or applicationthat’s labeled ‘nanotechnology’ — whether it actuallyis nanotechnology or not -- could dampen public con-fidence and financial investment in nanotechnology’sfuture, and could even lead to unwise regulation. Weshould not let this happen,” Lane said.

To ward off this possibility, Lane emphasized amajor educational effort “ to investigate nanotechnol-ogy’s possible environmental, health, and safetyrisks.” A second educational effort should be pursuedin schools. He compared such an effort to the Sputnik-generated interest in science, and he said America’s“children and workforce need that same level ofnational commitment to lead and keep them compet-itive in the Nano Age.”

Finally, Lane called for “a deliberate effort to pro-vide the public with balanced and easily understoodinformation about nanotechnology’s potential bene-fits and its possible risks and for more public engage-ment” -- led by government, industry and the scienceand engineering community working together.

Lane proposed that the UK’s Royal Society andthe US’s National Academies set up interagency clear-inghouses to coordinate public education and synthe-size the latest scientific findings. Transmitting the lat-est information about both risks and benefits, in atimely, thorough and transparent way, will minimizethe likelihood of a polarized public debate that turnson rumor and supposition.”

Shear forces key to lubricationTaking a cue from machines that gently flex

patients’ knees to help them recover faster from jointsurgery, bioengineering researchers at University ofCalifornia San Diego (USCD) have shown that slid-ing forces applied to cartilage surfaces prompt cells inthat tissue to produce molecules that lubricate andprotect joints. The results, reported in Osteoarthritisand Cartilage, are important in the ongoing efforts ofthe group led by Robert Sah, a Howard Hughes Med-ical Institute (HHMI) professor at UCSD’s JacobsSchool of Engineering, to grow cartilage in the labo-ratory that can be used to replace patients’ injured ordiseased joint surfaces.

“We have shown that shear forces on cartilageprompt chondrocyte cells in it to produce proteogly-can-4,” said Sah. “This is an important step towardour goal of eventually growing joint tissue for trans-plantation.” Proteoglycan, a name that reflects its pro-tein and polysaccharide components, is a basic build-ing block of connective tissue throughout the body.The chondrocyte cells of cartilage make several formsof proteoglycans, including several that build up incartilage and contribute to its stiffness. However, pro-teoglycan-4 is primarily secreted into the joint fluidwhere it coats and lubricates cartilage surfaces.

Unfortunately, the smooth surface of the articularcartilage at the ends of bones located at joints oftendeteriorates with aging, becoming increasinglyroughened and eroded. Those joints become painfuland progress to osteoarthritis. Surgeons can replacedamaged and diseased joints with artificial joints, butthey would like to be able to simply resurfacepatients’ existing joints with cartilage.

In a series of experiments, Sah’s team attachedbovine stifle joints, which are similar to human kneejoints, to a bio-reactor that provided continuous irri-gation with sterile nutritional fluids under normalphysiological conditions. Immobile joints were com-pared to joints that were flexed 24 hours in a way thatmimicked walking motions. The flexing was provid-ed by a specially designed continuous passive motiondevice.

The team measured up to a three-fold increase inchondrocytes secreting proteoglycan 4 in continuous-ly flexed joints compared to immobile controls. Theflexing motion caused cartilage on the surfaces ofopposing bones to slide against each other, creating



so-called shear forces. In one large surface region ofcontinuously sliding cartilage, 40 percent of the chon-drocytes were secreting proteoglycan 4, whereas inthe same areas of cartilage in immobilized joints only13 percent of the chondrocytes were secreting proteo-glycan 4. In areas of the joints exposed to only inter-mittent cartilage sliding, the effect on proteoglycan 4production was intermediate between continuouslysliding and immobilized regions of the joints.

“A challenge for us is to create large tissue graftsfor transplantation,” said Sah. “We are systematicallyaddressing the technical challenges to maintain andgrow healthy fragments of bone and cartilage in thelaboratory and now we can use nature’s self-regulat-ing system, whereby application of shear forces to thistissue increases its synthesis of proteoglycan 4.”

Senators back diabetes screeningNineteen senators have sent a letter to Mike Leav-

itt, secretary of U.S. Health and Human Serivces,requesting that he “make diabetes screening and pre-vention for Medicare beneficiaries a top priority.”

According to the letter, findings from a recentstudy in the journal Diabetes Care show that 61% ofMedicare beneficiaries — 21 million of an estimated32 million seniors — have either diabetes or pre-dia-betes. Of those, 14 million beneficiaries are believed tohave undiagnosed pre-diabetes.

“Please include in your FY 2008 budget proposalan aggressive collaborative effort between the CDC,[CMS], and other key agencies to find and screen”those beneficiaries who have not yet been diagnosed,the letter states.

The senators, including John Cornyn (R-Texas)and Charles Schumer (D-N.Y.), noted that a clinicaltrial conducted by NIH found that “modest” changesto diet and exercise prevented diabetes in 58% of par-ticipants considered to be at high risk of contractingdiabetes. The trial also found that such changes pre-vented the onset of diabetes in participants over age60 by 71%. The trial “shows that such an initiative willsave lives and money” the letter states.

Weyden lays out universal insurance planSen. Ron Wyden (D-Oregon) in late December

said that early this year he will introduce legislationthat would guarantee health insurance for all U.S. res-idents. According to Wyden, his plan would call forprivate health insurers would provide coverage toindividuals directly, rather than through employers,and employers would initially shift funds currentlyused to pay for coverage to employee wages. Overtime, employers would to pay the federal governmenta health insurance contribution.

The legislation would require individuals to usethe funds contributed by employers to purchasethrough state purchasing pools private health insur-

ance, which would provide coverage at the same levelas the BlueCross BlueShield Standard Plan offered tofederal employees. Individuals would not have to payhigher income taxes as a result of the funds theyreceive from their employers. Additionally, stateagencies would be established to give advice on theacquisition of private health insurance converage.

The uninsured also would have to purchasehealth insurance, but the federal government wouldsubsidize premiums for those in low-income cate-gories and partially subsidize premiums for middle-income individuals. Similar to the protocol for autoinsurance, those failing to buy a health insurance planwould be fined. The federal government would col-lect premiums paid by individuals and contributionsfrom employers through the tax system and distributethe funds to health insurers. The legislation wouldapply to individuals until they reach retirement andwould not apply to Medicare beneficiaries. In addi-tion, the legislation would not apply to those whoreceive health insurance through the military.

Wyden cited comments from business leaderswho previously have said that the reform of health-care would be too costly. He said that now those busi-ness leaders are saying “We can't afford not to reformhealth care.”

Steve Burd, CEO of Safeway Supermarkets,joined Burd in announcing the legislation and saidthat “dramatic change” is needed to keep the Ameri-can worker from becoming “less competitive.”

The legislation is intended to extend coverage tothe estimated 47 million in the U.S. not insured andlimit employer exposure to cost increases for health-care coverate. Experts in this field said, however, thatthe legilsation is unlikely to pass without being cham-pioned by a chief executive committed to seeing it —or a similar plan — adopted.

IHI unveils safety planThe Institute for Healthcare Improvement (IHI; )

Cambridge, Massachusetts), a non-profit organiza-tion, late last year launched a campaign to cut thenumber of patient injuries in hospitals by 5 millionover the next two years. IHI said that there arebetween 40 and 50 “incidents of harm” for every 100hospital patients in the U.S., meaning that about 15million harm events occur each year.

IHI’s plan includes calls for improved beddingand hand hygiene, better treatment of congestiveheart failure and thorough disinfection of roomswhere previous patients have had antibiotic-resistantinfections. The plan calls for random audits of patientcharts as a tool to determine the source of preventableaccident.

IHI in 2004 launched a campaign to prevent100,000 deaths as a result of what it termed hospital“failures.”



ANS puts more speed,power, efficiency intoEon microchip

More speed. More power. More efficiency. That’swhat Advanced Neuromodulation Systems (ANS;Plano, Texas), the neuromodulation business of St.Jude Medical (St. Paul, Minnesota), says it put into itsNeuroDynamix technology, an upgraded microchipfor its rechargeable implantable pulse generator (IPG)system, the Eon.

Spinal cord stimulators, like the Eon, are similarin function and appearance to cardiac pacemakers,ANS said, except that the mild electrical pulses fromthe device are sent to electrical leads near the spinalcord instead of the heart and the device is implantedin the patient’s upper buttocks, rather than theirchest. The pulses are intended to interrupt the painsignals as they travel to the brain, replacing painfulsensations with a more pleasing sensation calledparesthesia, the company said.

ANS highlighted the new technology and theRapid Programmer 3.0, the clinician programmer thatsupports the Eon, at the December annual meeting ofthe North American Neuromodulation Society(NANS; Glenview, Illinois) in Las Vegas.

“There was a very positive reaction at the NANSmeeting to the new NeuroDynamix technology andthe EON and to the Rapid Programmer 3.0,” TomHickman, VP of production management for ANS,told Biomedical Business & Technology.

By putting more speed, power, and efficiency intothe new technology, the Eon is able to offer a broaderrange of stimulation for the patient, Hickman said.

In June 2005 ANS expanded the U.S. marketlaunch of the Eon. The device can power up to 16independent electrodes in a dual eight-electrode leadconfiguration, according to the company (MedicalDevice Daily, June 22, 2005). The company reportedreceiving FDA approval for the device in March 2005.

Hickman said the new NeuroDynamix technolo-gy enables the Eon system to process programmingfaster. “The Eon is our flagship, 16-connector spinalcord stimulation system that really enables patientsand physicians to have the most advanced spinal cordstimulation on the market,” Hickman said. The Eonsystem is designed to aid in the management ofchronic pain of the arms, legs and trunk, or pain

resulting from failed back surgery. Although not acure, ANS said spinal cord stimulation therapy canreduce pain that is the result of dysfunction or dam-age to the nervous system caused by injury, disease orlocalized trauma.

According to ANS, chronic pain is a largelyunder-treated and misunderstood disease that affectsmillions of people worldwide. The company said it isdefined as moderate to severe pain that persists forone or more months longer than would generally beexpected for recovery to a specific disease, injury orsurgery. The National Institutes of Health estimatesthat chronic pain affects more than 90 million peoplein the U.S. and costs about $79 billion a year in lostwork time.

A spinal cord stimulation system includes a neu-rostimulator or generator — the device itself which issurgically implanted, battery-operated and operateslike a pacemaker for pain; leads — one or more thinwires with several electrodes or contacts that carrymild electrical pulses from the device to specific seg-ments of the spinal cord; a patient controller — aremote control device that turns the system on and offand allows patients to adjust stimulation withinparameters set by physicians; and the programmer —a device that enables the doctor or clinician to adjustand fine-tune the stimulation programs.

According to ANS, the best candidates for spinalcord stimulation (SCS) systems are individuals withchronic, neuropathic pain who have unsuccessfullytried less aggressive pain therapies, ranging fromexercise and over-the-counter medications to nerveblocks, systemic opioids and surgery. A number offactors affect whether a patient is a good candidate forSCS, the company said, including the patient’s diag-nosis and medical history, as well as the severity, loca-tion and type of pain.

Other companies involved in the neurostimula-tion space for these conditions include Medtronic(Minneapolis), Boston Scientific (Natick, Massachu-setts), Northstar Neurosience (Seattle) and Cyberon-ics (Houston).

Elsewhere in the product pipeline:• Abaxis (Union City, California), manufacturer

of point-of-care (POC) blood analysis systems, report-ed that the FDA has granted waived status underClinical Laboratory Improvement Amendments(CLIA) regulations for six additional analytes —Albumin, Alkaline Phosphatas, Amylase, GammaGlutamyltransferase, Total Bilirubin and Total Protein—when used in conjunction with its Piccolo POC ana-lyzer. The company said it now has 12 analytes thathave received CLIA-waived status. The system con-sists of a compact, 6.9 kilogram, portable analyzer anda series of 8 cm diameter single-use plastic reagentdiscs that contain all the reagents necessary to per-form a fixed menu of tests. Abaxis manufactures



Productbriefs

portable blood analysis systems for use in patient-care settings to provide rapid blood constituent meas-urements.

• Artes Medical (San Diego), focused, it says, onmaking “a new category of aesthetic injectable prod-ucts for men and women,” reported FDA approval ofits ArteFill product, calling it “the first and only non-resorbable aesthetic injectable implant approved bythe FDA. The product is indicated for the correction offacial wrinkles known as nasolabial folds (smilelines). Unlike existing dermal fillers that are com-pletely metabolized by the body, ArteFill representsthe first product in a new category of non-resorbabledermal fillers providing a permanent support struc-ture for enduring wrinkle correction, according toArtes. ArteFill contains a combination of ArteFill Pre-cision-Filtered Microspheres suspended in a carriergel containing purified bovine collagen. Artes said itwill begin marketing and selling ArteFill to dermatol-ogists, plastic surgeons and cosmetic surgeons in theU.S. through its direct sales force.

• BioSphere Medical (Rockland, Massachusetts),which says it pioneered the use of bioengineeredmicrospheres to treat uterine fibroids, hypervascular-ized tumors and vascular malformations, reportedFDA 510(k) clearance for its BioSphere’s QuadraS-phere Microspheres. U.S. shipments through BioS-phere’s direct sales force are expected to begin imme-diately. BioSphere’s QuadraSphere Microspheres,indicated to treat hypervascularized tumors andperipheral arteriovenous malformations, are deliv-ered by interventional radiologists who performembolization procedures. QuadraSphere is technical-ly identical to BioSphere’s HepaSpheres Micros-pheres, an embolic currently marketed in Europe.QuadraSphere’s spherical shape allows for a “pre-dictable, flow-directed occlusion,” the company said.The product expands up to four times its dry-statediameter and thus absorbs aqueous media up to 64times its dry-state volume. In addition to the absorp-tion process, the negatively charged polymer is alsocapable of selective bonding with positively chargedsubstances through ionic interaction. Also, QuadraS-phere affords atraumatic conformability to the vesselarchitecture, leading to a more complete vessel occlu-sion, the company said.

• Cardiocom (Chanhassen, Minnesota) is addingblood glucose monitoring and the Autolink DiabetesTelemonitoring System to its existing telemonitoringdevices for chronic diseases such as congestive heartfailure, chronic obstructive pulmonary disease, asth-ma, coronary artery disease and obesity. The compa-ny also has formed a new division, Glucocom, tofocus on its diabetes products. The new system con-sists of the GlucoCom Blood Glucose Monitor thatcollects glucose data and sends it to the secure Gluco-Com Diabetes Management Website using telehealth

technology, specifically the AutoLink Blood GlucoseTelemonitoring Device.

• CardioDynamics (San Diego), a developer ofBioZ impedance cardiography (ICG) technology,reported the publication of a cost-effectiveness studyin the American Heart Hospital Journal’s Fall 2006edition. The study showed that use of ICG was cost-effective in both the short and long term compared tostandard treatment of uncontrolled hypertension. Inthe previously-published CONTROL trial, use of ICGin the treatment of uncontrolled hypertension result-ed in an 8 mm Mercury (mm Hg) greater systolicblood pressure (BP) reduction and a 7 mm Hg greaterdiastolic BP reduction than standard care. Until thecompletion of this study, it was unknown whether theclinical benefits of using ICG in uncontrolled hyper-tension could also be considered cost-effective, Car-dioDynamics said. The short-term cost-effectivenessanalysis demonstrated that the additional BP reduc-tion with ICG care in the CONTROL trial wasachieved at a significantly lower incremental costthan the cost of reducing blood pressure with stan-dard care. ICG care incremental cost per mm Hgreduced was $20 for systolic blood pressure (44% lessthan standard care’s $36 cost per mm Hg reduced)and $23 for diastolic blood pressure (71% less thanstandard care’s $79 cost per mm Hg reduced).

• Celleration (Eden Prairie, Minnesota) reportedthe results of a clinical study on the effectiveness ofMIST Ultrasound Therapy for the healing of chronicwounds. The study was conducted in a tertiary-refer-ral hospital-based wound clinic. Overall, 69% of thewounds in the study were healed using an intent-to-treat model, Celleration said. When low-frequency,non-contact ultrasound (MIST Therapy) was used asa stand-alone device, median time to healing wasseven weeks. Historic controls were healed with amedian time to healing of 10 weeks; however, a sig-nificant number of them required wound-related hos-pitalization and surgical procedures to achieve clo-sure compared with the wounds in the study. Celler-ation says that its non-contact MIST Technology canbe used on a variety of wounds including acute, trau-matic, chronic and dehisced wounds to promotewound healing. MIST Therapy is a bioactive therapyintended to promote healing through cell stimulationwhile removing bacteria. Celleration is the developerof a therapeutic ultrasound platform.

• Cepheid (Sunnyvale, California) has received510(k) clearance from the U.S. Food & Drug Adminis-tration to market its Smart GBS test for Group B Strep-tococcus (GBS) on its SmartCycler platform. SmartGBS is intended for rapid detection of GBS coloniza-tion in pregnant women. The system is designed as aPCR testing platform for hospitals, universityresearch labs and government agencies. Cepheid is amolecular diagnostics company that creates systems



for genetic analysis in the clinical, industrial and bio-threat markets.

• CoreValve (Irvine, California) said its patentedReValving System, consisting of an 18 Fr deliverycatheter, was used to percutaneously implant itsporcine pericardial tissue bioprostheses over theseverely calcified aortic heart valves of an 88-year-oldfemale patient and a 77-year-old male patient — with-out using extracorporeal bypass, other cardiac assis-tance or rapid pacing. The procedures were done atthe Helios Heart Center (HHC; Siegburg, Germany),by Eberhard Grube, MD, chief of cardiology and angi-ology at HHC a consulting professor of medicine atStanford University. Founded in 2001, privately heldCoreValve has developed a delivery system for per-cutaneous heart valve replacement, based on acatheter-and-self-expanding-frame approach on abeating heart, thus avoiding open-heart surgery. TheCoreValve procedure can be done in a cardiac cathlab, the same as angioplasty/stenting, resulting inreduced patient trauma and substantial cost savings,the company said.

• CryoCath Technologies (Montreal) reported 12-month follow-up data on the feasibility stage of theSTOP AF trial. This trial assesses the Arctic Frontcatheter to treat atrial fibrillation (AF). A total of 33patients were treated during the feasibility stage. Atthe six-month mark, eleven of the original 15 patients(73%) were AF free. Of the 11, nine are AF free at 12months and off anti-arrhythmic drugs (AAD's) andtwo did not show up for their one year visits. All orig-inal 15 patients AF-free at six months and that attend-ed their 12-month visit, remain AF free; all original 15patients are off AAD's; and all of the remaining 18patients have similar freedom from AF levels at threeand six months and all are off AADs. CryoCath pro-duces cryotherapy products to treat cardiovasculardisease, the company said.

• Cynosure (Westford, Massachusetts), maker oflight-based aesthetic treatment systems, said it hasreceived FDA clearance for its Smartlipo system forlaser-assisted lipolysis, or LaserBodySculpting, a pro-cedure that disrupts fat cells and causes coagulationof the tissue leading to skin tightening. Laser-BodySculpting uses a small cannula containing a laserfiber inserted into the skin and passed throughout thetreatment area. The laser’s energy is applied directlyto the fat cells, causing them to rupture and drainaway. Treatments with the Smartlipo system general-ly result in less swelling and bleeding as compared totraditional liposuction methods and can usually beperformed in one 45-minute session, Cynosure says.Cynosure develops aesthetic treatment systems.

• Draeger Medical (Telford, Pennsylvania)reports the launch of its newest ventilation system,the Oxylog 3000, into the U.S. market. This system isdesigned for emergency and transport environments.

Its tidal volume begins at 50 ml so it can be used forboth small children and adults. It is also suitable foruse in helicopters and extreme environments.Draeger Medical is a manufacturer of medical equip-ment.

• Eastman Kodak (Rochester, New York) said ithas submitted the final module of a pre-marketapproval submission to the FDA for approval of itscomputed radiography (CR) system for mammogra-phy. The final module contains data and test resultsfrom the clinical trials Kodak has concluded at sever-al sites in the U.S. and Canada. The FDA has alreadyaccepted and closed review of the previously submit-ted modules covering manufacturing informationand non-clinical data. Kodak said the FDA filing is ontrack with its plan to obtain regulatory approval inthe U.S., so that, when approved, the company maybegin selling its Kodak Directview CR Mammogra-phy Feature in the U.S. in 2007. Kodak’s CR mam-mography feature will offer the ability to producehigh-resolution scans for mammography applications(50 microns per pixel — or 20 pixels per mm) whenusing Kodak Directview CR Mammography Cas-settes and EHR-M screens.

• eyeonics (Aliso Viejo, California), developer ofthe crystalens, has introduced the crystalens Five-O,an intraocular lens. The Five-O has been redesignedto include new features: the optic size has beenincreased from 4.5 to 5.0 mm; the plates are parallelrather than trapezoidal; 17% greater surface area forcontact between the optic, plates and capsular bag;90% more plate arc length. Surgeons’ preference for alarger optic led to the development of the redesign,the company said.

• Ethicon Women’s Health & Urology(Somerville, New Jersey) said results from a multi-center, prospective clinical trial showed that nine outof 10 women undergoing treatment with GynecareThermachoice III Uterine Balloon Therapy System totreat menorrhagia, heavy menstrual periods, returnedto a normal bleeding rate or less. The data were pre-sented at the annual meeting of the American Associ-ation of Gynecologic Laparoscopists (AAGL;Cypress, California) in Las Vegas. Women in the 250-patient trial were randomized to receive post-ablationcurettage (PAC) or to no PAC following treatmentwith Gynecare Thermachoice III. The success rates inthe groups were comparable. At the 12-month follow-up, the intent-to-treat analysis showed that 37% ofwomen experienced amenorrhea (no menstrualbleeding). The study also compared this amenorrhearate to that of historic patient-matched controls.Among the intent-to-treat matched patients, theamenorrhea rate was 32.6%, significantly greater thanthe 13.7% reported in the matched patients from theThermachoice I study.

• GE Healthcare (Waukesha, Wisconsin) intro-



duced a new ultrasound imaging system, Voluson E8,with early diagnostic tools for women’s healthcare.Voluson E8 includes new tools designed to improveclinical workflow, including Sonography-based Vol-ume Computer Aided Diagnosis (SonoVCAD), anautomated imaging tool intended to make it easier toacquire volume images of the fetal heart. GE Health-care is a major provider of medical imaging and infor-mation technologies.

• Genzyme (Cambridge, Massachusetts) report-ed commercial availability of cystic fibrosis (CF) genesequencing, a new diagnostic tool that it said candetect about 98% of the more than 1,200 disease-caus-ing mutations in the CFTR gene. Mutations in theCFTR gene can cause CF, as well as other health issuessuch as pancreatitis and male infertility. MaraAspinall, president of Genzyme Genetics, a testingservices provider business unit of Genzyme, said thenew test “will help physicians identify a greater num-ber of patients [who] are impacted by CFTR-relateddiseases, and who otherwise may not have been diag-nosed.” Most genetic CF testing is performed bymutation panels, which detect the most commonCFTR mutations. CF gene sequencing detects themost common mutations, as well as less commonmutations not included in the available mutation pan-els. According to the Cystic Fibrosis Foundation(Bethesda, Maryland), more than 10 million Ameri-cans are carriers of CF gene mutations.

• Instrumentation Laboratory (IL; Lexington,Massachusetts) reported that the FDA has given510(k) clearance for its HemosIL Homocysteine assay,an automated, latex-enhanced immunoassay for thequantitative determination of total L-homocysteine(Hcy) in human citrated plasma on IL CoagulationSystems. Elevated levels of Hcy are associated with avariety of pathologies, particularly those whichincrease risk of cardiovascular disease and venousthromboembolism. HemosIL Homocysteine is thefirst fully automated Hcy assay dedicated to theHemostasis laboratory, the company said. It allowsfor an extended thrombophilia work-up on a singlecoagulation instrument, in combination with otherspecialty assays. Hcy is derived from the metabolismof methionine, an essential amino acid in the diet. Thenormal adult range of total Hcy is 5 umol/L-15umol/L. An increase of 5 umol/L total Hcy corre-sponds to a 27% higher risk of venous thromboem-bolism (VTE). Instrumentation Laboratory makes invitro diagnostic instruments, related reagents andcontrols for use primarily in hospitals and independ-ent clinical laboratories.

• Luminex (Austin, Texas) reported the marketrelease of its pneumococcal assay, developed by itsLuminex Bioscience Group (LBG). Luminex createdthe LBG in 2005 as a response to market demand formultiplexed solutions in emerging bio-assay applica-

tions. LBG’s goal is to identify key assay developmentopportunities and provide effective solutions to bothLuminex partners and xMAP customers. Luminexmakes biological testing technologies with applica-tions throughout the life sciences industry.

• A study published in the Nov. 9 issue of TheNew England Journal of Medicine is expected to instillconfidence in using deep brain stimulation (DBS) totreat dystonia, a neurological movement disorder thatforces parts of the body into abnormal, sometimespainful, movements or postures, according to a state-ment from Medtronic (Minneapolis). The studyshowed that dystonia patients receiving deep brainstimulation experienced significant and sustainableimprovements in motor control and functional abilitywhen compared to patients who did not. The treat-ment — Activa DBS Therapy from Medtronic — usesimplantable technology to send a electrical pulses totargeted areas of the brain involved in motor control.

• Neoteric Technology (Vancouver, BritishColumbia) reported receiving FDA clearance forBloodTrack, a suite of products used in hospitals tomanage blood inventory and ensure safe transfusionsat the bedside. The company said that by using Blood-Track, some locations have experienced a reduction inblood usage by as much as 25%. BloodTrack Courieris a kiosk-based system used at remote refrigerators toelectronically track blood units and monitor invento-ry levels while BloodTrack Hemosafe is a sophisticat-ed refrigerated vending machine that provides con-trolled allocation of blood in locations such as theoperating room and the emergency department. Oncethe blood unit arrives at the bedside, nurses use ahand-held PDA with BloodTrack SafeTx to scan theblood unit and patient’s barcoded wristband toensure the right patient receives the right blood.

• Nikon Instruments (Melville, New York), adeveloper of optical technology, has introduced theMA100, a compact inverted microscope designed forthe observation and analysis of prepped material andmetallurgical samples in the medical, aersospace andelectronics industries. The MA100 delivers brightimages at every magnification, the company said, andcan be connected to digital cameras and image analy-sis software for seamless digital image processing.Using the Nikon Digital Sight Camera and the NISElements software combination enables easy imagecapture and image analysis. The MA100 featuresNikon’s CFI60 objective lenses which produce high-resolution, high-contrast images because of the largeObjective lens barrel size and unique optical design.

• Phadia U.S. (Portage, Michigan) reported thatthe FDA has cleared the EliA CCP, calling it the onlyfully automated assay for the measurement of cycliccitrullinated peptide antibodies, a highly specificindicator in the blood for rheumatoid arthritis (RA),an autoimmune disease. The test expands on the



offerings of Phadia U.S., a division of Phadia AB(Uppsala, Sweden), specifically in allergy testing.These offerings include the ImmunoCAP specificimmunoglobulin E (IgE) blood test to test for aller-gens.

• PLC Systems (Franklin, Massachusetts) said theFDA has granted it a conditionally approved investi-gational device exemption (IDE) to conduct a pilotclinical trial to evaluate the safety of the RenalGuardsystem and its ability to accurately measure and bal-ance fluid inputs and outputs on patients undergoinga catheterization procedure where contrast media willbe administered. PLC hopes to be able to demonstratethrough its future clinical trials that its RenalGuardtherapy effectively limits kidney exposure to toxins incontrast media by generating a high urine flow intreated patients. RenalGuard is a fully-automated,real-time fluid measurement and replacement systemintended to provide balanced replacement hydration

therapy to high risk patients undergoing imagingprocedures where contrast agents are administered.PLC Systems specializes in technologies for the car-diac and vascular markets.

• Quest Diagnostics (Lyndhurst, New Jersey)reported that a recent study in the journal Cancerreported that InSure, its Fecal Immunochemical Test(FIT), detected three times as many early-stage col-orectal cancers and nearly two times as many signif-icant (pre-cancerous) adenomas compared to Hemo-ccult II Sensa(1), the traditional guaiac fecal occultblood test. Of all stage I cancers — where the tumoris limited to the lining of the bowel wall — the InSureFIT was positive in 12 of 13 cases, compared to onlyfour of 13 with the Hemoccult II Sensa (P = 0.002).The study results also showed that the InSure test ismore capable than the Hemoccult II Sensa in detect-ing lower gastrointestinal bleeding in early-stagelesions or significant adenomas. The InSure test had



Abaxis 31Abbott Diagnostics 5Access Pharmaceuticals 13Accuray 26Acton Medical Device 20Acuo Technologies 26Acusphere 12Adeza Biomedical 12Adiana 15Advanced BioScience Laboratories 12Advanced Medical Optics 24Advanced Medical Technology

Association 27Advanced Molecular Imaging 22Advanced Neurmodulation Systems 31Airsep 5Allergan Medical 14ALZA 12American Association of

Gynecologic Laparoscopists 14, 33American College of Cardiology 5American Heart Association 8American Medical Systems 15, 22AMIC 5Anika Therapeutics 14Anlylam Pharmaceuticals 12Antares Pharma 13Applied Digital Solutions 20Ardana 13Artes Medical 32ATS Medical 22Audit Diagnostics 4Avitar 26Axis-Shield PoC AS 4B. Braun 12B. Braun Medical 12Bassett Healthcare 25Bausch & Lomb 14, 24Bayer Diagnostics 4Beth Israel Deaconess Hospital 9Biocompatibles 12Biogen Idec 12Biomedical Instruments 7Biomoda 22Bio-Rad Laboratories 4BioSante Pharmaceuticals 13BioSphere Medical 12, 32Biosync Scientific 22Biovail 13Boston Scientific 15, 31Bradley Pharmaceuticals 13Braun 22Cairo University 21Cambridge-MIT Institute 19Cardiac Care Medical Group 9Cardialysis 26Cardiocom 3, 32CardioDynamics 32Cardiomedix 7Cardiovascular Research Foundation 26Cedars Sinai Medical Center 9Celleration 32

Center for Biological and Environmental Nanotechnol-ogy 29

Centers for Medicare & Medicaid Services 18, 27

Cepheid 32Cholestech 4City of Hope 11Clearant 26Clement Clarke International 7Cleveland Clinic 9Columbia Laboratories 12CoreValve 33CryoCath Technologies 33Cyberonics 23, 31Cynosure 33Cystic Fibrosis Foundation 34CytRx 12Depomed 13DePuy Mitek 14Diagenics 5Diazyme Laboratories 4Digene 19Drager Medical 6, 33Dukal 26Durect 19DUSA Pharmaceuticals 13Eastman Kodak 33ECR Pharmaceuticals 13Edwards Lifesciences 25Egyptian Hypertension Society 21eHIT 3Eli Lilly 13Elite Pharmaceuticals 13EM Vascular 22Energy Lab Technologies 7Esprit Pharma 13Ethicon Women's Health & Urology 33European Society of Cardiology 5eyeonics 33Focus Surgery 20Galderma Pharma 14Galil 16Gamma Medica-Ideas 22gbo Medizintechnik 8GE Healthcare 33Generex Biotechnology 11Generic Medical Devices 24Genzyme 34GlucoTel Scientific 3Greystone Associates 14Gynasonics 16Gynecare 16Gynecare/Ethicon 16Hahn & Hahn 3Howard Hughes Medical Institute 29Hunter-Fleming 13iCAD 26Inditherm 26Infopia 3Informatics Corporation of America 25Innovara 21Inovio Biomedical 12

Insightec 15-16Institute for Healthcare Improvement 30Institute of Medicine 18Instrumentation Laboratory 34Interventional Spine 19Intuitive Surgical 15-16Invacare 5Invectus 15Inverness Medical 6Iridex 22Jacobs School of Engineering 29Johns Hopkins Medicine International 21Johns Hopkins University

School of Medicine 12Johnson & Johnson 12Joint Commission on Accreditation

of Health Care Organizations 18Kaz 22King Pharmaceuticals 13Kyphon 24Laserscope 22Lifestream Technologies 25London Business School 29Luminex 34MAAF Sante 19Madaus 13Mannkind 11Massachusetts General Hospital 9Massachusetts Institute of Technology 19Medicis Pharmaceuticals 14Medtronic 8, 25, 31, 34Merck 11-12Metrika 4Microsulis Americas 17Micrus Endovascular 22Mipharm 13Misonix 20Mitsubishi Kagaku Iatron 5MIV Therapeutics 22Nano-Ditech 4Nanomedics Technology 5Nastech Pharmaceutical 11National Diagnostics Products 4National Health Service 20National Institutes of Health 31Nellcor Puritan Bennett 26Neoteric Technology 34Nikon Instruments 34North American Neuromodulation

Society 31Northern California Kaiser Permanente 9Novartis 12Novomedicus 15NU Design Medical Technologies 26Nycomed 19O.R. Specialties 26Ochsner Clinic 9OrthoMimetics 19Ovion 15Par Pharmaceutical 11Phadia AB 35Phadia US 34

Pharma 11Physio-Control 25PLC Systems 25, 35Polymer Technology Systems 25Premier 26Premier Purchasing Partners 26Procter & Gamble 22Procter & Gamble Pharmaceuticals 11, 13Provalis 4Quest Diagnostics 35Quinecrine pellets 15Quotient Diagnostics 4Radiant Medical 36Respironics 5Rice University 29Roche Diagnostics 4Safe-com GmbH & Co. 3Sand County Biotechnology 4Sangamo BioSciences 25Sanofi-Aventis Egypt 21SeQual 7Siemens Medical Solutions 26Siemens/Bayer Diagnostics 4Sinai School of Medicine 16Sirius Laboratories 13Sirna Therapeutics 11Smiths Medical 26Smiths Medical ASD 26Spallanzi National Institute 20St. Bartholomew's Hospital 4St. Francis Medical 24St. Jude Medical 36Stanford University 26Stereotaxis 36Sunrise Medical 5Talecris Biotherapeutics 21Talecris Biotherapeutics AG 21Teva Pharmaceutical Industries 13Texas Medical Branch 14Thomas Jefferson University 17Toshiba America Medical Systems 36Transport Pharmaceuticals 12Tyco Healthcare 26UCB-Celltech 13University College London 29University of California San Diego 29University of Cambridge 19University of Massachusetts Medical School 12University of Mississippi 16University of Texas 15University of Western Ontario 16Vanderbilt Medical Center 25VasCon 22Vascular Control Systems 16VeriChip 20Viatronix 26Volcano 26Vyteris Holdings 12Wristop Technologies 8Wyeth 12ZRO-Operculum 15

Companies and organizations in this issue

a marginally higher false-positive rate than didHemoccult II Sensa (3.4% vs. 2.5%, respectively). Thisdifference was due to difference in false-positiverates became statistically insignificant (1.2% vs. 1.3%,respectively for the InSure and Hemoccult II Sensatests). InSure FIT is a test using anti-human hemo-globin antibodies highly specific to human globin,the primary protein in blood that is released in stoolwhen cancer and significant pre-cancerous adenomasare present in the colon and rectum. In contrast, gua-iac-based fecal occult blood tests detect peroxidaseactivity of heme — the part of hemoglobin that con-tains iron — in feces; dietary peroxidases and hemefrom red meat may cause false positives.

• Radiant Medical (Redwood City, California)reported initiation of its COOL RCN trial, a safety andefficacy study of catheter-based cooling in patientsundergoing cardiac catheterization who are at risk ofdeveloping radiocontrast nephropathy (RCN). TheReprieve Endovascular Temperature Therapy System isdesigned to enable the rapid induction of hypothermiain a conscious or unconscious patient by use of avenous heat exchange catheter. A catheter is threadedinto the femoral vein and positioned in the inferior venacava. As cool sterile saline is circulated within thecatheter, blood flowing past the catheter is cooled, andthe blood then reduces the body temperature. Torewarm the patient, the sterile saline within the catheteris simply warmed. Radiant Medical develops endovas-cular temperature therapy systems to advance the treat-ment of patients with acute ischemic or inflammatorymedical conditions, such as heart attack, radiocontrastnephropathy, stroke and cardiac arrest.

• Stereotaxis (St. Louis) reported FDA 510(k)clearance of its Niobe magnetic navigation systemused in neurovascular and peripheral applications

with the company’s family of Cronus magnetically-enabled .014” vascular guidewires. Stereotaxis previ-ously received FDA clearance to use the Niobe Systemand Cronus guidewire family in coronary vasculatureprocedures only. The Cronus guidewire family willnow integrate with the Niobe magnetic navigationsystem to provide precise magnetic guidewire navi-gation in coronary, neurovascular and peripheralanatomy. Stereotaxis manufactures cardiology instru-ment control systems used in the interventional sur-gical suite for the treatment of coronary artery diseaseand arrhythmias.

• St. Jude Medical (St. Paul, Minnesota) report-ed FDA approval of its new tachycardia softwarefor the Merlin Patient Care System, a computerused to program and interrogate cardiac rhythmmanagement devices like pacemakers andimplantable cardioverter defibrillators (ICDs). TheMerlin Patient Care System, which received FDAapproval in April 2006, is a programmer designedto help physicians more efficiently conduct testsand analyze therapeutic and diagnostic data.

• Toshiba America Medical Systems (TAMS;Tustin, California) said it received FDA clearance for anew CAN Level 1 injector synchronization option forits Aquilion 64- and 32-slice computed tomography(CT) systems. The new option facilitates contrastenhanced CT exams by interfacing the CT scanner toa contrast injection system — giving clinicians theoption to activate the contrast and the scanner with-out leaving the patient’s side. The new injector proto-col will be available on all Aquilion CT systemsequipped with Toshiba’s Version 3.0 software and isfield upgradeable. Version 3.0 software supports syn-chronization of the injector and CT system using theLevel 1 scan protocol option.



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