Dental Biomaterials - Medical Devices Pipeline Assessment, 2016

Table Of Contents
1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 6
1.2 List of Figures 9
2 Introduction 10
2.1 Dental Biomaterials Overview 10
3 Products under Development 11
3.1 Dental Biomaterials - Pipeline Products by Stage of Development 11
3.2 Dental Biomaterials - Pipeline Products by Segment 12
3.3 Dental Biomaterials - Pipeline Products by Territory 13
3.4 Dental Biomaterials - Pipeline Products by Regulatory Path 14
3.5 Dental Biomaterials - Pipeline Products by Estimated Approval Date 15
3.6 Dental Biomaterials - Ongoing Clinical Trials 16
4 Dental Biomaterials - Pipeline Products under Development by Companies 17
4.1 Dental Biomaterials Companies - Pipeline Products by Stage of Development 17
4.2 Dental Biomaterials - Pipeline Products by Stage of Development 19
5 Dental Biomaterials Companies and Product Overview 21
5.1 3-D Matrix Ltd Company Overview 21
5.1.1 3-D Matrix Ltd Pipeline Products & Ongoing Clinical Trials Overview 21
5.2 Advanced Medical Solutions Group plc Company Overview 23
5.2.1 Advanced Medical Solutions Group plc Pipeline Products & Ongoing Clinical Trials Overview 23
5.3 botiss dental GmbH Company Overview 28
5.3.1 botiss dental GmbH Pipeline Products & Ongoing Clinical Trials Overview 28
5.4 CoreBone Ltd. Company Overview 36
5.4.1 CoreBone Ltd. Pipeline Products & Ongoing Clinical Trials Overview 36
5.5 credentis AG Company Overview 37
5.5.1 credentis AG Pipeline Products & Ongoing Clinical Trials Overview 37
5.6 curasan AG Company Overview 38
5.6.1 curasan AG Pipeline Products & Ongoing Clinical Trials Overview 38
5.7 Daewoong Pharmaceutical Co Ltd Company Overview 40
5.7.1 Daewoong Pharmaceutical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 40
5.8 Datum Dental Ltd Company Overview 42
5.8.1 Datum Dental Ltd Pipeline Products & Ongoing Clinical Trials Overview 42
5.9 Harvard University Company Overview 44
5.9.1 Harvard University Pipeline Products & Ongoing Clinical Trials Overview 44
5.10 Histocell SL Company Overview 45
5.10.1 Histocell SL Pipeline Products & Ongoing Clinical Trials Overview 45
5.11 Ironwood Material Science Inc Company Overview 46
5.11.1 Ironwood Material Science Inc Pipeline Products & Ongoing Clinical Trials Overview 46
5.12 Maxigen Biotech Inc Company Overview 47
5.12.1 Maxigen Biotech Inc Pipeline Products & Ongoing Clinical Trials Overview 47
5.13 Medisse BV Company Overview 49
5.13.1 Medisse BV Pipeline Products & Ongoing Clinical Trials Overview 49
5.14 Medtronic plc Company Overview 50
5.14.1 Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 50
5.15 Meta Biomed Co Ltd Company Overview 52
5.15.1 Meta Biomed Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 52
5.16 NDSU Research Foundation Company Overview 55
5.16.1 NDSU Research Foundation Pipeline Products & Ongoing Clinical Trials Overview 55
5.17 Nobel Biocare Holding AG Company Overview 56
5.17.1 Nobel Biocare Holding AG Pipeline Products & Ongoing Clinical Trials Overview 56
5.18 NovaBone Products LLC Company Overview 57
5.18.1 NovaBone Products LLC Pipeline Products & Ongoing Clinical Trials Overview 57
5.19 Novatissue SAS Company Overview 58
5.19.1 Novatissue SAS Pipeline Products & Ongoing Clinical Trials Overview 58
5.20 Orthocell Limited Company Overview 59
5.20.1 Orthocell Limited Pipeline Products & Ongoing Clinical Trials Overview 59
5.21 PolyPid Ltd Company Overview 61
5.21.1 PolyPid Ltd Pipeline Products & Ongoing Clinical Trials Overview 61
5.22 REGENECURE, Ltd. Company Overview 65
5.22.1 REGENECURE, Ltd. Pipeline Products & Ongoing Clinical Trials Overview 65
5.23 Straumann Holding AG Company Overview 68
5.23.1 Straumann Holding AG Pipeline Products & Ongoing Clinical Trials Overview 68
5.24 SurgaColl Technologies Ltd Company Overview 70
5.24.1 SurgaColl Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 70
5.25 SweetBio, Inc. Company Overview 71
5.25.1 SweetBio, Inc. Pipeline Products & Ongoing Clinical Trials Overview 71
5.26 The University of Queensland Company Overview 72
5.26.1 The University of Queensland Pipeline Products & Ongoing Clinical Trials Overview 72
5.27 Tigran Technologies AB Company Overview 73
5.27.1 Tigran Technologies AB Pipeline Products & Ongoing Clinical Trials Overview 73
5.28 Universitat Politecnica de Catalunya Company Overview 74
5.28.1 Universitat Politecnica de Catalunya Pipeline Products & Ongoing Clinical Trials Overview 74
5.29 University of Strasbourg Company Overview 76
5.29.1 University of Strasbourg Pipeline Products & Ongoing Clinical Trials Overview 76
6 Dental Biomaterials- Recent Developments 77
6.1 Nov 16, 2016: Medtronic Releases FY16 Integrated Performance Report 77
6.2 Nov 10, 2016: Curasan Continues Dynamic Growth in the Third Quarter 77
6.3 Nov 04, 2016: Dentsply Sirona Reports Third Quarter 2016 Results 78
6.4 Nov 03, 2016: DSM Q3 2016 Results 79
6.5 Oct 31, 2016: Zimmer Biomet Reports Third Quarter 2016 Financial Results 81
6.6 Oct 31, 2016: Exactech Q3 Revenue Up 7% to $59.9 Million. Net Income up 10% to $3.2 Million. Diluted EPS $0.22 vs. $0.20. 82
6.7 Oct 27, 2016: Karolinska Development Portfolio Company Promimic Appoints New Chairman and Directors to its Board 83
6.8 Oct 27, 2016: Stryker reports third quarter 2016 results 83
6.9 Oct 27, 2016: Another Strong Quarter (+13% Organic) Keeps Straumann On Track To Achieve Full-Year Targets 84
6.10 Oct 24, 2016: Philips' Third Quarter Results 2016 87
6.11 Oct 21, 2016: Modern Dental Acquires MicroDental Labs from Healthpointcapital 89
6.12 Oct 19, 2016: Karolinska Development portfolio company Promimic and Danco announce completion of US production line for HAnano Surface medical implant coating 89
6.13 Sep 28, 2016: Glidewell Laboratories Launches Newport Biologics Line of Regenerative Materials 89
6.14 Sep 19, 2016: Organogenesis Announces New Chief Financial Officer 90
6.15 Sep 15, 2016: Medtronic Names Mark Ploof Senior Vice President of Global Operations and Business Services 90
6.16 Sep 14, 2016: Advanced Medical Solutions Group: Interim Results for the six months ended 30 June 2016 91
6.17 Sep 13, 2016: Promimic Raises USD3.2 Million in Venture Financing 99
6.18 Sep 01, 2016: Philips appoints Sophie Bechu as Chief of Operations 99
6.19 Aug 25, 2016: Medtronic Reports First Quarter Financial Results 99
6.20 Aug 23, 2016: Strong Performance Continues As Organic Growth Of 14% Lifts First-Half Revenue To Record Level 102
6.21 Aug 23, 2016: Straumann reports strong performance continues as organic growth of 14% lifts first-half revenue to record level 106
6.22 Aug 18, 2016: curasan accelerates sales growth in the first six months due to rising foreign demand 111
6.23 Aug 16, 2016: NovaBone Products Receives GMP Medical Device Certificate 111
6.24 Aug 05, 2016: Dentsply Sirona Reports Second Quarter 2016 Results 112
6.25 Aug 01, 2016: Exactech Q2 Revenue Up 8% to $66.1 Million; Net Income up 20% to $4.4 Million; Diluted EPS $0.31 vs. $0.26 113
6.26 Jul 28, 2016: Zimmer Biomet Reports Second Quarter 2016 Financial Results 114
6.27 Jul 25, 2016: Philips' Second Quarter Results 2016 115
6.28 Jul 21, 2016: Stryker reports second quarter 2016 results 116
6.29 Jul 18, 2016: Straumann takes over distribution of botiss products in Germany 117
6.30 Jul 14, 2016: Straumann to Acquire Controlling Stake in MegaGen 118
6.31 Jul 12, 2016: Philips and Spanish hospital Campus de la Salud start implementation of multi-year strategic partnership agreement 118
6.32 Jun 30, 2016: NuVasive Agrees to Settle Patent Litigation With Medtronic 118
6.33 Jun 29, 2016: BoneAlbumin Induces Better Bone Formation 119
6.34 Jun 27, 2016: Dentsply Sirona to Acquire MIS Implants Technologies for USD375 Million 119
6.35 Jun 24, 2016: Collagen Matrix Names Bill Messer as Vice President, Sales and Marketing 119
6.36 Jun 14, 2016: Credentis presents first data for periodontitis treatment with CUROLOX TECHNOLOGY 120
6.37 Jun 13, 2016: Zimmer Biomet Raises USD1.28 Billion in Public Offering of Shares 120
6.38 Jun 08, 2016: First Future Health Index reveals developed markets have better access to healthcare, but emerging markets lead in adoption of connected technologies 120
6.39 Jun 07, 2016: Zimmer Biomet Plans to Raise USD750 Million in Public Offering of Notes 121
6.40 Jun 06, 2016: Medtronic Outlines Future Growth Vision at Investor Day 122
6.41 Jun 03, 2016: Philips empowers patients, care teams and health systems through connected solutions for personal and population health at eHealth Week 2016 122
6.42 May 31, 2016: Medtronic Reports Fourth Quarter and Fiscal Year 2016 Financial Results 124
6.43 May 23, 2016: Straumann Announces Change In Board Of Directors And Compensation Committee 126
6.44 May 17, 2016: Geistlich Bio-Oss Portfolio Expands 126
6.45 May 12, 2016: Philips Annual General Meeting of Shareholders approves re-appointment of Neelam Dhawan as member of the Supervisory Board 127
6.46 May 11, 2016: curasan posts sales growth in the first quarter 127
6.47 May 03, 2016: Straumann Emdogain launched in new wound-healing indication 128
6.48 May 03, 2016: Straumann reports strong start to the year with organic revenue growth of 12% in Q1 128
6.49 Apr 28, 2016: Curasan: Annual results influenced by positive trends in growth regions 130
6.50 Apr 08, 2016: Karolinska Development’s portfolio company Promimic AB announces that its HAnano Surface improves implant-to-bone integration for PEEK implants 130
6.51 Feb 25, 2016: Straumann And Anthogyr Announce Partnership 131
6.52 Feb 15, 2016: 3-D Matrix: Announcement of Change of Representative Directors 131
6.53 Jan 17, 2016: SurgaColl Technologies to Raise up to USD3.3 Million in Financing Round 132
6.54 Jan 04, 2016: Salvin Dental Specialties Acquires Dental Biologics Business from Exactech 132
6.55 Dec 09, 2015: Orthocell key scaffold patent granted in Canada 132
7 Appendix 133
7.1 Methodology 133
7.2 About GlobalData 136
7.3 Contact Us 136
7.4 Disclaimer 136

List Of Tables
1.1 List of Tables
Table 1: Dental Biomaterials - Pipeline Products by Stage of Development 11
Table 2: Dental Biomaterials - Pipeline Products by Segment 12
Table 3: Dental Biomaterials - Pipeline Products by Territory 13
Table 4: Dental Biomaterials - Pipeline Products by Regulatory Path 14
Table 5: Dental Biomaterials - Pipeline Products by Estimated Approval Date 15
Table 6: Dental Biomaterials - Ongoing Clinical Trials 16
Table 7: Dental Biomaterials Companies - Pipeline Products by Stage of Development 17
Table 8: Dental Biomaterials - Pipeline Products by Stage of Development 19
Table 9: 3-D Matrix Ltd Pipeline Products & Ongoing Clinical Trials Overview 21
Table 10: TDM-711 - Product Status 21
Table 11: TDM-711 - Product Description 22
Table 12: Advanced Medical Solutions Group plc Pipeline Products & Ongoing Clinical Trials Overview 23
Table 13: PARASORB Fleece - Product Status 23
Table 14: PARASORB Fleece - Product Description 24
Table 15: PARASORB Fleece Genta HD - Product Status 24
Table 16: PARASORB Fleece Genta HD - Product Description 25
Table 17: PARASORB Fleece HD - Product Status 25
Table 18: PARASORB Fleece HD - Product Description 26
Table 19: PARASORB RESODONT - Product Status 26
Table 20: PARASORB RESODONT - Product Description 27
Table 21: botiss dental GmbH Pipeline Products & Ongoing Clinical Trials Overview 28
Table 22: Cerabone - Product Status 28
Table 23: Cerabone - Product Description 28
Table 24: Jason Collagen Fleece - Product Status 29
Table 25: Jason Collagen Fleece - Product Description 29
Table 26: Jason Membrane - Product Status 29
Table 27: Jason Membrane - Product Description 30
Table 28: maxresorb - Product Status 30
Table 29: maxresorb - Product Description 31
Table 30: maxresorb Inject - Product Status 31
Table 31: maxresorb Inject - Product Description 32
Table 32: mucoderm - Product Status 32
Table 33: mucoderm - Product Description 32
Table 34: perossal - Product Status 33
Table 35: perossal - Product Description 33
Table 36: botiss dental GmbH - Ongoing Clinical Trials Overview 34
Table 37: Cerabone - Radiographic Peri-implant Alveolar Bone Changes in Post-menopausal Osteoporotic Women 35
Table 38: CoreBone Ltd. Pipeline Products & Ongoing Clinical Trials Overview 36
Table 39: Dental Bone Graft - Product Status 36
Table 40: Dental Bone Graft - Product Description 36
Table 41: credentis AG Pipeline Products & Ongoing Clinical Trials Overview 37
Table 42: CUROLOX Scaffold - Product Status 37
Table 43: CUROLOX Scaffold - Product Description 37
Table 44: curasan AG Pipeline Products & Ongoing Clinical Trials Overview 38
Table 45: Cerasorb Foam Dental - Product Status 38
Table 46: Cerasorb Foam Dental - Product Description 39
Table 47: Cerasorb Paste Dental - Product Status 39
Table 48: Cerasorb Paste Dental - Product Description 39
Table 49: Daewoong Pharmaceutical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 40
Table 50: NOVOSIS - DENT - Product Status 40
Table 51: NOVOSIS - DENT - Product Description 41
Table 52: Datum Dental Ltd Pipeline Products & Ongoing Clinical Trials Overview 42
Table 53: OSSIX VOLUMAX - Product Status 42
Table 54: OSSIX VOLUMAX - Product Description 43
Table 55: Harvard University Pipeline Products & Ongoing Clinical Trials Overview 44
Table 56: Artificial Teeth - Product Status 44
Table 57: Artificial Teeth - Product Description 44
Table 58: Histocell SL Pipeline Products & Ongoing Clinical Trials Overview 45
Table 59: Neofibrin - Product Status 45
Table 60: Neofibrin - Product Description 45
Table 61: Ironwood Material Science Inc Pipeline Products & Ongoing Clinical Trials Overview 46
Table 62: GEMOSIL - Dental Implant - Product Status 46
Table 63: GEMOSIL - Dental Implant - Product Description 46
Table 64: Maxigen Biotech Inc Pipeline Products & Ongoing Clinical Trials Overview 47
Table 65: MaxiBone - Product Status 47
Table 66: MaxiBone - Product Description 48
Table 67: MaxiGuide - Product Status 48
Table 68: MaxiGuide - Product Description 48
Table 69: Medisse BV Pipeline Products & Ongoing Clinical Trials Overview 49
Table 70: Dental Membrane - Product Status 49
Table 71: Dental Membrane - Product Description 49
Table 72: Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 50
Table 73: MD05-P Bone Graft Substitute Material - Product Status 50
Table 74: MD05-P Bone Graft Substitute Material - Product Description 51
Table 75: MD08 Injectable Paste - Product Status 51
Table 76: MD08 Injectable Paste - Product Description 51
Table 77: Meta Biomed Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 52
Table 78: Biocompatible Sealer - Product Status 52
Table 79: Biocompatible Sealer - Product Description 53
Table 80: Endodontic Sealer - Product Status 53
Table 81: Endodontic Sealer - Product Description 53
Table 82: Root Canal Sealer - Product Status 54
Table 83: Root Canal Sealer - Product Description 54
Table 84: NDSU Research Foundation Pipeline Products & Ongoing Clinical Trials Overview 55
Table 85: Synthetic Mandible - Product Status 55
Table 86: Synthetic Mandible - Product Description 55
Table 87: Nobel Biocare Holding AG Pipeline Products & Ongoing Clinical Trials Overview 56
Table 88: Bone Inductive Implant - Product Status 56
Table 89: Bone Inductive Implant - Product Description 56
Table 90: NovaBone Products LLC Pipeline Products & Ongoing Clinical Trials Overview 57
Table 91: Bioengineered Resorbable Bone Graft - Dental - Product Status 57
Table 92: Bioengineered Resorbable Bone Graft - Dental - Product Description 57
Table 93: Novatissue SAS Pipeline Products & Ongoing Clinical Trials Overview 58
Table 94: Dental NovaOss - Product Status 58
Table 95: Dental NovaOss - Product Description 58
Table 96: Orthocell Limited Pipeline Products & Ongoing Clinical Trials Overview 59
Table 97: CelGro Collagen Scaffold - Product Status 59
Table 98: CelGro Collagen Scaffold - Product Description 60
Table 99: PolyPid Ltd Pipeline Products & Ongoing Clinical Trials Overview 61
Table 100: BonyPid-500 - Product Status 61
Table 101: BonyPid-500 - Product Description 62
Table 102: PolyPid Ltd - Ongoing Clinical Trials Overview 63
Table 103: BonyPid-500 - PolyPid, Ltd. Pilot Study of the BonyPid-500 Bone Graft Substitute 64
Table 104: REGENECURE, Ltd. Pipeline Products & Ongoing Clinical Trials Overview 65
Table 105: Regenecure AMCA GBR Dental Membrane Implant - Product Status 65
Table 106: Regenecure AMCA GBR Dental Membrane Implant - Product Description 65
Table 107: REGENECURE, Ltd. - Ongoing Clinical Trials Overview 66
Table 108: Regenecure AMCA GBR Dental Membrane Implant - Horizontal Guided Bone Regeneration for Dental Implants Using Synthetic Membrane (Regenecures' AMCA GBR Dental Membrane) a Prospective Controlled Study 67
Table 109: Straumann Holding AG Pipeline Products & Ongoing Clinical Trials Overview 68
Table 110: Enhanced Bone Graft - Product Status 68
Table 111: Enhanced Bone Graft - Product Description 69
Table 112: Soft Tissue Control Implant - Product Status 69
Table 113: Soft Tissue Control Implant - Product Description 69
Table 114: SurgaColl Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 70
Table 115: DentaColl - Product Status 70
Table 116: DentaColl - Product Description 70
Table 117: SweetBio, Inc. Pipeline Products & Ongoing Clinical Trials Overview 71
Table 118: SweetBio GTR (Guided Tissue Regeneration) Membrane - Product Status 71
Table 119: SweetBio GTR (Guided Tissue Regeneration) Membrane - Product Description 71
Table 120: The University of Queensland Pipeline Products & Ongoing Clinical Trials Overview 72
Table 121: Dental Material - Product Status 72
Table 122: Dental Material - Product Description 72
Table 123: Tigran Technologies AB Pipeline Products & Ongoing Clinical Trials Overview 73
Table 124: Tigran Porous Titanium Granules - Alveolar Fillings - Product Status 73
Table 125: Tigran Porous Titanium Granules - Alveolar Fillings - Product Description 73
Table 126: Universitat Politecnica de Catalunya Pipeline Products & Ongoing Clinical Trials Overview 74
Table 127: Inorganic Dental Cement - Product Status 74
Table 128: Inorganic Dental Cement - Product Description 75
Table 129: University of Strasbourg Pipeline Products & Ongoing Clinical Trials Overview 76
Table 130: Nanostructured Biomaterial - Product Status 76
Table 131: Nanostructured Biomaterial - Product Description 76
Table 132: Glossary 134

List Of Figures
1.2 List of Figures
Figure 1: Dental Biomaterials - Pipeline Products by Stage of Development 11
Figure 2: Dental Biomaterials - Pipeline Products by Segment 12
Figure 3: Dental Biomaterials - Pipeline Products by Territory 13
Figure 4: Dental Biomaterials - Pipeline Products by Regulatory Path 14
Figure 5: Dental Biomaterials - Pipeline Products by Estimated Approval Date 15
Figure 6: Dental Biomaterials - Ongoing Clinical Trials 16

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