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

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Deep Brain Stimulators (DBS) Pipeline Market Report Overview

Deep brain stimulators (DBS) comprise 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.

The DBS pipeline market research report provides a comprehensive understanding of the pipeline products along with their comparative analysis at various stages of development. The report also includes information about the territories wherein the clinical trials are in progress, the regulatory paths followed by the trials, and the companies associated with the trials.

Key Territories ·       The United States

·       Europe

·       China

·       India

·       United Kingdom

Key Segment ·       Non-Rechargeable Deep Brain Stimulators

·       Rechargeable Deep Brain Stimulators

Key Regulatory Paths ·       510(k)

·       PMA

·       CE

·       UKCA

·       TGA

Leading Companies ·       Abbott Laboratories

·       Adaptive Neuromodulation GmbH

·       Adept Neuro SA

·       Aleva Neurotherapeutics SA

·       Allegheny Health Network

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DBS Pipeline Market Segments

A few of the key segments in the DBS pipeline market are non-rechargeable deep brain stimulators and rechargeable deep brain stimulators. As of August 2024, non-rechargeable deep brain stimulators have a higher number of pipeline products.

DBS Pipeline Market Analysis by Segments, 2024 (%)

DBS Pipeline Market Analysis by Segments, 2024 (%)

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DBS Pipeline Market Segmentation by Territories

A few of the key territories with the DBS pipeline market are Europe, the United States, India, China, and the United Kingdom among others. As of August 2024, the US had the highest number of DBS pipeline products.

DBS Pipeline Market Analysis by Territories, 2024 (%)

DBS Pipeline Market Analysis by Territories, 2024 (%)

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DBS Pipeline Market Segmentation by Regulatory Paths

A few of the key regulatory paths in the DBS pipeline products market are 510(k), CE, PMA, TGA, and UKCA among others. As of August 2024, PMA was the most followed pathway for pipeline products in the DBS market.

DBS Pipeline Market Analysis by Regulatory Paths, 2024 (%)

DBS Pipeline Market Analysis by Regulatory Paths, 2024 (%)

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DBS Pipeline Market – Competitive Landscape

A few of the key companies associated with the DBS pipeline market are Abbott Laboratories, Adaptive Neuromodulation GmbH, Adept Neuro SA, Aleva Neurotherapeutics SA, and Allegheny Health Network among others.

Abbott Laboratories: Abbott discovers, develops, manufactures, and sells a diverse range of healthcare products including branded generic pharmaceuticals, diagnostic systems and tests, and pediatric and adult nutritional products. The company also offers various medical devices including heart failure, electrophysiology, rhythm management, vascular and structural heart devices, and neuromodulation devices. The company also offers mineral nutrition products and dietary supplements. It has research and development facilities in the US, Colombia, India, Singapore, Spain, and the UK and operates manufacturing facilities across the world. The company markets products in North America, Latin America, the Middle East, Europe, Asia-Pacific and Africa. Abbott is headquartered in Abbott Park, Illinois, the US.

DBS Pipeline Market Analysis by Companies, 2024
DBS Pipeline Market Analysis by Companies, 2024Buy the Full Report for More Company Insights into the DBS Pipeline Market
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Segments Covered in the Report

DBS Pipeline Market Segments Outlook (2024)

  • Non-Rechargeable Deep Brain Stimulators
  • Rechargeable Deep Brain Stimulators

DBS Pipeline Market Territories Outlook (2024)

  • Europe
  • The United States
  • India
  • China
  • United Kingdom

DBS Pipeline Market Regulatory Paths Outlook (2024)

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

Scope

This report provides:

  • Extensive coverage of the DBS devices under development.
  • Exhaustive list of major pipeline products and their details, including product description, licensing and collaboration details, and other developmental activities.
  • Reviews of major players involved in the development of DBS and lists all their pipeline projects.
  • Coverage of pipeline products based on various stages of development ranging from early development to approved/issued stage.
  • Key clinical trial data of ongoing clinical trials specific to pipeline products.
  • Recent developments in the segment/industry.

Reasons to Buy

  • 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.
  • Carry out an in-depth analysis of the product’s current stage of development, territory, and estimated launch date.

Abbott Laboratories
Adaptive Neuromodulation GmbH
Adept Neuro SA
Aleva Neurotherapeutics SA
Allegheny Health Network
Amber Therapeutics Ltd
Baylor College of Medicine
Boston Scientific Corp
Clinatec
Deep Brain Innovations, LLC
Deep Brain Stimulation Technologies Pty Ltd
Enspire DBS Therapy Inc
Hangzhou General Stim Biotechnology Co Ltd
Hangzhou Promise Medical Technology Co Ltd
Louisiana State University
Massachusetts General Hospital
Medtronic Plc
National Cheng-Kung University Hospital
NeuroOne Medical Technologies Corp
NeuroPro Technologies Inc
Neurosigma Inc
Newronika s.r.l.
Nexeon MedSystems Inc
Nia Therapeutics Inc
Oxford University Innovation Ltd
Sree Chitra Tirunal Institute for Medical Sciences & Technology
St. Jude Medical LLC
Stanford University
Sunnybrook Health Sciences Centre
UConn School of Medicine
University of California Los Angeles
University of California San Francisco
University of Central Florida
University of Florida
University of Illinois
University of Milan
University of Minnesota
University of Oxford
University of Pittsburgh
University of Rochester
University of South Florida

Table of Contents

|1 Table of Contents 3

|1.1 List of Tables 7

|1.2 List of Figures 11

2 Introduction 12

2.1 Deep Brain Stimulators (DBS) Overview 12

3 Products under Development 13

3.1 Deep Brain Stimulators (DBS) – Pipeline Products by Stage of Development 13

3.2 Deep Brain Stimulators (DBS) – Pipeline Products by Segment 14

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

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

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

3.6 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 21

5 Deep Brain Stimulators (DBS) Companies and Product Overview 23

5.1 Abbott Laboratories Company Overview 23

5.1.1 Abbott Laboratories Pipeline Products & Ongoing Clinical Trials Overview 23

5.2 Adaptive Neuromodulation GmbH Company Overview 25

5.2.1 Adaptive Neuromodulation GmbH Pipeline Products & Ongoing Clinical Trials Overview 25

5.3 Adept Neuro SA Company Overview 26

5.3.1 Adept Neuro SA Pipeline Products & Ongoing Clinical Trials Overview 26

5.4 Aleva Neurotherapeutics SA Company Overview 27

5.4.1 Aleva Neurotherapeutics SA Pipeline Products & Ongoing Clinical Trials Overview 27

5.5 Allegheny Health Network Company Overview 30

5.5.1 Allegheny Health Network Pipeline Products & Ongoing Clinical Trials Overview 30

5.6 Amber Therapeutics Ltd Company Overview 35

5.6.1 Amber Therapeutics Ltd Pipeline Products & Ongoing Clinical Trials Overview 35

5.7 Baylor College of Medicine Company Overview 40

5.7.1 Baylor College of Medicine Pipeline Products & Ongoing Clinical Trials Overview 40

5.8 Boston Scientific Corp Company Overview 41

5.8.1 Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 41

5.9 Clinatec Company Overview 43

5.9.1 Clinatec Pipeline Products & Ongoing Clinical Trials Overview 43

5.10 Deep Brain Innovations, LLC Company Overview 44

5.10.1 Deep Brain Innovations, LLC Pipeline Products & Ongoing Clinical Trials Overview 44

5.11 Deep Brain Stimulation Technologies Pty Ltd Company Overview 49

5.11.1 Deep Brain Stimulation Technologies Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 49

5.12 Enspire DBS Therapy Inc Company Overview 50

5.12.1 Enspire DBS Therapy Inc Pipeline Products & Ongoing Clinical Trials Overview 50

5.13 Hangzhou General Stim Biotechnology Co Ltd Company Overview 53

5.13.1 Hangzhou General Stim Biotechnology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 53

5.14 Hangzhou Promise Medical Technology Co Ltd Company Overview 56

5.14.1 Hangzhou Promise Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 56

5.15 Louisiana State University Company Overview 57

5.15.1 Louisiana State University Pipeline Products & Ongoing Clinical Trials Overview 57

5.16 Massachusetts General Hospital Company Overview 58

5.16.1 Massachusetts General Hospital Pipeline Products & Ongoing Clinical Trials Overview 58

5.17 Medtronic Plc Company Overview 60

5.17.1 Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 60

5.18 National Cheng-Kung University Hospital Company Overview 61

5.18.1 National Cheng-Kung University Hospital Pipeline Products & Ongoing Clinical Trials Overview 61

5.19 NeuroOne Medical Technologies Corp Company Overview 62

5.19.1 NeuroOne Medical Technologies Corp Pipeline Products & Ongoing Clinical Trials Overview 62

5.20 NeuroPro Technologies Inc Company Overview 65

5.20.1 NeuroPro Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 65

5.21 Neurosigma Inc Company Overview 66

5.21.1 Neurosigma Inc Pipeline Products & Ongoing Clinical Trials Overview 66

5.22 Newronika s.r.l. Company Overview 68

5.22.1 Newronika s.r.l. Pipeline Products & Ongoing Clinical Trials Overview 68

5.23 Nexeon MedSystems Inc Company Overview 71

5.23.1 Nexeon MedSystems Inc Pipeline Products & Ongoing Clinical Trials Overview 71

5.24 Nia Therapeutics Inc Company Overview 73

5.24.1 Nia Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 73

5.25 Oxford University Innovation Ltd Company Overview 74

5.25.1 Oxford University Innovation Ltd Pipeline Products & Ongoing Clinical Trials Overview 74

5.26 Sree Chitra Tirunal Institute for Medical Sciences & Technology Company Overview 75

5.26.1 Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview 75

5.27 St. Jude Medical LLC Company Overview 77

5.27.1 St. Jude Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 77

5.28 Stanford University Company Overview 81

5.28.1 Stanford University Pipeline Products & Ongoing Clinical Trials Overview 81

5.29 Sunnybrook Health Sciences Centre Company Overview 82

5.29.1 Sunnybrook Health Sciences Centre Pipeline Products & Ongoing Clinical Trials Overview 82

5.30 UConn School of Medicine Company Overview 85

5.30.1 UConn School of Medicine Pipeline Products & Ongoing Clinical Trials Overview 85

5.31 University of California Los Angeles Company Overview 86

5.31.1 University of California Los Angeles Pipeline Products & Ongoing Clinical Trials Overview 86

5.32 University of California San Francisco Company Overview 89

5.32.1 University of California San Francisco Pipeline Products & Ongoing Clinical Trials Overview 89

5.33 University of Central Florida Company Overview 90

5.33.1 University of Central Florida Pipeline Products & Ongoing Clinical Trials Overview 90

5.34 University of Florida Company Overview 91

5.34.1 University of Florida Pipeline Products & Ongoing Clinical Trials Overview 91

5.35 University of Illinois Company Overview 92

5.35.1 University of Illinois Pipeline Products & Ongoing Clinical Trials Overview 92

5.36 University of Milan Company Overview 93

5.36.1 University of Milan Pipeline Products & Ongoing Clinical Trials Overview 93

5.37 University of Minnesota Company Overview 94

5.37.1 University of Minnesota Pipeline Products & Ongoing Clinical Trials Overview 94

5.38 University of Oxford Company Overview 96

5.38.1 University of Oxford Pipeline Products & Ongoing Clinical Trials Overview 96

5.39 University of Pittsburgh Company Overview 98

5.39.1 University of Pittsburgh Pipeline Products & Ongoing Clinical Trials Overview 98

5.40 University of Rochester Company Overview 99

5.40.1 University of Rochester Pipeline Products & Ongoing Clinical Trials Overview 99

5.41 University of South Florida Company Overview 100

5.41.1 University of South Florida Pipeline Products & Ongoing Clinical Trials Overview 100

6 Deep Brain Stimulators (DBS)- Recent Developments 101

6.1 Aug 20, 2024: Self-Adjusting Brain Pacemaker May Help Reduce Parkinson’s Disease Symptoms 101

6.2 Aug 19, 2024: Taming Parkinson’s Disease with Intelligent Brain Pacemakers 102

6.3 Aug 15, 2024: NIH Funds UK’s Groundbreaking DBS-Plus Trial for Parkinson’s 104

6.4 Aug 12, 2024: Medtronic Receives Landmark FDA Approval for Asleep Deep Brain Stimulation Surgery 106

6.5 Aug 04, 2024: Medtronic Receives Humanitarian Device Exemption (HDE) For Percept RC With BrainSense 106

6.6 Jul 15, 2024: Medtronic Neuromodulation Receives Humanitarian Device Exemption (HDE) For Percept PC BrainSense Neurostimulator Model – B35200 107

6.7 Jul 15, 2024: Medtronic Receives Humanitarian Device Exemption For Reclaim DBS System 107

6.8 Jul 15, 2024: Medtronic Neuromodulation Receives Humanitarian Device Exemption (HDE) For Activa Dystonia Therapy System 107

6.9 Jul 10, 2024: Medtronic Receives Humanitarian Device Exemption (Hde) For Reclaim DBS System 107

6.10 Jul 10, 2024: Medtronic Neuromodulation Receives Additional Humanitarian Device Exemption (HDE) Clearance for Percept PC BrainSense Neurostimulator Model – B35200 108

6.11 Jul 10, 2024: Medtronic Neuromodulation Obtains Additional Humanitarian Device Exemption (HDE) Clearance for the Activa Dystonia Therapy System 108

6.12 Jun 18, 2024: New Technology Allows Researchers to Precisely, Flexibly Modulate Brain 108

6.13 Jun 13, 2024: Nexalin Technology Announces Regulatory Approval to Sell Nexalin’s Gen-2, 15 mA Neurostimulation Device by the Brazilian Health Regulatory Agency (Anvisa) 109

6.14 Jun 13, 2024: Medtronic Confirms Global Layoffs 110

6.15 Jun 06, 2024: Medtronic Neuromodulation obtains Additional Humanitarian Device Exemption (HDE) clearance for Activa Dystonia Therapy System 110

6.16 May 16, 2024: Medtronic Neuromodulation Receives Additional 510(K) Clearance For Percept PC BrainSense Neurostimulator Model – B35200 110

6.17 May 13, 2024: Medtronic Neuromodulation receives additional 510(k) clearance for Activa Dystonia Therapy System 110

6.18 May 08, 2024: Medtronic Neuromodulation Receives Additional Humanitarian Device Exemption (HDE) clearance for Activa Dystonia Therapy System 111

6.19 May 08, 2024: Medtronic Receive Additional Humanitarian Device Exemption (HDE) clearance for Reclaim DBS System 111

6.20 May 08, 2024: Medtronic Receives Additional Humanitarian Device Exemption (HDE) clearance for Percept PC Neurostimulator DBS System 111

6.21 Apr 23, 2024: Medtronic Neuromodulation Receives Additional Humanitarian Device Exemption (HDE) Clearance for Activa Dystonia Therapy System 112

6.22 Apr 23, 2024: Medtronic ) Receives Humanitarian Device Exemption (HDE) for Percept RC With BrainSense 112

6.23 Apr 15, 2024: Labcorp Announces First-of-Its-Kind Test for Early Indication of Neurodegenerative Diseases and Brain Injuries Using a Blood Draw 112

6.24 Apr 12, 2024: Rice team demonstrates miniature brain stimulator in humans 113

6.25 Mar 12, 2024: Medtronic To Present At Barclays Global Healthcare Conference 114

6.26 Mar 04, 2024: Medtronic Neuromodulation Receives Additional Humanitarian Device Exemption (HDE) For Activa Dystonia Therapy System 114

6.27 Mar 04, 2024: Medtronic Receives Additional Humanitarian Device Exemption (HDE) For Reclaim DBS System 115

6.28 Feb 28, 2024: Boston Scientific Raises $2.2B to Support Purchase of California Medical Device Company 115

6.29 Feb 23, 2024: Medical Tech Leader, Boston Scientific (BSX), Announces Notes Offering 115

6.30 Feb 15, 2024: Stephen Agostini Named UCLA’s Vice Chancellor and Chief Financial Officer 115

6.31 Feb 14, 2024: UT Health San Antonio doctors among first to implant rechargeable deep brain stimulation device 116

6.32 Jan 28, 2024: Medtronic Receives An Additional HDE Clearance for Reclaim DBS System 117

6.33 Jan 26, 2024: Abbott scores FDA approval for small, long lasting rechargeable DBS 117

6.34 Jan 11, 2024: AHN Team Performs Region’s First Deep Brain Stimulation Therapy to Treat Opioid Addiction 118

6.35 Jan 11, 2024: Nexalin Technology Unveils Next-Generation HALO Clarity 119

6.36 Jan 09, 2024: US FDA approves Medtronic’s Percept RC neurostimulator 120

6.37 Jan 05, 2024: Boston Scientific Announces Conference Call Discussing Fourth Quarter 2023 Results 121

6.38 Dec 05, 2023: Medtronic Receives CE Mark for the Percept RC Rechargeable DBS Neurostimulator With BrainSense Technology 121

6.39 Dec 04, 2023: NeuroPace to Leverage the Power of its RNS System’s Novel Data Collection, Brain Monitoring and Analysis Capabilities in Groundbreaking Collaboration 122

6.40 Dec 04, 2023: UCF Welcomes Alum and Distinguished Military Leader as Associate VP of Federal Affairs 123

6.41 Nov 16, 2023: Neuroone Announces Patent Allowance for Drug Delivery Utilizing a Novel Neural Probe 124

6.42 Nov 02, 2023: Medtronic Obtains Additional Humanitarian Device Exemption (HDE) Clearance for Activa Dystonia Therapy System 124

6.43 Nov 02, 2023: Medtronic Receives Additional HDE Clearance for Reclaim DBS System 124

6.44 Nov 02, 2023: Medtronic Neuromodulation Receives Additional HDE Clearance for Percept PC BrainSense 125

6.45 Nov 02, 2023: Medtronic Neuromodulation Receives Additional HDE Clearance for Percept PC BrainSense 125

6.46 Oct 17, 2023: NeuroPace Announces RNS System Enhancements Designed to Streamline Care 125

6.47 Oct 12, 2023: Medtronic Neuromodulation Obtains Additional Humanitarian Device Exemption (HDE) Clearance for Percept PC BrainSense 126

6.48 Oct 12, 2023: Medtronic Obtains Additional Humanitarian Device Exemption (HDE) Clearance for Activa Dystonia Therapy System 126

6.49 Sep 07, 2023: UCF Names Saiful Khondaker as Interim Assistant Vice President for Research Advancement 127

7 Appendix 128

7.1 Methodology 128

7.2 About GlobalData 131

7.3 Contact Us 131

7.4 Disclaimer 131

Table

Deep Brain Stimulators (DBS) – Pipeline Products by Stage of Development 13

Deep Brain Stimulators (DBS) – Pipeline Products by Segment 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 21

Abbott Laboratories Pipeline Products & Ongoing Clinical Trials Overview 23

Infinity Deep Brain Stimulation (DBS) System – Treatment Resistant Depression – Product Status 23

Infinity Deep Brain Stimulation (DBS) System – Treatment Resistant Depression – Product Description 24

Adaptive Neuromodulation GmbH Pipeline Products & Ongoing Clinical Trials Overview 25

CR-Capable Implant – Product Status 25

CR-Capable Implant – Product Description 25

Adept Neuro SA Pipeline Products & Ongoing Clinical Trials Overview 26

Stereo-Electro-Encephalo-Graphie Electrode – Product Status 26

Stereo-Electro-Encephalo-Graphie Electrode – Product Description 26

Aleva Neurotherapeutics SA Pipeline Products & Ongoing Clinical Trials Overview 27

directSTIM – Product Status 27

directSTIM – Product Description 27

Aleva Neurotherapeutics SA – Ongoing Clinical Trials Overview 28

directSTIM – A Prospective, Multi-center, Post-market Clinical Follow-up Study of the directSTIM Deep Brain Stimulation (DBS) System 29

Allegheny Health Network Pipeline Products & Ongoing Clinical Trials Overview 30

Deep Brain Stimulation System – Alzheimer’s Disease – Product Status 30

Deep Brain Stimulation System – Alzheimer’s Disease – Product Description 30

Deep Brain Stimulation System – Obesity – Product Status 31

Deep Brain Stimulation System – Obesity – Product Description 31

Deep Brain Stimulation System – Opioid Addiction – Product Status 31

Deep Brain Stimulation System – Opioid Addiction – Product Description 32

Allegheny Health Network – Ongoing Clinical Trials Overview 33

Deep Brain Stimulation System – Opioid Addiction – Pilot Study to Evaluate Deep Brain Stimulation (DBS) of the Nucleus Accumbens (NAc) for Patients with Treatment-refractory Opioid Use Disorder 34

Amber Therapeutics Ltd Pipeline Products & Ongoing Clinical Trials Overview 35

Picostim – Product Status 35

Picostim – Product Description 35

Picostim-DyNeuMo – Product Status 36

Picostim-DyNeuMo – Product Description 36

Amber Therapeutics Ltd – Ongoing Clinical Trials Overview 37

Picostim – Simpler and Safer Deep Brain Stimulation for Parkinson’s Disease 38

Picostim-DyNeuMo – Children’s Adaptive Deep Brain Stimulation for Epilepsy Trial (CADET): Pilot 39

Picostim-DyNeuMo – Efficacy of Pain Intervention With Deep Brain Stimulation Neuromodulation 39

Baylor College of Medicine Pipeline Products & Ongoing Clinical Trials Overview 40

Adaptive Deep Brain Stimulation (aDBS) Device – Product Status 40

Adaptive Deep Brain Stimulation (aDBS) Device – Product Description 40

Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 41

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

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

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

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

Clinatec Pipeline Products & Ongoing Clinical Trials Overview 43

Intracranial Deep Brain Stimulation Device – Product Status 43

Intracranial Deep Brain Stimulation Device – Product Description 43

Deep Brain Innovations, LLC Pipeline Products & Ongoing Clinical Trials Overview 44

TOPS Device – Alzheimer’s disease – Product Status 44

TOPS Device – Alzheimer’s disease – Product Description 44

TOPS Device – Depression – Product Status 45

TOPS Device – Depression – Product Description 45

TOPS Device – Epilepsy – Product Status 45

TOPS Device – Epilepsy – Product Description 46

TOPS Device – Obesity – Product Status 46

TOPS Device – Obesity – Product Description 46

TOPS Device – Obsessive-Compulsive Disorder – Product Status 47

TOPS Device – Obsessive-Compulsive Disorder – Product Description 47

TOPS Device – Parkinson’s disease – Product Status 47

TOPS Device – Parkinson’s disease – Product Description 48

Deep Brain Stimulation Technologies Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 49

Adaptive Deep Brain Stimulation Device – Product Status 49

Adaptive Deep Brain Stimulation Device – Product Description 49

Enspire DBS Therapy Inc Pipeline Products & Ongoing Clinical Trials Overview 50

Enspire DBS Therapy System – Product Status 50

Enspire DBS Therapy System – Product Description 50

Enspire DBS Therapy Inc – Ongoing Clinical Trials Overview 51

Enspire DBS Therapy System – Rehab With Electrical Stimulation Therapy to Optimize Rehabilitation Effect (RESTORE): A Pivotal Study 52

Hangzhou General Stim Biotechnology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 53

Dual-Channel Implantable Deep Brain Stimulation System – Product Status 53

Dual-Channel Implantable Deep Brain Stimulation System – Product Description 53

Hangzhou General Stim Biotechnology Co Ltd – Ongoing Clinical Trials Overview 54

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 55

Hangzhou Promise Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 56

Deep Brain Neurostimulation System – Product Status 56

Deep Brain Neurostimulation System – Product Description 56

Louisiana State University Pipeline Products & Ongoing Clinical Trials Overview 57

Wireless Implantable Neural Stimulator – Product Status 57

Wireless Implantable Neural Stimulator – Product Description 57

Massachusetts General Hospital Pipeline Products & Ongoing Clinical Trials Overview 58

Deep Brain Stimulation Device – Product Status 58

Deep Brain Stimulation Device – Product Description 58

Deep Brain Stimulation System – Product Status 59

Deep Brain Stimulation System – Product Description 59

Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 60

Reclaim Deep Brain Stimulation System – Depression – Product Status 60

Reclaim Deep Brain Stimulation System – Depression – Product Description 60

National Cheng-Kung University Hospital Pipeline Products & Ongoing Clinical Trials Overview 61

Responsive Epilepsy Control System-On-Chip – Product Status 61

Responsive Epilepsy Control System-On-Chip – Product Description 61

NeuroOne Medical Technologies Corp Pipeline Products & Ongoing Clinical Trials Overview 62

Deep Brain Stimulation System – Product Status 62

Deep Brain Stimulation System – Product Description 62

Next-Generation Stimulation Electrode – Parkinson’s Disease – Product Status 63

Next-Generation Stimulation Electrode – Parkinson’s Disease – Product Description 63

Therapeutic Electrode – Chronic Stimulation – Product Status 63

Therapeutic Electrode – Chronic Stimulation – Product Description 64

NeuroPro Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 65

Deep Brain Stimulation – Product Status 65

Deep Brain Stimulation – Product Description 65

Neurosigma Inc Pipeline Products & Ongoing Clinical Trials Overview 66

Deep Brain Stimulation System – Cachexia – Product Status 66

Deep Brain Stimulation System – Cachexia – Product Description 66

Deep Brain Stimulation System – Obesity – Product Status 67

Deep Brain Stimulation System – Obesity – Product Description 67

Newronika s.r.l. Pipeline Products & Ongoing Clinical Trials Overview 68

AlphaDBS – Product Status 68

AlphaDBS – Product Description 68

Newronika s.r.l. – Ongoing Clinical Trials Overview 69

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 70

Nexeon MedSystems Inc Pipeline Products & Ongoing Clinical Trials Overview 71

Viant Deep Brain Stimulation System – Product Status 71

Viant Deep Brain Stimulation System – Product Description 72

Nia Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 73

Smart Neurostimulation System – Product Status 73

Smart Neurostimulation System – Product Description 73

Oxford University Innovation Ltd Pipeline Products & Ongoing Clinical Trials Overview 74

Closed-Loop DBS Device – Product Status 74

Closed-Loop DBS Device – Product Description 74

Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview 75

Deep Brain Stimulator – Parkinson’s Disease – Product Status 75

Deep Brain Stimulator – Parkinson’s Disease – Product Description 75

Indigenous Deep Brain Stimulation Device – Product Status 76

Indigenous Deep Brain Stimulation Device – Product Description 76

St. Jude Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 77

Libra Deep Brain Stimulation System – Depression – Product Status 77

Libra Deep Brain Stimulation System – Depression – Product Description 77

Next Generation Implantable DBS System – Primary Cell – Product Status 78

Next Generation Implantable DBS System – Primary Cell – Product Description 78

St. Jude Medical LLC – Ongoing Clinical Trials Overview 79

Libra Deep Brain Stimulation System – Depression – Long Term Follow-up of Deep Brain Stimulation for Treatment-Resistant Depression 80

Stanford University Pipeline Products & Ongoing Clinical Trials Overview 81

Inductive Light Generator – Product Status 81

Inductive Light Generator – Product Description 81

Sunnybrook Health Sciences Centre Pipeline Products & Ongoing Clinical Trials Overview 82

Deep Brain Stimulation Device – PTSD – Product Status 82

Deep Brain Stimulation Device – PTSD – Product Description 82

Sunnybrook Health Sciences Centre – Ongoing Clinical Trials Overview 83

Deep Brain Stimulation Device – PTSD – Deep Brain Stimulation (DBS) for the Treatment of Refractory Post-traumatic Stress Disorder (PTSD): Pilot Trial 84

UConn School of Medicine Pipeline Products & Ongoing Clinical Trials Overview 85

Deep Brain Stimulator – Product Status 85

Deep Brain Stimulator – Product Description 85

University of California Los Angeles Pipeline Products & Ongoing Clinical Trials Overview 86

Deep Brain Stimulation Device – Product Status 86

Deep Brain Stimulation Device – Product Description 87

Implantable Ultrasound Neuromodulation Device – Product Status 87

Implantable Ultrasound Neuromodulation Device – Product Description 88

Wireless Deep Brain Stimulating System – Product Status 88

Wireless Deep Brain Stimulating System – Product Description 88

University of California San Francisco Pipeline Products & Ongoing Clinical Trials Overview 89

Deep Brain Stimulation Device – Severe Depression – Product Status 89

Deep Brain Stimulation Device – Severe Depression – Product Description 89

University of Central Florida Pipeline Products & Ongoing Clinical Trials Overview 90

Deep Brain Stimulation System – Product Status 90

Deep Brain Stimulation System – Product Description 90

University of Florida Pipeline Products & Ongoing Clinical Trials Overview 91

Deep Brain Stimulation System – Product Status 91

Deep Brain Stimulation System – Product Description 91

University of Illinois Pipeline Products & Ongoing Clinical Trials Overview 92

Wireless Deep Brain Stimulation System – Essential Tremor – Product Status 92

Wireless Deep Brain Stimulation System – Essential Tremor – Product Description 92

University of Milan Pipeline Products & Ongoing Clinical Trials Overview 93

Smart Brain Device – Product Status 93

Smart Brain Device – Product Description 93

University of Minnesota Pipeline Products & Ongoing Clinical Trials Overview 94

Closed-Loop Deep Brain Stimulation Device – Product Status 94

Closed-Loop Deep Brain Stimulation Device – Product Description 94

Two-Shank Auditory Midbrain Implant – Product Status 95

Two-Shank Auditory Midbrain Implant – Product Description 95

University of Oxford Pipeline Products & Ongoing Clinical Trials Overview 96

Adaptive Deep Brain Stimulation System – Product Status 96

Adaptive Deep Brain Stimulation System – Product Description 96

Deep Brain Stimulation Device – Gait Impairment – Product Status 97

Deep Brain Stimulation Device – Gait Impairment – Product Description 97

University of Pittsburgh Pipeline Products & Ongoing Clinical Trials Overview 98

Deep Brain Stimulation Device – Seizures – Product Status 98

Deep Brain Stimulation Device – Seizures – Product Description 98

University of Rochester Pipeline Products & Ongoing Clinical Trials Overview 99

Deep Brain Magnetic Stimulator – Product Status 99

Deep Brain Magnetic Stimulator – Product Description 99

University of South Florida Pipeline Products & Ongoing Clinical Trials Overview 100

Deep Brain Stimulator – Product Status 100

Deep Brain Stimulator – Product Description 100

Glossary 130

Figures

Deep Brain Stimulators (DBS) – Pipeline Products by Stage of Development 13

Deep Brain Stimulators (DBS) – Pipeline Products by Segment 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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