Spinal Cord Stimulators (SCS) Pipeline by Development Stages, Segments, Region and Countries, Regulatory Path and Key Companies

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Spinal Cord Stimulators (SCS) Pipeline Market Report Overview

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 (SCS) 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 Segments ·       Rechargeable Spinal Cord Stimulators

·       Non-Rechargeable Spinal Cord Stimulators

Key Territory ·       The US

·       Europe

·       Australia

·       China

·       The UK

Key Regulatory Paths ·       PMA

·       CE

·       510(k)

·       TGA

·       NMPA

Leading Companies ·       Beijing Leading Medical Valley Technology Development Co Ltd

·       Beijing Lingchuang Yigu Technology Development Co Ltd

·       Beijing Xinyun Medical Technology Co Ltd

·       Boston Scientific Corp

·       Cerevast Therapeutics Inc

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Spinal cord stimulators (SCS) Pipeline Market by Segments

The key segments in the spinal cord stimulators (SCS) pipeline products market are Rechargeable Spinal Cord Stimulators and Non-Rechargeable Spinal Cord Stimulators. As of June 2024, the  rechargeable spinal cord stimulators segment accounts for the highest number of spinal cord stimulators (SCS) pipeline market products.

Spinal Cord Stimulators (SCS) Pipeline Market Analysis by Segments, 2024 (%)

Spinal Cord Stimulators (SCS) Pipeline Market Analysis by Segments, 2024 (%)

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Spinal cord stimulators (SCS) Pipeline Market Segmentation by Territories

A few of the key territories with the spinal cord stimulators (SCS) pipeline market are the US, Europe, Australia, China, and the UK among others. As of June 2024, the US accounts for the highest number of spinal cord stimulators (SCS) pipeline products.

Spinal Cord Stimulators (SCS) Pipeline Market Analysis by Territories, 2024 (%)

Spinal Cord Stimulators (SCS) Pipeline Market Analysis by Territories, 2024 (%)

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Spinal cord stimulators (SCS) Pipeline Market Segmentation by Regulatory Paths

A few of the key regulatory paths in the spinal cord stimulators (SCS) pipeline products market are PMA, CE, 510(k), TGA, and NMPA among others. As of June 2024, PMA accounts for the most followed pathway for pipeline products in the spinal cord stimulators (SCS) market.

Spinal Cord Stimulators (SCS) Pipeline Market Analysis by Regulatory Paths, 2024 (%)

Spinal Cord Stimulators (SCS) Pipeline Market Analysis by Regulatory Paths, 2024 (%)

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Spinal Cord Stimulators (SCS) Pipeline Market – Competitive Landscape

A few of the key companies associated with the spinal cord stimulators (SCS) pipeline market are Beijing Leading Medical Valley Technology Development Co Ltd, Beijing Lingchuang Yigu Technology Development Co Ltd, Beijing Xinyun Medical Technology Co Ltd, Boston Scientific Corp, and Cerevast Therapeutics Inc among others.

Beijing Leading Medical Valley Technology Development Co Ltd: Beijing Leading Medical Valley Technology Development Co Ltd (Medical Valley Technology) is a medical device company that is engaged in developing technologies for implantable neuroelectric stimulation to treat neurological functioning disorders. Medical Valley Technology is headquartered in Beijing, China.

Beijing Lingchuang Yigu Technology Development Co Ltd: Beijing Lingchuang Yigu Technology Development Co Ltd (Lingchuang Yigu) focuses on the development of medical devices specializing in pain medicine. Lingchuang Yigu is headquartered in Beijing, China.

Spinal Cord Stimulators (SCS) Pipeline Market Analysis by Companies, 2024

Spinal Cord Stimulators (SCS) Pipeline Market Analysis by Companies, 2024

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Segments Covered in the Report

Spinal cord stimulators (SCS) Pipeline Market Segment Outlook (2024)

  • Rechargeable Spinal Cord Stimulators
  • Non-Rechargeable Spinal Cord Stimulators

Spinal cord stimulators (SCS) Pipeline Market Territories Outlook (2024)

  • The US
  • Europe
  • Australia
  • China
  • The UK

Spinal cord stimulators (SCS) Pipeline Market Regulatory Paths Outlook (2024)

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

Scope

This report provides:

  • Extensive coverage of the spinal cord stimulators (SCS) under development.
  • An 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 spinal cord stimulators (SCS) 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 spinal cord stimulators (SCS) 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.

Beijing Leading Medical Valley Technology Development Co Ltd
Beijing Lingchuang Yigu Technology Development Co Ltd
Beijing Xinyun Medical Technology Co Ltd
Boston Scientific Corp
Cerevast Therapeutics Inc
Cosyma
Direct Spinal Therapeutics, Inc.
Duke University
Hangzhou Shenluo Medical Technology Co Ltd
Imperial College London
Lawson Health Research Institute
Meagan Medical Inc.
Medtronic Plc
Micro-Leads Inc
MicroTransponder Inc
Neuronoff Inc
NeuroOne Medical Technologies Corp
Nevro Corp
Nexstim Plc
Onward Medical NV
Onward Technologies Ltd
Quantum Nanostim LLC
Reach Neuro Inc
Rowan University
Saluda Medical Pty Ltd
Soin Neuroscience Inc
Soterix Medical Inc
SpineX Inc
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 Illinois at Chicago
University of Minnesota
Wavegate Corp
WISE s.r.l.

Table of Contents

|1 Table of Contents 3

|1.1 List of Tables 7

|1.2 List of Figures 12

2 Introduction 13

2.1 Spinal Cord Stimulators (SCS) Overview 13

3 Products under Development 14

3.1 Spinal Cord Stimulators (SCS) – Pipeline Products by Stage of Development 14

3.2 Spinal Cord Stimulators (SCS) – Pipeline Products by Segment 15

3.3 Spinal Cord Stimulators (SCS) – Pipeline Products by Territory 16

3.4 Spinal Cord Stimulators (SCS) – Pipeline Products by Regulatory Path 17

3.5 Spinal Cord Stimulators (SCS) – Pipeline Products by Estimated Approval Date 18

3.6 Spinal Cord Stimulators (SCS) – Ongoing Clinical Trials 19

4 Spinal Cord Stimulators (SCS) – Pipeline Products under Development by Companies 20

4.1 Spinal Cord Stimulators (SCS) Companies – Pipeline Products by Stage of Development 20

4.2 Spinal Cord Stimulators (SCS) – Pipeline Products by Stage of Development 22

5 Spinal Cord Stimulators (SCS) Companies and Product Overview 24

5.1 Beijing Leading Medical Valley Technology Development Co Ltd Company Overview 24

5.1.1 Beijing Leading Medical Valley Technology Development Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 24

5.2 Beijing Lingchuang Yigu Technology Development Co Ltd Company Overview 25

5.2.1 Beijing Lingchuang Yigu Technology Development Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 25

5.3 Beijing Xinyun Medical Technology Co Ltd Company Overview 26

5.3.1 Beijing Xinyun Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 26

5.4 Boston Scientific Corp Company Overview 27

5.4.1 Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 27

5.5 Cerevast Therapeutics Inc Company Overview 28

5.5.1 Cerevast Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 28

5.6 Cosyma Company Overview 29

5.6.1 Cosyma Pipeline Products & Ongoing Clinical Trials Overview 29

5.7 Direct Spinal Therapeutics, Inc. Company Overview 33

5.7.1 Direct Spinal Therapeutics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 33

5.8 Duke University Company Overview 34

5.8.1 Duke University Pipeline Products & Ongoing Clinical Trials Overview 34

5.9 Hangzhou Shenluo Medical Technology Co Ltd Company Overview 35

5.9.1 Hangzhou Shenluo Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 35

5.10 Imperial College London Company Overview 36

5.10.1 Imperial College London Pipeline Products & Ongoing Clinical Trials Overview 36

5.11 Lawson Health Research Institute Company Overview 37

5.11.1 Lawson Health Research Institute Pipeline Products & Ongoing Clinical Trials Overview 37

5.12 Meagan Medical Inc. Company Overview 38

5.12.1 Meagan Medical Inc. Pipeline Products & Ongoing Clinical Trials Overview 38

5.13 Medtronic Plc Company Overview 39

5.13.1 Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 39

5.14 Micro-Leads Inc Company Overview 43

5.14.1 Micro-Leads Inc Pipeline Products & Ongoing Clinical Trials Overview 43

5.15 MicroTransponder Inc Company Overview 45

5.15.1 MicroTransponder Inc Pipeline Products & Ongoing Clinical Trials Overview 45

5.16 Neuronoff Inc Company Overview 46

5.16.1 Neuronoff Inc Pipeline Products & Ongoing Clinical Trials Overview 46

5.17 NeuroOne Medical Technologies Corp Company Overview 47

5.17.1 NeuroOne Medical Technologies Corp Pipeline Products & Ongoing Clinical Trials Overview 47

5.18 Nevro Corp Company Overview 48

5.18.1 Nevro Corp Pipeline Products & Ongoing Clinical Trials Overview 48

5.19 Nexstim Plc Company Overview 63

5.19.1 Nexstim Plc Pipeline Products & Ongoing Clinical Trials Overview 63

5.20 Onward Medical NV Company Overview 64

5.20.1 Onward Medical NV Pipeline Products & Ongoing Clinical Trials Overview 64

5.21 Onward Technologies Ltd Company Overview 68

5.21.1 Onward Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 68

5.22 Quantum Nanostim LLC Company Overview 78

5.22.1 Quantum Nanostim LLC Pipeline Products & Ongoing Clinical Trials Overview 78

5.23 Reach Neuro Inc Company Overview 79

5.23.1 Reach Neuro Inc Pipeline Products & Ongoing Clinical Trials Overview 79

5.24 Rowan University Company Overview 80

5.24.1 Rowan University Pipeline Products & Ongoing Clinical Trials Overview 80

5.25 Saluda Medical Pty Ltd Company Overview 81

5.25.1 Saluda Medical Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 81

5.26 Soin Neuroscience Inc Company Overview 86

5.26.1 Soin Neuroscience Inc Pipeline Products & Ongoing Clinical Trials Overview 86

5.27 Soterix Medical Inc Company Overview 87

5.27.1 Soterix Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 87

5.28 SpineX Inc Company Overview 94

5.28.1 SpineX Inc Pipeline Products & Ongoing Clinical Trials Overview 94

5.29 Sree Chitra Tirunal Institute for Medical Sciences & Technology Company Overview 99

5.29.1 Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview 99

5.30 St. Jude Medical LLC Company Overview 100

5.30.1 St. Jude Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 100

5.31 Stimdia Medical Inc Company Overview 104

5.31.1 Stimdia Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 104

5.32 SynerFuse Inc Company Overview 107

5.32.1 SynerFuse Inc Pipeline Products & Ongoing Clinical Trials Overview 107

5.33 Teliatry Inc Company Overview 110

5.33.1 Teliatry Inc Pipeline Products & Ongoing Clinical Trials Overview 110

5.34 University of California Los Angeles Company Overview 111

5.34.1 University of California Los Angeles Pipeline Products & Ongoing Clinical Trials Overview 111

5.35 University of Cambridge Company Overview 113

5.35.1 University of Cambridge Pipeline Products & Ongoing Clinical Trials Overview 113

5.36 University of Illinois at Chicago Company Overview 115

5.36.1 University of Illinois at Chicago Pipeline Products & Ongoing Clinical Trials Overview 115

5.37 University of Minnesota Company Overview 116

5.37.1 University of Minnesota Pipeline Products & Ongoing Clinical Trials Overview 116

5.38 Wavegate Corp Company Overview 119

5.38.1 Wavegate Corp Pipeline Products & Ongoing Clinical Trials Overview 119

5.39 WISE s.r.l. Company Overview 120

5.39.1 WISE s.r.l. Pipeline Products & Ongoing Clinical Trials Overview 120

6 Spinal Cord Stimulators (SCS)- Recent Developments 121

6.1 Jun 04, 2024: Nalu PNS System Achieves Significant and Durable Pain Reduction, Meeting the Primary Endpoint of the COMFORT RCT Study 121

6.2 Jun 04, 2024: Medtronic Announces Dr. Goran Petrovski to Join Diabetes Medical Affairs Team 122

6.3 Jun 04, 2024: Medtronic Announces Retirement of Rob Ten Hoedt as Executive Vice President and President, Global Regions, Effective as of June 28, 2024 122

6.4 May 28, 2024: WVU Researchers Develop 3D Model to Better Treat Neurological Disorders 122

6.5 May 20, 2024: Nature Medicine Highlights Significant Improvement in Hand and Arm Function After Spinal Cord Injury with Use of ONWARD ARC-EX Therapy 123

6.6 May 09, 2024: ‘Wraparound’ Implants Represent New Approach to Treating Spinal Cord Injuries 124

6.7 Apr 26, 2024: Medtronic Receives FDA Approval for Inceptiv Closed-Loop Spinal Cord Stimulator 125

6.8 Apr 25, 2024: ONWARD Medical Reports Full Year 2023 Financial and Operating Results and Shares 2024 Highlights Year-to-Date 126

6.9 Apr 24, 2024: Medtronic Names Yarmela Pavlovic as Chief Regulatory Officer 129

6.10 Apr 23, 2024: Neuronoff Announces Safety and Functionality Success in First-in-Human Trial of Injectrode for Minimally Invasive Chronic Pain Relief (LIFE study) 129

6.11 Apr 10, 2024: Cigna and EviCore Add Positive Coverage for the Evoke System 130

6.12 Apr 09, 2024: SpineX eyes FDA submission as neurogenic bladder trial hits milestone 130

6.13 Apr 02, 2024: ONWARD Medical Submits De Novo Application to FDA for its ARC-EX System 131

6.14 Mar 22, 2024: VA Stand Act Introduced in the United States Senate 131

6.15 Mar 19, 2024: Canadian First – Abbott Advances Chronic Pain Management with the World’s Smallest Implanted, Rechargeable Spinal Cord Stimulation System 132

6.16 Mar 19, 2024: Mainstay Medical Announces Publication of the First Neuromodulation Study for Low Back Pain with 5-Year Follow-Up 133

6.17 Mar 18, 2024: ONWARD’s ARC-EX System advances towards commercial launch 134

6.18 Mar 12, 2024: Mainstay Medical Announces Publication of Clinical Results Comparing Older Patients and Younger Patients 134

6.19 Mar 12, 2024: Medtronic To Present At Barclays Global Healthcare Conference 135

6.20 Feb 29, 2024: Onward Medical Awarded 10th Breakthrough Device Designation for Brain-Computer Interface (BCI) From US FDA 135

6.21 Feb 28, 2024: Boston Scientific Raises $2.2B to Support Purchase of California Medical Device Company 136

6.22 Feb 23, 2024: Medical Tech Leader, Boston Scientific (BSX), Announces Notes Offering 136

6.23 Feb 19, 2024: Boston Scientific Appoints Madan Krishnan to Lead India Subcontinent 136

6.24 Feb 13, 2024: Mainstay Medical’s ReActiv8 MRI labelling secures FDA approval 136

6.25 Feb 07, 2024: FDA approves Boston Scientific’s WaveWriter SCS Systems 136

6.26 Feb 07, 2024: Onward Medical Announces Presentation at Biocapital Europe 137

6.27 Feb 07, 2024: Onward Medical Announces Presentation at Biocapital Europe 137

6.28 Feb 01, 2024: Neuronoff Announces Successful First-in-Human Study of Injectrode Technology for Chronic Pain 138

6.29 Feb 01, 2024: Nevro Announces Consensus Statement Supporting High-Frequency (10 kHz) Spinal Cord Stimulation Therapy for Refractory Painful Diabetic Neuropathy 139

6.30 Jan 31, 2024: Boston Scientific Announces Results for Fourth Quarter and Full Year 2023 139

6.31 Jan 29, 2024: Nevro to Report Fourth-Quarter and Full-Year 2023 Financial Results and Host Conference Call on February 21, 2024 141

6.32 Jan 25, 2024: ONWARD ARC Therapy Highlighted at 2024 Annual Meeting of the North American Neuromodulation Society (NANS) 142

6.33 Jan 23, 2024: Nalu Medical Presents Long-term and Holistic Outcomes from the COMFORT RCT for PNS at NANS 2024 142

6.34 Jan 23, 2024: Nalu Medical Presents Long-Term and Holistic Outcomes From the COMFORT RCT for PNS at NANS 2024 143

6.35 Jan 22, 2024: ONWARD to Participate in Basel Healthtech Conference 2024 144

6.36 Jan 20, 2024: Boston Scientific Presents Key Data at the 2024 North American Neuromodulation Society Meeting 144

6.37 Jan 19, 2024: ONWARD to Participate in Degroof Petercam Healthcare Conference 145

6.38 Jan 18, 2024: ONWARD Announces Start of HemON NL Clinical Study 145

6.39 Jan 18, 2024: Nevro Announces Positive Coverage Update from Carelon Healthcare for the Treatment of Painful Diabetic Neuropathy 146

6.40 Jan 18, 2024: Abbott’s Proclaim Drg Neurostimulation System Offers Expanded MRI Access for People Suffering From Chronic Pain 146

6.41 Jan 18, 2024: Revolutionizing Spine Surgery Techniques: Inspan Publishes First L5-S1 Spinal Fixation Research for Degenerative Disc and Stenosis in Premier Spine Surgery Journal 147

6.42 Jan 17, 2024: Nevro to Highlight 25 Scientific Abstracts at 2024 North American Neuromodulation Society (NANS) Annual Meeting 148

6.43 Jan 16, 2024: Saluda Medical Announces Late Breaking Data at NANS 2024 Annual Meeting 149

6.44 Jan 10, 2024: Nevro Laying Off 63 People To Strengthen Financial Position 149

6.45 Jan 05, 2024: Boston Scientific Announces Conference Call Discussing Fourth Quarter 2023 Results 150

6.46 Jan 03, 2024: SpineX Announces Successful in-Human Results to Treat Adults with Cerebral Palsy 150

6.47 Nov 29, 2023: Nalu Medical, Announces Positive Results of US Spinal Cord Stimulation Clinical Study in Pain Physician Journal 150

6.48 Nov 20, 2023: Nevro Delivers Long-Term Relief with High-Frequency Spinal Cord Stimulation: 24-Month Data Demonstrates Profound Improvements for Non-Surgical Refractory Back Pain 151

6.49 Nov 10, 2023: Medtronic Announces 12-Month Study Results Showing DTM Spinal Cord Stimulation Programming Provides Long-Term, Significant Pain Relief for Indicated Chronic Back Pain Patients Not Eligible for Spine Surgery 152

6.50 Nov 09, 2023: SpineX Demonstrates Ground Breaking Technology to Improve Bladder Function in Stroke Survivors 153

6.51 Nov 06, 2023: Nature Medicine Publication Highlights Potential for ONWARD ARC Therapy to Improve Mobility After Parkinson’s Disease 154

6.52 Oct 26, 2023: Boston Scientific Announces Results for Third Quarter 2023 154

6.53 Oct 17, 2023: Enrollment Completed in Synerfuse Proof-Of-Concept Study 156

6.54 Oct 11, 2023: Boston Scientific Receives FDA Approval of Spinal Cord Stimulation Therapy for People Living with Diabetic Peripheral Neuropathy 157

6.55 Oct 11, 2023: ONWARD Schedules Webcast to Provide Third Quarter 2023 Business Update 158

6.56 Oct 05, 2023: Newly Published Data Supports Effectiveness of BIOTRONIK Neuro’s RESONANCE Stimulation 158

6.57 Oct 04, 2023: Medtronic Names Paolo Di Vincenzo President of the Neuromodulation Business 159

6.58 Oct 04, 2023: Nevro to Report Third Quarter 2023 Financial Results 159

6.59 Oct 03, 2023: Stimdia Medical Initiates FDA Approved IDE Pivotal Trial to Investigate Impact of Neuromuscular Stimulation on Mechanically Ventilated Patients 160

6.60 Sep 27, 2023: ONWARD Announces First-in-Human Implant of ARC-IM Stimulator with Brain-Computer Interface (BCI) to Restore Arm, Hand, and Finger Function after Spinal Cord Injury 160

6.61 Sep 26, 2023: SpineX Receives NIH SBIR Phase II Award for SCiP Clinical Trial in Children With CP 161

6.62 Sep 19, 2023: Onward Medical Reports 2023 Half Year Results and Business Update 161

6.63 Sep 18, 2023: New Data Demonstrate the Health Economic Benefits of Nevro’s High-Frequency Spinal Cord Stimulation Therapy 163

6.64 Sep 06, 2023: Mainstay Medical Announces Issuance of Statement from the International Society for the Advancement of Spine Surgery (ISASS) on Restorative Neurostimulation 164

6.65 Sep 05, 2023: ONWARD Schedules Webcast to Provide Half Year 2023 Business Update 165

6.66 Aug 30, 2023: Mainstay Medical Announces Completion of Enrollment of RESTORE Clinical Trial of ReActiv8 in the United States 165

6.67 Aug 28, 2023: Medtronic’s spinal cord stimulator receives CE Mark 166

6.68 Aug 26, 2023: Medtronic Q2 2024 Earnings Estimates Increased by William Blair 167

6.69 Aug 16, 2023: New 24-Month Data Shows Nevro’s SCS Therapy Provides Highly Effective, Long-Term Relief from Painful Diabetic Neuropathy 167

6.70 Aug 10, 2023: Nevro Announces Launch Of HFX Connect In Europe And CE Marking Of Expanded Labelling For The HFX SCS System 168

6.71 Aug 08, 2023: Medtronic to Announce Financial Results for its First Quarter of Fiscal Year 2024 169

6.72 Aug 07, 2023: Tiny, Flexible Spinal Probe System Could Lead to Better Therapies 169

6.73 Aug 04, 2023: Saluda Medical Announces Publication of Favorable Economic Analysis Demonstrating Cost-Dominance of Evoke® Closed-Loop SCS over Open-Loop SCS 171

6.74 Jul 27, 2023: Soin tests TunedTX platform using low-frequency stimulation on humans 171

6.75 Jul 27, 2023: Leading Medtech Company Spinex Releases Groundbreaking Results of New Cerebral Palsy Therapies 172

6.76 Jul 20, 2023: Mainstay Medical Announces Publication of Three-Year Clinical Trial Data from Post-Market Clinical Follow-up Registry of ReActiv8 in the United Kingdom 173

6.77 Jul 20, 2023: Nalu Medical, Presents Important New Clinical Data for PNS and SCS at ASPN 2023 173

6.78 Jul 19, 2023: Boston Scientific lays off 52 workers as it closes another Silicon Valley facility 174

6.79 Jul 13, 2023: Nevro Announces Presentations at American Society of Pain & Neuroscience Fifth Annual Conference 174

6.80 Jul 13, 2023: Medtronic Shares Impact of Medicare Coverage Updates That Now Allow Nationwide Access to Spinal Cord Stimulation Therapy for the Treatment of Painful Diabetic Peripheral Neuropathy 175

7 Appendix 176

7.1 Methodology 176

7.2 About GlobalData 179

7.3 Contact Us 179

7.4 Disclaimer 179

Table

Spinal Cord Stimulators (SCS) – Pipeline Products by Stage of Development 14

Spinal Cord Stimulators (SCS) – Pipeline Products by Segment 15

Spinal Cord Stimulators (SCS) – Pipeline Products by Territory 16

Spinal Cord Stimulators (SCS) – Pipeline Products by Regulatory Path 17

Spinal Cord Stimulators (SCS) – Pipeline Products by Estimated Approval Date 18

Spinal Cord Stimulators (SCS) – Ongoing Clinical Trials 19

Spinal Cord Stimulators (SCS) Companies – Pipeline Products by Stage of Development 20

Spinal Cord Stimulators (SCS) – Pipeline Products by Stage of Development 22

Beijing Leading Medical Valley Technology Development Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 24

InnoPulse-SCS – Product Status 24

InnoPulse-SCS – Product Description 24

Beijing Lingchuang Yigu Technology Development Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 25

Neural Electrical Stimulation Device – Pain – Product Status 25

Neural Electrical Stimulation Device – Pain – Product Description 25

Beijing Xinyun Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 26

Implantable Rechargeable Spinal Cord Electrical Stimulation System – Product Status 26

Implantable Rechargeable Spinal Cord Electrical Stimulation System – Product Description 26

Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 27

Next Generation SCS System – Product Status 27

Next Generation SCS System – Product Description 27

Cerevast Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 28

Transdermal Electrical Neurostimulation Device – Product Status 28

Transdermal Electrical Neurostimulation Device – Product Description 28

Cosyma Pipeline Products & Ongoing Clinical Trials Overview 29

Biostim-5 Transcutaneous Spinal Stimulator – Product Status 29

Biostim-5 Transcutaneous Spinal Stimulator – Product Description 29

Cosyma – Ongoing Clinical Trials Overview 30

Biostim-5 Transcutaneous Spinal Stimulator – Neuromodulation of Blood Pressure Using Transcutaneous Spinal Stimulation in Chronic Spinal Cord Injury 31

Biostim-5 Transcutaneous Spinal Stimulator – Neuromodulation of Blood Pressure Using Transcutaneous Spinal Stimulation in Individuals With an Acute Spinal Cord Injury – A Safety, Feasibility and Efficacy Study 31

Biostim-5 Transcutaneous Spinal Stimulator – Neuromodulatory Rehabilitation for Respiratory Motor Function in Individuals With Chronic Spinal Cord Injury 31

Biostim-5 Transcutaneous Spinal Stimulator – Non-invasive Spinal Stimulation as an Adjuvant Therapy for Trunk Control after Pediatric Spinal Cord Injury 32

Direct Spinal Therapeutics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 33

Iowa-Patch System – Product Status 33

Iowa-Patch System – Product Description 33

Duke University Pipeline Products & Ongoing Clinical Trials Overview 34

Spinal Cord Stimulator – Product Status 34

Spinal Cord Stimulator – Product Description 34

Hangzhou Shenluo Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 35

Neuromodulation Device – Epilepsy – Product Status 35

Neuromodulation Device – Epilepsy – Product Description 35

Imperial College London Pipeline Products & Ongoing Clinical Trials Overview 36

Wireless Intraspinal Microstimulation System – Product Status 36

Wireless Intraspinal Microstimulation System – Product Description 36

Lawson Health Research Institute Pipeline Products & Ongoing Clinical Trials Overview 37

Spinal Implant – Parkinson’s Disease – Product Status 37

Spinal Implant – Parkinson’s Disease – Product Description 37

Meagan Medical Inc. Pipeline Products & Ongoing Clinical Trials Overview 38

DISCSS IFC System – Product Status 38

DISCSS IFC System – Product Description 38

Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 39

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

Intellis – Non-Surgical Refractory Back Pain – Product Description 40

Intellis – Painful Diabetic Neuropathy – Product Status 40

Intellis – Painful Diabetic Neuropathy – Product Description 40

Intellis – Upper Limb And Neck – Product Status 41

Intellis – Upper Limb And Neck – Product Description 41

Next Generation Intellis – Rechargeable – Product Status 41

Next Generation Intellis – Rechargeable – Product Description 42

PrimeADVANCED – Heart Failure – Product Status 42

PrimeADVANCED – Heart Failure – Product Description 42

Micro-Leads Inc Pipeline Products & Ongoing Clinical Trials Overview 43

HD64 Implantable Therapy System – Product Status 43

HD64 Implantable Therapy System – Product Description 43

Intelligent Spinal Interface – Product Status 44

Intelligent Spinal Interface – 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

NeuroOne Medical Technologies Corp Pipeline Products & Ongoing Clinical Trials Overview 47

Spinal Cord Stimulation System – Chronic Back Pain – Product Status 47

Spinal Cord Stimulation System – Chronic Back Pain – Product Description 47

Nevro Corp Pipeline Products & Ongoing Clinical Trials Overview 48

Senza HF10 Therapy System – Back Pain – Product Status 49

Senza HF10 Therapy System – Back Pain – Product Description 49

Senza HF10 Therapy System – Chronic Abdominal Pain – Product Status 49

Senza HF10 Therapy System – Chronic Abdominal Pain – Product Description 50

Senza HF10 Therapy System – Chronic Migraine – Product Status 50

Senza HF10 Therapy System – Chronic Migraine – Product Description 50

Senza HF10 Therapy System – Chronic Neck Pain – Product Status 51

Senza HF10 Therapy System – Chronic Neck Pain – Product Description 51

Senza HF10 Therapy System – CPSP – Product Status 51

Senza HF10 Therapy System – CPSP – Product Description 52

Senza HF10 Therapy System – Leg Pain – Product Status 52

Senza HF10 Therapy System – Leg Pain – Product Description 52

Senza HF10 Therapy System – Opioid Reduction – Product Status 53

Senza HF10 Therapy System – Opioid Reduction – Product Description 53

Senza HF10 Therapy System – Painful Diabetic Neuropathy – Product Status 53

Senza HF10 Therapy System – Painful Diabetic Neuropathy – Product Description 54

Senza HF10 Therapy System – Pelvic Pain – Product Status 54

Senza HF10 Therapy System – Pelvic Pain – Product Description 54

Senza HF10 Therapy System – Peripheral Polyneuropathy – Product Status 55

Senza HF10 Therapy System – Peripheral Polyneuropathy – Product Description 55

Senza HF10 Therapy System – Post-Surgical Pain – Product Status 55

Senza HF10 Therapy System – Post-Surgical Pain – Product Description 56

Senza HF10 Therapy System – Rescue Therapy – Product Status 56

Senza HF10 Therapy System – Rescue Therapy – Product Description 56

Senza HF10 Therapy System – Thoracic Pain – Product Status 57

Senza HF10 Therapy System – Thoracic Pain – Product Description 57

Senza HF10 Therapy System – Upper Extremity Pain – Product Status 57

Senza HF10 Therapy System – Upper Extremity Pain – Product Description 58

Senza HF10 Therapy System – Upper Limb Pain – Product Status 58

Senza HF10 Therapy System – Upper Limb Pain – Product Description 58

Senza HFX iQ Spinal Cord Stimulation System – Product Status 59

Senza HFX iQ Spinal Cord Stimulation System – Product Description 59

Nevro Corp – Ongoing Clinical Trials Overview 60

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 61

Senza HF10 Therapy System – Painful Diabetic Neuropathy – PDN-SENSORY: A Multi-Center Randomized Controlled Trial to Evaluate Pain and Neurological Function with 10 kHz SCS in Treatment of Painful Diabetic Neuropathy 61

Senza HF10 Therapy System – Pelvic Pain – A Prospective Clinical Study to Assess the Spinal Cord Stimulation System in the Treatment of Chronic Pelvic Pain 62

Nexstim Plc Pipeline Products & Ongoing Clinical Trials Overview 63

Navigated Brain Therapy System – Chronic Spinal Cord Injury – Product Status 63

Navigated Brain Therapy System – Chronic Spinal Cord Injury – Product Description 63

Onward Medical NV Pipeline Products & Ongoing Clinical Trials Overview 64

ARC-IM – Bladder – Product Status 64

ARC-IM – Bladder – Product Description 64

ARC-IM BCI – Mobility – Product Status 65

ARC-IM BCI – Mobility – Product Description 65

Onward Medical NV – Ongoing Clinical Trials Overview 66

ARC-IM BCI – Mobility – Brain Controlled Spinal Cord Stimulation in Participants With Cervical Spinal Cord Injury for Upper Limb Rehabilitation (UP2) 67

ARC-IM BCI – Mobility – Efficacy of Spinal Epidural Electrical Stimulation (EES) in Combination with Robot-assisted Neurorehabilitation in Patients with Spinal Cord Injury (STIMO) 67

ARC-IM BCI – Mobility – Targeting Improvements in Bowel Function and Quality of Life Using Epidural Stimulation and Training After Severe Spinal Cord Injury 67

Onward Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 68

ARC-BCI – Upper Limb – Product Status 68

ARC-BCI – Upper Limb – Product Description 69

ARC-BSI – Product Status 69

ARC-BSI – Product Description 69

ARC-EX – Product Status 70

ARC-EX – Product Description 70

ARC-EX – Bladder Control – Product Status 70

ARC-EX – Bladder Control – Product Description 71

ARC-EX – Mobility – Product Status 71

ARC-EX – Mobility – Product Description 71

ARC-EX – Sexual Function – Product Status 72

ARC-EX – Sexual Function – Product Description 72

ARC-IM – Blood Pressure And Trunk Control – Product Status 72

ARC-IM – Blood Pressure And Trunk Control – Product Description 73

ARC-IM – Parkinson’s Disease – Product Status 73

ARC-IM – Parkinson’s Disease – Product Description 73

Onward Technologies Ltd – Ongoing Clinical Trials Overview 74

ARC-EX – Activity Dependent Rehabilitation Via Transcutaneous Electrical Spinal Stimulation to Restore Upper Extremity Functions in Spinal Cord Injury 75

ARC-EX – Transcutaneous Spinal Cord Stimulation to Promote Walking Recovery after Spinal Cord Injury 75

ARC-IM – Blood Pressure And Trunk Control – Epidural Electrical Stimulation to Restore Hemodynamic Stability and Trunk Control in People with Spinal Cord Injury 76

ARC-IM – Parkinson’s Disease – Study on Preliminary Safety and Efficacy of the ARC-IM Therapy to Alleviate Locomotor Deficits in People With Parkinson’s Disease 77

Quantum Nanostim LLC Pipeline Products & Ongoing Clinical Trials Overview 78

Clone System – Product Status 78

Clone System – Product Description 78

Reach Neuro Inc Pipeline Products & Ongoing Clinical Trials Overview 79

Avantis Device – Product Status 79

Avantis Device – Product Description 79

Rowan University Pipeline Products & Ongoing Clinical Trials Overview 80

Spinal Cord Stimulation Device – Chronic Pain – Product Status 80

Spinal Cord Stimulation Device – Chronic Pain – Product Description 80

Saluda Medical Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 81

Evoke Spinal Cord Stimulator System – Product Status 81

Evoke Spinal Cord Stimulator System – Product Description 81

Saluda Medical Pty Ltd – Ongoing Clinical Trials Overview 82

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 83

Evoke Spinal Cord Stimulator System – A prospective Feasibility Study Examining the Ability of Closed-loop Spinal Cord Stimulation to Reduce Lower Limb Spasticity in Children Living with Cerebral Palsy: “The Liberty Trial” 83

Evoke Spinal Cord Stimulator System – A Prospective, Multicenter, Single-arm Study Evaluating the Clinical Utility of Neurophysiological Measurements of ECAP-controlled Closed-loop Spinal Cord Stimulation (SCS) to Guide Treatment of Patients With Chronic Pain of the Trunk and/or Limbs. 83

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 84

Evoke Spinal Cord Stimulator System – Assessment of Effectiveness and Stimulation Coverage of Closed-loop Spinal Cord 84

Evoke Spinal Cord Stimulator System – EVOKE ECAP-Controlled Lead Placement and Programming in Chronic Pain Patients 84

Evoke Spinal Cord Stimulator System – Real-World Efficacy of Evoke Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy in Chronic Pain Patients (ULTRA) 85

Evoke Spinal Cord Stimulator System – Targeting the Conus Medullaris With ECAP-Controlled Closed-Loop SCS for the Treatment of Chronic Pelvic Pain: HOPE Trial 85

Soin Neuroscience Inc Pipeline Products & Ongoing Clinical Trials Overview 86

Spinal Cord Stimulation System – Product Status 86

Spinal Cord Stimulation System – Product Description 86

Soterix Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 87

1×1 tDCS Device – Product Status 87

1×1 tDCS Device – Product Description 87

tSDCS Cervical Strap – Product Status 88

tSDCS Cervical Strap – Product Description 88

tSDCS Lumbar BODYstrap – Product Status 88

tSDCS Lumbar BODYstrap – Product Description 89

tSDCS Shoulder Strap – Product Status 89

tSDCS Shoulder Strap – Product Description 89

Soterix Medical Inc – Ongoing Clinical Trials Overview 90

1×1 tDCS Device – Altering Multitasking Behavior Using Low Current Brain Stimulation 91

1×1 tDCS Device – Effects of Transcranial Direct Current Stimulation (tDCS) on Motor Function in Schizophrenia Patients and Individuals at Risk for Psychotic Onset 91

1×1 tDCS Device – Non-invasive Neuromodulation to Enhance Targeted Cognitive Remediation in Older Adults With Depression 91

1×1 tDCS Device – Phase II Clinical Trial of Transcranial Direct Current Stimulation in the Treatment of Primary Progressive Aphasia 92

1×1 tDCS Device – Pragmatic Trial of Remote tDCS and Somatosensory Training for Phantom Limb Pain with Machine Learning to Predict Treatment Response 92

1×1 tDCS Device – SMART Stimulation: Precision Neuromodulation of Cognition in Older Adults 92

1×1 tDCS Device – Transcranial Direct Current Stimulation for Gait Recovery Following Stroke 93

1×1 tDCS Device – Using tDCS in Speech-based Stroke Rehabilitation 93

SpineX Inc Pipeline Products & Ongoing Clinical Trials Overview 94

SCiP – Product Status 94

SCiP – Product Description 94

Scone Device – Product Status 95

Scone Device – Product Description 95

SpineX Inc – Ongoing Clinical Trials Overview 96

Scone Device – Noninvasive Spinal Neuromodulation Enables Locomotor Recovery in Individuals with Cerebral Palsy 97

Scone Device – The Effects of Transcutaneous Electrical Stimulation on Arm Functions in Individuals with Cervical Spinal Cord Injury 97

SCiP – A Multi-centered Clinical Study to Assess the Effects of the SCiP in Children’s with Cerebral Palsy 98

SCiP – A Pivotal Clinical Study to Examine the Safety and Efficacy of SCiP Device in Children Living with Cerebral Palsy 98

SCiP – Transcutaneous Stimulation and Mobility Device Use for Individuals with Neurologic Conditions 98

Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview 99

Spinal Cord Stimulator – Chronic Pain – Product Status 99

Spinal Cord Stimulator – Chronic Pain – Product Description 99

St. Jude Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 100

Next Generation Implantable SCS System – Primary Cell – Product Status 100

Next Generation Implantable SCS System – Primary Cell – Product Description 100

Next Generation Implantable SCS System – Rechargeable – Product Status 101

Next Generation Implantable SCS System – Rechargeable – Product Description 101

Proclaim Rechargeable Model – Product Status 101

Proclaim Rechargeable Model – Product Description 101

Proclaim Upgrade HC – Product Status 102

Proclaim Upgrade HC – Product Description 102

Proclaim Upgrade LC – Product Status 102

Proclaim Upgrade LC – Product Description 103

Stimdia Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 104

pdSTIM System – Product Status 104

pdSTIM System – Product Description 104

Stimdia Medical Inc – Ongoing Clinical Trials Overview 105

pdSTIM System – Randomized Study of the pdSTIM System (Phrenic Nerve to Diaphragm STIMulation) in Failure to Wean Mechanically Ventilated Patients 106

SynerFuse Inc Pipeline Products & Ongoing Clinical Trials Overview 107

NeuroFuse DRG System – Product Status 107

NeuroFuse DRG System – Product Description 107

SynerFuse Inc – Ongoing Clinical Trials Overview 108

NeuroFuse DRG System – SynerFuse Spinal Fusion and Neuromodulation Proof of Concept Study 109

Teliatry Inc Pipeline Products & Ongoing Clinical Trials Overview 110

16 Channel Spinal Cord Stimulator – Product Status 110

16 Channel Spinal Cord Stimulator – Product Description 110

University of California Los Angeles Pipeline Products & Ongoing Clinical Trials Overview 111

32-Electrode Neurostimulator – Product Status 111

32-Electrode Neurostimulator – Product Description 111

Spinal Cord Electrical Stimulator – Product Status 112

Spinal Cord Electrical Stimulator – Product Description 112

University of Cambridge Pipeline Products & Ongoing Clinical Trials Overview 113

360° Implant – Spinal Cord Injuries – Product Status 113

360° Implant – Spinal Cord Injuries – Product Description 113

Inflatable Spinal Implant – Product Status 114

Inflatable Spinal Implant – Product Description 114

University of Illinois at Chicago Pipeline Products & Ongoing Clinical Trials Overview 115

Paddle Electrodes Insertion Device – Product Status 115

Paddle Electrodes Insertion Device – Product Description 115

University of Minnesota Pipeline Products & Ongoing Clinical Trials Overview 116

Spinal Cord Stimulation Device – Product Status 116

Spinal Cord Stimulation Device – Product Description 116

University of Minnesota – Ongoing Clinical Trials Overview 117

Spinal Cord Stimulation Device – Epidural Stimulation for Spinal Cord Injury 118

Wavegate Corp Pipeline Products & Ongoing Clinical Trials Overview 119

StimuLux – Product Status 119

StimuLux – Product Description 119

WISE s.r.l. Pipeline Products & Ongoing Clinical Trials Overview 120

SCS EXPERT – Product Status 120

SCS EXPERT – Product Description 120

Glossary 178

Figures

Spinal Cord Stimulators (SCS) – Pipeline Products by Stage of Development 14

Spinal Cord Stimulators (SCS) – Pipeline Products by Segment 15

Spinal Cord Stimulators (SCS) – Pipeline Products by Territory 16

Spinal Cord Stimulators (SCS) – Pipeline Products by Regulatory Path 17

Spinal Cord Stimulators (SCS) – Pipeline Products by Estimated Approval Date 18

Spinal Cord Stimulators (SCS) – Ongoing Clinical Trials 19

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