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Deep Brain Stimulators - Medical Devices Pipeline Assessment, 2016

Summary

GlobalData's Medical Devices sector report, “Deep Brain Stimulators - Medical Devices Pipeline Assessment, 2016" provides an overview of Deep Brain Stimulators currently in pipeline stage.

The report provides comprehensive information on the pipeline products with comparative analysis of the products at various stages of development. The report reviews major players involved in the pipeline product development. It also provides information about clinical trials in progress, which includes trial phase, trial status, trial start and end dates, and, the number of trials for the key Deep Brain Stimulators pipeline products.

This report is prepared using data sourced from in-house databases, secondary and primary research by GlobalData's team of industry experts.

*Note: Certain sections in the report may be removed or altered based on the availability and relevance of data in relation to the equipment type.

Scope

- Extensive coverage of the Deep Brain Stimulators under development
- The report reviews details of major pipeline products which includes, product description, licensing and collaboration details and other developmental activities
- The report reviews the major players involved in the development of Deep Brain Stimulators and list all their pipeline projects
- The coverage of pipeline products based on various stages of development ranging from Early Development to Approved / Issued stage
- The report provides key clinical trial data of ongoing trials specific to pipeline products
- Recent developments in the segment / industry

Reasons to buy

The report enables you to -
- Formulate significant competitor information, analysis, and insights to improve R&D strategies
- Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage
- Identify and understand important and diverse types of Deep Brain Stimulators under development
- Develop market-entry and market expansion strategies
- Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline
- In-depth analysis of the product’s current stage of development, territory and estimated launch date

Table Of Contents

Deep Brain Stimulators - Medical Devices Pipeline Assessment, 2016
1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 5
1.2 List of Figures 10
2 Introduction 11
2.1 Deep Brain Stimulators Overview 11
3 Products under Development 12
3.1 Deep Brain Stimulators - Pipeline Products by Stage of Development 12
3.2 Deep Brain Stimulators - Pipeline Products by Territory 13
3.3 Deep Brain Stimulators - Pipeline Products by Regulatory Path 14
3.4 Deep Brain Stimulators - Pipeline Products by Estimated Approval Date 15
3.5 Deep Brain Stimulators - Ongoing Clinical Trials 16
4 Deep Brain Stimulators - Pipeline Products under Development by Companies 17
4.1 Deep Brain Stimulators Companies - Pipeline Products by Stage of Development 17
4.2 Deep Brain Stimulators - Pipeline Products by Stage of Development 19
5 Deep Brain Stimulators Companies and Product Overview 21
5.1 Adaptive Neuromodulation GmbH Company Overview 21
5.1.1 Adaptive Neuromodulation GmbH Pipeline Products and Ongoing Clinical Trials Overview 21
5.2 Aleva Neurotherapeutics SA Company Overview 22
5.2.1 Aleva Neurotherapeutics SA Pipeline Products and Ongoing Clinical Trials Overview 22
5.3 Boston Scientific Corp Company Overview 25
5.3.1 Boston Scientific Corp Pipeline Products and Ongoing Clinical Trials Overview 25
5.4 Brainsway Ltd Company Overview 30
5.4.1 Brainsway Ltd Pipeline Products and Ongoing Clinical Trials Overview 30
5.5 Cerene Biomedics, Inc. Company Overview 40
5.5.1 Cerene Biomedics, Inc. Pipeline Products and Ongoing Clinical Trials Overview 40
5.6 Cerevast Therapeutics Inc Company Overview 41
5.6.1 Cerevast Therapeutics Inc Pipeline Products and Ongoing Clinical Trials Overview 41
5.7 Children's Hospital Boston Company Overview 42
5.7.1 Children's Hospital Boston Pipeline Products and Ongoing Clinical Trials Overview 42
5.8 Cleveland Medical Devices Inc Company Overview 43
5.8.1 Cleveland Medical Devices Inc Pipeline Products and Ongoing Clinical Trials Overview 43
5.9 Clinatec Company Overview 44
5.9.1 Clinatec Pipeline Products and Ongoing Clinical Trials Overview 44
5.10 Deep Brain Innovations, LLC Company Overview 45
5.10.1 Deep Brain Innovations, LLC Pipeline Products and Ongoing Clinical Trials Overview 45
5.11 Duke University Company Overview 50
5.11.1 Duke University Pipeline Products and Ongoing Clinical Trials Overview 50
5.12 Functional Neuromodulation Inc. Company Overview 51
5.12.1 Functional Neuromodulation Inc. Pipeline Products and Ongoing Clinical Trials Overview 51
5.13 Highland Instruments, Inc. Company Overview 53
5.13.1 Highland Instruments, Inc. Pipeline Products and Ongoing Clinical Trials Overview 53
5.14 Massachusetts General Hospital Company Overview 54
5.14.1 Massachusetts General Hospital Pipeline Products and Ongoing Clinical Trials Overview 54
5.15 Massachusetts Institute of Technology Company Overview 56
5.15.1 Massachusetts Institute of Technology Pipeline Products and Ongoing Clinical Trials Overview 56
5.16 Mayo Clinic US Company Overview 57
5.16.1 Mayo Clinic US Pipeline Products and Ongoing Clinical Trials Overview 57
5.17 Medtronic plc Company Overview 58
5.17.1 Medtronic plc Pipeline Products and Ongoing Clinical Trials Overview 58
5.18 National Cheng-Kung University Hospital Company Overview 62
5.18.1 National Cheng-Kung University Hospital Pipeline Products and Ongoing Clinical Trials Overview 62
5.19 NeuroPro Technologies Inc Company Overview 63
5.19.1 NeuroPro Technologies Inc Pipeline Products and Ongoing Clinical Trials Overview 63
5.20 Neurosigma Inc Company Overview 64
5.20.1 Neurosigma Inc Pipeline Products and Ongoing Clinical Trials Overview 64
5.21 Newronika s.r.l. Company Overview 66
5.21.1 Newronika s.r.l. Pipeline Products and Ongoing Clinical Trials Overview 66
5.22 Nuraleve Inc. Company Overview 67
5.22.1 Nuraleve Inc. Pipeline Products and Ongoing Clinical Trials Overview 67
5.23 Soterix Medical Inc Company Overview 68
5.23.1 Soterix Medical Inc Pipeline Products and Ongoing Clinical Trials Overview 68
5.24 Sree Chitra Tirunal Institute for Medical Sciences and Technology Company Overview 81
5.24.1 Sree Chitra Tirunal Institute for Medical Sciences and Technology Pipeline Products and Ongoing Clinical Trials Overview 81
5.25 St. Jude Medical Inc Company Overview 83
5.25.1 St. Jude Medical Inc Pipeline Products and Ongoing Clinical Trials Overview 83
5.26 SUNY Downstate Medical Center Company Overview 86
5.26.1 SUNY Downstate Medical Center Pipeline Products and Ongoing Clinical Trials Overview 86
5.27 The University of Utah Company Overview 87
5.27.1 The University of Utah Pipeline Products and Ongoing Clinical Trials Overview 87
5.28 University of California Los Angeles Company Overview 89
5.28.1 University of California Los Angeles Pipeline Products and Ongoing Clinical Trials Overview 89
5.29 University of Central Florida Company Overview 91
5.29.1 University of Central Florida Pipeline Products and Ongoing Clinical Trials Overview 91
5.30 University of Illinois Company Overview 93
5.30.1 University of Illinois Pipeline Products and Ongoing Clinical Trials Overview 93
5.31 University of Michigan Company Overview 95
5.31.1 University of Michigan Pipeline Products and Ongoing Clinical Trials Overview 95
5.32 University of Milan Company Overview 96
5.32.1 University of Milan Pipeline Products and Ongoing Clinical Trials Overview 96
5.33 University of Oxford Company Overview 97
5.33.1 University of Oxford Pipeline Products and Ongoing Clinical Trials Overview 97
5.34 University of South Florida Company Overview 98
5.34.1 University of South Florida Pipeline Products and Ongoing Clinical Trials Overview 98
5.35 Wedge Therapeutics Company Overview 99
5.35.1 Wedge Therapeutics Pipeline Products and Ongoing Clinical Trials Overview 99
6 Deep Brain Stimulators- Recent Developments 100
6.1 Nov 28, 2016: Brainsway Reports Continued Financial Growth for Q3 of 2016 100
6.2 Nov 22, 2016: Medtronic Reports Second Quarter Financial Results 100
6.3 Nov 16, 2016: Medtronic Releases FY16 Integrated Performance Report 103
6.4 Nov 15, 2016: CEVA to work with Medtronic for distribution facility construction 103
6.5 Nov 01, 2016: Sheppard Pratt Health System Appoints New Chief Financial Officer 104
6.6 Oct 26, 2016: Boston Scientific Announces Results For Third Quarter 2016 104
6.7 Oct 19, 2016: St. Jude Medical Reports Third Quarter 2016 Results 106
6.8 Oct 13, 2016: Baylor College of Medicine researcher and collaborators awarded grant through NIH BRAIN Initiative 107
6.9 Oct 10, 2016: Professor Ian Meredith To Join Boston Scientific As Executive Vice President And Global Chief Medical Officer 108
6.10 Oct 07, 2016: Directional deep brain stimulation for movement disorders now being used 109
6.11 Oct 06, 2016: St. Jude Medical Announces U.S. Launch and First Implant of New Deep Brain Stimulation System and Directional Lead for Patients Suffering from Movement Disorders 110
6.12 Sep 28, 2016: Soterix Medical Launches PainX tDCS Treatment in Canada with Health Canada Approval 110
6.13 Sep 15, 2016: Medtronic Names Mark Ploof Senior Vice President of Global Operations and Business Services 111
6.14 Aug 25, 2016: Medtronic Reports First Quarter Financial Results 112
6.15 Aug 17, 2016: Jersey Shore University Medical Center is First Hospital In New Jersey to Offer Deep Transcranial Magnetic Stimulation (DTMS) 114
6.16 Aug 03, 2016: Deep Transcranial Magnetic Stimulation Enables Controlled Opening of Blood-Brain Barrier 115
6.17 Jul 28, 2016: Boston Scientific Announces Results For Second Quarter 2016 115
6.18 Jul 21, 2016: TGA Hazard Alert On Medtronic Neuromodulation Deep Brain Stimulation system pocket adaptors 117
6.19 Jul 20, 2016: St. Jude Medical Reports Second Quarter 2016 Results 117
6.20 Jul 19, 2016: Deep Brain Stimulation Continues To Show Promise For Patients With Mild Alzheimer's Disease 119
6.21 Jul 13, 2016: Boston Scientific Elects Yoshiaki Fujimori to Board of Directors 120
6.22 Jun 30, 2016: NuVasive Agrees to Settle Patent Litigation With Medtronic 120
6.23 Jun 16, 2016: TGA Hazard Alert on Medtronic deep brain stimulation therapy DBS Extension models 7483 and 37086 120
6.24 Jun 16, 2016: St. Jude Medical Broadens Treatment Options for Patients Suffering Movement Disorders with the European Launch of New Deep Brain Stimulation System and Directional Lead 121
6.25 Jun 15, 2016: Soterix Medical awarded $2.5M NIH grant to run Phase-2 Efficacy Trial to treat Aphasia after Stroke with HD-tDCS 121
6.26 Jun 08, 2016: Boston Scientific Announces Restructuring Program to Support Long-Term Growth and Innovation 122
6.27 Jun 06, 2016: Medtronic Outlines Future Growth Vision at Investor Day 123
6.28 May 31, 2016: Medtronic Reports Fourth Quarter and Fiscal Year 2016 Financial Results 123
6.29 May 27, 2016: Aleva Neurotherapeutics Raises USD18 Million in Series C Financing Round 126
6.30 May 17, 2016: Soterix Medical, Announces tDCS-LTE Depression Treatment Partnership Program for Clinicians and Medical Centers based on its Non-invasive Neuromodulation Platform 126
6.31 May 04, 2016: Medtronic Welcomes Karen L. Parkhill as Its New Chief Financial Officer 126
6.32 Apr 06, 2016: Medtronic Statement on U.S. Department of Treasury's Recent Temporary and Proposed Regulations 127
6.33 Apr 04, 2016: Sheppard Pratt Health System Names New President and CEO 128
6.34 Mar 17, 2016: Medtronic Proposes Proxy Access 128
6.35 Mar 01, 2016: Medtronic Reports Third Quarter Financial Results 129
6.36 Feb 19, 2016: Medtronic to Announce Financial Results for Its Third Quarter of Fiscal Year 2016 130
6.37 Feb 17, 2016: FDA Approves Medtronic Deep Brain Stimulation for People with Parkinson's Disease with Recent Onset of Motor Complications 130
6.38 Feb 02, 2016: Clinatec Raises USD10.6 Million in Venture Financing 132
6.39 Feb 01, 2016: Aleva Neurotherapeutics Enters into Agreement with Greatbatch 132
6.40 Feb 01, 2016: Aleva Neurotherapeutics to Raise Funds in Series C Financing 132
6.41 Jan 14, 2016: Soterix Medical Launches PainX tDCS Treatment in EU with CE Approval 132
6.42 Jan 11, 2016: Medtronic Updates Capital Allocation Plans and Fiscal 2016 EPS Guidance 133
6.43 Dec 29, 2015: Soterix Medical Receives CE Mark Approval for 1x1 tDCS Depression Therapy 134
6.44 Dec 14, 2015: The Medtronic Bakken Invitation Award Honors 12 Patients from Around the World for Giving Back 134
6.45 Dec 09, 2015: Medtronic Announces FDA Approval for the Only Full-Body MR Conditional Deep Brain Stimulation Systems 135
7 Appendix 137
7.1 Methodology 137
7.2 About GlobalData 140
7.3 Contact Us 140
7.4 Disclaimer 140

1.1 List of Tables
Table 1: Deep Brain Stimulators - Pipeline Products by Stage of Development 12
Table 2: Deep Brain Stimulators - Pipeline Products by Territory 13
Table 3: Deep Brain Stimulators - Pipeline Products by Regulatory Path 14
Table 4: Deep Brain Stimulators - Pipeline Products by Estimated Approval Date 15
Table 5: Deep Brain Stimulators - Ongoing Clinical Trials 16
Table 6: Deep Brain Stimulators Companies - Pipeline Products by Stage of Development 17
Table 7: Deep Brain Stimulators - Pipeline Products by Stage of Development 19
Table 8: Adaptive Neuromodulation GmbH Pipeline Products and Ongoing Clinical Trials Overview 21
Table 9: CR-Capable Implant - Product Status 21
Table 10: CR-Capable Implant - Product Description 21
Table 11: Aleva Neurotherapeutics SA Pipeline Products and Ongoing Clinical Trials Overview 22
Table 12: directSTIM - Product Status 22
Table 13: directSTIM - Product Description 23
Table 14: spiderSTIM - Product Status 23
Table 15: spiderSTIM - Product Description 23
Table 16: Aleva Neurotherapeutics SA - Ongoing Clinical Trials Overview 24
Table 17: spiderSTIM - Evaluation of Directional Recording and Stimulation Using the spiderSTN During the Implantation of DBS Leads 24
Table 18: Boston Scientific Corp Pipeline Products and Ongoing Clinical Trials Overview 25
Table 19: Directional Lead - Product Status 25
Table 20: Directional Lead - Product Description 26
Table 21: Enspire DBS Therapy System - Stroke - Product Status 26
Table 22: Enspire DBS Therapy System - Stroke - Product Description 26
Table 23: Enspire DBS Therapy System - Traumatic Brain Injury - Product Status 27
Table 24: Enspire DBS Therapy System - Traumatic Brain Injury - Product Description 27
Table 25: Vercise Deep Brain Stimulation System - Parkinson's Disease - Product Status 27
Table 26: Vercise Deep Brain Stimulation System - Parkinson's Disease - Product Description 28
Table 27: Boston Scientific Corp - Ongoing Clinical Trials Overview 28
Table 28: Vercise Deep Brain Stimulation System - Parkinson's Disease - Directional Lead: Investigation of Rotational Current Steering, Ease of Use of Clinical Effects Map, and Therapeutic Outcomes of Deep Brain Stimulation 29
Table 29: Vercise Deep Brain Stimulation System - Parkinson's Disease - Implantable Neurostimulator for the Treatment of Parkinson's Disease 29
Table 30: Vercise Deep Brain Stimulation System - Parkinson's Disease - Registry of Deep Brain Stimulation with the VERCISE System: Vercise DBS Registry 29
Table 31: Brainsway Ltd Pipeline Products and Ongoing Clinical Trials Overview 30
Table 32: Deep TMS System - Alzheimer's Disease - Product Status 30
Table 33: Deep TMS System - Alzheimer's Disease - Product Description 31
Table 34: Deep TMS System - Autism - Product Status 31
Table 35: Deep TMS System - Autism - Product Description 31
Table 36: Deep TMS System - Bipolar Disorder - Product Status 32
Table 37: Deep TMS System - Bipolar Disorder - Product Description 32
Table 38: Deep TMS System - Multiple Sclerosis - Product Status 32
Table 39: Deep TMS System - Multiple Sclerosis - Product Description 33
Table 40: Deep TMS System - Obsessive Compulsive Disorder - Product Status 33
Table 41: Deep TMS System - Obsessive Compulsive Disorder - Product Description 33
Table 42: Deep TMS System - PTSD - Product Status 34
Table 43: Deep TMS System - PTSD - Product Description 34
Table 44: Deep TMS System - Smoking Cessation - Product Status 34
Table 45: Deep TMS System - Smoking Cessation - Product Description 35
Table 46: Deep TMS System - Stroke - Product Status 35
Table 47: Deep TMS System - Stroke - Product Description 35
Table 48: Brainsway Ltd - Ongoing Clinical Trials Overview 36
Table 49: Deep TMS System - Bipolar Disorder - Evaluation Clinical, Cognitive and Safety in the Treatment of Bipolar Depression with H1-Coil Deep Transcranial Magnetic Stimulation 36
Table 50: Deep TMS System - Smoking Cessation - A Prospective, Double Blind, Randomized, Controlled Study to Evaluate the Safety and Efficacy of the Deep Transcranial Magnetic Stimulation (DTMS) (with the H-ADD Coil) Intended as an Aid to Smoking Cessation 37
Table 51: Deep TMS System - PTSD - A Prospective, Double Blind, Randomized, Controlled Study to Evaluate the Safety and Efficacy of the Brainsway (HAC-Coil) Deep Transcranial Magnetic Stimulation (DTMS) System for the Treatment of Post-traumatic Stress Disorder (PTSD) 38
Table 52: Deep TMS System - PTSD - Multi-center Investigational Device Exemption Study of Brainsway's Deep Transcranial Magnetic Stimulation for Treatment of Post Traumatic Stress Disorder 38
Table 53: Deep TMS System - Obsessive Compulsive Disorder - Tolerability, Safety and Efficacy of the HAC-coil Deep Transcranial Magnetic Stimulation in Medication Resistance Obsessive Compulsive Disorder (OCD) Subjects 39
Table 54: Cerene Biomedics, Inc. Pipeline Products and Ongoing Clinical Trials Overview 40
Table 55: Implantable Cooling Therapy Device - Product Status 40
Table 56: Implantable Cooling Therapy Device - Product Description 40
Table 57: Cerevast Therapeutics Inc Pipeline Products and Ongoing Clinical Trials Overview 41
Table 58: Neurosonx SR - Product Status 41
Table 59: Neurosonx SR - Product Description 41
Table 60: Children's Hospital Boston Pipeline Products and Ongoing Clinical Trials Overview 42
Table 61: rTMS H-Coil - Product Status 42
Table 62: rTMS H-Coil - Product Description 42
Table 63: Cleveland Medical Devices Inc Pipeline Products and Ongoing Clinical Trials Overview 43
Table 64: ParkinTune - Product Status 43
Table 65: ParkinTune - Product Description 43
Table 66: Clinatec Pipeline Products and Ongoing Clinical Trials Overview 44
Table 67: Intracranial Deep Brain Stimulation Device - Product Status 44
Table 68: Intracranial Deep Brain Stimulation Device - Product Description 44
Table 69: Deep Brain Innovations, LLC Pipeline Products and Ongoing Clinical Trials Overview 45
Table 70: TOPS Device - Alzheimer's disease - Product Status 45
Table 71: TOPS Device - Alzheimer's disease - Product Description 45
Table 72: TOPS Device - Depression - Product Status 46
Table 73: TOPS Device - Depression - Product Description 46
Table 74: TOPS Device - Epilepsy - Product Status 46
Table 75: TOPS Device - Epilepsy - Product Description 47
Table 76: TOPS Device - Obesity - Product Status 47
Table 77: TOPS Device - Obesity - Product Description 47
Table 78: TOPS Device - Obsessive-Compulsive Disorder - Product Status 48
Table 79: TOPS Device - Obsessive-Compulsive Disorder - Product Description 48
Table 80: TOPS Device - Parkinson's disease - Product Status 48
Table 81: TOPS Device - Parkinson's disease - Product Description 49
Table 82: Duke University Pipeline Products and Ongoing Clinical Trials Overview 50
Table 83: DBS Electrode - Product Status 50
Table 84: DBS Electrode - Product Description 50
Table 85: Functional Neuromodulation Inc. Pipeline Products and Ongoing Clinical Trials Overview 51
Table 86: Deep Brain Stimulation - Mild Alzheimer's Disease - Product Status 51
Table 87: Deep Brain Stimulation - Mild Alzheimer's Disease - Product Description 51
Table 88: Functional Neuromodulation Inc. - Ongoing Clinical Trials Overview 52
Table 89: Deep Brain Stimulation - Mild Alzheimer's Disease - A Twelve Month Double-blind Randomized Controlled Feasibility Study to Evaluate the Safety, Efficacy and Tolerability of Deep Brain Stimulation of the Fornix (DBS-f) in Patients with Mild Probable Alzheimer's Disease 52
Table 90: Highland Instruments, Inc. Pipeline Products and Ongoing Clinical Trials Overview 53
Table 91: ESStim - Parkinson's Disease - Product Status 53
Table 92: ESStim - Parkinson's Disease - Product Description 53
Table 93: Massachusetts General Hospital Pipeline Products and Ongoing Clinical Trials Overview 54
Table 94: Deep Brain Stimulation Device - Product Status 54
Table 95: Deep Brain Stimulation Device - Product Description 54
Table 96: Deep Brain Stimulation System - Product Status 55
Table 97: Deep Brain Stimulation System - Product Description 55
Table 98: Massachusetts Institute of Technology Pipeline Products and Ongoing Clinical Trials Overview 56
Table 99: Implantable Micro - Cannula Device - Product Status 56
Table 100: Implantable Micro - Cannula Device - Product Description 56
Table 101: Mayo Clinic US Pipeline Products and Ongoing Clinical Trials Overview 57
Table 102: Sensor System - DBS - Product Status 57
Table 103: Sensor System - DBS - Product Description 57
Table 104: Medtronic plc Pipeline Products and Ongoing Clinical Trials Overview 58
Table 105: Intercept Patient Programmer For Activa PC - Refractory Epilepsy - Product Status 58
Table 106: Intercept Patient Programmer For Activa PC - Refractory Epilepsy - Product Description 59
Table 107: Reclaim Deep Brain Stimulation System - Depression - Product Status 59
Table 108: Reclaim Deep Brain Stimulation System - Depression - Product Description 59
Table 109: Sapiens DBS Field Steering System - Product Status 60
Table 110: Sapiens DBS Field Steering System - Product Description 60
Table 111: Medtronic plc - Ongoing Clinical Trials Overview 60
Table 112: Intercept Patient Programmer For Activa PC - Refractory Epilepsy - Medtronic Registry for Epilepsy (MORE) 61
Table 113: National Cheng-Kung University Hospital Pipeline Products and Ongoing Clinical Trials Overview 62
Table 114: Responsive Epilepsy Control System-On-Chip - Product Status 62
Table 115: Responsive Epilepsy Control System-On-Chip - Product Description 62
Table 116: NeuroPro Technologies Inc Pipeline Products and Ongoing Clinical Trials Overview 63
Table 117: Deep Brain Stimulation - Product Status 63
Table 118: Deep Brain Stimulation - Product Description 63
Table 119: Neurosigma Inc Pipeline Products and Ongoing Clinical Trials Overview 64
Table 120: Deep Brain Stimulation System - Cachexia - Product Status 64
Table 121: Deep Brain Stimulation System - Cachexia - Product Description 64
Table 122: Deep Brain Stimulation System - Obesity - Product Status 65
Table 123: Deep Brain Stimulation System - Obesity - Product Description 65
Table 124: Newronika s.r.l. Pipeline Products and Ongoing Clinical Trials Overview 66
Table 125: Implantable Deep Brain Stimulation Device - Product Status 66
Table 126: Implantable Deep Brain Stimulation Device - Product Description 66
Table 127: Nuraleve Inc. Pipeline Products and Ongoing Clinical Trials Overview 67
Table 128: SmartStim M200 Device - Product Status 67
Table 129: SmartStim M200 Device - Product Description 67
Table 130: Soterix Medical Inc Pipeline Products and Ongoing Clinical Trials Overview 68
Table 131: 1×1 tDCS Device - Product Status 68
Table 132: 1×1 tDCS Device - Product Description 69
Table 133: HD-tDCS Platform - Product Status 69
Table 134: HD-tDCS Platform - Product Description 70
Table 135: PainX tDCS System - Product Status 70
Table 136: PainX tDCS System - Product Description 71
Table 137: Soterix Medical Inc - Ongoing Clinical Trials Overview 72
Table 138: HD-tDCS Platform - Association of Transcranial Direct Current Stimulation (tDCS) with Gait Training with Partial Body Weight Support on the Robotic Device (Lokomat) for Treatment of Patients with Incomplete Spinal Cord Injury 74
Table 139: HD-tDCS Platform - High Definition Cathodal Transcranial Direct Current Stimulation for Treatment of Refractory Partial Onset Epilepsy 74
Table 140: HD-tDCS Platform - Targeted Transcranial Electrotherapy for Stroke Rehabilitation - Exploratory Trial on Aphasia 74
Table 141: 1×1 tDCS Device - Boston-Harvard Burn Injury Model System: Cortical Modulation with Transcranial Direct Current Stimulation (tDCS) for Neuropathic Symptoms Following Burn Injury 75
Table 142: 1×1 tDCS Device - Effects of Transcranial Direct Current Stimulation (tDCS) in Spoken and Written Production in Primary Progressive Aphasia (PPA) 75
Table 143: 1×1 tDCS Device - Escitalopram and Transcranial Direct Current Stimulation in Major Depressive Disorder: A Double-blind, Placebo-controlled, Randomized, Non-inferiority Trial 75
Table 144: 1×1 tDCS Device - Evaluating Anodal tDCS Preceding Aphasia Therapy 76
Table 145: 1×1 tDCS Device - Home-Administered Transcranial Direct Current Stimulation (tDCS) Treatment for Depression 76
Table 146: 1×1 tDCS Device - Neural Correlates of Pain-related Cognitive Processing in Chronic Pain of the Cornea: An ERP and Electrical Stimulation Study 76
Table 147: 1×1 tDCS Device - Optimizing Rehabilitation for Phantom Limb Pain Using Mirror Therapy and Transcranial Direct Current Stimulation (tDCS) 77
Table 148: 1×1 tDCS Device - Promoting Adaptive Neuroplasticity in Mild Cognitive Impairment 77
Table 149: 1×1 tDCS Device - Spaulding-Harvard Spinal Cord Injury (SH-SCI) Study: Effects of tDCS on Chronic Pain in Spinal Cord Injury 78
Table 150: 1×1 tDCS Device - tDCS and Aphasia Treatment 78
Table 151: 1×1 tDCS Device - The Influence of tDSC on the Arm and Hand Function in Stroke Patients 78
Table 152: 1×1 tDCS Device - Transcranial Direct Current Stimulation for Hallucinations in First-episode Schizophrenia 79
Table 153: 1×1 tDCS Device - Transcranial Direct Current Stimulation to Enhance Cognition in Mild Cognitive Impairment 79
Table 154: PainX tDCS System - Predicting Pain Response to Transcranial Direct Current Stimulation for Phantom Limb Pain in Limb Amputees 80
Table 155: Sree Chitra Tirunal Institute for Medical Sciences and Technology Pipeline Products and Ongoing Clinical Trials Overview 81
Table 156: Implantable Electrode - Epilepsy Surgery - Product Status 81
Table 157: Implantable Electrode - Epilepsy Surgery - Product Description 81
Table 158: Indigenous Deep Brain Stimulation Device - Product Status 82
Table 159: Indigenous Deep Brain Stimulation Device - Product Description 82
Table 160: St. Jude Medical Inc Pipeline Products and Ongoing Clinical Trials Overview 83
Table 161: Libra Deep Brain Stimulation System - Depression - Product Status 83
Table 162: Libra Deep Brain Stimulation System - Depression - Product Description 84
Table 163: Next Generation Implantable DBS System - Primary Cell - Product Status 84
Table 164: Next Generation Implantable DBS System - Primary Cell - Product Description 84
Table 165: St. Jude Medical Inc - Ongoing Clinical Trials Overview 85
Table 166: Libra Deep Brain Stimulation System - Depression - A Clinical Evaluation of Subcallosal Cingulate Gyrus Deep Brain Stimulation for Treatment-Resistant Depression 85
Table 167: Libra Deep Brain Stimulation System - Depression - Deep Brain Stimulation for Treatment-Resistant Depression 85
Table 168: SUNY Downstate Medical Center Pipeline Products and Ongoing Clinical Trials Overview 86
Table 169: Low-Frequency Sine Wave Neurostimulation Therapy Device - Product Status 86
Table 170: Low-Frequency Sine Wave Neurostimulation Therapy Device - Product Description 86
Table 171: The University of Utah Pipeline Products and Ongoing Clinical Trials Overview 87
Table 172: DBS10k - Product Status 87
Table 173: DBS10k - Product Description 87
Table 174: Neural Recording Array - Product Status 88
Table 175: Neural Recording Array - Product Description 88
Table 176: University of California Los Angeles Pipeline Products and Ongoing Clinical Trials Overview 89
Table 177: Implantable Ultrasound Neuromodulation Device - Product Status 89
Table 178: Implantable Ultrasound Neuromodulation Device - Product Description 89
Table 179: Wireless Deep Brain Stimulating System - Product Status 90
Table 180: Wireless Deep Brain Stimulating System - Product Description 90
Table 181: University of Central Florida Pipeline Products and Ongoing Clinical Trials Overview 91
Table 182: Deep Brain Stimulation System - Product Status 91
Table 183: Deep Brain Stimulation System - Product Description 92
Table 184: University of Illinois Pipeline Products and Ongoing Clinical Trials Overview 93
Table 185: Wireless Deep Brain Stimulation System - Essential Tremor - Product Status 93
Table 186: Wireless Deep Brain Stimulation System - Essential Tremor - Product Description 94
Table 187: Wireless Deep Brain Stimulation System - Parkinson's Disease - Product Status 94
Table 188: Wireless Deep Brain Stimulation System - Parkinson's Disease - Product Description 94
Table 189: University of Michigan Pipeline Products and Ongoing Clinical Trials Overview 95
Table 190: Deep Brain Stimulation System - Product Status 95
Table 191: Deep Brain Stimulation System - Product Description 95
Table 192: University of Milan Pipeline Products and Ongoing Clinical Trials Overview 96
Table 193: Implantable Brain Pacemaker - Product Status 96
Table 194: Implantable Brain Pacemaker - Product Description 96
Table 195: University of Oxford Pipeline Products and Ongoing Clinical Trials Overview 97
Table 196: Adaptive Deep Brain Stimulation System - Product Status 97
Table 197: Adaptive Deep Brain Stimulation System - Product Description 97
Table 198: University of South Florida Pipeline Products and Ongoing Clinical Trials Overview 98
Table 199: Deep Brain Stimulator - Product Status 98
Table 200: Deep Brain Stimulator - Product Description 98
Table 201: Wedge Therapeutics Pipeline Products and Ongoing Clinical Trials Overview 99
Table 202: SONS System - Product Status 99
Table 203: SONS System - Product Description 99
Table 204: Glossary 138

1.2 List of Figures
Figure 1: Deep Brain Stimulators - Pipeline Products by Stage of Development 12
Figure 2: Deep Brain Stimulators - Pipeline Products by Territory 13
Figure 3: Deep Brain Stimulators - Pipeline Products by Regulatory Path 14
Figure 4: Deep Brain Stimulators - Pipeline Products by Estimated Approval Date 15
Figure 5: Deep Brain Stimulators - Ongoing Clinical Trials 16

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