Deep Brain Stimulators (DBS) Pipeline by Stages of Development, Segments, Region, Regulatory Path and Key Companies

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DBS Pipeline Market Report Overview

A Deep Brain Stimulators (DBS) is a device that is comprised of a brain-oriented pacemaker (an implantable pulse generator) that sends electrical stimulation through surgically-implanted electrodes to specific targets in the brain. DBSs are commonly used to treat movement disorders as well as neuropsychiatric disorders. One unit refers to one Deep Brain Stimulator.

The DBS pipeline market research report provides comprehensive information about the DBS pipeline products with a comparative analysis of the products at various stages of development and information about the clinical trials which are in progress.

Key Territories ·       The US

·       Europe

·       China

·       Australia

·       Germany

Key Regulatory Paths ·       PMA

·       510(k)

·       CE

·       NMPA

·       TGA

·       ICAC

·       UKCA

Leading Companies ·       Actipulse Neuroscience Inc

·       Allegheny Health Network

·       Baylor College of Medicine

·       Bioinduction Limited

·       Boston Scientific Corp

·       Brainsway Ltd

·       ClearPoint Medical

·       ClearPoint Neuro Inc

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DBS Pipeline Market Segmentation by Territories

Some of the key territories in the DBS market are the US, Europe, China, Australia, and Germany among others. As of May 2023, the US has the highest number of pipeline products.

DBS Pipeline Market Analysis, by Territories, 2023 (%)

DBS Pipeline Market Analysis, by Territories, 2023 (%)

For more territory insights into the DBS pipeline market, download a free report sample

DBS Pipeline Market Segmentation by Regulatory Paths

Some of the regulatory paths in the DBS pipeline market are PMA, 510(k), CE, NMPA, TGA, ICAC, and UKCA among others. As of May 2023, PMA is the most followed pathway for pipeline products.

DBS Pipeline Market Analysis, by Regulatory Paths, 2023 (%)

DBS Pipeline Market Analysis, by Regulatory Paths, 2023 (%)

For more regulatory path insights into the DBS pipeline market, download a free report sample

DBS Pipeline Market – Competitive Landscape

Some of the key companies in the DBS pipeline market are Actipulse Neuroscience Inc, Allegheny Health Network, Baylor College of Medicine, Bioinduction Limited, Boston Scientific Corp, Brainsway Ltd, ClearPoint Medical, and ClearPoint Neuro Inc among others.

Actipulse Neuroscience Inc: Actipulse Neuroscience Inc, is a provider of non-invasive brain stimulation technologies for the treatment of neurological diseases. The company is headquartered in the United States. It is producing Fast Gamma Magnetic Stimulation Device. It is a wearable, neurostimulation headset intended for neuromodulation therapy. It is designed to deliver high-frequency and low-intensity magnetic pulses directly to the skull to treat Alzheimer’s disease or other neurodegenerative disorders. It is based on Wearable Technology.

Segments Covered in the Report

DBS Pipeline Market Territories Outlook

  • The US
  • Europe
  • China
  • Australia
  • Germany

DBS Pipeline Market Regulatory Paths Outlook

  • PMA
  • 510(k)
  • CE
  • NMPA
  • TGA
  • ICAC
  • UKCA

Scope

  • Extensive coverage of the DBS under development
  • Reviews details of major pipeline products which include, product description, licensing and collaboration details, and other developmental activities
  • Reviews the major players involved in the development of DBS 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 portfolios and create effective counter strategies to gain a competitive advantage
  • Identify and understand important and diverse types of DBS 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

Actipulse Neuroscience Inc
Adaptive Neuromodulation GmbH
Adept Neuro SA
Aleva Neurotherapeutics SA
Allegheny Health Network
Baylor College of Medicine
Bioinduction Limited
Boston Scientific Corp
Brainsway Ltd
ClearPoint Medical
ClearPoint Neuro Inc
Cleveland Medical Devices Inc
Clinatec
Deep Brain Innovations, LLC
Deep Brain Stimulation Technologies Pty Ltd
Endonovo Therapeutics Inc
Enspire DBS Therapy Inc
Functional Neuromodulation Inc.
Hangzhou General Stim Biotechnology Co Ltd
Louisiana State University
Massachusetts General Hospital
Massachusetts Institute of Technology
Medtronic Neuromodulation
Medtronic Plc
National Cheng-Kung University Hospital
Neurode Pty Ltd
NeuroOne Medical Technologies Corp
Neuroparticle Corp
NeuroPro Technologies Inc
Neurosigma Inc
Newronika s.r.l.
Nexeon MedSystems Inc
Nia Therapeutics Inc
Onward Technologies Ltd
Oxford University Innovation Ltd
Salvia Bioelectronics BV
Soterix Medical Inc
Sree Chitra Tirunal Institute for Medical Sciences & Technology
St. Jude Medical LLC
Sunnybrook Health Sciences Centre
SUNY Downstate Medical Center
The Magstim Co Ltd
University of California Los Angeles
University of California San Francisco
University of Central Florida
University of Florida
University of Houston
University of Illinois
University of Milan
University of Minnesota
University of Oxford
University of Queensland
University of Rochester
University of South Florida
Wedge Therapeutics

Table of Contents

1 Table of Contents 3

1.1 List of Tables 6

1.2 List of Figures 12

2 Introduction 13

2.1 Deep Brain Stimulators (DBS) Overview 13

3 Products under Development 14

3.1 Deep Brain Stimulators (DBS) – Pipeline Products by Stage of Development 14

3.2 Deep Brain Stimulators (DBS) – Pipeline Products by Territory 15

3.3 Deep Brain Stimulators (DBS) – Pipeline Products by Regulatory Path 16

3.4 Deep Brain Stimulators (DBS) – Pipeline Products by Estimated Approval Date 17

3.5 Deep Brain Stimulators (DBS) – Ongoing Clinical Trials 18

4 Deep Brain Stimulators (DBS) – Pipeline Products under Development by Companies 19

4.1 Deep Brain Stimulators (DBS) Companies – Pipeline Products by Stage of Development 19

4.2 Deep Brain Stimulators (DBS) – Pipeline Products by Stage of Development 22

5 Deep Brain Stimulators (DBS) Companies and Product Overview 25

5.1 Actipulse Neuroscience Inc Company Overview 25

5.1.1 Actipulse Neuroscience Inc Pipeline Products & Ongoing Clinical Trials Overview 25

5.2 Adaptive Neuromodulation GmbH Company Overview 26

5.2.1 Adaptive Neuromodulation GmbH Pipeline Products & Ongoing Clinical Trials Overview 26

5.3 Adept Neuro SA Company Overview 27

5.3.1 Adept Neuro SA Pipeline Products & Ongoing Clinical Trials Overview 27

5.4 Aleva Neurotherapeutics SA Company Overview 28

5.4.1 Aleva Neurotherapeutics SA Pipeline Products & Ongoing Clinical Trials Overview 28

5.5 Allegheny Health Network Company Overview 31

5.5.1 Allegheny Health Network Pipeline Products & Ongoing Clinical Trials Overview 31

5.6 Baylor College of Medicine Company Overview 33

5.6.1 Baylor College of Medicine Pipeline Products & Ongoing Clinical Trials Overview 33

5.7 Bioinduction Limited Company Overview 34

5.7.1 Bioinduction Limited Pipeline Products & Ongoing Clinical Trials Overview 34

5.8 Boston Scientific Corp Company Overview 39

5.8.1 Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 39

5.9 Brainsway Ltd Company Overview 43

5.9.1 Brainsway Ltd Pipeline Products & Ongoing Clinical Trials Overview 43

5.10 ClearPoint Medical Company Overview 53

5.10.1 ClearPoint Medical Pipeline Products & Ongoing Clinical Trials Overview 53

5.11 ClearPoint Neuro Inc Company Overview 54

5.11.1 ClearPoint Neuro Inc Pipeline Products & Ongoing Clinical Trials Overview 54

5.12 Cleveland Medical Devices Inc Company Overview 57

5.12.1 Cleveland Medical Devices Inc Pipeline Products & Ongoing Clinical Trials Overview 57

5.13 Clinatec Company Overview 58

5.13.1 Clinatec Pipeline Products & Ongoing Clinical Trials Overview 58

5.14 Deep Brain Innovations, LLC Company Overview 59

5.14.1 Deep Brain Innovations, LLC Pipeline Products & Ongoing Clinical Trials Overview 59

5.15 Deep Brain Stimulation Technologies Pty Ltd Company Overview 64

5.15.1 Deep Brain Stimulation Technologies Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 64

5.16 Endonovo Therapeutics Inc Company Overview 65

5.16.1 Endonovo Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 65

5.17 Enspire DBS Therapy Inc Company Overview 66

5.17.1 Enspire DBS Therapy Inc Pipeline Products & Ongoing Clinical Trials Overview 66

5.18 Functional Neuromodulation Inc. Company Overview 69

5.18.1 Functional Neuromodulation Inc. Pipeline Products & Ongoing Clinical Trials Overview 69

5.19 Hangzhou General Stim Biotechnology Co Ltd Company Overview 73

5.19.1 Hangzhou General Stim Biotechnology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 73

5.20 Louisiana State University Company Overview 76

5.20.1 Louisiana State University Pipeline Products & Ongoing Clinical Trials Overview 76

5.21 Massachusetts General Hospital Company Overview 77

5.21.1 Massachusetts General Hospital Pipeline Products & Ongoing Clinical Trials Overview 77

5.22 Massachusetts Institute of Technology Company Overview 79

5.22.1 Massachusetts Institute of Technology Pipeline Products & Ongoing Clinical Trials Overview 79

5.23 Medtronic Neuromodulation Company Overview 80

5.23.1 Medtronic Neuromodulation Pipeline Products & Ongoing Clinical Trials Overview 80

5.24 Medtronic Plc Company Overview 83

5.24.1 Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 83

5.25 National Cheng-Kung University Hospital Company Overview 86

5.25.1 National Cheng-Kung University Hospital Pipeline Products & Ongoing Clinical Trials Overview 86

5.26 Neurode Pty Ltd Company Overview 87

5.26.1 Neurode Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 87

5.27 NeuroOne Medical Technologies Corp Company Overview 88

5.27.1 NeuroOne Medical Technologies Corp Pipeline Products & Ongoing Clinical Trials Overview 88

5.28 Neuroparticle Corp Company Overview 90

5.28.1 Neuroparticle Corp Pipeline Products & Ongoing Clinical Trials Overview 90

5.29 NeuroPro Technologies Inc Company Overview 91

5.29.1 NeuroPro Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 91

5.30 Neurosigma Inc Company Overview 92

5.30.1 Neurosigma Inc Pipeline Products & Ongoing Clinical Trials Overview 92

5.31 Newronika s.r.l. Company Overview 94

5.31.1 Newronika s.r.l. Pipeline Products & Ongoing Clinical Trials Overview 94

5.32 Nexeon MedSystems Inc Company Overview 97

5.32.1 Nexeon MedSystems Inc Pipeline Products & Ongoing Clinical Trials Overview 97

5.33 Nia Therapeutics Inc Company Overview 99

5.33.1 Nia Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 99

5.34 Onward Technologies Ltd Company Overview 100

5.34.1 Onward Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 100

5.35 Oxford University Innovation Ltd Company Overview 101

5.35.1 Oxford University Innovation Ltd Pipeline Products & Ongoing Clinical Trials Overview 101

5.36 Salvia Bioelectronics BV Company Overview 102

5.36.1 Salvia Bioelectronics BV Pipeline Products & Ongoing Clinical Trials Overview 102

5.37 Soterix Medical Inc Company Overview 103

5.37.1 Soterix Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 103

5.38 Sree Chitra Tirunal Institute for Medical Sciences & Technology Company Overview 107

5.38.1 Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview 107

5.39 St. Jude Medical LLC Company Overview 109

5.39.1 St. Jude Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 109

5.40 Sunnybrook Health Sciences Centre Company Overview 113

5.40.1 Sunnybrook Health Sciences Centre Pipeline Products & Ongoing Clinical Trials Overview 113

5.41 SUNY Downstate Medical Center Company Overview 116

5.41.1 SUNY Downstate Medical Center Pipeline Products & Ongoing Clinical Trials Overview 116

5.42 The Magstim Co Ltd Company Overview 117

5.42.1 The Magstim Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 117

5.43 University of California Los Angeles Company Overview 120

5.43.1 University of California Los Angeles Pipeline Products & Ongoing Clinical Trials Overview 120

5.44 University of California San Francisco Company Overview 123

5.44.1 University of California San Francisco Pipeline Products & Ongoing Clinical Trials Overview 123

5.45 University of Central Florida Company Overview 126

5.45.1 University of Central Florida Pipeline Products & Ongoing Clinical Trials Overview 126

5.46 University of Florida Company Overview 127

5.46.1 University of Florida Pipeline Products & Ongoing Clinical Trials Overview 127

5.47 University of Houston Company Overview 130

5.47.1 University of Houston Pipeline Products & Ongoing Clinical Trials Overview 130

5.48 University of Illinois Company Overview 131

5.48.1 University of Illinois Pipeline Products & Ongoing Clinical Trials Overview 131

5.49 University of Milan Company Overview 132

5.49.1 University of Milan Pipeline Products & Ongoing Clinical Trials Overview 132

5.50 University of Minnesota Company Overview 133

5.50.1 University of Minnesota Pipeline Products & Ongoing Clinical Trials Overview 133

5.51 University of Oxford Company Overview 134

5.51.1 University of Oxford Pipeline Products & Ongoing Clinical Trials Overview 134

5.52 University of Queensland Company Overview 135

5.52.1 University of Queensland Pipeline Products & Ongoing Clinical Trials Overview 135

5.53 University of Rochester Company Overview 136

5.53.1 University of Rochester Pipeline Products & Ongoing Clinical Trials Overview 136

5.54 University of South Florida Company Overview 137

5.54.1 University of South Florida Pipeline Products & Ongoing Clinical Trials Overview 137

5.55 Wedge Therapeutics Company Overview 138

5.55.1 Wedge Therapeutics Pipeline Products & Ongoing Clinical Trials Overview 138

6 Deep Brain Stimulators (DBS)- Recent Developments 139

6.1 May 11, 2023: Medtronic to announce financial results for its fourth quarter and full fiscal year 2023 139

6.2 Apr 12, 2023: Medtronic has a layoff in California 139

6.3 Mar 16, 2023: Medtronic joins in $25M funding round for home monitoring company 139

6.4 Mar 15, 2023: BrainsWay Reports Fourth Quarter and Full-Year 2022 Financial Results and Operational Highlights 139

6.5 Jan 09, 2023: NeuroPace Announces Preliminary Unaudited Fourth Quarter and Full-Year 2022 Revenue and Appoints Dr. Uri Geiger to Board of Directors 141

6.6 Nov 23, 2022: Medtronic Reports Quarterly Earnings 142

6.7 Nov 22, 2022: Medtronic reports second quarter fiscal 2023 financial results 142

6.8 Nov 22, 2022: Mayo Clinic surgeon takes the wheel as Kwik Trip’s new CEO 148

6.9 Nov 15, 2022: Medtronic Set to Announce Earnings on Tuesday 148

6.10 Nov 01, 2022: BrainsWay Appoints Dr. Colleen A. Hanlon as Vice President of Medical Affairs 148

6.11 Sep 30, 2022: Natalie Caine named chief administrative officer at Mayo Clinic in Rochester 149

6.12 Sep 07, 2022: Medtronic to appear at September investor conferences 149

6.13 Aug 23, 2022: Medtronic reports first quarter fiscal 2023 financial results 150

6.14 Aug 23, 2022: NeuroPace to Present at the Morgan Stanley 20th Annual Global Healthcare Conference 152

6.15 Aug 23, 2022: Medtronic Announces Quarterly Earnings Results 152

6.16 Aug 16, 2022: Boston Scientific Announces Upcoming Conference Schedule 155

6.17 Aug 11, 2022: NeuroPace Reports Second Quarter 2022 Financial Results and Provides a Business Update 155

6.18 Jul 21, 2022: NeuroPace to Report Second Quarter 2022 Financial Results on August 11, 2022 157

6.19 Jul 12, 2022: Aspire & USF Pass $10M in ticket & donation revenue 157

6.20 Jun 27, 2022: Medtronic Board appoints Lidia Fonseca as a new director 158

6.21 Jun 22, 2022: BrainsWay to Present at the H.C. Wainwright 1st Annual Mental Health Conference 158

6.22 May 27, 2022: Medtronic reports full year and fourth quarter fiscal year 2022 financial results 159

6.23 May 26, 2022: Medtronic reports full year and fourth quarter fiscal year 2022 financial results announces 8% dividend increase 159

7 Appendix 160

7.1 Methodology 160

7.2 About GlobalData 163

7.3 Contact Us 163

7.4 Disclaimer 163

Table

Deep Brain Stimulators (DBS) – Pipeline Products by Stage of Development 14

Deep Brain Stimulators (DBS) – Pipeline Products by Territory 15

Deep Brain Stimulators (DBS) – Pipeline Products by Regulatory Path 16

Deep Brain Stimulators (DBS) – Pipeline Products by Estimated Approval Date 17

Deep Brain Stimulators (DBS) – Ongoing Clinical Trials 18

Deep Brain Stimulators (DBS) Companies – Pipeline Products by Stage of Development 19

Deep Brain Stimulators (DBS) – Pipeline Products by Stage of Development 22

Actipulse Neuroscience Inc Pipeline Products & Ongoing Clinical Trials Overview 25

Fast Gamma Magnetic Stimulation Device – Product Status 25

Fast Gamma Magnetic Stimulation Device – Product Description 25

Adaptive Neuromodulation GmbH Pipeline Products & Ongoing Clinical Trials Overview 26

CR-Capable Implant – Product Status 26

CR-Capable Implant – Product Description 26

Adept Neuro SA Pipeline Products & Ongoing Clinical Trials Overview 27

Stereo-Electro-Encephalo-Graphie Electrode – Product Status 27

Stereo-Electro-Encephalo-Graphie Electrode – Product Description 27

Aleva Neurotherapeutics SA Pipeline Products & Ongoing Clinical Trials Overview 28

directSTIM – Product Status 28

directSTIM – Product Description 28

Aleva Neurotherapeutics SA – Ongoing Clinical Trials Overview 29

directSTIM – A Prospective, Multi-center, Post-market Clinical Follow-up Study of the directSTIM Deep Brain Stimulation (DBS) System 30

directSTIM – A Prospective, Multi-center, Single Arm, Observational, Post-market Clinical Follow-up Study on the Use of the directSTIM DBS System to Treat Essential Tremor 30

Allegheny Health Network Pipeline Products & Ongoing Clinical Trials Overview 31

Deep Brain Stimulation System – Alzheimer’s Disease – Product Status 31

Deep Brain Stimulation System – Alzheimer’s Disease – Product Description 31

Deep Brain Stimulation System – Obesity – Product Status 32

Deep Brain Stimulation System – Obesity – Product Description 32

Baylor College of Medicine Pipeline Products & Ongoing Clinical Trials Overview 33

Adaptive Deep Brain Stimulation (aDBS) Device – Product Status 33

Adaptive Deep Brain Stimulation (aDBS) Device – Product Description 33

Bioinduction Limited Pipeline Products & Ongoing Clinical Trials Overview 34

Picostim – Product Status 34

Picostim – Product Description 34

Picostim-DyNeuMo – Product Status 35

Picostim-DyNeuMo – Product Description 35

Bioinduction Limited – Ongoing Clinical Trials Overview 36

Picostim – Simpler and Safer Deep Brain Stimulation for Parkinson’s Disease 37

Picostim-DyNeuMo – Exploratory Safety and Electrophysiological Study of Closed-loop Pudendal Neuromodulation Using an Implantable (Picostim-DyNeuMo) Device in Women With Urinary Incontinence 38

Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 39

Deep Brain Stimulation Device – Depression – Product Status 39

Deep Brain Stimulation Device – Depression – Product Description 40

Deep Brain Stimulation Device – Stroke – Product Status 40

Deep Brain Stimulation Device – Stroke – Product Description 40

Enspire DBS Therapy System – Traumatic Brain Injury – Product Status 40

Enspire DBS Therapy System – Traumatic Brain Injury – Product Description 41

Next Generation DBS System – Product Status 41

Next Generation DBS System – Product Description 41

Vercise Deep Brain Stimulation System – Alzheimer’s Disease – Product Status 41

Vercise Deep Brain Stimulation System – Alzheimer’s Disease – Product Description 42

Brainsway Ltd Pipeline Products & Ongoing Clinical Trials Overview 43

Deep TMS System – Alcohol Use Disorder – Product Status 43

Deep TMS System – Alcohol Use Disorder – Product Description 44

Deep TMS System – Alzheimer’s Disease – Product Status 44

Deep TMS System – Alzheimer’s Disease – Product Description 44

Deep TMS System – Bipolar Disorder – Product Status 45

Deep TMS System – Bipolar Disorder – Product Description 45

Deep TMS System – Chronic Pain – Product Status 45

Deep TMS System – Chronic Pain – Product Description 46

Deep TMS System – Multiple Sclerosis – Product Status 46

Deep TMS System – Multiple Sclerosis – Product Description 46

Deep TMS System – Obesity – Product Status 47

Deep TMS System – Obesity – Product Description 47

Deep TMS System – Opioid Use Disorder – Product Status 47

Deep TMS System – Opioid Use Disorder – Product Description 48

Deep TMS System – Post-Stroke – Product Status 48

Deep TMS System – Post-Stroke – Product Description 48

Deep TMS System – PTSD – Product Status 49

Deep TMS System – PTSD – Product Description 49

Next-Generation Multi-Channel TMS Stimulator – Product Status 49

Next-Generation Multi-Channel TMS Stimulator – Product Description 50

Brainsway Ltd – Ongoing Clinical Trials Overview 51

Deep TMS System – Bipolar Disorder – A Prospective, Double Blind, Randomized, Controlled Trial to Evaluate the Safety and Efficacy of the H1-coil Deep Transcranial Magnetic Stimulation (TMS) in Conjunction with Mood Stabilizers in Subjects with Bipolar Depression 52

ClearPoint Medical Pipeline Products & Ongoing Clinical Trials Overview 53

Neuro Navigation Device – OCD – Product Status 53

Neuro Navigation Device – OCD – Product Description 53

ClearPoint Neuro Inc Pipeline Products & Ongoing Clinical Trials Overview 54

Neuro Navigation Device – Insomnia – Product Status 54

Neuro Navigation Device – Insomnia – Product Description 54

Neuro Navigation Device – Parkinson’s Disease – Product Status 55

Neuro Navigation Device – Parkinson’s Disease – Product Description 55

Neuro Navigation Device – Stroke Rehabilitation – Product Status 55

Neuro Navigation Device – Stroke Rehabilitation – Product Description 56

Cleveland Medical Devices Inc Pipeline Products & Ongoing Clinical Trials Overview 57

ParkinTune – Product Status 57

ParkinTune – Product Description 57

Clinatec Pipeline Products & Ongoing Clinical Trials Overview 58

Intracranial Deep Brain Stimulation Device – Product Status 58

Intracranial Deep Brain Stimulation Device – Product Description 58

Deep Brain Innovations, LLC Pipeline Products & Ongoing Clinical Trials Overview 59

TOPS Device – Alzheimer’s disease – Product Status 59

TOPS Device – Alzheimer’s disease – Product Description 59

TOPS Device – Depression – Product Status 60

TOPS Device – Depression – Product Description 60

TOPS Device – Epilepsy – Product Status 60

TOPS Device – Epilepsy – Product Description 61

TOPS Device – Obesity – Product Status 61

TOPS Device – Obesity – Product Description 61

TOPS Device – Obsessive-Compulsive Disorder – Product Status 62

TOPS Device – Obsessive-Compulsive Disorder – Product Description 62

TOPS Device – Parkinson’s disease – Product Status 62

TOPS Device – Parkinson’s disease – Product Description 63

Deep Brain Stimulation Technologies Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 64

Adaptive Deep Brain Stimulation Device – Product Status 64

Adaptive Deep Brain Stimulation Device – Product Description 64

Endonovo Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 65

DSF-rTMS – Product Status 65

DSF-rTMS – Product Description 65

Enspire DBS Therapy Inc Pipeline Products & Ongoing Clinical Trials Overview 66

Enspire DBS Therapy System – Product Status 66

Enspire DBS Therapy System – Product Description 66

Enspire DBS Therapy Inc – Ongoing Clinical Trials Overview 67

Enspire DBS Therapy System – Rehab With Electrical Stimulation Therapy to Optimize Rehabilitation Effect (RESTORE): A Pivotal Study 68

Functional Neuromodulation Inc. Pipeline Products & Ongoing Clinical Trials Overview 69

Deep Brain Stimulation Device – Mild Alzheimer’s Disease – Product Status 69

Deep Brain Stimulation Device – Mild Alzheimer’s Disease – Product Description 69

Deep Brain Stimulation Device – OCD – Product Status 70

Deep Brain Stimulation Device – OCD – Product Description 70

Functional Neuromodulation Inc. – Ongoing Clinical Trials Overview 71

Deep Brain Stimulation Device – Mild Alzheimer’s Disease – A 12-month Double-blind, Randomized, Controlled Study to Evaluate the Safety and Efficacy of Deep Brain Stimulation of the Fornix (DBS-f) in Patients with Mild Probable Alzheimer’s Disease: ADvance II 72

Hangzhou General Stim Biotechnology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 73

Dual-Channel Implantable Deep Brain Stimulation System – Product Status 73

Dual-Channel Implantable Deep Brain Stimulation System – Product Description 73

Hangzhou General Stim Biotechnology Co Ltd – Ongoing Clinical Trials Overview 74

Dual-Channel Implantable Deep Brain Stimulation System – A Prospective, Multi-center, Blinded, Randomized Controlled Clinical Trial Evaluating the Safety and Efficacy of a Dual-channel Implantable Deep Brain Stimulation System for Improving Clinical Symptoms of Parkinson’s Disease 75

Louisiana State University Pipeline Products & Ongoing Clinical Trials Overview 76

Wireless Implantable Neural Stimulator – Product Status 76

Wireless Implantable Neural Stimulator – Product Description 76

Massachusetts General Hospital Pipeline Products & Ongoing Clinical Trials Overview 77

Deep Brain Stimulation Device – Product Status 77

Deep Brain Stimulation Device – Product Description 77

Deep Brain Stimulation System – Product Status 78

Deep Brain Stimulation System – Product Description 78

Massachusetts Institute of Technology Pipeline Products & Ongoing Clinical Trials Overview 79

Implantable Micro – Cannula Device – Product Status 79

Implantable Micro – Cannula Device – Product Description 79

Medtronic Neuromodulation Pipeline Products & Ongoing Clinical Trials Overview 80

Percept PC BrainSense – Product Status 80

Percept PC BrainSense – Product Description 80

Medtronic Neuromodulation – Ongoing Clinical Trials Overview 81

Percept PC BrainSense – Adaptive DBS Algorithm for Personalized Therapy in Parkinson’s Disease 82

Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 83

Cranial Mounted DBS – Product Status 83

Cranial Mounted DBS – Product Description 83

Reclaim Deep Brain Stimulation System – Depression – Product Status 84

Reclaim Deep Brain Stimulation System – Depression – Product Description 84

Sapiens DBS Field Steering System – Product Status 84

Sapiens DBS Field Steering System – Product Description 85

National Cheng-Kung University Hospital Pipeline Products & Ongoing Clinical Trials Overview 86

Responsive Epilepsy Control System-On-Chip – Product Status 86

Responsive Epilepsy Control System-On-Chip – Product Description 86

Neurode Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 87

Neurode Wave – Product Status 87

Neurode Wave – Product Description 87

NeuroOne Medical Technologies Corp Pipeline Products & Ongoing Clinical Trials Overview 88

Deep Brain Stimulation System – Product Status 88

Deep Brain Stimulation System – Product Description 88

Therapeutic Electrode – Chronic Stimulation – Product Status 89

Therapeutic Electrode – Chronic Stimulation – Product Description 89

Neuroparticle Corp Pipeline Products & Ongoing Clinical Trials Overview 90

Non-Invasive Deep Brain Stimulation Device – Product Status 90

Non-Invasive Deep Brain Stimulation Device – Product Description 90

NeuroPro Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 91

Deep Brain Stimulation – Product Status 91

Deep Brain Stimulation – Product Description 91

Neurosigma Inc Pipeline Products & Ongoing Clinical Trials Overview 92

Deep Brain Stimulation System – Cachexia – Product Status 92

Deep Brain Stimulation System – Cachexia – Product Description 92

Deep Brain Stimulation System – Obesity – Product Status 93

Deep Brain Stimulation System – Obesity – Product Description 93

Newronika s.r.l. Pipeline Products & Ongoing Clinical Trials Overview 94

AlphaDBS – Product Status 94

AlphaDBS – Product Description 94

Newronika s.r.l. – Ongoing Clinical Trials Overview 95

AlphaDBS – A Double-blind Crossover Study to Evaluate the Safety and Efficacy of Adaptive Deep Brain Stimulation Delivered through AlphaDBS System in Patients with Parkinson’s Disease 96

AlphaDBS – A Prospective, Multi-center, Open-label, Pivotal Clinical Trial to Compare the Safety and Effectiveness of Adaptive Versus Conventional Stimulation in Advanced Levodopa-Responsive Parkinson’s Disease Treated With Bilateral Deep Brain Stimulation 96

Nexeon MedSystems Inc Pipeline Products & Ongoing Clinical Trials Overview 97

Synapse – Product Status 97

Synapse – Product Description 97

Viant Deep Brain Stimulation System – Product Status 98

Viant Deep Brain Stimulation System – Product Description 98

Nia Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 99

Smart Neurostimulation System – Product Status 99

Smart Neurostimulation System – Product Description 99

Onward Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 100

ARC-DBS-Mobility – Product Status 100

ARC-DBS-Mobility – Product Description 100

Oxford University Innovation Ltd Pipeline Products & Ongoing Clinical Trials Overview 101

Closed-Loop DBS Device – Product Status 101

Closed-Loop DBS Device – Product Description 101

Salvia Bioelectronics BV Pipeline Products & Ongoing Clinical Trials Overview 102

Neuromodulation Device – Chronic Migraine – Product Status 102

Neuromodulation Device – Chronic Migraine – Product Description 102

Soterix Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 103

HD-tDCS System – Product Status 103

HD-tDCS System – Product Description 103

Soterix Medical Inc – Ongoing Clinical Trials Overview 104

HD-tDCS System – Modulating Prospective Memory in Older Adults with Noninvasive Brain Stimulation 105

HD-tDCS System – Targeted Noninvasive Brain Stimulation (T-NIBS) for Improving Hand Dexterity in Stroke Patients 105

HD-tDCS System – Testing High Definition Transcranial Direct Current Stimulation (HD-tDCS) as Treatment of Mild Cognitive Impairment 105

HD-tDCS System – Transcranial Direct Current Stimulation for Gait Recovery Following Stroke 106

Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview 107

Deep Brain Stimulator – Parkinson’s Disease – Product Status 107

Deep Brain Stimulator – Parkinson’s Disease – Product Description 107

Indigenous Deep Brain Stimulation Device – Product Status 108

Indigenous Deep Brain Stimulation Device – Product Description 108

St. Jude Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 109

Libra Deep Brain Stimulation System – Depression – Product Status 109

Libra Deep Brain Stimulation System – Depression – Product Description 109

Next Generation Implantable DBS System – Primary Cell – Product Status 110

Next Generation Implantable DBS System – Primary Cell – Product Description 110

St. Jude Medical LLC – Ongoing Clinical Trials Overview 111

Libra Deep Brain Stimulation System – Depression – Long Term Follow-up of Deep Brain Stimulation for Treatment-Resistant Depression 112

Sunnybrook Health Sciences Centre Pipeline Products & Ongoing Clinical Trials Overview 113

Deep Brain Stimulation Device – PTSD – Product Status 113

Deep Brain Stimulation Device – PTSD – Product Description 113

Sunnybrook Health Sciences Centre – Ongoing Clinical Trials Overview 114

Deep Brain Stimulation Device – PTSD – Deep Brain Stimulation (DBS) for the Treatment of Refractory Post-traumatic Stress Disorder (PTSD): Pilot Trial 115

SUNY Downstate Medical Center Pipeline Products & Ongoing Clinical Trials Overview 116

Low-Frequency Sine Wave Neurostimulation Therapy Device – Product Status 116

Low-Frequency Sine Wave Neurostimulation Therapy Device – Product Description 116

The Magstim Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 117

Magstim Super Rapid2 Plus1 – Product Status 117

Magstim Super Rapid2 Plus1 – Product Description 117

The Magstim Co Ltd – Ongoing Clinical Trials Overview 118

Magstim Super Rapid2 Plus1 – Neuromodulation for Rehabilitation of Post-Stroke Fatigue: An rTMS Pilot Study 119

Magstim Super Rapid2 Plus1 – Neuromodulation in the Elderly Depressed: A Brain Im-aging Pilot Study 119

University of California Los Angeles Pipeline Products & Ongoing Clinical Trials Overview 120

Deep Brain Stimulation Device – Product Status 120

Deep Brain Stimulation Device – Product Description 121

Implantable Ultrasound Neuromodulation Device – Product Status 121

Implantable Ultrasound Neuromodulation Device – Product Description 121

Wireless Deep Brain Stimulating System – Product Status 122

Wireless Deep Brain Stimulating System – Product Description 122

University of California San Francisco Pipeline Products & Ongoing Clinical Trials Overview 123

Deep Brain Stimulation Device – Severe Depression – Product Status 123

Deep Brain Stimulation Device – Severe Depression – Product Description 123

University of California San Francisco – Ongoing Clinical Trials Overview 124

Deep Brain Stimulation Device – Severe Depression – Study Evaluating the Efficacy of Closed-loop Neuromodulation in Patients with Treatment-resistant Depression 125

University of Central Florida Pipeline Products & Ongoing Clinical Trials Overview 126

Deep Brain Stimulation System – Product Status 126

Deep Brain Stimulation System – Product Description 126

University of Florida Pipeline Products & Ongoing Clinical Trials Overview 127

Closed-Loop Deep Brain Stimulation System – Product Status 127

Closed-Loop Deep Brain Stimulation System – Product Description 127

Closed-Loop Seizure Control System – Product Status 128

Closed-Loop Seizure Control System – Product Description 128

Deep Brain Stimulation System – Product Status 128

Deep Brain Stimulation System – Product Description 129

University of Houston Pipeline Products & Ongoing Clinical Trials Overview 130

Closed-Loop Brain Stimulator – PTSD – Product Status 130

Closed-Loop Brain Stimulator – PTSD – Product Description 130

University of Illinois Pipeline Products & Ongoing Clinical Trials Overview 131

Wireless Deep Brain Stimulation System – Essential Tremor – Product Status 131

Wireless Deep Brain Stimulation System – Essential Tremor – Product Description 131

University of Milan Pipeline Products & Ongoing Clinical Trials Overview 132

Smart Brain Device – Product Status 132

Smart Brain Device – Product Description 132

University of Minnesota Pipeline Products & Ongoing Clinical Trials Overview 133

Closed-Loop Deep Brain Stimulation Device – Product Status 133

Closed-Loop Deep Brain Stimulation Device – Product Description 133

University of Oxford Pipeline Products & Ongoing Clinical Trials Overview 134

Adaptive Deep Brain Stimulation System – Product Status 134

Adaptive Deep Brain Stimulation System – Product Description 134

University of Queensland Pipeline Products & Ongoing Clinical Trials Overview 135

Automated Brain Stimulation System – Product Status 135

Automated Brain Stimulation System – Product Description 135

University of Rochester Pipeline Products & Ongoing Clinical Trials Overview 136

Deep Brain Magnetic Stimulator – Product Status 136

Deep Brain Magnetic Stimulator – Product Description 136

University of South Florida Pipeline Products & Ongoing Clinical Trials Overview 137

Deep Brain Stimulator – Product Status 137

Deep Brain Stimulator – Product Description 137

Wedge Therapeutics Pipeline Products & Ongoing Clinical Trials Overview 138

SONS System – Product Status 138

SONS System – Product Description 138

Glossary 162

Figures

Deep Brain Stimulators (DBS) – Pipeline Products by Stage of Development 14

Deep Brain Stimulators (DBS) – Pipeline Products by Territory 15

Deep Brain Stimulators (DBS) – Pipeline Products by Regulatory Path 16

Deep Brain Stimulators (DBS) – Pipeline Products by Estimated Approval Date 17

Deep Brain Stimulators (DBS) – Ongoing Clinical Trials 18

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