Cranio Maxillofacial Fixation (CMF) - Medical Devices Pipeline Assessment, 2017

Published : Apr-2017

No. of Pages : 64

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1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 4
1.2 List of Figures 4
2 Introduction 5
2.1 Cranio Maxillofacial Fixation (CMF) Overview 5
3 Products under Development 6
3.1 Cranio Maxillofacial Fixation (CMF) - Pipeline Products by Stage of Development 6
3.2 Cranio Maxillofacial Fixation (CMF) - Pipeline Products by Segment 7
3.3 Cranio Maxillofacial Fixation (CMF) - Pipeline Products by Territory 8
3.4 Cranio Maxillofacial Fixation (CMF) - Pipeline Products by Regulatory Path 9
3.5 Cranio Maxillofacial Fixation (CMF) - Pipeline Products by Estimated Approval Date 10
4 Cranio Maxillofacial Fixation (CMF) - Pipeline Products under Development by Companies 11
4.1 Cranio Maxillofacial Fixation (CMF) Companies - Pipeline Products by Stage of Development 11
4.2 Cranio Maxillofacial Fixation (CMF) - Pipeline Products by Stage of Development 12
5 Cranio Maxillofacial Fixation (CMF) Companies and Product Overview 13
5.1 Advanced BioMedical Technologies, Inc. Company Overview 13
5.1.1 Advanced BioMedical Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 13
5.2 Biologitech Srl Company Overview 15
5.2.1 Biologitech Srl Pipeline Products & Ongoing Clinical Trials Overview 15
5.3 Clemson University Company Overview 16
5.3.1 Clemson University Pipeline Products & Ongoing Clinical Trials Overview 16
5.4 Histocell SL Company Overview 17
5.4.1 Histocell SL Pipeline Products & Ongoing Clinical Trials Overview 17
5.5 IlluminOss Medical, Inc. Company Overview 18
5.5.1 IlluminOss Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 18
5.6 OssDsign AB Company Overview 20
5.6.1 OssDsign AB Pipeline Products & Ongoing Clinical Trials Overview 20
5.7 OsteoVantage Inc Company Overview 22
5.7.1 OsteoVantage Inc Pipeline Products & Ongoing Clinical Trials Overview 22
5.8 Renishaw Plc Company Overview 23
5.8.1 Renishaw Plc Pipeline Products & Ongoing Clinical Trials Overview 23
5.9 University of South Florida Company Overview 24
5.9.1 University of South Florida Pipeline Products & Ongoing Clinical Trials Overview 24
5.10 Xtant Medical Holdings Inc Company Overview 25
5.10.1 Xtant Medical Holdings Inc Pipeline Products & Ongoing Clinical Trials Overview 25
6 Cranio Maxillofacial Fixation (CMF)- Recent Developments 26
6.1 Mar 23, 2017: SpineGuard Reports Full-Year 2016 Financial Results 26
6.2 Mar 14, 2017: LISI Medical Remmele Planning Big Lake Expansion 27
6.3 Mar 13, 2017: Oxford Performance Materials: European Patent Granted for OsteoFab Implants 28
6.4 Mar 09, 2017: Xtant Medical Reports Record Fourth Quarter Revenue of $24.5 million, 10% Growth Compared to Prior Year Period 28
6.5 Mar 09, 2017: Cantel Medical Reports Financial Results For The Second Quarter Ended January 31, 2017 30
6.6 Feb 23, 2017: Renishaw exhibiting at BioWales 2017 31
6.7 Feb 22, 2017: Xtant Medical Announces Appointment of Carl O'Connell to Permanent CEO 31
6.8 Feb 02, 2017: Karolinska Development portfolio company OssDsign announces agreement for distribution of OSSDSIGN Cranial in the USA with Matador Medical 32
6.9 Feb 02, 2017: OssDsign Enters into Agreement with Matador Medical 33
6.10 Jan 31, 2017: Zimmer Biomet Reports Fourth Quarter and Full-Year 2016 Financial Results 33
6.11 Jan 24, 2017: Stryker reports 2016 results and 2017 outlook 34
6.12 Jan 23, 2017: Xtant Medical CEO Dan Goldberger announces resignation 36
6.13 Jan 20, 2017: OssDsign Announces FDA 510(k) Clearance of OSSDSIGN Cranial for Sale in the USA 36
6.14 Jan 17, 2017: Zimmer Biomet Announces Americas Leadership Transition 37
6.15 Jan 12, 2017: OssDsign Enters into Agreement for its Products Distribution 37
6.16 Jan 12, 2017: Zimmer Biomet Announces Resolution with DOJ and SEC Regarding Previously Disclosed Legacy Biomet FCPA Matters 37
6.17 Jan 11, 2017: XTNT Announces Preliminary Fourth Quarter and Full Year 2016 Revenue & Adjusted EBITDA 38
6.18 Jan 10, 2017: Stryker provides 2016 preliminary net sales results 38
6.19 Jan 10, 2017: Zimmer Biomet Announces Fourth Quarter and Full-Year 2016 Preliminary Sales Results 40
6.20 Jan 03, 2017: Cantel Medical Appoints Dottie Donnelly Brienza as Senior Vice President and Chief Human Resources Officer 40
6.21 Dec 14, 2016: Zimmer Biomet Update on Product Supply Matters and Responsive Statement on Recently Completed FDA Inspection 41
6.22 Dec 08, 2016: Cantel Medical Reports Record Results For The First Quarter Ended October 31, 2016 41
6.23 Nov 07, 2016: Xtant Medical Holdings Reports Record Third Quarter 2016 Results 42
6.24 Nov 01, 2016: Xtant Medical Receives Approval of Compliance Plan from NYSE MKT 43
6.25 Oct 31, 2016: Xtant Medical Amends Terms of Rights Offering of Units for USD11.3 Million 44
6.26 Oct 31, 2016: Zimmer Biomet Reports Third Quarter 2016 Financial Results 44
6.27 Oct 27, 2016: Stryker reports third quarter 2016 results 45
6.28 Oct 11, 2016: Xtant Medical Pre-Announces Record Third Quarter 2016 Revenue 46
6.29 Oct 06, 2016: Xtant Medical Announces the Appointment of Carl O'Connell as President 47
6.30 Sep 29, 2016: Cantel Medical Reports Record Results for the Fourth Quarter Ended July 31, 2016 47
6.31 Sep 14, 2016: SpineGuard Reports Six-Month 2016 Financial Results 48
6.32 Sep 04, 2016: Cranioplasty using OSSDSIGN Cranial - preliminary data from a retrospective study 49
6.33 Sep 01, 2016: Cantel Medical Promotes Seth M. Yellin to Executive Vice President 50
6.34 Aug 19, 2016: Xtant Medical Receives Non Compliance Notice from NYSE MKT 50
6.35 Aug 16, 2016: Xtant Medical Expands AR Credit Facility with Silicon Valley Bank 50
6.36 Aug 01, 2016: Xtant Medical Reports Second Quarter 2016 Results 51
6.37 Aug 01, 2016: Cantel Medical Names Jorgen B. Hansen as New President and CEO 52
6.38 Jul 28, 2016: Zimmer Biomet Reports Second Quarter 2016 Financial Results 52
6.39 Jul 26, 2016: Xtant Medical Announces the Operations Expansion of Montana's Tissue Processing Rooms 53
6.40 Jul 21, 2016: Stryker reports second quarter 2016 results 54
6.41 Jul 20, 2016: Xtant Medical Pre-Announces Second Quarter 2016 Revenue and EBITDA 55
6.42 Jul 19, 2016: DePuy Synthes Announces Agreement with Materialise for 3D-Printed Titanium Cranio-Facial Implants 55
6.43 Jul 19, 2016: Materialise Enters into Distribution Agreement with DePuy Synthes 56
6.44 Jul 12, 2016: SpineGuard Reports 29% Growth and 1.9M Revenue for the Second Quarter 2016 56
6.45 Jun 17, 2016: Cantel Medical Announces Appointment of Dr. Ronnie Myers to its Board of Directors 57
6.46 Jun 16, 2016: Xtant Medical Announces Changes to Its Executive Management and Board of Directors 57
6.47 Jun 13, 2016: Zimmer Biomet Raises USD1.28 Billion in Public Offering of Shares 58
6.48 Jun 08, 2016: Cantel Medical Announces Record Financial Results for Third Quarter 2016 58
6.49 Jun 07, 2016: Zimmer Biomet Raises USD532 Million in Public Offering of 2.42% Notes Due 2026 59
6.50 Jun 07, 2016: Zimmer Biomet Raises USD532 Million in Public Offering of 1.4% Notes Due 2022 60
6.51 May 26, 2016: Xtant Medical completes new accounts receivable revolver credit facility with Silicon Valley Bank 60
6.52 May 02, 2016: Xtant Medical Raises USD65 Million in Private Placement of Notes 60
7 Appendix 61
7.1 Methodology 61
7.2 About GlobalData 64
7.3 Contact Us 64
7.4 Disclaimer 64

1.1 List of Tables
Table 1: Cranio Maxillofacial Fixation (CMF) - Pipeline Products by Stage of Development 6
Table 2: Cranio Maxillofacial Fixation (CMF) - Pipeline Products by Segment 7
Table 3: Cranio Maxillofacial Fixation (CMF) - Pipeline Products by Territory 8
Table 4: Cranio Maxillofacial Fixation (CMF) - Pipeline Products by Regulatory Path 9
Table 5: Cranio Maxillofacial Fixation (CMF) - Pipeline Products by Estimated Approval Date 10
Table 6: Cranio Maxillofacial Fixation (CMF) Companies - Pipeline Products by Stage of Development 11
Table 7: Cranio Maxillofacial Fixation (CMF) - Pipeline Products by Stage of Development 12
Table 8: Advanced BioMedical Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 13
Table 9: Bioabsorbable Miniscrew - Product Status 13
Table 10: Bioabsorbable Miniscrew - Product Description 13
Table 11: Polyamide Biodegradable Plate - Product Status 14
Table 12: Polyamide Biodegradable Plate - Product Description 14
Table 13: Biologitech Srl Pipeline Products & Ongoing Clinical Trials Overview 15
Table 14: Surgiplanner - Product Status 15
Table 15: Surgiplanner - Product Description 15
Table 16: Clemson University Pipeline Products & Ongoing Clinical Trials Overview 16
Table 17: Velox - Product Status 16
Table 18: Velox - Product Description 16
Table 19: Histocell SL Pipeline Products & Ongoing Clinical Trials Overview 17
Table 20: Maxillofacial Implant - Product Status 17
Table 21: Maxillofacial Implant - Product Description 17
Table 22: IlluminOss Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 18
Table 23: Photodynamic Bone Stabilization System - Cranio-maxillofacial - Product Status 18
Table 24: Photodynamic Bone Stabilization System - Cranio-maxillofacial - Product Description 19
Table 25: OssDsign AB Pipeline Products & Ongoing Clinical Trials Overview 20
Table 26: OSSDSIGN Cranial PSI - Product Status 20
Table 27: OSSDSIGN Cranial PSI - Product Description 20
Table 28: OSSDSIGN Facial PSI - Product Status 21
Table 29: OSSDSIGN Facial PSI - Product Description 21
Table 30: OsteoVantage Inc Pipeline Products & Ongoing Clinical Trials Overview 22
Table 31: Electroconductive Mesh - Product Status 22
Table 32: Electroconductive Mesh - Product Description 22
Table 33: Renishaw Plc Pipeline Products & Ongoing Clinical Trials Overview 23
Table 34: Facial Implant - Product Status 23
Table 35: Facial Implant - Product Description 23
Table 36: University of South Florida Pipeline Products & Ongoing Clinical Trials Overview 24
Table 37: Custom Reduction Splint - Product Status 24
Table 38: Custom Reduction Splint - Product Description 24
Table 39: Xtant Medical Holdings Inc Pipeline Products & Ongoing Clinical Trials Overview 25
Table 40: Anti-Microbial Coated GenerOs CF - Product Status 25
Table 41: Anti-Microbial Coated GenerOs CF - Product Description 25
Table 42: Glossary 63

1.2 List of Figures
Figure 1: Cranio Maxillofacial Fixation (CMF) - Pipeline Products by Stage of Development 6
Figure 2: Cranio Maxillofacial Fixation (CMF) - Pipeline Products by Segment 7
Figure 3: Cranio Maxillofacial Fixation (CMF) - Pipeline Products by Territory 8
Figure 4: Cranio Maxillofacial Fixation (CMF) - Pipeline Products by Regulatory Path 9
Figure 5: Cranio Maxillofacial Fixation (CMF) - Pipeline Products by Estimated Approval Date 10

Filed in: Medical Device, Orthopedic Devices

Publisher : GlobalData

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