Reportlinker:Reportlinker Adds World Bone Grafts Market Report

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World Bone Grafts Market

http://www.reportlinker.com/p0119465/World-Bone-Grafts-Market.html

This report analyzes the US market for Bone Grafts in Millions of US$. The
market for Bone Grafts is analyzed by the following segments: Standard
Allografts, Machined Bone Allografts, Demineralized Bone Matrix (DBM), Bone
Morphogenetic Protein (BMP), Platelet Concentrators, and Synthetic Bone Grafts.
Annual forecasts are provided for the period of 2006 through 2015. A six-year
historic analysis is also provided for this markets.The report profiles 59
companies including many key and niche players such as AlloSource, Biomet Inc,
Interpore Cross International, BioMimetic Therapeutics Inc., DePuy Spine Inc.,
Exactech Inc., Integra LifeSciences Holdings Corporation, Integra
OrthoBiologics, Lifelink Tissue Bank, LifeNet Health, Medtronic Inc., Medtronic
Sofamor Danek Inc., Musculoskeletal Transplant Foundation, NovaBone Products
LLC, NuVasive Inc., Orthovita Inc., Osiris Therapeutics Inc., Osteotech Inc.,
RTI Biologics, Inc., Smith & Nephew Plc., Stryker Corporation, Synthes Inc.,
Wright Medical Technology, Inc., and Zimmer Holdings, Inc. Market data and
analytics are derived from primary and secondary research. Company profiles are
mostly extracted from URL research and reported select online sources.

BONE GRAFTS A US MARKET REPORT MCP-1637

CONTENTS

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

Study Reliability and Reporting Limitations I-1 Disclaimers I-2 Data
Interpretation & Reporting Level I-2 Quantitative Techniques & Analytics I-3
Product Definitions and Scope of Study I-3 A. Standard Allografts I-3 B.
Machined Bone Allografts I-3 C. Demineralized Bone Matrix (DBM) I-4 D. Bone
Morphogenetic Protein (BMP) I-4 E. Platelet Concentrators I-4 F. Synthetic Bone
Grafts I-4

II. A US MARKET REPORT

1. Industry Overview II-1 Bone Grafts: A Prelude II-1 Orthobiologics Gain
Traction in the Bone Grafts Market II-1

Table 1: Worldwide Market for Orthobiologics (2007): Percentage Share Breakdown
of Value Sales by Company- Medtronic, Synthes, J&J, Osteotech, Stryker, and
Others (includes corresponding Graph/Chart) II-2 Statistical Insights Into the
World Orthopaedic Implants Market II-3

Table 2: Worldwide Orthopaedic Market (2007): Percentage Share Breakdown of
Value Sales by Company - Stryker, J&J, Zimmer, Medtronic, Synthes, Smith &
Nephew, Biomet and Others (includes corresponding Graph/Chart) II-3

Table 3: Worldwide Market for Orthopaedic Implants in Spinal Procedures (2007):
Percentage Share Breakdown of Value Sales by Company - Medtronic, J&J, Synthes,
Stryker, Biomet, Zimmer, and Others (includes corresponding Graph/Chart) II-3

Table 4: Worldwide Market for Orthopaedic Implants for Reconstructive Procedures
(2007): Percentage Share Breakdown of Value Sales by Company - Zimmer, J&J,
Stryker, Smith & Nephew, Biomet and Others (includes corresponding Graph/Chart)
II-3

Table 5: Worldwide Market for Orthopaedic Implants for Trauma &
Craniomaxillofacial Procedures (2007): Percentage Share Breakdown of Value Sales
by Company - Synthes, Stryker, Smith & Nephew, J&J, Zimmer, Biomet and Others
(includes corresponding Graph/Chart) II-4 Hospital Pricing, Not GDP is the Key
Driver of Growth II-4 Orthopedic Implant Pricing Grows Independent of Medicare
Reimbursement: Why? II-4 Medicare Reimbursement Higher for Spinal Fusions With
Growth Factors II-5 Is Consolidation Blowing in the Wind? II-5 Patient Safety
Emerges to Become a Top Priority II-5 Bone Grafts Termed as Tissues Suffer From
Inconsistent Patient Outcomes II-5 What Drives Physicians` Choice of Bone
Grafts? II-6 Key Market Trends & Issues: A Review II-6 Aging Population: A
Strong Demographic Driver II-6

Table 6: Population Over 65 Years and Above in North America, Western Europe and
Eastern Europe for the year 2007 (In Millions) (includes corresponding
Graph/Chart) II-7 Rising Incidences of Degenerative Intervertebral Disc Diseases
II-7

Table 7: Average Annual Number of Spinal Fusions Procedures in the United States
& Europe for the Year 2005 & 2008 (in Thousands) II-8

Table 8: Osteoporosis Population in the US: 2002, 2005, 2008 & 2012 (includes
corresponding Graph/Chart) II-8

Table 9: Breakdown of Osteoporotic Fractures by Site in the US (includes
corresponding Graph/Chart) II-8 Rise in Revision Orthopaedic Surgeries II-9 Rise
in Spinal Fusions in Private Healthcare II-9 Increasing Visibility of
Orthobiological Products to Spur Grafting Options II-9 Precision Machined
Allograft Gain Surgeon Preference II-9 Strong Prices Will Continue to
Characterize Bone Graft Technologies II-9 Unmet Clinical Needs to Foster R&D
Engine II-10 Synthetic Bone Grafts To Fan Growth II-10 Dental Bone Grafts On the
Rise II-10 Alliances with Organ Procurement Organizations: A Shot in the Arm
II-11 Advanced Allografts Encroaching into the Use of Autografts in Surgical
Procedures II-11 DBM: Strong Growth But Tough Competition II-11 Adequate
Reimbursement: An Impetus for Growth & Profitability II-12

Table 10: Payer Mix for Spinal (Cervical) Fusion Procedures in the US (includes
corresponding Graph/Chart) II-12

Table 11: Payer Mix for Spinal (Lumbar) Fusion Procedures in the US (includes
corresponding Graph/Chart) II-12 Aging Baby Boomers Render a Decreased Donor
Pool II-12 Limited Availability of Donor Tissues II-13 Intense Competition from
Alternative Tissue Repair Therapies II-13 Substitute Technologies Threaten to
Replace Spinal Fusions II-13 Growing Off-Label Use of Infuse Bone Graft Raises
Eyebrows II-13 Technology Innovations in Orthopedic Biomaterials: The Way to Go!
II-14 MPCs: Offer Promising Breakthroughs in Bone-Graft Substitute II-14 Peptide
Signaling Molecules to the Rescue II-14 Prostaglandin Agonists: Emerging From
their Drawbacks II-14 Platelet Concentrate Systems II-15 Synthetic Bone Grafts
II-15 Combination of Bone Marrow and Bone Graft Substitute II-15 Stem Cell
Therapy II-16 Bone Morphogenetic Proteins II-16 GEM OS1 Shows Promise II-16
geneX Synthetic Bone Graft Substitute II-17 ACCELL Total Bone Matrix II-17
Tissue Recovery & Processing: A Structural Review II-17 Tissue Banks II-17

Table 12: Tissue Processing Market in the US (2006): Breakdown of Number of
Donors by Select Processing Organization/Company - Musculoskeletal Transplant
Foundation, Regeneration Technologies Inc, LifeNet, Allosource, Community Tissue
Services, Osteotech, LifeLink and Tissue Banks International (includes
corresponding Graph/Chart) II-18

Table 13: Tissue Processing Market in the US (2006): Percentage Breakdown of
Market Share of Processing Organization/Company - Musculoskeletal Transplant
Foundation, Regeneration Technologies Inc, LifeNet, Allosource, Community Tissue
Services, Osteotech, LifeLink, Tissue Banks International, and others (includes
corresponding Graph/Chart) II-18 Tissue Processing II-19 Tissue Distribution
II-19 An Illustration of the Tissue Recovering, Processing, & Distribution
Network II-20

2. Competition II-21 Competitive Scenario: A Primer II-21 The New Batting Order
in Key Product Markets in the US II-21 Standard Bone Allografts II-21

Table 14: US Market for Standard Bone Allografts (2006): Percentage Market Share
Breakdown of Leading Tissue Processors - Musculoskeletal Transplant Foundation,
Regeneration Technologies Inc, Lifenet, Allosource, Lifelink, Osteotech and
Tutogen Medical (includes corresponding Graph/Chart) II-21 Machined Bone
Allografts II-22

Table 15: US Market for Machined Bone Allografts (2006): Percentage Market Share
Breakdown of Leading Tissue Processors - Musculoskeletal Transplant Foundation
(MTF), Regeneration Technologies, Lifenet, Osteotech Inc, Allosource, and
Tutogen Medical (includes corresponding Graph/Chart) II-22 Demineralized Bone
Matrix (DBM) II-22

Table 16: US Market for Demineralized Bone Matrix (2006): Percentage Share
Breakdown of Value Sales by Company- Synthes, Osteotech, RTI, J&J, Biomet,
Wright Medical Group, and Others (includes corresponding Graph/Chart) II-23
Synthetic Bone Graft Substitutes II-23

Table 17: US Market for Synthetic Bone Graft Substitutes (2006): Percentage
Share Breakdown of Value Sales by Company - Orthovita, Wright Medical, Biomet,
J&J and Others (includes corresponding Graph/Chart) II-23 Platelet Concentration
Systems II-24

Table 18: US Market for Platelet Concentration Systems (2006): Percentage Share
Breakdown of Value Sales of Key Players -DePuy, and Interpore Cross II-24
Allograft Tendon/Ligament II-24

Table 19: US Market for Allograft Tendon/Ligament (2006): Percentage Market
Share Breakdown of Major Companies/Organizations - Musculoskeletal Transplant
Foundation, Arthrex, RTI, and Others (includes corresponding Graph/Chart) II-24
Spinal Fusion II-24

Table 20: US Spinal Fusion Market (2006): Percentage Share Breakdown of Value
Sales by Company - Medtronic, DePuy Spine, Stryker Spine, Zimmer, Biomet and
Others (includes corresponding Graph/Chart) II-24 The New Batting Order in Key
Product Markets in Europe II-25 Acceptance of Synthetic Bone Grafts in Europe:
An Uphill Task II-25 EU directive 2003/32/EC II-25 DBM-based Products in Europe
& Rest of World II-25 Standard Bone Allografts II-25

Table 21: European Market for Standard Bone Allografts (2007): Percentage Market
Share Breakdown of Leading Companies/Organizations - Musculoskeletal Transplant
Foundation, RTI Biologics Inc, LifeNet Health, Osteotech Inc, Allosource, and
Others (includes corresponding Graph/Chart) II-25 Machined Bone Allografts II-26

Table 22: European Market for Machined Bone Allografts (2007): Percentage Market
Share Breakdown of Leading Companies/Organizations - Musculoskeletal Transplant
Foundation, RTI Biologics, Osteotech Inc and Others (includes corresponding
Graph/Chart) II-26 Demineralised Bone Matrix Market II-26

Table 23: European Market for Demineralized Bone Matrix (2007): Percentage
Market Share Breakdown of Leading Companies/Organizations - Osteotech Inc,
Musculoskeletal Transplant Foundation, RTI Biologics Inc, Wright Medical
Technology and Others (includes corresponding Graph/Chart) II-26 Bone Graft
Substitutes Market: II-27

Table 24: European Market for Bone Graft Substitutes (2007): Percentage Share
Breakdown of Value Sales by Leading Players - Interpore Cross International,
Orthovita Inc, Wright Medical Technology Inc, Zimmer Inc, Medtronic Sofamer
Danek, DePuy Inc, Smith & Nephew, and Others (includes corresponding
Graph/Chart) II-27

3. Regulatory Environment & Reimbursements II-28 Regulatory Issues II-28 FDA
Classification of Bone Products II-28 Human Cells, Tissues and Cellular and
Tissue-Based Products (HCT/Ps) II-28 National Organ Transplant Act (NOTA) II-29
Good Tissue Practices II-29 Tissue Banking Regulation II-29 FDA Regulations on
Xenograft II-29 DBM-based Products in US II-30 Synthetic Bone Graft Substitutes
II-30 Reimbursement Issues II-30 CMS Implements 2008 Hospital IPPS II-30 CMS
Proposal for 2007 Hospital IPPS II-30 (i) Fracture Treatment II-30 (ii) C-codes
for Spine Devices II-31 (iii) Revised Payment Rates for DRG 497, 498 II-31

Table 25: CMS Payment Rates for DRG 497, 498 for the years 2002 & 2007 II-31

4. Product Overview II-32 Bone Grafts: A Definition II-32 Pricing Trends II-32
Bone Grafts: A Peek Into their Mechanism of Action II-32 Types of Bone Grafts
II-33 Scoring of Osteoconduction, Osteoinduction, and Osteogenesis Properties of
Bone Grafts by Type II-33 Autografts II-33 Advantages II-34 Disadvantages II-34
Standard Allografts II-34 Advantages II-35 Disadvantages II-35 Machined Bone
Allografts II-35 Demineralized Bone Matrix II-36 Commercially Available
Demineralized Bone Matrix Products II-36 Bone Morphogenetic Proteins (BMPs)
II-36 Basic Functions of TGF-Beta II-37 Commercially Available BMP-Products in
the Marketplace II-37 Infuse II-37 OP-1 II-37 Platelet Concentrators II-37
Synthetic Bone Grafts II-38 Collagen-based Matrices II-38 Advantages II-39
Disadvantages II-39 Ceramic: A Material of Choice II-39 Hydroxyapatite: A Major
Calcium Phosphate Based Ceramic II-40 Calcium Sulfate II-40 Polymer Based Bone
Grafts II-40 Coral: A Valuable Synthetic Graft Material II-40 Commercially
Available Bone Substitutes Products II-41 Application of Bone Grafts II-42

Table 26: Worldwide Market for Orthopaedic Implants in Spinal Procedures (2007):
Percentage Share Breakdown of Value Sales by Application - Thoracolumbar
Interbody Devices, Vertebral Compression Fractures, Cervical, and Electrical
Stimulation (includes corresponding Graph/Chart) II-42 Spinal Fusion II-42
Trauma & Reconstructive Surgeries II-43 Trauma II-43 Reconstructive Surgeries
II-43 Joint Revision Arthroplasty II-43

Table 27: Worldwide Market for Orthopaedic Implants in Reconstructive Procedures
(2007): Percentage Share Breakdown of Value Sales by Application - Knees, Hips,
and Extremities (includes corresponding Graph/Chart) II-43 Oral, Periodontal,
and Cranio-Maxillofacial II-44

Table 28: Worldwide Market for Orthopaedic Implants in Trauma &
Craniomaxillofacial Procedures (2007): Percentage Share Breakdown of Value Sales
by Application -Hip Fracture, Lower Extremity, Neuro & Craniomaxillofacial,
Deformities, Pediatric & Foot and Upper Extremity (includes corresponding
Graph/Chart) II-44

5. Product Launches II-45 RTI Biologics Introduces CopiOs Implant for Dental
Procedures II-45 ETEX Unveils `EquivaBone` Bone Graft Substitute II-45 NovaBone
Introduces New Type of Synthetic Bone Graft II-45 Pioneer Surgical Unleashes
FortrOss II-45 Alphatec Launches ProFUSE II-45 Medtronic Releases Nanostim
Synthetic Bone Paste II-45 NovaBone Unveils `NovaBone Putty` II-46 RTI
Introduces Fresh-Stored OC Allograft Range II-46 Integra LifeSciences Unveils
Smaller Size `Accell TBM II-46 Orthovita Launches VITOSS Bioactive Foam Pack
II-46 NovaBone Launches `NovaBone Porous Morsels` II-46 Wright Medical Group
Introduces BIOFOAM II-46 Integra LifeSciences Releases Accell Evo3 II-47 DePuy
Spine Launches New Bone Graft Product II-47 Medtronic Offers Progenix DBM Putty
II-47 Global Medical Launches Bone Graft Portfolio II-47 Integra LifeSciences
Introduces Mozaik II-47 Collagen Unveils 'OssiMend Bone Graft Matrix II-48
Wright Medical Launches PRO-DENSE Injectable Regenerative Graft II-48 ApaTech
Introduces Actifuse ABX Easyfill Putty II-48 ApaTech Releases Actifuse E-Z-Prep
II-48 RTI to Launch Sterling Xenograft and BioSet DBM II-48 Medtronic Inc
Unveils Mastergraft Matrix and Putty II-49 Regeneration Technologies Inc
Introduces Adjustable BTB Implant II-49 Regeneration Technologies Inc Releases
Pre-Shaped Achilles Tendons II-49 Millenium Biologix Corporation Launches
Primacoll II-49 Millenium Biologix Corporation Unveils Skelite Bone Graft
Substitute II-49 Orthovita Inc Releases VITOSS Foam Pack II-49 Osteotech
Launches Grafton(R) DBM II-50 ApaTech Introduces Actifuse II-50 Osiris Unleashes
Osteocel Line of Products II-50 OsteoBiologics Introduces TruWedge BGS II-50
Isotis Orthobiologics Releases OsSatura TCP II-50 Orthovita Launches Vitoss
Scaffold Foam Flow II-50 Stellar Introduces Skelite Bone Void Filler II-51
Wright Medical Launches OSTEOSET DBM II-51 Wright Medical Group Releases MIIG X3
II-51

6. Recent Industry Activity II-52 Regeneration Technologies Merges with Tutogen
Medical II-52 Wright Medical Takes Over INBONE Technologies II-52 NuVasive
Acquires Osteocel Biologics II-52 Integra LifeSciences Takes Over Theken II-52
Osteotech Inks Distribution Contract with BioHorizons II-52 Pioneer Surgical
Secures FDA Approval for FortrOss II-52 Inion Secures FDA Approval for
Biodegradable Spine Products II-53 Biocomposites Bags FDA Approval for geneX
Putty II-53 IFGL Establishes Dental BioGraft Plant II-53 Osteotech Receives FDA
Approval for Plexur M Biocomposite II-53 Millenium Signs an Asset Sale Agreement
with Two Companies II-53 INBONE Technologies Merges with Reiley Orthopedic II-53
AlloSource Signs a License Agreement with IsoTis II-54 Osteotech Inks Single
Source Agreement for Allograft Products II-54 Bonesupport Enters Into
Distribution Agreement with Signus Medical II-54 Tornier Takes Over DVO II-54
Zimmer Holdings Acquires Endius Inc. II-54 Wright Medical Group Takes Over Darco
International II-54 Integra LifeSciences Completes Acquisition of IsoTis II-55
Synthes Gets FDA Clearance for Bone Graft Substitute II-55 Collagen Receives
510(k) Clearance from FDA for SynOss II-55 ISTO Technologies Obtains 510(k)
Clearance for InQu II-55 RTI Signs Supply Contract with Stryker II-55 RTI Signs
a 10-Year Supply Agreement with Zimmer Holdings II-55 Medtronic Sofamor Danek
Receives FDA Approval for INFUSE II-55 Smith and Nephew Acquires Plus
Orthopedics II-56 Medtronic Signs Development Agreement with OsteoGenix II-56
NuVasive Buys Technology from Radius Medical II-56 AlloSource Join Hands with
Osiris II-56 Orthofix International Takes Over Blackstone Medical, Inc. II-56
Vertebron Enters into a Distribution Agreement with medArtis II-56 Exactech Gets
FDA Approval for New Optecure Formulation II-56 Osteotech and Premier Enter Into
an Agreement II-57 RTI Signs Production Agreement with Blackstone II-57 Wright
Medical's ALLOMATRIX Receives FDA Clearance II-57 ApaTech Opens New Facility and
Global Headquarters II-57 Smith & Nephew Takes Over Osteo Biologics Inc. II-57
CeraPedics LLC Partners with BioD LLC II-57 Aastrom Biosciences Join Hands with
Orthovita II-58 IsoTis Signs Agreement with Alphatec Holdings II-58 Osteo
Biologics, Inc. Partners with Alphatec Spine II-58 Pioneer Surgical Signs Supply
Agreement with Regeneration Technologies II-58 Aap Implantate Acquires FAME
Medical II-58 PrimeCell Therapeutics Collaborates with Regeneration Technologies
II-58 Medtronic Obtains Australian Nod for Spinal Fusion Device II-58 Biomet
Obtains FDA Approval for Regenerex Acetabular System Consent II-59 IsoTis Bags
FDA Clearance for Orthoblast II and Accell Connexus II-59 Orthofix Signs
Distribution Contract with Berkeley Advanced Biomaterials II-59 Kensey Nash and
Orthovita Enter Into Agreement II-59 Aap Implantate Acquires Osartis and
Majority Stakes in ADC II-59 Alphatec Spine Takes Over Cortek II-59 IsoTis and
PLUS Orthopedics Enter Into Distribution Agreement II-59 OsteoBiologics Inks
Distribution Agreement with ConMed Linvatec II-60 Biomet Granted Approval for
Ceramic-On-Ceramic Hip System II-60 IsoTis Granted 510(k) Clearance for
DynaGraft II II-60 Ceramisys Obtains EU Approval for Bone Graft Substitutes
II-60 Biomet Inc Acquires Interpore International II-60 Ascension Orthopedics
Signs Supply Agreement with Curasan AG II-60 Blackstone Pens a Supply Contract
with Berkeley II-60 ApaTech's Pore-Si Bone Graft Gains Approval from FDA II-61
Wright Medical Bags FDA Approval for ALLOMATRIX Products II-61 FDA Offers
Clearance to Medtronic's Infuse Bone Graft II-61 DePuy Acquires Orquest's Assets
II-61

7. Focus on Select Players II-62 AlloSource (USA) II-62 Biomet Inc (USA) II-62
Interpore Cross International (USA) II-62 BioMimetic Therapeutics Inc (USA)
II-63 DePuy Spine Inc (USA) II-63 Exactech Inc (USA) II-63 Integra LifeSciences
Holdings Corporation (USA) II-63 Integra OrthoBiologics (USA) II-64 Lifelink
Tissue Bank (USA) II-64 LifeNet Health (USA) II-64 Medtronic Inc (USA) II-64
Medtronic Sofamor Danek Inc (USA) II-65 Musculoskeletal Transplant Foundation
(USA) II-65 NovaBone Products LLC (USA) II-65 NuVasive Inc (USA) II-65 Orthovita
Inc (USA) II-65 Osiris Therapeutics Inc (USA) II-66 Osteotech Inc (USA) II-66
RTI Biologics, Inc. (USA) II-66 Smith & Nephew Plc (UK) II-67 Stryker
Corporation (USA) II-67 Synthes Inc (USA) II-67 Wright Medical Technology, Inc
(USA) II-67 Zimmer Holdings, Inc (USA) II-68

8. Market Perspective II-69 By Product II-69

Table 29: US Recent Past, Current & Future Analysis for Bone Grafts by Product
Segment - Standard Allografts, Machined Bone Allografts, Demineralized Bone
Matrix (DBM), Bone Morphogenetic Protein (BMP), Platelet Concentrators, and
Synthetic Bone Grafts Markets Independently Analyzed with Annual Sales Figures
in US$ Million for Years 2006 through 2015 (includes corresponding Graph/Chart)
II-69

Table 30: US Historic Review for Bone Grafts by Product Segment - Standard
Allografts, Machined Bone Allografts, Demineralized Bone Matrix (DBM), Bone
Morphogenetic Protein (BMP), Platelet Concentrators, and Synthetic Bone Grafts
Markets Independently Analyzed with Annual Sales Figures in US$ Million for
Years 2000 through 2005 (includes corresponding Graph/Chart) II-70

Table 31: US 10-Year Perspective for Bone Grafts by Product Segment - Percentage
Breakdown of Dollar Sales for Standard Allografts, Machined Bone Allografts,
Demineralized Bone Matrix (DBM), Bone Morphogenetic Protein (BMP), Platelet
Concentrators, and Synthetic Bone Grafts for Years 2006, 2009 & 2015 (includes
corresponding Graph/Chart) II-71 By Application II-72

Table 32: US Recent Past, Current & Future Analysis for Bone Grafts by End-Use
Application - Spinal Procedures, and Trauma & Reconstruction Procedures
Independently Analyzed with Annual Sales Figures in US$ Million for Years 2006
through 2015 (includes corresponding Graph/Chart) II-72

Table 33: US Historic Review for Bone Grafts by End-Use Application - Spinal
Procedures, and Trauma & Reconstruction Procedures Independently Analyzed with
Annual Sales Figures in US$ Million for Years 2000 through 2005 (includes
corresponding Graph/Chart) II-72

Table 34: US 10-Year Perspective for Bone Grafts by End-Use Application -
Percentage Breakdown of Dollar Sales for Spinal Procedures, and Trauma &
Reconstruction Procedures for Years 2006, 2009 & 2015 II-73

III. COMPETITIVE LANDSCAPE

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