Arthroscopy-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 Arthroscopy Overview 7

3 Products under Development 9

3.1 Arthroscopy-Pipeline Products by Stage of Development 9

3.2 Arthroscopy-Pipeline Products by Segment 10

3.3 Arthroscopy-Pipeline Products by Territory 11

3.4 Arthroscopy-Pipeline Products by Regulatory Path 12

3.5 Arthroscopy-Pipeline Products by Estimated Approval Date 13

3.6 Arthroscopy-Ongoing Clinical Trials 14

4 Arthroscopy-Pipeline Products under Development by Companies 15

4.1 Arthroscopy Companies-Pipeline Products by Stage of Development 15

4.2 Arthroscopy-Pipeline Products by Stage of Development 16

5 Arthroscopy Companies and Product Overview 17

5.1 Arthroscopic Innovations, LLC Company Overview 17

5.1.1 Arthroscopic Innovations, LLC Pipeline Products Ongoing Clinical Trials Overview 17

5.2 ArthroSurface Inc Company Overview 19

5.2.1 ArthroSurface Inc Pipeline Products Ongoing Clinical Trials Overview 19

5.3 CartiHeal Ltd. Company Overview 20

5.3.1 CartiHeal Ltd. Pipeline Products Ongoing Clinical Trials Overview 20

5.4 Cartimage Medical SAS Company Overview 24

5.4.1 Cartimage Medical SAS Pipeline Products Ongoing Clinical Trials Overview 24

5.5 Clemson University Company Overview 25

5.5.1 Clemson University Pipeline Products Ongoing Clinical Trials Overview 25

5.6 Cleveland Clinic Hospital Company Overview 26

5.6.1 Cleveland Clinic Hospital Pipeline Products Ongoing Clinical Trials Overview 26

5.7 DePuy Synthes Inc Company Overview 27

5.7.1 DePuy Synthes Inc Pipeline Products Ongoing Clinical Trials Overview 27

5.8 Hospital for Special Surgery Company Overview 29

5.8.1 Hospital for Special Surgery Pipeline Products Ongoing Clinical Trials Overview 29

5.9 Jointech-Med Ltd. Company Overview 30

5.9.1 Jointech-Med Ltd. Pipeline Products Ongoing Clinical Trials Overview 30

5.10 MinInvasive Ltd. Company Overview 31

5.10.1 MinInvasive Ltd. Pipeline Products Ongoing Clinical Trials Overview 31

5.11 Naviswiss AG Company Overview 32

5.11.1 Naviswiss AG Pipeline Products Ongoing Clinical Trials Overview 32

5.12 OneFit Medical Company Overview 35

5.12.1 OneFit Medical Pipeline Products Ongoing Clinical Trials Overview 35

5.13 Pro-Dex Inc Company Overview 36

5.13.1 Pro-Dex Inc Pipeline Products Ongoing Clinical Trials Overview 36

5.14 Sheba Medical Center Company Overview 37

5.14.1 Sheba Medical Center Pipeline Products Ongoing Clinical Trials Overview 37

5.15 SpineSmith Holdings, LLC Company Overview 38

5.15.1 SpineSmith Holdings, LLC Pipeline Products Ongoing Clinical Trials Overview 38

5.16 The University of Utah Company Overview 40

5.16.1 The University of Utah Pipeline Products Ongoing Clinical Trials Overview 40

5.17 Ti-TaMed (PTY) LTD. Company Overview 41

5.17.1 Ti-TaMed (PTY) LTD. Pipeline Products Ongoing Clinical Trials Overview 41

5.18 University of Florida Company Overview 42

5.18.1 University of Florida Pipeline Products Ongoing Clinical Trials Overview 42

6 Arthroscopy-Recent Developments 43

6.1 Jul 11, 2017: VEXIM: Continued Growth and Adoption of the SpineJack in Q2 2017 43

6.2 Jul 04, 2017: Appointment of Angie Risley as Non-Executive Director and Chairman Elect of the Remuneration Committee 43

6.3 Jun 02, 2017: Episurf Medical's Board Names Pal Ryfors New CEO and Appoints New CFO 43

6.4 May 31, 2017: Depuy Synthes and Ethicon to Showcase Intra Operative Solutions Aiming to Mitigate Surgical Site Infection During Efort Congress 44

6.5 May 25, 2017: Medtronic Reports Fourth Quarter and Fiscal Year 2017 Financial Results 45

6.6 May 23, 2017: Brainlab Chief Financial Officer Joseph Doyle to Retire 48

6.7 May 15, 2017: Precision Optics Announces Operating Results for the Third Quarter and Nine Months of Fiscal Year 2017 49

6.8 May 15, 2017: Bovie Medical Reports First Quarter 2017 Financial Results and Introduces Fiscal Year 2017 Financial Outlook 50

6.9 May 11, 2017: Johnson Johnson Innovation Announces 40+ Resident Companies now at JLABS Toronto 51

6.10 May 10, 2017: Science Reconfirms Benefits of Shoulder Inlay Glenoid Arthroplasty For Active Patients 52

6.11 May 05, 2017: Smith Nephew 2017 First Quarter Trading Report 53

6.12 May 02, 2017: Brainlab Names New Member of Executive Board 55

6.13 Apr 26, 2017: CONMED Announces First Quarter 2017 Financial Results 55

6.14 Apr 25, 2017: Stryker reports first quarter 2017 results 56

6.15 Apr 24, 2017: Bioventus Names David Varner Vice President of Marketing, Active Healing Therapies 57

6.16 Apr 19, 2017: VEXIM: Continued sales growth in Q1 2017 58

6.17 Apr 18, 2017: Implanet announces Q1 2017 revenue 58

6.18 Apr 11, 2017: Intellijoint Surgical Completes One Thousand Total Hip Replacement Procedures with intellijoint HIP 59

6.19 Mar 14, 2017: LISI Medical Remmele Planning Big Lake Expansion 59

6.20 Mar 14, 2017: Arthrex Welcomes Mark Ferguson, MD, as Director of Medical Education, Asia-Pacific (APAC) Region 60

6.21 Mar 09, 2017: Bovie Medical Reports Fourth Quarter and Full Year 2016 Results 61

6.22 Mar 09, 2017: FDA inspection summary in TAG Medical Products 62

6.23 Feb 21, 2017: Medtronic Reports Third Quarter Financial Results 62

6.24 Feb 14, 2017: Precision Optics Announces Operating Results for the Second Quarter and Six Months of Fiscal Year 2017 65

6.25 Feb 09, 2017: Smith Nephew Fourth Quarter Trading and Full Year 2016 Results 66

6.26 Feb 09, 2017: Smith Nephew: Directorate Change 71

6.27 Feb 06, 2017: Medtronic Awarded U.S. Department of Veterans Affairs National Contracts for Home Telehealth Technologies, with Three Other Vendors 71

6.28 Feb 01, 2017: CONMED Announces Fourth Quarter and Fiscal Year 2016 Financial Results 72

6.29 Feb 01, 2017: Bovie Medical Confirms Its 2017 Outlook 74

6.30 Jan 24, 2017: Stryker reports 2016 results and 2017 outlook 74

6.31 Jan 24, 2017: Bovie Medical Appoints Eminent Gynecologic Oncologist to Medical Advisory Board 75

6.32 Jan 16, 2017: Implanet Reports 2016 Sales Growth of +18% to EUR7.8 Million 76

6.33 Jan 12, 2017: Confirmation of CFO leaving Smith Nephew 77

6.34 Jan 10, 2017: Stryker provides 2016 preliminary net sales results 77

6.35 Jan 10, 2017: Integrated Endoscopy Appoints Nationally Recognized Orthopedic Surgeon David Bailie as Chief Medical Officer Chairman of Advisory Board 78

6.36 Jan 09, 2017: CartiHeal Performs First Clinical Cases with its New Unicondylar Implant 79

6.37 Dec 20, 2016: CartiHeal Announces FDA IDE Approval of Its Agili-C Implant for the Treatment of Joint Surface Lesions 79

6.38 Nov 30, 2016: Graham Baker appointed Chief Financial Officer 80

6.39 Nov 22, 2016: Medtronic Reports Second Quarter Financial Results 81

6.40 Nov 17, 2016: Zimmer Biomet Announces Launch of the Comprehensive Vault Reconstruction System-the First Commercially Available Patient-matched Glenoid Implant 84

6.41 Nov 16, 2016: Medtronic Releases FY16 Integrated Performance Report 84

6.42 Nov 15, 2016: Integrated Endoscopy Significantly Expands Management Team in Advance of U.S. Product Launch 85

6.43 Nov 15, 2016: CEVA to work with Medtronic for distribution facility construction 85

6.44 Nov 14, 2016: Precision Optics Announces Operating Results for the First Quarter of Fiscal Year 2017 Ended September 30, 2016 86

6.45 Nov 07, 2016: Bioventus Appoints Andrew McCartney Managing Director, International for EMEA 86

6.46 Nov 06, 2016: The new TAG Medical Products website Launch 87

6.47 Nov 03, 2016: Smith Nephew Third Quarter 2016 Trading Report 87

6.48 Oct 27, 2016: Stryker reports third quarter 2016 results 88

6.49 Oct 27, 2016: CONMED Announces Third Quarter 2016 Financial Results 90

6.50 Oct 26, 2016: Bovie Medical Reports 2016 Third Quarter and Nine Month Results 91

6.51 Oct 13, 2016: VEXIM: +37% sales increase to EUR13.3 million as of September 30, 2016 (9 months) 93

6.52 Oct 10, 2016: Implanet Announces Q3 2016 Sales of EUR1.5 Million 93

6.53 Oct 06, 2016: Trice Medical Receives FDA 510(K) Clearance for mi-eye 2 94

6.54 Sep 28, 2016: Precision Optics Announces Operating Results for the Fourth Quarter and Fiscal Year Ended June 30, 2016 94

6.55 Sep 23, 2016: Implanet Announces Its 2016 First-Half Results: Buoyant Growth in Revenue and Substantial Gross Margin Improvement 95

6.56 Sep 23, 2016: RMS Medical Products Posts Second Quarter 2017 Results 97

6.57 Sep 15, 2016: Medtronic Names Mark Ploof Senior Vice President of Global Operations and Business Services 98

6.58 Sep 14, 2016: Orthopaedic Surgeons to Use HipGrid Drone at the ICJR 2016 5th Annual Direct Anterior Approach Hip Course 99

6.59 Aug 25, 2016: Medtronic Reports First Quarter Financial Results 99

6.60 Aug 18, 2016: Total Hip Arthroplasty --Orthogrid Systems Provides Vital Solutions for Outpatient Procedures 102

6.61 Aug 10, 2016: Episurf Medical: Interim report 1 April – 30 June, 2016 103

6.62 Aug 01, 2016: Bovie Medical Reports Second Quarter and First Half 2016 Results 103

6.63 Aug 01, 2016: Episurf Medical has been granted additional European patent 105

6.64 Jul 28, 2016: Smith Nephew Second Quarter Trading and First Half 2016 Results 105

6.65 Jul 27, 2016: CONMED Announces Second Quarter 2016 Financial Results 109

7 Appendix 111

7.1 Methodology 111

7.2 About GlobalData 114

7.3 Contact Us 114

7.4 Disclaimer 114

List of Figure

1.2 List of Figures

Figure 1: Arthroscopy-Pipeline Products by Stage of Development 9

Figure 2: Arthroscopy-Pipeline Products by Segment 10

Figure 3: Arthroscopy-Pipeline Products by Territory 11

Figure 4: Arthroscopy-Pipeline Products by Regulatory Path 12

Figure 5: Arthroscopy-Pipeline Products by Estimated Approval Date 13

Figure 6: Arthroscopy-Ongoing Clinical Trials 14

List of Table

1.1 List of Tables

Table 1: Arthroscopy-Pipeline Products by Stage of Development 9

Table 2: Arthroscopy-Pipeline Products by Segment 10

Table 3: Arthroscopy-Pipeline Products by Territory 11

Table 4: Arthroscopy-Pipeline Products by Regulatory Path 12

Table 5: Arthroscopy-Pipeline Products by Estimated Approval Date 13

Table 6: Arthroscopy-Ongoing Clinical Trials 14

Table 7: Arthroscopy Companies-Pipeline Products by Stage of Development 15

Table 8: Arthroscopy-Pipeline Products by Stage of Development 16

Table 9: Arthroscopic Innovations, LLC Pipeline Products Ongoing Clinical Trials Overview 17

Table 10: Biocleat-Product Status 17

Table 11: Biocleat-Product Description 17

Table 12: Intersector-Product Status 18

Table 13: Intersector-Product Description 18

Table 14: ArthroSurface Inc Pipeline Products Ongoing Clinical Trials Overview 19

Table 15: Inlay Glenoid-Product Status 19

Table 16: Inlay Glenoid-Product Description 19

Table 17: CartiHeal Ltd. Pipeline Products Ongoing Clinical Trials Overview 20

Table 18: Agili-C-Product Status 20

Table 19: Agili-C-Product Description 20

Table 20: CartiHeal Ltd.-Ongoing Clinical Trials Overview 21

Table 21: Agili-C-Agili-C Implant for the Treatment of Joint Surface Lesions 22

Table 22: Agili-C-Agili-C Implant Performance Evaluation in the Repair of Cartilage and Osteochondral Defects (OCD) 22

Table 23: Agili-C-Agili-C Implant Performance Evaluation in the Treatment of Osteoarthritis of the Great Toe 22

Table 24: Agili-C-Evaluation of the Agili-C Bi-phasic Implant Performances in the Repair of Cartilage and Osteochondral Defects 23

Table 25: Cartimage Medical SAS Pipeline Products Ongoing Clinical Trials Overview 24

Table 26: ChondroSight-Product Status 24

Table 27: ChondroSight-Product Description 24

Table 28: Clemson University Pipeline Products Ongoing Clinical Trials Overview 25

Table 29: Insita Pro-Product Status 25

Table 30: Insita Pro-Product Description 25

Table 31: Cleveland Clinic Hospital Pipeline Products Ongoing Clinical Trials Overview 26

Table 32: Elbow Implant-Product Status 26

Table 33: Elbow Implant-Product Description 26

Table 34: DePuy Synthes Inc Pipeline Products Ongoing Clinical Trials Overview 27

Table 35: Next Gen Arthroscopy Visualization System-Product Status 27

Table 36: Next Gen Arthroscopy Visualization System-Product Description 27

Table 37: Reamer-Irrigator-Aspirator (RIA) II-Product Status 28

Table 38: Reamer-Irrigator-Aspirator (RIA) II-Product Description 28

Table 39: Hospital for Special Surgery Pipeline Products Ongoing Clinical Trials Overview 29

Table 40: Arthroscopic Hip Knife-Product Status 29

Table 41: Arthroscopic Hip Knife-Product Description 29

Table 42: Jointech-Med Ltd. Pipeline Products Ongoing Clinical Trials Overview 30

Table 43: Synovial Shunt-Product Status 30

Table 44: Synovial Shunt-Product Description 30

Table 45: MinInvasive Ltd. Pipeline Products Ongoing Clinical Trials Overview 31

Table 46: OmniCuff-Product Status 31

Table 47: OmniCuff-Product Description 31

Table 48: Naviswiss AG Pipeline Products Ongoing Clinical Trials Overview 32

Table 49: 6D Hip Surgery Measurement Device-Product Status 32

Table 50: 6D Hip Surgery Measurement Device-Product Description 32

Table 51: Clipon System-Hip Replacement-Product Status 33

Table 52: Clipon System-Hip Replacement-Product Description 33

Table 53: Clipon System-Knee Replacement-Product Status 33

Table 54: Clipon System-Knee Replacement-Product Description 34

Table 55: OneFit Medical Pipeline Products Ongoing Clinical Trials Overview 35

Table 56: Knee Ligament Balancing Device-Product Status 35

Table 57: Knee Ligament Balancing Device-Product Description 35

Table 58: Pro-Dex Inc Pipeline Products Ongoing Clinical Trials Overview 36

Table 59: Arthroscopic System-Product Status 36

Table 60: Arthroscopic System-Product Description 36

Table 61: Sheba Medical Center Pipeline Products Ongoing Clinical Trials Overview 37

Table 62: Temporomandibular Joint Arthroscopy Guide Device-Product Status 37

Table 63: Temporomandibular Joint Arthroscopy Guide Device-Product Description 37

Table 64: SpineSmith Holdings, LLC Pipeline Products Ongoing Clinical Trials Overview 38

Table 65: Aspiration Device-Product Status 38

Table 66: Aspiration Device-Product Description 38

Table 67: Distraction Pin Aspiration Device-Product Status 39

Table 68: Distraction Pin Aspiration Device-Product Description 39

Table 69: The University of Utah Pipeline Products Ongoing Clinical Trials Overview 40

Table 70: Distractor For Ankle and Subtalar Arthroscopy-Product Status 40

Table 71: Distractor For Ankle and Subtalar Arthroscopy-Product Description 40

Table 72: Ti-TaMed (PTY) LTD. Pipeline Products Ongoing Clinical Trials Overview 41

Table 73: Arthroscopic Device-Product Status 41

Table 74: Arthroscopic Device-Product Description 41

Table 75: University of Florida Pipeline Products Ongoing Clinical Trials Overview 42

Table 76: Shoulder Labral Anchor Delivery System-Product Status 42

Table 77: Shoulder Labral Anchor Delivery System-Product Description 42

Table 78: Glossary 113