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Bone grafting is a surgical procedure that replaces missing bone with material from the patient's own body, an artificial, synthetic, or natural substitute. Bone grafting is used to repair bone fractures that are extremely complex, pose a significant health risk to the patient, or fail to heal properly.
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.
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 OS®1 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
To order this report:
Contacts:
Nicolas: nbo@reportlinker.com
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Intl: +1 805-652-2626
