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ArthroCare Corporation
Biorthex, Inc.
Centerpulse AG (Spine-Tech)
Clarus Medical, LLC
Endius, Inc.
Interpore Cross International, Inc.
Johnson & Johnson (Codman & Shurtleff, DePuy AcroMed)
Kyphon, Inc
Link Spine Group, Inc
Medtronic, Inc. (Sofamor Danek)
Mekanika, Inc.
Orthovita, Inc.
Osteotech, Inc.
Parallax Medical, Inc.
Raymedica, Inc.
Smith & Nephew, plc
Spine Solutions, Inc.
Spine Wave, Inc.
St. Francis Medical Technologies, Inc
Stryker Corporation (Howmedica Osteonics, Surgical Dynamics)
Synthes-Stratec, Inc.
Trimedyne, Inc.
Vertis Neuroscience, Inc.
EXECUTIVE SUMMARY
Expanding Treated Patient Population
Total Market Opportunity
Minimally Invasive Discectomy
Interventional Pain Management
Management of Vertebral Fractures and Tumors
Prosthetic Discs
Other Emerging Fusion Alternatives
Summary Exhibit 1: Non-Fusion Technologies, Procedure Forecast, 2001-2008
Summary Exhibit 2: Non-Fusion Technologies, Market Forecast, 2001-2008
Summary Exhibit 3: Minimally Invasive Discectomy, Procedure and Market Forecast, 2001-2008
Summary Exhibit 4: Interventional Pain Management, Procedure and Market Forecast, 2001-2008
Summary Exhibit 5: Vertebral Fracture Management, Procedure and Market Forecast, 2001-2008
Summary Exhibit 6: Overview of Near Term Prosthetic Disc Programs
Summary Exhibit 7: Prosthetic Discs, Procedure and Market Forecast, 2004-2008
Summary Exhibit 8: Flexible Stabilization, Procedure and Market Forecast, 2004-2008
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 MINIMALLY INVASIVE DISCECTOMY
2.1 Microdiscectomy Techniques
2.1.1 Microlumbar Discectomy
2.1.2 Percutaneous Discectomy
2.1.3 Endoscopic Discectomy
2.1.4 Microendoscopic Discectomy
2.2 Indications
2.3 Patient Profile
2.4 Complications
2.5 Procedure Costs
2.6 Products and Technology
2.6.1 Visualization and Access Products
2.6.1.1 Biomet/EBI
2.6.1.2 Blackstone Medical
2.6.1.3 Clarus Medical
2.6.1.4 Endius
2.6.1.5 Myelotec (Clarus Medical)
2.6.1.6 NuVasive
2.6.1.7 Sofamor Danek
2.6.1.8 Spinal Concepts
2.6.1.9 Surgical Dynamics (Stryker)
2.6.1.10 Richard Wolf Medical Instruments
2.6.2 Disc Removal Technologies
2.6.2.1 Chemonucleolysis
2.6.2.2 Manual and Powered Systems
2.6.2.2.1 Endius
2.6.2.2.2 HydroCision
2.6.2.2.3 Pain Concepts (Stryker)
2.6.2.2.4 Sofamor Danek
2.6.2.2.5 Surgical Dynamics (Stryker)
2.6.2.3 Electrothermal (ArthroCare)
2.6.2.4 Laser-Assisted Discectomy
2.6.2.4.1 Clarus Medical
2.6.2.4.2 EKL Medical
2.6.2.4.3 Laserscope
2.6.2.4.4 Lumenis
2.6.2.4.5 Trimedyne
2.6.2.5 High Intensity Focused Ultrasound
2.6.3 Product Trends: Annulus Repair
2.6.3.1 Anulex Technologies
2.6.3.2 Intrinsic Therapeutics
2.6.3.3 SpinaLabs
2.6.3.4 Spine Partners
2.7 Procedure Forecasts
2.8 Market Analysis
2.9 Competitive Analysis
Exhibit 2-1: Intervertebral Disc Illustrations
Exhibit 2-2: Comparison of Minimally Invasive Discectomy Techniques
Exhibit 2-3: Advantages and Disadvantages of Minimally Invasive Discectomy Techniques
Exhibit 2-4: Indications for Minimally Invasive Discectomy
Exhibit 2-5: Most Common Clinical Manifestations of Lumbar Disc Herniation
Exhibit 2-6: Risks Associated with Minimally Invasive Discectomy
Exhibit 2-7: Cost of Laminectomy versus Laparoscopic Lumbar Discectomy
Exhibit 2-8: Current and Emerging Product Options for Minimally Invasive Discectomy, 2003
Exhibit 2-9: Biomet/EBI's VueCath Spinal Endoscopic System
Exhibit 2-10: Blackstone Medical's Discectomy Products
Exhibit 2-11: Endius' Atavi System
Exhibit 2-12: The METRx System
Exhibit 2-13: METRx System Outcomes Assessment Data
Exhibit 2-14: Spinal Concepts' Access Dilatation Port
Exhibit 2-15: The Yeung Endoscopic Spine Surgery (YESS) System
Exhibit 2-16: Comparison of Disc Removal Techniques
Exhibit 2-17: Endius' MDS MicroDebrider System
Exhibit 2-18: Pain Concepts' Dekompressor Percutaneous Discectomy Probe
Exhibit 2-19: Selected ArthroCare Nucleoplasty Products
Exhibit 2-20: Selected Laser Systems Utilized in Discectomy
Exhibit 2-21: Clarus Medical's LASE System
Exhibit 2-22: Trimedyne OmniTip Laser Needle Technology
Exhibit 2-23: Early Stage Annulus Repair Technologies
Exhibit 2-24: Discectomies, Procedure Forecast, 2001-2008
Exhibit 2-25: Minimally Invasive Diskectomies by Approach and Disc Removal Technology, 2001-2008
Exhibit 2-26: Minimally Invasive Discectomy Products, Market Forecast, 2001-2008
Exhibit 2-27: Minimally Invasive Discectomy Products, Supplier Shares, 2002
3.0 INTERVENTIONAL PAIN MANAGEMENT
3.1 Traditional Approaches
3.1.1 Drug Therapy
3.1.2 Injections
3.1.3 Epiduroscopy
3.1.4 Spinal Cord Stimulation
3.1.5 Spinal Infusion Pump
3.2 Intradiscal Heating
3.2.1 IntraDiscal ElectroThermal Therapy (Smith & Nephew)
3.2.1.1 Product
3.2.1.2 IDET Procedure
3.2.1.3 Clinical Experience
3.2.1.4 Indications and Benefits
3.2.1.5 Regulatory Status
3.2.1.6 Pricing & Reimbursement
3.2.1.7 Distribution
3.2.1.8 Additional Products
3.2.2 Radiofrequency Annuloplasty (Radionics)
3.2.2.1 Product
3.2.2.2 Procedure
3.2.2.3 Clinical Experience
3.2.2.4 Indications and Benefits
3.2.2.5 Regulatory Status
3.2.3 Procedure Forecasts
3.2.4 Market Analysis
3.3 Percutaneous Neuromodulation Therapy
3.3.1 Product
3.3.2 PNT Procedure
3.3.3 Clinical Experience
3.3.4 Indications and Benefits
3.3.5 Regulatory Status
3.3.6 Pricing & Reimbursement
3.3.7 Distribution
3.3.8 Procedure and Market Forecasts
3.4 Intradiscal Hypothermia Therapy
3.4.1 Clinical Rationale
3.4.2 Product
3.4.3 Procedure
3.4.4 Indications and Benefits
3.4.5 Regulatory Status
Exhibit 3-1: Emerging Approaches to Interventional Pain Management
Exhibit 3-2: Traditional Pain Management Approaches
Exhibit 3-3: Smith & Nephew's IDET Technology
Exhibit 3-4: IDET: Long-Term Clinical Improvements
Exhibit 3-5: Randomized, Double-Blinded, Placebo Controlled IDET Trial Results
Exhibit 3-6: Overview of IntraDiscal ElectroThermal Therapy
Exhibit 3-7: The Smith & Nephew Decompression Catheter
Exhibit 3-8: Radionics' discTRODE Technology for RF Annuloplasty
Exhibit 3-9: Overview of discTRODE RF Annuloplasty
Exhibit 3-10: Thermal Therapy, Procedure Forecast, 2001-2008
Exhibit 3-11: Thermal Therapy Products, Market Forecast, 2001-2008
Exhibit 3-12: Thermal Therapy Market Shares, 2002
Exhibit 3-13: The Vertis PNT System
Exhibit 3-14: Summary of Clinical Studies Forming the Basis for the Vertis PNT System
Exhibit 3-15: Overview of Percutaneous Neuromodulation Therapy (PNT)
Exhibit 3-16: PNT Patient and Procedure Forecast, 2002-2008
Exhibit 3-17: PNT Market Forecast, 2002-2008
4.0 MANAGEMENT OF VERTEBRAL FRACTURES AND TUMORS
4.1 Indications
4.1.1 Osteoporotic Compression Fractures
4.1.2 Vertebral Trauma Fractures
4.1.3 Malignant Spinal Tumors
4.1.4 Spinal Hemangiomas
4.2 Clinical Goals of Therapy
4.3 Techniques
4.3.1 Vertebroplasty
4.3.1.1 Technique
4.3.1.2 Setting and Specialties
4.3.1.3 Clinical Experience
4.3.1.3.1 Pain Relief Outcomes
4.3.1.3.2 Stabilization Outcomes
4.3.1.3.3 Complications
4.3.1.4 Product Requirements
4.3.1.5 Contraindications
4.3.1.6 Procedure Cost and Reimbursement
4.3.1.7 Regulatory Issues
4.3.1.8 Bone Cements
4.3.1.8.1 Biomet Merck/ScandiMed
4.3.1.8.2 Codman & Shurtleff (Johnson & Johnson)
4.3.1.8.3 DePuy AcroMed (Johnson & Johnson)
4.3.1.8.4 Howmedica Osteonics (Stryker)
4.3.1.8.3 Interpore Cross International
4.3.1.8.4 Mitsubishi Materials Corporation
4.3.1.8.5 Orthovita
4.3.1.8.6 Parallax Medical, Inc.
4.3.1.8.7 Regeneration Technologies
4.3.1.8.8 Smith & Nephew
4.3.1.8.9 Synthes USA (Norian)
4.3.1.8.10 Zimmer
4.3.1.9 Delivery Systems
4.3.1.9.1 Biomet Merck
4.3.1.9.2 Cook
4.3.1.9.3 I-Flow Corporation
4.3.1.9.4 Interpore Cross International
4.3.1.9.5 Parallax Medical
4.3.1.9.6 Stryker Instruments
4.3.2 Kyphoplasty
4.3.2.1 Technique
4.3.2.2 Setting and Specialties
4.3.2.3 Product Requirements
4.3.2.4 Procedure Cost
4.3.2.5 Patient Profile
4.3.2.6 Advantages and Limitations
4.3.2.7 Contraindications
4.3.2.8 Clinical Experience
4.3.2.8.1 Cleveland Clinic Foundation
4.3.2.8.2 Retrospective Multicenter Study
4.3.2.8.3 Role of Fracture Age
4.3.2.8.4 Sagittal Angulation of Spine
4.3.2.8.5 Restoration of Vertebral Height
4.3.2.8.6 Restoration of Mechanical Strength
4.3.2.8.7 Incidence of Adjacent Fracture
4.3.2.8.8 Use in Osteolytic Disease and Cancer
4.3.2.9 Complications
4.3.2.10 Regulatory Status
4.3.2.11 Reimbursement
4.3.2.12 Product Launch and Training
4.3.2.13 Product Distribution
4.3.2.14 Emerging Applications for Kyphoplasty Products
4.3.3 Vertebral Body Replacement
4.3.3.1 Technique
4.3.3.2 Indications
4.3.3.3 Contraindications
4.3.3.4 Complications
4.3.3.5 Product Requirements
4.3.3.6 Clinical Experience
4.3.3.7 Procedure and Product Reimbursement
4.3.3.8 Vertebral Body Replacement Devices
4.3.3.8.1 Biomet/Biomet Merck
4.3.3.8.2 Biorthrex
4.3.3.8.3 DePuy AcroMed
4.3.3.8.4 Implex
4.3.3.8.5 Interpore Cross International
4.3.3.8.6 Osteotech
4.3.3.8.7 Sofamor Danek
4.3.3.8.8 Surgical Dynamics (Stryker)
4.3.3.8.9 Synthes USA
4.4 Procedure Forecasts
4.5 Market Analysis
4.5.1 Bone Cements
4.5.2 Cement Delivery Systems
4.5.3 Kyphoplasty Products
4.5.4 Vertebral Body Replacement Devices
Exhibit 4-1: Major Indications for Vertebral Intervention
Exhibit 4-2: Techniques for Managing Vertebral Fractures and Tumors
Exhibit 4-3: Approaches to Spine for Vertebroplasty
Exhibit 4-4: Vertebral Compression Fracture Pre- and Post-Treatment
Exhibit 4-5: Complications Associated with Vertebroplasty
Exhibit 4-6: Contraindications to Vertebroplasty
Exhibit 4-7: Selected Reimbursement Codes for Vertebroplasty
Exhibit 4-8: ICD-9 Codes that Support Medical Necessity for Vertebroplasty
Exhibit 4-9: Selected Bone Cements, 2003
Exhibit 4-10: Selected Percutaneous Bone Cement Delivery Systems, 2003
Exhibit 4-11: Kyphoplasty Procedure
Exhibit 4-12: KyphX Kyphoplasty System
Exhibit 4-13: Advantages and Limitations of Kyphoplasty
Exhibit 4-14: Indications for Vertebral Body Replacement
Exhibit 4-15: Cancers With Probable Bone Metastases, 2003
Exhibit 4-16: Contraindications for Vertebral Body Replacement
Exhibit 4-17: Potential Complications Associated with Vertebral Body Replacement
Exhibit 4-18: Selected Vertebral Body Replacement Devices, 2003
Exhibit 4-19: Biomet Merck Vertebral Body Replacement Devices
Exhibit 4-20: DePuy Acromed Vertebral Body Replacement Devices
Exhibit 4-21: Interpore Cross International Vertebral Body Replacement Devices
Exhibit 4-22: Osteotech VBR Device
Exhibit 4-23: Sofamor Danek Verte-Span Vertebral Body Replacement Device
Exhibit 4-24: Synthes' Synex Spacer
Exhibit 4-25: Vertebral Fracture Management, Procedure Forecast, 2001-2008
Exhibit 4-26: Vertebral Fracture Management Products, Market Forecast, 2001-2008
Exhibit 4-27: Vertebroplasty and Kyphoplasty Bone Cement, Market Forecast, 2001-2008
Exhibit 4-28: Vertebroplasty and Kyphoplasty Bone Cements, Supplier Shares, 2002
Exhibit 4-29: Bone Cement Delivery Kits, Market Forecast, 2001-2008
Exhibit 4-30: Bone Cement Delivery Kits, Supplier Shares, 2002
Exhibit 4-31: Kyphoplasty Bone Tamps and Accessories, Market Forecast, 2001-2008
Exhibit 4-32: Vertebral Body Replacement Devices, Market Forecast, 2001-2008
Exhibit 4-33: Vertebral Body Replacement Devices, Supplier Shares, 2002
5.0 PROSTHETIC DISCS
5.1 Approaches
5.1.1 Total Disc Replacement
5.1.1.1 Technology
5.1.1.2 Indications
5.1.2 Nucleus Replacement
5.1.2.1 Technology
5.1.2.2 Indications
5.2 Implantation Techniques
5.2.1 Total Disc Implantation
5.2.2 Nucleus Implantation
5.3 Regulatory Issues
5.4 Total Prosthetic Disc Products
5.4.1 AxioMed Spine
5.4.1.1 Clinical Rationale
5.4.1.2 Product Description
5.4.1.3 Indications and Contraindications
5.4.1.4 Clinical Path
5.4.2 Biorthex
5.4.3 DePuy AcroMed
5.4.3.1 Acroflex
5.4.3.1.1 Product Description
5.4.3.1.2 Clinical Experience
5.4.3.2 Disc Replacement Technologies
5.4.3.3 Next Generation Programs
5.4.4 Hokkaido University
5.4.5 Link Spine Group
5.4.5.1 Background
5.4.5.2 Product Description
5.4.5.3 Implantation
5.4.5.4 Indications
5.4.5.5 Clinical Experience
5.4.5.6 Regulatory Status
5.4.5.7 Pricing and Distribution
5.4.5.8 Additional Products
5.4.6 Pearsalls
5.4.7 ReGen Biologics
5.4.8 Scient'x
5.4.9 Sofamor Danek (Medtronic)
5.4.9.1 Maverick
5.4.9.2 Prestige
5.4.9.3 Spinal Dynamics
5.4.9.3.1 Product Description
5.4.9.3.2 Implantation
5.4.9.3.3 Clinical Experience
5.4.9.3.4 Regulatory Status
5.4.10 SpineCore
5.4.11 Spine Solutions
5.4.11.1 Product Description
5.4.11.2 Implantation
5.4.11.3 Clinical Experience
5.4.11.4 Regulatory Status
5.4.12 Other Potential Programs
5.4.12.1 SaluMedica
5.4.12.2 Spine Partners
5.4.12.3 Stryker/Surgical Dynamics
5.5 Nucleus Replacement Products
5.5.1 Aberdeen Orthopaedic Developments
5.5.2 Centerpulse Spine-Tech
5.5.2.1 Product Description
5.5.2.2 Implantation
5.5.2.3 Indications and Benefits
5.5.2.4 Clinical Experience
5.5.2.5 Regulatory Status
5.5.3 CryoLife
5.5.4 Disc Dynamics
5.5.4.1 Implantation
5.5.4.2 Clinical Status
5.5.5 Dynamic Spine
5.5.6 Gelifex Inc.
5.5.6.1 Product Description
5.5.6.2 Implantation
5.5.6.3 Clinical Status
5.5.7 Li Medical
5.5.8 Mathys Medical
5.5.9 Raymedica
5.5.9.1 Product Description
5.5.9.2 Implantation
5.5.9.2.1 Posterior
5.5.9.2.2 ALPA
5.5.9.2.3 Learning Curve
5.5.9.3 Complications
5.5.9.4 Indications and Contraindications
5.5.9.5 Clinical Experience
5.5.9.6 Regulatory Status
5.5.9.7 Pricing and Reimbursement
5.5.9.8 Distribution
5.5.10 Replication Medical
5.5.11 Spine Wave
5.5.12 Stryker Howmedica Osteonics
5.5.12.1 Implantation
5.5.12.2 Clinical Experience
5.6 Market Analysis
5.6.1 Procedure Forecasts
5.6.2 Market Forecasts
5.6.3 Competitive Analysis
Exhibit 5-1: Total Disc Replacement versus Nucleus Replacement
Exhibit 5-2: Overview of Indication Criteria for Total Disc Replacement
Exhibit 5-3: Selected Total Disc Replacement Products, 2003
Exhibit 5-4: The Acroflex Artificial Disc
Exhibit 5-5: Evolution of the LINK SB Charité Intervertebral Dynamic Disc Spacer
Exhibit 5-6: Sofamor Danek's Disc Replacement Technologies
Exhibit 5-7: SpineCore's FlexiCore Intervertebral Disc
Exhibit 5-8: Spine Solutions' ProDisc
Exhibit 5-9: Other Potential Total Disc Replacement Programs
Exhibit 5-10: Selected Nucleus Replacement Products and Programs, 2003
Exhibit 5-11: Centerpulse Spine-Tech's Newcleus Implant
Exhibit 5-12: Injection of CryoLife's BioDisc
Exhibit 5-13: Raymedica’s PDN Prosthetic Disc Nucleus
Exhibit 5-14: Indications & Contraindications for the Prosthetic Disc Nucleus
Exhibit 5-15: Market Drivers and Concerns of Prosthetic Disc Products
Exhibit 5-16: Prosthetic Disc Products, Procedure Forecast, 2004-2008
Exhibit 5-17: Prosthetic Disc Products, Market Forecast, 2004-2008
6.0 OTHER EMERGING FUSION ALTERNATIVES
6.1 Flexible Stabilization
6.1.1 CISAD (Mekanika)
6.1.1.1 Product Description
6.1.1.2 Indications
6.1.1.3 Adjunctive Technology
6.1.1.4 Regulatory Status
6.1.1.5 Distribution
6.1.2 DYNESYS (Centerpulse Spine-Tech)
6.1.2.1 Product Description
6.1.2.2 Implantation
6.1.2.3 Indications and Benefits
6.1.2.4 Clinical Experience
6.1.2.5 Regulatory Status
6.1.3 Fulcrum-Assisted Soft Stabilization (FASS)
6.1.4 Graf Ligamentoplasty
6.1.4.1 Indications and Benefits
6.1.4.2 Clinical Experience
6.1.5 Leeds-Keio Ligamentoplasty
6.1.6 Orthobiom (Biorthex)
6.1.7 Staple/Tether Approach (Sofamor Danek)
6.1.8 Wallis System (Clinique Saint Martin/Biomet Merck)
6.1.8.1 Product Description
6.1.8.2 Indications and Benefits
6.1.8.3 Clinical Experience
6.1.8.4 Regulatory Status
6.1.9 X STOP (St. Francis Medical Technologies)
6.1.9.1 Product Description
6.1.9.2 Indications
6.1.9.3 Implantation
6.1.9.4 Clinical Experience
6.1.9.5 Regulatory Status
6.1.10 Market Analysis
6.2 Facet Joint Arthroplasty
6.2.1 Clinical Rationale
6.2.2 Patient Population
6.2.3 Artificial Facet Joint Products
6.2.3.1 Archus Orthopedics
6.2.3.2 Fitz Artificial Facet Joint
6.2.3.3 Martin Vertebral Joint Facets Prostheses
6.2.3.4 MedicineLodge (Fallin Joint Prosthesis)
6.3 Extra-Ligamentous Repair
6.3.1 Clinical Rationale
6.3.2 Technology
6.4 Spinal Biologics: Disc Regeneration & Resorption
6.4.1 Primer on Gene Therapy
6.4.1.1 Gene Selection
6.4.1.2 Delivery Vehicles
6.4.1.3 Delivery Approaches
6.4.2 Clinical Goals of Discal Gene Therapy
6.4.2.1 Nucleus Pulposus Regeneration
6.4.2.1.1 co.don Tissue Engineering
6.4.2.1.2 Emory University
6.4.2.1.3 TEI Biosciences (Sofamor Danek)
6.4.2.1.4 University of Chicago
6.4.2.1.5 University of Pennsylvania
6.4.2.1.6 University of Pittsburgh
6.4.2.2 Total Disc Restoration (Rush Medical College)
6.4.2.3 Disc Resorption (Vanderbilt University)
Exhibit 6-1: Overview of Emerging Fusion Alternatives
Exhibit 6-2: Selected Technologies for Flexible Stabilization, 2003
Exhibit 6-3: Mekanika's CISAD System
Exhibit 6-4: Centerpulse Spine-Tech's DYNESYS System
Exhibit 6-5: FASS System
Exhibit 6-6: The Graf System
Exhibit 6-7: Indications & Contraindications for Graf Ligamentoplasty
Exhibit 6-8: The Wallis System
Exhibit 6-9: The X STOP Interspinous Process Distraction System
Exhibit 6-10: Preliminary Results from the X STOP IPD Pivotal IDE Clinical Trial
Exhibit 6-11: Flexible Stabilization Procedure and Market Forecast, 2004-2008
Exhibit 6-12: Selected Early Stage Facet Joint Replacement Programs, 2003
Exhibit 6-13: Gene Therapy Delivery Options
Exhibit 6-14: Selected Disc Regeneration Programs, 2003
7.0 COMPANY PROFILES
7.1 ArthroCare Corporation
7.2 Biorthex, Inc.
7.3 Centerpulse AG (Spine-Tech)
7.4 Clarus Medical, LLC
7.5 Endius, Inc.
7.6 Interpore Cross International, Inc.
7.7 Johnson & Johnson (Codman & Shurtleff, DePuy AcroMed)
7.8 Kyphon, Inc
7.9 Link Spine Group, Inc
7.10 Medtronic, Inc. (Sofamor Danek)
7.11 Mekanika, Inc.
7.12 Orthovita, Inc.
7.13 Osteotech, Inc.
7.14 Parallax Medical, Inc.
7.15 Raymedica, Inc.
7.16 Smith & Nephew, plc
7.17 Spine Solutions, Inc.
7.18 Spine Wave, Inc.
7.19 St. Francis Medical Technologies, Inc
7.20 Stryker Corporation (Howmedica Osteonics, Surgical Dynamics)
7.21 Synthes-Stratec, Inc.
7.22 Trimedyne, Inc.
7.23 Vertis Neuroscience, Inc.
APPENDIX: COMPANY LIST