Spinal Cord Stimulators (SCS) Pipeline Report including Stages of Development, Segments, Region and Countries, Regulatory Path and Key Companies, 2022 Update

Pages: 129 Published: July 29, 2022 Report Code: GDME1409EPD

An SCS is a device that comprises a surgically-implanted electrical pacemaker and electrodes that connect to the spinal cord to treat chronic pain disorders. One unit refers to one Spinal Cord Stimulator. The spinal cord stimulators pipeline product market report provides comprehensive information about the pipeline products with comparative analysis of the products at various stages of development and information about the clinical trials which are in progress.

Key Territories in the Spinal Cord Stimulators Pipeline Market

The key territories in the spinal cord stimulators pipeline market are the United States, Europe, Australia, United Kingdom, Canada, China, and Germany. The United States has the highest number of pipeline products.

Spinal Cord Stimulators Pipeline Market, by Territories

Spinal Cord Stimulators Pipeline Market, by Territories

For more territory insights, download a free report sample

Key Regulatory Path in the Spinal Cord Stimulators Pipeline Market

The key regulatory paths in the spinal cord stimulators pipeline market are PMA, CE, 510(k), TGA, UKCA, de novo, MDL, and NMPA. PMA has the highest number of pipeline products.

Spinal Cord Stimulators Pipeline Market, by Regulatory Paths

Spinal Cord Stimulators Pipeline Market, by Regulatory Paths

For more regulatory path insights, download a free report sample

Key Companies in the Spinal Cord Stimulators Pipeline Market

The key companies in the spinal cord stimulators pipeline market are Beijing Lingchuang Yigu Technology Development Co Ltd, Biotronik Inc, Boston Scientific Corp, Cerevast Therapeutics Inc, Direct Spinal Therapeutics, Inc., Duke University, GTX Medical BV, Imperial College London, and Lawson Health Research Institute.

Market report overview

Key territories The United States, Europe, Australia, United Kingdom, Canada, China, and Germany
Key regulatory paths PMA, CE, 510(k), TGA, UKCA, de novo, MDL, and NMPA
Key companies Beijing Lingchuang Yigu Technology Development Co Ltd, Biotronik Inc, Boston Scientific Corp, Cerevast Therapeutics Inc, Direct Spinal Therapeutics, Inc., Duke University, GTX Medical BV, Imperial College London, and Lawson Health Research Institute

Scope

This report provides an in-depth analysis of the following:

  • Extensive coverage of the spinal cord stimulator (SCS)s under development.
  • Details of major pipeline products which includes, product description, licensing and collaboration details and other developmental activities.
  • Major players involved in the development of spinal cord stimulator (SCS)s and list 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 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 portfolio and create effective counter strategies to gain competitive advantage.
  • Identify and understand important and diverse types of Spinal cord stimulator (SCS)s 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.

Key Players

Beijing Lingchuang Yigu Technology Development Co Ltd

Biotronik Inc

Boston Scientific Corp

Cerevast Therapeutics Inc

Direct Spinal Therapeutics, Inc.

Duke University

GTX Medical BV

Imperial College London

Lawson Health Research Institute

Meagan Medical Inc.

Medtronic Inc

Medtronic Plc

Micro-Leads Inc

MicroTransponder Inc

Neuronoff Inc

NeuroOne Medical Technologies Corp

Nevro Corp

Nexstim Plc

Nuvectra Corp

Onward Technologies Ltd

Quantum Nanostim LLC

Saluda Medical Pty Ltd

Soin Neuroscience Inc

Soterix Medical Inc

SpineX

Sree Chitra Tirunal Institute for Medical Sciences & Technology

St. Jude Medical LLC

Stimdia Medical Inc

SynerFuse Inc

Teliatry Inc

University of California Los Angeles

University of Cambridge

University of Minnesota

Wavegate Corp

WISE s.r.l.

Table of Contents

1 Table of Contents 3

|1.1 List of Tables 5

|1.2 List of Figures 10

2 Introduction 11

2.1 Spinal Cord Stimulators (SCS) Overview 11

3 Products under Development 12

3.1 Spinal Cord Stimulators (SCS) – Pipeline Products by Stage of Development 12

3.2 Spinal Cord Stimulators (SCS) – Pipeline Products by Territory 13

3.3 Spinal Cord Stimulators (SCS) – Pipeline Products by Regulatory Path 14

3.4 Spinal Cord Stimulators (SCS) – Pipeline Products by Estimated Approval Date 15

3.5 Spinal Cord Stimulators (SCS) – Ongoing Clinical Trials 16

4 Spinal Cord Stimulators (SCS) – Pipeline Products under Development by Companies 17

4.1 Spinal Cord Stimulators (SCS) Companies – Pipeline Products by Stage of Development 17

4.2 Spinal Cord Stimulators (SCS) – Pipeline Products by Stage of Development 19

5 Spinal Cord Stimulators (SCS) Companies and Product Overview 21

5.1 Beijing Lingchuang Yigu Technology Development Co Ltd Company Overview 21

5.1.1 Beijing Lingchuang Yigu Technology Development Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 21

5.2 Biotronik Inc Company Overview 22

5.2.1 Biotronik Inc Pipeline Products & Ongoing Clinical Trials Overview 22

5.3 Boston Scientific Corp Company Overview 25

5.3.1 Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 25

5.4 Cerevast Therapeutics Inc Company Overview 26

5.4.1 Cerevast Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 26

5.5 Direct Spinal Therapeutics, Inc. Company Overview 27

5.5.1 Direct Spinal Therapeutics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 27

5.6 Duke University Company Overview 28

5.6.1 Duke University Pipeline Products & Ongoing Clinical Trials Overview 28

5.7 GTX Medical BV Company Overview 29

5.7.1 GTX Medical BV Pipeline Products & Ongoing Clinical Trials Overview 29

5.8 Imperial College London Company Overview 32

5.8.1 Imperial College London Pipeline Products & Ongoing Clinical Trials Overview 32

5.9 Lawson Health Research Institute Company Overview 33

5.9.1 Lawson Health Research Institute Pipeline Products & Ongoing Clinical Trials Overview 33

5.10 Meagan Medical Inc. Company Overview 34

5.10.1 Meagan Medical Inc. Pipeline Products & Ongoing Clinical Trials Overview 34

5.11 Medtronic Inc Company Overview 35

5.11.1 Medtronic Inc Pipeline Products & Ongoing Clinical Trials Overview 35

5.12 Medtronic Plc Company Overview 38

5.12.1 Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 38

5.13 Micro-Leads Inc Company Overview 42

5.13.1 Micro-Leads Inc Pipeline Products & Ongoing Clinical Trials Overview 42

5.14 MicroTransponder Inc Company Overview 45

5.14.1 MicroTransponder Inc Pipeline Products & Ongoing Clinical Trials Overview 45

5.15 Neuronoff Inc Company Overview 46

5.15.1 Neuronoff Inc Pipeline Products & Ongoing Clinical Trials Overview 46

5.16 NeuroOne Medical Technologies Corp Company Overview 49

5.16.1 NeuroOne Medical Technologies Corp Pipeline Products & Ongoing Clinical Trials Overview 49

5.17 Nevro Corp Company Overview 50

5.17.1 Nevro Corp Pipeline Products & Ongoing Clinical Trials Overview 50

5.18 Nexstim Plc Company Overview 68

5.18.1 Nexstim Plc Pipeline Products & Ongoing Clinical Trials Overview 68

5.19 Nuvectra Corp Company Overview 69

5.19.1 Nuvectra Corp Pipeline Products & Ongoing Clinical Trials Overview 69

5.20 Onward Technologies Ltd Company Overview 70

5.20.1 Onward Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 70

5.21 Quantum Nanostim LLC Company Overview 76

5.21.1 Quantum Nanostim LLC Pipeline Products & Ongoing Clinical Trials Overview 76

5.22 Saluda Medical Pty Ltd Company Overview 77

5.22.1 Saluda Medical Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 77

5.23 Soin Neuroscience Inc Company Overview 81

5.23.1 Soin Neuroscience Inc Pipeline Products & Ongoing Clinical Trials Overview 81

5.24 Soterix Medical Inc Company Overview 82

5.24.1 Soterix Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 82

5.25 SpineX Company Overview 90

5.25.1 SpineX Pipeline Products & Ongoing Clinical Trials Overview 90

5.26 Sree Chitra Tirunal Institute for Medical Sciences & Technology Company Overview 94

5.26.1 Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview 94

5.27 St. Jude Medical LLC Company Overview 95

5.27.1 St. Jude Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 95

5.28 Stimdia Medical Inc Company Overview 101

5.28.1 Stimdia Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 101

5.29 SynerFuse Inc Company Overview 102

5.29.1 SynerFuse Inc Pipeline Products & Ongoing Clinical Trials Overview 102

5.30 Teliatry Inc Company Overview 105

5.30.1 Teliatry Inc Pipeline Products & Ongoing Clinical Trials Overview 105

5.31 University of California Los Angeles Company Overview 106

5.31.1 University of California Los Angeles Pipeline Products & Ongoing Clinical Trials Overview 106

5.32 University of Cambridge Company Overview 108

5.32.1 University of Cambridge Pipeline Products & Ongoing Clinical Trials Overview 108

5.33 University of Minnesota Company Overview 109

5.33.1 University of Minnesota Pipeline Products & Ongoing Clinical Trials Overview 109

5.34 Wavegate Corp Company Overview 112

5.34.1 Wavegate Corp Pipeline Products & Ongoing Clinical Trials Overview 112

5.35 WISE s.r.l. Company Overview 113

5.35.1 WISE s.r.l. Pipeline Products & Ongoing Clinical Trials Overview 113

6 Spinal Cord Stimulators (SCS)- Recent Developments 114

6.1 Jul 14, 2022: Nalu Medical names Thomas West President and Chief Executive Officer 114

6.2 Jun 30, 2022: Spinal cord stimulation delivers improved arm function 114

6.3 Jun 27, 2022: Medtronic Board appoints Lidia Fonseca as a new director 115

6.4 Jun 20, 2022: MicroTransponder Appoints New CEO 116

6.5 May 27, 2022: Medtronic reports full year and fourth quarter fiscal year 2022 financial results 116

6.6 May 26, 2022: Medtronic reports full year and fourth quarter fiscal year 2022 financial results announces 8% dividend increase 116

6.7 Apr 28, 2022: Boston Scientific reports net sales of $3.03bn in Q1 2022 116

6.8 Apr 27, 2022: Boston Scientific Announces Results for First Quarter 2022 117

6.9 Apr 06, 2022: Nevro to Report First Quarter 2022 Financial Results 119

6.10 Jan 04, 2022: Medtronic Chairman and CEO Geoff Martha to speak at J.P. Morgan healthcare conference 120

6.11 Nov 08, 2021: Boston Scientific Announces Upcoming Conference Schedule 120

6.12 Oct 27, 2021: Boston Scientific Announces Results For Third Quarter 2021 120

6.13 Oct 11, 2021: Nevro to Report Third Quarter 2021 Financial Results 125

6.14 Sep 09, 2021: Boston Scientific Announces 2021 Investor Day Meeting 125

6.15 Aug 26, 2021: Nevro to Present at Baird 2021 Global Healthcare Conference 125

7 Appendix 126

7.1 Methodology 126

7.2 About GlobalData 129

7.3 Contact Us 129

7.4 Disclaimer 129

List of Tables

Spinal Cord Stimulators (SCS) – Pipeline Products by Stage of Development 12

Spinal Cord Stimulators (SCS) – Pipeline Products by Territory 13

Spinal Cord Stimulators (SCS) – Pipeline Products by Regulatory Path 14

Spinal Cord Stimulators (SCS) – Pipeline Products by Estimated Approval Date 15

Spinal Cord Stimulators (SCS) – Ongoing Clinical Trials 16

Spinal Cord Stimulators (SCS) Companies – Pipeline Products by Stage of Development 17

Spinal Cord Stimulators (SCS) – Pipeline Products by Stage of Development 19

Beijing Lingchuang Yigu Technology Development Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 21

Neural Electrical Stimulation Device – Pain – Product Status 21

Neural Electrical Stimulation Device – Pain – Product Description 21

Biotronik Inc Pipeline Products & Ongoing Clinical Trials Overview 22

Prospera SCS System – Product Status 22

Prospera SCS System – Product Description 22

Biotronik Inc – Ongoing Clinical Trials Overview 23

Prospera SCS System – BENEFIT-03 Clinical Study 24

Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 25

Next Generation SCS System – Product Status 25

Next Generation SCS System – Product Description 25

Cerevast Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 26

Transdermal Electrical Neurostimulation Device – Product Status 26

Transdermal Electrical Neurostimulation Device – Product Description 26

Direct Spinal Therapeutics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 27

Iowa-Patch System – Product Status 27

Iowa-Patch System – Product Description 27

Duke University Pipeline Products & Ongoing Clinical Trials Overview 28

Spinal Cord Stimulator – Product Status 28

Spinal Cord Stimulator – Product Description 28

GTX Medical BV Pipeline Products & Ongoing Clinical Trials Overview 29

Go-2 Targeted Epidural Spinal Stimulation Device – Product Status 29

Go-2 Targeted Epidural Spinal Stimulation Device – Product Description 29

GTX Medical BV – Ongoing Clinical Trials Overview 30

Go-2 Targeted Epidural Spinal Stimulation Device – Efficacy of Spinal Epidural Electrical Stimulation (EES) in Combination with Robot-assisted Neurorehabilitation in Patients with Spinal Cord Injury (STIMO) 31

Go-2 Targeted Epidural Spinal Stimulation Device – Targeting Improvements in Bowel Function and Quality of Life Using Epidural Stimulation and Training After Severe Spinal Cord Injury 31

Imperial College London Pipeline Products & Ongoing Clinical Trials Overview 32

Wireless Intraspinal Microstimulation System – Product Status 32

Wireless Intraspinal Microstimulation System – Product Description 32

Lawson Health Research Institute Pipeline Products & Ongoing Clinical Trials Overview 33

Spinal Implant – Parkinson’s Disease – Product Status 33

Spinal Implant – Parkinson’s Disease – Product Description 33

Meagan Medical Inc. Pipeline Products & Ongoing Clinical Trials Overview 34

DISCSS IFC System – Product Status 34

DISCSS IFC System – Product Description 34

Medtronic Inc Pipeline Products & Ongoing Clinical Trials Overview 35

Inceptiv SCS – Product Status 35

Inceptiv SCS – Product Description 35

Medtronic Inc – Ongoing Clinical Trials Overview 36

Inceptiv SCS – Evaluation of Long-term Patient Experience with a Medtronic Closed-Loop Spinal Cord Stimulation System 37

Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 38

Intellis – Non-Surgical Refractory Back Pain – Product Status 38

Intellis – Non-Surgical Refractory Back Pain – Product Description 39

Intellis – Painful Diabetic Neuropathy – Product Status 39

Intellis – Painful Diabetic Neuropathy – Product Description 39

Intellis – Upper Limb And Neck – Product Status 40

Intellis – Upper Limb And Neck – Product Description 40

Next Generation Intellis – Rechargeable – Product Status 40

Next Generation Intellis – Rechargeable – Product Description 41

PrimeADVANCED – Heart Failure – Product Status 41

PrimeADVANCED – Heart Failure – Product Description 41

Micro-Leads Inc Pipeline Products & Ongoing Clinical Trials Overview 42

HD64 Implantable Therapy System – Product Status 42

HD64 Implantable Therapy System – Product Description 42

Intelligent Spinal Interface – Product Status 43

Intelligent Spinal Interface – Product Description 43

STIM-GRID MAP Spinal Cord Paddle – Product Status 43

STIM-GRID MAP Spinal Cord Paddle – Product Description 44

MicroTransponder Inc Pipeline Products & Ongoing Clinical Trials Overview 45

SAINT System – Chronic Pain – Product Status 45

SAINT System – Chronic Pain – Product Description 45

Neuronoff Inc Pipeline Products & Ongoing Clinical Trials Overview 46

Injectrode – Product Status 46

Injectrode – Product Description 46

Neuronoff Inc – Ongoing Clinical Trials Overview 47

Injectrode – Basic Assessment of Safety and Minimally Invasive Stimulation via Injectrode 48

NeuroOne Medical Technologies Corp Pipeline Products & Ongoing Clinical Trials Overview 49

Spinal Cord Stimulation System – Chronic Back Pain – Product Status 49

Spinal Cord Stimulation System – Chronic Back Pain – Product Description 49

Nevro Corp Pipeline Products & Ongoing Clinical Trials Overview 50

Omnia Upgrade – Product Status 51

Omnia Upgrade – Product Description 51

Senza HF10 Therapy System – Back Pain – Product Status 51

Senza HF10 Therapy System – Back Pain – Product Description 52

Senza HF10 Therapy System – Chronic Abdominal Pain – Product Status 52

Senza HF10 Therapy System – Chronic Abdominal Pain – Product Description 52

Senza HF10 Therapy System – Chronic Migraine – Product Status 53

Senza HF10 Therapy System – Chronic Migraine – Product Description 53

Senza HF10 Therapy System – Chronic Neck Pain – Product Status 53

Senza HF10 Therapy System – Chronic Neck Pain – Product Description 54

Senza HF10 Therapy System – CPSP – Product Status 54

Senza HF10 Therapy System – CPSP – Product Description 54

Senza HF10 Therapy System – Leg Pain – Product Status 55

Senza HF10 Therapy System – Leg Pain – Product Description 55

Senza HF10 Therapy System – Non-Surgical Refractory Back Pain – Product Status 55

Senza HF10 Therapy System – Non-Surgical Refractory Back Pain – Product Description 56

Senza HF10 Therapy System – Opioid Reduction – Product Status 56

Senza HF10 Therapy System – Opioid Reduction – Product Description 57

Senza HF10 Therapy System – Painful Diabetic Neuropathy – Product Status 57

Senza HF10 Therapy System – Painful Diabetic Neuropathy – Product Description 57

Senza HF10 Therapy System – Pelvic Pain – Product Status 58

Senza HF10 Therapy System – Pelvic Pain – Product Description 58

Senza HF10 Therapy System – Peripheral Polyneuropathy – Product Status 58

Senza HF10 Therapy System – Peripheral Polyneuropathy – Product Description 59

Senza HF10 Therapy System – Post-Surgical Pain – Product Status 59

Senza HF10 Therapy System – Post-Surgical Pain – Product Description 59

Senza HF10 Therapy System – Rescue Therapy – Product Status 60

Senza HF10 Therapy System – Rescue Therapy – Product Description 60

Senza HF10 Therapy System – Thoracic Pain – Product Status 60

Senza HF10 Therapy System – Thoracic Pain – Product Description 61

Senza HF10 Therapy System – Upper Extremity Pain – Product Status 61

Senza HF10 Therapy System – Upper Extremity Pain – Product Description 61

Senza HF10 Therapy System – Upper Limb Pain – Product Status 62

Senza HF10 Therapy System – Upper Limb Pain – Product Description 62

Nevro Corp – Ongoing Clinical Trials Overview 63

Senza HF10 Therapy System – Post-Surgical Pain – A Prospective, Post-market Study to Investigate the Effect of HF10 Therapy for the Treatment of Chronic Post-Surgical Shoulder Pain 64

Senza HF10 Therapy System – Painful Diabetic Neuropathy – A Post-market, Multicenter, Prospective, Global Clinical Study to Evaluate the Real-world Experience of Spinal Cord Stimulation That Includes 10 kHz in the Management of Chronic Intractable Pain Associated with Diabetic Neuropathy 65

Senza HF10 Therapy System – Painful Diabetic Neuropathy – A Post-market, Multicenter, Prospective, Randomized Clinical Trial Comparing 10 kHz Spinal Cord Stimulation (HF10 Therapy) Combined with Conventional Medical Management to Conventional Medical Management Alone in the Treatment of Chronic, Intractable, Neuropathic Limb Pain 65

Senza HF10 Therapy System – Back Pain – A Multi-center, Prospective, Pragmatic, Randomized, Controlled Clinical Trial to Compare HF10 Therapy to Conventional Medical Management in the Treatment of Non-surgical Refractory Back Pain 66

Senza HF10 Therapy System – Leg Pain – A Multi-center Prospective Observational Clinical Study to Evaluate HF10 Therapy in Patients with Chronic Intractable Predominant Leg Pain 67

Senza HF10 Therapy System – Leg Pain – A Prospective Post-market Study to Investigate the Effect of HF10 Therapy on Opioid Analgesic Use for the Treatment of Chronic Intractable Low Back and/or Radicular Leg Pain 67

Nexstim Plc Pipeline Products & Ongoing Clinical Trials Overview 68

Navigated Brain Therapy System – Chronic Spinal Cord Injury – Product Status 68

Navigated Brain Therapy System – Chronic Spinal Cord Injury – Product Description 68

Nuvectra Corp Pipeline Products & Ongoing Clinical Trials Overview 69

Algovita SCS System – Full Body MRI – Product Status 69

Algovita SCS System – Full Body MRI – Product Description 69

Onward Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 70

ARC-EX – Product Status 70

ARC-EX – Product Description 71

ARC-IM – Blood Pressure And Trunk Control – Product Status 71

ARC-IM – Blood Pressure And Trunk Control – Product Description 71

ARCEX Neurostimulator – Product Status 72

ARCEX Neurostimulator – Product Description 72

Onward Technologies Ltd – Ongoing Clinical Trials Overview 73

ARC-EX – Activity Dependent Rehabilitation Via Transcutaneous Electrical Spinal Stimulation to Restore Upper Extremity Functions in Spinal Cord Injury 74

ARC-EX – Clinical Assessment of Upper Extremity Performance in Individuals with Spinal Cord Injury Using the LIFT System to Deliver Non-invasive Electrical Spinal Stimulation (ARC Therapy) 74

ARC-EX – Safety and Performance Assessment of the LIFT System When Used to Support Home-based Upper Extremity Training in Individuals with Spinal Cord Injury 74

ARC-IM – Blood Pressure And Trunk Control – Epidural Electrical Stimulation to Restore Hemodynamic Stability and Trunk Control in People with Spinal Cord Injury 75

Quantum Nanostim LLC Pipeline Products & Ongoing Clinical Trials Overview 76

Clone System – Product Status 76

Clone System – Product Description 76

Saluda Medical Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 77

Evoke Spinal Cord Stimulator System – Product Status 77

Evoke Spinal Cord Stimulator System – Product Description 77

Saluda Medical Pty Ltd – Ongoing Clinical Trials Overview 78

Evoke Spinal Cord Stimulator System – A Feasibility Study Evaluating Saluda Medical’s Spinal Cord Stimulation System Incorporating Feedback Control to Treat Patients with Chronic Pain of Upper Limb and/or Neck 79

Evoke Spinal Cord Stimulator System – A Prospective Study to Evaluate the Long-term Effectiveness, Safety, and Performance of the Saluda Medical’s Evoke Closed-Loop Spinal Cord Stimulation System to Treat Patients with Chronic Pain of the Trunk and/or Limbs 79

Evoke Spinal Cord Stimulator System – A Prospective, Multicenter, Randomized Double-blind Study Examining the Safety and Efficacy of Using the Evoke Spinal Cord Stimulator (SCS) System with Feedback to Treat Patients with Chronic Pain of the Trunk and/or Limbs 79

Evoke Spinal Cord Stimulator System – A Prospective, Multicentre, Single-arm Feasibility Study Examining Novel Treatment Delivery of the Evoke Spinal Cord Stimulator (SCS) System to Treat Patients with Chronic Pain of the Trunk And/or Limbs 80

Evoke Spinal Cord Stimulator System – Prospective Data Collection to Evaluate the Feedback Control of the Saluda Medical’s Evoke Spinal Cord Stimulation System in the Treatment of Patients With Chronic Pain of the Trunk and/or Limbs 80

Soin Neuroscience Inc Pipeline Products & Ongoing Clinical Trials Overview 81

Spinal Cord Stimulation System – Product Status 81

Spinal Cord Stimulation System – Product Description 81

Soterix Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 82

1×1 tDCS Device – Product Status 82

1×1 tDCS Device – Product Description 83

tSDCS Cervical Strap – Product Status 83

tSDCS Cervical Strap – Product Description 83

tSDCS Lumbar BODYstrap – Product Status 84

tSDCS Lumbar BODYstrap – Product Description 84

tSDCS Shoulder Strap – Product Status 84

tSDCS Shoulder Strap – Product Description 85

Soterix Medical Inc – Ongoing Clinical Trials Overview 86

1×1 tDCS Device – Altering Multitasking Behavior Using Low Current Brain Stimulation 87

1×1 tDCS Device – Effects of Transcranial Direct Current Stimulation (tDCS) in Spoken and Written Production in Primary Progressive Aphasia (PPA) 87

1×1 tDCS Device – Effects of Transcranial Direct Current Stimulation (tDCS) on Motor Function in Schizophrenia Patients and Individuals at Risk for Psychotic Onset 87

1×1 tDCS Device – Impact of Neuromodulation on Language Impairments in Stroke Patients: A Multimodal Double-blind Randomized Controlled Study 88

1×1 tDCS Device – Non-invasive Neuromodulation to Enhance Targeted Cognitive Remediation in Older Adults With Depression 88

1×1 tDCS Device – Phase II Clinical Trial of Transcranial Direct Current Stimulation in the Treatment of Primary Progressive Aphasia 88

1×1 tDCS Device – The Combined Effect of Robotic Rehabilitation and Transcranial Direct Current Stimulation on Proprioception in Chronic Stroke: a Pilot Study 89

SpineX Pipeline Products & Ongoing Clinical Trials Overview 90

SCiP – Product Status 90

SCiP – Product Description 90

Scone Device – Product Status 91

Scone Device – Product Description 91

SpineX – Ongoing Clinical Trials Overview 92

Scone Device – Noninvasive Spinal Neuromodulation Enables Locomotor Recovery in Individuals with Cerebral Palsy 93

Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview 94

Spinal Cord Stimulator – Chronic Pain – Product Status 94

Spinal Cord Stimulator – Chronic Pain – Product Description 94

St. Jude Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 95

Next Generation Implantable SCS System – Primary Cell – Product Status 95

Next Generation Implantable SCS System – Primary Cell – Product Description 95

Next Generation Implantable SCS System – Rechargeable – Product Status 96

Next Generation Implantable SCS System – Rechargeable – Product Description 96

Proclaim Rechargeable Model – Product Status 96

Proclaim Rechargeable Model – Product Description 96

Proclaim Upgrade HC – Product Status 97

Proclaim Upgrade HC – Product Description 97

Proclaim Upgrade LC – Product Status 97

Proclaim Upgrade LC – Product Description 98

Proclaim XR – Product Status 98

Proclaim XR – Product Description 98

St. Jude Medical LLC – Ongoing Clinical Trials Overview 99

Proclaim XR – Effects of Active Versus Passive Recharge Burst Spinal Cord Stimulation on Pain Experience in Persistent Spinal Pain Syndrome Type 2: A Multicenter Randomized Trial (BURST-RAP Study) 100

Stimdia Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 101

pdSTIM System – Product Status 101

pdSTIM System – Product Description 101

SynerFuse Inc Pipeline Products & Ongoing Clinical Trials Overview 102

NeuroFuse DRG System – Product Status 102

NeuroFuse DRG System – Product Description 102

SynerFuse Inc – Ongoing Clinical Trials Overview 103

NeuroFuse DRG System – Pilot Trial to Investigate NeuroFuse DRG Therapy in Patients with Chronic Lower Back Pain 104

Teliatry Inc Pipeline Products & Ongoing Clinical Trials Overview 105

16 Channel Spinal Cord Stimulator – Product Status 105

16 Channel Spinal Cord Stimulator – Product Description 105

University of California Los Angeles Pipeline Products & Ongoing Clinical Trials Overview 106

32-Electrode Neurostimulator – Product Status 106

32-Electrode Neurostimulator – Product Description 106

Spinal Cord Electrical Stimulator – Product Status 107

Spinal Cord Electrical Stimulator – Product Description 107

University of Cambridge Pipeline Products & Ongoing Clinical Trials Overview 108

Inflatable Spinal Implant – Product Status 108

Inflatable Spinal Implant – Product Description 108

University of Minnesota Pipeline Products & Ongoing Clinical Trials Overview 109

Spinal Cord Stimulation Device – Product Status 109

Spinal Cord Stimulation Device – Product Description 109

University of Minnesota – Ongoing Clinical Trials Overview 110

Spinal Cord Stimulation Device – Epidural Stimulation for Spinal Cord Injury 111

Wavegate Corp Pipeline Products & Ongoing Clinical Trials Overview 112

StimuLux – Product Status 112

StimuLux – Product Description 112

WISE s.r.l. Pipeline Products & Ongoing Clinical Trials Overview 113

SCS EXPERT – Product Status 113

SCS EXPERT – Product Description 113

Glossary 128

List of Figures

Spinal Cord Stimulators (SCS) – Pipeline Products by Stage of Development 12

Spinal Cord Stimulators (SCS) – Pipeline Products by Territory 13

Spinal Cord Stimulators (SCS) – Pipeline Products by Regulatory Path 14

Spinal Cord Stimulators (SCS) – Pipeline Products by Estimated Approval Date 15

Spinal Cord Stimulators (SCS) – Ongoing Clinical Trials 16

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