• DANEK
`
`GROUP, INC.
`
`MEOICAL DIVISION
`
`21!1:2 DIAECI'OAS ION
`-S.TMleT~o
`111011:11114133
`WAf$, IIDOII1 .. 3T:P
`t=u:.-, 1 ,x~:~..J810
`
`MEMORANDUM
`
`TO:
`
`RON PICKARD
`JOHN PAFFORD
`TED BIRD
`DAVID BRUMFli;:.LD
`BRAD ESTES./
`
`FROM:
`
`DATE:
`
`LARRY BOYD
`
`JANUARY 26, 1994
`
`ALEX LUKIANOV
`RICK TREHARNE
`BAILEY.UPSCOMB
`JEAN-PIERRE CAPOEVlELL£
`
`SUBJECT: MICHELSON DEVICES - INTERBOOY FUSION DEVICES
`
`Attached please find a report on interbody fusion devices. This report discusses
`sorne of tne current interbody fusion device concepts, especially Dr. Michelson'~
`technology, and the development, marketing and manufacturing issues
`associated with the commercialization of interbody fusion devices.
`
`I hope this information is useful to you in beginning to plan our strategy in this
`important area. Please let me know if you have any questions, comments or
`concerns. I would appreciate any feedback you may have on this report. Please
`feel tree to call me at any time.
`
`Best Regards,
`
`THE SPINE SPECIALISTsm
`
`DEPOSITION
`f11 EXHIBIT
`f(Q@-350
`
`eo•11u111 1*1111• - -
`AllomiJI' Ep• Dnlr
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`WARSAW2003
`NuVasive, Inc. v. Warsaw Orthopedic, Inc.
`Case IPR2013-00208
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`Page 1
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`

`
`· ..... ~
`
`~·
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`::.;..,
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`· St
`DANEK
`
`GROUP, INC.
`
`MEDICAL OMSION
`
`a:m DIR[CTORS ODN
`~1W-1::;tt
`oftQlJ~13l
`W~TS; . . 11'5.31;:!3
`FA1:1'1)113:1Z·:mo:l
`
`CONE!QENTJAL
`
`INTERBODY FUSION DEVICE CONCEPTS
`
`January 1994
`
`Lawrence M. Boyd
`Manager, Product Development
`Sofamor Danek Group
`Danek Medical Division
`
`3092 Directors Row
`Memphis, TN 38131
`
`(901) 396-3133
`
`~·' . ·.: .
`
`. ,~::
`
`THE SPINE SPECtALJSTsm
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`

`
`Table of Contents
`
`1
`
`2
`
`3
`
`4
`
`Present Situation
`
`Objectives
`
`Proi«:lNaAagementiResources
`
`Product Description
`
`Competition
`
`5
`6 Manuiacturing
`
`7
`
`8
`
`Future TasksiSummary
`
`. Appendix
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`

`
`lnterbody Fusion Devices
`
`Present Situation
`
`Market Environment
`
`On January 12, Sofamor Danek group acquired tne interbody fusion deVice concepts of
`Dr. Gary Karlin Michelson via licensing and purchase agreements. The acquisition of
`these implant and .instrumentation concepts puts Danek in a strong position to dominate
`the evolving market for interbody iusion devices. The Michelson technology
`complements our existing product line, as wall as supporting and complementing
`various produd development p~s currently underway.
`
`The spinal implant marketplace is undergong rapid changes as new technologies for
`achieving interbody fusion appear on the horizon.
`Implants specifically designed for
`interbody fusion (lnterbody Fusion Deviees-IBFDs} are being developed by all major
`spinal implant manufacturers. Several designs are currently undergoing controlled
`clinical evaluation. Interest in the devices is growing, as these new devices begin to
`show the feasi:lility of developing implants that are superior to the use of allograft, or
`auK)Qraft bone grafting alone.
`
`Sofamor Danek Group currently has under development an interbody fusion device
`(with Dr. Jeffrey Kozak of HouS1on) designed solely for anterior interbody fusion.
`Additionally, bone substitutes are under development by both Sofamor (HAITCP Paste
`with Dr. Passuti in Nantes) and Danek (OPLA with bone proteins from Genetics
`Institute). These materials will likely require the use of a device to provide for load
`bearing due to their relatively poor mechanical properties. The purchase of the
`Michelson tectnology expands this product offering and gives the company access to a
`broad range of technology for anterior, posterior, lateral and laparoscopfc surgery oNhe
`cervical, thoracic and lumbar ~pine. SOfamor Danek Group is now poised to become a
`major player in this new marke1 segment-tnterbody Fusion Devices.
`
`Products and Services
`
`The present stage of interbody fusion device product design and development varies.
`The Kozak IBFD is currently undergoing mechanical cadaveric testing, animal testing
`and finite element analysis. Initial results from mechanical testing show favorable stiff(cid:173)
`ness of the IBFD vs. the Harms Cage and femoral ring allograft. Pilot animal studies
`appeared to show bone fusion. but histological processing will be required. The bone
`substitutes are in various stages, but initial data is encouraging for the OPLA with bone
`stimulating proteins and the HA/TCP paste. The Michelson technology has been initially
`developed by Zimmer. It appears that some testing and analysis has been performed,
`but additional testing will be required. We are currently evaluating the anticipated
`testing required for the Michelsoo threaded IBFD concept.
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`
`2
`
`lnterbody Fusion Devices
`
`Product Ufe Cycle
`
`Our current flagship product line is the Texas Scottish Rite (TSRH) Spinal System. As a
`forward-looking spinal implant manufacturer we recognize the potential for new
`technologies to both augment this existing technology and poterniatly supplant this
`technology, depending on the surgical application. Ciearly, a strong market for the
`TSRH system and related systems wiH continue to exist ln the near future and some
`clear indications for those rod-based and ptate-based fixation devices will always exist
`(e.g, deformity, trauma, tumor ••. ).
`
`The market for interbody fusion devices will take time to develop. However, we are now
`beginning to see the initial penetration of this technology into the marke1place. Time
`factors influencing our ability to realize significant U.S. sales for this technology center
`around the potentially long process requited to receive U.S. FDA dearance tor the
`devices. Addttlonally, the process of finalizing the design. testing and manufacturing
`launch quantities is now being analyzed.
`
`Pricing and Profitability
`
`Current prices for interbody fusion devices appear high. The reported price for a single
`Spine Tach BAK devicec is on the order of $2,000. Two devices are required per spi1al
`level, so the cost per fused level is around $4,000. Dr. Gary Michelson has estimated
`that the manufacturing cost for these devices is in the $50 range for large quantities.
`Prior manufacturing quotes in the Zimmer files show costs of $100 to $200 for 100
`pieces. This would .lead one to conclude that the potential profitability of these products
`is quite significant. Reimbursement issues would appear to be addressable, if the
`apparent success of the Spine Tech BAK implant and the Surgical Dynamics Ray Cage
`clinicals are an indicator.
`·
`
`Customers
`
`It would appear that several of our current leading-edge customers are using the BAK or
`Ray Cage tor posterior lumbar interbody fusions (PLIFs), anterior lumbar interbody
`fusions (AUFs) and laparoscopic AUFs. These are considered innovative devices and
`unique approaches to interbody fusions. These loyal Danek {or Sofamor) customers
`represent a potential source of design input and Mure clinicians as we develop our own
`innovative devices. Many of these users have requested that we dB\ielop such a
`threaded device to compete with the Spine Tech and Surgical Dynamics technologies.
`They have recognized the potential for improvements to the current technology and we
`should make an effon to factor these comments into the design process, where
`possible.
`
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`3
`
`lnterbody Fusion Devices
`
`Distribution
`
`We have an existing network of customer distributors ready 10 begin selling these
`devices to spinal surgeons in the U.S. and globally. Many of them have already begun
`to see their key, influential surgeons being evaluating the BAK or Ray devices and,
`therefore, are strongly motivated to present aHemative and superior interbody fusion
`devices to these surgeons.
`
`Staffing
`
`Most of the development, marketing, manufacturing and regulatory staffing needed to
`bring the Michelson device to market exist~ within the company. Reallocation and
`reprioritization may be required, especially in the short-term, to bring the technology to
`market In a timely manner. Significant development and drafting resourc85 will be
`required to move from the initial prototype inplants and instruments into large-scale
`production. Marketing resources will be required to further define the market and plan
`the strategy for global introduction of the various IBFO technologies. Regulatory
`resources will be needed to coordinate the applications for clinical studies and to
`coordinate these studies. Use of external resources is anticipated to accelerate various
`aspects cf the project e.g., analysis, tasting and manufacturing.
`
`Financial Resources
`
`The Michelson technology was not part of the 1994 budget planning process.
`Therefore, funding for the development and marketing of this project will have to occur
`at the expense of other projects. Analysis of all projects and priori1iza1ion of these wiU
`be required to determine sources of funding and resources to move this project forward.
`
`COIIHIIIIIIforallll - -
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`lnterbody Fusion Devices
`
`4
`
`ObJpctiyes
`
`The primary objsctives of an interbody fusion device are to:
`
`A. RestorG nonnat spinal anatomy and motion segment stability via fusion
`B. Eliminate the need for additional fixation to achieve fusion
`C. Res1ore the nonnal curvature of the spine
`D. Allow for a surgical procedure that is simple, safe and effective
`
`Sofamor Danek currently has under development a variety of approaches to interbody
`iusion, including the Kozak IBFD, injectable and carvable bone substitutes, ceramic
`(HA/TCP) bone substitutes, flexible vertebral body replacement (primarily for verte(cid:173)
`brectomy, but could be used for IBFD), percutaneous IBFO and the many devices
`covered by the Michelson technology. Additional information on the status of these
`vario~ pn;~jects is available from the Product Development Department These devices
`can. be ana lyzecl by looking at both their intended anatomical sites and the surgical
`pathology they are intended to address.
`
`Spinal Level
`
`Procedure
`
`KozakiBFD
`
`Percutaneous IBFD
`
`Flexible VB Replacement
`
`Injectable Bone Substitute
`
`Carvable Bone Substitutes
`(OPLA. HNTCP Paste &
`HA'TCP Porous Ceramic)
`
`Michelson Threaded Dowels
`
`Lumbar
`
`Lumbar
`
`Cervical
`Thoracic
`ltJmbar
`
`Cervical
`Thoracic
`Lumbar
`
`Cervical
`Thoracic
`Lumbar
`
`Cervical
`Thoracic
`Lumbar
`
`AUF
`
`Minimally Invasive PUF
`
`Vertebrectomy
`(AUF possible)
`
`AUF (inside IBFO)
`PU F (inside I BFO)
`Laparcscopic AUF
`Minimally Invasive PUF
`
`Posterolateral Fusion
`ALIF (inside IBFD}
`PUF (inside IBFO)
`
`ALIF
`PLIF
`Laparoscopic AUF
`Lateral AUF
`
`Michelson Non·Threaded
`
`Cervical
`
`Anterior Cervical Fusion
`
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`5
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`lnterbody Fusion Devices
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`Compared to the relatively limited current offering of interbody fusion devices in the
`spnaf implant marketplaea. Sofamor Danek Group has the opportunity to develop a full
`line of interbody fusion devices to address a complete range of spinal conditions,
`surgical approaches and anatomical areas. These devices are uniQue, innovative tech(cid:173)
`nology that will complement our existing product selection.
`
`Rationale
`
`Based on various market analysis (e.g .• Biomedical Business lntemationa~ Medical
`Data International) the potential market for interbody fusion devices that meet the spinal
`surgeon's requirements is great Biomedical Business International Report #1651
`{February 1991) states:
`
`"The excitement in spine surgery Implant development is on the disc
`space. Technological innovations that are anticipated to drive growth in
`the spinal surgery market beyond the five year forecast period include
`prosthetic discs and lnterbody fusion devices ••• These devices represent a
`technology with an apportun~ to replace and expand the current implants
`market because they can produce results that more naturally imitate the
`healthy spine's anatomy and motion."
`
`Medical Data International states in a recent report (1992) that
`
`, "The potential market for interbody fusion devices is very large, essentially
`all one and two level fusions of the lumbar spile.
`Industry estimates
`suggest that 80% are one or two levels. Thus the potential market per yet
`in the U.S. is over 60,000 patients per year:
`
`Biomedical Business International predicts a total market for interbodY fusion devices ot
`25,000 implants per year by the tum of the century. They also state that the relative
`simplicity of the procedure will resuH in a substantial savings over pedicle screw fixation.
`
`Additional comments by MDI predict that bone substitutes wUI be packaged with inter(cid:173)
`body fusion devices during the later forecast periods, since their poor crush strength
`requires combina1ion with an interbody fusion device. The time advantage by not
`needing to harvest bone graft will add to the cost effectiveness of the procedure. espe(cid:173)
`cially for anterior implants.
`
`Retum on Investment
`
`Sofamor Danek Group currently dominates the U.S. and global markets tor spinal
`implants. This fact can be used to leverage the sales and marketing of interbody fusion
`devices. A leading market share for these devices would be anticipated. As previously
`mentioned, this market will take time to fully develop, with controlled clinical studies
`
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`6
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`lliterbody Fusion Devices
`
`required to secure FDA clearance and general acceptance of the technology by the sur·
`gical community.
`
`Return on investment will need to be estimated for the various interbody fusion device
`technologies once we have a better estimate of the required development steps and the
`manufacturing costs. Given the current device attematives, it would appear that a very
`ample return on investment could be realized for both Kozak and Michelson IBFD
`designs. As previously stated, the current cost of the SpinaTech BAK implants is
`approximately $2,000 ($4,000 per level). A femoral ring allograft from bone bank costs
`on the order of $1,000.
`
`Financial ObJectives
`
`The following could be used as an outline for beginning to estimate the potential rev(cid:173)
`enues realized from the two primary devices, the Kozak and Michelson IBFDs. We
`probably need manufacturing cost estimates for various quantities to accurately estj.
`mate these numbers. The general magnitudes might be as follows:
`
`Kozak IBFD
`Michelson IBFD
`
`1994
`~
`
`$
`$
`
`1995
`~
`
`$$
`$$$
`
`1996
`Dla
`$$$
`$$$$$
`
`Market segments could be analyzed by spinal level (cervical, thoracic, lumbar) or by
`surgical approach/procedure (AUF, PUF, Laparoscopic, Lateral...}. Clearly, the
`Michelson technology has greater potential, due to the large range of areas that can be
`addressed·using the threaded and non-threaded concepts.
`
`Additional financial figures we should attempt to estimate include: Total Category
`Sales, $Volume, Unit Volume, Share of Marlcet, Gross Profit, Manufacturing Costs,
`Fully Burdened Costs, Marketing Expenses, Advertising, Sales Promotion, Trade
`Allowances. Financial analysis should consider both U.S. and global introcluction of the
`devices.
`
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`7
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`lnterbody Fusion Devices
`
`prg)ect team
`
`Larry Boyd is product development manager worKing on the development of the
`interbody fusion device systems. Brad Estes will assist in the design and development
`of these systems. Additionally, at least one CAD designerltechnician will be required for
`design and drafting. This will be critica~ given the extremely large number of
`instruments and implants that will require documentation via CAD modeling and drawing
`eeneration. An initial project plan is in process, which outlines the various steps needed
`to commercialize the technologies.
`
`Marketing support will be required to manage market planning, advertising, public
`relations. sales promotion, merchandising and facillt"ating staff services, to Identify new
`markets and corporate scope and market research and to identify foreign markets. Both
`U.S. and global markets will need analysis, with the identification of key tai'get surgeons
`for clinical studies.
`
`Sales support will be needed to manage field sales organization, territories and quotas,
`manage sales office activities related to the interbody fusion devices and provide
`customer support services as more U.S. and global spinal surgeons begin using the
`devices.
`
`Financial group support will likely be needed eventually to help to manage working
`capital including receivables, inventory, and for financial forecasting, including capital
`budget, cash budget, pro forma financial statements, external financing requirements,
`financial condition requirements.
`
`Danek Manufacturing and/or Sofamor S.A. can assist with the manufacturing. raw
`materials management and allocation functions. Local vendors are currently being
`contacted for manufacture of test implants and instrumentation.
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`lnterbody Fusion Devices
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`8
`
`product Description
`
`The two primary interbody fusion device concepts are the Kozak IBFD and all Michelson
`IBFD concepts. The Kozak IBFD has been well described in previous documents
`(contact Larry Boyd for additional information). It is a modular concept Intended for
`anterior insertion. The U.S. patent claims have recently been allowed by the patent
`office. Mechanical cadaveric testing, animal testing and finite element analysis is
`currently underway to characterize the performance of this devtce.
`
`The Michelson technology covers a very broad range of fusion device concepts.
`Detailed .drawings of the various Michelson concepts are shown in the attached
`Appendix as Items , thru 9. An additional concept for the anterolateral placement of
`the ·device has recently been disclosed, but no drawings are currently available.
`
`Item 1 shows the cover pages from the current patents issued for the Michelson
`technology. Additional patent applications have.been filed as continuation-in-part
`applications or design patents related to the fundamental patents. As you can see. the
`initial U.S. patent was issued in May, 1991.
`
`Item 2 shows various th readad dowel concepts. Item 2A glvas a mora detailed View of
`the current implant design features - thread pattern. hole size and spacing.:
`
`Item 3 shows some push-in concepts envisioned by Dr. Michelson. These concepts
`help to protect the primary Michelson concept from competitors using a push-in concept
`to circumvent the original threaded patant. Additionally, these could be concepts that
`we may want to pursue at some future time.
`
`Item 4 shows the truncated cylinder concepts. These were developed to frt disc spaces
`that have a height to width ratio such that the placement of dual cylinders without the
`two devices touching is not possible. These are currently envisioned as push-in
`devices.
`
`Item 5 shows the cervical concepts. These are push-in cages that could be filled with
`bone via either a screw-in top opening or a slide-in front panel. An additional concept
`for distraction and piercing the endptates via wedges is also disclosed.
`
`Item 6 and Item 7 are both related concepts not covered by the current agreement, but
`subject to future addition if needed. The staple fixation concept provides additional
`fixation, but it is anticipated ttlat the threaded device should be very stable without this
`fixation. The staples could help to funher anchor push·in devices like the cervical
`cages. The staple fixation could be useful in other non-spine applications, for example,
`fusion of the ankle, great toe and other small joints.
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`9
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`lnterbody Fusion Devices
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`Item B shows some of the instrumentation used to perform a PUF. A detailed patent is
`available that fully details all the instruments. This schematic shows the basic steps o1
`pre-distraction, outer guide engagement, drilling/reaming, tapping (optional}, implant
`bone loading, and ·implant placement
`
`Item 9A shows an alternative to the drilling/reaming concept that would use a trephine to
`core out the disc space. This allows for. drilling over a distractor and could be important
`in maintaining lordosis throughout the procedure. lt would also allow the surgeon to
`work on one side at a time, without the placement of a short distractor on the opposite
`side to maintain spacing.
`
`Item 96 shows some of the additional instrumentation used for anterior procedures.
`The anterior procedure Is slmpllfled by being able to full visualize the operative site
`withol,lt concerns about moving the spinal cord to the opposite side. The dual
`chambered (•shotgun•) outer sleeve assures appropriate spacing between the devices.
`
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`•
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`10
`
`lnterbody Fusion Devices
`
`Competl11on
`
`lnterbody fusion devices are manufactured by the following companies:
`
`1 .l SplneTech has developed a fusion basket tor anterior and posterior interbody
`fusions. The device is based on the earty work of Bagby (1988), who developed a bone
`basket for use in the cervical spine of horses with Wobler syndrome. Bagby patented
`this work in 1985 (U.S. Patent 4,501,269) and 1990 (U.S. Patent 4,936,848). The
`implant and procedure was later further developed by Kusllch. It Is marketed as the
`BAK (Bagby and Kuslich) implant. They are the only company with an approved IDE for
`both anterior and posterior approaches. Company management beDeves it will receive
`.excellent surgeon acceptance from surgeons who now do anterior lumbar interbody
`fusions with posterior fixation {360 fusion). The deviccls retaft for $2,000 each, with two
`normally placsd in each disc level, for a total cost of at least $4,000 per disc level. Item
`1 0 in the Appendix documents some of the kay differences between his device and the
`BAK implant.
`
`BAKimplant _, __
`
`~.)Surgical pynamlcs toe. has developed a tnreaded fusion basket for PUFs with or.
`Charles A. Ray of Minneapolis. The deVices are rigid, threaded, titanium cages With
`multiple perforations that penetrate well into the threaded spongiosa bone. They are
`available in 14, 1El and 18 mm diameters. They are packed with 5 mL of autologous.
`cancellous bone chips {Aay,1991). A 10 patient feasibility study was conducted by Or.
`Ray. It was found that consolidation of the bone graft took an average of 3 months. In
`3 cases there was a transient foot drop and they re-designed instruments to bet1er
`protect the nerve. According 1o Ray (1991), no~·metallic {ceramic or composite) cages
`ar~ under development
`·
`
`Ray Threaded Fusion Cage
`
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`
`11
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`lnterbody F!-~sion Devices
`
`3J Acromeg has developed comp®~e implams with John Brantigan. The cages are
`made of carbOn-fiber reinforced poly:~ulfone. lhe PUF devices withstand 5,000 N
`compressive loads (Eirantigan, et al. 1991). The authors note concerns about potential
`fiber debris, but state that none was noted in the testing, They note the splitting of
`several cages during the pullout testing and the stripping of the threaded hole with
`insertfon of the chopped fiber composite. Later testing was performed to attemp1 to
`optinize the fiber orientation (Warden. et al, 1992). Also, some have noted that the
`sQuare shape of the implant may make ilsertion via PUF more diffiCtJit by requiring
`greater nerve retraction. Recent clinical experience (Brantlgan and Steffes, 1992)
`showed a 100 percent fusion rate when used with a posterior plating system, with a
`73% excellent or good results.
`
`BranUgan 1IF Cage tor PUF
`
`·~··-~· ..
`•
`
`.
`
`•
`
`··
`
`•
`
`.
`
`'
`
`;..-
`
`Brantigan has also developed a •racetrack-shaped" composite interbody fusion device
`for anterior approaches (U.S. Patent 5.192.327). The devices may be stacked for
`vertebral body replacement. Tha device is a large single component, requiring a difficult
`(and potentially dangerous) incision ol the entire anterior portion of the amulus for
`insertion. Additionally, limited area is provided for load bearing, so subsidence into the
`vertebral bodies may become an issue in clinical use of the device.
`
`Brantlgan IIF Cage for AUF
`
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`12
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`lirterbody Fusion Devices
`
`4.) pepuy distributes a titanium cage designed by Dr. Jurgen Harms and Lutz
`Biedermann of Langensteinbach, Germany. The titanium cage i& manufac:tured by
`Biedermann Motech lntematlonal and is distributed in Europe by Fehling AG. The
`titanium cages were designed to bridge bony defects in tumor surgery of the spinal
`column, but have recently been used in interbody fusions (Lowery, at al .• 1992). The
`implant consiats of a cytindrical jacket of pure titanium with a mesh wall structure. The
`serrated ends provide a solid anchorage for the implant in the endplates, but may also
`contribute to subsidence into the vertebral body. The length of 1he cages can be
`reduced in 5 mm increments by trimming. The implant is packed with bone graft or
`bone slurry.
`
`Harms Cages
`
`,_,_
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`
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`- ··- ~ .....
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`
`These would appear to be the major competitors at this time. The following devices
`have atso begun distribution tor interbody fusion;
`
`HartsUI Horseshoe for Anterior Spinal Fusion
`{Surglcraft • Worcestershlre, England)
`
`~~
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`
`MSD 1041696
`
`Confidential Information- Patent Prosecution Sensitive
`
`MNUV0274063
`
`PX0116-0015
`
`Page 15
`
`

`
`ln1erbody Fusion Devices
`
`13
`
`l _ .... ,
`
`1
`
`-~·· "\
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`{SclenflC - PariS. Franca)
`
`~ --(cid:173)
`...... -
`
`C.aledll ldnlliaa - -
`AIIDIIIIYI' IYN Dn ir
`
`MsD 1041697
`
`('.orll'idential lntcmaliO-:'t- ='ati!'nl Pl'<l!lll!lti.J~on S1Bm1~1n:
`
`PX0116-0016
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`Page 16
`
`

`
`14
`
`lnterbody Fusion Devices
`
`Manufacturing
`
`Many instruments and implants will require manufacture. We will need to determine
`qualified vendors (lntemaVextemal). Additional issues for discussion will involve
`sterilization issues, packaging, U.S. vs. European distnbution, etc. The following is a
`partial list of the anticipated implant and inst~UT~entation components that will require
`manufacture for the P UF .set alone, to give an overaJI sensa for the magnitude of the
`manufacturing requirements:
`
`14 mm Diameter Endcap
`
`16 mm Diameter Endcap
`
`1 a mm Diameter Endcap
`
`Implants
`
`14 mm Diameter • 23 mm Length
`1 4 mm Diameter • 26 mm Length
`14 mm Diameter· 29 mm Length
`
`16 mm. Diameter • 23 mm Length
`16 mm Diameter- 26 rnm Length
`1 6 mm Diameter - 29 mm Length
`
`18 mm Diameter- 23 mm Length
`1 8 mm Diameter- 26 mm Length
`18 mm Diameter - 29 mm Length
`
`Instruments
`
`Mallet
`Bone Press
`Instrument Remover (Slap Hammer}
`Remote Oistractor Inserter
`Bone Trephine
`Implant Inserter
`Air Drive Adapter
`Cap Driver
`CorkScrew
`Driver cap
`
`14 rom Set 12.5 mm diameter reamer
`14 mm x 23 mm teamer sleeve
`14 mm x 26 mm reamer sleeve
`14 mm x29 mm reamer sleeve
`14 mm diameter tap
`6 mm fixed distractor
`6 mm remote dis1ractor
`
`MSD 1041698
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`Confidential Information- Patent Prosecution Sensitive
`
`MNUV0274065
`
`PX0116-0017
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`Page 17
`
`

`
`15
`
`lnterbody Fusion Devices
`
`16 mm Set 14.5 mm diameter reamer
`1 e mm x 23 mm reamer sleeve
`16 mm x 26 mm reamer sleeve
`16 mm x 29 m reamer steeve
`16 mm diameter tap
`6 mm fixed distractor
`8 mm fixed distractar
`6 mm remote distractor
`8 mm remote distractor
`
`1 8 mm Set 16.5 mm diameter reamer
`1 8 mm x 23 mm reamer sleeve
`18 mm x 26 mm reamer sleeve
`18 mm x 29 mm reamer sleeve
`1 8 mm diameter tap
`6 riun fixed distrac1or
`B mm fixed distractor
`1 0 mm fixed distrador
`6 mm remote distractor
`8 mm remote distract or
`1 0 mm remote distractor
`
`N01e that the ALIF set would be similar, with longer handled instruments and larger
`diameter implants. The photo below shows some at the instrumentation discussed
`above:
`
`MSD 1041699
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`Confidential Information - Patent Prosecution Sensitive
`
`MNUV0274066
`
`PX0116-0018
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`Page 18
`
`

`
`lnterbody Fusion Devices
`
`Future Tasks/Summary
`
`Clearly, a detailed plan will need to evolve as the various Research, Development,
`Marketing, Regulatory, Sales, and Manufacturing groups add their input to the
`Micheison project. Some key future steps might include:
`
`1.) Identify & Involve Surgeon Champion(s)
`Deflne Dr. Michelson's Role
`Defme Dr. Zdeblick's Role
`Identify Other Key Surgeons (U.S., Globaij and Oef111e Roles
`
`2.) Priertize IBFD and Related Projects - Budget/Resource Shifting
`
`3.) Determine Clinical Focus (e.g., Spine· PLIF, AUF, etc.; Small Joint- AnJde, Great
`Toe, etc.) & Regulatory Strategy
`
`·4.) Determine Global Release Strategy (U.S., Europe, Asia)
`
`5.} Finalize Implant Design
`
`6.) Full Implant & Instrument Drawings
`
`7.) Identify & Qualify Vendor(s}
`
`8.) Assure Global Patent Coverage for All Michelson Concepts
`
`9.) Determine Potential Testing, Develop Protocols, Begin Testing
`Bench-top Mechanical Testing • Static/Fatigue
`Cadaveric Instrumentation Evaluation
`Cadaveric Implant Mechanical Testing
`Finite Element Analysis
`Animal Studies
`
`1 o.) Clinical Evaluations
`
`These are a few of my thoughts on the current status and future plans for this project.
`Please feel free to call me with any questions, comments or concerns concerning this
`project.
`
`MSD 1041700
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`Confidential Information - Patent Prosecution Sensitive
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`MNUV0274067
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`PX0116-0019
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`Page 19
`
`

`
`Appendix
`
`CoaldlllllllntDnllllh1 • -
`~ltor111¥1' Eyn Only
`
`MSD :1041'701
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`Confidential Information- Patent Prosecution Sensitive
`
`MNUV0274068
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`PX0116-0020
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`Page 20
`
`

`
`MICH!LSOJ PArENTS
`
`THR!ADED DOWEL. HON-TUEADED CF.llVICAL
`
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`Ili!ER!UJIOMAL PAl'!IIT FOR. NON-TII!E.UIED COI'ICE.FTS
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`TRP.EADED DOwtL
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`- OUCINAL U.S. PATtN'l'
`
`CnldtiiiiiiiDnniDI - -
`AltomiYI' Eta Onll'
`
`MSD 1041.702
`
`Confidential Information- Patent Prosecution Sensitive
`
`MNUV0274069
`
`PX0116-0021
`
`Page 21
`
`

`
`rl'Dl 2 - miAJlr:D 00\lEL CONCEPTS
`
`(DESIGN PATENT)
`
`(~
`FIG. P. ® F I C. 4
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`
`MSD 1041703
`
`Confidential Information- Patent Prosecution Sensitive
`
`MNUV0274070
`
`PX0116-0022
`
`Page 22
`
`

`
`..
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`SECTION B-B
`SCAlE -i.OOO
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`
`MSD 1041704
`
`Confidential Information - P atent Prosecution Sensitive
`
`MNUV0274071
`
`PX0116-0023
`
`Page 23
`
`

`
`ITEM 3 -
`
`PUSH-