Vagus Nerve Stimulators (VNS) Pipeline Report including Stages of Development, Segments, Region and Countries, Regulatory Path and Key Companies, 2022 Update

Pages: 134 Published: July 14, 2022 Report Code: GDME1400EPD

A Vagus Nerve Stimulators (VNS) is a device comprising an electrical pacemaker that sends electrical stimulation through surgically-implanted electrodes to target the vagus nerve. The vagus nerve stimulators pipeline products 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 VNS Pipeline Market

Key territories in the VNS pipeline market are the United States, Europe, United Kingdom, India, Japan, and New Zealand. US has the highest number of pipeline products.

VNS Pipeline Market, by Territories

VNS Pipeline Market, by Territories

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Key Regulatory Paths in the VNS Pipeline Market

Key regulatory paths in the VNS pipeline market are PMA, 510(k), CE, UKCA, Shonin, TGA, de novo, EUA, and ICAC. PMA has the highest number of pipeline products.

VNS Pipeline Market, by Regulatory Paths

VNS Pipeline Market, by Regulatory Paths

For more regulatory path insights, download a free report sample

Key Companies in the VNS Pipeline Market

Some of the key companies in the VNS pipeline market are Adriakaim Inc, Afferent Technologies, Aucta Technologies Inc, Boston Scientific Corp, Cala Health Inc, CerboMed GmbH, Cyberonics Inc, DuoCure Ltd., ElectroCore Inc, and Evren Technologies Inc.

Adriakaim Inc – Adriakaim Inc is engaged in planning, research, design, development, manufacturing, and sales of medical and health-related equipment that stimulates the vagus nerve and reduces the myocardial infarction area. The company is headquartered in Japan.

Boston Scientific Corp – Boston Scientific Corp (Boston Scientific) is a medical technology company that is involved in the development, manufacturing and commercialization of devices for a range of interventional medical specialties. The company offers products in the areas of electrophysiology, gastroenterology, gastrointestinal surgery, female pelvic medicine, gynecology, interventional cardiology, interventional radiology, neurological surgery, orthopedic surgery, pain medicine, pulmonology, urology and vascular surgery. Boston Scientific serves hospitals, clinics, outpatient facilities and medical offices across the world. The company has manufacturing facilities in the US, Ireland, Costa Rica, Brazil, Malaysia, Puerto Rico and Switzerland. It sells products directly and also through a network of distributors and dealers in Europe, the Middle East, Africa, Asia Pacific and the Americas. Boston Scientific is headquartered in Marlborough, Massachusetts, the US.

CerboMed GmbH – CerboMed GmbH (CerboMed) is a medical equipment provider that offers neurological and psychiatric treatment devices. The company offers neuro therapy solutions and technologies in the areas of neuromodulation. It also offers transcutaneous vagus nerve stimulation solutions. CerboMed’s nemos is used for the treatment of epilepsies and related brain cell diseases. The company’s nemos provide targeted stimulation of the vagus nerve that supplies the skin of the concha in the human ear without the risks of a surgical intervention. It markets products across Germany. CerboMed is headquartered in Erlangen, Germany.

Cala Health Inc – Cala Health Inc (Cala Health) is a bioelectronic company that strives to develop new class of electrical medicines. The company’s neuroperipheral therapy treats chronic disease by activating peripheral nerves with body-worn electronics. Its Cala ONE is a non-invasive, targeted nerve stimulator for the treatment of essential tremor. Cala Health aims to provide individualized, prescription neuromodulation therapies in combination with neuroscience and electronics. The company is funded by Lightstone Ventures, Lux Capital, dRx Capital, GV and Action Potential Venture Capital. Cala Health is headquartered in Burlingame, California, the US.

Market report overview

Key territories The United States, Europe, United Kingdom, India, Japan, and New Zealand
Key regulatory paths PMA, 510(k), CE, UKCA, Shonin, TGA, de novo, EUA, and ICAC
Key companies Adriakaim Inc, Afferent Technologies, Aucta Technologies Inc, Boston Scientific Corp, Cala Health Inc, CerboMed GmbH, Cyberonics Inc, DuoCure Ltd., ElectroCore Inc, and Evren Technologies Inc

Scope

This report provides:

  • Extensive coverage of the vagus nerve stimulators 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 vagus nerve stimulators and 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 vagus nerve stimulators 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

  • Adriakaim Inc

    Afferent Technologies

    Aucta Technologies Inc

    Boston Scientific Corp

    Cala Health Inc

    CerboMed GmbH

    Cyberonics Inc

    DuoCure Ltd.

    ElectroCore Inc

    Evren Technologies Inc

    Flint Rehabilitation

    FRD Accel LLC

    LivaNova PLC

    Medical University of South Carolina

    MicroTransponder Inc

    Nemechek Technologies LLC

    Neuroloop Gmbh

    Nexeon MedSystems Inc

    Otto Bock HealthCare GmbH

    Parasym Ltd

    Pulsetto UAB

    Pulsus Medical LLC (Inactive)

    Purdue University

    ReShape Lifesciences Inc

    Setpoint Medical Corp

    Soterix Medical Inc

    SUNY Downstate Medical Center

    Synergia Medical SA

    SzeleSTIM GmbH

    The Feinstein Institute for Medical Research

    Trifectas Medical Corp.

    University of Alabama

    University of Auckland

    University of Pittsburgh

    University of Wisconsin Madison

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 Vagus Nerve Stimulators (VNS) Overview 11

3 Products under Development 12

3.1 Vagus Nerve Stimulators (VNS) – Pipeline Products by Stage of Development 12

3.2 Vagus Nerve Stimulators (VNS) – Pipeline Products by Territory 13

3.3 Vagus Nerve Stimulators (VNS) – Pipeline Products by Regulatory Path 14

3.4 Vagus Nerve Stimulators (VNS) – Pipeline Products by Estimated Approval Date 15

3.5 Vagus Nerve Stimulators (VNS) – Ongoing Clinical Trials 16

4 Vagus Nerve Stimulators (VNS) – Pipeline Products under Development by Companies 17

4.1 Vagus Nerve Stimulators (VNS) Companies – Pipeline Products by Stage of Development 17

4.2 Vagus Nerve Stimulators (VNS) – Pipeline Products by Stage of Development 19

5 Vagus Nerve Stimulators (VNS) Companies and Product Overview 21

5.1 Adriakaim Inc Company Overview 21

5.1.1 Adriakaim Inc Pipeline Products & Ongoing Clinical Trials Overview 21

5.2 Afferent Technologies Company Overview 22

5.2.1 Afferent Technologies Pipeline Products & Ongoing Clinical Trials Overview 22

5.3 Aucta Technologies Inc Company Overview 23

5.3.1 Aucta Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 23

5.4 Boston Scientific Corp Company Overview 24

5.4.1 Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 24

5.5 Cala Health Inc Company Overview 26

5.5.1 Cala Health Inc Pipeline Products & Ongoing Clinical Trials Overview 26

5.6 CerboMed GmbH Company Overview 27

5.6.1 CerboMed GmbH Pipeline Products & Ongoing Clinical Trials Overview 27

5.7 Cyberonics Inc Company Overview 28

5.7.1 Cyberonics Inc Pipeline Products & Ongoing Clinical Trials Overview 28

5.8 DuoCure Ltd. Company Overview 29

5.8.1 DuoCure Ltd. Pipeline Products & Ongoing Clinical Trials Overview 29

5.9 ElectroCore Inc Company Overview 30

5.9.1 ElectroCore Inc Pipeline Products & Ongoing Clinical Trials Overview 30

5.10 Evren Technologies Inc Company Overview 51

5.10.1 Evren Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 51

5.11 Flint Rehabilitation Company Overview 52

5.11.1 Flint Rehabilitation Pipeline Products & Ongoing Clinical Trials Overview 52

5.12 FRD Accel LLC Company Overview 53

5.12.1 FRD Accel LLC Pipeline Products & Ongoing Clinical Trials Overview 53

5.13 LivaNova PLC Company Overview 54

5.13.1 LivaNova PLC Pipeline Products & Ongoing Clinical Trials Overview 54

5.14 Medical University of South Carolina Company Overview 65

5.14.1 Medical University of South Carolina Pipeline Products & Ongoing Clinical Trials Overview 65

5.15 MicroTransponder Inc Company Overview 68

5.15.1 MicroTransponder Inc Pipeline Products & Ongoing Clinical Trials Overview 68

5.16 Nemechek Technologies LLC Company Overview 74

5.16.1 Nemechek Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 74

5.17 Neuroloop Gmbh Company Overview 75

5.17.1 Neuroloop Gmbh Pipeline Products & Ongoing Clinical Trials Overview 75

5.18 Nexeon MedSystems Inc Company Overview 76

5.18.1 Nexeon MedSystems Inc Pipeline Products & Ongoing Clinical Trials Overview 76

5.19 Otto Bock HealthCare GmbH Company Overview 79

5.19.1 Otto Bock HealthCare GmbH Pipeline Products & Ongoing Clinical Trials Overview 79

5.20 Parasym Ltd Company Overview 81

5.20.1 Parasym Ltd Pipeline Products & Ongoing Clinical Trials Overview 81

5.21 Pulsetto UAB Company Overview 85

5.21.1 Pulsetto UAB Pipeline Products & Ongoing Clinical Trials Overview 85

5.22 Pulsus Medical LLC (Inactive) Company Overview 86

5.22.1 Pulsus Medical LLC (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 86

5.23 Purdue University Company Overview 87

5.23.1 Purdue University Pipeline Products & Ongoing Clinical Trials Overview 87

5.24 ReShape Lifesciences Inc Company Overview 88

5.24.1 ReShape Lifesciences Inc Pipeline Products & Ongoing Clinical Trials Overview 88

5.25 Setpoint Medical Corp Company Overview 89

5.25.1 Setpoint Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 89

5.26 Soterix Medical Inc Company Overview 92

5.26.1 Soterix Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 92

5.27 SUNY Downstate Medical Center Company Overview 95

5.27.1 SUNY Downstate Medical Center Pipeline Products & Ongoing Clinical Trials Overview 95

5.28 Synergia Medical SA Company Overview 96

5.28.1 Synergia Medical SA Pipeline Products & Ongoing Clinical Trials Overview 96

5.29 SzeleSTIM GmbH Company Overview 100

5.29.1 SzeleSTIM GmbH Pipeline Products & Ongoing Clinical Trials Overview 100

5.30 The Feinstein Institute for Medical Research Company Overview 103

5.30.1 The Feinstein Institute for Medical Research Pipeline Products & Ongoing Clinical Trials Overview 103

5.31 Trifectas Medical Corp. Company Overview 107

5.31.1 Trifectas Medical Corp. Pipeline Products & Ongoing Clinical Trials Overview 107

5.32 University of Alabama Company Overview 108

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

5.33 University of Auckland Company Overview 109

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

5.34 University of Pittsburgh Company Overview 110

5.34.1 University of Pittsburgh Pipeline Products & Ongoing Clinical Trials Overview 110

5.35 University of Wisconsin Madison Company Overview 111

5.35.1 University of Wisconsin Madison Pipeline Products & Ongoing Clinical Trials Overview 111

6 Vagus Nerve Stimulators (VNS)- Recent Developments 112

6.1 Jun 20, 2022: MicroTransponder Appoints New CEO 112

6.2 Apr 28, 2022: Boston Scientific reports net sales of $3.03bn in Q1 2022 112

6.3 Apr 27, 2022: Boston Scientific Announces Results for First Quarter 2022 113

6.4 Feb 14, 2022: Bioelectronic Medicine, vagus nerve stimulation show promise to treat a common Post-Op Heart Arrhythmia 115

6.5 Jan 19, 2022: Feinstein Institutes bioelectronic medicine scientists develop first-of-its-kind wireless neuromodulation device for research 116

6.6 Jan 04, 2022: electroCore to Present at H.C. Wainwright BIOCONNECT Virtual Conference 117

6.7 Nov 08, 2021: Boston Scientific Announces Upcoming Conference Schedule 117

6.8 Nov 04, 2021: electroCore Announces Third Quarter 2021 Financial Results 117

6.9 Nov 03, 2021: LivaNova Reports Third Quarter 2021 Results 119

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

6.11 Sep 30, 2021: electroCore Presentation at the Cantor Fitzgerald Virtual Global Healthcare Conference 125

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

6.13 Aug 05, 2021: electroCore Announces Second Quarter 2021 Financial Results 125

6.14 Jul 28, 2021: LivaNova Reports Second Quarter 2021 Results and Appoints Alex Shvartsburg as Chief Financial Officer 126

6.15 Jul 13, 2021: electroCore Provides Business Update and Select Second Quarter 2021 Financial Guidance 128

7 Appendix 131

7.1 Methodology 131

7.2 About GlobalData 134

7.3 Contact Us 134

7.4 Disclaimer 134

List of Tables

Vagus Nerve Stimulators (VNS) – Pipeline Products by Stage of Development 12

Vagus Nerve Stimulators (VNS) – Pipeline Products by Territory 13

Vagus Nerve Stimulators (VNS) – Pipeline Products by Regulatory Path 14

Vagus Nerve Stimulators (VNS) – Pipeline Products by Estimated Approval Date 15

Vagus Nerve Stimulators (VNS) – Ongoing Clinical Trials 16

Vagus Nerve Stimulators (VNS) Companies – Pipeline Products by Stage of Development 17

Vagus Nerve Stimulators (VNS) – Pipeline Products by Stage of Development 19

Adriakaim Inc Pipeline Products & Ongoing Clinical Trials Overview 21

Vagus Nerve Stimulation Device – Product Status 21

Vagus Nerve Stimulation Device – Product Description 21

Afferent Technologies Pipeline Products & Ongoing Clinical Trials Overview 22

WiNerve4 System – Product Status 22

WiNerve4 System – Product Description 22

Aucta Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 23

DECIMA Device – Product Status 23

DECIMA Device – Product Description 23

Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 24

AMT System – Product Status 24

AMT System – Product Description 24

Vagus Nerve Stimulation (VNS) System – Product Status 25

Vagus Nerve Stimulation (VNS) System – Product Description 25

Cala Health Inc Pipeline Products & Ongoing Clinical Trials Overview 26

Wearable Neuromodulation Device – Product Status 26

Wearable Neuromodulation Device – Product Description 26

CerboMed GmbH Pipeline Products & Ongoing Clinical Trials Overview 27

t-VNS – Dementia – Product Status 27

t-VNS – Dementia – Product Description 27

Cyberonics Inc Pipeline Products & Ongoing Clinical Trials Overview 28

Nerve Wrap – Product Status 28

Nerve Wrap – Product Description 28

DuoCure Ltd. Pipeline Products & Ongoing Clinical Trials Overview 29

Intraluminal Implantable Device – Product Status 29

Intraluminal Implantable Device – Product Description 29

ElectroCore Inc Pipeline Products & Ongoing Clinical Trials Overview 30

ElectroCore RMS-1100 Resolution Motility System – Post-Operative Ileus – Product Status 31

ElectroCore RMS-1100 Resolution Motility System – Post-Operative Ileus – Product Description 31

GammaCore – Gastroparesis – Product Status 31

GammaCore – Gastroparesis – Product Description 32

GammaCore – Opioid Use Disorder – Product Status 32

GammaCore – Opioid Use Disorder – Product Description 32

GammaCore – Parkinsonian Gait – Product Status 33

GammaCore – Parkinsonian Gait – Product Description 33

GammaCore – Post-Traumatic Headache – Product Status 33

GammaCore – Post-Traumatic Headache – Product Description 34

GammaCore – Post-Traumatic Stress Disorder – Product Status 34

GammaCore – Post-Traumatic Stress Disorder – Product Description 34

Gammacore – Reactive Airway Disease – Product Status 35

Gammacore – Reactive Airway Disease – Product Description 35

GammaCore – Rheumatoid Arthritis – Product Status 35

GammaCore – Rheumatoid Arthritis – Product Description 36

GammaCore – Sjogren’s Syndrome – Product Status 36

GammaCore – Sjogren’s Syndrome – Product Description 36

GammaCore – Stroke – Product Status 37

GammaCore – Stroke – Product Description 37

GammaCore – Subarachnoid Hemorrhage – Product Status 37

GammaCore – Subarachnoid Hemorrhage – Product Description 38

GammaCore – Traumatic Brain Injury – Product Status 38

GammaCore – Traumatic Brain Injury – Product Description 38

GammaCore – Ulcerative Colitis – Product Status 39

GammaCore – Ulcerative Colitis – Product Description 39

GammaCore Sapphire – Post-Traumatic Headache – Product Status 39

GammaCore Sapphire – Post-Traumatic Headache – Product Description 40

GammaCore Sapphire CV – Product Status 40

GammaCore Sapphire CV – Product Description 40

Resolve Stimulator and Proximity Electrode – Product Status 41

Resolve Stimulator and Proximity Electrode – Product Description 41

ElectroCore Inc – Ongoing Clinical Trials Overview 42

GammaCore – Gastroparesis – Non-invasive Vagal Nerve Stimulation (nVNS) for Symptomatic Exacerbation of Nausea in Patients with Gastroparesis and Related Disorders 43

GammaCore Sapphire CV – A Prospective, Randomized, Controlled Study Assessing Vagus Nerve Stimulation in CoViD-19 Respiratory Symptoms (SAVIORII) 44

GammaCore Sapphire – Post-Traumatic Headache – A Randomized, Multi-center, Double-blind, Sham-controlled Study of GammaCore Sapphire for the Treatment of Patients with Post-traumatic Headache 45

ElectroCore RMS-1100 Resolution Motility System – Post-Operative Ileus – Transcutaneous Vagal Nerve Stimulation to Reduce Ileus: A Feasibility Study (TRANSIT) 46

GammaCore – Post-Traumatic Stress Disorder – Transcutaneous Cervical Vagal Nerve Stimulation in Patients with Posttraumatic Stress Disorder (PTSD): A Pilot Study of Effects on PTSD Symptoms and Interleukin-6 Response to Stress 47

GammaCore – Subarachnoid Hemorrhage – Safety and Efficacy of Non-invasive Vagus Nerve Stimulation in the Treatment of Headache in Subarachnoid Hemorrhage 48

GammaCore – Subarachnoid Hemorrhage – Safety, Feasibility, and Efficacy of Non-invasive Vagus Nerve Stimulation (nVNS) in the Treatment of Aneurysmal Subarachnoid Hemorrhage: STORM 48

GammaCore – Opioid Use Disorder – Non-Invasive Vagal Nerve Stimulation in Opioid Use Disorders 49

GammaCore – Traumatic Brain Injury – Non-Invasive Vagal Nerve Stimulation in Veterans with Mild Traumatic Brain Injury (mTBI) 50

Evren Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 51

Phoenix Earbud Device – Product Status 51

Phoenix Earbud Device – Product Description 51

Flint Rehabilitation Pipeline Products & Ongoing Clinical Trials Overview 52

FitMi VNS System – Product Status 52

FitMi VNS System – Product Description 52

FRD Accel LLC Pipeline Products & Ongoing Clinical Trials Overview 53

BabyStrong TaVNS Bottle Feeding System – Product Status 53

BabyStrong TaVNS Bottle Feeding System – Product Description 53

LivaNova PLC Pipeline Products & Ongoing Clinical Trials Overview 54

Aspire NP – Product Status 54

Aspire NP – Product Description 55

Centro Generator – Product Status 55

Centro Generator – Product Description 55

CentroSR Generator – Product Status 56

CentroSR Generator – Product Description 56

EpiTrace – Product Status 56

EpiTrace – Product Description 56

Equilia – Product Status 57

Equilia – Product Description 57

Griffin – Pulse Generator – Product Status 57

Griffin – Pulse Generator – Product Description 58

Intense Neuromodulation System – Heart Failure – Product Status 58

Intense Neuromodulation System – Heart Failure – Product Description 58

Microburst VNS Stimulator – Product Status 58

Microburst VNS Stimulator – Product Description 59

PhoenixRF SR – Product Status 59

PhoenixRF SR – Product Description 59

VITARIA System – Chronic Heart Failure – Product Status 60

VITARIA System – Chronic Heart Failure – Product Description 60

WaveLink – Product Status 60

WaveLink – Product Description 61

LivaNova PLC – Ongoing Clinical Trials Overview 62

VITARIA System – Chronic Heart Failure – Autonomic Regulation Therapy to Enhance Myocardial Function and Reduce Progression of Heart Failure with Reduced Ejection Fraction 63

Microburst VNS Stimulator – Microburst VNS Therapy Feasibility Study in Subjects with Refractory Epilepsy 64

Medical University of South Carolina Pipeline Products & Ongoing Clinical Trials Overview 65

BabyStrong Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) – Product Status 65

BabyStrong Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) – Product Description 65

Medical University of South Carolina – Ongoing Clinical Trials Overview 66

BabyStrong Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) – BabyStrong taVNS-Paired Bottle Feeding to Improve Oral Feeding 67

MicroTransponder Inc Pipeline Products & Ongoing Clinical Trials Overview 68

SAINT System – Anxiety Disorders – Product Status 68

SAINT System – Anxiety Disorders – Product Description 68

SAINT System – Tinnitus – Product Status 69

SAINT System – Tinnitus – Product Description 69

Serenity System – Product Status 69

Serenity System – Product Description 70

Vivistim Paired VNS System – Product Status 70

Vivistim Paired VNS System – Product Description 71

MicroTransponder Inc – Ongoing Clinical Trials Overview 72

Vivistim Paired VNS System – A Pivotal Randomized Study Assessing Vagus Nerve Stimulation (VNS) During Rehabilitation for Improved Upper Limb Motor Function after Stroke: VNS-REHAB 73

Vivistim Paired VNS System – Vivistim Registry for Paired VNS Therapy (GRASP) 73

Nemechek Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 74

Vitality Smartcable – COVID-19 – Product Status 74

Vitality Smartcable – COVID-19 – Product Description 74

Neuroloop Gmbh Pipeline Products & Ongoing Clinical Trials Overview 75

Neurostimulation System – Product Status 75

Neurostimulation System – Product Description 75

Nexeon MedSystems Inc Pipeline Products & Ongoing Clinical Trials Overview 76

Auricular Vagus Nerve Stimulator – Asthma – Product Status 76

Auricular Vagus Nerve Stimulator – Asthma – Product Description 76

aVNS Device – Product Status 77

aVNS Device – Product Description 77

Vagus Nerve Stimulator – Asthma – Product Status 77

Vagus Nerve Stimulator – Asthma – Product Description 78

Otto Bock HealthCare GmbH Pipeline Products & Ongoing Clinical Trials Overview 79

Neuromodulation Device – Epilepsy – Product Status 79

Neuromodulation Device – Epilepsy – Product Description 79

Neuromodulation Device – Sleep Apnea – Product Status 80

Neuromodulation Device – Sleep Apnea – Product Description 80

Parasym Ltd Pipeline Products & Ongoing Clinical Trials Overview 81

Parasym Device – Product Status 81

Parasym Device – Product Description 81

Parasym Ltd – Ongoing Clinical Trials Overview 82

Parasym Device – Multimodal Investigation of Post COVID-19 in Females: A Pilot Study 83

Parasym Device – Neuromodulation to Regulate Inflammation and Autonomic Imbalance in Sepsis 83

Parasym Device – Non-invasive Vagal Stimulation for Frequent Premature Ventricular Complexes (NoVa-PVC) 83

Parasym Device – The Effect of Different Low-level Tragus Stimulation Parameters on Autonomic Nervous System Function 84

Parasym Device – Tragus Stimulation to Prevent Atrial Fibrillation After Cardiac Surgery: The TraP-AF Study 84

Pulsetto UAB Pipeline Products & Ongoing Clinical Trials Overview 85

Vagus Nerve Stimulator – Product Status 85

Vagus Nerve Stimulator – Product Description 85

Pulsus Medical LLC (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 86

VNS Device – Product Status 86

VNS Device – Product Description 86

Purdue University Pipeline Products & Ongoing Clinical Trials Overview 87

Bionode Device – Product Status 87

Bionode Device – Product Description 87

ReShape Lifesciences Inc Pipeline Products & Ongoing Clinical Trials Overview 88

Diabetes Bloc-Stim Neuromodulation Device – Product Status 88

Diabetes Bloc-Stim Neuromodulation Device – Product Description 88

Setpoint Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 89

Implantable Bioelectronic Device – Product Status 89

Implantable Bioelectronic Device – Product Description 89

Setpoint Medical Corp – Ongoing Clinical Trials Overview 90

Implantable Bioelectronic Device – Long Term Extension Study of the Safety and Efficacy of Neurostimulation Using a Vagus Nerve Stimulation Device in Patients with Rheumatoid Arthritis 91

Implantable Bioelectronic Device – US Pivotal Trial Evaluate the Safety and Efficacy of Bioelectronic Platform in Rheumatoid Arthritis Patients 91

Implantable Bioelectronic Device – Vagus Nerve Stimulation Using the SetPoint System for Moderate to Severe Rheumatoid Arthritis: The RESET-RA Study 91

Soterix Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 92

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Device – Product Status 92

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Device – Product Description 92

Soterix Medical Inc – Ongoing Clinical Trials Overview 93

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Device – Clinical Trial Evaluating the Efficacy of Home-based Auricular Vagus Nerve Stimulation (taVNS) in Post-COVID-19 Subjects 94

SUNY Downstate Medical Center Pipeline Products & Ongoing Clinical Trials Overview 95

Vagus Nerve Stimulator – Ventricular Arrhythmia – Product Status 95

Vagus Nerve Stimulator – Ventricular Arrhythmia – Product Description 95

Synergia Medical SA Pipeline Products & Ongoing Clinical Trials Overview 96

NAO·VNS – Chronic Pain – Product Status 96

NAO·VNS – Chronic Pain – Product Description 96

NAO·VNS – Depression – Product Status 97

NAO·VNS – Depression – Product Description 97

NAO·VNS – Epilepsy – Product Status 97

NAO·VNS – Epilepsy – Product Description 98

NAO·VNS – Parkinson’s Disease – Product Status 98

NAO·VNS – Parkinson’s Disease – Product Description 98

NAO·VNS – Sleep Apnoea – Product Status 99

NAO·VNS – Sleep Apnoea – Product Description 99

SzeleSTIM GmbH Pipeline Products & Ongoing Clinical Trials Overview 100

AuriMod – Product Status 100

AuriMod – Product Description 100

SzeleSTIM GmbH – Ongoing Clinical Trials Overview 101

AuriMod – Personalized Auricular Vagus Nerve Stimulation in Patients with Intractable Chronic Low Back Pain: A Randomized Controlled Pilot Study 102

The Feinstein Institute for Medical Research Pipeline Products & Ongoing Clinical Trials Overview 103

Bioelectronic Medicine Device – Heart Failure – Product Status 103

Bioelectronic Medicine Device – Heart Failure – Product Description 103

Bioelectronic Medicine Device – Lupus – Product Status 104

Bioelectronic Medicine Device – Lupus – Product Description 104

Bioelectronic Medicine Device – Obesity – Product Status 104

Bioelectronic Medicine Device – Obesity – Product Description 105

Bioelectronic Medicine Device – Pulmonary Hypertension – Product Status 105

Bioelectronic Medicine Device – Pulmonary Hypertension – Product Description 105

Neurochip – Product Status 106

Neurochip – Product Description 106

Trifectas Medical Corp. Pipeline Products & Ongoing Clinical Trials Overview 107

Neurostimulation Device – Stroke Recovery – Product Status 107

Neurostimulation Device – Stroke Recovery – Product Description 107

University of Alabama Pipeline Products & Ongoing Clinical Trials Overview 108

VNS Device – Depression – Product Status 108

VNS Device – Depression – Product Description 108

University of Auckland Pipeline Products & Ongoing Clinical Trials Overview 109

Electroceutical Device – Product Status 109

Electroceutical Device – Product Description 109

University of Pittsburgh Pipeline Products & Ongoing Clinical Trials Overview 110

Closed-Loop Neuroelectric Device – Product Status 110

Closed-Loop Neuroelectric Device – Product Description 110

University of Wisconsin Madison Pipeline Products & Ongoing Clinical Trials Overview 111

Implantable Weight-Loss Device – Product Status 111

Implantable Weight-Loss Device – Product Description 111

Glossary 133

List of Figures

Vagus Nerve Stimulators (VNS) – Pipeline Products by Stage of Development 12

Vagus Nerve Stimulators (VNS) – Pipeline Products by Territory 13

Vagus Nerve Stimulators (VNS) – Pipeline Products by Regulatory Path 14

Vagus Nerve Stimulators (VNS) – Pipeline Products by Estimated Approval Date 15

Vagus Nerve Stimulators (VNS) – Ongoing Clinical Trials 16

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