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Enquiry No 2

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In The Next Issue

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FROM THE EDITORDear Doctor

SURGEON AS ENTREPRENEURObtaining Patent Rights to the Invention

SURGEON AS ENTREPRENEURPeter Bonutti, M.D.

IN-HOUSE DME INVENTORY MANAGEMENT ANDBILLING USING A THIRD-PARTY MANUFACTURERMAKES FINANCIAL SENSEArticle By Serian Frahm

FUTURETECHEmerging Orthopaedic Technologies and Treatments

ORTHOINVESTOR UPDATEIncluding Ticker Track and Company Performance

EXECUTIVE PROFILEAndre Bessette, Director of Marketing, Instruments, ArthroCareSports Medicine

PRODUCT NEWSProduct News Section

PRODUCT LIABILITY EXPOSURES OF START-UPORTHOPAEDIC COMPANIESArticle By Michael Cremeans

ENTREPRENEURIAL EVENTS CALENDARA comprehensive guide to alternative meetings and events

FISCAL FITNESSLooking Back at 2005 - The Good, the Bad and the Ugly

SURGEON AS ENTREPRENEURDavid Kirschman, M.D.

SPECIAL FEATUREC. Scott Harrison, M.D.

PRODUCT FEATURESAAOS

THE TOP LINEThe Basics of Negotiating with Industry

HERE’S TO YOUR WEALTHCreating an Effective Financial Plan

January/February 2006

Published in the U.S. by: Knowledge Enterprises, Inc.Address: 147 Bell Street, Suite 303, Chagrin Falls,

Ohio 44022 USATel: 440-247-9051 Fax: 440-247-9053

Web Site: www.orthoworld.com

Editor in Chief: John Engelhardt - [email protected] Editor: Julie Vetalice - [email protected] Editorial Consultant: Ann Monk - [email protected]

Production Coordinator: Julia Ewell - [email protected]: April Bright - [email protected]

Every effort is made to ensure that information given in this magazine is accurate but no legalresponsibility is accepted by the Editor or Publisher for errors or omissions in that information.Readers are advised to contact manufacturers directly. Views expressed by contributors are not

necessarily shared by OPN.

Copyright © 2006 Pelican Magazines Ltd and Knowledge Enterprises, Inc.

Upcoming IssuesMay/June 2006Fixation & Trauma and Hand Surgery

July/August 2006Revision & Custom Implants and Hip & Knee Surgery

Submissions or enquiries to any future issues of OPN can be emailed [email protected].

USA February 20/1/06 2:44 pm Page 4

January/February 2006 • Orthopaedic Product News 5

FFRROOMM TTHHEE EEDDIITTOORR

Dear Doctor,As we move into a new year, we here at OPNwish each of you continued stellar success,both personally and professionally. We areexcited to be joining you on your journey intothe future, and hope that this issue providesmore key information that will help you bestprepare yourselves for the comingchallenges.

To start us properly on our sojourn into 2006,orthopaedic market diva Shirley Engelhardtreviews 2005 and the events that might mostshape the future.

We have three fascinating glimpses of surgeon entrepreneurs. Dr. David Kirschman shareswith us his story and some sage advice on the trials and tribulations of a practicing surgeonbuilding his own spine company. We are honored to be able to include an interview withDr. Peter Bonutti, who is a prolific inventor, pioneer in minimally invasive surgery and theCEO of a successful technology development company. His insights into the process ofinnovation are especially illuminating. Finally, we provide an interview with Dr. ScottHarrison, whose orthopaedic life has traversed successes as a surgeon, corporate CEO andfinally benefactor, through his non-profit charity, CURE International.

Teresa Ford provides another highly erudite and timely discussion, this time on the basicsof agreements between surgeons and industry, and insurance expert Mike Cremeansexplains the requirements of product liability coverage for start-up companies. In one ofour most anticipated features, Perry Van Over continues with the next golden rule ofintellectual property.

A fascinating article by Serian Frahm explains the details and opportunities of alternativerevenue streams though in-house durable equipment programs, and in his second install-ment on wealth accrual and preservation, financial guru Jeff Mackevich takes youpainlessly through the financial planning process and provides a free financial checkupspecifically designed for orthopaedic surgeons.

With the AAOS approaching, we have included an overview of exciting products to beshowcased there, with a special emphasis on Arthroscopy. That focus is especiallysharpened by our executive interview with Andre Bessette, who shares with you hisperspective on ArthroCare, a true innovator in the space.

You have our continued commitment to provide you with expert, accurate and state of theart commentary and practical wisdom on issues most dramatically affecting you assurgeons. Your ongoing assistance in fulfilling this commitment is essential.

John A. EngelhardtEditor in Chief

ANDRER

-UP


6 Orthopaedic Product News • January/February 2006

SSUURRGGEEOONN AASS EENNTTRREEPPRREENNEEUURR

Previous installments in this series of articles pointed out specific stepsin the pathway to obtaining patent protection that an inventor shouldtake, and also identified certain pitfalls to avoid. Importantly, while theinventor must step very carefully along this path, it is critical that he keephis eyes on the prize and take care not to lose sight of the intended goal:obtaining the patent.

Years ago, when I flew for the Marine Corps, young aviators intraining were commonly told to “keep your head out of the cockpit.”Other equally overworked reminders, such as “stay ahead of youraircraft,” have been recited to young steely-eyed aviators over the pastcentury with the same meaning, which is, avoid focusing so intently onincremental matters that you lose sight of where you are going. Thelesson for the young pilot learning to fly and the surgeon inventorembarking on a journey down a strange, untraveled pathway to patentprotection is the same: know where you are going before you start thejourney and don’t focus so intently on immediate issues as to lose sightof the goal.

This installment provides the surgeon inventor with an understandingof where the patent pathway leads and how a failure to exercise realisticplanning for the journey can lead to a far different destination than thatwhich was originally intended.

In addition to the noble motivation of most inventors to discover newand useful devices or methods that will benefit mankind, the commer-cialization of the invention is an almost universal outcome.Commercialization of the invention was briefly discussed in an earlierinstallment article only for the purpose of informing the inventor thatpremature sales or offers to sell the invention could thwart his efforts toobtain patent protection. Here, commercialization of the invention willbe discussed in terms of its legal foundation in the patent laws of the U.S.

It is the provision of an exclusive right for the inventor under Section8 of the U.S. Constitution that serves as the basis for our patent system.When an inventor obtains a patent for his invention, he is given the rightto exclude others from making, using or selling his invention for aprescribed number of years.

Obviously, such an exclusionary right provides the opportunity for theinventor to take advantage of a period of time when it is possible to enjoya relative monopoly market environment and thus realize a commercialreward for his inventive work.

The stepping stones that have been thus far identified in this series ofarticles lead to a destination of potential commercial opportunity for theinventor; a commercial opportunity that can be seen as a coin having twosequentially viewed aspects: 1) obtaining patent protection for the invention, and 2) enforcing the patent holder’s exclusionary right.

Obtaining Patent Rights to theInvention

This article is directed to the first of these aspects, and at this time,only U.S. patent protection will be discussed. Foreign patent protectionas well the enforcing of patent rights will be addressed in later install-ments.

As suggested in my earlier analogy of the aviator, the inventor mustconstantly remind himself that while dealing with the details of each stepin the pathway, he must also keep his eye on his ultimate goal ofobtaining the broadest possible patent protection consistent with theconcept of his invention.

In planning the patent application and establishing the goal ofobtaining an issued U.S. patent, the inventor must view his inventiveconcept in the light of the relevant commercial market. It is also criticalthat the inventor recognize that the relevant commercial market is fluidand always subject to change. In the current environment, a patentapplication may require two years or more from the date of first filing tothe issuance of a U.S. patent. For this reason, when the inventor and hispatent attorney discuss the plan for drafting the patent application,considerable foresight and contingency planning must be given to themany possible uses for the invention and changes in the relevant market.

In the normal course, an inventor recognizes a particular need that isnot met by conventionally available technologies. The initial inventiveconcept is directed specifically to that perceived need. Often, the initialconcept proves to be only the first movement in a cascade of ideas thatmay prove to have additional uses and advantages not directly related tothe initial need recognized by the inventor. This serendipitous expansionof useful ideas from a singular initial inventive conception is notuncommon; it is more to be expected than not.

Critical to recognizing the expansive value of an invention is theinventor’s study and understanding of the relevant commercial market inwhich his invention will be useful. In the drafting of a patent application,the inventor must consider what would happen if the invention weremodified slightly for a different use, or made of different materials, oremployed with another device to create an altogether different usefuldevice or system. In exploring such possibilities, many inventors havediscovered additional uses that far surpass the originally recognizedcommercial value. In drafting the patent application, it is extremelyimportant that claims be prepared to protect what the inventor sees as thecommercial embodiment of his invention. To provide the broadestpossible protection, claims should also be drafted to include as manypossible variations or embodiments of the invention as can beenvisioned. The patent application should not be merely a technicalwriting exercise directed to the basic concept of the invention, but

Author: Perry E. Van Over, Esquire

continued on page 7




instead should include reflections of the foresight and vision of theinventor.

In the first aspect of commercialization, that of obtaining patentprotection, the inventor must recognize that the patent is the legaldescription of his intellectual property. Much like a title to real estate, theissued U.S. patent specifically limits the metes and bounds of theinventor’s intellectual property.

Without the granting of a patent, the invention will simply be donatedto the public and others will quite legally reap the financial benefits ofthe inventor’s unclaimed intellectual property.

A critical consideration for the inventor is the obtaining of the earliestpossible priority date (first filing date). As discussed in an earlier article,the inventor must keep careful records to prove the date of conception ofthe invention, and such records can potentially be of great value.However, to firmly establish a date of constructive reduction to practice

for the invention, which will be recognized by both U.S. and foreignpatent authorities, it is important that a description of the invention befiled in a patent application as soon after conception of the invention aspossible. This initial filing can be accomplished by filing a ProvisionalPatent Application, a Non-Provisional (Utility) Patent Application, or aPCT (Patent Cooperation Treaty) Application (recognized by all membercountries). PCT Applications generally relate to foreign patent filings,which will be discussed in a subsequent article.

It is often the case that the inventor, having discovered the basicconcept of the invention, will for a time continue to develop and moreclearly define certain aspects or embodiments of the invention and thusnot be fully prepared to file a complete Non-Provisional PatentApplication that is ready for examination on the merits. In such cases, theinventor can file what is known as a Provisional Patent Application withthe U.S. Patent and Trademark Office (USPTO).

continued on page 8

continued from page 6

If you have developed a new or improvedsurgical techniqueand would like to share it with yourcolleagues, please send details to us and we will feature it in future issues.

Send your emails to: [email protected]

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A provisional patent application can be less extensive and writtenwith less expense than a Non-Provisional (Utility) application, and thuscan be filed more expediently to establish an early priority date. Further,the filing fee for a Provisional Patent Application is very inexpensivebecause the Provisional Application will not be examined by a patentexaminer. After one year, it will expire. The Provisional PatentApplication serves to simply establish a priority date with the U.S. PatentOffice. If, within one year of the Provisional Patent Application filingdate, the inventor files a Non-Provisional (Utility) Patent Applicationclaiming priority to the first filed Provisional Application, the patentexaminer will only consider information published prior to theProvisional Application filing date as prior art to the invention. Thus, aProvisional Application serves as a placeholder to allow the inventor anadditional year to expand and improve his written description and toprepare his claims to the invention for filing in a Non-Provisional PatentApplication.

As indicated above, the Non-Provisional (Utility) Patent Applicationis generally written in more detail and with expanded support for theinvention described in the original Provisional Patent Application. Itshould be noted that there is no requirement to file a Provisional PatentApplication prior to filing the Non-Provisional Patent Application. Awell-prepared and expeditiously filed Non-Provisional PatentApplication will be entered into the examiner’s queue for full examina-tion as much as one year earlier than in cases where a Provisional PatentApplication filing preceded the Non-Provisional Application filing.

While a Provisional Patent Application must simply provide a specifi-cation having a sufficient written description and enabling disclosure ofthe invention, the Non-Provisional Patent Application must also includeat least one claim. In both applications, if drawings are required to fullyunderstand the written description, they must also be included.

The specification of a patent application can be relatively brief orquite lengthy depending on the description that is required for a partic-ular invention. It provides a description of the invention and a teachingof how to make and use it. Importantly, the description and the enablingdisclosure that is provided must be directly related to the invention asdefined in the claims of the application.

Much like a participant in an historic land rush, the inventor identifiesthat property to which he is laying claim by placing stakes or markers atthe borders of his possession. In a patent, the intellectual property isprecisely identified by carefully chosen and arranged words (rather thanstakes), which are placed in a single sentence known as a “claim.” Anapplication can and generally does have more than one claim; each onebeing somewhat different from other claims in the same application.

For example, an invention of a device upon which a person can sit canhave a first numbered claim to a surface upon which a person can sit, thesurface being attached to four legs which support the seating surfaceabove the floor, while a second numbered claim can be identical to thefirst with the addition of another element, an attached chair back toprovide back support of the person using the chair. Again, no matter howmany claims are included in the application and how they may vary onefrom the other, it is important that anything included in any claim of thepatent must have descriptive support in the specification of the applica-tion.

The above recitation of the basics of a patent is remedial informationfor many readers, but is provided as a reminder that the content of thespecification and the invention defined by the claims must be approached

with extreme care. It is not uncommon for one or more claims in anapplication to fail examination simply because care was not taken toensure that the content of the failed claim was adequately described andenabled in the specification. When an inventor is assisting his attorney inthe preparation of a patent application, the inventor must not forget thatany elements, details of shape or materials, alternative embodiments orany other disclosure that is omitted from the patent can be costly.

After the Non-Provisional Patent Application is filed with theUSPTO, it cannot be revised to add new matter that was entirely omitteddue to haste, neglect or any other reason. Such omissions can only becorrected by filing a subsequent and separate Non-Provisional PatentApplication. This new application is referred to as a Continuation-in-Part(CIP) Application because it continues the description of the originalUtility Patent Application in part and additionally may contain newmatter or information. Unfortunately, the newly added matter will onlybe entitled to a priority date of the second filed application. This can becritical if the new matter added is essential to obtaining a patentallowance from a Patent Examiner and an intervening publication of thatnew matter took place before the CIP filing date.

Finally, the inventor must be aware that the examiner’s duty to thepublic is to examine the patent application so thoroughly as to not allowan issued patent for an invention that was already described in the priorart. For that reason, the patent prosecution process can be long, tedious,and at times discouraging for the inventor. After all is done and if it somerits, the allowed patent will be issued and the inventor can lookforward to the next aspect of commercialization of the invention, that ofenforcing his patent rights against infringers. That topic will be discussedin a subsequent article.

The intention of this series of articles is only to acquaint the readerwith the need to exercise due care in seeking patent protection for aninvention and to call attention to some of the frequently encounteredpitfalls that lie along the pathway to obtaining patent protection. As such,these articles are not intended as legal advice, but as a caution that properlegal counsel should be engaged by anyone seeking to obtain patentprotection for an invention.

Perry E. Van Over is a partner in the Washington, DC law firm ofManelli Denison & Selter PLLC (www.mdslaw.com), specializing inpatent procurement, licensing and litigation in the technical fields ofsurgical instruments, medical devices, molecular biology, pharmaceuti-cals, biochemistry and polymer chemistry. He can be reached at 202-261-1051 or [email protected].

Expeditiously obtain patent protection inthe relevant market

THE GOLDEN RULES OF INTELLECTUAL PROPERTY

#9


Enquiry No 24


Enquiry No 3




OPN: What first inspired you to establish your own developmentcompany?

Peter Bonutti, M.D. (PB): Dr. Arthur Steffee gave me initial inspirationand guidance. I met him during my internship and worked with himthrough his residency. During this time he pioneered a number of surgi-cal techniques and orthopaedic implants, going on to found AcroMed,which is now DePuy Spine, a Johnson & Johnson company. I watchedhow he developed his ideas to prototypes, patents and ultimately surgi-cal procedures—taking an idea and developing it to the point of a suc-cessful product. Some were licensed to companies and others werebrought into his own research facility for prototyping. This led me tounderstand that ideas alone are useful, but developing these ideas intoprototypes, patents and working surgical products is where true valueexists. In fact, in 1989, I bought the research facility he used, which wasmy primary motivation to move to Effingham, Illinois.

OPN: What caused you to decide to license your inventions to existingcompanies instead of starting your own?

PB: I’ve actually taken two separate paths. The Bonutti Group is a net-work of medical device and research companies dedicated to improvingpatient care. It includes Joint Active Systems (JAS), which offers a lineof rehabilitative devices.

We also have surgical instrumentation device companies includingMultitak, TranSet and Unity. On the other hand, some inventions are bet-ter in the hands of large corporations which have strong marketing andsales organizations.

In licensing inventions, we look for a partner with strong marketing,sales and regulatory experience, but especially those that have marketingplans with a future surgical vision.

OPN: How do you go about selecting the optimal company to license to?

PB: We assess many factors that vary depending on the technologies weare developing. However, some universal factors include whether com-panies are forward thinking, aggressive about marketing new technolo-gies and have the sales force to distribute the technology. It is also criti-cal that companies have a track record of dealing with innovators in anhonest and forthright manner.

OPN: What would you say is the most important lesson in entrepreneur-ship that you have learned?

PB: You must be willing to invest your own money and time and take therisk before you involve others. If you believe in an idea, you must stickwith it through the development cycle. You can’t expect others to do allthe work for you.

Too few surgeons are willing to take a personal risk in terms of time,but especially financial risk—putting their own money on the line todesign, develop, prototype and protect their ideas. Also, one must investin good patent and legal counsel.

Peter Bonutti, M.D.

Peter Bonutti is unique in the world of entrepreneurial orthopaedics. A renowned orthopaedic sur-geon, he is responsible for significant advancements in knee surgery, including several pioneeringminimally invasive techniques. He is also a prolific inventor, holding more than 100 patents onorthopaedic devices, implants and instrumentation.

In addition, Dr. Bonutti has created several successful companies and products, including BonuttiResearch; Joint Active Systems, a novel rehabilitation system; Multitak®, a minimally invasive softtissue fixation system; Unity®, a suture fixation system; and TranSet®, an endoscopic fracture repairsystem. He has licensed a number of patented technologies firms such as Hitachi Medical and Tyco—General Surgery.

He recently shared his insights with U.S. Orthopaedic Product News.

continued on page 11




OPN: Do you feel that the industry at large has responded adequately tothe needs of orthopaedic surgeon inventors?

PB: Not really. The industry looks to surgeons for ideas, but doesn’t helpthem develop their ideas to mutually beneficial ends. I have spoken tomany colleagues who resent the fact that companies often link develop-ing a surgeon’s ideas with the surgeon’s use of a company’s products.Companies would be better off educating surgeons about the develop-mental process, including how to best partner with a company. Somecompanies are looking for surgeons more as marketing spokesmen for aproduct.

I would recommend that a company assist the surgeon in developingan idea to the point of a provisional patent application. This is a strategythat is not costly for the company. If the company then decides not to pur-sue the idea, the surgeon at least has the basis for idea protection or forproduct protection. When the patent and development process is delayed,the surgeon loses time that is critical when it relates to intellectual prop-erty protection.

OPN: For your colleagues who wish to commercialize their inventions,what advice can you provide?

PB: Even if you consider yourself a clinician/scientist/inventor, youmust be a business person as well. One should understand the productand product development cycle from the corporate side, especially howmuch time and cost is involved with taking a product from conception tocommercialization. Again, the surgeon must be willing to take at leastsome financial risk to help develop the product.

OPN: What are your plans for the future?

PB: We have two development paths ahead of us. One is evolutionary—developing minimally invasive surgical techniques and instrumentation,which will continue to be a major focus for our research. Also, advancesin orthopaedic health will continue the unique work environment thatmarries research at Bonutti Technologies with clinical practice at theBonutti Clinic. The Bonutti Group is also a think tank. We have a revo-lutionary track with a goal of linking the medical device industry with thepharmaceutical and biologic industries. We are developing and workingas an overall innovative center.

Dr. Bonutti can be reached at [email protected].

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Enquiry No 25

Enquiry No 4



AARRTTIICCLLEE

IntroductionThis article will illustrate how an orthopaedic practice moved theirdurable medical equipment (DME) service in-house and set up inventorymanagement and billing procedures needed to ensure success. Manypractices across the U.S. are realizing the benefits in both revenue andpatient care that can be gained from taking control of their DME process.Ancillary revenue is a prevalent topic around the U.S. and mainlyincludes MRI machines, surgery centers and physical therapy clinics.However, in-house DME is also on the rise and it may become asignificant source of revenue for the practice when it is implementedeffectively.

Our case study is SportsMedicine Grant (SMG), an orthopaedicpractice that implemented an in-house DME consulting program andinventory management system in 2004. The following will discuss theirsituation prior to bringing their DME in-house, their reasons for doingso, how they implemented their new processes and what the resultsactually show.

BackgroundSMG consists of six physicians, three of whom are orthopaedic sportsmedicine surgeons: Raymond Tesner, M.O., Randall Wroble, M.D. and

Rodney Comisar, M.D. Previously, they used a revenue-sharing DMEmodel, mainly dispensing bracing and soft goods. Their primary reasonfor making the in-house change was to increase their revenue stream andhave improved control over product offerings and patient care. Dr.Tesner tells us, “After a year, we have found it to be much more of afinancial advantage for us to take (DME) in-house as opposed to havingit managed by an outside firm.”

The first step was to choose a consultant to educate them on the mostefficient way accomplish their goals. When moving DME in-house,consideration must be given to the payer mix of your patients; the codingfor products; and how to submit and receive claims, manage inventory,track your expenses and streamline all activities to ensure maximumefficiency. The group decided upon an orthopaedic manufacturer’sconsulting program because of the expertise and experience of the groupand the hands-on attention to detail.

Challenge: Bring DME solutions in-house, minimizing ramp-up time • Select group to consult and teach the practice on DME in-house• Train staff on processes involved in DME implementation• Streamline inventory management processes to increase efficiencies• Minimize inventory shrinkage and time spent managing the process• Become profitable in DME within a year of implementation

ImplementationSMG began their in-house DME process in May 2004. A consultantvisited the practice to complete a pro forma evaluation and discuss theimplementation process with the group. The pro forma gave the practicea snapshot of what revenue could be based upon payer and product mix.After completing the pro forma, a coordinator was hired to oversee theprogram. In addition, the manufacturer set up a visit to an existingaccount to illustrate a practice that is up and running successfully withthe program.

During the first few months of implementation, the practice had somedifficulty setting par levels and maintaining inventory. They frequentlyhad an excessive amount of some items and were completely out ofothers. Inventory had to be counted twice a week, taking 30-45 minuteseach time. Additionally, they had to drive to satellite offices every weekfor a physical count.

A decent amount of inventory shrinkage occurred when braces wereput on patients without the completion of a bill slip. The practice alsocarried too much inventory at one time, overstocking rooms and takingup space with items sitting on shelves for extended periods. A moreefficient inventory management solution was needed.

In-house DME InventoryManagement and Billing Using aThird-party Manufacturer MakesFinancial Sense

Author: Serian Frahm

Interested in sharing your wisdom with fellow surgeons in

future articles of OPN?

Editorial content and topics of interest are always

welcomed.Contact OPN at: [email protected]




AARRTTIICCLLEE

Enquiry No 5

Enquiry No 26

Part of the reason they chose the program they did was the inventorymanagement system. This web-based software solution enabled the useof barcode scanners to track all inventory. By implementing this systemthe practice consolidated all ordering, had greater visibility of all itemson the shelf at any time, and could view inventory at satellite offices andreduce the frequency of physical inventory counts. Within a few monthsinventory had decreased significantly, freeing up more room for chartsand x-rays.

The practice now stocks a four-day supply of items on the shelves,with a few extra of more widely-used items. They must place ordersmore frequently, but they are still spending much less time each week oninventory management.

Further, SMG noted an increase in patient convenience and comfort.By keeping the correct inventory stocked at satellite offices, they havenearly eliminated additional travel to pick up braces that were not onhand for a patient’s original visit. Serian Frahm, the OrthoSelectcoordinator for SMG, says, “Essentially, when a patient schedules anappointment, she has the ability to be seen by a doctor, have x-rays,complete an MRI, schedule surgery and obtain pre-op medicalequipment and instructions as well as physical therapy at ALL of ourlocations. This convenience alone can be responsible for numerousreferrals and return business.”

ResultsWith over a year of the program under their belts, Dr. Wroble estimatesthat the group is making $17,000 per month with minimal shrinkage. Inhis opinion, the doctors needed to have their hands in the program frominception to ongoing management.

The practice has weekly, monthly and quarterly meetings to ensurethe same level of success and efficiency and to track processes that needto be adjusted. It took a little less than a year to arrive at a profitableventure.

The group knew that it would not be an overnight miracle, but withdiscipline and the right guidance and processes in place, they wereconfident that it would be a positive situation. Dr. Tesner remarked, “Thebottom line is that it is no more of a hassle and we make more money,therefore it seems to be a no-brainer that this was a good move for us tomake.”

Contributors to this article include Raymond J. Tesner, M.O., Randall R.Wroble, M.D. and Serian Frahm of SportsMedicine Grant. To contactany of the physicians or coordinators about their experiences, please feelfree to call SportsMedicine Grant at 614-461-8174.

Robin Young, CFA, award winning 27-year orthopedic industry analyst - named "Best on the Street" by the Wall Street Journal - named top tenHome Run Hitter by Institutional Investor Magazine - continues his series of leading technology summits with this March's Stem Cell Summit. 25Presenters. Leading stem cell companies. Chicago, IL

The use of stem cells, specifically MSCs, to grow bone, repair cartilage and in general improve orthopedic patient outcomes in both the OR andon an outpatient basis is an emerging reality for today's orthopedic practitioner. One thing we know for sure - stem cells will transform the prac-tice of orthopedics. Hear from both surgeons who are using adult stem cells and research scientists. (To date, we estimate, 300 patients havebeen treated with stem cell therapies.)

Past Robin Young Organized Conferences

2004 Dynamic Stabilization Chicago2004 Surgical Biomaterials New York2003 Spine Industry Summit New York2002 Anti-Cancer Conference San Francisco2001 Surgical Biomaterial New York2000 Surgical Glues and Adhesives New York

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Attend In-PersonView WebcastReceive Podcast To Receive Stem Cell BookGO TO: www.ryortho.com




FFUUTTUURREETTEECCHH

Under Medicare’s 2006 Physician Fee Schedule, payments to physicians for totalhip and total knee arthroplasty procedures will fall by 5% from 2005 rates to$1,321.88 and $1,427.92, respectively.

(CMS.HHS.gov, 11/2/05)

To remove cervical spine tumors, a surgeon has developed the lateralparamedian transpedicular approach that offers direct access to tumor removalwith minimal or no neural manipulation. Following tumor removal, the spine isrebuilt with pedicle screws.

(University of California - San Francisco, 11/4/05)

More than 200 surgeons at HCA hospitals have agreed to participate in a savingsprogram similar to gainsharing, and ~40 surgeons have switched device brandsto participate. HCA’s program includes only devices from DePuy, Stryker andZimmer.

Under the plan, an orthopaedic surgeon may receive 20% of price savings whenswitching to a preferred device, and 15% if currently using one. Surgeons doingrevision work may use any brand, and those who wish to use a non-preferred devicemay petition HCA for an exception.

(New York Times, 11/18/05)

Studies suggest that people whose bodies lack selenium run a higher risk ofdeveloping knee osteoarthritis.

(News-Medical.net, 11/20/05)

Research suggests that overweight children appear to have fractures and hipjoint problems more often than their peers of normal weight.

(Associated Press, 11/21/05)

A draft bill, tentatively titled Maintenance and Improvement of Hospital Qualityand Performance Act of 2005, requires hospitals to make available “therapeuticequivalent medical products” that are excluded from gainsharing programs. Further,the bill would authorize 3-year initial demonstration projects, which would bevoluntary, and would require hospitals to create steering committees to monitorgainsharing programs.

(Health News Daily, 11/21/05)

A new study indicates that older women who undergo pelvic radiation to treatcancer may have an increased risk of pelvic fracture. These women could betargeted for preventative strategies such as bone mineral density screening, drugtherapy to prevent osteoporosis and fall prevention.

(Journal of the American Medical Association, 11/22/05)

Three primary care trusts in the U.K. have ruled that patients with a body massindex (BMI) over 30 will be denied hip and knee replacements under the NationalHealth Service as a means of cutting costs.

Those with a lower BMI may have to try painkillers or therapy beforeconsideration, and guidelines state that surgery will only be performed if pain anddisability interfere with daily life and sleep.

(Daily Mail, 11/23/05)

Emerging Orthopaedic Technologies & Treatments

ArcTec Semi-Rigid Plating System(ALTIVA)

Artelon Surgical Suture(ARTIMPLANT)

Ascension MUH Ulnar Prosthesis(ASCENSION ORTHOPEDICS)

Tricos T Bone Void Filler(BAXTER HEALTHCARE)

Navigation SW Hip 3.1(BRAINLAB)

GII Spinal Fixation System(CO-LIGNE)

Collagen Bone Healing Protective Sheet(COLLAGEN MATRIX)

Fragment Specific Fixator(DAVID J. SLUTSKY, M.D.)

Wrist Fusion Plate(DVO EXTREMITY SOLUTIONS)

Expanse Vertebral Body Replacement Device(FLEXUSPINE)

Lunar iDXA(GE MEDICAL SYSTEMS ULTRASOUND)

External Fixation(GEXFIX USA)

Global Resurfacing Unicompartmental Knee System; RBK Patella Femoral Knee

(GLOBAL ORTHOPAEDIC TECHNOLOGY)SmartSuction Harmony Device

(HAEMONETICS)S-1 Biodegradable Anterior Cervical Plate; OTPS Biodegradable Distal Radius Plate

(INION)Tectonic Cervical Plate System

(K2M)Optium DBM Gell and Putty

(LIFENET)Skelite Resorbable Cement Restrictor

(MILLENIUM BIOLOGIX)OCT (Osteochondral Transplant) Comprehensive System

(OSTEOBIOLOGICS)Grafton Plus DBM Paste

(OSTEOTECH)Equator Plus Acetabular Cup System

(PORTLAND ORTHOPAEDICS)Ligafix Resorbable Interference Screw

(SCIENCES FOR BIO MATERIALS)Scient’x Cement Restrictor; Stella Cervical Plate

(SCIENT’X)Kimba Spinal Implant

(SIGNUS MEDIZINTECHNIK)SBI Autofix

(SMALL BONE INNOVATIONS)Control Digital Operating Room System

(SMITH & NEPHEW)Topez Total Ankle Replacement

(TOPEZ ORTHOPEDICS)Spider Cervical Plating System

(X-SPINE SYSTEMS)

FDA 510(k) releasable database 10/05 and 11/05

Recent FDA ClearancesIssued October and November 2005



OORRTTHHOOIINNVVEESSTTOORR UUPPDDAATTEE

Ticker Track (Based on close of business, 11/30/05)

Ticker 52-Wk 52-Wk Chg vs. Chg vs. Company Symbol High Low Close Prior Mo. Prior Yr.

aap † AAQ 2.4 1.46 2.20 1.9% 16.4%

ArthroCare ARTC 41.74 25.32 38.26 4.2% 26.4%

Biomet BMET 49.64 32.50 35.64 2.3% -25.5%

co.don AG † CNW 9.01 0.62 3.20 -42.7% 180.7%

ConMed CNMD 32.61 22.33 22.60 -5.8% -22.0%

Corin Group †† CRG.L 7.10 5.10 5.81 -0.9% -12.1%

curasan † CUR 4.39 2.10 3.06 -7.0% N/A

Cytori Therapeutics † XMPA 9.25 2.11 8.13 21.0% 160.6%

dj Orthopedics DJO 31.93 19.84 31.25 7.5% 54.9%

Encore Medical ENMC 7.18 3.86 5.24 4.6% -16.7%

Exactech EXAC 19.73 10.86 12.92 -0.2% -30.9%

Hanger Ortho Group HGR 8.89 4.45 6.33 3.1% -18.8%

Inion †† IIN 3.62 1.20 1.50 -14.8% N/A

IsoTis OrthoBiologics ‡ ISON 1.70 1.02 1.37 -11.0% 8.7%

Kyphon KYPH 46.87 22.88 42.52 6.1% 76.7%

Langer GAIT 8.24 4.25 5.15 -1.7% -30.2%

Millenium Biologix ‡‡ MBC 0.85 0.17 0.25 -28.6% -52.8%

NuVasive NUVA 21.08 8.91 17.15 -1.6% 80.5%

Orthofix OFIX 48.61 35.30 36.68 -2.7% -3.3%

OrthoLogic OLGC 6.57 2.93 4.15 28.5% -27.6%

ORTHOsoft ‡‡ OSH 0.89 0.25 0.35 9.4% -56.3%

Orthovita VITA 4.60 2.99 3.48 -8.4% -9.6%

Osteotech OSTE 6.25 2.45 3.57 5.0% -34.4%

ReGen Biologics RGBI 1.52 0.71 0.84 -1.2% -30.6%

Regeneration Technologies RTIX 11.72 5.60 8.19 13.3% -11.9%

Smith & Nephew SNN 53.79 40.10 44.55 4.8% -13.5%

Stryker SYK 56.32 39.74 43.35 5.6% -1.5%

Symmetry Medical SMA 25.90 16.10 18.31 -17.3% N/A

Synthes ‡ SYST 122.23 90.85 107.22 1.2% -0.9%

Wright Medical Group WMGI 30.10 18.29 19.38 4.1% -26.7%

Zimmer Holdings ZMH 89.10 60.19 62.65 -1.8% -23.2%

†Converted from Euro to USD; 1€ = 1.1711 USD.††Converted from British Pound to USD; 1£ = 1.7319 USD.‡Converted from Swiss Franc to USD, 1CHF = 0.7577 USD. ‡‡Converted from Canadian to USD; 1CDN = 0.8564 USD.

In order for a company to qualify for inclusion in the OrthoInvestor Update, orthopaedics must represent

at least 60% of its revenues.

Company Performance3Q05 vs 3Q04

Company Sales vs.($MM) Prior

aap Implantate $3.91 +20%

ArthroCare $51.6 +40%Sports Med $34.5 +49%Spine $6.2 flatEar/Nose/Throat $10.8 +49%

CryoLife $1.3 +62%Orthopaedic tissue processing

IsoTis OrthoBiologics $8.1 +37%U.S. $6.8 +38%International $1.4 +27%

Kyphon $79.0 +42%U.S. $66.9 +35%International $12.1 +97%

Langer $10.5 +68%

ORTHOsoft $2.02 -16%Software $0.4 +78%Hardware $1.2 flatSoftware $0.6 -48%development contracts

Orthovita $8.4 +22%

Osteotech $22.2 +<1%DBM Matrix $12.5 +4%Base Allograft $9.3 -3%

Symmetry Medical $67.2 +24%

1 € 3.3MM 2 CAN $2.4MM

Other Financial Periods

Company Sales vs.($MM) Prior

Artimplant $0.243 +64%

Hologic $19.64 +11%Osteoporosis assessment

Medtronic $539.05 +20%Spinal Constructs $382.0 +15%Spinal Biologics $134.0 +35%Navigation $23.0 +15%

Millenium Biologix $0.36 +7%

3 9 months ended 9/30/05; SEK 1.8MM 4 4Q05 ended 9/24/05 5 2Q06 ended 10/28/05; Spinal and Navigation revenue only6 2Q06 ended 9/30/05; CAN $0.3MM

(Company news releases, 11/05)



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OPN: First, please share some background on ArthroCare and its SportsMedicine business.

Andre Bessette (AB): ArthroCare is a relatively young company. Wewere founded in 1993 with a mission to design surgical instruments thatcould benefit clinicians and patients by using our patented Coblationtechnology. ArthroCare essentially created a multi-business medicaldevice company around this platform technology—developing, manu-facturing and marketing products for a variety of soft tissue surgicalapplications.

The company has been able to leverage Coblation technology to cap-italize on a multi-billion dollar market opportunity across several surgi-cal specialties, including arthroscopy; spine and neurology; ear, nose andthroat; cosmetic; urology; gynecology and laparoscopy/general surgery.Upon the acquisition of Opus Medical and Atlantech Medical Devices,the Arthroscopy Division became known as ArthroCare Sports Medicine.

OPN: What are the specific goals of the Sports Medicine business?

AB: Orthopaedic conditions found in shoulders, knees, tendons, hips,ankles and small joints such as elbows and wrists affect millions of peo-ple worldwide—ranging from adolescents to adults and from profession-al athletes to the weekend walker. Our Sports Medicine business unit iscommitted to improving patient outcomes and making orthopaedic pro-cedures easier and faster for the surgeon.

Since we received FDA clearance in 1995 for our first Coblation-based arthroscopy system, ArthroCare has continued to offer a compre-hensive line of pioneering products used in a number of orthopaedic pro-cedures, including subacromial decompression, rotator cuff and labral

repair, anterior cruciate ligament (ACL) reconstruction, tendinosis treat-ment and cartilage debridement.

OPN: For the uninitiated, can you describe Coblation and how it works?

AB: Coblation technology is a controlled, non-heat driven process thatuses bipolar radiofrequency energy to excite the electrolytes in a conduc-tive medium, such as saline solution, creating a precisely focusedcharged plasma gas. The energized particles in this plasma have suffi-cient energy to break the molecular bonds within tissue, causing tissue todissolve at relatively low temperatures. The result is volumetric removalof the target tissue with minimal damage to surrounding healthy tissue.Inherent in the Coblation technology is the ability to coagulate or sealbleeding vessels.

In essence, our Coblation technology offers a more precise way ofremoving tissue with simultaneous hemostasis as compared to tradition-al surgical techniques for removing and treating tissue, like the mechan-ical shaver. The significant benefits of Coblation have led to its adoptionby a number of surgical specialties, including arthroscopy. Coblationtechnology is embodied in a broad range of surgical tools—ArthroWands, we call them—that enable orthopaedic surgeons to under-take minimally invasive surgical procedures such as arthroscopic shoul-der, knee, hip, and foot and ankle surgery, making them faster, easier,more precise and safer to perform.

We are constantly developing new and improved instruments andcomplementary devices that open doors to further applications that cantake advantage of the benefits of Coblation. Within the arthroscopy

Andre Bessette joined ArthroCare in 2000 as a project manager and later became Director of Marketingfor the company’s Arthroscopy (Coblation RFAblation) division. Upon the acquisition of Opus Medical,he was promoted to Director of Marketing, Instruments, for ArthroCare Sports Medicine. Prior to join-ing the team at ArthroCare, Bessette served as a product manager for VivaScan Corporation and aClinical Research Associate for the University of California San Francisco in partnership with GEMedical Systems’ MRI Division.

He is presently involved in the marketing of an array of products developed and produced byArthroCare Sports Medicine, including a series of technologies pertaining to enhancement of treat-ments for the shoulder. In this interview, Bessette provides some background on the company’s existingshoulder-related products and a glimpse into the future.

Andre BessetteDirector of Marketing, Instruments

ArthroCare Sports Medicine



Enquiry No 6



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arena, our TurboVac and Paragon Wands are market leaders for subacro-mial decompression and articular cartilage debridement, respectively.

OPN: Focusing on the shoulder, ArthroCare Sports Medicine has seencontinued growth with the Opus AutoCuff System, which is actually nota Coblation-based technology. How does this technology work?

AB: You’re right that AutoCuff is not a Coblation technology, but it com-plements Coblation perfectly in arthroscopic rotator cuff repair scenar-ios. The AutoCuff system consists of the SmartStitch Suturing Deviceand Magnum Knotless Implant. These products together with ourAtlantech CapsLock Cannula system create a very simple to use, repeat-able cuff repair system, which enables surgeons to easily perform a total-ly arthroscopic rotator cuff surgery. It’s unique in that it accomplishes oreliminates a number of technically challenging and time consumingarthroscopic procedures like suture passing, knot tying, tissue transport,tissue tensioning and anchor locking. Unlike other suturing devices, theSmartStitch places an Incline Mattress stitch directly into the tissue infive seconds rather than requiring cumbersome snares or suture shuttlingsystems.

The addition of Opus technology to our existing orthopaedic productselection has enabled us to accelerate the execution of our strategic plans.

OPN: You recently launched the “sequel” to AutoCuff with your newLabraFix System. How is LabraFix different than AutoCuff, and what areits applications?

AB: The LabraFix System was designed to provide orthopaedic surgeonswith an enhanced arthroscopic approach to repairing labrum tears(Bankart and SLAP lesions) without having to tie complex and time-con-suming surgical knots.

The LabraFix System takes the same scientific principles and technol-ogy behind AutoCuff and applies them to Bankart and SLAP repair pro-cedures. The system consists of two components—the SpeedStitchSuturing Device and the MiniMagnum Knotless Implant. When usedtogether, they enable the surgeon to arthroscopically repair the tornlabrum quickly and securely. Among the key benefits are a strong andreproducible tissue to bone fixation due to a tissue tensioning mecha-nism, a superior bone lock or hold, and a secure knotless suture lock.

We’re excited about LabraFix because the technology has the poten-tial to lower procedure costs by minimizing surgery time. (It is faster thanconventional arthroscopic techniques, enabling five-second direct, sin-gle-step suturing and knotless fixation.) It takes us another step closer toour goal of developing fast, simple and reliable solutions to challengingshoulder problems. It’s also a powerful extension to our collection ofshoulder-related products and a technology requested by many of the sur-geons with whom we work.

continued from page 16 OPN: Do you view shoulder treatment as a primary area of concentra-tion for 2006?

AB: It is definitely an area of concentration we’re optimistic about. Ourlist of shoulder-related applications for the ArthroWands and the Opustechnology, as well as for our TOPAZ Microdebrider and our AtlantechCollection of instruments, is quite extensive and growing. It should benoted that many of our most innovative technologies pertain as much tothe elbow, knee and foot—so we aren’t limiting ourselves to shoulderapplications.

That said, we are definitely making a move to become the shoulderrepair company—especially in the area of rotator cuff and labral tears.Maintaining and expanding upon our success in that area is absolutelyone of our goals. Shoulder surgery is the largest indication for ourCoblation technology, so it makes a lot of sense that we come full circlewith complementary suturing, anchors and instrumentation that are of astandard to place us at the forefront for surgeons who work on shoulders.

We’ve been growing steadily in a number of areas outside of theshoulder as well—with our Atlantech ACL reconstruction systems andHandheld Instruments, for example—and we believe we have the righttechnology moving forward to fuel our continued expansion of marketshare across the board.

OPN: What other shoulder-related products might we expect fromArthroCare Sports Medicine in 2006?

AB: I can’t confirm all of the details now, but you can expect to see acomprehensive, multi-application shoulder tray system within the com-ing year. We applied a great deal of feedback from surgeons as we put thetray system together, and we feel it will be an excellent tool kit in the ORfor doctors who frequently treat shoulder conditions and injuries.

We are also excited about our ParaFix and ParaSorb screw-in anchorline that was well received in test marketing performed this past year. Welook forward to a full launch of these products early in 2006. Of course, wewill continue to develop and advance the Opus Technologies in both rota-tor cuff and labral repair. We anticipate launching a new and improvedMagnum Knotless anchor for the AutoCuff System sometime in the spring.Shortly after that, we anticipate having a more advanced SmartStitchSuturing Device capable of handling various cuff tear pathologies.

OPN: Sounds like you are aiming to make shoulder procedures moreconvenient for the surgeons.

AB: That’s right. That’s exactly what we are aiming for. Whether it’swith Coblation via our ArthroWands, with Opus technologies such asAutoCuff and LabraFix, with Atlantech Instruments and CapsLockCannulas, or just the general convenience of having an easy to use traysystem combining everything you’d need for shoulder procedures, we’reall about making procedures easier and faster for the surgeons.

...on any Products within the Product News or Product Featuresection, simply mark the Numbers off the Reader Enquiry Cardand send it to us - we’ll put you in touch with the right people.

Mail it back to us or fax the card to: 440-247-9053

FFoorr MMoorree IInnffoorrmmaattiioonn......Enquiry No 27


Enquiry No 7



PPRROODDUUCCTT NNEEWWSS

CobaltTM High Viscosity Bone Cement

Biomet is pleased to announce the addition of Cobalt™ HV (HighViscosity) and Cobalt G-HV (High Viscosity with Gentamicin) BoneCements to our cement line. Cobalt HV Bone Cement is blue for high opti-cal contrast and maintains the same clinical formula as Palacos® R BoneCement. The monomer for Cobalt Bone Cement is packaged in the exclu-sive patent pending SoftPac™ pouch, an innovation thatis a safer alternative to traditional glass ampoules.Cobalt Bone Cement is indicated for use in minimal-ly invasive, primary and revision arthroplasty proce-dures. SoftPac™ and Cobalt™ are trademarks ofBiomet Manufacturing Corp. Palacos® is a trade-mark of Heraus Kulzer GmbH. Find us at theAAOS in Chicago, Booth 2020.

Biomet, Inc. Tel: 800-348-9500www.biomet.com Enquiry No 31

Growth-Factor Enhanced Matrix

GEM 21S from BioMimetic Therapeutics is a biologically-enhanced tissueregeneration system for the treatment of periodontal bone defects and asso-ciated gingival recession. In a pivotal clinical study in which both clinicaland radiographic measurements were evaluated, GEM 21S was demon-strated to be effective in treating moderate to severe peridontally-relateddefects, leading to earlier resolution of periodontal lesions.

GEM 21S is a completely synthetic bone grafting system combiningrecombinant human Platelet-derived growth factor (rhPDGF-BB) withBeta-tricalcium phosphate (ß-TCP). The ß-TCP physically fills bonedefects, providing a biocompatible scaffold that facilitates new bone for-mation, while the rhPDGF-BB actively promotes both the in-growth andproliferation of osteoblasts at the treatment site.

Each GEM 21S kit consists of allnecessary components for clinicians tofacilitate sample preparation andimplantation. Each kit and its compo-nents are for single use only. For fullprescribing information, please reviewthe package insert at www.biomimet-ics.com. GEM 21S is marketed and dis-tributed by Osteohealth.

Osteohealth Tel: 800-874-2334www.osteohealth.com Enquiry No 29

NovaRad’s ClinicPACS

Orthopaedic clinics can now afford to become filmless with ClinicPACS,NovaRad’s affordable, proven, powerful PACS product. ClinicPACS pro-vides a single, self-contained, “plug and play” workstation with a powerfulviewer and orthopaedic templates and trauma tools. Its out-of-the-box capa-bilities eliminate expensive on-site installation and costly equipment.

The workstation includes a two-year on-site archive, with DVD archiveburning capabilities for a seven-year archive; PACS server; Web server;Administrative and Quality Control capabilities and full three-year warran-ty. It also features a full DICOM paper printer and patient CD burner.Options include fully integrated patient information system, scheduler,billing interface, modality worklist, tablet PC viewers for patient rooms,home viewers, dictation/transcriptionand additional clinical viewers. For moreinformation, visit our web site and clickon “ClinicPACS” under “Products.”Find us at the AAOS in Chicago, Booth2849.

NovaRad Tel: 877-668-2723www.novapacs.com Enquiry No 28

The ERMI Knee Extensionater II is a portable, easy-to-use device thatallows patients with flexion contractures to work on improving extensionat home, at work or just about anywhere. The device uses a comfortablyfitting air cuff to accomplish overpressure therapy with more precision andwithout the discomfort of the traditional hanging of weights.

It uses ERMI’s patented pneumatic air-bladder technology for movingarthrofibrotic joints. This device borrows from the time-tested protocols ofoverpressure therapy for treating extension loss. It provides the patientwith complete control to add and remove load to the joint in very smallincrements to match the load required to stretch the soft-tissue restrictionsin the joint. Patient compliance is high with ERMI’s Patient ActuatedSerial Stretch (P.A.S.S.) protocol. With the ERMI Knee Extensionater II,

as with all of ERMI’s devices, patients typically see improvement veryquickly after stating therapy. Rapid improve-ment creates enthusiasm for continuing withthe treatment plan. Additionally, the shorttreatment time of 60 minutes per day is anappealing alternative to the longer protocolsrequired by some mechanical therapy options.Find us at the AAOS in Chicago, Booth 5435.

End Range of Motion Improvement, Inc. Tel: 877-503-0505www.getmotion.com Enquiry No 32

Spider Cervical Plating System

The Spider Cervical Plating System consists of a cervical fixation platewith a proprietary “resilient arm” locking mechanism to prevent screwbackout. “The Spider Cervical effectively addresses the number one prob-lem with locking cervical plates, which is false locking,” states DavidKirschman, M.D., President of X-spine. “I feel that in many cases of inad-vertent screw backout, the screw was never properly locked in the firstplace, since the surgeon didn’t get adequate feed-back from the locking mechanism.”

The system provides positive auditory, tactileand visual feedback to the surgeon to indicatescrew locking, while not requiring any additionallocking steps. The 2.5mm plate is manufacturedfrom a single titanium alloy block with no addi-tional parts, i.e. rings/springs/fasteners. It incorpo-rates graft windows for central visualization com-bined with side scalloping for lateral visualization.Fixed and 15 degree variable screws are available.

X-spine Systems, Inc. Tel: 800-903-0640 www.x-spine.com Enquiry No 30

ERMI Knee Extensionater II®


Announcing...

OMTEC 2006“For my purpose, your show was far more interesting than the MD&M show—which I will no longer attend.”

-post-event feedback from a Director of Materials Management at one of our industry’s leading OEMs.

Educational Sessions are currently being scheduled. Your opinions and participation are welcomed. Contact Jack Detweiler, [email protected]

www.orthosupplier.com

The 2nd Annual

Orthopaedic Manufacturing & Technology

Exposition and Conference

June 21-22, 2006

Donald E. Stephens Convention Center,

Rosemont, Illinois USA

Enquiry No 8



For many start-up operations, product liability has historically been a lowpriority item. Does this sound like you: “How can I possibly be sued if Ifollow someone else’s specifications?” Or perhaps this one: “I don’t havethe time to think about product liability right now.” Identifying productliability exposures is actually easier than you might think, especially if youuse the right team of professionals. This article is intended to simplify theprocess of identifying product liability and what you can do about it.

Where Does Liability Come From?License Agreements: Indemnification of an institution or other party forgeneral liability including product liability, human clinical trial exposures,intellectual property, Workers Compensation and sole negligence. Watchout for “cookie cutter” agreements. You can usually negotiate lower limitsof liability by benchmarking your risks vs. that of other similar technolo-gies, or add language whereby you are required to purchase product liabilityonly if you are the trial sponsor or have a commercially viable product.Patent Exposures: If you own intellectual property, it can be very expensiveto defend an allegation of infringement made against you and outrageouslyexpensive if you try to stop someone else marketing a product that mayinfringe upon your product. The best way to reduce the risk is to hire thebest patent counsel you can afford. Insurance products are available, but canbe expensive and usually contain restrictive terms and conditions. Other Contractual Liability Obligations: I’ve reviewed many contractsand they frequently state that one or both parties will indemnify each otherfor “any and all losses or costs associated with the product or serviceprovided.” Those are pretty strong words, “any and all.” Include yourinsurance broker on every contract. The broker should work with yourattorney to match the insurance policies with any contractual obligations.The broker should also advise on what cannot be insured. If you requireoutside funding sources in order to get your product to market, you mayfind that term sheets require management liability (D&O) and lifeinsurance for principal employees.

The PlaintiffThe plaintiff’s cause of action against a manufacturer typically alleges oneof the following:• Manufacturing Defects in which the product departed from its intended

design, is physically flawed, damaged or incorrectly assembled and speaks for itself.

• Design Defects due to foreseeable risks that could have been reduced by the adoption of a reasonable alternative design; this omission createdan unsafe product.

• Defective Design due to non-conformance with state of the art design development or the allegation that alternative, technologically-feasible and practical designs were not used; this resulted in an unsafe product.

• Defects in Warnings because foreseeable risks in the use of the productcould have been reduced at the design stage by providing reasonable

warnings and instructions; the omission of these warnings and instructions rendered the product unsafe.

Medical Malpractice Tort ReformForty-eight states have introduced over 400 tort reform bills. I believe at lastcount that 29 states have passed over 50 bills. A Federal bill has been passedby the House of Representatives, but many say it is unlikely to pass theSenate any time soon. These new laws put caps on economic and non-economic damages and expressions of sympathy are usually not admissible.Medical device insurance carriers are very concerned about being draggedinto lawsuits where plaintiffs “don’t receive the compensation they want”and it is alleged that the liability actually exists with the device itself. Here’sa clue – if the insurance carrier is concerned, then you need to be as well.

Miscellaneous ExposuresWorkers Compensation, employee benefits liability, physical property,automobile exposures, animal testing (contractual liability and how wouldan interruption of the testing affect the company), lab testing (loss of labbooks, destruction of materials and/or work in progress), equipment andstock, loss of electronic data, foreign travel, inability to meet milestonepayments if you have a fire or other insurable loss.Clinical Trials: Contractual requirements of IRB process, institution wheretrials are held, SABs, CRO or possibly the P.I. can all create potentialliability (remember contractual) for you.

So, What Can You Do About These Risks?First, you need to “control what you can control.” Hire an experiencedquality control staff, find a good product liability defense attorney to assistin preventing a product liability lawsuit and seek an experienced insurancebroker or risk advisor who specializes in medical devices or orthopaedics.

How Do You Find the Right Insurance Coverage?Even the most careful and diligent person cannot mitigate or transfer allpotential liability. Here are few things to consider when looking for theright insurance coverage:1. Find an insurance professional with specific experience in placing

insurance for medical device companies. Specialists will know the right questions to ask, which will save you time and money. Many times,these brokers have checklists which are specific to your industry.

2. Investigate “group buying.” You may save money by joining a buying group which might provide some premium savings, but remember – youare now sharing limits of liability with others. One claim may reduce thelimits available for future claims. It won’t matter how much money yousaved if you have an uncovered claim! Be extra careful when looking at“who is insured” provisions – you may not be getting what you paid for.

AARRTTIICCLLEE

Product Liability Exposures ofStart-up Orthopaedic Companies

Author: Michael Cremeans




AARRTTIICCLLEE

3. Value, Value, Value. Specialty insurance carriers (the ones who have specific policies for medical device exposures) provide more than just policies. Take advantage of the value-added services they offer, such as loss control and risk avoidance advice.

4. Even though you may not be familiar with insurance policies, there area few “safe” questions to ask your broker or insurance professional. Whyare you recommending this insurance carrier? What are the important exclusions? How many insurance carriers offered a bid on my business?What value-added services are available? Did the insurance carrier lookover our contracts? What ways can I reduce my exposures and/or costs?

The Insurance Marketplace for Product LiabilityIn the world of orthopaedics, you have several choices. Specialty insurancecarriers (the ones with specific policies for medical device exposures)provide more than just policies. They may offer such value-added servicesas loss control and risk avoidance advice. Some of those services include:1. Web-based risk control product offerings like online training, white paper

discussions or specific loss control tips and other practical guidelines2. Benchmarking services3. Personalized risk management reports based on interviews done by

insurance employees4. Establishment of internal and external litigation teams

Several carriers offer these services. If you have no interest in thesecomprehensive services (many of which are automatically included withthe premium), you can access the “excess and surplus lines market.” Start-up companies may find this more attractive due to lower minimumpremiums; however, you will probably find their rate per thousand of sales

(a portion of the method used to determine final premium) will be substan-tially higher. If you are on a fast track growth pattern, you’ll quicklyoutgrow these markets and an insurance carrier assessment will be in order.

Specialty companies require the completion of a more detailed applica-tion for coverage. Don’t be intimidated by the length of these applications- use them to your advantage! They give very clear insight into what youshould strive for regarding quality systems, document control, productsafety and other important SOPs. If you want to be a “world class risk” inthe eyes of the insurance market, it makes sense to start planning for it!

Your insurance professional should match your company’s risktolerance, strategic goals and financial goals to the insurance carrier thatmeets those needs. That might sound a little obvious, but experiencedbrokers can identify the appropriate insurance carrier very quickly. If yourcurrent broker seems to be taking way too much time in finding acceptablesolutions, perhaps you should seek someone who specializes in your typeof business – and save yourself tremendous amounts of time and energy.

It Just Makes SenseYou insist on quality throughout the manufacturing process. Doesn’t it makesense to find a professional risk specialist or broker? Take the time to asklots of questions when it comes to assessing product liability risk. A littlerisk management planning will reduce your liability, improve your compet-itive position in the marketplace and ultimately save you significant dollars.

Michael Cremeans is a Senior Vice President and Principal at Britton-Gallagher & Associates. He has published several articles on riskmanagement and insurance for orthopaedic and other medical devicecompanies. He can be reached at 800-607-4711 ext. 2703 or by email [email protected].


Enquiry No 33

Enquiry No 9



Enquiry No 10



EENNTTRREEPPRREENNEEUURRIIAALL EEVVEENNTTSS CCAALLEENNDDAARR

February 2006

February 23-24Investment In Innovation (In3) WEST: APreview of Early-Stage MedicalTechnology CompaniesIrvine, Californiawww.medtechinsight.com Tel: 949-219-0150 or 888-290-2225 E-mail [email protected]

March 2006

March 6-9S.G. Cowen 26th Annual Health CareConferenceThe Boston Marriott Copley Place, Bostonwww.sgcowen.com/UpcomingConferences

March 21First Annual 2006 Stem Cell SummitHotel Sofitel O'Hare, Chicagowww.ryortho.com/stem_cell/index

March 30BioConference and Thomson present

Future Leaders in the Biotech Industry -The 26th Clear Route InvestmentConferenceMillennium Broadway Hotel & ConferenceCenter, New York Citywww.biocentury.com/html/conferences

April 2006

April 6-7The 7th Annual Conference on HealthcareTransactions: Successful Strategies forMergers, Acquisitions, Divestitures, andRestructuringsMillennium Knickerbocker Hotel, Chicagowww.healthcaredatasource.com/health-care_transactions_conference

May 2006

May 15-16Rodman & Renshaw 3rd Annual GlobalHealthcare ConferenceLe Meridien Beach Plaza Hotel, MonteCarlo, Monacowww.rodmanandrenshaw.com/rodman

June 2006

June 22-23Medtech Insight/Windhover InformationMedical Device SummitThe Palace Hotel, San Francisco, Californiawww.medtechinsight.com Tel: 949-219-0150 or 888-290-2225 E-mail [email protected]

October 2006

October 19-20In3 EAST: A Preview of Early-StageMedical Technology CompaniesBoston, Massachusettswww.medtechinsight.com Tel: 949-219-0150 or 888-290-2225 E-mail [email protected]

November 2006

November 29 - December 1Piper Jaffray Health Care ConferenceNew York Citywww.piperjaffray.com

Enquiry No 11


MaxBraid™ PE Suture

• Unique braid whichallows the suture tolie fl at, improvingknot security

• Silky smooth feel isgentle on tissue and gloves

• Braided with Dyneema®

purity fi ber

LactoSorb® L15 Copolymer

• LactoSorb®

material retains70% of its strengthat 8 – 10 weekswhile being fullyresorbed in12 – 18 months1

More than an ordinarypush-in suture anchor.

P.O. Box 587, Warsaw, IN 46581-0587 • 574.267.6639©2005 Arthrotek, Inc. All Rights Reserved

web site: www.arthrotek.com • eMail: [email protected]

I N V E N T I N G T H E F U T U R E O F A R T H R O S C O P Y

MicroMax™ and MaxBraid™ are trademarks of Arthrotek, Inc.LactoSorb® is a trademark of Biomet Manufacturing Corp.Dyneema® Purity is a registered trademark of DSM DyneemaB.V or an affiliate of Koninklijke DSM N.V.1. Data on file at Arthrotek, Inc.2.Testing performed by Arthrex, Oct. 2000.

The MicroMax™ Anchor is loaded with MaxBraid™ PE Suture and comprised of LactoSorb® L15 copolymer.

120

100

80

60

40

20

0

0 2 4 6 8 10 12-20

Per

cen

t St

ren

gth

Ret

enti

on

Weeks

LactoSorb® in vitro flexural strength loss1

Healing curve1

Strength Comparison (lbs.)

Ethibond™

Excell #22

FiberwireSuture2

MaxBraid™

Suture

Tensile 27.01 60.96 69.18

Knot 12.61 29.83 39.45

Dynamics of Healing and LactoSorb®

Copolymer Strength Retention Profi le

Enquiry No 12



FFIISSCCAALL FFIITTNNEESSSS

As this issue of USOPN goes to press, we’re still a month or two awayfrom knowing how companies ended 2005, so we don’t know yet aboutoverall market growth. However, we can speculate pretty accurately thatgrowth will slow (it has already), driven by declining growth in jointreplacement (which accounts for 38 percent of the market’s value). Aslowdown in growth for hips and knees will combine with solid, healthyincreases once again in other joint replacement and spine and, to a lesserextent, biologics, trauma, sports medicine and power equipment. Weshould finish 2005 with global orthopaedic revenues reaching $26 billionor more. Not bad for an industry that generated worldwide sales of just$7 billion ten years ago!

Anyway, I thought I’d capture some of the activity in the orthopaedicindustry over the past 12 months, with an eye towards the non-clinicalaspects of the business. From financing to litigation, all will impact theorthopaedic surgeon in one way, shape or form.

Funding the FutureTo begin, on the funding side of the business, 2005 brought nearly $300million in grant, venture capital and private equity monies to a variety ofcompanies. (This amount doesn’t include stock repurchases or meansused by public companies to generate cash.) When put to good use, thesefunds could bring surgeons and their patients new generations of (read:improvements in) soft tissue repair, motion preservation and cell therapyproducts. Exhibit 1 (See page 29.) provides a list of companies thatreceived financial support and what they intend to do with the capital. It’squite an interesting array of players.

Allies, Suitors and ConsolidationStrategic activities in orthopaedics went beyond financing, steppingsquarely into the realm of mergers, acquisitions and alliances betweenmanufacturers of all ilks. For some, agreements extended acrossnumerous market segments, as exemplified by Inion partnering with bothRichard Wolf and Aesculap, OsteoBiologics with Linvatec and Nexa.Companies used relationships to fill gaps in their product matrices, mostnotably Stryker in hip resurfacing and large diameter heads; Zimmer inlocking plates and Blackstone, Orthofix and PLUS in biologics. Exhibit2 (See page 30.) provides a comprehensive list of strategic alliancesconsummated during the year.

Orthovita and Osteotech both declined overtures from potentialsuitors. Angiotech offered $216 million for Orthovita, an offer consid-ered “inadequate” by Orthovita. At nearly eight times trailing 12-monthrevenues, Angiotech’s bid was among the highest we’ve seen outside ofspine since the late 1990s. And Osteotech turned away MusculoskeletalTransplant Foundation (MTF), whose $6.25/share offer (~$108 million)represented a 66 percent premium over the company’s average shareprice since the first of the year. Kind of leaves you breathless.

Looking Back at 2005 - TheGood, the Bad and the Ugly

Author: Shirley A. Engelhardt


Takeover offers that materialized ranged from Stryker’s acquisition ofeTrauma (Office PACS picture archive and communications imagemanagement software) to dj Orthopedics’ purchase of Superior Medicalequipment (for soft goods and rigid bracing) and Encore’s soft goodsbusiness. Encore found itself as a buyer, too, picking up OsteoimplantTechnology, whose joint replacement and spine products expand theEncore portfolio.

Nexa began its spending spree with its early 2005 purchase of FuturaBiomedical. The company continued “shopping” throughout the year, buy-ing interphalangeal fusion products from Pioneer Surgical and acquiringBIOProfile (pyrolytic carbon orthopaedic implants) in December.

In biologics, Theken acquired the assets of Therics, Alphatec pickedup Cortek and MTF bought assets related to the allograft tissue bankingoperations of the American Red Cross. Ferring Pharmaceuticalspurchased the biologics manufacturing business from SavientPharmaceuticals and launched EuFlexxa (non-avian derived hyaluronicacid) in the U.S., while competitor Genzyme acquired Verigen tostrengthen its autologous chondrocyte implantation product offerings(and geographic presence).

Among spine companies, NuVasive was busiest on the acquisitionfront. The company added IP and related assets from RSB Spine (forcervical plate technology) to its product line, bought the Pearsalls’Neodisc cervical device and IP related to its embroidery technology foruse in implants and acquired assets and IP from Riverbend Designs,whose technologies center on dynamic stabilization products. WhileNuVasive was certainly active, the company did not spend nearly asmuch as Medtronic did with its $1.3+ billion purchase of substantially allof the spine-related IP and related contracts and rights of KarlinTechnology and Gary K. Michelson, M.D. (Note, the Medtronic settle-ment puts Gary Karlin Michelson at #258 among the 400 richestAmericans according to Forbes.)

Finally, Integra completed its acquisition of Newdeal; DePuy Mitekexpanded on a distribution agreement with Surgical Solutions andpurchased two of the company’s suture passing systems; OMNI lifescience entered the joint replacement arena with its purchase of ApexSurgical and Össur beefed up its rehabilitation product line by buyingRoyce Medical and Innovative Medical Products.

While some companies spent time deciding who and what to buy,others found themselves in court. Often.

Protecting the IP PortfolioKyphon reigned victorious against Disc-O-Tech, which was permanentlybarred from importing or selling its SKy Bone Expander in the U.S. (Thedevice was found to infringe three kyphoplasty patents.)





Company ($MM) Expected Use of Funds

Aastrom Biosciences $0.74 Investigation of increasing bone-forming and other cells and how they affect stem and progenitor cell growth

Active Implants $4.00 Research/development of pliable-structured materials for joint replacement and spinal implants

Angstrom $0.50 Development of nanocrystalline calcium phosphate

ApaTech $3.60 Introduction of new synthetic bone graft products; expansion of facilities

Applied Spine Technologies $15.00 Testing/commercialization of MIS posterior dynamic stabilization system

Arthrosurface $10.50 Completion of development of HemiCAP joint resurfacing products

Axial Biotech $4.10 Acceleration of ongoing product development efforts for improving diagnosis and treatment of scoliosis

AxioMed Spine $18.00 Further clinical trials of Freedom lumbar disc

Axya Medical $12.30Development of wound closure technology for arthroscopic procedures; expansion of sales/marketing network; development of additional products to complement existing shoulder fixation line

BioMimetic Therapeutics $11.80 Mostly for oral maxillofacial; also for development of tissue growth factor + synthetic bone matrix for orthopaedic applications

DVO Extremity Solutions $6.00 Product development (extremity products) and staff expansion

Impliant $18.00 Further clinical trials, marketing, regulatory clearance of spine motion preservation system and cushion bearing implant for joint replacement

Inion $2.30 Development of OPTIMAPLUS resorbable and bioactive implant materials

Innovative Spinal Technologies $39.00 Launch of “next generation” spinal devices; expansion of personnel

ISTO Technologies $10.80 Further clinical trials of cartilage repair products and chondrocyte-based therapies

KFx Medical $6.20 Further development of knotless fixation technology for rotator cuff repair

MAKO Surgical $20.00 Product development/clinicals for early stage, MIS knee treatments

Nspine $0.42 Test marketing/regulatory clearance of pedicle screw system with dynamic motion segment support

Pegasus Biologics $10.00 Launch of OrthADAPT Bioimplant for soft tissue repair and further development of biological ACL

Ranier Technology $7.30 Development of CAdisc (elastomeric device) through clinicals

ReGen Biologics $11.80 Commercialization of Collagen Meniscal Implant in Europe; regulatory clearance in U.S.

Replication Medical * Expanded development of hydrogels and other implants for spinal use

Scandius BioMedical $8.00 Expansion of distribution network; further product development

Schwartz Biomedical $1.30 Investigation of BioPoly, biological enhancement for self-lubrication of joint replacement devices

SpinalMotion $20.00 Complete enrollment in U.S. clinicals of lumbar and cervical disc implants

SpineMedica $10.60 Development of SaluDisc (Salubria hydrogel) for lumbar application

SpineVision $16.00 Creation of FlexSpine subsidiary with focus on motion preservation

U.S. Spine $4.10 Launch of Facet Gun fixation system and clinical trials of non-linear fiber matrix lumbar disc

Total Funding $272.36

*Total amount unknown; $15MM received from Abbott Spine

Exhibit 1Orthopaedic Compnies And Funding Received In 2005





Lawsuits involving trauma products resulted in judgments againstSynthes in a patent infringement case brought by Smith & Nephew(regarding certain trochanteric fixation and proximal femoral nails),while Stryker was found to infringe a patent relating to Acumed’sspecialized rod (e.g. Polarus). A favorable ruling came to Stryker,however, when a U.S. court affirmed a summary judgment of non-infringement in its favor, concluding that the company’s BoneSourcebone cement never infringed upon any valid Norian patent.

After four years in the courts, ArthroCare won in its patent infringe-ment battle against Smith & Nephew regarding bipolar radiofrequencyproducts. The companies settled their legal disputes through a variety ofagreements including worldwide product supply (ArthroCare will

manufacture bipolar and monopolar arthroscopy products for global saleby Smith & Nephew), a joint licensing agreement (ArthroCare willreceive royalty payments for all bipolar products sold by Smith &Nephew in the U.S. and for Smith & Nephew’s bipolar shaver productssold worldwide) and others.

Smith & Nephew received some good news on the litigation frontwith the granting of a preliminary injunction barring Arthrotek from U.S.manufacture and sale of its Surefire meniscal device and a ruling inGermany that certain Arthronet shaver blade products infringe Smith &Nephew patents.


Company Providing Company Receiving Product/Technology/Asset Involved

Alexandria Research Technologies Smith & Nephew License to next generation implants and instruments for MIS knee arthroplasty

Anika DePuy Mitek U.S. distribution of Orthovisc to arthroscopists and orthopaedic surgeons

ArthroCare SNN Endoscopy Supply/manufacture of bipolar and monopolar arthroscopy products

Artimplant ArthroCare North American distribution of Artelon Surgical Suture

Berkeley Advanced Biomaterials Orthofix U.S. marketing/distribution of resorbable bone repair products

BrainLAB Biomet Partnership for development of computer-assisted surgical (CAS) navigation technology with Biomet products

Corin Stryker U.S. distribution of Cormet hip resurfacing and Optimom large diameter articulation systems

Cytomedix DePuy Spine License to certain patents related to autologous platelet releasate therapy

Cytomedix Medtronic License to certain patents related to autologous platelet releasate therapy

Heraeus Zimmer Global distribution of Palacos bone cement products

Inion Aesculap USA U.S. and Canada distribution of resorbable products for spine

Inion Richard Wolf U.S. distribution of resorbable products for sports medicine

IsoTis PLUS, Lifetek and Endoplant Global distribution of DynaGraft II and OrthoBlast DBM products

ORTHOsoft Zimmer Global distribution of CAS for non-MIS hip, knee and spine

Osiris Blackstone U.S. distribution of allogeneic bone matrix to spine surgeons

OsteoBiologics (OBI) Linvatec Ex-U.S. distribution of PolyGraft cartilage and bone repair products

OBI Nexa Private label distribution of certain hand, foot and ankle products

Quantum Orthopedics Endius U.S. distribution of PEEK-OPTIMA lumbar and cervical replacement systems

Swiss Orthopaedic Solutions Zimmer Worldwide distribution of universal locking plate technologies

ThermoGenesis Cell Factor Technologies Supply of disposable autologous thrombin production kits

Exhibit 2Strategic Alliances In Orthopaedics In 2005





Medtronic faced mixed results in its court cases. Certain BrainLABimage-guided surgery technologies were found to infringe certain ofMedtronic Navigation’s patents; certain Medtronic transverse connectorswere found to infringe a Cross patent, as were redesigned Medtronicpolyaxial screws. At the same time, one Cross anterior cervical plate wasdetermined to infringe Medtronic patents. A case brought by Cross wasremanded back to the lower courts, with next steps to be decided in lateDecember. The saga will continue into 2006. Finally, the courts found infavor of Medtronic on antitrust, fraud and tort claims alleged by Etex;however, Medtronic was found in breach of its agreement with Etex andordered to pay.

Funeral Homes, Lawyers on the Prowl, Gainsharing and Uncle Sam

As the year came to a close, companies faced troubles outside of thecourtroom. LifeCell, Regeneration Technologies and Tutogen voluntarilyrecalled certain tissue as a result of questions about donor documentationfrom one of their suppliers, Biomedical Tissue Services (BTS). None ofthe companies relies on BTS for the majority of its tissue (thankfully),but the press got hold of the story and reports that a tissue processormight have taken body parts from funeral homes made front-page news.We shudder to think…

Then we got wind of The International Charité Artificial Disc PracticeGroup, attorneys joining together to review and accept injury casesrelated to postoperative complications from the Charité in the U.S. andother parts of the world. We harken back to Sulzer’s billion dollar legaltroubles.

Could trouble be looming, as well, for the big five? In March, theDepartment of Justice (DoJ) served subpoenas on Biomet, DePuyOrthopaedics, Smith & Nephew, Stryker and Zimmer. The DoJ is investi-gating the companies’ consulting/professional-service agreements withorthopaedic surgeons as they relate to various joint replacement devices.We’ll have to wait to learn what becomes of the investigations, but wedon’t expect a quick resolution.

While the results of the DoJ investigations remain anyone’s guess, thesame cannot be said for the country’s first gainsharing efforts. Despite alot of hoopla, 200+ surgeons “on the bus” and a much-anticipatednegative backlash on growth in the U.S. joint replacement market, HCAwas not able to meet expectations in its gainsharing-laden joint replace-ment contracts with DePuy, Stryker and Zimmer. In mid-December2005, we learned that HCA apparently did not obtain the compliance ithad promised in exchange for implant price reductions and, as a result,pricing could revert back to pre-discount levels.

The government reached into orthopaedics, as well, with a number ofdecisions made with respect to Medicare reimbursement and policies.First, with the new fiscal year (started October 1), hospitals will now beable to obtain more equitable reimbursement (read: they’ll get moremoney, ~27% more) for revision hip and knee procedures performed. Inthe past, CMS reimbursed the same amount for primaries and revisions,despite the far more resource intensive revision procedure. CMS alsoruled to stop add-on payments for InFuse and refused to grant add-onpayments for ceramic-on-ceramic hips, artificial discs and use of InFusein treatment of tibial fractures.

Genzyme won a victory of sorts with CMS ruling that Synvisc wouldhave its own reimbursement code and rate for the new year (rescindingan earlier decision to lump it in with all the others), and Smith &Nephew’s Exogen bone healing system received expanded coverage to

include treatment of all nonunions, regardless of prior surgical interven-tion. And, finally, CMS approved an Orthofix request to create specificreimbursement codes for hospital procedures using external fixationdevices.

The DRG assigned to disc replacement won’t change for 2006, sohospitals will continue to get a paltry sum for Charité proceduresperformed on Medicare patients. To add insult to injury, insurers remainreluctant to reimburse for the Charité (many still consider it experi-mental). At the end of the third quarter, just over 3,400 Charité deviceshad been implanted in the U.S. and revenues have not even come closeto many analysts’ projections (e.g. $150MM to more than $300MM!).Makes us wonder if Wall Street’s 2010 multi-billion dollar disc marketwill ever materialize.

CMS was busy on other fronts, as well, most notably with its mid-year report to Congress in which it addressed ways to disadvantagephysician-owned specialty hospitals. The agency also reduced surgeonreimbursements for some Medicare joint replacement and “thigh”fracture procedures.

DTC and Tours to IndiaWhile some tried to stem the movement of patients to non-hospitalsettings, no one could stop the momentum of direct-to-consumer (DTC)marketing campaigns. Family and friends from around the country spokeof the Jack Nicklaus hip, a Johnson & Johnson knee and Biomet’s primetime ad for joint replacement during 60 Minutes. For Johnson & Johnson,DTC is paying off – the company’s DTC campaign has brought in morethan 3,500 qualified patient leads per week.

No, we haven’t exported our DTC madness to other parts of theworld, yet, but we are shipping out patients to India, Thailand and otherAsian countries for joint replacement and arthroscopy procedures. Youcan also visit the Cayman Islands for disc replacement, resurfacing hipand other non-FDA cleared procedures (if you have the money) or booka tour to India and spend ten to 20 percent of what you would in the U.S.on a joint replacement procedure.

All in all, 2005 was a busy year, albeit not particularly exciting for some.No huge mergers. No near-bankrupting lawsuits. No significant productfailures. Just a little bit of price pressure, the threat of gainsharingchanging the game and a government more involved in our business. Atthe same time, money continues to pour into new start-ups, signaling abelief in the health of the industry. Most of us know that we’ll experiencesome mitigation of the robust 15 to 20 percent growth the industry hasboasted for the past few years.

But, we don’t expect any catastrophic market-changing events toburst our bubble of optimism for this business. We may have to settle forgrowth in the low- to mid-teens, but, things could be a whole lot worse.After all, we could be in Malaysia. There, although among the country’sbest-paid doctors, orthopaedic surgeons in private sector/group practicecan earn from $18,400 to $26,300 annually (excluding allowances).Wow.

Shirley A. Engelhardt is President and Founder of KnowledgeEnterprises, Inc. (www.theorthopeople.com) She can be reached at 440-247-9051 or [email protected].

The author owns a small stake in all publicly-traded orthopaedic companies aswell as Ascension Orthopedics, BioMimetic Therapeutics and DVO ExtremitySolutions.


Enquiry No 34


“MY CAREER PATHS AND OBJECTIVES HAVE

EXPANDED CONSIDERABLY SINCE MY

MEMBERSHIP BEGAN, AND

CONTINUE TO GROW

EXPONENTIALLY.THANK YOU!!!”

- Member since 2000

THE INSTITUTE FOR ORTHOPAEDICS™BUSINESS INTELLIGENCE NETWORK

(http://www.orthoworld.com/member_benefits.php)email: [email protected]


THE INSTITUTE FOR ORTHOPAEDICS™

An international business intelligence network of industry professionals andentrepreneurs, designed to keep you abreast of the latest business develop-ments and ahead of your competition, both inside and outside your company.

Covers Reconstructive, Spine, Trauma, Arthroscopy/Sports Medicine Biologics and other market segments.

Membership provides you the following

Access to the private members area of www.orthoworld.com, which includes:

Daily OrthoFlash™ - Real-time, strategic orthopaedic news flashes emailed directly to you and available with links to full text citations.

The OrthoWorld Archives - The world’s largest database of strategic orthopaedic intelligence.

Comprehensive directories of orthopaedic specific resources including:

- 510(k)s, Patent Offices, M&A Activities, Databases/Libraries, etc.

- Manufacturers, Products, Suppliers, Consultants, Distributors, Institute Members, Meetings, Societies, etc.

- Members Discussion Forum

Members also receive the following publications

Bare Bones®:The premier monthly executive summary of key strategic orthopaedic events.

OrthoKnow®:Monthly high-level strategic insights into theorthopaedic industry.

The Worldwide OrthopaedicMarket Overview:The annual summary of the global orthopaedic market that features:

• Product sales by region and segment

• Company sales overall and by segment

• Strategic alliance activity• Product and company news• Emerging technologies in

orthopaedics

Executives, product managers, engineers, venture capitalists, distributors and sales reps all stay on top and out ahead by knowing the latest technologies, treatments, products and trends affecting the market.

KNOWLEDGE ENTERPRISES, INC.The OrthoPeople

147 Bell Street, Suite 303 Chagrin Falls OH 44022 USA440 247 9051 Fax 440 247 9053 www.orthoworld.com Enquiry No 13




Innovation is the specific instrument of entrepreneurship...the act thatendows resources with a new capacity to create wealth.-Peter Drucker (1909 - 2005), Innovation and Entrepreneurship, 1985.

Many, if not most, surgeons are unintentional entrepreneurs. Anysurgeon who participates in a private practice is effectively abusinessperson as well as a health care professional. Successful surgeonslearn well the concepts of assets, liabilities, revenue and overhead—thebasics any business needs in order to function. The delivery of amarketable product, surgical treatment, to a well-defined customer baseis a powerful and proven business model. Of course, individual practiceonly represents a tiny sliver of the business opportunities available in arelentlessly growing health care industry. Some adventurous surgeonsseek to test the waters of entrepreneurship outside of their practices. Themotivations behind this include the desire to commercialize a personalinnovation, to develop an alternate income stream or to satisfy a thirst forchallenge.

Opportunity and InnovationLike many surgeons, I conceived ideas about improving the surgicaldevices I used every day. As a spine surgeon, I was frustrated by the lackof meaningful product choice in spinal fixation designs. The marketplacewas crowded with companies offering multiple brands, but these weremostly “me-too” products with similar drawbacks. Through informaldiscussions with other surgeons, I discovered that many shared myfrustrations.

Sensing a need and opportunity, I committed to paper several ideas forimproving spinal fixation devices. One of these was the Caplesspolyaxial pedicle screw. I reasoned that I could eliminate a troublesomestep from standard pedicle screw fixation systems—namely, rod fixationvia a cap threaded into a pedicle screw head. I submitted a patent applica-tion for a concept using a rotary locking mechanism to lock the polyaxialhead directly to the rod without a separate locking cap. I went on tosubmit additional patent applications for interbody cage, cervical plateand arthroplasty products. These conceptualizations represented thebeginning of a four-year odyssey to deliver products to the marketplace.

Products Versus ConceptsI initially attempted to interest some major orthopaedic companies in myearly ideas. Several executives confessed that they liked the concepts butpolitely stated that they could not justify the investment in a brand newdesign. I discovered that established orthopaedic companies very rarelydevelop unsolicited concepts from surgeons. I learned that in the highly-regulated medical device business, unproven ideas on paper haveessentially no value. Only developed products have intrinsic value.

Developed products have undergone validation: they have been built,biomechanically tested and have a clear regulatory pathway throughFDA.

Undeterred by the corporate response, I decided in earnest to take onthe responsibility of product development. I believed in the products andrealized that a new company would be needed to facilitate investment,provide a tax benefit and move toward FDA clearance. The purpose ofthe new company, X-spine Systems, would be to develop novel spinaldevices and to deliver them to the marketplace, initially throughlicensing agreements, then via traditional distribution channels. Asidefrom the practical benefits, I was excited by the entrepreneurial challengeof building a company. It could also be a financial disaster.

Getting Started Developing a new product in a highly technical and regulated field wouldnot be a cheap or easy proposition. My first order of business was tolearn. I voraciously consumed any information I could about productdevelopment, drafting, designing, biomechanical testing, quality controland regulatory issues. I learned how to use AutoCAD design software tomove my designs from paper and produce accurate dimensionaldrawings. I read books like Titanium in Medicine by D.M. Brunette andDevelopment of FDA-Regulated Medical Products by Elaine Whitmore.The second order of business was capitalization.

Financing initially came from my checkbook. After investing asubstantial sum of my own money, mostly in drafting, modeling andpatent fees, I felt that outside investment would be needed.

There are several financing options for a physician entrepreneurseeking to start a company. These include small business loans, bankloans, individual investors and venture capital. Some orthopaedic start-ups have cultivated surgeon investors who would then become acustomer base for the products. I ruled out this arrangement because I feltit would put the company and investors at risk for potential ethical andlegal entanglements.

Since I wished to avoid leveraging my personal property, but wantedto keep control of the company, I decided to pursue individual investors.Several local investors with experience in the entrepreneurial arenabecame interested in X-spine. We initiated a private stock agreementunder which I would continue investing and maintain significantownership. Even with my new partners contributing, this was a verysignificant financial commitment on my part. I viewed it as an invest-ment, albeit a high risk one, in a promising new medical device company.Based on my experiences building this enterprise, I would like to sharesome key points and pitfalls for any prospective surgeon entrepreneur.


Surgeon Entrepreneurship: Risksand Rewards

Author: David Kirschman, M.D.


spine.X TM

© 2006 X-spine Systems, Inc. 7081 Corporate Way, Centerville, Oh 45459 800.903.0640 www.x-spine.com

ntroducing the Next Revolution in Polyaxial Screw Fixation...

The X-spine CAPLESS pedicle screw system.

Designed by surgeons for surgeons.

500N

400N

300N

200N

100N

0CAPLESS

297 299

388

438

Axial Compression Yield Strength (Newtons) per ASTM F1717.

References:Stanford RE, et al. Multiaxial Pedicle Screw Designs: Static and Dynamic Mechanical Testing.Spine 2004; 29: 367-365.

American Society for Testing Materials (ASTM) “Standard Test Methods for Spinal ImplantConstructs in a Vertebrecomy Model.”

Note: Please refer to package insert for additional labeling information.Patents Pending.

I

CAPLESSTM

Brand A Brand B Brand C

Combines common-sense simplicity with superior biomechanical performance.

Uses integral rotary locking mechanism to fixate rod directly to screw.

No separate cap or set screw to become lost or loosen.

Positive rod fixation with 90 degree locking rotation.

No threaded socket with risk of cross-threading or splaying.

One step rod persuader allows rod persuasion and rod locking with a single instrument.

Omnidirectional cross-connector system.

5.5 mm rod diameter.

55 degree polyaxial freedom.

Enquiry No 14



Keys to Success1. Innovate a great product. The price of entry for any surgeon lookingto be an orthopaedic industry entrepreneur is a great product. Having agreat product won’t guarantee success, but finding success without onewill be nearly impossible. A medical advisory group of surgical peersshould evaluate the product frankly and confirm its marketability. Theproduct must be FDA clearable within given financial resources, attrac-tively marketable and must not infringe on prior intellectual property. Pitfall: Many ideas with potential are prohibitively expensive for a smallcompany to develop alone. Concepts which represent a brand newparadigm in the field (such as disc nucleus replacement) will require afull prospective clinical trial by FDA, which will take years and costmillions. This can only be achieved through major venture efforts orpartnership with a larger organization.

2. Know the FDA. Any surgeons seeking to develop a new medicalproduct, particularly an implanted one, must dedicate themselves tolearning the applicable FDA regulations intimately. Consider hiring anFDA consultant and review some of the many books on FDA-compliantproduct development. FDA’s website also contains a wealth of informa-tion, if not particularly well organized.Pitfall: FDA will audit your company and you must be prepared. Anyentity registered by, or that submits an application to, FDA is subject toFDA auditing and quality guidelines. FDA has jurisdiction over not onlyyour product, but also your facility. The requirements are complex andcan be challenging for a small company to achieve. Noncompliance canresult in warning letters, recalls, fines or even criminal penalties. Istrongly recommend hiring an experienced quality/regulatory manageras early as possible.

3. Develop a comprehensive business plan. With few exceptions,surgeons are not versatile businesspeople. I recommend seeking advicefrom experienced managers and having a written business plan in placeprior to undertaking major investment. The business plan must includean assessment of the market, product development timeline, competition,projected sales, insurance requirements, budget, employees and capital-ization. Subcontractors may be needed for biomechanical testing,independent engineering consulting and manufacturing. Productdevelopment is an unpredictable process—costly redesigns are commonand should be planned for within the budget.Pitfall: Practicing physicians can find themselves in the unenviableposition of chronically siphoning income from their clinical practice intoa money-losing business venture. While this can be expected during theinitial investment phases of a business, it shouldn’t be allowed tocontinue for a significant period of time. “Working to support thebusiness” is a most undesirable situation which can prop up a failingcompany at the cost of running its owner on a financial treadmill. If thebusiness doesn’t become profitable within a predetermined period oftime, seek exit.

4. Obtain early patent protection. The orthopaedic industry has acrowded intellectual property landscape. Lengthy patent searching needsto be undertaken to determine the possibility of infringement prior toinvestment in development. An experienced patent attorney is a must. Pitfall: Patent infringement claims are a frequent occurrence in theorthopaedic industry. You may wish to obtain a “freedom to operate”letter from your patent attorney stating that there is no apparent infringe-ment. I have had to abandon several concepts because of previous patentpublications.

5. Manage time demands. One of the greatest challenges for a surgeonentrepreneur is striking a balance between clinical and company duties.Cutbacks in clinical load (and income) are inevitable. It may be best toreserve regular times, such as two recurring days a week, to devote to thecompany. This allows the scheduling of company business in advancewithout conflicts.Pitfall: I feel it’s important to keep one’s hands in the clinical world evenwhile growing a company. Most of a surgeon’s ideas originate in theoperating room. This is the greatest advantage that a surgeoninventor/entrepreneur has over big-company product developmentdepartments: a surgical procedure is not an abstraction, but rather a dailyhands-on experience. Giving up that experience would undoubtedlyhinder thoughtful concept development.

ConclusionStarting and running your own orthopaedic company is a challenge withreward proportional to risk. It is certainly not for everyone. The market-place is crowded and there are many pitfalls; however, it can be greatlyrewarding to those with a mind for innovation, tolerance for risk and anentrepreneurial spirit.

X-spine continues to grow and bring surgeon-centric spinal productsto the marketplace. Our first product was the XACP Compact cervicalplate which was FDA-cleared in October 2004, followed by the SpiderCervical plate in October 2005. After extensive development and testing,the Capless pedicle screw was FDA-cleared in December 2005.

David Kirschman, M.D. received his medical degree from the Universityof Colorado and completed neurosurgical training at the University ofKansas. He is currently in private practice at the Ohio NeurosurgicalInstitute in Dayton and is President of X-spine Systems. He can bereached at [email protected].

Enquiry No 35



To see your products listed within the Product

News and Product Feature sections

email your information [email protected]

18 Orthopaedic Product News • July/August 2005

PRODUCTT NEWSS PRODUCT NEWS

Echoes Pacs System

The echoeSYSTEMTM browser-based viewing software allows authorizedusers access from virtually any network accessible personal computer totheir practices images. The system also automates offsite data backup fordisaster recovery of archives, simplifying Health Insurance Portability andAccountability Act conformance by practices.

Furthermore, the product allows authorized users to award secureInternet access to referring physicians and other healthcare professionals.Clinical users select either compressed or uncompressed file options onsecure echoeSYSTEMTM web servers balancing the tradeoff between clin-ical need and bandwidth availability. The echoeSTATIONTM softwareuniquely aids orthopedic professionals in preoperative planning and post-operative evaluation. The software allows overlaying of implant templateson images, and includes tools for performing analysis measurements on theimage and positioning of the templates. Surgeons digitally template jointreconstruction cases for pre-operative selection of implants from all themajor implant manufacturers. Surgeons can evaluate patients' operativeresults in relation to saved pre-operative plans.

Medstrat Tel: 800-882-4224www.medstrat.com Enquiry No 20

The WristoreTM Distal RadiusFracture Fixator

A new innovation in distal radius fracture fixation has arrived fromZimmer. The Wristore™* Distal Radius Fracture Fixator is an external fix-ation device designed to allow for minimally invasive treatment of com-plex wrist fractures.

With its innovative outrigger design, the Wristore fixator allows sur-geons to rigidly fix bony fragments and facilitate early return of motion tothe wrist.

The Wristore fixator is supplied in a sterile kit that includesall of the implants and non-powered instruments neces-sary to apply the fixator (a standard OR drill is alsorequired). The Wristore fixator is radiolucent andallows a surgeon to achieve the kind of surgical out-come previously associated with plates and screw fix-ation with a much less invasive, temporary device.

The Wristore fixator is a solution for sur-geons looking to help restore their patients tonormal activity after difficult wrist injuries.

*Wristore is a trademark of Millennium MedicalTechnologies, Inc.

Zimmer Tel: 800-348-2759www.zimmer.com Enquiry No 20

ZipKnotTM Suture Fastener

The ZipKnotTM suture fastener, developed by MedicineLodge, Inc., is animplant device for use in approximation and/or ligation of soft tissuesusing surgical suture, making it useful in a broad spectrum of surgical pro-cedures. The device is used in place of surgically tied knots, saving oper-ating room time and providing a stronger, more reliable fastening of surgi-cal suture. The ZipKnotTM is provided in a cartridge contained within a ster-ile package. The cartridge includes suture threaders that pass the free endsof surgical sutures through the ZipKnotTM. The threaded ZipKnotTM is eas-ily advanced to the repair site using a conventional knot-pushing tool, andit can be re-tensioned at any time before the final trimming of the suture.The ZipKnotTM, made from polyetheretherketone (PEEK), recentlyreceived FDA 510(k) clearance.The device has also been devel-oped in a bioabsorbable poly L-lactic acid (PLLA) material, andis scalable to all sizes of suture.

MedicineLodge, Inc. Tel: 435 753 7675www.medicine-lodge.com Enquiry No 14

Signus Medical LLC announced receipt of spinal VBR clearance from theFDA for its Semial® Spinal Implant. Semial®, manufactured by SignusMedizintechnik GmbH, has a proven clinical record in Europe and isindicated as a spinal intervertebral body fixation orthosis. The implant isavailable in a range of diameters, heights and lordotic angles to optimiseits match to the surgical site.

With the extensive range of geometries and as the implant can beinserted from either a direct anterior or an anteriolateral approach it maybe used at a wide variety of vertebral levels and in both primary and

revision cases. The addition of the Semial®system furtherextends Signus Medcal’s strong product offering inPEEK Optima®. In addition to the instrumentsfor insertion of the implant, the set includesan array of well-crafted site preparationinstruments.

Signus Medical LLC Tel: 952-294-8700www.signusmedical.com Enquiry No 15

Topaz MicroDebrider

ArthroCare Sports Medicine’s Topaz MicroDebrider, designed for use intreatment of tendon conditions, is a wand-like device about the diameterof a pencil tip. Through a small incision, generally an inch in length, thephysician applies the device to the problem tendon for multiple 500 mil-lisecond intervals of treatment.

By combining low temperature radiofrequency energy with saline, acharged plasma gas is formed at the tip of the TOPAZ wand and is pre-cisely directed into and through the damaged tissues. From start to fin-ish, the whole process takes less than 20 minutes. New study data pub-lished last month in Arthroscopy: The Journal of Arthroscopic & RelatedSurgery showed Topaz tobe effective when used inthe treatment of commontendon disorders such aslateral epicondylitis, thecondition commonlyknown as tennis elbow.

ArthroCare Tel: 408-736-0224www.arthrocare.com Enquiry No 17

Semial Announcement


Hips

Whitney Curettes

For removing excessbone cement duringhip and knee replace-ment surgery, theWhitney Curette ispreferred by ortho-paedic surgeons.

Made of sturdyplastic, WhitneyCurettes and SculpsTools reduce marringof the polished sur-faces of the prosthe-sis, thereby loweringthe risk of shortened joint life. The ergonomic handle design makes it easyto maneuver around hard-to-see spaces, and just feels right for fingertipcontrol.

For OR nurses, the advantage is the convenience of tools individuallypackaged, sterile and ready for use. And the single-use design eliminatesthe need for removing hardened cement and resterilizing instruments.Whitney Curettes and Sculps Tools save time, cost less and are safer to usethan traditional metal tools. For a free sample please contact us at:

Whitney Products, Inc. Tel: 800-338-4237www.whitneycurettes.com Enquiry No 25

SL-PLUS® Hip Stem

The SL-PLUS, designed by Prof.Karl Zweymüller, incorporates aphilosophy with over 25 years ofclinical use worldwide. Its taperedgeometry and rectangular crosssection provide high axial androtational stability. Because the site isbroached instead of reamed, boneparticles stay in the periprostheticregion.

A precision grit blasting processcreates a 4 – 6 micron surface thatpromotes secondary stability. Becauseof its highly osteoconductive nature, grit blasted surfaces represent animportant and valuable technology for the design of non-cementedimplants 1,2.

With its flat sides, the SL-PLUS does not completely fill the medullarycanal. By maintaining this area, the endosteal blood supply is stillmaintained. The SL-PLUS is available in 14 standard and 12 lateralizedoffset sizes with lengths from 128–188mm for increased clinical flexibility.

1 Lester D: J Arthoplasty Vol 12 No. 8 19972 Hacking S: CORR Number 364, 1999

PLUS Orthopedics Tel: 888-741-7587www.plusortho.com Enquiry No 24

PRODUCTT FEATURES

The WoodpeckerIMT-USA, LLC intro-duces the Woodpecker®,Total Hip Broachingsystem. It is a uniqueproduct that has beenearning the attentionand acclaim of Ortho-paedic Surgeons world-wide since 1992.

The Woodpeckereasily adapts to standardindustry broaches. Itsgentle, rapid linearmotion for improvedmodeling on the Prox-imal Femur creates inti-mate contact between the bone and press fit implants. Furthermore, theWoodpecker can reduce the risk of fissuring the bone, and reduces opera-tor fatigue and the amount of time necessary to perform Total HipArthroplasty when compared with traditional procedures.

Along with THA you can also use the Woodpecker for MIS and extrac-tion of intramedullary nails. The Woodpecker is available with a completeline of Compatible Broach Adapters, Sterilization Tray, Extended Warrantyprogram and leasing options. For Sales and Service, please contact:

IMT-USA, LLC Tel: 651-493-9634www.imt-medicalusa.com Enquiry No 33

Unparalleled ExposureThe OmniAccess™ HipRetractor System isdesigned to provideunparalleled exposurefor THA—using anyapproach, any incisionsize, any implant andindependent of patientsize, weight and thenumber of personnelavailable to you duringyour case. This table-mounted retraction system offers stable, reliable hands-free access whileaccommodating the most widely-used handheld retractors to accommodatesurgeon preferences and techniques.

It’s about unparalleled exposure: our articulating blade holders sweeptissue away from the operative site producing more exposure at the depthof the wound through an inverted, truncated cone. Tension on the skin andsuperficial structures is lessened and trauma to the skin and incisionaledges is minimized.

The system is compatible with all surgical approaches and provides forconstant, simple, reproducible exposure. Call us today for a free 30-daytrial evaluation.

Omni-Tract® Surgical Tel: 800-367-8657www.omni-tract.com Enquiry No 35

PRODUCT FEATUREPRODUCT FEATURES


Enquiry No 15



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OPN: You have been both a successful orthopaedic surgeon and a busi-nessman. What motivated you to start a nonprofit?

C. Scott Harrison, M.D. (SH): During my time both as an orthopaedicsurgeon and as a businessman, I worked on a part-time basis with domes-tic and international nonprofit organizations. In the late 1970s andthrough much of the early 1980s, my wife and I worked at a local rescuemission. I was impressed with the dedication and hard work demonstrat-ed by many in the nonprofit sector. Although there were numerous frus-trations, I also recognized the important changes they could make in peo-ple’s lives.

When Sally and I went to Africa in the mid- and late 1980s, we saw theeffectiveness of nonprofits in bringing orthopaedic care to people whowould otherwise be doomed to living with their crippling deformities.

OPN: How do you decide where to locate a hospital?

SH: The first criterion is a clear medical need in the country. This doesn’tnarrow the field very much, since there are 150 to 200 countries thatdesperately need care for their disabled children. Next, the country mustbe relatively safe, although our extensive work in Afghanistan stretchesthat somewhat.

Next, we have to either have access to or have reason to believe wewill be able to recruit skilled orthopaedists and other healthcareprofessionals to work in that area. Finally, it is helpful to have a source

of financial support for the area selected, although in many cases this hascome after our decision to go to a particular location.

OPN: How are the hospitals structured and managed?

SH: CURE International is building a network of hospitals. In the 1980s,I saw many Third World freestanding hospitals that were started by reli-gious denominations or others that, as standalones, were having greatdifficulty surviving. This continues, and the demise of the traditionalmission hospital is accelerating.

Therefore, we elected to have an intertwined network of hospitals thatare owned and managed by CURE. We operate these through local advi-sory boards of concerned national citizens. Our staff, when possible, con-tains as many nationals as we can recruit. Typically, 98 percent of ouremployees at each hospital are locals whom we have trained.

OPN: Does each hospital have its own specialty?

SH: Yes. I am an orthopaedist, and people therefore assume that all ofour hospitals are orthopaedic. This is not the case. The ones in Kenya,Malawi, the Dominican Republic and Honduras are principally, althoughnot exclusively, orthopaedic. The hospital in Uganda is exclusively pedi-atric neurosurgery and has one of the higher volumes for such hospitals

C. Scott Harrison, M.D.

CURE International

Dr. Scott Harrison’s 26 years of service as an orthopaedic surgeon began as a graduate of the University ofPittsburgh Medical School in 1963 and included a year of medical service in Vietnam during the war; ClinicalProfessor of Orthopedic Surgery at Penn State Medical School; Director of Scoliosis Service for thePennsylvania State Crippled Children’s Hospital; and Chief of Orthopedics at Harrisburg Hospital inPennsylvania. In 1991, Dr. Harrison was asked to serve as CEO and President of Kirschner MedicalCorporation, an international orthopaedic company. In 1994, the company merged with Biomet, Inc. and thesuccess of that merger provided the capital funding for construction of CURE’s first hospital in Kenya in1998 with the vision of bringing state of the art care to those most in need.

He and his wife, Sally, founded CURE International, a faith-based, nonprofit organization that establish-es and operates teaching hospitals in the developing world for the medical and spiritual healing of disabledchildren and their families. The organization manages and staffs hospitals with highly-qualified Americanand British orthopaedists and neurosurgeons. The physicians are committed to training host-country doctorsin the most modern surgical procedures and techniques to enhance healthcare for countries with few med-ical facilities and skilled medical personnel. Since the organization opened its first hospital in Kenya, CURE’smedical staff has treated more than 400,000 patients and performed over 26,000 surgeries. CURE hospitalsare located in Afghanistan, the Dominican Republic, Honduras, Malawi, Kenya and Uganda. Four addition-al hospitals will open in the next 12 to 24 months in Bethlehem, Egypt, Ethiopia and Zambia. Dr. Harrisonwas recently interviewed about his experiences.



SSPPEECCIIAALL FFEEAATTUURREE

in the world. The hospital that is under construction in Zambia will beequally plastic surgery, neurosurgery and orthopaedics, while the one inAddis Ababa will be a traditional orthopaedic hospital for the care of thedisabled. The unit in Cairo, Egypt will be principally adult and pediatricorthopaedics. We are working in Kandahar where we support the localregional general hospital. In Kabul, we have a general hospital which hasa strong orthopaedic presence but has, as well, a general practice residen-cy, and we are working to create an OB/GYN residency as well. We alsomanage the principal obstetrics and gynecologic hospital in that country.

OPN: What impact do the hospitals have on the countries in which theyare located?

SH: All of our hospitals are teaching hospitals. As well, we draw patientsfrom the entire country. In Kenya, we have had as many as 20 clinicsaccessing the entire country. In places like Uganda, because of theuniqueness of our service, we receive patients not only from the entirecountry but from all of East Africa. We therefore are a provider of spe-cialty services which otherwise would be unavailable in the country. Thefact that we are teaching the local doctors means that, as time goes on,these services will eventually be available in some regional hospitals aswell as whatever principal medical facility exists in the country.

OPN: Where do you find staff and funding for the hospitals?

SH: As I mentioned, the staff is principally locals who are given anextensive training course. We have found it is most difficult to get skilledcandidates to be the chief financial person within the hospital. Likewise,


™

Enquiry No 16

Enquiry No 36

finding capable hospital administrators is often difficult. The governmenthospital systems in Third World countries are often inefficient and poor-ly run, and these are not usually a source of senior administrative people.

Funding for the hospitals comes from a blend of many sources. Wehave found in the developing world, as we have found in America, thatpatients who don’t contribute anything to their care often treat the serviceas worthless. So we ask for some, often token, payment by the patients.This may support as little as five percent of our expenses or as much as75 percent at some of our orthopaedic facilities. We have an activefundraising arm of CURE International. The American public has beenvery generous, and we are also working in England and on the continentof Europe to raise funds. We access a limited amount of governmentfunding as well. Finally, because of the unique type and high volume ofpatients that we have, we are seeing research funding available.

OPN: What do you envision the CURE hospital network will look like inten years?

SH: We opened our first hospital in 1998 and most recently have signeddocumentation to begin our thirteenth. If we continue at the current rate,that would place us at over 30 hospitals ten years from now. There are,of course, many obstacles to overcome if we would get to that point. Iwould be immensely pleased if, in ten years, we had 25 vigorous, wellfunctioning teaching hospitals for the care of the disabled. Who knows—if we get to that number, I might even think about retiring!

CURE International is found online at www.cureinternational.org. Dr.Harrison can be reached via Lisa Wolf, Director of Communications, [email protected].



AAOS

PPRROODDUUCCTT FFEEAATTUURREESS

Ascension® Neurolac® Nerve GuideThe Ascension® Neurolac®

Nerve Guide is indicatedfor reconstruction of aperipheral nerve disconti-nuity. Neurolac providesguidance and protection toregenerated axons andprevents ingrowth offibrous tissue into thenerve gap during nerveregeneration from theproximal to the distalnerve stump of the tran-sected nerve. Neurolac istransparent and allowsclear visualization of theposition of nerve stumps.Tension-less nerve repair offers optimal nerve healing.

There is no need for autologous transplants, thus eliminating donorsite morbidity. Neurolac aids in containing neurotrophic factors to createan environment for nerve regeneration. Within this environment, there isno need to align fascicles of distal and proximal nerve ends – saving timein the operating room. Neurolac is designed to prevent both kinking andcollapse. Patient comfort is increased, and early flexion of joints is fea-sible. Find us at the AAOS in Chicago, Booth 4608.

Ascension Orthopedics Tel: 877-370-5001www.ascensionortho.com Enquiry No 40

ARC Wrist Traction TowerThe ARC Surgical Wrist traction tower is an excel-lent example of form following function.Featuring an advanced design and quality, it pro-duces and maintains traction with ease whileallowing better access to the wrist from allangles. Drop the curved support arm to the hor-izontal position and the tower becomes aninvaluable aid in treating distal radius and otherwrist fractures. Providing the “extra set ofhands” that can be so valuable in the OR, theARC Surgical Wrist traction tower is an assis-tant whose time has come. • Curved Support ARC• Swiveling Support Arm • Vertical/Horizontal Support Arm • Ventilated Arm Bed and Support• Fitted Non-slip Finger Traps in

Four Sizes Find us at the AAOS in

Chicago, Booth 3115.

ARC Surgical LLC Tel: 503-645-9300 www.arcsurgical.comEnquiry No 38

EPOCA Humerus ResurfacingHead

In cases of solid bone structureand support, an anatomicalreconstruction of the articulat-ing surface with minimal boneremoval, called resurfacing,should be considered. The newEPOCA RH humeral resurfac-ing head has been speciallydesigned to replace only thearticulating surface and pre-serve a maximum of bonestock.

It is so thin that it is morelike a cartilage replacementwith minimal bone removal.The implant is anatomicallyadapted and has progressivehead sizes in 2mm increments.Diameter, height and the fixa-tion crown increase proportionally. In the epiphysis, the implant is fixedwith a slightly conical crown giving strong primary pressfit and, with itslarge surface, stable long-term fixation. Being minimally invasive, it offersfast rehabilitation with good function and range of motion and reliable painrelief. The humeral diaphysis remains unchanged, leaving all options incase of potential revision. Find us at the AAOS in Chicago, Booth 1935.

Argomedical Tel: 760-931-4763www.argomedical.com Enquiry No 37

Hemi Toe ImplantBioPro’s 1st MPJ hemi toeimplant is an excellent alterna-tive to fusion. Manufacturedfrom cobalt chrome, it isavailable as both porousand non-porous coated.It offers patients painrelief, restores range ofmotion and allows for a return to an active lifestyle.

The BioPro implant is the most extensively studied hemi toe replace-ment available. It has been successfully used since 1952 and has a 38-yearclinical study showing a 97.4% survivorship rate. Additionally, there aremultiple independent studies available showing similar results.

The BioPro hemi toe is simple to implant, removes the minimumamount of bone possible and preserves the anatomy of the first toe. The con-servative bone removal and simple surgical technique allow for easilyreproducible results.

The same successful design of the 1st MPJ implant is available in LesserMPJ Hemi Implant for treating arthritis, Friebergs disease, post traumaticarthritis and metatarsal head fractures in the lesser digits. Find us at theAAOS in Chicago, Booth 1224.

BioPro Tel: 800-252-7707www.bioproimplants.com Enquiry No 39




Dorsal PF Night Splint ImprovesPatient Compliance

AliMed’s Freedom®

Dorsal PF NightSplint gently stretch-es the plantar fasciaand calf musculatureto help relieve heelpain associated withplantar fasciitis. Itssimple dorsal designis easy for patients totolerate, significant-ly improving com-pliance. The softbase constructionallows for safenighttime ambula-tion.

Adjustable neoprene calf and toe straps make the Dorsal PF NightSplint easy to apply and remove. Its padded instep is also adjustable,ensuring the perfect fit. It is low profile and lightweight, constructed witha Kydex shell, latex free foam, and attached neoprene calf and toe straps.The Dorsal PF Night Splint fits either the right or left foot and is avail-able in medium or large. Find us at the AAOS in Chicago, Booth 1323.

AliMed Inc. Tel: 800-225-2610www.alimed.com Enquiry No 45

Acumed Expands The PolarusFamily

With the Polarus PHP Locking ProximalHumeral Plate, Acumed has designed anadvanced solution for repairing fracturesof the proximal humerus. The plate andinstrumentation contain numerous fea-tures that help to maximize surgical out-come and address the issues faced withother plating systems.

Acumed’s goal was to design a platethat incorporated a locking constructwith an anatomical size and contour thatbest accommodate the patient. Whendesigning the Polarus PHP, Acumed rec-ognized that the humeral anatomy dif-fers from patient to patient. To maximizestability in the humeral head, the proxi-mal screws needed to be preciselyangled to capture and secure fracturefragments.

The design and placement of thePolarus PHP minimize impingement and soft tissue irritation for thepatient. Acumed’s unique instrumentation is designed to improve the over-all surgical technique and maximize surgical outcome. Visit Acumed atAAOS Booth 4007 for more information.

Acumed Tel: 888-627-9957www.acumed.net Enquiry No 42

New Shoulder Arthroscopy TrainingSystem

Aptic Superbones,makers of orthopaedictraining and workshopmodels, have intro-duced their first com-plete shoulder arthro-scopic training sys-tem. The new ApticShoulder ArthroscopyModel, known as the“S.A.M.,” is a surgicalsimulation model usedto teach and practiceshoulder repair tech-niques. In addition toits use in surgeonworkshops and resi-dent training, the S.A.M. is designed for use by sales professionals anddevice manufacturers in the shoulder repair market.

The complete system includes the shoulder arthroscopy model with arotating humerus, two covers (tan and clear) with customized port sites,replaceable glenoid, humerus head and rotator cuff/labrum, all in a hardtravel case. Several material choices are available for the replaceableparts, and the entire system can be branded to reflect your marketingagenda. AAOS Booth #4158.

Aptic Superbones Tel: 206-463-4774www.apticsuperbones.com Enquiry No 44

S4 Brace (Spine and ScapulaStabilizing System)

AlignMed introduces thefunctional and dynamic S4Brace (Spine and ScapulaStabilizing System) forimproving shoulder andspine function by optimizingscapular position, spinalalignment and propriocep-tive retraining. The S4 is per-fect for pre- and post-opera-tive rehabilitation, and com-plements physical therapy.This dynamic retrainingdevice is suitable for varioustypes of patients: school stu-dents who spend time on thecomputer, people who sit at adesk for a long period oftime, a surgeon in surgery,patients with back pain,patients with upper body weakness, athletes and many more. Find us at theAAOS in Chicago, Booth 5610.

AlignMed Tel: 800-916-2544 www.alignmed.com Enquiry No 41


Ascension® RADFx®

proximal radius fixation kit –one call, three options

Radial Head Platefixed angle locking plate

Compression Screw Systemmini 1.5mm cannulated compression

screw – smallest on the market

Modular Radial Head Prosthesiscementless short & long stem options

Our new RADFx® system offers a complete solution to proximal radius fractures.

The system consists of a compression screw system, a fixed angle locking

plate, and a radial head prosthesis – all in one instrument set.

8700 Cameron Rd, Suite 100 • Austin, TX 78754

512.836.5001 • Toll-Free 877.370.5001

www.ascensionortho.com

Enquiry No 17



U-ARCThe Del Medical U-ARC has been designed as a world class directdigital imaging system for use in hospitals, orthopaedics, trauma centersand general radiology applications. The U-arm design maintains constantalignment between the x-ray tube and image receptor, regardless of U-arm tilt position or image receptor angle.

The extraordinary flexibility makes the system ideal for all patients instanding, sitting or lying position, including those who are disabled orphysically restricted. All movements are motorized and all positions canbe achieved with the simple push of a button, andthe device is equipped with an anti-collisionsystem making movements easy and safe. The DelMedical U-ARC provides a variable source toimage distance from 40-72 to accommodate a widerange of radiographic studies.

Equipped with a17”x17” digital flat paneland workstation, the U-ARC produces fasterexam times, greaterthroughput and in-creased productivity.Please visit our booth at theannual AAOS meet-ing in Chicago,#3969.

Del Medical Systems Tel: 800-800-6006www.delmedical.com Enquiry No 54

Orthocere Practice Management

Orthocere is an Internet-based ASPpractice management productoffering solutions to make yourorthopaedic practice more pro-ductive. This fully HIPAA ready andsecure application can be accessedanytime, anywhere and dramaticallyimproves communication amongpatients, ancillary service providersand physician networks. Orthocerecan even provide patients with thereal-time capability to requestspecific appointments online.

Best of all, you can access all ofyour practice’s data and businessprocesses from anywhere at any time.Both cost effective and easy to use,Orthocere manages scheduling, coding, billing, accounts receivable andElectronic Medical Records. Backed by Medcere, a healthcare informationtechnology company, Orthocere is made specifically for orthopaedicpractices with the mission of delivering secure, integrated and real-timepractice management solutions and services in the most cost effective andeasily accessible manner. Designed with doctors, for doctors, Orthocereprovides practical and efficient means to help any practice run moreefficiently, enabling doctors to focus on what they do best, practicemedicine. Find us at the AAOS in Chicago, Booth xx.

Medcere Tel: 888-573-1233www.medcere.com Enquiry No 51

The CLEARANT PROCESS®

The CLEARANT PROCESS® is theonly final-packaging inactivationmethodology that offers allograftsterility equal to OR-ready medicaldevices with no tissue damage,inactivates all types of microbialpathogens, including viruses, bacteria,fungi and spores, without impactingthe structural or biomechanicalintegrity of the allograft.

The CLEARANT PROCESS is themost comprehensive inactivation tech-nology available today, clearlysuperior to alternate methods thatcompromise between safety andefficacy. You can now have higherconfidence that allografts arrive sterileand pathogen free, allowing betteroutcomes for all your patients andpreventing infection and diseasetransmission.

Find out more about this importantbreakthrough in sterilization adv-ancement. Join us at the AAOS AnnualMeeting, Booth 5633.

Clearant, Inc. Tel: 310-479-4570.www.clearant.com Enquiry No 52

Cryopreserved Meniscus AllograftsCryoLife is the industry leaderin providing cryopreservedmeniscus allografts to ortho-paedic surgeons, and hasshipped for implantation over4,500 meniscal allografts withdocumented long-term clinicaldata.

CryoLife cryopreservedmeniscus allograft transplantis an ideal treatment option formeniscal deficient patientswho are eager to maintain anactive lifestyle, free of pain.

CryoLife’s cryopreservedmeniscal allografts containviable cells and an intactcollagen matrix, and are sizedmatched to the requireddimensions of the patient’sown knee. CryoLife offersphysician surgical skills workshops, insurance reimbursement support andan extensive inventory with a highly experienced staff for specific sizematching. Find us at the AAOS in Chicago, Booth 3607.

CryoLife Inc. Tel: 800-438-8285www.cryolife.com Enquiry No 53




ERMI Knee/Ankle Flexionater®

The ERMI Knee/Ankle Flexionater allows patients who have failedtraditional physical therapy regimens to practice overpressure therapy athome to improve both knee flexion and ankle dorsiflexion. Studies haveshown success rates of over 90% in patients who would otherwise havereturned for surgical management of flexion loss.

The hydraulic load delivery is patient-controlled and is designed tomimic the manual therapy protocols used by physical therapists in theclinic. Patients are instructed to apply a load that approximates the feelingthey experience when they are being stretched by their therapist. TheERMI Knee/Ankle Flexionater can generate loads from zero to several 100foot-pounds of torque to accommodate the unique mechanicalcharacteristics of scar tissue found in each patient, thus providing sufficientloads to stretch the stiffest of joints.

ERMI’s Patient Actuated Serial Stretch (P.A.S.S.) protocols follow theTotal End Range Time (TERT) theory for stretching scar tissue1. Thistheory calls for 60 minutes of end-range stretching daily with applied loadscomparable to those employed by the therapist during in-clinic, manualstretching sessions. When practiced daily, theprotocol helps patients maintain and even gainmotion between PT visits. Find us at theAAOS in Chicago, Booth 5435.

1Davies, George J., PT, ATC and Ellenbecker, ToddS., PT. Focused exercise aids shoulder hypomobility.Biomechanics 1999, 77-81.

End Range of Motion Improvement, Inc. Tel: 877-503-0505www.getmotion.com Enquiry No 57

SP Gel Adhesion Barrier For Spine Surgery

Oxiplex/SP Gel is ind-icated as an adjunct toposterior lumbar lamin-ectomy, laminotomy ordiscectomy proceduresfor reducing the inci-dence, extent and severityof postoperative adhe-sions at the site of gelplacement.

Oxiplex/SP Gel isplaced at the surgical site prior to closure and serves as a temporarybarrier protecting the dura and nerve roots from adhesions. Oxiplex/SPGel is composed of carboxymethylcellulose (CMC) and polyethyleneoxide (PEO) and is:• Biocompatible• Absorbable• Synthetic• Water Soluble• Tissue Adherent• Viscous

Oxiplex/SP Gel is CE Marked and available for sale outside the U.S.Stored at room temperature, it is provided ready for use in a 3cc syringewith a flexible applicator tip, instructions for use and patient trackinglabels. Oxiplex/SP Gel is an investigational device in the U.S. Find us atthe AAOS in Chicago, Booth 4038.

FzioMed, Inc. Tel: 805-546-0610www.fziomed.com Enquiry No 58

QuickAnchor® Plus Family OfSuture Anchors

The QuickAnchor Plus Family, the market’s best selling suture anchors,made by DePuy Mitek, Inc., a Johnson & Johnson company, is beingcombined with the company’s high-strength orthopedic suture, OrthoCord.

The combination results in three new products:• The GII QuickAnchor Plus with OrthoCord • The Rotator Cuff QuickAnchor Plus with dual-suture OrthoCord • Super QuickAnchor Plus with dual suture OrthoCord

With approximately one million GII Family anchors sold worldwidesince 1989, the latest addition to the DePuy Mitek portfolio of preloadedanchors combines the power and proven performance of the GII Family ofanchors with high strength yet supple OrthoCord Suture. OrthoCordSuture is coated with a proprietary material to increase the slide-ability ofthe suture and enhance its knot tying characteristics.

The QuickAnchor Plus Family with OrthoCord features OrthoCordSuture, which has 55 lbs. straight tensile strength3 and is 45 percent lessstiff than other high strength suture4. A permanent suture with a PDScomponent, OrthoCord creates less mass postoperatively.

3 Results of Strength Analysis White Paper, May 26,2005; data on file DePuy Mitek, Inc.4 Results of Stiffness Analysis Test MT 007-03performed by ETHICON INC., CPC and SutureStiffness White Paper, 9/04; data on file

DePuy Mitek, Inc. Tel: 800-356-4835www.mitek.com Enquiry No 55

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The Reverse® Shoulder Prosthesis

The Reverse Shoulder Prosthesis fromEncore Medical, L.P. is indicated foruse in patients with an irreparable,severely torn or deficient rotatorcuff. Patients presenting with arotator-cuff-deficient shoulder andglenohumeral arthritis typically showevidence of upward displacement of the humeralhead with respect to the glenoid and loss of the glenohumeraljoint space. Conventional surgical methods, such ashemiarthroplasty, bipolar and total shoulder arthroplasty areoften unreliable in improving comfort and function in patientswhose shoulders have the above-mentioned pathology.

The Reverse Shoulder Prosthesis is a semiconstrained balland socket device that provides a stable fulcrum of theglenohumeral joint. Stable fixation ensures confidence inselecting from an array of reconstructive options that optimizemuscular function and avoid scapular notching. This results inproviding patients with the potential for pain relief, restoredfunction and motion with improved stability, which is essential toperform daily activities that were once unachievable. Find us atthe AAOS in Chicago, Booth 2258.

Encore Medical, L.P. Tel: 800-456-8696www.encoremed.com Enquiry No 56




Inion TrinionTM Meniscus ScrewThe Inion® TrinionTM Meniscus Screw is an all inside meniscal repairdevice indicated for use in the fixation of longitudinal vertical meniscuslesions (bucket handle) located in the vascularized area of the meniscus(red-red and red-white zones).

The innovative dual thread design provides effective gap closure andgood soft tissue apposition to optimize the healing environment of thedamaged tissue. The unthreaded section in the middle (dual thread) allowsbetter gap closure as it helps to bring sides of the tear together. Controlledscrew insertion also provides the surgeon with complete management overthe position and screw depth, which is absent from many other devices.The headless screw design allows the screw to fully seat inside themeniscus to avoid chondral lesions. In vitro biomechanical pull out testdata indicates that the Inion Trinion Meniscus Screw provides equal initialstrength to a single vertical polydioxanone suture. Approximately 50% and30% of the initial strength remains after six and 12 weeks, respectively.*

Manufactured by Inion from Inion Optima™, a biodegradable materialmade by blending rigid and elastic polymer components to create implantswith the most appropriate strength, malleability and degradation profiles tomeet their specific clinical requirements. The Inion TrinionTM MeniscusScrew is distributed by Richard Wolf in the U.S. Find us at the AAOS inChicago, Booth 4453.

* Nurmi et al. Initial fixation strengths of bioabsorbable meniscus screws. EFORT,Lisbon June 2005.

Richard Wolf Medical Instrument Corp. Tel: 800-323-9653Enquiry No 61

Extremity MRI Systems

Hologic has signed an exclusive distribution and service agreement inthe U.S. for extremity MRI imaging systems manufactured by Esaote.Esaote is the world leader in this product category with over 1,000 sys-tems installed to date. The first two products available under the agree-ment are the E-Scan and C-scan systems. The E-Scan system combinesthe benefits of open MRI and dedicated MRI, providing the ability tooffer high-quality extremity MR imaging in the office. The system usesa permanent, open design magnet that provides excellent image qualityin a variety of applications that include shoulders. A dedicated shieldingsolution is also offered to eliminate costly build out costs.

The C-Scan MR imager provides convenient, low cost MR scans to awide patient population. Integrated RF shielding and a small footprintmean C-Scan can be installed in a 10' x 10' room with no special roompreparation required. Both systems are fully DICOM compliant provid-ing easy connectivity to other systems. Find us at the AAOS in Chicago,Booth 3641.

Hologic Tel: 781-999-7300www.hologic.com Enquiry No 60

Consensus® Knee System

The Consensus® Knee System has beendeveloped on a foundation of establisheddesign principles incorporating time testedfeatures and state of the art technologies.• The Consensus Knee femoral and tibial

components are anatomically designedand available for cemented and non-cemented applications

• Tibial components feature a patentedanatomically positioned Tibial Stem with an anatomic profile

• The CoCr porous coated femoral and tibial components are available with ourpatented Titanium Surface Technology™to enhance bone in-growth

• The Consensus Knee instrumentation offers three stylesof surgical techniques: Standard, Reduced Incision and MIS instrumentation

• The Consensus Knee patella is available in both round and oval configurations

The Consensus Knee System has been implanted in more than 16,000patients worldwide with excellent results. Come see the Consensus KneeSystem, along with the Consensus Hip and UniSynTM Hip System at the2006 AAOS in Chicago, Booth #4266.

Hayes Medical Inc. Tel: 800-240-0500www.hayesmed.com Enquiry No 59

Open Heel Posterior Leaf Spring AFO

The Open Heel Posterior Leaf SpringAFO offers the same anatomical designas Maramed’s traditional PLS with anopen heel cutout that allows patient towear any shoe comfortably without heelcontact. The cutout will not cause win-dow edema. The traditional design com-pensates for atrophy and avoids calca-neus irritation. The Open Heel PLS isfabricated from a specially formulateddurable polypropylene and formed in apredorsifexed position to provide superi-or dorsiflexion assist. Three styles tochoose from in four different sizes,Small to Extra Large. (Shown: Full FootOpen Heel PLS.) Find us at the AAOS inChicago, Booth 1931.

Maramed Orthopedic Systems Tel: 305-823-8300 www.maramed.com Enquiry No 62



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Low Energy Shock Wave Therapy

After years of experience and research in producing shock wave therapyfor lithotripsy, Siemens has successfully modified this proven technologyto utilize low-energy, pulsed sound waves for the non-invasive andanesthesia-free treatment of tendinopathies and other specific types oflocalized painful musculoskeletal conditions. This therapeutic system isoptimally designed with the patient in mind. As an alternative to surgeryand ongoing therapy, Ortho Shock Wave Therapy (OSWTI) provides thisin-office treatment with certified trained technicians, at no cost to thephysician.

The Sonocour provides a risk-free and highly effective therapy by usingbio-feedback to clinically focus finely tuned pulsed sound waves to thepoint of pain. The bi-weekly, short three-treatment protocol treats specificsoft tissue areas of the elbow, shoulder, hand,foot and knee. The short recovery periodslead to increased patient value and ofteneliminate the need for surgery. After threetreatments, most cases are resolved. See us atthe Siemens Booth #3661 at AAOS.

Ortho Shock Wave Therapy, Inc.Tel: 877-438-6798www.oswti.com Enquiry No 64

Bauerfeind DorsoTrain® ActiveSupport

Active support with stabilizing functionalelements. Find us at the AAOS in Chicago,Booth 207.

Bauerfeind USA, Inc.Tel: 800-423-3405www.bauerfeindusa.comwww.bauerfeind.comEnquiry No 65

Bauerfeind SofTec Genu® KneeOrthosis

Multifunctional orthosis for stabilization ofthe knee. Find us at the AAOS in Chicago,Booth 207

Bauerfeind USA, Inc.Tel: 800-423-3405www.bauerfeindusa.comwww.bauerfeind.comEnquiry No 66

Artelon® Spacer CMC-I for ThumbBase Osteoarthritis

Artelon® Spacer CMC-I isdeveloped for patients withthumb base osteoarthritis. TheArtelon Spacer CMC-I is a T-shaped, woven constructionmade of Artelon fibers. Thedevice is patented and CE-marked*.

Artelon Spacer CMC-Iis designed to achieveboth resurfacing andstabilization of theosteoarthritic trapez-iometacarpal (TMC)joint. The TMC jointis also named car-pometacarpal joint,CMC-I. The purpose of the vertical portion is to separate the surfaces ofthe arthritic joint and to act as a spacer between the trapezium and thefirst metacarpal. The horizontal portion acts to stabilize the joint andthereby prevent subluxation.

By using the Artelon Spacer CMC-I, the trapezial bone will not haveto be removed, thus keeping the anatomy of the hand intact. This avoidsshortening or restricted mobilization of the thumb. Surgery is performedunder local anesthesia. Find us at the AAOS in Chicago on Booth 4003.

*CE Marked Product labeled Artelon® TMC Spacer

Small Bone Innovations, LLC Tel: 800-778-8837www.totalsmallbone.com Enquiry No 63

Panta® NailNewdeal, a division of Integra LifeSciences, introduces the Panta® Nail, aninnovative solution for tibiotalocal-caneal fusion. The unique Panta Nailcompression device allows the applica-tion of up to 12mm of bilateral axialcompression across the ankle and subta-lar joints. Compression is applied equal-ly on the medial and lateral sides of theconstruct to avoid the introduction oftorque and coronal tilt. The idealamount of compression is dialed inusing the wheel mechanism, and islocked in by simply placing the tibialscrews.

The Panta Nail is manufactured fromtitanium alloy and is available in multi-ple lengths and diameters to accommo-date anatomic variation. The calcaneusscrews are oriented in the anterior/pos-terior plane for increased purchase. Thetibial screws are oriented perpendicular(medial/lateral) to the calcaneus screwsfor increased rotational stability.

An optional talus screw may be placed, if desired. Fully threaded5mm screws are available in 20 to 110mm lengths. The Panta Nail instru-mentation is color-coded to simplify the surgical technique. The drillguides and sleeves and drills corresponding to the tibia, calcaneus and talarscrews match the corresponding insertion points on the targeting/compres-sion device. Find us at the AAOS in Chicago, Booth 1255.

Integra-Life Sciences Tel: 800-654-2873www.integra-ls.com Enquiry No 67




Hallux Valgus Repair

The Merete MetaFix™ I offers theadvantage of a new low profilelocking plate technology for theproximal “Opening or ClosingBase Wedge” osteotomy in case ofa Hallux Valgus repair. Additionalindications are fusion of the MTPjoint and fusion of the MT 1/C 1joint (Lapidus procedure).

MetaFix I System was devel-oped in conjunction with DiedrichHaesen, M.D., Medical Director ofFoot and Joint Surgery, Clinic FleetinselHamburg, Germany. In that clinic aloneit has undergone successful use over600 times. The system is used through-out Germany and abroad, and also in theUnited States since 2005, for examplein the Mayo Clinic in Jacksonville. TheMerete MetaFix I is manufactured fromtitanium alloy. It consists of profile T-Oblique plates, right or left, and lockingscrews in lengths from 12mm to 32mm. The right and left styles ensurebest fit to bone and allow for optimal positioning. In addition, they areanatomically preformed and can even be further adjusted. The MetaFix Iplates and screws incorporate a screw-to-plate locking feature which cre-ates a locked, fixed angle construction to hold osteotomy reduction firmly.The crossing direction of the locking screws at the head of the plate createsan optimized fixed angle and firm bicortical fixation of the screws.

With the MetaFix I plate, the load bearing function of the foot isrestored to near normal under consideration of all other factors related topatient condition, and accelerates the patient’s functional recovery. Find usat the AAOS in Chicago, Booth 3417.

Merete Medical, Inc. Tel: 914-967-1532www.merete-medical.com Enquiry No 68

Apex ModularTM Femoral StemSystem

The Apex Modular™ femoral stem system byOMNI life science is designed to provide sur-geons with a concise and logical set of options toaccurately restore joint mechanics, leg length discrepan-cy and soft tissue balance.

By using modular stems, necks and heads, this systemcombines clinically proven design features that are impor-tant for long-term performance with several new and innova-tive options. With the ability to independently choose stemsize, neck offset, version angles and head size, the ApexModular system allows surgeons to precisely address patient-specific anatomical needs to achieve accurate leg length and softtissue balance. Find us at the AAOS in Chicago, Booth 1051.

OMNI life science, Inc.Tel: 800-448-6664www.omnils.comEnquiry No 70

MaxLockTM Plate And Screw SystemOrthoHelix™ Surgical Designintroduces the MaxLock™ Plateand Screw System designed bysmall bone surgeons for foot andankle internal fixation. TheMaxLock system is a low profile,anatomically designed plate thatoffers multiplanar fixation. Thesystem contains ten plate sizes,2.7 mm and 3.5 mm screws and awide variety of instruments, manycustom-designed. The system isextremely versatile and has been used for 12 different indications, such asMTPJ, lapidus, Lisfranc, fibula fractures, calcaneocubid, calcanealosteotomy, navicular cuneiform, ankle arthodesis and more. Thecancellous screw in conjunction with the plate design offers 30º conicalplacement, which enhances pullout strength and torsional stability.

OrthoHelix Surgical Design is an early stage medical device companydeveloping a comprehensive line of implants and instruments for use inhand and foot reconstructive surgery. Our mission is to develop and deliverinnovative orthopaedic implants and instruments that elevate the art ofsmall bone surgery. OrthoHelix is translating this focus on surgeons andpatients into a high growth market opportunity. Our executive team bringsover 70 years of successful orthopaedic industry experience and is backedby an elite Medical Advisory Board whose membership consists of thenation’s top surgeons practicing hand/wrist, foot/ankle and podiatrysurgery. “Surgeons Speak, We DELIVER.”™

The OrthoHelix product line is based on a portfolio of patented andpatent pending designs that will offer the most complete and innovativeline of specialized instruments and implants for the foot, ankle and handsurgeon. Visit us at AAOS, booth 5237.

OrthoHelix™ Surgical Design, Inc. Tel: 800-90 HELIXwww.orthohelix.com Enquiry No 71

GenuTrain®

Active support for relief and stabilization of the knee. Find us at the AAOSin Chicago, Booth 207.

Bauerfeind USA, Inc. Tel: 800-423-3405www.bauerfeindusa.com www.bauerfeind.comEnquiry No 69


� PRIMARY TOTAL HIP REPLACEMENT

“OUR FINDINGS SUGGEST THAT THELONG-TERM RESULTS OF THESEHYDROXYAPATITE-COATED PROSTHESESARE MORE THAN SATISFACTORY” Results of a hydroxyapatite-coated [Furlong] total hip replacement – A 13 to 15 year follow up (2005)AA Shetty, R Slack, A Tindall, KD James & C Rand, Medway Maritime Hospital, Kent, England,J BONE JOINT SURG [BR] 2005;87-B:1050-4

� REVISION TOTAL HIP REPLACEMENT

“WE PRESENT EXCELLENT MEDIUM-TOLONG-TERM CLINICAL, RADIOLOGICALAND SURVIVORSHIP RESULTS WITH THEFULLY HYDROXYAPATITE-CERAMIC-COATED FEMORAL COMPONENT INREVISION HIP SURGERY” Hydroxyapatite-ceramic-coated femoral stems in revision hip surgery (2005)SP Trikha, S Singh, OW Raynham, JC Lewis, PA Mitchell & AJ Edge, Worthing & Southlands NHS TrustWorthing, England,J BONE JOINT SURG [BR] 2005;87-B:1055-60

�“OUR STUDY SUPPORTS THE CONTINUEDUSE OF THIS ARTHROPLASTY ANDDOCUMENTS THE DURABILITY OFHYDROXYAPATITE-CERAMIC-COATEDCOMPONENTS” Revision of cemented hip arthroplasty using hydroxyapatite-ceramic-coated femoral component (2005)R Raman, RP Kamath, A Parikh & PD Angus, Dewsbury Hospital, Dewsbury, England,J BONE JOINT SURG [BR] 2005;87-B:1061-7

A B S T R A C T S A V A I L A B L E O N R E Q U E S Twww.jri-ltd.co.ukQ U A L I T Y W I T H O U T C O M P R O M I S E

THE CLINICALLY PROVEN FURLONG® H-A.C.

FDA APPROVED:SEEKING U.S. DISTRIBUTION PARTNER

1

2

3AAOS

Booth 5235HALL A

Enquiry No 18




UnderstandOrtho.com

UnderstandOrtho.com offers web-and office-based patient educationfeaturing high quality computer ani-mation. Surgeons and healthcarecompanies around the world areusing this unique tool to explain thecomplexities of orthopaedic surgeryto patients and their families. Ourextensive library details over 80 pro-cedures for Sports Medicine, JointReplacement and Spine surgery. The patient education modules can bepurchased on CD-ROM or can be easily added to your website. Save time,improve patient understanding and differentiate your practice in the com-munity. Find us at the AAOS in Chicago, Booth 3240.

UnderstandSurgery.com, LLC Tel: 800-747-9002www.UnderstandOrtho.com Enquiry No 72

Evolution-CTeleflex Medical OEM includesthe Beere Medical® brand. Beere’snewest product, the Evolution-C,allows surgeons to perform cervi-cal implant revisions with greaterease. Evolution-C includes nearly40 specialized removal bits,essential for removing cervicalimplants that are smaller andsometimes in more intricate formsand shapes.

The kit includes instrumentssuch as ratcheting handle, fixedaxial and T-handle, shaft exten-sions, adjustable pliers and a rodcutter. Instruments are stored in asingle container for added convenience. The Evolution-C kit follows thesuccessful Evolution SRK lumbar system, providing surgeons with a com-prehensive family of solutions for a majority of spinal revision surgeriesfrom cervical to lumbar. Find us at the AAOS in Chicago, Booth 4202.

Teleflex Medical OEM Tel: 800-295-8505www.teleflexmedicaloem.com Enquiry No 74

OrthADAPTTMBioimplant

The revolutionary newOrthADAPT™ Bioimplantfrom Pegasus Biologics is anatural, decellularized bio-logic scaffold that fortifiesand promotes tissue in-growth while resistingenzymatic degradation toprovide long-term perform-ance. It is intended to beused in the reinforcement,repair and reconstruction ofsoft tissues in a variety oforthopaedic procedures.

Throughout the healing process, the Bioimplant provides a reliablescaffold that integrates with host tissue by revascularizing and supportingthe remodeling cascade to lay down new collagen. The OrthADAPTBioimplant mimics natural tissue and elicits a quiet non-inflammatoryresponse. It is strong, but at the same time conformable, making it suitablefor many current and developing surgical techniques. Developed overtime, Pegasus Biologics’ breakthrough technologies provide theOrthADAPT Bioimplant with unique advantages in versatility, biocompat-ibility and reliability. The Bioimplant is terminally sterilized using a bio-compatible and safe liquid sterilant that does not adversely alter physicalproperties. Find us at the AAOS in Chicago, Booth 5432.

Pegasus Biologics Tel: 949-502-3240www.pegasusbio.com Enquiry No 73

Limbrel - A New Aproach toManaging OA

Limbrel is a prescriptionmedical food product for theclinical dietary managementof the metabolic processes ofosteoarthritis (OA) under aphysician’s supervision.

Limbrel (flavocoxid) isfirst a new product class todeliver Dual Inhibition (COX+ LOX, lipoxygenase) andtherefore not be selective toany one inflammatory path-way. Because Limbrel is notselective to COX-1 or COX-2, it does not upset the balance of thrombox-anes (vasoconstriction) and prostacyclins (vasodilation), and helps to min-imize cardiovascular, gastrointestinal and renal side effects.

Limbrel inhibits 5-LOX to down-regulate excess production ofleukotrienes, which can lead to stomach ulceration as well as cartilagedegradation. Limbrel’s 5-LOX inhibition provides additional GI safety andadditional effectiveness to manage inflammation in the joints notaddressed by COX-1/COX-2 inhibition.

Limbrel’s ingredients are Generally Recognized As Safe (GRAS) perFDA standards. Find us at the AAOS in Chicago, Booth 5535.

Primus Pharmaceuticals, Inc. Tel: 480-483-1410www.limbrel.com Enquiry No 75

To see yourproducts listedwithin the ProductNews and ProductFeature sections

email your information to [email protected]


Hips

Whitney Curettes





SL-PLUS® Hip Stem






PRODUCTT FEATURES











Pass…™

Prep…

ACL Reconstruction in its

Simplest form.




EZLoc™ is a trademark of Arthrotek, Inc.

EZLoc™ Femoral Fixation:

• Technique has minimal steps

• Reproducible insertion

• Cortical fi xation eliminatesslippage

• All-titanium construction

Enquiry No 19




ParaSorb Bio Anchors

ParaSorb is a bioabsorbable PLLA suture anchor for soft tissue to bone fix-ation. It features the patented Elliptical Eyelets that are suture friendly. The5mm and 6.5mm also feature two individual suture eyelets that eliminatesuture binding. These anchors have a straight pull-out force that exceeds350 Newtons and are pre-loaded with MagnumWire. This suture is threetimes stronger than #2 braided polyester suture. Find us at the AAOS inChicago, Booth 4253.

ArthroCare Corporation Tel: 408-736-0224www.arthrocare.com Enquiry No 76

The LabraFixTM System

The LabraFix System from ArthroCare Sports Medicine applies the clini-cally proven, simple and time-saving AutoCuff® technology to Bankart andSLAP repair. It consists of two parts—the SpeedStitchTM Suturing Deviceand the MiniMagnumTM Knotless Implant.

The SpeedStitch Suturing Device enables rapid and direct placement ofan ultra-high strength MagnumWireTM stitch in the labral tissue. It is spe-cially designed with a low jaw profile to allow easy access to the entirelabral circumference, while providing a deep bite into the labral and cap-sular tissue for optimal stitch placement. Once the lower jaw is positioned,the telescoping “upper jaw” of the device immobilizes the labral tissue.Next, the SpeedStitch needle is deployed to capture the suture and pull itthrough the labrum, placing the labral stitch in a matter of seconds.

Once the SpeedStitch Suturing Device has placed a stitch in the tornlabrum, the surgeon loads and deploys the MiniMagnum Implant into theglenoid rim. This implant’s internal mechanism provides cinchable andreversible tissue tensioning to achieve an optimal tissue-to-bone contact.The MiniMagnum Implant utilizes its suture locking mecha-nism to eliminate the need forcumbersome and difficultarthroscopic knot tying. Findus at the AAOS in Chicago,Booth 4253.

ArthroCare CorporationTel: 408-736-0224www.arthrocare.com Enquiry No 77

Caps-Lock CannulaArthroCare Sports Medicine’s Atlantech Collection brings you a uniqueCannula System. The Caps-Lock Cannula, abbreviated from “capsularlocking,” comprises a guidewire, driver and cannula. We offer physiciansguidewire control to ensure accurate placement of the cannula within thejoint. The obturator and cannula present continuous threads for easierinsertions. Additionally, the cannula’s thread design provides a secure fix-ation and seal, minimizing swelling caused by leakage into the soft tissue.The threads lock into the capsule, thus preventing inadvertent pull-out ofthe device. These Cannulae are available in a range of sizes and are recom-mended for use in Shoulder and Hip arthroscopy. Find us at theAAOS in Chicago, Booth 4253.

ArthroCare CorporationTel. 408-736-0224www.arthrocare.comEnquiry No 78

Zimmer® Trabecular MetalTM PrimaryHip Prosthesis

The Zimmer® Trabecular Metal™ Primary HipProsthesis brings the distinctive properties andclinically proven benefits of Trabecular Metaltechnology to a bone conserving and proximal loadingstem design.

The combination of a 14-degree proximal taper, 23.5-degree neck resection angle and Zimmer MIS™Technology friendly instruments are designed to result inoptimal initial stability, enhanced, long-term biological fixa-tion and efficient proximal load transfer. The stem is availablein both Standard (sizes 9-18) and Extended (sizes 11-18) off-sets. It combines a Tivanium® Alloy substrate that providesexcellent biocompatibility and strength without excessivestiffness, along with a proprietary, diffusion-bonded, proximalTrabecular Metal pad.

A reduced neck geometry below the 12/14 Taper helpsincrease range of motion. Find us at the AAOS in Chicago,Booth 1028.

Zimmer, Inc. Tel: 574-267-6131www.zimmer.com Enquiry No 79

SmartSuction HarmonyTM Device

The SmartSuction Harmony™ Powered Suction Device fromHaemonetics® supplies high air flow, self-regulatingsuction that rapidly removes fluid from the surgicalfield at low suction levels…bringing “high-tech” to the“no-tech” world of surgical suction.The device’s self-regulating high airflow and low vacu-um levels (maximum vacuum of 150 mmHg) enablesrapid clearance of blood and fluids from the surgicalfield—at a rate of up to 4 liters per minute—assuring fastvisualization of the surgical field for the surgeon, gentlecell salvage for the perfusionist and optimal red blood cellrecovery for the patient. The SmartSuction Harmony sys-tem replaces wall suction, delivering consistent operation.Its proprietary SmartSuction technology eliminates theneed to adjust suction levels during surgery…it auto-matically differentiates between skimming and pool-ing and adjusts suction levels accordingly.

The SmartSuction Harmony device is designed towork as a companion product to Haemonetics’ familyof autotransfusion systems: Cell Saver®, cardioPAT™ andOrthoPAT® systems. It is small, easy to use and mountseasily onto an IV pole or a Cell Saver system’s cart.SmartSuction Harmony…suction that is both gentleand strong. Find us at the AAOS in Chicago, Booth3815.

Haemonetics Tel: 800-537-2802www.haemonetics.com Enquiry No 80




ActiPatchTM Drug-Free Anti-Inflammatory Patch

ActiPatch™ from BioElectronics is a drug-free, anti-inflam-matory patch, that is proven safe, low-cost and easy to useby doctors and patients alike.ActiPatch uses an embeddedmicrochip and battery thatdelivers an effective dosageof energy from a low-powerpulsed electromagnetic field(PEMF). The result is a sig-nificant acceleration in therecovery of the body’s injuredsoft tissue and a shorter recovery time for the patient.

PEMF technology has been used extensively for decades by physi-cians for a variety of tissue injuries; including sprains and strains, bonehealing and post-surgical care. Currently, ActiPatch™ is FDA-clearedunder a 510(k) for use in the reduction of edema following blepharo-plasty.

BioElectronics Tel: 301-874-0326 www.bioelectronicscorp.com Enquiry No 81

Orthopaedic Product NewsU.S. Orthopaedic ProductNews (OPN) is distributedthroughout the U.S. Themagazine is primarilydevoted to new orthopaedicproducts and innovationsand also includes special fea-tures on topics of interest.OPN provides a medium fordiscussion of contemporaryissues affecting orthopaedicsurgeons and the future ofthe specialty. OPN is pub-lished by KnowledgeEnterprises, Inc. Visit us atAAOS booth # 1770.

Knowledge Enterprises Tel: 440-247-9051www.orthoworld.com Enquiry No 82

Keeping you firmly

in the loop.

• Suspension and Compression

giving the strongest fixation

on the market

• Osteoconductive Composite

(PLLA/TCP) with over 6 years

of clinical experience

Manufactured by

ProductNews

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Precious Metal Precise Results


Finally an instrument with all the features you needto perform efficient procedures time after time.• Unique double tooth design for accurate cutting• Pinless hinge for safety and strength• Ergonomically looped handle for comfort and control

EHTTHE TAATL CETNAANTECH™

NOITCELLOCCOLLECTION

ProductNews January/February 2006

Orthopaedicg 1

The Ascension® PyroHemiSphere® is a new conservative approach fortreatment of CMC arthritis. Easy-to-use instrumentation minimizes boneremoval and promotes implant stability. The PyroHemiSphere allowspreservation of the trapezium and reduces the chances of thumb shorten-ing. The hemispherical design provides functional articulation and repro-duces normal range-of-motion.

The surgical procedure is easy to learn and faster than traditional sus-pension arthroplasty. The PyroHemiSphere is available in five sizes, pro-viding the optimal range for all patient types. Benefits of the AscensionPyroHemiSphere:

Made from PyroCarbon• Similar elastic modulus to cortical bone.• Significant reduction in wear against bone.

Preserves the Trapezium• Preserves natural joint and anatomy.• Provides a revision path, if needed.

Easy and Efficient Surgery• Reduces OR time.• Eliminates additional surgery to harvest the tendon graft.

Fixed Fulcrum Articulation• Enhances pinch and grip strength.

Ascension Orthopedics Tel: 877-370-5001www.ascensionortho.com Enquiry No 83

PyroHemiSphere®

To see your productslisted in the Product News and Product Feature sections

email your information to [email protected] Orthopaedic Product News • July/August 2005

PRODUCTT NEWSS PRODUCT NEWS

Echoes Pacs System

The echoeSYSTEMTM browser-based viewing software allows authorizedusers access from virtually any network accessible personal computer totheir practices images. The system also automates offsite data backup fordisaster recovery of archives, simplifying Health Insurance Portability andAccountability Act conformance by practices.

Furthermore, the product allows authorized users to award secureInternet access to referring physicians and other healthcare professionals.Clinical users select either compressed or uncompressed file options onsecure echoeSYSTEMTM web servers balancing the tradeoff between clin-ical need and bandwidth availability. The echoeSTATIONTM softwareuniquely aids orthopedic professionals in preoperative planning and post-operative evaluation. The software allows overlaying of implant templateson images, and includes tools for performing analysis measurements on theimage and positioning of the templates. Surgeons digitally template jointreconstruction cases for pre-operative selection of implants from all themajor implant manufacturers. Surgeons can evaluate patients' operativeresults in relation to saved pre-operative plans.

Medstrat Tel: 800-882-4224www.medstrat.com Enquiry No 20

The WristoreTM Distal RadiusFracture Fixator

A new innovation in distal radius fracture fixation has arrived fromZimmer. The Wristore™* Distal Radius Fracture Fixator is an external fix-ation device designed to allow for minimally invasive treatment of com-plex wrist fractures.

With its innovative outrigger design, the Wristore fixator allows sur-geons to rigidly fix bony fragments and facilitate early return of motion tothe wrist.

The Wristore fixator is supplied in a sterile kit that includesall of the implants and non-powered instruments neces-sary to apply the fixator (a standard OR drill is alsorequired). The Wristore fixator is radiolucent andallows a surgeon to achieve the kind of surgical out-come previously associated with plates and screw fix-ation with a much less invasive, temporary device.

The Wristore fixator is a solution for sur-geons looking to help restore their patients tonormal activity after difficult wrist injuries.

*Wristore is a trademark of Millennium MedicalTechnologies, Inc.

Zimmer Tel: 800-348-2759www.zimmer.com Enquiry No 20

ZipKnotTM Suture Fastener

The ZipKnotTM suture fastener, developed by MedicineLodge, Inc., is animplant device for use in approximation and/or ligation of soft tissuesusing surgical suture, making it useful in a broad spectrum of surgical pro-cedures. The device is used in place of surgically tied knots, saving oper-ating room time and providing a stronger, more reliable fastening of surgi-cal suture. The ZipKnotTM is provided in a cartridge contained within a ster-ile package. The cartridge includes suture threaders that pass the free endsof surgical sutures through the ZipKnotTM. The threaded ZipKnotTM is eas-ily advanced to the repair site using a conventional knot-pushing tool, andit can be re-tensioned at any time before the final trimming of the suture.The ZipKnotTM, made from polyetheretherketone (PEEK), recentlyreceived FDA 510(k) clearance.The device has also been devel-oped in a bioabsorbable poly L-lactic acid (PLLA) material, andis scalable to all sizes of suture.

MedicineLodge, Inc. Tel: 435 753 7675www.medicine-lodge.com Enquiry No 14

Signus Medical LLC announced receipt of spinal VBR clearance from theFDA for its Semial® Spinal Implant. Semial®, manufactured by SignusMedizintechnik GmbH, has a proven clinical record in Europe and isindicated as a spinal intervertebral body fixation orthosis. The implant isavailable in a range of diameters, heights and lordotic angles to optimiseits match to the surgical site.

With the extensive range of geometries and as the implant can beinserted from either a direct anterior or an anteriolateral approach it maybe used at a wide variety of vertebral levels and in both primary and

revision cases. The addition of the Semial®system furtherextends Signus Medcal’s strong product offering inPEEK Optima®. In addition to the instrumentsfor insertion of the implant, the set includesan array of well-crafted site preparationinstruments.

Signus Medical LLC Tel: 952-294-8700www.signusmedical.com Enquiry No 15

Topaz MicroDebrider

ArthroCare Sports Medicine’s Topaz MicroDebrider, designed for use intreatment of tendon conditions, is a wand-like device about the diameterof a pencil tip. Through a small incision, generally an inch in length, thephysician applies the device to the problem tendon for multiple 500 mil-lisecond intervals of treatment.

By combining low temperature radiofrequency energy with saline, acharged plasma gas is formed at the tip of the TOPAZ wand and is pre-cisely directed into and through the damaged tissues. From start to fin-ish, the whole process takes less than 20 minutes. New study data pub-lished last month in Arthroscopy: The Journal of Arthroscopic & RelatedSurgery showed Topaz tobe effective when used inthe treatment of commontendon disorders such aslateral epicondylitis, thecondition commonlyknown as tennis elbow.

ArthroCare Tel: 408-736-0224www.arthrocare.com Enquiry No 17

Semial Announcement


Hips

Whitney Curettes





SL-PLUS® Hip Stem






PRODUCTT FEATURES












TTHHEE TTOOPP LLIINNEE

As I have said so many times before, the collaboration between industryand orthopaedic surgeons in connection with design, development andevaluation of new technologies and improvement of existing ones is acritical factor for the health and welfare of the orthopaedic industry andits patients. An important part of making such collaboration work well issurgeon familiarity with the basics of an industry contract, which willhelp ensure that he is not placed in an undesirable situation once the inkon the contract dries. While I am convinced that industry is determinedto treat its surgeon consultants fairly, the reality remains that the two par-ties have divergent interests at some point in the negotiation. This articlehighlights a few basic contractual issues with which surgeons should befacile in order to protect their fundamental rights under a consulting,design or product development agreement. Of course, along with havinga good working knowledge of these concepts, it is always recommendedthat a qualified health care attorney assist you with your contract reviewand negotiation.

Conflict of InterestPerhaps the biggest bone of contention between manufacturers and theirconsultants is the restriction of services the consultant may provide tocompetitors. Industry understandably does not want their consulting sur-geons to do the same or similar work for a competitor. Consulting sur-geons, also understandably, want to be able to explore any and all design,development and other consulting opportunities that come along. Thetruly innovative and motivated designing surgeon is interested in work-ing with any reputable company that recognizes the value of bringing thesurgeon’s design ideas to market. Nonetheless, it is appropriate to limitwhat work can be done for competitors during the course of an agree-ment with industry. Manufacturers have a reasonable expectation whencontracting with a surgeon to provide services specific to a certainimplant system or other device: that the consultant will not work on iden-tical products with a direct competitor at the same time. Policing the pro-tection of confidential information and intellectual property in such ascenario is nightmarish at best, and furthermore, when compensating aconsultant, part of what a manufacturer is paying for is a certain degreeof loyalty to the company’s project.

However, surgeons should be cautious not to sign agreements thatrestrict them from working for competitive companies on similar prod-ucts after the term of the agreement has expired. Many companies havetraditionally attempted to restrict surgeons in this manner, and the reali-ty is that such restriction is not necessary, not appropriate and, quitefrankly, not fair. Surgeons should be on the lookout for any post-termi-nation restrictions on their ability to work with other companies on anyproject.

A final thought on conflicts of interest — working with other compa-nies on different projects at the same time is perfectly appropriate andshould not be foreclosed in any agreement signed by a consulting surgeon.

Contracting Party Surgeons who have a PA, a research or teaching foundation, or someother corporate entity through which they want their consulting moniesto flow must specify that desire when negotiating the contract. If a con-tract is made between a company and the surgeon individually, it is notthe best practice to then put checks made out to the individual surgeoninto a corporate entity’s bank account. The contracting party should bethe surgeon’s company, and the contract should then contain languagestating that the services being provided under the contract are to be pro-vided by the individual surgeon and no one else. Manufacturers rarelyhave a problem with this issue and addressing it will save the surgeonmuch time and hassle once the consulting monies have been earned.

IndemnificationIt is standard operating procedure for orthopaedic device manufacturersto provide their consultants with indemnification in the event of certaincontingencies. Such indemnification will not provide protection in theevent that the consultant is negligent, but it should provide that the con-sultant be held harmless, defended and indemnified if they are everbrought into a lawsuit that alleges product liability and/or patentinfringement relative to the company’s product line. Recall and relatedsituations can wreak havoc on a consultant’s medical practice and it isperfectly appropriate for surgeons to seek assurance through the form ofindemnification that their practice will only be minimally disrupted inthe event that a company is forced to issue a recall or any other fieldaction that is product liability or patent infringement related.

Intellectual PropertyAnd the granddaddy of them all, the issue of intellectual property own-ership. It cannot be stressed enough how important this issue is to bothparties. For the manufacturer, the obvious goal is to tie up as much intel-lectual property as possible for as little compensation as possible. For thesurgeon, the goal is much different — fair market value compensation forall of the intellectual property that is transferred, assigned or otherwisemade available to the manufacturer to do with what it will. The issue ofownership becomes particularly critical when, after years of develop-ment, a manufacturer decides for whatever reason that the product underdesign will not be commercialized. If the designing surgeon has assigned


The Basics of Negotiating withIndustry

Author: Teresa Ford



TTHHEE TTOOPP LLIINNEE

all of his intellectual property relating to the product, he is not in a posi-tion to take that intellectual property to another manufacturer or even todevelop the product on his own. The ideas, drawings, implant design andwhatever else was transferred belongs to the company, lock, stock andbarrel. This can be a particularly frustrating situation for the surgeon whohas great faith in his design ideas and who wants to see them come tofruition for the betterment of both industry and the patient population.

A possible solution to this dilemma is a reverting license or some othervehicle that allows the surgeon to have access to the intellectual propertyin the event that the company does not want to commercialize it. Thelicense should be exclusive and should allow the surgeon to go anywhere

and do anything with the intellectual property in collaboration with anycompany of the surgeon’s choosing. This provision may take a little addi-tional negotiation, but will be worth it in terms of protecting one of themost valuable assets that a consulting surgeon brings to the table - his ideas.

The Law Offices of Teresa Ford, PC (www.tfordlaw.com), located inHouston, Texas, specialize in healthcare and medical device issues.Areas of expertise include healthcare compliance program structuringand training, as well as advising individual physician clients. Foundingpartner Teresa Ford spent many years in the medical-legal arena, mostrecently as senior counsel for Sulzer Medica USA Inc. She can bereached at 832-251-9595 or [email protected].


Enquiry No 84

Law Offices of Teresa Ford, PC

Proud to serve the physician community in matters of health care compliance and business structuring

2500 Tanglewilde, Suite 318, Houston, Texas 77063tel: 832.251.9595 • fax: 832.251.9599

email: [email protected]

Not Certified by the Texas Board of Legal Specialization

Enquiry No 20



HHEERREE’’SS TTOO YYOOUURR WWEEAALLTTHH

Happy New Year! With the holidays behind us and a fresh year ahead, I’mwilling to assume that many of you are taking part in the tradition ofidentifying resolutions for the coming months. I would like to suggestadding a very important one to your list—getting your financial plan inorder. The new year presents a great opportunity to take the first step insuccessfully managing your personal wealth.

In order to create an effective financial plan that enables you to makesound investment decisions and easily track your progress, you’ll need astarting point. I recommend to all investors that their first step be identi-fying the critical goals of their investment plan. After working with manysurgeons over the years, I think it is safe to say that some of the mostcritical aspects of your investment plan are:

• Develop an inventory of your current financial landscape• Identify your specific investment needs and objectives• Construct a personal timeline• Reduce income taxes with tax-advantaged investments• Protect your assets from lawsuits and creditors

With these objectives in mind, it is important to determine if your currentinvestment strategies are moving you toward these objectives or pushingyou further away from your ultimate goals. On page 57, you will find aConfidential Financial Profile for your use. This document takes 20 to 30minutes to complete and serves as a summary of your finances, goals andinvestment style.

Here are some helpful hints for completing the Confidential FinancialProfile.

1. On the line designated for Investment Objectives, list your top three priorities in order of importance. The choices are safety, income, growth, tax reduction, retirement, education funding and estate planning.

2. In the space provided for Pension Plan, write the total value of your plan or the estimated monthly payments you will receive starting on your retirement date.

3. The Investment Philosophy scale at the bottom of the page helps you rate yourself as a conservative (1-3), moderate (4-6) or aggressive (7-10) investor.

4. To determine your net worth, add your liquid assets and fixed assets, then subtract any liabilities.

I recommend that you make three copies of the completed ConfidentialFinancial Profile. Keep one for your records, file the second with your

wills and trusts as a simple summary of your finances and send the thirdcopy to your financial advisor. Your advisor will utilize this document to:

• Learn more about your unique situation• Rebalance your portfolio if necessary• Introduce tax-advantaged investments where appropriate• Track the progress in growing your net worth• Analyze how well you save money• Determine what isn’t working and devise a strategy to repair it• Project your retirement income

When I read a Confidential Financial Profile, it is similar to you analyzinga patient’s x-ray. With a trained eye, I look for clues about the way aperson has handled his investment plan in relation to his goals, and Idetermine areas for improvement. Throughout my career I have noticedseveral investment patterns common to surgeons:

• Not taking advantage of tax deferred and tax exempt investments• Investing in programs they don’t understand, are the latest fad, or have

more than an acceptable risk• Neglecting to save enough in relation to earnings• Procrastinating in planning for retirement

The Confidential Financial Profile is one of the best tools for avoidingthese common mistakes because it helps ensure that your portfolio isconsistent with your investment objectives. However, it is important thatyou discuss this information with an investment professional who canprovide you with research and market data to help you make knowledge-able decisions about your investment strategies.

I would like to offer readers of this publication a complimentaryreview of their Confidential Financial Profile. If you are interested, pleasecomplete the form (See page 57.) and fax it to my attention at 312-595-7220. For no cost, I will review the document and contact you with myanalysis and recommendations. If you would like to receive an electroniccopy of this form, or if you have any questions, please email me.

Jeff Mackevich is a managing director in the Investment Brokerage groupat Mesirow Financial. With more than 25 years of wealth managementexperience, Jeff specializes in analyzing and strengthening the investmentprograms, income portfolios and tax strategies of affluent individuals. Hecan be reached at [email protected] or 312-595-6384.Mesirow Financial, Inc. does not provide tax advice. Services offered byMesirow Financial, Inc. Member NYSE, SIPC.

Creating an Effective FinancialPlan

Author: Jeffrey B. Mackevich

Enquiry No 85



HHEERREE’’SS TTOO YYOOUURR WWEEAALLTTHH

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Helping You Grows i n c e 1 9 9 2

147 Bell Street, Suite 303Chagrin Falls, OH 44022

Phone 440 247 9051Fax 440 247 9053

email [email protected]

Enquiry No 21


Think T2®

The Broadest IM Nail Platform.

Stryker Orthopaedics™ 325 Corporate Drive, Mahwah, NJ 07430A surgeon is the best person to decide with the patient which treatments and products are right for them. Surgeons must always rely on their ownclinical judgment when deciding which treatments and procedures to use with patients. Copyright © 2005 Stryker. Stryker Corporation or its divisionsor other corporate affiliated entities own, use or have applied for the following trademarks or service marks: Stryker, Stryker Orthopaedics, T2.

For more information, contact your local Stryker sales representative.T2® Intramedullary Nailing System

Fixed Angle Stabilization

• Ability to lock proximal screws.

Active Compression Since 1991

• Up to 7mm. • Promotes fracture healing and

facilitates early weight bearing.*

Easier Nail Insertion

• 10 degree Proximal Herzog Bend.

• 4 degree distal bend.

Target Extremely Distal Fractures

• Two plane fixation with 3 holes within 25mm.

• 5mm distal hole.• Choice of 3 configurations.

Best-in-Class Instrumentation

• Utilizes a common instrumentationplatform across all nails.

• Radiolucent, carbon-fiber targetingdevices.

* Thomas Mueckley, Oliver Gonshorek, and VolkerBuehren, “Compression Nailing on Long Bones,”European Journal of Trauma, 2003, pp.113-128.

Humeral Femoral TibialArthrodesis

Enquiry No 22


Control is clearly in your hand…

Arthroscopy is the diagnostic Gold Standard.The InnerVue™

Diagnostic Scope allows surgeons to utilize the gold standard in a

more efficient, less invasive and time saving approach.The InnerVue™

Diagnostic Scope System presents to you the ability to visualize and

diagnose pathology actively and dynamically in your offi ce.

Features• Scope diameter roughly equivalent to an 18 gauge needle

• Local anesthesia

• Wide applications—knee, shoulder, small joints

• Proprietary visual enhancement media (patent pending)

• Enclosed in a mobile, user-friendly unit

For more information, go towww.InnerVueScope.com

Innovate your practice with the new…




Anterior Cruciate Ligament

Meniscus

Enquiry No 23


Documents

Orthopaedic Orthopaedic MastHead Product News MastHead ... lesson for the young pilot learning to fly and the surgeon inventor ... writing exercise directed to the basic concept of