Cardiac Valve Repairs - Medical Devices Pipeline Assessment, 2018

Table of Contents

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 5

1.2 List of Figures 8

2 Introduction 9

2.1 Cardiac Valve Repairs Overview 9

3 Products under Development 10

3.1 Cardiac Valve Repairs-Pipeline Products by Stage of Development 10

3.2 Cardiac Valve Repairs-Pipeline Products by Segment 11

3.3 Cardiac Valve Repairs-Pipeline Products by Territory 12

3.4 Cardiac Valve Repairs-Pipeline Products by Regulatory Path 13

3.5 Cardiac Valve Repairs-Pipeline Products by Estimated Approval Date 14

3.6 Cardiac Valve Repairs-Ongoing Clinical Trials 15

4 Cardiac Valve Repairs-Pipeline Products under Development by Companies 16

4.1 Cardiac Valve Repairs Companies-Pipeline Products by Stage of Development 16

4.2 Cardiac Valve Repairs-Pipeline Products by Stage of Development 18

5 Cardiac Valve Repairs Companies and Product Overview 20

5.1 Abbott Vascular Inc Company Overview 20

5.2 Admedus Ltd Company Overview 23

5.3 Ample Medical Inc Company Overview 24

5.4 Ancora Heart Inc Company Overview 25

5.5 BioStable Science & Engineering, Inc. Company Overview 28

5.6 Cardiosolutions Inc Company Overview 29

5.7 Celyad SA Company Overview 30

5.8 Children's Hospital Boston Company Overview 32

5.9 CollPlant Ltd Company Overview 34

5.10 CoreMedic AG Company Overview 35

5.11 Coroneo Inc. Company Overview 38

5.12 CUBE SRL Company Overview 39

5.13 Daidalos Solutions BV Company Overview 40

5.14 Edwards Lifesciences Corp Company Overview 42

5.15 Emory University Company Overview 46

5.16 Georgia Institute of Technology Company Overview 47

5.17 Hangzhou DeJin Medtech Co Ltd Company Overview 48

5.18 Kephalios SAS Company Overview 49

5.19 Lartim Medical Ltd Company Overview 50

5.20 Mardil Medical, Inc. Company Overview 51

5.21 Mayo Clinic Company Overview 54

5.22 Medtentia International Ltd Oy Company Overview 55

5.23 MiCardia Corp Company Overview 56

5.24 Michigan Critical Care Consultants, Inc. Company Overview 57

5.25 Micro Interventional Devices, Inc. Company Overview 59

5.26 Millipede LLC Company Overview 63

5.27 Mitralix Ltd. Company Overview 66

5.28 Mitre Medical Corp Company Overview 67

5.29 Neochord Inc Company Overview 69

5.30 Rambam Health Care Campus Company Overview 73

5.31 ReCor Medical Inc Company Overview 74

5.32 Strait Access Technologies (Pty) Ltd Company Overview 75

5.33 Symetis SA Company Overview 76

5.34 TransCardiac Therapeutics, LLC Company Overview 77

5.35 TTK Healthcare Ltd Company Overview 78

5.36 University of Manitoba Company Overview 79

5.37 Valcare Medical Company Overview 80

5.38 Valtech Cardio Ltd Company Overview 84

5.39 Viacor Inc Company Overview 91

6 Cardiac Valve Repairs- Recent Developments 92

6.1 May 24, 2018: Medtronic Reports Fourth Quarter And Fiscal Year 2018 Financial Results 92

6.2 May 24, 2018: CollPlant Announces First Quarter 2018 Financial Results 94

6.3 May 21, 2018: Edwards Announces Key Events For EuroPCR 2018 96

6.4 May 16, 2018: First patient treated in First-in-Man study of CoreMedic's ChordArt mitral valve repair system 97

6.5 May 14, 2018: Ancora Heart Expands Enrollment of U.S. Early Feasibility Study for the AccuCinch System for Left Ventricular Repair 97

6.6 May 08, 2018: Corindus Announces First Quarter 2018 Financial Results 98

6.7 May 07, 2018: Medtronic Appoints Mike Weinstein As Senior Vice President Of Strategy 99

6.8 May 02, 2018: Solvay's tough, biocompatible Radel PPSU selected for valve sizers in BioStable Science & Engineering's HAART 300 aortic annuloplasty kit 99

6.9 Apr 30, 2018: Edwards Granted CE Mark For First Transcatheter Tricuspid Therapy 100

6.10 Apr 30, 2018: Neochord DS1000 System Successfully Treats 20th Patient in Combination with Other Beating Heart Procedures 101

6.11 Apr 25, 2018: Minimally Invasive Investigational Procedure Treats Mitral Regurgitation as an Alternative to Open Heart Surgery 101

6.12 Apr 24, 2018: Edwards Lifesciences Announces First Quarter 2018 Financial Results 102

6.13 Apr 12, 2018: CollPlant Appoints Revital Mandil-Levin as Chief Business Development Officer 104

6.14 Apr 05, 2018: Dr. Laura Mauri to Join Medtronic as Vice President, Global Clinical Research & Analytics 104

6.15 Mar 29, 2018: Northwestern Memorial Hospital Surgeon First in Illinois to Repair Aortic Valve with Novel Ring 105

6.16 Mar 21, 2018: CollPlant Reports Fourth Quarter and Year End 2017 Financial Results and Provides Business Update 106

6.17 Mar 14, 2018: Corindus Reports Fourth Quarter and Full Year 2017 Results 107

6.18 Feb 22, 2018: Tricuspid Valve Repair Company 4Tech Appoints Tom Fleming as President and CEO, and Dr. Keith Dawkins as CMO 108

6.19 Feb 01, 2018: Edwards Lifesciences Reports Fourth Quarter Results 109

6.20 Jan 30, 2018: Alex Gu Named Senior Vice President and President of Medtronic's Greater China Region 111

6.21 Jan 29, 2018: Mardil Medical Appoints Martin Madden to Board of Directors 111

6.22 Jan 18, 2018: KEPHALIOS reports first patient implanted with Kalios, its breakthrough mitral valve repair device 112

6.23 Jan 16, 2018: CollPlant Appoints David Tsur as Chairman of the Board 113

6.24 Dec 19, 2017: Bob White Named Executive Vice President and President of Medtronic's Minimally Invasive Therapies Group; Chris Lee to Assume Leadership of Medtronic's Asia Pacific Region 113

6.25 Dec 08, 2017: HighLife Names Former Biosensors CEO as Chairman of the Board 114

6.26 Dec 07, 2017: Edwards Lifesciences Outlines Growth Strategy At Annual Investor Conference 115

6.27 Nov 21, 2017: Medtronic Reports Second Quarter Financial Results 116

6.28 Nov 09, 2017: Dextera Surgical Reports Fiscal 2018 First Quarter Financial Results 119

6.29 Nov 08, 2017: Medtronic Announces Preliminary Second Quarter Revenue 120

6.30 Nov 07, 2017: Corindus Vascular Robotics Reports Third Quarter 2017 Results 121

6.31 Nov 02, 2017: Medtronic Releases Fiscal Year 2017 Integrated Performance Report 122

6.32 Oct 24, 2017: Edwards Lifesciences Announces Third Quarter Results 123

6.33 Oct 23, 2017: Micro Interventional Devices Continues Clinical Success of MIA Technology 125

6.34 Oct 06, 2017: Medtronic Provides Update on Impact from Hurricane Maria 126

6.35 Oct 05, 2017: Dextera Surgical Provides Corporate Update 127

6.36 Sep 26, 2017: BioStable Science & Engineering Announces the First Commercial Use of the HAART 200 Aortic Annuloplasty Device 127

6.37 Sep 24, 2017: Edwards Announces Key Events For PCR London Valves 2017 128

6.38 Sep 18, 2017: Cardiosolutions Key US Patent Application for Adjustable Spacer Technology to Treat Heart Valve Regurgitation Receives Notice of Allowance 128

6.39 Sep 07, 2017: Micro Interventional Devices Completes First Clinical Tricuspid Bicuspidization Procedure Utilizing MIA Technology 129

6.40 Aug 22, 2017: Medtronic Reports First Quarter Financial Results 130

6.41 Aug 15, 2017: BioStable Science & Engineering Announces FDA Clearance of the HAART 200 Aortic Annuloplasty Device for Bicuspid Aortic Valve Repair 133

6.42 Aug 09, 2017: Abbott Leads Way In First Clinical Trial Of Minimally Invasive Clip-Based Repair System For Leaky Tricuspid Heart Valves 133

6.43 Aug 08, 2017: John K. Bakewell Joins Corindus Vascular Robotics Board of Directors 134

6.44 Aug 08, 2017: Dextera Surgical Reports Fiscal 2017 Fourth Quarter Financial Results 135

6.45 Aug 08, 2017: Corindus Vascular Robotics Reports Second Quarter 2017 Results 136

6.46 Jul 26, 2017: Edwards Lifesciences Reports Second Quarter Results 136

6.47 Jul 24, 2017: Millipede, Announces First Cases with 50mm Transcatheter Annuloplasty Ring Expanding Treatable Patient Population 138

6.48 Jul 18, 2017: Karolinska Institutet: Fewer infections in mechanical heart valves 138

6.49 Jul 10, 2017: Andrew ElBardissi, M.D. Named to NeoChord Board of Directors 139

6.50 Jun 14, 2017: BioStable Science & Engineering Announces U.S. Pilot Launch and First Commercial Use of the HAART 300 Aortic Annuloplasty Device 140

7 Appendix 141

7.1 Methodology 141

7.2 About GlobalData 144

7.3 Contact Us 144

7.4 Disclaimer 144

List of Figure

1.2 List of Figures

Figure 1: Cardiac Valve Repairs-Pipeline Products by Stage of Development 11

Figure 2: Cardiac Valve Repairs-Pipeline Products by Segment 12

Figure 3: Cardiac Valve Repairs-Pipeline Products by Territory 13

Figure 4: Cardiac Valve Repairs-Pipeline Products by Regulatory Path 14

Figure 5: Cardiac Valve Repairs-Pipeline Products by Estimated Approval Date 15

Figure 6: Cardiac Valve Repairs-Ongoing Clinical Trials 16

List of Table

1.1 List of Tables

Table 1: Cardiac Valve Repairs-Pipeline Products by Stage of Development 11

Table 2: Cardiac Valve Repairs-Pipeline Products by Segment 12

Table 3: Cardiac Valve Repairs-Pipeline Products by Territory 13

Table 4: Cardiac Valve Repairs-Pipeline Products by Regulatory Path 14

Table 5: Cardiac Valve Repairs-Pipeline Products by Estimated Approval Date 15

Table 6: Cardiac Valve Repairs-Ongoing Clinical Trials 16

Table 7: Cardiac Valve Repairs Companies-Pipeline Products by Stage of Development 17

Table 8: Cardiac Valve Repairs-Pipeline Products by Stage of Development 19

Table 9: Abbott Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 21

Table 10: Transcatheter Tricuspid Valve Repair System-Product Status 21

Table 11: Transcatheter Tricuspid Valve Repair System-Product Description 21

Table 12: Abbott Vascular Inc-Ongoing Clinical Trials Overview 22

Table 13: Transcatheter Tricuspid Valve Repair System-Trial to Evaluate Treatment with Abbott Transcatheter Clip Repair System in Patients with Moderate or Greater Tricuspid Regurgitation: TRILUMINATE 23

Table 14: Admedus Ltd Pipeline Products & Ongoing Clinical Trials Overview 24

Table 15: 3D Curve-Product Status 24

Table 16: 3D Curve-Product Description 24

Table 17: Ample Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 25

Table 18: PS3 System-Product Status 25

Table 19: PS3 System-Product Description 25

Table 20: Ancora Heart Inc Pipeline Products & Ongoing Clinical Trials Overview 26

Table 21: AccuCinch Ventriculoplasty System-Product Status 26

Table 22: AccuCinch Ventriculoplasty System-Product Description 26

Table 23: Ancora Heart Inc-Ongoing Clinical Trials Overview 27

Table 24: AccuCinch Ventriculoplasty System-A Study of Percutaneous Treatment of Mitral Regurgitation Using the AccuCinch System 28

Table 25: BioStable Science & Engineering, Inc. Pipeline Products & Ongoing Clinical Trials Overview 29

Table 26: HAART 200 Aortic Annuloplasty Device-Product Status 29

Table 27: HAART 200 Aortic Annuloplasty Device-Product Description 29

Table 28: Cardiosolutions Inc Pipeline Products & Ongoing Clinical Trials Overview 30

Table 29: Mitra-Spacer-Product Status 30

Table 30: Mitra-Spacer-Product Description 30

Table 31: Celyad SA Pipeline Products & Ongoing Clinical Trials Overview 31

Table 32: Heart Access Sheath-Mitral Valve Repair-Product Status 31

Table 33: Heart Access Sheath-Mitral Valve Repair-Product Description 31

Table 34: Mitral Valve Neo-chordae-Product Status 32

Table 35: Mitral Valve Neo-chordae-Product Description 32

Table 36: Children's Hospital Boston Pipeline Products & Ongoing Clinical Trials Overview 33

Table 37: Endovascular Prosthesis-Product Status 33

Table 38: Endovascular Prosthesis-Product Description 33

Table 39: Mitral Valve Repair Clip-Product Status 34

Table 40: Mitral Valve Repair Clip-Product Description 34

Table 41: Tricuspid Valve Repair Device-Product Status 34

Table 42: Tricuspid Valve Repair Device-Product Description 34

Table 43: CollPlant Ltd Pipeline Products & Ongoing Clinical Trials Overview 35

Table 44: VergenixHVR-Product Status 35

Table 45: VergenixHVR-Product Description 35

Table 46: CoreMedic AG Pipeline Products & Ongoing Clinical Trials Overview 36

Table 47: ChordArt-Product Status 36

Table 48: ChordArt-Product Description 36

Table 49: CoreMedic AG-Ongoing Clinical Trials Overview 37

Table 50: ChordArt-First-in-man Chagall Study on Safety and Efficacy of ChordArt Mitral Valve Repair System 38

Table 51: Coroneo Inc. Pipeline Products & Ongoing Clinical Trials Overview 39

Table 52: Extra-Aortic Annuloplasty Ring-Product Status 39

Table 53: Extra-Aortic Annuloplasty Ring-Product Description 39

Table 54: CUBE SRL Pipeline Products & Ongoing Clinical Trials Overview 40

Table 55: Mitral-FERCube Ring-Product Status 40

Table 56: Mitral-FERCube Ring-Product Description 40

Table 57: Daidalos Solutions BV Pipeline Products & Ongoing Clinical Trials Overview 41

Table 58: Sutureless Mitral Valve Repair Ring-Product Status 41

Table 59: Sutureless Mitral Valve Repair Ring-Product Description 41

Table 60: Sutureless Tricuspid Valve Repair Ring-Product Status 42

Table 61: Sutureless Tricuspid Valve Repair Ring-Product Description 42

Table 62: Edwards Lifesciences Corp Pipeline Products & Ongoing Clinical Trials Overview 43

Table 63: Coapsys-Product Status 43

Table 64: Coapsys-Product Description 43

Table 65: FORMA Tricuspid Repair System-Product Status 44

Table 66: FORMA Tricuspid Repair System-Product Description 44

Table 67: MOBIUS Leaflet Repair System-Product Status 44

Table 68: MOBIUS Leaflet Repair System-Product Description 44

Table 69: Edwards Lifesciences Corp-Ongoing Clinical Trials Overview 45

Table 70: FORMA Tricuspid Repair System-Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System 46

Table 71: FORMA Tricuspid Repair System-International Multisite Transcatheter Tricuspid Valve Therapies Registry 46

Table 72: FORMA Tricuspid Repair System-The SPACER Trial-Repair of Tricuspid Valve Regurgitation Using the Edwards Tricuspid Transcatheter Repair System 46

Table 73: Emory University Pipeline Products & Ongoing Clinical Trials Overview 47

Table 74: MitraSurg-Product Status 47

Table 75: MitraSurg-Product Description 47

Table 76: Georgia Institute of Technology Pipeline Products & Ongoing Clinical Trials Overview 48

Table 77: Tricuspid Annuloplasty Rings-Product Status 48

Table 78: Tricuspid Annuloplasty Rings-Product Description 48

Table 79: Hangzhou DeJin Medtech Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 49

Table 80: Second Generation Mitral Valve Repair Device-Product Status 49

Table 81: Second Generation Mitral Valve Repair Device-Product Description 49

Table 82: Kephalios SAS Pipeline Products & Ongoing Clinical Trials Overview 50

Table 83: Mitral Annuloplasty Ring-Product Status 50

Table 84: Mitral Annuloplasty Ring-Product Description 50

Table 85: Lartim Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 51

Table 86: Mitral Valve Repair Device-Product Status 51

Table 87: Mitral Valve Repair Device-Product Description 51

Table 88: Mardil Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 52

Table 89: VenTouch Triad Targeted Ventricular Reshaping System-Product Status 52

Table 90: VenTouch Triad Targeted Ventricular Reshaping System-Product Description 52

Table 91: Mardil Medical, Inc.-Ongoing Clinical Trials Overview 53

Table 92: VenTouch Triad Targeted Ventricular Reshaping System-Evaluation of the Minimally Invasive VenTouch System in the Treatment of Functional Mitral Regurgitation (FMR) a First-in Man Continuation Study 54

Table 93: Mayo Clinic Pipeline Products & Ongoing Clinical Trials Overview 55

Table 94: Catheter-Based Mitral Valve Repair Device-Product Status 55

Table 95: Catheter-Based Mitral Valve Repair Device-Product Description 55

Table 96: Medtentia International Ltd Oy Pipeline Products & Ongoing Clinical Trials Overview 56

Table 97: Double Helix Mitral Annuloplasty System-Product Status 56

Table 98: Double Helix Mitral Annuloplasty System-Product Description 56

Table 99: MiCardia Corp Pipeline Products & Ongoing Clinical Trials Overview 57

Table 100: enCorTC-Product Status 57

Table 101: enCorTC-Product Description 57

Table 102: Michigan Critical Care Consultants, Inc. Pipeline Products & Ongoing Clinical Trials Overview 58