Interbody Devices - Medical Devices Pipeline Assessment, 2017

Published : Oct-2017

No. of Pages : 238

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1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 8
1.2 List of Figures 11
2 Introduction 12
2.1 Interbody Devices Overview 12
3 Products under Development 13
3.1 Interbody Devices - Pipeline Products by Stage of Development 13
3.2 Interbody Devices - Pipeline Products by Segment 14
3.3 Interbody Devices - Pipeline Products by Territory 15
3.4 Interbody Devices - Pipeline Products by Regulatory Path 16
3.5 Interbody Devices - Pipeline Products by Estimated Approval Date 17
3.6 Interbody Devices - Ongoing Clinical Trials 18
4 Interbody Devices - Pipeline Products under Development by Companies 19
4.1 Interbody Devices Companies - Pipeline Products by Stage of Development 19
4.2 Interbody Devices - Pipeline Products by Stage of Development 21
5 Interbody Devices Companies and Product Overview 23
5.1 Alphatec Holdings Inc Company Overview 23
5.2 Amedica Corp Company Overview 26
5.3 Choice Spine LLC Company Overview 32
5.4 Corelink, LLC Company Overview 33
5.5 Corentec Co Ltd Company Overview 35
5.6 DePuy Synthes Inc Company Overview 36
5.7 DiFusion Technologies Inc Company Overview 37
5.8 DSM Biomedical BV Company Overview 38
5.9 Eminent Spine, LLC Company Overview 39
5.10 GS Medical LLC Company Overview 41
5.11 H. Lee Moffitt Cancer Center & Research Institute Inc Company Overview 43
5.12 Implants International Ltd Company Overview 44
5.13 Jemo Spine, LLC. Company Overview 46
5.14 Medicrea Group Company Overview 47
5.15 Meditech Spine LLC Company Overview 48
5.16 Medtronic plc Company Overview 53
5.17 MicroPort Scientific Corp Company Overview 54
5.18 Nasseo, Inc. Company Overview 55
5.19 NuVasive Inc Company Overview 56
5.20 Pharmaco-Kinesis Corp Company Overview 63
5.21 Precision Spine, Inc. Company Overview 64
5.22 Safe Orthopaedics SA Company Overview 65
5.23 SeaSpine, Inc. Company Overview 67
5.24 Spinal Balance Inc. Company Overview 69
5.25 Spinal Elements Inc Company Overview 70
5.26 Spinal Simplicity, LLC Company Overview 71
5.27 SpinalVu Inc (Inactive) Company Overview 72
5.28 SpineFrontier, Inc. Company Overview 74
5.29 SpineSmith Holdings, LLC Company Overview 75
5.30 Stryker Corporation Company Overview 76
5.31 Taragenyx Ltd Company Overview 77
5.32 University of Kansas Company Overview 78
5.33 University of South Florida Company Overview 79
5.34 Vertebral Technologies Inc Company Overview 81
5.35 X-spine Systems Inc Company Overview 88
5.36 Xtant Medical Holdings Inc Company Overview 90
6 Interbody Devices- Recent Developments 92
6.1 Sep 14, 2017: Safe Orthopaedics Announces the Forthcoming Arrival of Its New Chief Financial Officer and the Strengthening of Its Sales Team 92
6.2 Sep 12, 2017: Titan Spine Appoints Chad Kolean as Chief Financial Officer 92
6.3 Aug 29, 2017: Globus Medical Appoints David M. Demski as CEO 93
6.4 Aug 29, 2017: NuVasive Announces World-Class Innovation Center At San Diego Headquarters 93
6.5 Aug 25, 2017: Aurora Spine Files Condensed Consolidated Financial Statements for the Three and Six Months Ended June 30, 2017 94
6.6 Aug 22, 2017: Medtronic Reports First Quarter Financial Results 96
6.7 Aug 15, 2017: Camber Spine Technologies Announces FDA Clearance And National Launch Of SPIRA Open Matrix ALIF 98
6.8 Aug 15, 2017: NuVasive Appoints Rajesh J. Asarpota As Chief Financial Officer 99
6.9 Aug 11, 2017: Renovis Surgical Receives FDA Clearance for 3D-Printed Posterior Lumbar Interbody Fusion Systems 99
6.10 Aug 10, 2017: Alphatec Holdings Reports Second Quarter 2017 Financial Results 100
6.11 Aug 09, 2017: Xtant Medical Receives FDA Clearance For Calix-C Cervical Interbody Line Extension And Expanded Indications 101
6.12 Aug 09, 2017: Novadaq Receives Court Approval for Arrangement With Stryker 102
6.13 Aug 08, 2017: Life Spine Announces First Clinical Use of TiBOW MIS TLIF Expandable Spacer System 102
6.14 Aug 08, 2017: RTI Surgical Announces 2017 Second Quarter Results 103
6.15 Aug 02, 2017: Globus Medical Reports Second Quarter 2017 Results 104
6.16 Aug 02, 2017: Stryker announces election of new Director, Mary K. Brainerd 105
6.17 Aug 02, 2017: Titan Spine Continues Strong Sales Performance with 49% YOY Growth Rate at Mid-Year 2017 105
6.18 Jul 27, 2017: 4WEB Medical Announces First U.S. Surgeries with 3D Printed Lateral Spine Truss System 106
6.19 Jul 27, 2017: Stryker reports second quarter 2017 results 107
6.20 Jul 27, 2017: Exactech Q2 Revenue $67.3 Million On Continuing Strong Extremities Revenue 108
6.21 Jul 27, 2017: NuVasive Announces New Organizational Structure To Drive Growth And Profitability Goals 109
6.22 Jul 27, 2017: NuVasive Reports Second Quarter 2017 Financial Results 110
6.23 Jul 26, 2017: Integra LifeSciences Reports Second Quarter 2017 Financial Results 111
6.24 Jul 25, 2017: Vertera Spine Announces FDA Clearance of COALESCE porous PEEK Lumbar Interbody Fusion Device 113
6.25 Jul 25, 2017: CTL Medical Secures FDA Clearance For Titanium Cage Device 113
6.26 Jul 25, 2017: Providence Medical Technology Announces Regulatory Approval From Australian Therapeutic Goods Administration For its DTRAX Line of Tissue-sparing Cervical Fusion Products 114
6.27 Jul 21, 2017: Camber Spine Technologies Announces Exceeding the 150th Implantation of ENZA Zero-Profile ALIF 114
6.28 Jul 19, 2017: Richard Grant joins Spinal Simplicity as an Advisor and to serve on the Board of Managers 115
6.29 Jul 18, 2017: Spineway: Confirmed growth Revenue for the first half of 2017: 6M (+146%) 116
6.30 Jul 13, 2017: Skipjack Vertical And Lordotic Expandable Interbody Device 116
6.31 Jul 11, 2017: Spinal Elements Promotes Jason Blain to President & Chief Operating Officer 117
6.32 Jul 11, 2017: Medicrea Reports First Half 2017 Sales 117
6.33 Jul 10, 2017: Providence Medical Technology Announces Publication of Two New Studies Supporting Tissue-Sparing Posterior Cervical Fusion 118
6.34 Jul 10, 2017: Safe Orthopaedics: Strong Growth Momentum in Q2 2017: +37% 119
7 Appendix 235
7.1 Methodology 235
7.2 About GlobalData 238
7.3 Contact Us 238
7.4 Disclaimer 238

1.1 List of Tables
Table 1: Interbody Devices - Pipeline Products by Stage of Development 13
Table 2: Interbody Devices - Pipeline Products by Segment 14
Table 3: Interbody Devices - Pipeline Products by Territory 15
Table 4: Interbody Devices - Pipeline Products by Regulatory Path 16
Table 5: Interbody Devices - Pipeline Products by Estimated Approval Date 17
Table 6: Interbody Devices - Ongoing Clinical Trials 18
Table 7: Interbody Devices Companies - Pipeline Products by Stage of Development 19
Table 8: Interbody Devices - Pipeline Products by Stage of Development 21
Table 9: Alphatec Holdings Inc Pipeline Products & Ongoing Clinical Trials Overview 23
Table 10: Lateral Interbody with Expandable Cage - Product Status 23
Table 11: Lateral Interbody with Expandable Cage - Product Description 23
Table 12: PCB - Product Status 24
Table 13: PCB - Product Description 24
Table 14: Samarys RF - Product Status 24
Table 15: Samarys RF - Product Description 25
Table 16: Amedica Corp Pipeline Products & Ongoing Clinical Trials Overview 26
Table 17: Biologically Enhanced Spinal Fusion Device - Product Status 26
Table 18: Biologically Enhanced Spinal Fusion Device - Product Description 27
Table 19: Composite Silicon Nitride Interbody Device - Product Status 27
Table 20: Composite Silicon Nitride Interbody Device - Product Description 27
Table 21: Valeo II AL Interbody Fusion Device - Product Status 28
Table 22: Valeo II AL Interbody Fusion Device - Product Description 28
Table 23: Valeo II Cervical Interbody Fusion Device - Product Status 28
Table 24: Valeo II Cervical Interbody Fusion Device - Product Description 29
Table 25: Valeo II Lateral Lumbar Interbody Fusion Device - Product Status 29
Table 26: Valeo II Lateral Lumbar Interbody Fusion Device - Product Description 29
Table 27: Valeo II PL/OL Interbody Fusion Device - Product Status 30
Table 28: Valeo II PL/OL Interbody Fusion Device - Product Description 30
Table 29: Valeo II TL Interbody Fusion Device - Product Status 30
Table 30: Valeo II TL Interbody Fusion Device - Product Description 31
Table 31: Choice Spine LLC Pipeline Products & Ongoing Clinical Trials Overview 32
Table 32: Expandable PEEK Interbody Cage - Product Status 32
Table 33: Expandable PEEK Interbody Cage - Product Description 32
Table 34: Corelink, LLC Pipeline Products & Ongoing Clinical Trials Overview 33
Table 35: 3D Printed Cervical Titanium Interbody System - Product Status 33
Table 36: 3D Printed Cervical Titanium Interbody System - Product Description 33
Table 37: 3D Printed Lumbar Titanium Interbody System - Product Status 34
Table 38: 3D Printed Lumbar Titanium Interbody System - Product Description 34
Table 39: Corentec Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 35
Table 40: IS Cage - Product Status 35
Table 41: IS Cage - Product Description 35
Table 42: DePuy Synthes Inc Pipeline Products & Ongoing Clinical Trials Overview 36
Table 43: TLIF Cage - Product Status 36
Table 44: TLIF Cage - Product Description 36
Table 45: DiFusion Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 37
Table 46: ZFUZE - Product Status 37
Table 47: ZFUZE - Product Description 37
Table 48: DSM Biomedical BV Pipeline Products & Ongoing Clinical Trials Overview 38
Table 49: Spine Inter-Body Fusion Cage - Product Status 38
Table 50: Spine Inter-Body Fusion Cage - Product Description 38
Table 51: Eminent Spine, LLC Pipeline Products & Ongoing Clinical Trials Overview 39
Table 52: Boomslang Snake - Product Status 39
Table 53: Boomslang Snake - Product Description 39
Table 54: King Snake - Product Status 40
Table 55: King Snake - Product Description 40
Table 56: Queen Snake - Product Status 40
Table 57: Queen Snake - Product Description 40
Table 58: GS Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 41
Table 59: AnyPlus Anterior Cervical Interbody Fusion Implant - Product Status 41
Table 60: AnyPlus Anterior Cervical Interbody Fusion Implant - Product Description 41
Table 61: AnyPlus Direct Lateral Interbody Fusion Implant - Product Status 42
Table 62: AnyPlus Direct Lateral Interbody Fusion Implant - Product Description 42
Table 63: H. Lee Moffitt Cancer Center & Research Institute Inc Pipeline Products & Ongoing Clinical Trials Overview 43
Table 64: Laterally Expanding Cage - Product Status 43
Table 65: Laterally Expanding Cage - Product Description 43
Table 66: Implants International Ltd Pipeline Products & Ongoing Clinical Trials Overview 44
Table 67: FILL AND FIX PEEK OPTIMA ANATOMIC Cervical Cage - Product Status 44
Table 68: FILL AND FIX PEEK OPTIMA ANATOMIC Cervical Cage - Product Description 44
Table 69: FILL AND FIX PEEK OPTIMA ANATOMIC Lumbar Cage - Product Status 45
Table 70: FILL AND FIX PEEK OPTIMA ANATOMIC Lumbar Cage - Product Description 45
Table 71: Jemo Spine, LLC. Pipeline Products & Ongoing Clinical Trials Overview 46
Table 72: MOAB Interbody Spacer - Product Status 46
Table 73: MOAB Interbody Spacer - Product Description 46
Table 74: Medicrea Group Pipeline Products & Ongoing Clinical Trials Overview 47
Table 75: 3D-Printed Titanium Spinal Interbody Device - Product Status 47
Table 76: 3D-Printed Titanium Spinal Interbody Device - Product Description 47
Table 77: Meditech Spine LLC Pipeline Products & Ongoing Clinical Trials Overview 48
Table 78: Talos-A (HA) - Product Status 48
Table 79: Talos-A (HA) - Product Description 48
Table 80: Talos-L (HA) - Product Status 49
Table 81: Talos-L (HA) - Product Description 49
Table 82: Talos-P (HA) - Product Status 49
Table 83: Talos-P (HA) - Product Description 50
Table 84: Talos-P WB (HA) - Product Status 50
Table 85: Talos-P WB (HA) - Product Description 50
Table 86: Talos-T (HA) - Product Status 51
Table 87: Talos-T (HA) - Product Description 51
Table 88: Talos-TL (HA) - Product Status 51
Table 89: Talos-TL (HA) - Product Description 52
Table 90: Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 53
Table 91: CAPSTONE PTC Spinal System - Product Status 53
Table 92: CAPSTONE PTC Spinal System - Product Description 53
Table 93: MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 54
Table 94: Spine Cage - Product Status 54
Table 95: Spine Cage - Product Description 54
Table 96: Nasseo, Inc. Pipeline Products & Ongoing Clinical Trials Overview 55
Table 97: PEEK Spinal Cage Implant System - Product Status 55
Table 98: PEEK Spinal Cage Implant System - Product Description 55
Table 99: NuVasive Inc Pipeline Products & Ongoing Clinical Trials Overview 56
Table 100: COALESCE Posterior Lumbar Interbody Fusion Device - Product Status 56
Table 101: COALESCE Posterior Lumbar Interbody Fusion Device - Product Description 57
Table 102: COALESCE Transforaminal Lumbar Interbody Fusion Device - Product Status 57
Table 103: COALESCE Transforaminal Lumbar Interbody Fusion Device - Product Description 57
Table 104: COHERE Cervical Interbody Fusion Device - Multiple Footprint Configuration - Product Status 58
Table 105: COHERE Cervical Interbody Fusion Device - Multiple Footprint Configuration - Product Description 58
Table 106: COHERE Cervical Interbody Fusion Device - Multiple Height Configuration - Product Status 58
Table 107: COHERE Cervical Interbody Fusion Device - Multiple Height Configuration - Product Description 59
Table 108: NuVasive Inc - Ongoing Clinical Trials Overview 60
Table 109: COHERE Cervical Interbody Fusion Device - Multiple Footprint Configuration - Comparison of Outcomes After ACDF Using Allograft Fusion Versus PEEK Fusion: A Prospective Clinical Trial 61
Table 110: COHERE Cervical Interbody Fusion Device - Multiple Height Configuration - Comparison of Outcomes After ACDF Using Allograft Fusion Versus PEEK Fusion: A Prospective Clinical Trial 62
Table 111: Pharmaco-Kinesis Corp Pipeline Products & Ongoing Clinical Trials Overview 63
Table 112: Intelligent Interbody Fusion Device - Product Status 63
Table 113: Intelligent Interbody Fusion Device - Product Description 63
Table 114: Precision Spine, Inc. Pipeline Products & Ongoing Clinical Trials Overview 64
Table 115: ShurFit Coated T-PLIF Cage - Product Status 64
Table 116: ShurFit Coated T-PLIF Cage - Product Description 64
Table 117: Safe Orthopaedics SA Pipeline Products & Ongoing Clinical Trials Overview 65
Table 118: SteriSpine CC - Product Status 65
Table 119: SteriSpine CC - Product Description 66
Table 120: SteriSpine LC - Product Status 66
Table 121: SteriSpine LC - Product Description 66
Table 122: SeaSpine, Inc. Pipeline Products & Ongoing Clinical Trials Overview 67
Table 123: Lateral Intervertebral Body Fusion Device - Product Status 67
Table 124: Lateral Intervertebral Body Fusion Device - Product Description 67
Table 125: Ventura NanoMetalene Lordotic System - Product Status 68
Table 126: Ventura NanoMetalene Lordotic System - Product Description 68
Table 127: Spinal Balance Inc. Pipeline Products & Ongoing Clinical Trials Overview 69
Table 128: Interbody Cage - Product Status 69
Table 129: Interbody Cage - Product Description 69
Table 130: Spinal Elements Inc Pipeline Products & Ongoing Clinical Trials Overview 70
Table 131: Clutch Interspinous Process Device - Product Status 70
Table 132: Clutch Interspinous Process Device - Product Description 70
Table 133: Spinal Simplicity, LLC Pipeline Products & Ongoing Clinical Trials Overview 71
Table 134: Scarab - Product Status 71
Table 135: Scarab - Product Description 71
Table 136: SpinalVu Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 72
Table 137: X - Wave Cervical Interbody Spacer - Product Status 72
Table 138: X - Wave Cervical Interbody Spacer - Product Description 72
Table 139: X - Wave Lumbar Interbody Spacer - Product Status 73
Table 140: X - Wave Lumbar Interbody Spacer - Product Description 73
Table 141: SpineFrontier, Inc. Pipeline Products & Ongoing Clinical Trials Overview 74
Table 142: Expanding P-Lift - Product Status 74
Table 143: Expanding P-Lift - Product Description 74
Table 144: SpineSmith Holdings, LLC Pipeline Products & Ongoing Clinical Trials Overview 75
Table 145: Posterior Lumbar Interbody Fusion Device - Product Status 75
Table 146: Posterior Lumbar Interbody Fusion Device - Product Description 75
Table 147: Stryker Corporation Pipeline Products & Ongoing Clinical Trials Overview 76
Table 148: Vitoss PEEK - Product Status 76
Table 149: Vitoss PEEK - Product Description 76
Table 150: Taragenyx Ltd Pipeline Products & Ongoing Clinical Trials Overview 77
Table 151: TRGYX-001 - Product Status 77
Table 152: TRGYX-001 - Product Description 77
Table 153: University of Kansas Pipeline Products & Ongoing Clinical Trials Overview 78
Table 154: Piezoelectric Spinal Fusion Interbody Device - Product Status 78
Table 155: Piezoelectric Spinal Fusion Interbody Device - Product Description 78
Table 156: University of South Florida Pipeline Products & Ongoing Clinical Trials Overview 79
Table 157: Asymmetric Disc Distracting Cage - Product Status 79
Table 158: Asymmetric Disc Distracting Cage - Product Description 79
Table 159: Vertebral Body Cage - Product Status 80
Table 160: Vertebral Body Cage - Product Description 80
Table 161: Vertebral Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 81
Table 162: InterFuse DA Intervertebral Body Fusion Device - Product Status 81
Table 163: InterFuse DA Intervertebral Body Fusion Device - Product Description 82
Table 164: InterFuse Intervertebral Body Fusion Device - Product Status 82
Table 165: InterFuse Intervertebral Body Fusion Device - Product Description 82
Table 166: InterFuse L - Intervertebral Body Fusion Device - Product Status 83
Table 167: InterFuse L - Intervertebral Body Fusion Device - Product Description 83
Table 168: InterFuse S Intervertebral Body Fusion Device - Product Status 83
Table 169: InterFuse S Intervertebral Body Fusion Device - Product Description 84
Table 170: InterFuse T - Intervertebral Body Fusion Device - Product Status 84
Table 171: InterFuse T - Intervertebral Body Fusion Device - Product Description 84
Table 172: Vertebral Technologies Inc - Ongoing Clinical Trials Overview 85
Table 173: InterFuse T - Intervertebral Body Fusion Device - A Multi-Center Prospective Study of Vertebral Technologies, Inc. (VTI) InterFuse S and InterFuse T for the Treatment of Scoliosis, Spondylolisthesis and Degenerative Disc Disease 86
Table 174: InterFuse T - Intervertebral Body Fusion Device - A Prospective Study of the InterFuse T 86
Table 175: InterFuse S Intervertebral Body Fusion Device - A Multi-Center Prospective Study of Vertebral Technologies, Inc. (VTI) InterFuse S and InterFuse T for the Treatment of Scoliosis, Spondylolisthesis and Degenerative Disc Disease 87
Table 176: X-spine Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 88
Table 177: Interbody Fusion Device - Product Status 88
Table 178: Interbody Fusion Device - Product Description 88
Table 179: Irix-A Lumbar Integrated Fusion System - Titanium Plasma Coating - Product Status 89
Table 180: Irix-A Lumbar Integrated Fusion System - Titanium Plasma Coating - Product Description 89
Table 181: Xtant Medical Holdings Inc Pipeline Products & Ongoing Clinical Trials Overview 90
Table 182: Calix-C - Product Status 90
Table 183: Calix-C - Product Description 90
Table 184: Xsert Lumbar Expandable Interbody System - Product Status 91
Table 185: Xsert Lumbar Expandable Interbody System - Product Description 91
Table 186: Glossary 237

1.2 List of Figures
Figure 1: Interbody Devices - Pipeline Products by Stage of Development 13
Figure 2: Interbody Devices - Pipeline Products by Segment 14
Figure 3: Interbody Devices - Pipeline Products by Territory 15
Figure 4: Interbody Devices - Pipeline Products by Regulatory Path 16
Figure 5: Interbody Devices - Pipeline Products by Estimated Approval Date 17
Figure 6: Interbody Devices - Ongoing Clinical Trials 18

Filed in: Medical Device, Orthopedic Devices

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Nerve Repair & Regeneration Market by Products (Neuromodulation Devices (Deep Brain Stimulation, Vagus Nerve Stimulation), Biomaterials (Nerve Conduits, Nerve Wraps), Application (Neurorrhaphy, Nerve Grafting, Stem Cell Therapy) – Global Forecast to 2027

Particle Therapy Market by Type (Proton Therapy, Heavy Ion), Products (Cyclotron, Synchrotron, Synchrocyclotron), Services, System (Single-room, Multi-room), Cancer Type (Pediatric, Prostate), Application (Treatment, Research) – Global Forecast to 2027

Restorative Dentistry Market by Product (Restorative Material (Glass-ionomers, Bonding Agents, Biomaterial), Implant, Prosthetic, Equipment (Handpiece, Articulator, Furnace), End User (Hospital, Clinic, Laboratory) – Global Forecast to 2027

Dental Laboratories Market by Material (Metal Ceramic, CAD/CAM Material (Zirconia, Glass Ceramic)), Equipment (Milling Equipment, CAD/CAM System, 3D Printing System, Scanner, Furnace), Prosthetics (Bridge, Crown, Veeners, Denture) – Global Forecast to 2027

Endoscope Reprocessing Market by Product (HLD and Test Strips, Detergents & Wipes, Automated Endoscope Reprocessors (AER), Endoscope Drying, Storage, & Transport Systems, Tracking Solutions), End User (Hospitals, ASCs & Clinics) (2022 – 2027)

Polymethyl Methacrylate (PMMA) Market by Grade (General Purpose, Optical), Form(Extruded Sheet, Cast Acrylic Sheet, Pellets, Beads),End-Use Industry(Signs & Displays, Construction, Automotive, Lighting Fixtures, Electronics, Marine, Healthcare) & Region – Global Forecast to 2027

Microtome Market by Product (Instruments, (Rotary), Accessories (Microtome Blades), Application (Disease Diagnosis, Medical Research), Technology (Fully Automated, Semi-automated, Manual), End User (Hospital, Clinical Labs) – Global Forecast to 2027