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Opportunities in U.S. Spinal Fusion Markets

621 Pages | 158 Exhibits | Forecasts Through 2008
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Table of Contents

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

 

Companies Covered

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.