Emerging Bioelectronic Medicine & Neurostimulation Technologies: Growing & Disrupting Global Medical Device Markets

Companies Covered

Abbott Laboratories (St. Jude Medical)

Aleva Neurotherapeutics 

Alfred Mann Foundation

Atrotech Oy 

Autonomic Technologies

Avery Biomedical 

Axonics Modulation Technologies

BioControl Medical

BioElectronics Corporation 

Bioinduction/Finetech Medical

Bioness 

Bionic Enterprises

BlueWind Medical 

Boston Scientific Corporation 

BrainsWay 

Burke Medical Research Institute

Cala Health 

Cardionomic 

Cephaly Technology (STX-Med)

Cerbomed GmbH

CerebralRx

Clinatec

Cogentix Medical 

CorTec/Wyss Center 

CVRx 

Deep Brain Innovations 

Defense Advanced Research Projects Agency

electroCore

Endonovo Therapeutics

EndoStim

eNeura

Enopace Medical 

Feinstein Institute for Medical Research (Northwell Health)

FemPulse LLC

Functional Neuromodulation 

Galvani Bioelectronics

Hanger 

Hobart Group (Lavita, MetaCure, Renal Dynamics, Impulse Dynamics)

Innovative Health Solutions

Inspire Medical Systems

IntraPace

Laboratoire MXM (Axonic Neuromodulation Systems)

LivaNova (Cyberonics, ImThera)

MagVenture 

Mainstay Medical

Medtronic 

Micro Transponder

Neurolief 

NeuroMetrix 

Neuronetics 

Neuronix

NeuroPace 

NeuroSigmaNeuros Medical

NeuroTech International Ltd./AAT Research Ltd.

NeuroTronik

Nevro 

Nexeon Medsystems/Nuviant Medical

Nuvectra 

Ottobock

(Beijing) PINS Medical 

ReShape Lifesciences (EnteroMedics)

Respicardia 

Saluda Medical 

Sanguistat

SceneRay 

Scion NeuroStim 

SetPoint Medical 

SPR Therapeutics

Stimwave

Synapse Biomedical 

Tal Medical 

CHUs Jean Monnet &Saint Etienne/Life Medical Control/NBA Techno

University of California Berkeley

Table of Contents

EXECUTIVE SUMMARY 

Markets by Clinical Application

Markets by Geography 

Suppliers 

Summary Exhibit 1: Global Markets by Approach and Clinical Application, 2016-2022  

Summary Exhibit 2: Global Market for Neurostimulation Technologies by Major Geography, 2016-2022 

Summary Exhibit 3: Global Biomedical Electronic and Neurostimulation Devices Market, Estimated Supplier Shares, 2017

1.0 BACKGROUND ON BIOELECTRONIC MEDICINE & NEUROSTIMULATION 

1.1 The Beginning: Cardiac Rhythm Management 

1.1.1 Pacemakers: Overwriting Abnormal Electrical Activity of the Heart 

1.1.2 High Power CRM Devices

1.1.3 External CRM Devices: Saving Lives Outside of Hospitals

1.1.4 Arrhythmia Ablation: Isolating Parasitic Conduction Pathways 

1.2 Expanding Technologies & Applications: Neuromodulation 

1.2.1 Spinal Cord Stimulation 

1.2.2 Deep Brain Stimulation 

1.2.3 Sacral Nerve Modulation 

1.2.4 Vagus Nerve Stimulation 

1.2.5 New and Emerging Neurostimulation Targets

Exhibit 1-1: Overview of Cardiac Rhythm Management (CRM) Products 

Exhibit 1-2 Overview of Selected Neurostimulation Technologies and Applications

2.0 VAGUS NERVE AND NATIVE HOMEOSTASIS MECHANISM

2.1 Overview of Native Homeostasis Mechanism

2.1.1 Parameters Monitored 

2.1.1.1 Core Temperature 

2.1.1.2 Blood Glucose 

2.1.1.3 Blood Calcium, Sodium, Potassium and Iron

2.1.1.4 Blood Oxygen, CO2 Saturation, pH 

2.1.1.5 Arterial Blood Pressure, Heart Rate, Respiration

2.1.2 Homeostatic Failures

2.2 Main Components of Homeostasis Mechanism 

2.2.1 Cell Signaling 

2.2.1.1 Neurotransmitters

2.2.1.2 Cell Receptors

2.2.2 Endocrinal Signaling Features

2.2.2.1 Hormones 

2.2.2.2 Cytokines and Other Components 

2.3 Vagus Nerve Functional Anatomy and Role in Homeostasis Processes 

2.3.1 Functional Anatomy 

2.3.2 Role in Homeostasis Process 

2.4 Challenges and Limitations

Exhibit 2-1: Schematic of Basic Native Homeostasis System

Exhibit 2-2: Key Parameters Monitored by Homeostasis Mechanism

Exhibit 2-3: Major Components of Homeostasis Mechanism

Exhibit 2-4: Anatomy of a Neuron

Exhibit 2-5: Schematic of Signaling Process

Exhibit 2-6: Components, Functions, and Peripheral Distribution of Vagus Nerve Fibers

3.0 NEUROSTIMULATION TARGETED CLINICAL APPLICATIONS

3.1 Inflammatory Conditions 

3.1.1 Rheumatoid Arthritis

3.1.2 Inflammatory Bowel Disease 

3.1.3 Multiple Sclerosis

3.2 Neurological Diseases

3.2.1 Refractory Epilepsy

3.2.2 Cluster Headaches 

3.2.3 Migraine

3.2.4 Chronic Depression

3.2.5 Post-Traumatic Stress Disorder

3.2.6 Ischemic Stroke 

3.2.7 Neurodegenerative Disorders 

3.2.7.1 Parkinson's Disease

3.2.7.2 Essential Tremor 

3.2.7.3 Alzheimers 

3.2.7.4 Amyotrophic Lateral Sclerosis (ALS)

3.3 Hematologic Conditions 

3.3.1 Postpartum Hemorrhage

3.3.2 Hemophilia

3.4 Metabolic Conditions

3.4.1 Obesity 

3.4.2 Type 2 Diabetes

3.5 Cardiology Conditions: Heart Failure

3.6 Sleep Apnea 

3.6.1 Obstructive Sleep Apnea (OSA)

3.6.1 Central Sleep Apnea (CSA) 

3.7 Urological Conditions

3.7.1 Urinary Incontinence

3.7.2 Overactive Bladder (OAB) 

3.8 Other Targeted Applications

Exhibit 3-1: Overview of Selected Inflammatory Conditions Potentially Amenable to VNS Therapy  

Exhibit 3-2: Incidence of Inflammatory Bowel Disease for Selected Nations 

Exhibit 3-3 : Prevalence of Inflammatory Bowel Disease by Geography, 2015 

Exhibit 3-4: Global Distribution of Multiple Sclerosis, 2017 

Exhibit 3-5: Overview of Selected Neurological Conditions Potentially Amenable to Neurostimulation Therapy 

Exhibit 3-6: Distribution of Depression by Geography, Age and Sex, 2015  

Exhibit 3-7: Current and Forecast Prevalence of Alzheimer's, 2015-2050 

Exhibit 3-8: Growth in Prevalence of Amyotrophic Lateral Sclerosis, 2015 – 2040 

Exhibit 3-9: Overview of Selected Hematologic Conditions Potentially Amenable to Neurostimulation Therapy  

Exhibit 3-10: Overview of Selected Metabolic Conditions Potentially Amenable to Neurostimulation Therapy  

Exhibit 3-11: Adult Obesity as Share of Population, 2012 or Most Recent Year 

Exhibit 3-12: Global Population 20-79 with Diabetes, 2017 and 2045 

Exhibit 3-13: Overview of Heart Failure 

Exhibit 3-14: Overview of Sleep Apnea Potentially Amenable to Neurostimulation Therapy  

Exhibit 3-15: Overview of Urological Conditions Potentially Amenable to Neurostimulation Therapy 

Exhibit 3-16: Other Clinical Applications Potentially Amenable to Neurostimulation Therapy

4.0 PRODUCTS AND TECHNOLOGIES 

4.1 Neurological Conditions 

4.1.1 Drug Refractory Epilepsy 

4.1.1.1 Bionic Enterprises

4.1.1.2 Cerbomed 

4.1.1.3 CerebralRX 

4.1.1.4 LivaNova 

4.1.1.5 NeuroPace 

4.1.1.6 NeuroSigma

4.1.1.7 PINS Medical

4.1.2 Drug Resistant Depression 

4.1.2.1 BrainsWay

4.1.2.2 Cerbomed 

4.1.2.3 CerebralRx

4.1.2.4 Endonova Therapeutics 

4.1.2.5 LivaNova

4.1.2.6 MagVenture 

4.1.2.7 Neuronetics 

4.1.2.8 Tal Medical 

4.1.3 Migraine/Cluster Headache

4.1.3.1 Automomic Technologies 

4.1.3.2 Cephaly Technology 

4.1.3.3 Cerbomed

4.1.3.4 electroCore 

4.1.3.5 eNeura 

4.1.3.6 Scion NeuroStim 

4.1.4 Neurodegenerative Disorders

4.1.4.1 Aleva Neurotherapeutics

4.1.4.2 Bioinduction 

4.1.4.3 Functional Neuromodulation

4.1.4.4 Neuronix 

4.1.5 Stroke, Spinal Cord Injury and Limb Loss 

4.1.5.1 Bioness

4.1.5.2 Finetech Medical 

4.1.5.3 Hanger 

4.1.5.4 MicroTransponder 

4.1.5.5 Ottobock 

4.1.5.6 Massachusetts General Hospital 

4.1.5.7 Sheffield Teaching Hospital 

4.2 Chronic Pain (ex Headache)

4.2.1 BioElectronic Corporation 

4.2.2 BlueWind Medical

4.2.3 Cerbomed

4.2.4 Mainstay Medical

4.2.5 NeuroMetrix 

4.2.6 Nevro 

4.2.7 Saluda Medical

4.2.8 SPR Therapeutics

4.2.9 Stimwave

4.3 Autoimmune Inflammatory Conditions (SetPoint Medical)

4.3.1 Rheumatoid Arthritis

4.3.2 Crohn's Disease 

4.4 Hematologic Disorders (Sanguistat)

4.5 Metabolic Disorders: Obesity

4.5.1 University of Saint Etienne Medical Center 

4.5.2 Federal University of São Paulo 

4.6 Cardiovascular Disorders: Heart Failure

4.6.1 BioControl Medical 

4.6.2 Cardionomic 

4.6.3 CVRx

4.6.4 Enopace Medical 

4.6.5 Impulse Dynamics

4.6.6 LivaNova

4.6.7 Oklahoma State University Health Sciences Center

4.7 Urologic Disorders

4.7.1 Axonics Modulation Technologies

4.7.2 BlueWind Medical 

4.7.3 Cogentix Medical

4.7.4 FemPulse LLC 

4.8 Sleep Disorders 

4.8.1 Inspire Medical

4.8.2 LivaNova/ImThera Medical 

4.8.3 Respicardia 

4.9 Hearing Disorders: Chronic Tinnitus

4.9.1 CorTec/Wyss Center

4.9.2 MicroTransponder 

4.10 Gastrointestinal Disorders: GERD 

4.11 Breathing Disorders: Respiratory Insufficiency 

4.12 Opioid Withdrawal Symptoms 

4.13 Autism 

Exhibit 4-1: Current & Emerging Bioelectronic Medicine and Neurostimulation By Clinical Application

5.0 MARKETS BY APPROACH AND CLINICAL APPLICATION

5.1 Neurological Disorders

5.1.1 Parkinson's/Essential Tremor/Alzheimer's (Deep Brain Stimulation) 

5.1.2 Drug-Refractory Epilepsy 

5.1.3 Major Depressive Disorder 

5.1.4 Migraine/Cluster Headache

5.1.5 Post-Stroke Mobility

5.2 Hematologic Disorders (Post-Partum Hemorrhage) 

5.3 AutoImmune Inflammatory Disorders

5.4 Chronic Widespread Pain

5.5 Cardiovascular Disorders (Heart Failure)

5.6 Incontinence

5.7 Sleep Apnea 

5.8 Respiratory Insufficiency (Diaphragm Pacing) 

5.9 Other Disorders

Exhibit 5-1: Global Markets by Approach and Clinical Application, 2016-2022 

Exhibit 5-2: Market for Technologies Targeting Neurological Disorders, 2016-2022

Exhibit 5-3: Global Market for Deep Brain Stimulation Technologies by Approach, 2016-2022

Exhibit 5-4: Global Deep Brain Stimulation Market, Estimated Supplier Shares, 2017

Exhibit 5-5: Global Market for Technologies Targeting Drug-Refractory Epilepsy by Approach, 2016-2022 

Exhibit 5-6: Global Drug Refractory Epilepsy Neurostimulation Devices Market, Estimated Supplier Shares, 2017

Exhibit 5-7: Global Market for Technologies Targeting Major Depressive Disorders by Approach, 2016-2022 

Exhibit 5-8: Global Major Depressive Disorder Neurostimulation Devices Market, Estimated Supplier Shares, 2017 

Exhibit 5-9: Global Market for Technologies Targeting Migraine and Cluster Headache, 2016-2022

Exhibit 5-10: Global Migraine/Cluster Headache Noninvasive VNS Therapies Market, Estimated Supplier Shares, 2017

Exhibit 5-11: Global Market for Technologies Targeting Post-Stroke Mobility, 2016-2022 

Exhibit 5-12: Global Post-Stroke Mobility Therapy Devices Market, Estimated Supplier Shares, 2017 

Exhibit 5-13: Global Market for Technologies Targeting Hematological Disorders, 2016-2022 

Exhibit 5-14: Global Market for Technologies Targeting Autoimmune Disorders, 2016-2022

Exhibit 5-15: Global Market for Technologies Targeting Chronic Widespread Pain, 2016-2022

Exhibit 5-16: Global Chronic Pain Market, Estimated Supplier Shares, 2017 

Exhibit 5-17: Global Market for Technologies Targeting Heart Failure, 2016-2022 

Exhibit 5-18: Global Heart Failure Market, Estimated Supplier Shares, 2017 

Exhibit 5-19: Global Market for Technologies Targeting Incontinence, 2016-2022 

Exhibit 5-20: Global Incontinence Market, Estimated Supplier Shares, 2017 

Exhibit 5-21: Global Market for Technologies Targeting Sleep Apnea, 2016-2022 

Exhibit 5-22: Global Sleep Apnea Market, Estimated Supplier Shares, 2017

Exhibit 5-23: Global Market for Diaphragm Pacing Technologies, 2016-2022 

Exhibit 5-24: Global Diaphragm Pacing Market, Estimated Supplier Shares, 2017 

Exhibit 5-25: Global Market for Other Neurostimulation Technologies, 2016-2022 

6.0 MARKETS BY MAJOR GEOGRAPHY

6.1 United States

6.2 Major Europe 

6.3 Major Asia

6.4 Rest of World

Exhibit 6-1: Global Market for Neurostimulation Technologies by Major Geography, 2016-2022 

Exhibit 6-2: U.S. Market for Neurostimulation Technologies by Clinical Application, 2016-2022

Exhibit 6-3: Major Europe Market for Neurostimulation Technologies by Clinical Application, 2016-2022

Exhibit 6-4: Major Asia Market for Neurostimulation Technologies by Clinical Application, 2016-2022  

Exhibit 6-5: Rest-of-World Market for Neurostimulation Technologies by Clinical Application, 2016-2022

7.0 COMPANY PROFILES 

7.1 Abbott Laboratories (St. Jude Medical)

7.2 Aleva Neurotherapeutics 

7.3 Alfred Mann Foundation

7.4 Atrotech Oy 

7.5 Autonomic Technologies

7.6 Avery Biomedical 

7.7 Axonics Modulation Technologies

7.8 BioControl Medical

7.9 BioElectronics Corporation 

7.10 Bioinduction/Finetech Medical

7.11 Bioness 

7.12 Bionic Enterprises

7.13 BlueWind Medical 

7.14 Boston Scientific Corporation 

7.15 BrainsWay 

7.16 Burke Medical Research Institute

7.17 Cala Health 

7.18 Cardionomic 

7.19 Cephaly Technology (STX-Med)

7.20 Cerbomed GmbH

7.21 CerebralRx

7.22 Clinatec

7.23 Cogentix Medical 

7.24 CorTec/Wyss Center 

7.25 CVRx 

7.26 Deep Brain Innovations 

7.27 Defense Advanced Research Projects Agency

7.28 electroCore

7.29 Endonovo Therapeutics

7.30 EndoStim

7.31 eNeura

7.32 Enopace Medical 

7.33 Feinstein Institute for Medical Research (Northwell Health)

7.34 FemPulse LLC

7.35 Functional Neuromodulation 

7.36 Galvani Bioelectronics

7.37 Hanger 

7.38 Hobart Group (Lavita, MetaCure, Renal Dynamics, Impulse Dynamics)

7.39 Innovative Health Solutions

7.40 Inspire Medical Systems

7.41 IntraPace

7.42 Laboratoire MXM (Axonic Neuromodulation Systems)

7.43 LivaNova (Cyberonics, ImThera)

7.44 MagVenture 

7.45 Mainstay Medical

7.46 Medtronic 

7.47 Micro Transponder

7.48 Neurolief 

7.49 NeuroMetrix 

7.50 Neuronetics 

7.51 Neuronix

7.52 NeuroPace 

7.53 NeuroSigma

7.54 Neuros Medical

7.55 NeuroTech International Ltd./AAT Research Ltd.

7.56 NeuroTronik

7.57 Nevro 

7.58 Nexeon Medsystems/Nuviant Medical

7.59 Nuvectra 

7.60 Ottobock

7.61 (Beijing) PINS Medical 

7.62 ReShape Lifesciences (EnteroMedics)

7.63 Respicardia 

7.64 Saluda Medical 

7.65 Sanguistat

7.66 SceneRay 

7.67 Scion NeuroStim 

7.68 SetPoint Medical 

7.69 SPR Therapeutics

7.70 Stimwave

7.71 Synapse Biomedical 

7.72 Tal Medical 

7.73 CHUs Jean Monnet &Saint Etienne/Life Medical Control/NBA Techno

7.74 University of California Berkeley