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B. Braun Melsungen AG (Aesculap)
Biomet, Inc. (EBI)
Biorthex, Inc.
Centerpulse AG (Spine-Tech)
Endius, Inc.
GenSci Regeneration Sciences, Inc.
Interpore Cross International, Inc.
Johnson & Johnson (DePuy AcroMed)
MacroPore Biosurgery, Inc.
Masor Robotics, Ltd.
Medtronic, Inc. (Sofamor Danek)
Mekanika, Inc.
Orquest, Inc.
Orthofix International NV
OrthoLogic Corporation
Orthovita, Inc.
Osteotech, Inc.
Regeneration Technologies, Inc.
Scient'x SA
Spinal Concepts, Inc.
Stryker Corporation (Howmedica Osteonics, Surgical Dynamics)
Synthes-Stratec, Inc.
Wright Medical Group, Inc.
Z-KAT, Inc.
EXECUTIVE SUMMARY
Trends in Spinal Fusions
Spinal Instrumentation
Interbody Fusion Products
Minimally Invasive Spine Surgery Devices
Bone Graft Substitutes and Growth Factors
Spinal Bone Growth Stimulators
Spinal Navigation and Robotic Systems
Companies
Summary Exhibit 1: Spinal Fusion Products Market, 2001-2008
Summary Exhibit 2: Distribution of Major Surgeries for Degenerative Disc Disease, Procedure Forecast, 2001-2008
Summary Exhibit 3: Traditional Spine Instrumentation, Market Forecast, 2001-2008
Summary Exhibit 4: Interbody Fusion Products, Procedures and Market Forecast, 2001-2008
Summary Exhibit 5: Minimally Invasive Spine Surgery Devices, Market Forecast, 2001-2008
Summary Exhibit 6: Bone Graft Substitutes and Growth Factors/Stem Cells, Market Forecast, 2001-2008
Summary Exhibit 7: Spinal Bone Growth Stimulation, Market Forecast, 2001-2008
Summary Exhibit 8: Spinal Navigation and Robotic Systems, Market Forecast, 2001-2008
Summary Exhibit 9: Core Spinal Fusion Products Market, Supplier Shares, 2002
1.0 OVERVIEW OF SPINAL DISORDERS
1.1 Anatomy of the Human Spine
1.1.1 Bone Physiology and Remodeling
1.1.2 Vertebrae
1.1.3 Intervertebral Discs
1.1.4 Spinal Cord
1.2 Spinal Conditions
1.2.1 Degenerative Disorders
1.2.1.1 Degenerative Disc Disease
1.2.1.1.1 Prevalence
1.2.1.1.2 Symptoms and Diagnosis
1.2.1.1.3 Treatment
1.2.1.2 Herniated Disc
1.2.1.2.1 Types
1.2.1.2.2 Symptoms and Diagnosis
1.2.1.2.3 Prevalence
1.2.1.2.4 Treatment
1.2.1.3 Spinal Stenosis
1.2.1.3.1 Symptoms and Diagnosis
1.2.1.3.2 Treatment
1.2.1.4 Spondylosis
1.2.1.4.1 Prevalence
1.2.1.4.2 Symptoms and Diagnosis
1.2.1.4.3 Treatment
1.2.1.5 Spondylolisthesis
1.2.1.5.1 Prevalence
1.2.1.5.2 Types
1.2.1.5.3 Diagnosis
1.2.1.5.4 Treatment
1.2.1.6 Osteoporosis
1.2.1.6.1 Prevalence
1.2.1.6.2 Types
1.2.1.6.3 Risk Factors
1.2.1.6.4 Diagnosis
1.2.1.6.5 Treatment
1.2.1.7 Osteoarthritis
1.2.1.7.1 Prevalence
1.2.1.7.2 Risk Factors
1.2.1.7.3 Diagnosis
1.2.1.7.4 Treatment
1.2.1.8 Rheumatoid Arthritis
1.2.2 Spinal Trauma
1.2.2.1 Cervical, Thoracic and Lumbar Trauma
1.2.2.2 Spinal Cord Trauma
1.2.3 Deformity Disorders
1.2.3.1 Scoliosis
1.2.3.1.1 Symptoms
1.2.3.1.2 Diagnosis
1.2.3.1.3 Treatment
1.2.3.2 Kyphosis
1.2.3.2.1 Symptoms
1.2.3.2.2 Diagnosis
1.2.3.2.3 Treatment
1.2.3.3 Lordosis
1.2.4 Spinal Tumors
1.2.4.1 Malignant Spinal Tumors
1.2.4.2 Spinal Hemangiomas
Exhibit 1-1: Structure of the Vertebrae
Exhibit 1-2: The Spine
Exhibit 1-3: Prolapsed Intervertebral Disc
Exhibit 1-4: Overview of Spine Conditions
Exhibit 1-5: Types of Spondylolisthesis
Exhibit 1-6: Overview of Osteoporosis
Exhibit 1-7: Comparison of Osteoarthritis and Rheumatoid Arthritis
Exhibit 1-8: Spinal Trauma
Exhibit 1-9: Comparison of Spinal Deformity Disorders
2.0 SPINAL STABILIZATION AND FUSION OVERVIEW
2.1 Clinical Goals and Outcomes
2.1.1 Failure of Fusion
2.1.2 Failure of Pain Relief
2.2 Classification of Spinal Fusions
2.2.1 Spine Segments Fused
2.2.2 Levels Fused
2.2.3 Use of Instrumentation and Cages
2.2.4 Surgical Approaches
2.2.5 Access Method
2.3 Specialists Performing Spine Surgery
2.4 Spinal Fusions versus Prosthetic Discs
2.5 Spinal Fusions by Segment and Instrumentation
2.5.1 Cervical Spine
2.5.1.1 Surgical Approaches to Cervical Spine
2.5.1.1.1 Anterior Cervical Plating
2.4.1.1.2 Posterior Approach
2.5.1.1.3 Posterolateral Approach
2.5.1.1.4 360o Circumferential Approach
2.5.1.2 Cervical Instrumentation
2.5.1.3 Procedures
2.5.2 Thoracolumbar Spine
2.5.2.1 Surgical Approaches to Thoracolumbar Spine
2.5.2.1.1 Anterior Approach
2.5.2.1.2 Posterior Approach
2.5.2.2 Thoracolumbar Instrumentation
2.5.2.2.1 Anterior Instrumentation
2.5.2.2.2 Posterior Instrumentation
2.5.2.3 Procedure Forecast
2.5.2.3.1 Thoracic Fusions
2.5.2.3.2 Lumbar Fusions
2.6 Spinal Fusions by Major Approach
Exhibit 2-1: Methods of Categorizing Spinal Fusion Procedures
Exhibit 2-2: Surgical Approaches for Spinal Fusion
Exhibit 2-3: Distribution of Major Surgeries for Degenerative Disc Disease, 2001-2008
Exhibit 2-4: Spinal Fusions by Segment and Type, Procedure Forecast, 2001-2008
Exhibit 2-5: Instrumented Fusions by Segment, 2001-2008
Exhibit 2-6: Cervical Fusions, Procedure Forecast by Instrumentation, 2001-2008
Exhibit 2-7: Cervical Fusions by Level Fused, 2002, 2005 and 2008
Exhibit 2-8: Thoracic Fusions, Procedure Forecast by Instrumentation, 2001-2008
Exhibit 2-9: Thoracic Fusions by Level Fused, 2002, 2005 and 2008
Exhibit 2-10: Lumbar Fusions, Procedure Forecast by Instrumentation, 2001-2008
Exhibit 2-11: Lumbar Fusions by Level Fused, 2002, 2005 and 2008
Exhibit 2-12: Spinal Fusions by Major Segment and Approach, 2001-2008
3.0 TRADITIONAL INSTRUMENTATION SYSTEMS
3.1 Product Configurations
3.1.1 Hook/Screw and Rod Systems
3.1.2 Plate Systems
3.1.3 Wires and Clamps
3.2 Products by Regulatory Category
3.3 Products and Suppliers by Segment
3.3.1 Thoracolumbar Instrumentation
3.3.1.1 A-Spine
3.3.1.2 Biomet/EBI Medical
3.3.1.3 Centerpulse Spine-Tech
3.3.1.4 Depuy AcroMed
3.3.1.5 Interpore Cross International
3.3.1.6 Medtronic Sofamor Danek
3.3.1.6.1 Texas Scottish Rite Hospital Spinal System (TSRH)
3.3.1.6.2 Cotrel-Dubousset Horizon Spinal System
3.3.1.6.3 New Products
3.3.1.7 Osteotech
3.3.1.8 Scient'x USA/Encore Medical
3.3.1.9 Spinal Concepts
3.3.1.10 Stryker Spine/Surgical Dynamics
3.3.1.10.1 Stryker Spine
3.3.1.10.2 Surgical Dynamics
3.3.1.11 Synthes USA
3.3.2 Cervical Instrumentation
3.3.2.1 B. Braun Aesculap
3.3.2.2 Biomet/EBI Medical
3.3.2.3 Centerpulse Spine-Tech
3.3.2.4 Depuy AcroMed
3.3.2.5 Interpore Cross International
3.3.2.6 Medtronic Sofamor Danek
3.3.2.7 Scient'x
3.3.2.8 Spinal Concepts
3.3.2.9 Stryker Spine/SDI
3.3.2.10 Synthes USA
3.3.3 Product Trends
3.4 Regulatory Issues
3.5 Reimbursement
3.6 Market Analysis
3.6.1 Cervical Instrumentation Systems
3.6.2 Thoracic Instrumentation Systems
3.6.3 Lumbar Instrumentation
3.6.4 Supplier Shares
Exhibit 3-1: Traditional Instrumentation Product Configurations
Exhibit 3-2: Traditional Spinal Instrumentation by Regulatory Classification
Exhibit 3-3: Selected Thoracolumbar Spine Systems, 2003
Exhibit 3-4: Selected Thoracolumbar Instrumentation Systems
Exhibit 3-5: Selected Cervical Spine Systems, 2002
Exhibit 3-6: Selected Cervical Instrumentation Systems
Exhibit 3-7: Selected CPT Codes for Spinal Instrumentation
Exhibit 3-8: Traditional Spine Instrumentation, Market Forecast, 2001-2008
Exhibit 3-9: Traditional Cervical Instrumentation, Market Forecast, 2001-2008
Exhibit 3-10: Traditional Thoracic Instrumentation, Market Forecast, 2001-2008
Exhibit 3-11: Traditional Lumbar Instrumentation, Market Forecast, 2001-2008
Exhibit 3-12: Traditional Instrumentation, Supplier Shares, 2002
4.0 INTERBODY FUSION DEVICES
4.1 Performance Criteria and Goals
4.2 Materials
4.2.1 Metal
4.2.2 Carbon Fiber
4.2.3 PEEK
4.2.4 Bioabsorbable Polymers
4.3 Cage Designs
4.3.1 Cylindrical Cages
4.3.2 Rectangular Cages
4.4 Implantation Technique
4.4.1 Anterior Lumbar Interbody Fusion
4.4.2 Posterior Lumbar Interbody Fusion
4.4.3 Transforaminal Lumbar Interbody Fusion
4.5 Failure of Interbody Fusion Devices
4.6 Regulatory Product Classifications
4.6.1 Traditional Interbody Fusion Devices
4.6.2 Off-Label Devices
4.7 Products and Suppliers
4.7.1 Advanced Spine Fixation Systems/OTI
4.7.2 Aesculap (B. Braun)
4.7.2.1 ProSpace
4.7.2.2 CeSpace
4.7.2.3 Other Products
4.7.3 Biomet EBI
4.7.4 Biorthex
4.7.5 Centerpulse Spine-Tech
4.7.5.1 BAK Interbody Fusion System (BAK/L)
4.7.5.2 BAK/Proximity (BP Cage)
4.7.5.3 BAK/C
4.7.5.4 Other Products
4.7.6 Cortek
4.7.7 DePuy AcroMed
4.7.7.1 Lumbar I/F
4.7.7.2 Cervical I/F
4.7.8 GM Reis
4.7.9 Implex
4.7.10 Medtronic Sofamor Danek
4.7.10.1 Inter Fix
4.7.10.1.1 Inter Fix RP
4.7.10.1.2 Inter Fix C
4.7.10.1.3 LT-Cage
4.7.10.2 Affinity
4.7.10.3 Cement Restrictors
4.7.11 Ortho Development
4.7.12 Scient'x
4.7.12.1 CC Cage
4.7.12.2 KLA Cage
4.7.12.3 Samarys
4.7.13 Signus Medical
4.7.13.1 Rabea
4.7.13.2 Tetris
4.7.14 Spinal Concepts
4.7.14.1 InFix
4.7.14.2 Coda
4.7.14.3 Cement Restrictors
4.7.15 Spineology
4.7.16 Surgical Dynamics (Stryker)
4.7.17 Surgicraft
4.7.17.1 Hartshill Horseshoe
4.7.17.2 STALIF
4.7.18 Synthes Spine
4.7.18.1 SynCage
4.7.18.2 Contact Fusion Cage
4.7.18.3 Titanium Interbody Spacer
4.7.19 U&I
4.8 Procedure Forecast
4.9 Market Analysis
4.10 Supplier Shares
Exhibit 4-1: Comparison of Materials Used for Interbody Fusion Devices
Exhibit 4-2: Interbody Fusion Device Designs
Exhibit 4-3: Approaches and Techniques Used for Lumbar Interbody Fusion Devices
Exhibit 4-4: Reasons for Failure of Interbody Fusion Device Procedures
Exhibit 4-5: Selected Interbody Fusion Devices, 2003
Exhibit 4-6: The VariLift Expandable Fusion System
Exhibit 4-7: Aesculap Interbody Fusion Devices
Exhibit 4-8: Biomet EBI Interbody Fusion Devices
Exhibit 4-9: Biorthex Interbody Fusion Devices
Exhibit 4-10: Centerpulse Spine-Tech's BAK Interbody Fusion Devices
Exhibit 4-11: Cortek's PolyLok Lumbar Interbody Fusion Device
Exhibit 4-12: DePuy AcroMed Interbody Fusion Devices
Exhibit 4-13: GM Reis Interbody Fusion Devices
Exhibit 4-14: Medtronic Sofamor Danek Interbody Fusion Devices
Exhibit 4-15: The IBS Interbody Spacer
Exhibit 4-16: Scient'x Interbody Fusion Devices
Exhibit 4-17: Signus Medical Interbody Fusion Devices
Exhibit 4-18: Spinal Concepts’ Interbody Fusion Devices
Exhibit 4-19: Surgical Dynamics Ray TFC Devices
Exhibit 4-20: Surgicraft Interbody Fusion Devices
Exhibit 4-21: Synthes-Stratec Interbody Fusion Devices
Exhibit 4-22: The NeoIC Cage
Exhibit 4-23: Spinal Fusions Using IBFDs, Procedure Forecast, 2001-2008
Exhibit 4-24: Interbody Fusion Devices, Market Forecast, 2001-2008
Exhibit 4-25: Interbody Fusion Devices, Supplier Shares, 2002
5.0 ALLOGRAFT IMPLANTS
5.1 Benefits and Limitations
5.2 Regulation
5.3 Materials Supply
5.4 Clinical Experience
5.5 Implantation
5.6 Products and Suppliers
5.6.1 B.Braun Aesculap
5.6.2 Biomet EBI
5.6.3 Centerpulse Spine-Tech/Tutogen Medical
5.6.4 Cortek
5.6.5 DePuy AcroMed
5.6.6 Endius
5.6.7 Medtronic Sofamor Danek/Regeneration Technologies
5.6.8 MTF/Synthes USA
5.6.8.1 FRA Spacer
5.6.8.2 PLIF Spacer
5.6.8.3 ACF Spacer
5.6.8.4 Other Products
5.6.8.5 Clinical Experience
5.6.9 NuVasive
5.6.10 Orthovita
5.6.11 Osteotech Inc.
5.6.11.1 Lumbar Implants
5.6.11.2 Cervical Implants
5.7 Procedures
5.8 Market Analysis
5.9 Supplier Shares
Exhibit 5-1: Selected Bone Supply and Processing Agreements
Exhibit 5-2: Selected Allograft Implant Products, 2003
Exhibit 5-3: Cortek Spinal Allograft Implants
Exhibit 5-4: DePuy AcroMed Spinal Allograft Implants
Exhibit 5-5: Medtronic Sofamor Danek/RTI Allograft Implants
Exhibit 5-6: Musculoskeletal Tissue Foundation Allograft Implants
Exhibit 5-7: Orthovita's RHAKOSS Spinal Implants
Exhibit 5-8: Osteotech's Graftech Allograft Implants
Exhibit 5-9: Spinal Fusions Using Allograft Implants, Procedure Forecast, 2001-2008
Exhibit 5-10: Spinal Allograft Implants, Market Forecast, 2001-2008
Exhibit 5-11: Allograft Implants, Supplier Shares, 2002
6.0 BIOABSORBABLE SPINAL IMPLANTS
6.1 Clinical Rationale
6.2 Polymer Materials
6.2.1 Polymer Chemistry
6.2.2 Degradation Profile
6.2.3 Biocompatibility
6.2.4 Packaging
6.2.5 Sterilization
6.3 Clinical Applications and Products
6.3.1 Iliac Reconstruction
6.3.1.1 Protective Bioabsorbable Sheeting
6.3.1.2 Clinical Experience
6.3.2 Anterior Cervical Plating
6.3.2.1 Products
6.3.2.2 Clinical Experience
6.3.3 Interbody Fusion Devices
6.3.3.1 Cambridge Scientific
6.3.3.2 MacroPore Biosurgery
6.3.3.3 Stryker Howmedica Osteonics
6.3.4 Posterolateral Graft Containment
6.3.5 Post-Surgical Adhesion Barriers
6.4 Market Analysis
Exhibit 6-1: Design Criteria for Medical Biodegradable Polymers
Exhibit 6-2: Polymer Degradation Cascade
Exhibit 6-3: Factors Influencing Polymer Degradation
Exhibit 6-4: Emerging Spinal Applications for Bioabsorbable Implants
Exhibit 6-5: Selected Bioabsorbable Interbody Fusion Development Programs, 2003
7.0 MINIMALLY INVASIVE SPINAL FUSION
7.1 Laparoscopic Anterior Spinal Fusion
7.1.1 Procedure
7.1.2 Advantages and Limitations
7.1.3 Products
7.1.4 Clinical Experience
7.2 Percutaneous Spinal Fusion
7.2.1 Procedure
7.2.2 Advantages and Limitations
7.2.3 Products
7.2.3.1 GM Reis
7.2.3.2 Medtronic Sofamor Danek
7.2.3.2.1 Components and Implantation
7.2.3.2.2 Clinical Experience
7.2.3.2.3 Product Pricing and Marketing
7.2.3.3 NuVasive
7.2.3.4 Spinal Concepts
7.3 Port-Access Spinal Fusion
7.3.1 Procedure
7.3.2 Advantages and Limitations
7.3.3 Products
7.3.3.1 Biomet EBI
7.3.3.2 DePuy AcroMed
7.3.3.3 Endius
7.3.3.3.1 Atavi System
7.3.3.3.2 Instrumentation
7.3.3.3.3 MiCOR Precision Bone Allograft and MiLIF
7.3.3.3.4 Regulatory
7.3.3.3.5 Product Costs vs. Reimbursement
7.3.3.3.6 Procedures
7.3.3.3.7 Clinical Experience
7.3.3.3.8 Surgeon Training
7.3.3.4 Medtronic Sofamor Danek
7.3.3.4.1 METRx Access System
7.3.3.4.2 CD Horizon Eclipse
7.3.3.5 Spinal Concepts
7.4 Procedure Forecast
7.5 Market Forecasts
7.5.1 Percutaneous Systems
7.5.2 Port Access Systems
7.6 Supplier Shares
Exhibit 7-1: Minimally Invasive Approaches for Spinal Fusion Surgery
Exhibit 7-2: Selected Percutaneous Implantation Systems and Instrumentation, 2003
Exhibit 7-3: GM Reis EndoPedimax System
Exhibit 7-4: Medtronic Sofamor Danek Sextant System
Exhibit 7-5: NuVasive SpineArc System and Triad Facet Screws
Exhibit 7-6: Endius' Atavi System
Exhibit 7-7: Endius' TriFix System
Exhibit 7-8: TiTLE Instrumentation System
Exhibit 7-9: Comparison of Endoscopic and Open Single-Level Lumbar Fusion
Exhibit 7-10: METRx System Access
Exhibit 7-11: Visualization Options for METRx System
Exhibit 7-12: Spinal Concepts' Access Dilatation Port
Exhibit 7-13: MI Spinal Fusion, Procedure Forecast by Type, 2001-2008
Exhibit 7-14: MI Spine Surgery Products, Market Forecast, 2001-2008
Exhibit 7-15: Percutaneous Fusion Devices, Market Forecast, 2001-2008
Exhibit 7-16: Port-Access Devices, Market Forecast by Type, 2001-2008
Exhibit 7-17: Minimally Invasive Spinal Fusion Products, Supplier Shares, 2002
8.0 BONE GRAFT SUBSTITUTES AND GROWTH FACTORS
8.1 Background on Bone Formation and Repair
8.1.1 Goals of Bone Grafting
8.1.2 Bone Graft Performance Properties
8.2 Bone Graft Substitutes
8.2.1 Types of Bone Graft Materials
8.2.1.1 Autograft
8.2.1.2 Base Allograft
8.2.1.3 Demineralized Bone Matrix
8.2.1.4 Ceramic and Synthetic Bone Graft Substitutes
8.2.1.5 Xenograft
8.2.2 Applications
8.2.3 Regulatory Issues
8.2.4 Products and Suppliers
8.2.4.1 Berkeley Advanced Biomaterials
8.2.4.2 Biocomposites Ltd.
8.2.4.3 Biomet/EBI
8.2.4.4 Cambridge Scientific
8.2.4.5 DePuy AcroMed
8.2.4.6 GenSci Regeneration Sciences
8.2.4.6.1 DynaGraft DBM
8.2.4.6.2 DynaGraft II
8.2.4.6.3 Accell DBM 100
8.2.4.7 Interpore Cross International
8.2.4.7.1 Pro Osteon
8.2.4.7.2 InterGro DBM
8.2 4.8 Millenium Biologix
8.2.4.9 Musculoskeletal Transplant Foundation/Synthes
8.2.4.10 NeuColl/Zimmer
8.2.4.11 NovaBone Products, LLC
8.2.4.12 Orquest
8.2.4.13 Orthovita
8.2.4.14 Osteotech
8.2.4.15 Regeneration Technologies/Medtronic Sofamor Danek
8.2.4.16 Synthes USA
8.2.4.17 Wright Medical Technology
8.2.4.17.1 OsteoSet
8.2.4.17.2 WMT-TCP
8.2.4.17.3 AlloMatrix
8.2.5 Procedure Forecasts
8.2.6 Market Analysis
8.2.7 Supplier Shares
8.3 Bone Growth Factors
8.3.1 Background
8.3.2 Product Components
8.3.3 Platelet-Derived Growth Factors
8.3.3.1 Interpore Cross International
8.3.3.1.1 AGF Features
8.3.3.1.2 Access System
8.3.3.1.3 Clinical Experience
8.3.3.2 Harvest Technologies/DePuy AcroMed
8.3.3.2.1 Procedure
8.3.3.2.2 Products
8.3.3.2.3 Advantages and Limitations
8.3.3.2.4 Clinical Experience
8.3.3.2.5 Distribution
8.3.4 Bone Morphogenetic Proteins and Stem Cell Technologies
8.3.4.1 Medtronic Sofamor Danek/Genetics Institute
8.3.4.1.1 InFUSE Features
8.3.4.1.2 Clinical Experience
8.3.4.1.3 Regulatory and Reimbursement
8.3.4.1.4 Alternative Carriers
8.3.4.2 Stryker Corporation/Curis
8.3.4.2.1 OP-1 Implant
8.3.4.2.2 Clinical Experience
8.3.4.2.3 Regulatory Status
8.3.4.2.4 Product Rights
8.3.4.3 DePuy Acromed/Orquest/Biopharm
8.3.4.3.1 Biopharm Agreement
8.3.4.3.2 Orquest Acquisition
8.3.4.3.3 CELLECT System
8.3.5 Local Gene Therapy
8.3.5.1 Medtronic Sofamor Danek
8.3.5.2 Selective Genetics
8.3.5.3 Smaller Gene Therapy Programs
8.3.5.3.1 OrthoLogic/Chrysalis BioTechnology
8.3.5.3.2 Osiris Therapeutics
8.3.5.3.3 CenterPulse Biologics
8.3.5.3.4 Millenium Biologix
8.3.6 Procedure Forecast
8.3.7 Market Analysis
8.3.8 Supplier Shares
Exhibit 8-1: Bone Repair Process
Exhibit 8-2: Design Criteria for "Ideal" Bone Graft Product
Exhibit 8-3: Types and Features of Bone Graft Materials
Exhibit 8-4: Selected Demineralized Bone Matrix Products, 2003
Exhibit 8-5: Selected Synthetic Bone Substitutes, 2003
Exhibit 8-6: Bone Graft Substitutes, Procedure Forecast, 2001-2008
Exhibit 8-7: Standard Bone Graft Substitutes, Market Forecast, 2001-2008
Exhibit 8-8: Base Allograft, Supplier Shares, 2002
Exhibit 8-9: Demineralized Bone Matrix, Supplier Shares, 2002
Exhibit 8-10: Synthetic Bone Substitutes, Supplier Shares, 2002
Exhibit 8-11: Selected Bone Growth Factor Programs, 2003
Exhibit 8-12: Harvest Technologies' SmartPReP Platelet Concentration System
Exhibit 8-13: Symphony Graft Delivery System
Exhibit 8-14: Advantages and Limitations of InFUSE (rhBMP-2)
Exhibit 8-15: Iliac Crest Graft Site Pain and Appearance Data
Exhibit 8-16: Bone Growth Factors and Stem Cells, Procedure Forecast, 2001-2008
Exhibit 8-17: Bone Growth Factors and Stem Cells, Market Forecast, 2001-2008
Exhibit 8-18: Bone Growth Factor Technologies, Supplier Shares, 2002
9.0 SPINAL BONE GROWTH STIMULATORS
9.1 Physiology of Fracture Healing
9.2 Technology
9.2.1 Electrical Bone Growth Stimulators
9.2.1.1 Direct Current
9.2.1.2 Capacitive Coupling
9.2.1.3 Pulsed Electromagnetic Field
9.2.1.4 Combined Magnetic Field
9.2.2 Ultrasound Bone Growth Stimulators
9.3 Spinal Applications
9.4 Impact of Graft Substitutes and Growth Factors
9.5 Products
9.5.1 Biomet/EBI
9.5.2 Orthofix
9.5.3 Orthologic
9.5.4 Smith & Nephew/Exogen
9.6 Potential Osteoporosis Application
9.6.1 Exogen
9.6.2 Orthofix
9.7 Clinical Experience
9.7.1 Clinical History
9.7.2 Ancillary Studies
9.8 Patient Forecast
9.9 Market Analysis
9.10 Supplier Shares
Exhibit 9-1: Types of Bone Growth Stimulation Devices
Exhibit 9-2: Selected Spinal Bone Growth Stimulators, 2003
Exhibit 9-3: Biomet/EBI SpF Plus System
Exhibit 9-4: Biomet/EBI SpinalPak System
Exhibit 9-5: Orthofix Spinal-Stim Lite System
Exhibit 9-6: OrthoLogic SpinaLogic System
Exhibit 9-7: Spinal Bone Growth Stimulation, Market Drivers and Limiters
Exhibit 9-8: Spinal Bone Growth Stimulation, Patient Forecast, 2001-2008
Exhibit 9-9: Spinal Bone Growth Stimulators, Market Forecast, 2001-2008
Exhibit 9-10: Spinal Bone Growth Stimulators, Supplier Shares, 2002
10.0 ADJUNCTIVE SPINAL TECHNOLOGIES
10.1 Spinal Navigation Systems
10.1.1 Basic System Features and Capabilities
10.1.2 Product Trends
10.1.3 Products
10.1.3.1 BrainLAB
10.1.3.2 CBYON
10.1.3.3 GE Medical Systems
10.1.3.4 Medivision (Synthes-Stratec)
10.1.3.5 Medtronic Surgical Navigation Technologies
10.1.3.5.1 StealthStation
10.1.3.5.2 FluoroNav
10.1.3.6 Odin Medical
10.1.3.7 ORTHOsoft
10.1.3.8 Radionics
10.1.3.9 Stryker
10.1.3.10 Z-Kat
10.2 Robotic Systems
10.2.1 Types of Robotic Systems
10.2.2 Applications in Spine Surgery
10.2.3 Regulatory Issues
10.2.4 Benefits and Reimbursement
10.2.5 Products
10.2.5.1 Accuray
10.2.5.2 The Acrobot Company Ltd.
10.2.5.3 Armstrong Healthcare Ltd
10.2.5.4 Computer Motion
10.2.5.5 Integrated Surgical Systems
10.2.5.6 Intuitive Surgical
10.2.5.7 Masor Robotics
10.2.5.8 MicroDexterity Systems
10.2.5.8.1 Components
10.2.5.8.2 NeuroDex and MicroDex
10.2.5.9 Universal Robot Systems Ortho
10.2.5.10 Z-KAT
10.3 Installations
10.3.1 Spinal Navigation Systems
10.3.2 Spinal Robotic Systems
10.4 Market Forecasts
10.5 Supplier Shares
Exhibit 10-1: Major Trends in Spinal Navigation Technologies
Exhibit 10-2: Selected Spinal Surgical Navigation Systems, 2003
Exhibit 10-3: BrainLab VectorVision
Exhibit 10-4: Pedicle Screw Placement Using CBYON Suite
Exhibit 10-5: GE Medical Systems InstraTrak 3500 Spine
Exhibit 10-6: Medtronic StealthStation
Exhibit 10-7: Medtronic FluoroNav in Operating Room
Exhibit 10-8: Odin Medical Technologies' PoleStar N-10
Exhibit 10-9: ORTHOsoft Navitrack System
Exhibit 10-10: Radionics’ Calyx Module and Optical Tracking System
Exhibit 10-11: Stryker Leibinger Surgical Navigation System
Exhibit 10-12: Z-KAT Voyager and FluoroLab Systems
Exhibit 10-13: Types of Surgical Robotics
Exhibit 10-14: Current & Emerging Applications for Robotics in Spine Surgery
Exhibit 10-15: Selected Spinal Robotics Systems, 2003
Exhibit 10-16: Accuray CyberKnife System
Exhibit 10-17: Basic Acrobot System
Exhibit 10-18: Armstrong Healthcare PathFinder Robot
Exhibit 10-19: Computer Motion ZEUS Robotic Surgical System
Exhibit 10-20: Intuitive Surgical daVinci System
Exhibit 10-21: Masor Robotics Micro Robotic System
Exhibit 10-22: Microdexterity RAMS Schematic and MicroDex Prototype
Exhibit 10-23: Universal Robot Systems' Evolution 1
Exhibit 10-24: Z-KAT/Barrett Technology WAM Robotic Arm
Exhibit 10-25: Estimated Installed Base of Spinal Surgical Navigation Systems, 2002
Exhibit 10-26: Spinal Navigation Systems, Installations and Sales, 2001-2008
Exhibit 10-27: Spinal Robotic Systems, Installations & Placements, 2004-2008
Exhibit 10-28: Surgical Spine Navigation Systems, Market Forecast, 2001-2008
Exhibit 10-29: Spinal Robotic Systems, Market Forecast, 2004-2008
Exhibit 10-30: Spinal Navigation Systems, Supplier Shares, 2002
11.0 COMPANY PROFILES
11.1 B. Braun Melsungen AG (Aesculap)
11.2 Biomet, Inc. (EBI)
11.3 Biorthex, Inc.
11.4 Centerpulse AG (Spine-Tech)
11.5 Endius, Inc.
11.6 GenSci Regeneration Sciences, Inc.
11.7 Interpore Cross International, Inc.
11.8 Johnson & Johnson (DePuy AcroMed)
11.9 MacroPore Biosurgery, Inc.
11.10 Masor Robotics, Ltd.
11.11 Medtronic, Inc. (Sofamor Danek)
11.12 Mekanika, Inc.
11.13 Orquest, Inc.
11.14 Orthofix International NV
11.15 OrthoLogic Corporation
11.16 Orthovita, Inc.
11.17 Osteotech, Inc.
11.18 Regeneration Technologies, Inc.
11.19 Scient'x SA
11.20 Spinal Concepts, Inc.
11.21 Stryker Corporation (Howmedica Osteonics, Surgical Dynamics)
11.22 Synthes-Stratec, Inc.
11.23 Wright Medical Group, Inc.
11.24 Z-KAT, Inc.
APPENDIX: COMPANY LIST