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1 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution 1 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution
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2 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Channel Setting Instructions for ResponseCard RF 1.Press and release the "GO" button. 2.While the light is flashing red and green, enter the 2 digit channel code: 41 3. After the second digit is entered, Press and release the "GO" button. 4. Press and release the "1/A" button. The light should flash yellow to confirm
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3 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Puros DBM Diana M. Martinez Brand Manager 3 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution
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4 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Are you in the correct breakout? Puros DBM Diana M. Martinez Brand Manager 10 1.Yes 2.No
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5 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution PUROS ® DEMINERALIZED BONE MATRIX (DBM)
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6 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution What Is It? 100% derived from human demineralized bone –Active DBM* –Carrier DBM –Water Open bore dispensers *DBM induced bone formation when implanted in an athymic rat assay. Findings from an animal model are not necessarily predictive of human clinical results.
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7 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution How It’s Made *DBM induced bone formation when implanted in an athymic rat assay. Findings from an animal model are not necessarily predictive of human clinical results.
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8 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Cortical Bone Grind Demineralize ground cortical bone through acid bath DBM Powder Lee, Kenneth J.H. Demineralized Bone Matrix and Spinal Arthrodesis. The Spine Journal. 2005; Journal 5. Pgs 217S-223S
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9 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution DBM Testing In VivoIn Animal –Ectopic Rat Assay In VitroIn Lab –ELISA –Alkaline Phosphatase –Osteosarcoma Correlation Lot-to-Lot vs. Validation Studies
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10 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Irradiated DBM 28 Days DBM induced bone formation when implanted in an athymic rat assay. Findings from an animal model are not necessarily predictive of human clinical results.
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11 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Screening criteria include osteoinductivity and inflammation. DBM that does not meet RTI’s criteria is not distributed.
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12 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Data on file at RTI Biologics
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13 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution An in vitro test for osteoinductive potential will always give the same result as an in vivo test. Question 10 A. True B.False
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14 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Question #1 An in vitro test for osteoinductive potential will always give the same result as an in vivo test.
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15 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Question #1 True of False
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16 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Question #1 Correct answer is False
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17 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution How It’s Made *DBM induced bone formation when implanted in an athymic rat assay. Findings from an animal model are not necessarily predictive of human clinical results.
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18 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Carrier 100% DBM - From same donor as active DBM* Proprietary process *DBM induced bone formation when implanted in an athymic rat assay. Findings from an animal model are not necessarily predictive of human clinical results.
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19 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution + + Carrier DBM =
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20 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution *DBM induced bone formation when implanted in an athymic rat assay. Findings from an animal model are not necessarily predictive of human clinical results. How It’s Made
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21 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution QC Release Testing Final Product Extrusion Dissolution DBM OI Residual Calcium Residual Moisture
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22 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Key Features: Sterility Terminal sterilization –Low-temperature, low-dose Gamma Irradiation –SAL 10 -6 Low-temperature, low-dose Gamma Irradiation has no significant impact on OI potential* Wientroub, S. Influence of Irradiation on the Osteoinductive Potential of Demineralized Bone Matrix. Calcified Tissue International. 1998; 42:255-260 *Data on file at RTI Biologics
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23 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Key Features: Convenience Ready-To-Use –Pre-mixed Stored at Room Temperature* –Off-the-shelf –Expiration dating: 12-months Open Bore Dispenser *Please see product label for specific temperature range
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24 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Availability Available Sizes: 0.5 cc 1 cc 2 cc 5 cc 10 cc (2 x 5cc) All in Open-bore Dispensers Puros DBM Putty
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25 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution 2) The shelf life of Puros DBM Putty is: Question 10 A.3 months B.6 months C.9 months D.12 months
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26 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Question #2 2) The shelf life of Puros DBM Putty is:
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27 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Question #2 a. 3 months b. 6 months c. 9 months d. 12 months
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28 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Question #2 The correct answer is: d. 12 months
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29 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Puros DBM Launch Materials Introductory letter FAQ Features & Benefits Sales Training Presentation Sales Sheet New Product Brochure
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30 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Puros DBM Launch Materials White papers –OI of Puros DBM Putty –Effects of Gamma Sterilization –Redundant Safegaurds of Puros DBM Product samples –Samples allow you to demonstrate handling characteristics –Not real DBM –Limited shelf life
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31 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution 3) The Puros DBM samples are not made from real DBM Question 10 A. True B.False
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32 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Question #3 3) The Puros DBM samples are not made from real DBM
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33 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Question #3 True or False
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34 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Question #3 (Correct answer is True)
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35 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Puros DBM Launch Materials Licenses & Certifications –RTI’s AATB Accreditation –Zimmer FDA Registration –State licenses (CA, MD, NY, FL) –Other available on RTI’s website www.rtix.com
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36 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Sales Tools: Coming Attractions White paper –Rat PLF model Competitive Guide Technical monograph
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37 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution 4) Since the Puros DBM samples are made from food products and not DBM they have an unlimited shelf life. Question 10 A. True B.False
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38 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Question #4 4) Since the Puros DBM samples are made from food products and not DBM they have an unlimited shelf life.
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39 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Question #4 True or False
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40 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Question #4 (Correct answer is False)
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41 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution DBM – Market Market Drivers 1 Market Limiters 1 Cost per case compared to BMP Lack of randomized human clinical trials Variety and availabilityPerception that all DBMs are the same More than 15 years of use Nimmi et. al. (2003) – osteoinductivity varies widely from bank to bank, and from lot to lot within same bank *2 1.Source: MRG Biomaterials 2007 2.J Orthopeadic Research 21 (2003) 648-656
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42 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Accell (Integra*) Grafton (Osteotech) DBX (Synthes) InterGro (Biomet) Puros DBM (Zimmer) Handling Watery, Dissolves Crumbly, Dissolves Slick, Sticks to Gloves Good; but soluble if wet too long Excellent: Robust, Moldable, Water Resistant OI Testing In Vitro Lot-to-Lot Validated Process No Lot-to-Lot In Vitro Lot-to-Lot In Vitro Lot-to-Lot In Vivo Lot-to-Lot Value Proposition 100% DBM therefore Best OI Most OI Product on the Market Highest Bone Content and Natural Carrier Fastest Growing DBM All Human, Excellent Handling, OI Testing, Safe Comparison Chart *Formerly IsoTis
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43 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution 5) Each lot of Puros DBM is tested for osteoinductive potential by an in vitro ALP assay. Question 10 A. True B.False
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44 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Question #5 5) Each lot of Puros DBM is tested for osteoinductive potential by an in vitro ALP assay.
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45 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Question #5 True or False
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46 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Question #5 (Correct answer is False)
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47 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Bone Graft Substitutes Market Diana M. Martinez Brand Manager Biologics
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48 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution BGS Market Segmentation: Two Categories 2008 Revenue Projection: $129 M 9.0% CAGR / often used as carrier / appealing alternative due to safety, consistency and price Zimmer Spine 2008 Revenue Projection: $6.2 M DBMs Synthetics Sources and Assumptions: 1) Based on US Spine Market CAGR from MRG, 2) Category Revenue Proj. ave.’ 07 ZMH MM & MRG 3) ZS Revenue: May Proj. 2008 Revenue Projection: $161 M 5.5% CAGR / well-accepted convenience and handling / fragmented market Zimmer Spine 2008 Revenue Projection: $557 K
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49 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Zimmer Spine: Two Categories Puros DBM CopiOs Bone Void Fillers Sources and Assumptions: 1) Based on US Spine Market CAGR from MRG, 2) Category Revenue Proj. ave.’ 07 ZMH MM & MRG 3) ZS Revenue: May Proj.
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50 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution 6) The market for synthetic Bone Graft Substitutes in the US was valued at ___________ for 2008. Question 10 A.$50 million B.$79 million C.$109 million D.$129 million
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51 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Question #6 6) The market for synthetic Bone Graft Substitutes in the US was valued at ___________ for 2008.
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52 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Question #6 a)$50 million b)$79 million c)$109 million d)$129 million
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53 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Question #6 The correct answer is: d) $129 million
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54 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution CopiOs Bone Void Filler Features & Benefits Excellent Handling Characteristics Two formulations: Sponge and Paste to meet various patient needs and surgeon preferences Easy to mold into irregularly shaped spaces Sponge is easy to shape and cut CopiOs Sponge provides collagen scaffold with porosity similar to cancellous bone Acidic conditions may preserve the solubility of naturally occurring BMPs Resorbs completely* *Data on file at Zimmer, Inc.
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55 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution CopiOs Bone Void Filler Features & Benefits Scaffold supports bone growth throughout the graft site Non-chemically cross-linked collagen provides strength and durability for the scaffold to persist until replaced by new bone Provides an abundance of minerals for bone growth With addition of BMA, the composite graft provides osteoconductive, osteoinductive and osteogenic properties (performing equivalent to autograft in preclinical studies)
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56 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Sales Tools
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57 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution 7) The mineral component of CopiOs (DICAL) provides more soluble bone mineral ions and moderately acidic environment may perseveres the solubility and ____________ of BMPs. Question 10 A.quantity B.biological activity C.integrity D.Types
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58 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Question #7 7) The mineral component of CopiOs (DICAL) provides more soluble bone mineral ions and moderately acidic environment may perseveres the solubility and ____________ of BMPs.
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59 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Question #7 a)quantity b)biological activity c)integrity d)types
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60 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Question #7 The correct answer is: b) biological activity
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61 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution New Sales Tools CopiOs DVD Animation CopiOs Family Brochure –Includes in depth overview of CopiOs Paste and Sponge technology including preclinical animal data –Currently awaiting internal approval CopiOs Pearls Sales Tool –Simplified key messages –Collection of sales pearls from top CopiOs sales reps
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62 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution 8) TCP bone substitutes have the same characteristics and offer the same benefits of the DICAL in CopiOs* Question 10 A. True B.False As determined by an animal study.
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63 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Question #8 8) TCP bone substitutes have the same characteristics and offer the same benefits of the DICAL in CopiOs*
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64 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Question #8 True or False
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65 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Question #8 Correct answer is False As determined by an animal study.
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66 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Sales Tools: Coming Attractions CopiOs Sponge Iliac Crest Study Single site study – investigator – M. David Dennis M.D Prospective, non-blinded, non-randomized Pts undergoing spinal procedure with iliac crest harvest CopiOs Sponge used to back fill the autograft harvest site 30 patients
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67 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Sales Tools: Coming Attractions CopiOs Sponge Iliac Crest Study - continued Evaluation at: –Post op –3 months post op –6 months post op Evaluation includes: –Surgeon Assessment –Patient Assessment Form –Iliac Crest Pain 11 point NRS current medication, complications –Concomitant Medical Events/Complications Report (if applicable) –Serial CT scans using 3mm slice thickness from the top of Iliac Crest to the Symphysis Pubis
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68 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Sales Tools: Coming Attractions CopiOs Sponge Iliac Crest Study - continued Current Status: Data being reviewed by independent radiologist
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69 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution On a scale of 1 to 10 (10=best), how would you rate this breakout? 1.Worst 2... 3.… 4.…. 5.….. 6.…… 7.……. 8.…….. 9.………. 10.Best 1…....…2….…...3…...….4……...5……….6……...7………8………9……..10 10
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70 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Thank You!
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71 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution All trademarks and registered trademarks are the property of their respective owners. © 2009 Zimmer Spine Inc. All rights reserved.
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72 of 60 of Slides ME09-0020 Rev.A Confidential- For Internal Use Only. Not for Distribution Participant Scores 100Susan 100Marjorie 100Judy 100Elaine 100Scott B 100Melanie 100Stefan
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