Electrostimulation Devices July 2012

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CHAPTER ONE: EXECUTIVE SUMMARY ..................................................................... 1

Electrostimulation and Neuroprosthetic Technology Introduction ................................... 1
Scope of This Report ............................................................................................................... 3
A Strong Market Foundation ................................................................................................. 4
Future Directions .................................................................................................................... 5
Market Size and Projections .................................................................................................. 6
CHAPTER TWO: INTRODUCTION TO ELECTROSTIMULATION
AND RELATED TECHNOLOGIES ................................................................................... 9
Stimulation Therapeutics for Muscles and Nerves .............................................................. 9
Medical Applications of External Electrode Modalities .................................................... 12
Electrical Stimulation ..................................................................................................... 12
Measurement and Diagnosis........................................................................................... 13
Stimulation by Magnetic Field Pulses ............................................................................ 14
Ultrasonic and Short Wavelength Diathermy ................................................................. 14
Medical Applications of Implanted Electrode Modalities ................................................. 15
Bladder Stimulators ........................................................................................................ 16
Carotid Sinus Nerve Stimulation .................................................................................... 17
Cochlear Implant ............................................................................................................ 17
Deep Brain Stimulation .................................................................................................. 18
Electrical Continence...................................................................................................... 19
Electrical Nerve Stimulation .......................................................................................... 20
Pelvic Floor Stimulation ................................................................................................. 20
Phrenic Nerve Stimulation ............................................................................................. 20
Sacral Nerve Stimulation ................................................................................................ 21
Spinal Cord Stimulation ................................................................................................. 21
Vagus Nerve Stimulation ............................................................................................... 22
Characteristics of the Electrostimulation Market ............................................................. 23
Market Segmentation of Neurostimulation Modalities .................................................. 23
Market Trends and Assumptions ........................................................................................ 24
Competitive Landscape and Issues ...................................................................................... 28
Applicable Industrial and Regulatory Codes .................................................................. 28
Companies in the Electrostimulation Market ................................................................. 30
End-User Segments ............................................................................................................... 33
CHAPTER THREE: EXTERNAL ELECTRICAL STIMULATION DEVICES .......... 35
Introduction ........................................................................................................................... 35
External Electrostimulation Technologies .......................................................................... 37
Bone Growth Stimulation ..................................................................................................... 39
Market Analysis ............................................................................................................. 42
EMS, NMS, TENS ................................................................................................................. 44
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Transcutaneous Electrical Nerve Stimulation (TENS) ................................................... 46

Early Observations of Pain Relief ................................................................................... 46
Physiological Model Theories ........................................................................................ 47
Interferential Current ...................................................................................................... 48
Galvanic Stimulation ...................................................................................................... 48
Electrodes ........................................................................................................................ 48
Market Analysis .............................................................................................................. 49
Ultrasound-Accelerated Fracture Healing .......................................................................... 53
Market Analysis .............................................................................................................. 54
Other Treatments .................................................................................................................. 56
ECT ................................................................................................................................. 56
TMS and rTMS ............................................................................................................... 57
Market Forecasts for Electrostimulation With External Electrodes ................................ 61
CHAPTER FOUR: IMPLANTED ELECTRICAL AND NEUROLOGICAL
STIMULATION DEVICES ................................................................................................. 67
Introduction ........................................................................................................................... 67
Types of Implanted Electrode Systems ................................................................................ 68
Implanted Bone Growth Stimulators................................................................................... 68
Market Analysis .............................................................................................................. 69
Cardiac Rhythm Management ............................................................................................. 72
Cardiac Resynchronization Therapy ............................................................................... 72
Implantable Cardiac Pacemakers .................................................................................... 72
Implantable Cardioverter-Defibrillators.......................................................................... 73
Market Analysis .............................................................................................................. 73
Spinal Cord Stimulation (SCS)............................................................................................. 77
Basic Implementation ..................................................................................................... 77
SCS vs TENS in Pain Relief ........................................................................................... 77
Cost-Benefit Analysis of SCS ......................................................................................... 78
Market Analysis .............................................................................................................. 78
Sacral Nerve Stimulation (SNS) ........................................................................................... 82
Control of Urinary Incontinence ..................................................................................... 82
Control of Fecal Incontinence ......................................................................................... 82
Market Analysis .............................................................................................................. 83
Vagus Nerve Stimulation (VNS) ........................................................................................... 86
Seizure Control in Epilepsy ............................................................................................ 86
Treatment of Depression ................................................................................................. 87
Market Analysis .............................................................................................................. 87
Deep Brain Stimulation (DBS) ............................................................................................. 91
Treatment of Neurological Movement Disorders ........................................................... 91
Market Analysis .............................................................................................................. 92
Gastric Electrical Stimulation (GES) ................................................................................... 96
Market Analysis .............................................................................................................. 96
Market Analysis for Implanted Electrical and Neurological Stimulation Devices ........ 100

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Table of Contents

CHAPTER FIVE: INDUSTRY TRENDS AND ISSUES ................................................ 105

New Innovations ................................................................................................................. 105
Brain Stimulation ......................................................................................................... 105
Obstructive Sleep Apnea .............................................................................................. 106
Neurostim and Obesity ................................................................................................. 107
Implantable Therapy for Resistant Hypertension ........................................................ 108
Pain Therapy................................................................................................................. 109
Epilepsy ........................................................................................................................ 110
New Developments and Alternative Technologies ........................................................... 110
Magnetic Stimulation ................................................................................................... 110
Transcranial Magnetic Stimulation (TMS)................................................................... 111
Neuroprosthetics ........................................................................................................... 116
Cochlear Implants......................................................................................................... 121
Retinal Implants ........................................................................................................... 122
Neurostimulation for Depression ....................................................................................... 123
The NeuronSilicon Interface ............................................................................................ 124
Physiology of EMS Applications ........................................................................................ 125
Endurance Training by Increased Oxygen Supply ....................................................... 125
Muscle Recovery via Increased Blood Flow ................................................................ 126
Muscle Diagnostics with Electromyography..................................................................... 126
Uncertainties in Electrostimulation Business Development Management..................... 127
future advancements ........................................................................................................... 130
new technology challenges .................................................................................................. 132
CHAPTER SIX: MARKET SUMMARY ......................................................................... 133
Total Market Overview ...................................................................................................... 133
Geographical Market Analysis .......................................................................................... 138
CHAPTER SEVEN: COMPANY PROFILES, PRODUCTS,
AND STRATEGIES........................................................................................................... 143
Amrex Electrotherapy Equipment (Division of Amrex-Zetron)..................................... 148
Biomet, Inc. .......................................................................................................................... 149
Bioness, Inc. ......................................................................................................................... 151
Boston Scientific, Inc ........................................................................................................... 152
Cyberonics, INC .................................................................................................................. 155
Delsys, INC .......................................................................................................................... 157
DJO International ............................................................................................................... 158
Dynatronics Corporation.................................................................................................... 161
Electromedical Products International (EPI) ................................................................... 163
Magstim Company, Ltd. ..................................................................................................... 164
MedFaxx, INC ..................................................................................................................... 166
Medtronic, INC ................................................................................................................... 167
Multi radiance Medical, Inc ............................................................................................... 170
Neuronetics, Inc ................................................................................................................... 171
Noraxon USA, Inc ............................................................................................................... 173
Orthofix International NV ................................................................................................. 175
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Prizm Medical, Inc............................................................................................................... 177

Rich-Mar Corporation ........................................................................................................ 178
RS Medical ........................................................................................................................... 179
Smith & Nephew .................................................................................................................. 181
Somatics, LLC ...................................................................................................................... 183
ST Jude Medical, Inc. .......................................................................................................... 184
Thought Technology Ltd. .................................................................................................... 187
APPENDIX: COMPANY DIRECTORY .......................................................................... 188

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Table of Contents

vii
L

CHAPTER ONE: EXECUTIVE SUMMARY

Summary Table: Electrical and Neurostimulation Equipment/Device Market
by Application Method, 2010-2017.........................................................................................7
Summary Figure: Electrical and Neurostimulation Equipment/Device Market by
Application Method, 2010-2017.. 8
CHAPTER TWO: INTRODUCTION TO ELECTROSTIMULATION AND RELATED
TECHNOLOGIES
Table 2-1: Energy/Radiation Stimulation Medical Electronics Products.11
Table 2-2: Implanted Electrode Stimulation Technologies....16
Table 2-3: Market Drivers Impacting Electrostimulation Equipment Sales26
Table 2-4: Market Restraints Limiting Electrostimulation Equipment Sales..26
Table 2-5: Standard Industrial Codes (SIC) for Electrical/Magnetic Stimulation
Equipment29
Table 2-6: North American Industry Classification System (NAICS)
Codes for Electrical/Magnetic Stimulation Equipment...29
Table 2-7: Major Players by Segment,
2012... .32
Table 2-8: US Healthcare Practitioners by Occupation Title, 2010.33
CHAPTER THREE: EXTERNAL ELECTRICAL STIMULATION DEVICES
Table 3-1: Electrode Stimulation Modalities with External Electrodes Type
and Description...36
Table 3-2The World Market for External Bone Growth Stimulation Devices 2010-2017
......43
Figure 3-1: The World Market for External Bone Growth Stimulation Devices 2010-2017
...44
Table 3-3: TENS and EMS Stimulation Mode........................................................46
Table 3-4: The World Market for TENS and EMS Devices 2010-2017....51
Figure 3-2: The World Market for TENS and EMS Devices 2010-2017...52
Table 3-5: The World Market for Ultrasound-Accelerated Fracture
Healing Systems 2010-2017...55
Figure 3-3: The World Market for Ultrasound-Accelerated Fracture Healing
Systems 2010-2017..56
Table 3-6: The World Market for Other External Electrostimulation Devices 20102017....59

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Figure 3-4: The World Market for Other External Electrostimulation

Devices 2010-2017................................................................................................60
Table 3-7: External Electrostimulation Device Market by Product Type 20102017........62
Figure 3-5: External Electrostimulation Device Market by Product Type 2010201763
Figure 3-6: External Electrostimulation Device Market by Product Type
2012 and 2017......64
CHAPTER FOUR:IMPLANTED ELECTRICAL AND NEUROLOGICAL
STIMULATION DEVICES
Table 4-1: The World Market for Implantable Bone Growth Stimulation
Devices 2010-2017..70
Figure 4-1: The World Market for Implantable Bone Growth Stimulation
Devices 2010-2017...71
Table 4-2: The World Market for Implantable Cardiac Rhythm Management
Devices 2010-2017...75
Figure 4-1: The World Market for Implantable Cardiac Rhythm Management
Devices 2010-2017.76
Table 4-3: The World Market for Spinal Cord Stimulation Devices 2010-201780
Figure 4-2: The World Market for Spinal Cord Stimulation Devices 2010-2017...81
Table 4-4: The World Market for Sacral Nerve Stimulation Devices 2010-201784
Figure 4-3: The World Market for Sacral Nerve Stimulation Devices 2010-2017\.....................85
Table 4-5: The World Market for Vagus Nerve Stimulation Devices 2010-201789
Figure 4-4: The World Market for Vagus Nerve Stimulation Devices 2010-2017...90
Table 4-6: The World Market for Deep Brain Stimulation Devices 2010-2017...94
Figure 4-5: The World Market for Deep Brain Stimulation Devices 2010-2017.95
Table 4-7: The World Market for Gastric Electrical Stimulation Devices 2010-201798
Figure 4-6: The World Market for Gastric Electrical Stimulation Devices 2010-2017...99
Table 4-8: Implantable Electrical and Neurological Stimulation
Market by Product Segment 2010-2017..101
Figure 4-7: Implantable Electrical and Neurological Stimulation Market by
Product Segment 2010-2017.102
Figure 4-8: Implantable Electrical and Neurological Stimulation Market by
Product Segment 2012 and 2017.103
CHAPTER SIX: MARKET SUMMARY
Table 6-1: Electrical and Neurostimulation Equipment/Device Market by
Application Method, 2010-2017135
Figure 6-1: Electrical and Neurostimulation Equipment/Device Market by
Application Method, 2010-2017136
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Figure 6-2: Electrical and Neurostimulation Equipment/Device Market by

Application Method, 2012 and 2017 .............................................................................. 137
Table 6-2: Electrical and Neurostimulation Equipment/Device Market
Estimated Sales by Geographic Region 2010-2017 ...................................................... 139
Figure 6-4: Electrical and Neurostimulation Equipment/Device Market
Estimated Sales by Geographic Region 2010-2017 ...................................................... 140
Figure 6-5: Electrical and Neurostimulation Equipment/Device Market
Estimated Sales by Geographic Region 2012 and 2017 ................................................ 141

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Chapter Two: Introduction to Electrostimulation and Related Technologies

13

stimulation by controlling voltage, current, and pulse width (duration) of each pulse.
Hundreds of clinical reports have confirmed the efficacy of TENS for various types
of conditions such as low back pain, myofascial and arthritic pain, sympathetically
mediated pain, bladder incontinence, neurogenic pain, visceral pain, and postsurgical
pain. Despite an ongoing controversy about the degree to which TENS is more
effective than placebo in reducing pain, the market for TENS equipment continues to
grow.
Electromuscular stimulation (EMS) of muscle tissue can aid in the
recuperation of overworked muscles. Electrostimulation of nerves and muscles has
also proven useful in rehabilitation from stroke or injury to the spinal cord. Neural
prosthetics, programmed electrostimulation aided by computer signal processing,
offers promise for amputees and the blind.
There are few complications or side effects associated with the use of most
external electrode neurostimulation units, such as TENS or EMS devices. The
demand for more product sales will continue from patients who have found these
modalities effective in reducing pain from arthritis and back pain or those with tight
muscles. These products are also popular with patients because of their ease of
operation and low costs.
Measurement and Diagnosis
Physicians rely on electromyography (EMG) to study patients with muscle
weakness. EMG helps to distinguish between muscle conditions in which the problem
begins in the muscle and muscle weakness due to nerve disorders. The two types of
EMG are intramuscular EMG and surface EMG. Intramuscular EMG involves
inserting a needle electrode through the skin into the muscle. Surface EMG involves
placing the electrodes on the skin above the muscle. The method evaluates evoked
responses to external stimuli.
Neurologists use electroencephalography (EEG) to characterize the actions of
the brain. Electrodes are placed at several points on the scalp to detect and record
patterns of electrical activity and check for abnormalities in the brain. The electrodes
are connected to a recording device. EEG can diagnose the presence and type of
seizure disorders and evaluate head injuries, tumors, and degenerative diseases. Both
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Chapter Three: External Electrical Stimulation Devices

43

Table 3-2

The World Market for External Bone Growth Stimulation Devices

2010-2017

REVENUES (IN
MILLIONS)

Year
2010
2011
2012
2013
2014
2015
2016
2017

Percent
Change

Compound Annual Growth Rate

Period
2010-2012
2012-2017
2010-2017

CAGR

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BrainGate offers a systems approach which applies the language of neurons in

both short and long-term settings. The platform technology is based on the results of
several years of research and development at premier academic institutions such as
Brown University, the Massachusetts Institute of Technology, Emory University, and
the University of Utah. By using the BrainGate Neural Interface System, a person
may be able to use his thoughts to control cursor motion and/or replicate keystrokes
on a computer screen. In another example, a doctor may study patterns of brain
electrical activity in patients with epilepsy before, during and after seizures.
Reclaim DBS offered by Medtronic is an adjustable, reversible and non-drug
therapy that uses a surgically implanted medical device, similar to a pacemaker, to
deliver carefully controlled electrical pulses to precisely targeted areas of the brain.
The stimulation can be programmed and adjusted non-invasively by a trained
clinician to find the most appropriate type and amount of stimulation for each patient
to maximize symptom control and minimize side effects. The neurostimulators used
for Reclaim DBS are the same as those used to treat common movement disorders
like Parkinsons disease. However, because the area of the brain targeted is different,
a unique DBS lead was specially designed. For OCD and treatment-resistant
depression, the anatomical target in the brain is the anterior limb of the internal
capsule (AIC), and more specifically, a region sometimes referred to as the ventral
capsule/ventral striatum (VC/VS), which is a central node in the neural circuits
believed to regulate mood and anxiety.
Obstructive Sleep Apnea
Apnex Medical is involved in the development of the Apnex Hypoglossal
Nerve Stimulation (HGNS) System for the treatment of obstructive sleep apnea
(OSA). The system is designed to activate the muscles in the upper airway to ensure
the airway remains open during sleep. The system monitors the individuals breathing
patterns and delivers mild stimulation to the hypoglossal nerve, which controls the
muscles of the tongue to keep the airway open. The product is currently listed as an
investigational implantable therapy.

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