Vagus Nerve Stimulators (VNS) Pipeline by Development Stages, Segments, Region and Countries, Regulatory Path and Key Companies

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Vagus Nerve Stimulators (VNS) Pipeline Market Report Overview

A vagus nerve stimulator (VNS) is a device comprising an electrical pacemaker that sends electrical stimulation through surgically implanted electrodes to target the vagus nerve. These devices are utilized to treat neurological disorders such as epilepsy and depression.

The VNS 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

·       Japan

·       New Zealand

·       United Kingdom

Key Segment ·       Non-Rechargeable Vagus Nerve Stimulators

·       Rechargeable Vagus Nerve Stimulators

Key Regulatory Paths ·       510(k)

·       PMA

·       CE

·       UKCA

·       TGA

Leading Companies ·       Adriakaim Inc

·       Bionics Institute

·       Boston Scientific Corp

·       DuoCure Ltd.

·       ElectroCore Inc

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VNS Pipeline Market Segments

A few of the key segments in the VNS pipeline market are non-rechargeable vagus nerve stimulators and rechargeable vagus nerve stimulators. As of August 2024, both segments in the VNS pipeline market had the highest number of VNS pipeline products.

VNS Pipeline Market Analysis by Segments, 2024 (%)

VNS Pipeline Market Analysis by Segments, 2024 (%)

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VNS Pipeline Market Segmentation by Territories

A few of the key territories with the VNS pipeline market are Europe, the United States, New Zealand, Japan, and the United Kingdom among others. As of August 2024, the US had the highest number of VNS pipeline products.

VNS Pipeline Market Analysis by Territories, 2024 (%)

VNS Pipeline Market Analysis by Territories, 2024 (%)

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VNS Pipeline Market Segmentation by Regulatory Paths

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

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

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

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VNS Pipeline Market – Competitive Landscape

A few of the key companies associated with the VNS pipeline market are Adriakaim Inc., Bionics Institute, Boston Scientific Corp, DuoCure Ltd., and ElectroCore Inc. among others.

The Bionics Institute: Bionics Institute, formerly The Bionic Ear Institute, is a medical research institute that develops technologies for eyes, ears, and central nervous system-related diseases. It offers Minder, a small implant for recording brain activity and monitoring seizures in people with epilepsy, and BiRD, a palm-worn device for early diagnosis of Parkinson’s disease. The institute is developing EarGenie to enhance language development in children with hearing disabilities and other medical devices to detect inflammatory bowel diseases. Bionics Institute also provides preclinical, analysis, rapid prototyping, and medical device testing services. It works in collaboration with universities, research institutes, hospitals, and commercial entities to develop medical devices. Bionics Institute is headquartered in East Melbourne, Victoria, Australia.

VNS Pipeline Market Analysis by Companies, 2024
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Segments Covered in the Report

VNS Pipeline Market Segments Outlook (2024)

  • Non-Rechargeable Vagus Nerve Stimulators
  • Rechargeable Vagus Nerve Stimulators

VNS Pipeline Market Territories Outlook (2024)

  • Europe
  • The United States
  • New Zealand
  • Japan
  • United Kingdom

VNS Pipeline Market Regulatory Paths Outlook (2024)

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

Scope

This report provides:

  • Extensive coverage of the VNS 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 VNS 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 VNS 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.

Adriakaim Inc
Bionics Institute
Boston Scientific Corp
DuoCure Ltd.
ElectroCore Inc
LivaNova PLC
LivaNova USA Inc
MicroTransponder Inc
Neurive Inc
Neuroloop Gmbh
Nexeon MedSystems Inc
Otto Bock HealthCare GmbH
Purdue University
ReShape Lifesciences Inc
Setpoint Medical Corp
Synergia Medical SA
The Feinstein Institute for Medical Research
Trifectas Medical Corp.
tVNS Technologies GmbH
University of Alabama
University of Auckland
University of Pittsburgh
University of Wisconsin Madison
West Virginia University

Table of Contents

|1 Table of Contents 3

|1.1 List of Tables 5

|1.2 List of Figures 8

2 Introduction 9

2.1 Vagus Nerve Stimulators (VNS) Overview 9

3 Products under Development 10

3.1 Vagus Nerve Stimulators (VNS) – Pipeline Products by Stage of Development 10

3.2 Vagus Nerve Stimulators (VNS) – Pipeline Products by Segment 11

3.3 Vagus Nerve Stimulators (VNS) – Pipeline Products by Territory 12

3.4 Vagus Nerve Stimulators (VNS) – Pipeline Products by Regulatory Path 13

3.5 Vagus Nerve Stimulators (VNS) – Pipeline Products by Estimated Approval Date 14

3.6 Vagus Nerve Stimulators (VNS) – Ongoing Clinical Trials 15

4 Vagus Nerve Stimulators (VNS) – Pipeline Products under Development by Companies 16

4.1 Vagus Nerve Stimulators (VNS) Companies – Pipeline Products by Stage of Development 16

4.2 Vagus Nerve Stimulators (VNS) – Pipeline Products by Stage of Development 18

5 Vagus Nerve Stimulators (VNS) Companies and Product Overview 20

5.1 Adriakaim Inc Company Overview 20

5.1.1 Adriakaim Inc Pipeline Products & Ongoing Clinical Trials Overview 20

5.2 Bionics Institute Company Overview 21

5.2.1 Bionics Institute Pipeline Products & Ongoing Clinical Trials Overview 21

5.3 Boston Scientific Corp Company Overview 22

5.3.1 Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 22

5.4 DuoCure Ltd. Company Overview 23

5.4.1 DuoCure Ltd. Pipeline Products & Ongoing Clinical Trials Overview 23

5.5 ElectroCore Inc Company Overview 24

5.5.1 ElectroCore Inc Pipeline Products & Ongoing Clinical Trials Overview 24

5.6 LivaNova PLC Company Overview 26

5.6.1 LivaNova PLC Pipeline Products & Ongoing Clinical Trials Overview 26

5.7 LivaNova USA Inc Company Overview 32

5.7.1 LivaNova USA Inc Pipeline Products & Ongoing Clinical Trials Overview 32

5.8 MicroTransponder Inc Company Overview 33

5.8.1 MicroTransponder Inc Pipeline Products & Ongoing Clinical Trials Overview 33

5.9 Neurive Inc Company Overview 39

5.9.1 Neurive Inc Pipeline Products & Ongoing Clinical Trials Overview 39

5.10 Neuroloop Gmbh Company Overview 40

5.10.1 Neuroloop Gmbh Pipeline Products & Ongoing Clinical Trials Overview 40

5.11 Nexeon MedSystems Inc Company Overview 44

5.11.1 Nexeon MedSystems Inc Pipeline Products & Ongoing Clinical Trials Overview 44

5.12 Otto Bock HealthCare GmbH Company Overview 45

5.12.1 Otto Bock HealthCare GmbH Pipeline Products & Ongoing Clinical Trials Overview 45

5.13 Purdue University Company Overview 46

5.13.1 Purdue University Pipeline Products & Ongoing Clinical Trials Overview 46

5.14 ReShape Lifesciences Inc Company Overview 47

5.14.1 ReShape Lifesciences Inc Pipeline Products & Ongoing Clinical Trials Overview 47

5.15 Setpoint Medical Corp Company Overview 49

5.15.1 Setpoint Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 49

5.16 Synergia Medical SA Company Overview 52

5.16.1 Synergia Medical SA Pipeline Products & Ongoing Clinical Trials Overview 52

5.17 The Feinstein Institute for Medical Research Company Overview 58

5.17.1 The Feinstein Institute for Medical Research Pipeline Products & Ongoing Clinical Trials Overview 58

5.18 Trifectas Medical Corp. Company Overview 60

5.18.1 Trifectas Medical Corp. Pipeline Products & Ongoing Clinical Trials Overview 60

5.19 tVNS Technologies GmbH Company Overview 61

5.19.1 tVNS Technologies GmbH Pipeline Products & Ongoing Clinical Trials Overview 61

5.20 University of Alabama Company Overview 62

5.20.1 University of Alabama Pipeline Products & Ongoing Clinical Trials Overview 62

5.21 University of Auckland Company Overview 63

5.21.1 University of Auckland Pipeline Products & Ongoing Clinical Trials Overview 63

5.22 University of Pittsburgh Company Overview 64

5.22.1 University of Pittsburgh Pipeline Products & Ongoing Clinical Trials Overview 64

5.23 University of Wisconsin Madison Company Overview 65

5.23.1 University of Wisconsin Madison Pipeline Products & Ongoing Clinical Trials Overview 65

5.24 West Virginia University Company Overview 66

5.24.1 West Virginia University Pipeline Products & Ongoing Clinical Trials Overview 66

6 Vagus Nerve Stimulators (VNS)- Recent Developments 67

6.1 Jul 10, 2024: Setpoint Medical Announces Positive Topline Results from Landmark Reset-Ra Study Evaluating Neuroimmune Modulation for the Treatment of Rheumatoid Arthritis 67

6.2 Jul 10, 2024: SetPoint Medical Announces Positive Topline Results from Landmark RESET-RA Study Evaluating Neuroimmune Modulation for the Treatment of Rheumatoid Arthritis 68

6.3 Jun 06, 2024: LivaNova Provides Update on RECOVER Clinical Study Evaluating VNS Therapy for Treatment-Resistant Depression in Unipolar Patients 69

6.4 Mar 21, 2024: SetPoint Medical Accepted into FDA Total Product Life Cycle Advisory Program for Development of its Neuroimmune Modulation Platform for the Treatment of Multiple Sclerosis 70

6.5 Mar 19, 2024: Tampa General Conducts First Procedure on the West Coast of Florida With Device Designed to Revive Arm Function After Stroke 70

6.6 Mar 13, 2024: SetPoint wins second FDA breakthrough device nod for neurostim device 71

6.7 Mar 13, 2024: SetPoint Medical Receives FDA Breakthrough Device Designation for its Neuroimmune Modulation Platform for the Treatment of Multiple Sclerosis 72

6.8 Mar 04, 2024: LivaNova to Present at the Barclays Global Healthcare Conference 73

6.9 Feb 28, 2024: Boston Scientific Raises $2.2B to Support Purchase of California Medical Device Company 73

6.10 Feb 23, 2024: Medical Tech Leader, Boston Scientific (BSX), Announces Notes Offering 73

6.11 Feb 23, 2024: Breakthrough Stroke Treatment at Penn State Health Offers Patients New Hope 73

6.12 Jan 05, 2024: Boston Scientific Announces Conference Call Discussing Fourth Quarter 2023 Results 75

6.13 Dec 26, 2023: electroCore Expands Intellectual Property Portfolio 75

6.14 Nov 15, 2023: Dr. Peter Staats to Host Analyst Day on the Science Behind gammaCore Non-Invasive Vagus Nerve Stimulation (nVNS) on Tuesday, November 21, 2023 75

6.15 Oct 24, 2023: TIME Picks MicroTransponder’s Vivistim Paired VNS System for 2023 Best Inventions List in Medical Care Category 76

6.16 Oct 17, 2023: electroCore Announces Two-Year Extension of gammaCore Device Listing in the NHS Supply Chain Catalogue 77

6.17 Oct 11, 2023: electroCore Expands Intellectual Property Portfolio for Non-Invasive Vagus Nerve Stimulation (nVNS) Technology 77

6.18 Oct 03, 2023: SetPoint Medical Announces Publication of Data for Neuroimmune Modulation to Treat Crohn’s Disease in Journal of Crohn’s and Colitis 77

6.19 Sep 14, 2023: ReShape Lifesciences Receives NIH SBIR Grant to Further Develop Proprietary Diabetes Bloc-Stim Neuromodulation™ Device 78

7 Appendix 80

7.1 Methodology 80

7.2 About GlobalData 83

7.3 Contact Us 83

7.4 Disclaimer 83

Table

Vagus Nerve Stimulators (VNS) – Pipeline Products by Stage of Development 10

Vagus Nerve Stimulators (VNS) – Pipeline Products by Segment 11

Vagus Nerve Stimulators (VNS) – Pipeline Products by Territory 12

Vagus Nerve Stimulators (VNS) – Pipeline Products by Regulatory Path 13

Vagus Nerve Stimulators (VNS) – Pipeline Products by Estimated Approval Date 14

Vagus Nerve Stimulators (VNS) – Ongoing Clinical Trials 15

Vagus Nerve Stimulators (VNS) Companies – Pipeline Products by Stage of Development 16

Vagus Nerve Stimulators (VNS) – Pipeline Products by Stage of Development 18

Adriakaim Inc Pipeline Products & Ongoing Clinical Trials Overview 20

Vagus Nerve Stimulation Device – Product Status 20

Vagus Nerve Stimulation Device – Product Description 20

Bionics Institute Pipeline Products & Ongoing Clinical Trials Overview 21

Vagus Nerve Stimulation Device – Rheumatoid Arthritis – Product Status 21

Vagus Nerve Stimulation Device – Rheumatoid Arthritis – Product Description 21

Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 22

Vagus Nerve Stimulation (VNS) System – Product Status 22

Vagus Nerve Stimulation (VNS) System – Product Description 22

DuoCure Ltd. Pipeline Products & Ongoing Clinical Trials Overview 23

Intraluminal Implantable Device – Product Status 23

Intraluminal Implantable Device – Product Description 23

ElectroCore Inc Pipeline Products & Ongoing Clinical Trials Overview 24

GammaCore – Post-Traumatic Headache – Product Status 24

GammaCore – Post-Traumatic Headache – Product Description 24

Resolve Stimulator And Proximity Electrode – Product Status 25

Resolve Stimulator And Proximity Electrode – Product Description 25

LivaNova PLC Pipeline Products & Ongoing Clinical Trials Overview 26

Aspire NP – Product Status 26

Aspire NP – Product Description 27

Centro Generator – Product Status 27

Centro Generator – Product Description 27

CentroSR Generator – Product Status 28

CentroSR Generator – Product Description 28

Equilia – Product Status 28

Equilia – Product Description 29

Griffin – Pulse Generator – Product Status 29

Griffin – Pulse Generator – Product Description 29

Intense Neuromodulation System – Heart Failure – Product Status 30

Intense Neuromodulation System – Heart Failure – Product Description 30

Microburst VNS Stimulator – Product Status 30

Microburst VNS Stimulator – Product Description 31

PhoenixRF SR – Product Status 31

PhoenixRF SR – Product Description 31

LivaNova USA Inc Pipeline Products & Ongoing Clinical Trials Overview 32

Nerve Wrap – Product Status 32

Nerve Wrap – Product Description 32

MicroTransponder Inc Pipeline Products & Ongoing Clinical Trials Overview 33

SAINT System – Tinnitus – Product Status 33

SAINT System – Tinnitus – Product Description 33

Serenity System – Product Status 34

Serenity System – Product Description 34

Vivistim Paired VNS System – Product Status 34

Vivistim Paired VNS System – Product Description 35

MicroTransponder Inc – Ongoing Clinical Trials Overview 36

Vivistim Paired VNS System – Safety and Feasibility of Paired Vagus Nerve Stimulation With Rehabilitation for Improving Upper Extremity Function in People With Cervical Spinal Cord Injury: A Pilot Randomized Control Trial. 37

Vivistim Paired VNS System – Vagal Nerve Stimulation in Enhanced Stroke Recovery: The VALOR Registry 37

Vivistim Paired VNS System – Vagus Nerve Stimulation (VNS) During Rehabilitation Using the Vivistim System: Post-Market Study for Stroke Rehabilitation in a Home Environment for Subjects With Chronic Stroke (VNS-REHAB At-Home) 37

Vivistim Paired VNS System – Vivistim Registry for Paired VNS Therapy (GRASP) 38

Neurive Inc Pipeline Products & Ongoing Clinical Trials Overview 39

Healaon – Product Status 39

Healaon – Product Description 39

Neuroloop Gmbh Pipeline Products & Ongoing Clinical Trials Overview 40

Baroloop System – Product Status 40

Baroloop System – Product Description 40

Neurostimulation System – Product Status 41

Neurostimulation System – Product Description 41

Neuroloop Gmbh – Ongoing Clinical Trials Overview 42

Baroloop System – Baroloop Multicenter Trial (Baroloop MCT) 43

Nexeon MedSystems Inc Pipeline Products & Ongoing Clinical Trials Overview 44

Auricular Vagus Nerve Stimulator – Asthma – Product Status 44

Auricular Vagus Nerve Stimulator – Asthma – Product Description 44

Otto Bock HealthCare GmbH Pipeline Products & Ongoing Clinical Trials Overview 45

Neuromodulation Device – Sleep Apnea – Product Status 45

Neuromodulation Device – Sleep Apnea – Product Description 45

Purdue University Pipeline Products & Ongoing Clinical Trials Overview 46

Bionode Device – Product Status 46

Bionode Device – Product Description 46

ReShape Lifesciences Inc Pipeline Products & Ongoing Clinical Trials Overview 47

Diabetes Bloc-Stim Neuromodulation Device – Product Status 47

Diabetes Bloc-Stim Neuromodulation Device – Product Description 48

Diabetes Bloc-Stim Neuromodulation Device – Hypoglycemia – Product Status 48

Diabetes Bloc-Stim Neuromodulation Device – Hypoglycemia – Product Description 48

Setpoint Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 49

Implantable Bioelectronic Device – Product Status 49

Implantable Bioelectronic Device – Product Description 49

Setpoint Medical Corp – Ongoing Clinical Trials Overview 50

Implantable Bioelectronic Device – Vagus Nerve Stimulation Using the SetPoint System for Moderate to Severe Rheumatoid Arthritis: The RESET-RA Study 51

Synergia Medical SA Pipeline Products & Ongoing Clinical Trials Overview 52

NAO·VNS – Chronic Pain – Product Status 52

NAO·VNS – Chronic Pain – Product Description 52

NAO·VNS – Depression – Product Status 53

NAO·VNS – Depression – Product Description 53

NAO·VNS – Epilepsy – Product Status 53

NAO·VNS – Epilepsy – Product Description 54

NAO·VNS – Parkinson’s Disease – Product Status 54

NAO·VNS – Parkinson’s Disease – Product Description 54

NAO·VNS – Sleep Apnoea – Product Status 55

NAO·VNS – Sleep Apnoea – Product Description 55

Synergia Medical SA – Ongoing Clinical Trials Overview 56

NAO·VNS – Epilepsy – A First in Human Study for Resistant Epilepsy With the Vagus Nerve Stimulation Device by Synergia Medical 57

The Feinstein Institute for Medical Research Pipeline Products & Ongoing Clinical Trials Overview 58

Bioelectronic Medicine Device – Heart Failure – Product Status 58

Bioelectronic Medicine Device – Heart Failure – Product Description 58

Bioelectronic Medicine Device – Obesity – Product Status 59

Bioelectronic Medicine Device – Obesity – Product Description 59

Trifectas Medical Corp. Pipeline Products & Ongoing Clinical Trials Overview 60

Neurostimulation Device – Stroke Recovery – Product Status 60

Neurostimulation Device – Stroke Recovery – Product Description 60

tVNS Technologies GmbH Pipeline Products & Ongoing Clinical Trials Overview 61

t-VNS – Dementia – Product Status 61

t-VNS – Dementia – Product Description 61

University of Alabama Pipeline Products & Ongoing Clinical Trials Overview 62

VNS Device – Depression – Product Status 62

VNS Device – Depression – Product Description 62

University of Auckland Pipeline Products & Ongoing Clinical Trials Overview 63

Electroceutical Device – Product Status 63

Electroceutical Device – Product Description 63

University of Pittsburgh Pipeline Products & Ongoing Clinical Trials Overview 64

Closed-Loop Neuroelectric Device – Product Status 64

Closed-Loop Neuroelectric Device – Product Description 64

University of Wisconsin Madison Pipeline Products & Ongoing Clinical Trials Overview 65

Implantable Weight-Loss Device – Product Status 65

Implantable Weight-Loss Device – Product Description 65

West Virginia University Pipeline Products & Ongoing Clinical Trials Overview 66

MouseFlex – Product Status 66

MouseFlex – Product Description 66

Glossary 82

Figures

Vagus Nerve Stimulators (VNS) – Pipeline Products by Stage of Development 10

Vagus Nerve Stimulators (VNS) – Pipeline Products by Segment 11

Vagus Nerve Stimulators (VNS) – Pipeline Products by Territory 12

Vagus Nerve Stimulators (VNS) – Pipeline Products by Regulatory Path 13

Vagus Nerve Stimulators (VNS) – Pipeline Products by Estimated Approval Date 14

Vagus Nerve Stimulators (VNS) – Ongoing Clinical Trials 15

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