Interventional Neurology-Medical Devices Pipeline Assessment, 2017

Table of Contents

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 8

1.2 List of Figures 14

2 Introduction 15

2.1 Interventional Neurology Overview 15

3 Products under Development 16

3.1 Interventional Neurology-Pipeline Products by Stage of Development 16

3.2 Interventional Neurology-Pipeline Products by Segment 17

3.3 Interventional Neurology-Pipeline Products by Territory 18

3.4 Interventional Neurology-Pipeline Products by Regulatory Path 19

3.5 Interventional Neurology-Pipeline Products by Estimated Approval Date 20

3.6 Interventional Neurology-Ongoing Clinical Trials 21

4 Interventional Neurology-Pipeline Products under Development by Companies 22

4.1 Interventional Neurology Companies-Pipeline Products by Stage of Development 22

4.2 Interventional Neurology-Pipeline Products by Stage of Development 25

5 Interventional Neurology Companies and Product Overview 28

5.1 Alcyone Lifesciences Inc Company Overview 28

5.2 Amnis Therapeutics Ltd Company Overview 29

5.3 Anaconda BioMed SL Company Overview 32

5.4 Aneuclose LLC Company Overview 33

5.5 Apeliotus Technologies Company Overview 35

5.6 Arterain Medical Inc (Inactive) Company Overview 36

5.7 Avantec Vascular Corporation Company Overview 37

5.8 BioCure, Inc. Company Overview 39

5.9 Ceretrieve Ltd Company Overview 40

5.10 Codman & Shurtleff Inc Company Overview 41

5.11 Collagen Matrix Inc Company Overview 44

5.12 Cordis Corp Company Overview 45

5.13 CranioVation Company Overview 46

5.14 CVTec Cerebrovascular Technologies GmbH Company Overview 47

5.15 Dartmouth College Company Overview 48

5.16 DePuy Synthes Inc Company Overview 50

5.17 EchoGuide Medical, Inc. (Inactive) Company Overview 52

5.18 Ecole Polytechnique Federale de Lausanne Company Overview 53

5.19 Gaudi Vascular, Inc. Company Overview 54

5.20 Hansen Medical Inc Company Overview 55

5.21 Hansjorg Wyss Institute for Biologically Inspired Engineering Company Overview 56

5.22 Hibernia Medical Company Overview 57

5.23 Insera Therapeutics, LLC Company Overview 58

5.24 InspireMD Inc Company Overview 59

5.25 Medikit Co Ltd Company Overview 60

5.26 Medtronic plc Company Overview 64

5.27 Merlin MD Pte. Ltd. Company Overview 71

5.28 Metactive Medical LLC Company Overview 72

5.29 MicroPort Scientific Corp Company Overview 73

5.30 MicroVention, Inc. Company Overview 79

5.31 MindFrame Inc Company Overview 88

5.32 MiVi Neuroscience, LLC Company Overview 89

5.33 MRI Interventions Inc Company Overview 90

5.34 NEOS Surgery SL Company Overview 91

5.35 Neuravi Ltd Company Overview 93

5.36 NeuroInterventional Therapeutics, Inc. Company Overview 97

5.37 NeuroInterventions Company Overview 98

5.38 Neurosigma Inc Company Overview 99

5.39 Neurosyntec LLC. (Inactive) Company Overview 100

5.40 NexGen Medical Systems Inc Company Overview 101

5.41 NSVascular, Inc. Company Overview 102

5.42 Oxford Endovascular Limited Company Overview 103

5.43 Palmaz Scientific Inc Company Overview 104

5.44 Penumbra Inc Company Overview 105

5.45 Philips Healthcare Company Overview 108

5.46 PhotoThera Inc (Inactive) Company Overview 109

5.47 Pulsar Vascular, Inc. Company Overview 114

5.48 Pulse Therapeutics Inc Company Overview 115

5.49 Rapid Medical Company Overview 118

5.50 Rontis AG Company Overview 119

5.51 Shape Memory Therapeutics, Inc. Company Overview 120

5.52 Sree Chitra Tirunal Institute for Medical Sciences & Technology Company Overview 122

5.53 Strategic Polymer Sciences, Inc Company Overview 123

5.54 Taewoong Medical Co Ltd Company Overview 124

5.55 Terumo Corp Company Overview 125

5.56 Triticum Medical Ltd. Company Overview 127

5.57 Twin Star Medical Inc Company Overview 128

5.58 University of California Los Angeles Company Overview 129

5.59 University of California San Francisco Company Overview 132

5.60 University of Minnesota Company Overview 133

5.61 University of South Florida Company Overview 134

5.62 University of Wisconsin Madison Company Overview 135

5.63 University of Wolverhampton Company Overview 137

5.64 Valor Medical Inc Company Overview 138

5.65 Vascular Solutions Inc Company Overview 139

5.66 Viket Medical Corporation Company Overview 140

5.67 Weill Cornell Medical College Company Overview 141

5.68 Zoll Medical Corporation Company Overview 142

6 Interventional Neurology- Recent Developments 143

6.1 May 11, 2017: Healthcare Veteran John Fletcher Joins MRI Interventions' Board of Directors 143

6.2 May 09, 2017: Penumbra Reports First Quarter 2017 Financial Results 143

6.3 May 09, 2017: Voyager Therapeutics Reports First Quarter 2017 Financial Results and Corporate Highlights 144

6.4 May 04, 2017: AxoGen Reports 2017 First Quarter Financial Results 145

6.5 Apr 27, 2017: Boston Scientific Announces Results For First Quarter 2017 146

6.6 Apr 27, 2017: MRI Interventions Announces 2017 First Quarter Results 147

6.7 Apr 27, 2017: Merit Medical Reports Results for First Quarter of 2017 149

6.8 Apr 25, 2017: Stryker reports first quarter 2017 results 150

6.9 Apr 24, 2017: Publication Provides Guidelines to Reduce Transportation Risks Associated with Neurosurgical Laser Ablation Multi-site Workflows 151

6.10 Apr 24, 2017: Medtronic Announces Most Advanced StealthStation for Neurosurgery 152

6.11 Apr 24, 2017: Anaconda Biomed Engages Creganna Medical 153

6.12 Apr 24, 2017: Nexstim Appoints Hanna Kotola as VP of Legal Affairs 153

6.13 Apr 23, 2017: Bard Announces First Quarter Results 153

6.14 Apr 21, 2017: Penumbra Appoints Bridget O'Rourke to its Board of Directors 154

6.15 Apr 19, 2017: ClearPoint Neuro Navigation System's Real-time MRI Guided Platform to be Featured at AANS Practical Clinics for Fourth Consecutive Year 155

6.16 Apr 19, 2017: Johnson & Johnson reports Q1 2017 results 155

6.17 Apr 18, 2017: Johnson & Johnson Reports 2017 First-Quarter Results 157

6.18 Apr 11, 2017: Stroke patients in England set to receive revolutionary new treatment 159

6.19 Apr 06, 2017: MRI Interventions Announces Record Quarterly Revenue, Record ClearPoint System Procedures in 2017 First Quarter 160

6.20 Apr 06, 2017: MRI Interventions Announces Record Quarterly Revenue, Record ClearPoint System Procedures in 2017 First Quarter 161

6.21 Apr 04, 2017: $3.6 million to fund personalized 3-D brain maps to guide neurosurgeries 161

6.22 Mar 30, 2017: MPSC Announces 2016 Annual Results 163

6.23 Mar 28, 2017: Nexstim: The decisions of the Board of Directors 164

6.24 Mar 23, 2017: Synaptive Medical Expands Medtech Expertise Through Board Additions 165

6.25 Mar 21, 2017: Metactive Medical Announces Issuance of Patent on Ballstent Embolization Device 166

6.26 Mar 20, 2017: MicroPort NeuroTech Hosts WILLIS Academic Symposium 166

6.27 Mar 15, 2017: Voyager Therapeutics Reports Fourth Quarter and Full Year 2016 Financial Results and Corporate Highlights 167

6.28 Mar 13, 2017: Cook Medical Announces Umesh Patel as President of Cook Biotech 170

6.29 Mar 09, 2017: Changes in Nexstim Management Team 170

6.30 Mar 07, 2017: MicroVention And Terumo Announce Data From Multicenter GREAT Study 170

6.31 Mar 07, 2017: Anteo Technologies Announces Verification Study With Cook Medical Australia 171

6.32 Feb 28, 2017: Nexstim: Financial Statement Release 2016 172

6.33 Feb 28, 2017: MRI Interventions Announces 2016 Fourth Quarter and Full Year Results 174

6.34 Feb 28, 2017: Penumbra Reports Fourth Quarter and Full Year 2016 Financial Results 177

6.35 Feb 28, 2017: Government of Canada Invests in Research to Advance Patient Care 178

6.36 Feb 23, 2017: New Solitaire Stent Retriever Study Validates Outcomes and Real-World Application of Stroke Treatment Best Practices 179

6.37 Feb 22, 2017: Independent Study Supports Use of Penumbra Aspiration as Frontline Thrombectomy Therapy for Acute Ischemic Stroke 180

6.38 Feb 22, 2017: AxoGen Reports 2016 Fourth Quarter and Full Year Financial Results 181

6.39 Feb 21, 2017: Neuravi Announces Completion of Patient Enrollment in Clinical Trial of a Novel Stent Retriever for Acute Ischemic Stroke 183

6.40 Feb 21, 2017: Medtronic Reports Third Quarter Financial Results 184

6.41 Feb 21, 2017: Merit Medical Reports Results for Fourth Quarter and Year Ended December 31, 2016 187

6.42 Feb 16, 2017: InspireMD Provides Year End Business Update and Reports Financial Results for the Fourth Quarter and Year Ended December 31, 2016 188

6.43 Feb 14, 2017: MicroPort Receives CFDA Approval for APOLLO Intracranial Stent System in Large Sizes 189

6.44 Feb 09, 2017: Terumo Announces Change of Executive Officers 189

6.45 Feb 06, 2017: Medtronic Awarded U.S. Department of Veterans Affairs National Contracts for Home Telehealth Technologies, with Three Other Vendors 190

6.46 Feb 02, 2017: Boston Scientific Announces Results For Fourth Quarter And Full Year Ended December 31, 2016 191

6.47 Jan 31, 2017: Terumo Opens a Branch in Yangon 193

6.48 Jan 26, 2017: Bard Announces Fourth Quarter Results 193

6.49 Jan 24, 2017: Stryker reports 2016 results and 2017 outlook 194

6.50 Jan 24, 2017: Johnson & Johnson Reports 2016 Fourth-Quarter Results 195

6.51 Jan 24, 2017: MRI Interventions Announces Year-End Update, Including 2016 Fourth Quarter and Full Year Revenues 198

6.52 Jan 16, 2017: MicroPort Attends 19th Annual Meeting of China Health Economics Association 199

6.53 Jan 10, 2017: Stryker provides 2016 preliminary net sales results 199

6.54 Jan 09, 2017: Anaconda BioMed Appoints Mr. Giovanni Leo to its Advisory Board 201

6.55 Jan 09, 2017: AxoGen Preannounces Estimated Fourth Quarter and Full Year 2016 Revenue 201

6.56 Jan 09, 2017: Johnson & Johnson Medical Devices Companies Launch CareAdvantage, a Suite of Holistic, Insights-Driven Capabilities to Help U.S. Health Systems Navigate Value-Based Care 202

6.57 Jan 05, 2017: AxoGen Appoints Ivica Ducic Medical Director 203

6.58 Jan 05, 2017: Voyager Therapeutics Elects Wendy Dixon, Ph.D. and Glenn Pierce, M.D., Ph.D. to Board of Directors 203

6.59 Jan 04, 2017: MRI Interventions' ClearPoint Surpasses Single-Year Milestone of 500 Procedures in 2016 204

6.60 Jan 03, 2017: Amnis Therapeutics Starts its First Clinical Trial with its Neuro Thrombectomy Device 205

6.61 Jan 03, 2017: Voyager Therapeutics Appoints Jane Pritchett Henderson as Chief Financial Officer 205

7 Appendix 287

7.1 Methodology 287

7.2 About GlobalData 290

7.3 Contact Us 290

7.4 Disclaimer 290

List of Figure

1.2 List of Figures

Figure 1: Interventional Neurology-Pipeline Products by Stage of Development 17

Figure 2: Interventional Neurology-Pipeline Products by Segment 18

Figure 3: Interventional Neurology-Pipeline Products by Territory 19

Figure 4: Interventional Neurology-Pipeline Products by Regulatory Path 20

Figure 5: Interventional Neurology-Pipeline Products by Estimated Approval Date 21

Figure 6: Interventional Neurology-Ongoing Clinical Trials 22

List of Table

1.1 List of Tables

Table 1: Interventional Neurology-Pipeline Products by Stage of Development 17

Table 2: Interventional Neurology-Pipeline Products by Segment 18

Table 3: Interventional Neurology-Pipeline Products by Territory 19

Table 4: Interventional Neurology-Pipeline Products by Regulatory Path 20

Table 5: Interventional Neurology-Pipeline Products by Estimated Approval Date 21

Table 6: Interventional Neurology-Ongoing Clinical Trials 22

Table 7: Interventional Neurology Companies-Pipeline Products by Stage of Development 23

Table 8: Interventional Neurology-Pipeline Products by Stage of Development 26

Table 9: Alcyone Lifesciences Inc Pipeline Products & Ongoing Clinical Trials Overview 29

Table 10: Alcyone Microcatheter-Product Status 29

Table 11: Alcyone Microcatheter-Product Description 29

Table 12: Amnis Therapeutics Ltd Pipeline Products & Ongoing Clinical Trials Overview 30

Table 13: Golden Retriever-Product Status 30

Table 14: Golden Retriever-Product Description 30

Table 15: Amnis Therapeutics Ltd-Ongoing Clinical Trials Overview 31

Table 16: Golden Retriever-Amnis Therapeutics Thrombectomy Device-First in Man (FIM) Safety and Performance Study 32

Table 17: Anaconda BioMed SL Pipeline Products & Ongoing Clinical Trials Overview 33

Table 18: ANCD BRAIN-Product Status 33

Table 19: ANCD BRAIN-Product Description 33

Table 20: Aneuclose LLC Pipeline Products & Ongoing Clinical Trials Overview 34

Table 21: Aneurysm Occlusion Saddle-Product Status 34

Table 22: Aneurysm Occlusion Saddle-Product Description 34

Table 23: Janjua Aneurysm Net-Product Status 35

Table 24: Janjua Aneurysm Net-Product Description 35

Table 25: Apeliotus Technologies Pipeline Products & Ongoing Clinical Trials Overview 36

Table 26: Polymer Stent for Cerebral Aneurysms-Product Status 36

Table 27: Polymer Stent for Cerebral Aneurysms-Product Description 36

Table 28: Arterain Medical Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 37

Table 29: Catheter Based System-Product Status 37

Table 30: Catheter Based System-Product Description 37

Table 31: Avantec Vascular Corporation Pipeline Products & Ongoing Clinical Trials Overview 38

Table 32: Endovascular Embolization Device-Product Status 38

Table 33: Endovascular Embolization Device-Product Description 38

Table 34: Ischemic Stroke Therapy Device-Product Status 39

Table 35: Ischemic Stroke Therapy Device-Product Description 39

Table 36: BioCure, Inc. Pipeline Products & Ongoing Clinical Trials Overview 40

Table 37: GelCoil-Product Status 40

Table 38: GelCoil-Product Description 40

Table 39: Ceretrieve Ltd Pipeline Products & Ongoing Clinical Trials Overview 41

Table 40: Device-Ischemic Stroke-Product Status 41

Table 41: Device-Ischemic Stroke-Product Description 41

Table 42: Codman & Shurtleff Inc Pipeline Products & Ongoing Clinical Trials Overview 42

Table 43: Covered Stent-Product Status 42

Table 44: Covered Stent-Product Description 42

Table 45: Next Generation Balloon Expandable Stent-Product Status 43

Table 46: Next Generation Balloon Expandable Stent-Product Description 43

Table 47: Next Generation REVIVE SE-Product Status 43

Table 48: Next Generation REVIVE SE-Product Description 44

Table 49: Self-Expanding Stent-Product Status 44

Table 50: Self-Expanding Stent-Product Description 44

Table 51: Collagen Matrix Inc Pipeline Products & Ongoing Clinical Trials Overview 45

Table 52: Collagen-based Coils-Product Status 45

Table 53: Collagen-based Coils-Product Description 45

Table 54: Cordis Corp Pipeline Products & Ongoing Clinical Trials Overview 46

Table 55: Flow Diverter-Product Status 46

Table 56: Flow Diverter-Product Description 46

Table 57: CranioVation Pipeline Products & Ongoing Clinical Trials Overview 47

Table 58: Brain Aneurysm Clip-Product Status 47

Table 59: Brain Aneurysm Clip-Product Description 47

Table 60: CVTec Cerebrovascular Technologies GmbH Pipeline Products & Ongoing Clinical Trials Overview 48

Table 61: CoilAlarm-Product Status 48

Table 62: CoilAlarm-Product Description 48

Table 63: Dartmouth College Pipeline Products & Ongoing Clinical Trials Overview 49

Table 64: Aneurysm Clip Applicator-Product Status 49

Table 65: Aneurysm Clip Applicator-Product Description 49

Table 66: Cerebral Aneurysm Clip-Product Status 50

Table 67: Cerebral Aneurysm Clip-Product Description 50

Table 68: DePuy Synthes Inc Pipeline Products & Ongoing Clinical Trials Overview 51

Table 69: Liquid Embolic System-Product Status 51

Table 70: Liquid Embolic System-Product Description 51

Table 71: Occlusion Balloons-Product Status 52

Table 72: Occlusion Balloons-Product Description 52

Table 73: EchoGuide Medical, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 53

Table 74: Ultrasound Catheter Navigation Device-Product Status 53

Table 75: Ultrasound Catheter Navigation Device-Product Description 53

Table 76: Ecole Polytechnique Federale de Lausanne Pipeline Products & Ongoing Clinical Trials Overview 54

Table 77: e-Dura Implant-Product Status 54

Table 78: e-Dura Implant-Product Description 54

Table 79: Gaudi Vascular, Inc. Pipeline Products & Ongoing Clinical Trials Overview 55

Table 80: Intracranial Stent-Product Status 55

Table 81: Intracranial Stent-Product Description 55

Table 82: Hansen Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 56

Table 83: Magellan Robotic System-Neurological Indication-Product Status 56

Table 84: Magellan Robotic System-Neurological Indication-Product Description 56

Table 85: Hansjorg Wyss Institute for Biologically Inspired Engineering Pipeline Products & Ongoing Clinical Trials Overview 57

Table 86: Blood Clots Clearing Device-Product Status 57

Table 87: Blood Clots Clearing Device-Product Description 57

Table 88: Hibernia Medical Pipeline Products & Ongoing Clinical Trials Overview 58

Table 89: Hybernia Safety Catheter-Neuroprotection-Product Status 58

Table 90: Hybernia Safety Catheter-Neuroprotection-Product Description 58

Table 91: Insera Therapeutics, LLC Pipeline Products & Ongoing Clinical Trials Overview 59

Table 92: SHELTER-Product Status 59

Table 93: SHELTER-Product Description 59

Table 94: InspireMD Inc Pipeline Products & Ongoing Clinical Trials Overview 60

Table 95: NVGuard Neurovascular-Product Status 60

Table 96: NVGuard Neurovascular-Product Description 60

Table 97: Medikit Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 61

Table 98: Aspirarecath-Product Status 61

Table 99: Aspirarecath-Product Description 62

Table 100: Axcelguide-Product Status 62

Table 101: Axcelguide-Product Description 62

Table 102: Cerulean G-Product Status 63

Table 103: Cerulean G-Product Description 63

Table 104: Slimguide-Product Status 63

Table 105: Slimguide-Product Description 64

Table 106: Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 65

Table 107: Artisse Intrasaccular Device-Product Status 65

Table 108: Artisse Intrasaccular Device-Product Description 66

Table 109: Lazarus Cover-Product Status 66

Table 110: Lazarus Cover-Product Description 66

Table 111: Lazarus ReCover-Product Status 67

Table 112: Lazarus ReCover-Product Description 67

Table 113: Medina Embolization Device-Product Status 67

Table 114: Medina Embolization Device-Product Description 68

Table 115: Pipeline Flex w/Shield-Surface Enhancement-Product Status 68

Table 116: Pipeline Flex w/Shield-Surface Enhancement-Product Description 68

Table 117: UNO Neurovascular Embolization System-Product Status 69

Table 118: UNO Neurovascular Embolization System-Product Description 69

Table 119: Medtronic plc-Ongoing Clinical Trials Overview 70

Table 120: Medina Embolization Device-Medina Embolization Device in Neurovascular Aneurysms Study-A Post Market Clinical Follow-up Study: The MEDINA Study 71

Table 121: Merlin MD Pte. Ltd. Pipeline Products & Ongoing Clinical Trials Overview 72

Table 122: Next Generation Device For Cerebral Aneurysm-Product Status 72

Table 123: Next Generation Device For Cerebral Aneurysm-Product Description 72

Table 124: Metactive Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 73

Table 125: Ballstent Microcatheter-Product Status 73

Table 126: Ballstent Microcatheter-Product Description 73

Table 127: MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 74

Table 128: Clot Retrieval Device-Product Status 74

Table 129: Clot Retrieval Device-Product Description 74

Table 130: Embolization Coils-Product Status 75

Table 131: Embolization Coils-Product Description 75

Table 132: Micro-Catheter-Product Status 75

Table 133: Micro-Catheter-Product Description 76

Table 134: Tubridge-Product Status 76

Table 135: Tubridge-Product Description 76

Table 136: Vertebral Artery Stent-Product Status 77

Table 137: Vertebral Artery Stent-Product Description 77

Table 138: MicroPort Scientific Corp-Ongoing Clinical Trials Overview 78

Table 139: Embolization Coils-Prospective, Randomized, Controlled, Open Label, All China, Multi-center, Registration Trial of the Microport Neurotech Coil Embolization System for the Treatment of Intracranial Aneurysms 79

Table 140: MicroVention, Inc. Pipeline Products & Ongoing Clinical Trials Overview 80

Table 141: Advanced Coil-Product Status 80

Table 142: Advanced Coil-Product Description 80

Table 143: Advanced WEB Aneurysm Embolization Device-Product Status 81

Table 144: Advanced WEB Aneurysm Embolization Device-Product Description 81

Table 145: Coated Stent-Product Status 81

Table 146: Coated Stent-Product Description 82

Table 147: ERIC Retrieval Device-Product Status 82

Table 148: ERIC Retrieval Device-Product Description 82

Table 149: FRED Flow-Diverting Stent-Product Status 83

Table 150: FRED Flow-Diverting Stent-Product Description 83

Table 151: WEB Aneurysm Embolization System-Product Status 83

Table 152: WEB Aneurysm Embolization System-Product Description 84

Table 153: MicroVention, Inc.-Ongoing Clinical Trials Overview 85

Table 154: WEB Aneurysm Embolization System-Clinical Assessment of Web Device in Ruptured Aneurysms 86

Table 155: WEB Aneurysm Embolization System-CLinical Assessment of WEB Device in Ruptured aneurysms (CLARYS): CLARYS 86

Table 156: WEB Aneurysm Embolization System-The WEB Intrasaccular Therapy Study (WEB-IT) 86

Table 157: WEB Aneurysm Embolization System-WEB Clinical Assessment of IntraSaccular Aneurysm Therapy 87

Table 158: WEB Aneurysm Embolization System-WEB French Observatory 87