Shoulder Replacement-Medical Devices Pipeline Assessment, 2017

Table of Contents

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 5

1.2 List of Figures 6

2 Introduction 7

2.1 Shoulder Replacement Overview 7

3 Products under Development 8

3.1 Shoulder Replacement-Pipeline Products by Stage of Development 8

3.2 Shoulder Replacement-Pipeline Products by Segment 9

3.3 Shoulder Replacement-Pipeline Products by Territory 10

3.4 Shoulder Replacement-Pipeline Products by Regulatory Path 11

3.5 Shoulder Replacement-Pipeline Products by Estimated Approval Date 12

4 Shoulder Replacement-Pipeline Products under Development by Companies 13

4.1 Shoulder Replacement Companies-Pipeline Products by Stage of Development 13

4.2 Shoulder Replacement-Pipeline Products by Stage of Development 14

5 Shoulder Replacement Companies and Product Overview 15

5.1 BioPoly RS LLC Company Overview 15

5.1.1 BioPoly RS LLC Pipeline Products Ongoing Clinical Trials Overview 15

5.2 DePuy Synthes Inc Company Overview 16

5.2.1 DePuy Synthes Inc Pipeline Products Ongoing Clinical Trials Overview 16

5.3 Exactech Inc Company Overview 18

5.3.1 Exactech Inc Pipeline Products Ongoing Clinical Trials Overview 18

5.4 Imperial College London Company Overview 21

5.4.1 Imperial College London Pipeline Products Ongoing Clinical Trials Overview 21

5.5 Integra LifeSciences Holdings Corp Company Overview 22

5.5.1 Integra LifeSciences Holdings Corp Pipeline Products Ongoing Clinical Trials Overview 22

5.6 MEDACTA International SA Company Overview 25

5.6.1 MEDACTA International SA Pipeline Products Ongoing Clinical Trials Overview 25

5.7 Medical Bionics Inc Company Overview 26

5.7.1 Medical Bionics Inc Pipeline Products Ongoing Clinical Trials Overview 26

5.8 Orbis Medisch Centrum Company Overview 27

5.8.1 Orbis Medisch Centrum Pipeline Products Ongoing Clinical Trials Overview 27

5.9 Shoulder Options, Inc. Company Overview 28

5.9.1 Shoulder Options, Inc. Pipeline Products Ongoing Clinical Trials Overview 28

5.10 Topsfield Medical GmbH Company Overview 31

5.10.1 Topsfield Medical GmbH Pipeline Products Ongoing Clinical Trials Overview 31

5.11 University of Missouri Company Overview 32

5.11.1 University of Missouri Pipeline Products Ongoing Clinical Trials Overview 32

5.12 Wright Medical Group NV Company Overview 33

5.12.1 Wright Medical Group NV Pipeline Products Ongoing Clinical Trials Overview 33

6 Shoulder Replacement-Recent Developments 35

6.1 Jul 11, 2017: Zimmer Biomet Announces Leadership Transition 35

6.2 Jul 11, 2017: Zimmer Biomet Reports Certain Preliminary Second Quarter 2017 Results 36

6.3 Jul 04, 2017: Appointment of Angie Risley as Non-Executive Director and Chairman Elect of the Remuneration Committee 36

6.4 Jun 26, 2017: Henry Ford Welcomes Three New Senior Executives 37

6.5 Jun 22, 2017: Exactech Expands Presence in Japan with Newly Approved Shoulder, Knee and Hip Replacement Systems 37

6.6 Jun 13, 2017: Zimmer Biomet Holdings Announces Resolution of FDA Warning Letter Related to Its Zhejiang, China Manufacturing Facility 38

6.7 May 31, 2017: Depuy Synthes and Ethicon to Showcase Intra Operative Solutions Aiming to Mitigate Surgical Site Infection During Efort Congress 38

6.8 May 15, 2017: Henry Ford Health System Welcomes New Lansing Based Government Affairs Manager 39

6.9 May 15, 2017: Henry Ford Wyandotte Hospital Welcomes Two Top Leaders 40

6.10 May 05, 2017: Smith Nephew 2017 First Quarter Trading Report 41

6.11 Apr 27, 2017: Zimmer Biomet Reports First Quarter 2017 Financial Results 43

6.12 Apr 26, 2017: Integra LifeSciences Reports First Quarter 2017 Financial Results 44

6.13 Apr 25, 2017: Stryker reports first quarter 2017 results 45

6.14 Apr 25, 2017: Exactech Q1 Revenue Up 6% to $69.5 Million on 21% Extremities Growth 46

6.15 Apr 21, 2017: Henry Ford Cancer Institute Appoints Vice President, Executive Director 47

6.16 Apr 03, 2017: Generous Foundation Grant to Help Start New Global Technology Development Program at Henry Ford Health System 48

6.17 Mar 28, 2017: Henry Ford Veteran Doctor Kimberly A. Brown to Help Lead Transplant Institute 49

6.18 Mar 24, 2017: Henry Ford Hospital Dermatologist Named Dermatology Chair 50

6.19 Mar 15, 2017: Integra LifeSciences Launches Press-Fit Reverse Shoulder for Fracture for the Titan Modular Shoulder System 50

6.20 Mar 14, 2017: Arthrex Welcomes Mark Ferguson, MD, as Director of Medical Education, Asia-Pacific (APAC) Region 51

6.21 Mar 13, 2017: DJO Global Announces The Launch of The AltiVate Anatomic Shoulder System 52

6.22 Feb 23, 2017: Integra LifeSciences Reports Fourth Quarter and Full-Year 2016 Financial Results and Updates 2017 Full-Year Guidance 52

6.23 Feb 22, 2017: Corin Group Launches FX Solutions Reverse Shoulder System In U.S. 54

6.24 Feb 21, 2017: Zimmer Biomet Shoulder Replacement Recall: High Fracture Rate Prompts Class I Recall for Comprehensive Reverse Shoulder Humeral Tray 54

6.25 Feb 21, 2017: Exactech 2016 Revenue Up 7% to $257.6 Million, Q4'16 Revenue Increased 6% to $66.2 Million 55

6.26 Feb 16, 2017: Zimmer Biomet Recalls Comprehensive Reverse Shoulder due to a High Fracture Rate 56

6.27 Feb 16, 2017: Medacta Enters Shoulder Surgery Market with Successful First Surgery Using its Medacta Shoulder System 57

6.28 Feb 09, 2017: Smith Nephew Fourth Quarter Trading and Full Year 2016 Results 58

6.29 Feb 09, 2017: Smith Nephew: Directorate Change 63

6.30 Feb 07, 2017: Henry Ford Health System Names New Chair of Neurology Department 63

6.31 Jan 31, 2017: Zimmer Biomet Reports Fourth Quarter and Full-Year 2016 Financial Results 64

6.32 Jan 26, 2017: Henry Ford Cancer Institute Earns Distinct Level of Accreditation 65

6.33 Jan 24, 2017: Stryker reports 2016 results and 2017 outlook 66

6.34 Jan 17, 2017: Zimmer Biomet Announces Americas Leadership Transition 67

6.35 Jan 12, 2017: Zimmer Biomet Announces Resolution with DOJ and SEC Regarding Previously Disclosed Legacy Biomet FCPA Matters 68

6.36 Jan 12, 2017: Confirmation of CFO leaving Smith Nephew 68

6.37 Jan 10, 2017: Stryker provides 2016 preliminary net sales results 69

6.38 Jan 10, 2017: Zimmer Biomet Announces Fourth Quarter and Full-Year 2016 Preliminary Sales Results 70

6.39 Jan 04, 2017: Henry Ford Health System Welcomes New President and CEO 71

6.40 Dec 14, 2016: Zimmer Biomet Update on Product Supply Matters and Responsive Statement on Recently Completed FDA Inspection 71

6.41 Dec 12, 2016: Shoulder Innovations Launches Simple, Innovative Total Shoulder Replacement System 72

6.42 Dec 05, 2016: Integra LifeSciences announces management changes 73

6.43 Dec 05, 2016: Integra LifeSciences Announces Key Executive Appointments 74

6.44 Nov 30, 2016: Graham Baker appointed Chief Financial Officer 74

6.45 Nov 17, 2016: New UK Business Manager Appointed At JRI Orthopaedics 75

6.46 Nov 15, 2016: Henry Ford Radiation Oncology Receives 3-Year ACR Accreditation 75

6.47 Nov 03, 2016: Smith Nephew Third Quarter 2016 Trading Report 76

6.48 Oct 31, 2016: Zimmer Biomet Reports Third Quarter 2016 Financial Results 78

6.49 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. 79

6.50 Oct 27, 2016: Stryker reports third quarter 2016 results 80

6.51 Oct 27, 2016: Integra LifeSciences Reports Third Quarter 2016 Financial Results 81

6.52 Oct 18, 2016: Ortho Regenerative Technologies announces changes in executive leadership 82

6.53 Oct 12, 2016: New Studies Support Exactech's Knee, Shoulder and Computer-Assisted Surgery Technologies 83

6.54 Oct 10, 2016: Northgate Public Services secures five year contract extension with the National Joint Registry 84

6.55 Oct 05, 2016: Henry Ford Health System Announces New CEO of Health Alliance Plan 85

6.56 Sep 23, 2016: RMS Medical Products Posts Second Quarter 2017 Results 86

6.57 Aug 02, 2016: Corin Group and FX Solutions enter strategic partnership in the US 87

6.58 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 87

6.59 Jul 28, 2016: Smith Nephew Second Quarter Trading and First Half 2016 Results 89

6.60 Jul 28, 2016: Zimmer Biomet Reports Second Quarter 2016 Financial Results 92

6.61 Jul 28, 2016: Integra LifeSciences Reports Second Quarter 2016 Financial Results 93

7 Appendix 95

7.1 Methodology 95

7.2 About GlobalData 98

7.3 Contact Us 98

7.4 Disclaimer 98

List of Figure

1.2 List of Figures

Figure 1: Shoulder Replacement-Pipeline Products by Stage of Development 8

Figure 2: Shoulder Replacement-Pipeline Products by Segment 9

Figure 3: Shoulder Replacement-Pipeline Products by Territory 10

Figure 4: Shoulder Replacement-Pipeline Products by Regulatory Path 11

Figure 5: Shoulder Replacement-Pipeline Products by Estimated Approval Date 12

List of Table

1.1 List of Tables

Table 1: Shoulder Replacement-Pipeline Products by Stage of Development 8

Table 2: Shoulder Replacement-Pipeline Products by Segment 9

Table 3: Shoulder Replacement-Pipeline Products by Territory 10

Table 4: Shoulder Replacement-Pipeline Products by Regulatory Path 11

Table 5: Shoulder Replacement-Pipeline Products by Estimated Approval Date 12

Table 6: Shoulder Replacement Companies-Pipeline Products by Stage of Development 13

Table 7: Shoulder Replacement-Pipeline Products by Stage of Development 14

Table 8: BioPoly RS LLC Pipeline Products Ongoing Clinical Trials Overview 15

Table 9: BioPoly RS Partial Resurfacing Shoulder-Product Status 15

Table 10: BioPoly RS Partial Resurfacing Shoulder-Product Description 15

Table 11: DePuy Synthes Inc Pipeline Products Ongoing Clinical Trials Overview 16

Table 12: Next Generation Shoulder System-Product Status 16

Table 13: Next Generation Shoulder System-Product Description 16

Table 14: OV Shoulder-Product Status 17

Table 15: OV Shoulder-Product Description 17

Table 16: Exactech Inc Pipeline Products Ongoing Clinical Trials Overview 18

Table 17: Ceramic Glenosphere-Product Status 18

Table 18: Ceramic Glenosphere-Product Description 18

Table 19: Revision/Tumor Humeral Stem-Product Status 19

Table 20: Revision/Tumor Humeral Stem-Product Description 19

Table 21: Shoulder System-Product Status 19

Table 22: Shoulder System-Product Description 19

Table 23: Stemless Shoulder System-Product Status 20

Table 24: Stemless Shoulder System-Product Description 20

Table 25: Imperial College London Pipeline Products Ongoing Clinical Trials Overview 21

Table 26: Total Shoulder Replacement System-Product Status 21

Table 27: Total Shoulder Replacement System-Product Description 21

Table 28: Integra LifeSciences Holdings Corp Pipeline Products Ongoing Clinical Trials Overview 22

Table 29: Advanced Glenoid Platform-Product Status 22

Table 30: Advanced Glenoid Platform-Product Description 22

Table 31: Advanced Shoulder System-Product Status 23

Table 32: Advanced Shoulder System-Product Description 23

Table 33: Conventional Pegged Glenoid-Product Status 23

Table 34: Conventional Pegged Glenoid-Product Description 23

Table 35: PyroCarbon Hemi Shoulder-Product Status 24

Table 36: PyroCarbon Hemi Shoulder-Product Description 24

Table 37: Pyrocarbon HRA-Product Status 24

Table 38: Pyrocarbon HRA-Product Description 24

Table 39: MEDACTA International SA Pipeline Products Ongoing Clinical Trials Overview 25

Table 40: Medacta Shoulder System-Product Status 25

Table 41: Medacta Shoulder System-Product Description 25

Table 42: Medical Bionics Inc Pipeline Products Ongoing Clinical Trials Overview 26

Table 43: Body Activated Robo-Shoulder-Product Status 26

Table 44: Body Activated Robo-Shoulder-Product Description 26

Table 45: Orbis Medisch Centrum Pipeline Products Ongoing Clinical Trials Overview 27

Table 46: Shoulder Implant-Product Status 27

Table 47: Shoulder Implant-Product Description 27

Table 48: Shoulder Options, Inc. Pipeline Products Ongoing Clinical Trials Overview 28

Table 49: AFT Proximal Humerus Fracture Prosthesis-Product Status 28

Table 50: AFT Proximal Humerus Fracture Prosthesis-Product Description 28

Table 51: aSpire Total Shoulder Arthroplasty System-Product Status 29

Table 52: aSpire Total Shoulder Arthroplasty System-Product Description 29

Table 53: Luna Anchored Stemless Humeral Prosthesis-Product Status 29

Table 54: Luna Anchored Stemless Humeral Prosthesis-Product Description 30

Table 55: Luna Stemless Humeral Prosthesis-Product Status 30

Table 56: Luna Stemless Humeral Prosthesis-Product Description 30

Table 57: Topsfield Medical GmbH Pipeline Products Ongoing Clinical Trials Overview 31

Table 58: Next Generation Shoulder Replacement System-Product Status 31

Table 59: Next Generation Shoulder Replacement System-Product Description 31

Table 60: University of Missouri Pipeline Products Ongoing Clinical Trials Overview 32

Table 61: Helical Conservative Shoulder Prosthesis-Product Status 32

Table 62: Helical Conservative Shoulder Prosthesis-Product Description 32

Table 63: Wright Medical Group NV Pipeline Products Ongoing Clinical Trials Overview 33

Table 64: Aequalis PyroCarbon Humeral Head-Product Status 33

Table 65: Aequalis PyroCarbon Humeral Head-Product Description 34

Table 66: Glossary 97