Neuromodulation Industry Report - Medical Alley PDF

SECTOR LANDSCAPES: NEUROMODULATION
Copyright 2015 by LifeScience Alley. All rights reserved.
About Sector Landscapes Publications

The Sector Landscapes provide in depth analysis of emerging and established industry
sectors in Minnesota. The reports highlight global industry insights, Minnesota core and
supporting assets, unique positioning, company lists, and industry trends. Identified sector
areas include: neuromodulation, cardiac active implantables, tissue based products,
research tools, animal health, diagnostics, vascular technologies, and digital health.
List of Contributors
PLEASE DIRECT CORRESPONDENCE TO:
Cheryl Matter, PhD, Vice President of Intelligence & Research, LifeScience Alley
cmatter@lifesciencealley.org | 952.746.3817
Anastasia N. Zink, PhD Candidate, Graduate Program in Neuroscience, UMN

Research Lead
Amanda K. Weber, LifeScience Alley Design Consultant

Visualization + Design
LifeScience Alley's intelligence and research work is generously supported by our

Foundational and Sustaining Members.
Foundational Members
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About LifeScience Alley

LifeScience Alley is a global leader in enabling health technology and care organizations
to innovate, succeed, and influence the evolution of healthcare. By influencing policy,
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EXECUTIVE SUMMARY
Three Minnesota companies were awarded their The global

first Premarket Approval (PMA) or Humanitarian market for
Device Exemption (HDE) approval from the FDA neuromodulation
for neuromodulation devices between June 2014 devices is strong
and January 2015. Activity in the state spans all and projected
major target regions of the nervous system: brain,
to double by
spine, and periphery. The Minnesota medical
2018, reaching
device ecosystem is tailored for active implantable
$6-7 billion.1,2
technology and electrotherapeutics. Technical
Minnesota-based
expertise is available for all stages of a products
Medtronic and
life-cycle, including pre-clinical research, product
St. Jude Medical
development, and commercialization. The Mayo
Clinic and University of Minnesota are leading
account for 72%
research institutions that attract world-class scien- of worldwide
tists and clinicians. Both institutions invest compet- sales.3 (See
itively in active programming to engage industry page 5 for an in
partnerships and promote technology commercial- depth look into
ization. Minnesotas early and continued foothold neuromodulation
in the medical device industry provides a mature revenue.)
foundation, open for innovation and entrepre-
neurship in neuromodulation.
KEY FINDINGS
+ 27 companies with major operations in Minnesota with more than 40
FDA-registered neuromodulation devices.
+ 42 companies providing products and services.
+ 25+ research and clinical centers for neuromodulation and related

expertise.
+ $1 billion in federal research funding and life science investments in

2014.4,5
+ Minnesota is ranked 1st in US for: electromedical manufacturing

employment;6 medical device patents;7 and PMA / 510(k) awards from
FDA for complex neurological devices.8
[1] GLOBAL OVERVIEW OF NEUROMODULATION
1
INDUSTRY
A fast growing segment of healthcare is the neuromodulation industry
MARKET 3
DEVICES 4
INDICATIONS 6
MAJOR PLAYERS 8
[2] NEUROMODULATION IN MINNESOTA 10
The Neuromodulation Industry has a strong history in Minnesota and

currently boasts 28 companies with more than 40 stimulation systems.
OVERVIEW OF MINNESOTA INDUSTRY 13
IMPLANTABLE & MINIMALLY INVASIVE SYSTEMS 15
NON-SURGICAL STIMULATION SYSTEMS 17
SUPPORTING ENTERPRISE 18
SUPPORTING INFRASTRUCTURE 19
[3] FUTURE FORECAST OF NEUROMODULATION

21
INDUSTRY IN MINNESOTA
EMERGING TECHNOLOGY 22
UNMET NEEDS 23
MARKET CLIMATE 24
CONCLUDING SUMMARY 24
ACKNOWLEDGEMENTS 25
[4] NEUROMODULATION RESOURCES DIRECTORY 27
[5] CLINICAL, SURGICAL, RESEARCH & BUSINESS

36
DIRECTORY
LIST OF FIGURES
FDA Neuromodulation Trials Open Worldwide

FIGURE 1. 2
by Subsector
FIGURE 2. Global Locations of Major Neuromodulation Companies 5
FIGURE 3. Neuromodulation Global Revenue Fiscal Year 2013 5
FIGURE 4. Indications Approved and Under Investigation 7
FIGURE 5. Minnesota Companies by Anatomical Target 11
Cumulative Growth of Neurosurgery & Neuromodulation

FIGURE 6. 14
in Minnesota
1. GLOBAL
OVERVIEW OF
NEUROMODULATION
INDUSTRY
2
Section # | Text
FIGURE 1. FDA NEUROMODULATION TRIALS OPEN WORLDWIDE BY SUBSECTOR
BRAIN: TRANSCRANIAL ELECTRICAL STIMULATION // 9%

BRAIN: DEEP BRAIN STIMULATION // 16%
BRAIN: TRANSCRANIAL MAGNETIC STIMULATION // 29%
BRAIN // 54%
SPINAL CORD STIMULATION // 10%
LS NEUROMUSCULAR ELECTRICAL STIMULATION
+ TRANSCUTANEOUS ELECTRICAL STIMULATION // 23%
TRIA
14
PERIPHERAL NERVE STIMULATION // 9%
1,0
COCHLEAR // 4%
Medical devices that alter brain, spine, or
nerve activity for therapeutic benefit are
a fast growing segment of the healthcare
industry. Neurostimulation devices were
initially developed in the 1980s, based on
cardiac pacemaker-inspired prototypes.
MARKET
Minnesota-based companies were the first to commercialize devices
for Deep Brain Stimulation (DBS), Spinal Cord Stimulation (SCS), and
Peripheral Nerve Stimulation (PNS). Minnesota-based companies continue
to hold a substantial (72%) share of the $3.5 billion global market, which is
estimated to reach $6-7 billion by 2018.1,2
The neuromodulation market is dominated by three medical device giants

- Medtronic, Boston Scientific, and St. Jude Medical - all of which have
headquarters or significant operations in the state of Minnesota. Greatbatch
is responsible for manufacturing critical components contained in 95% of
Active Implantable Medical Devices (AIMD) and has multiple operations in
Minnesota. The major players have successful histories of independently
developing or acquiring technologies for neuromodulation therapies and
associated surgical operations.
Significant industry activity is focused on:

+ Expanding approved indications for existing platforms.
+ Producing or acquiring de-risked technology for new patient markets.
+ Developing novel delivery systems specialized for unique anatomical

targets.
1
SOURCE: Global Neurostimulation / Neuromodulation Market. MicroMarketMonitor (Feb 2015).
2
SOURCE: The Market for Neurotechnology: 2014-2018. NeuroTechReport.com (Mar 2014).
Neuromodulation | Section 1 | Global Overview of Neuromodulation Industry 3

DEVICES
Neuromodulation therapies are available in implantable, minimally invasive,
and non-surgical options.
Implantable devices for brain stimulation deliver electricity deeply via

depth electrodes or cortical electrode arrays placed on the brain surface.
Similar technology is used for spinal cord stimulation, as well as peripheral
nerve targeting. Implanted-drug pumps that deliver small molecules to the
central nervous system via the intrathecal space also achieve targeted
neuromodulation.
Minimally invasive neuromodulation can be achieved by transcutaneous

stimulation through small needle-like electrodes and is typically restricted
to spinal and superficial nerve stimulation.
Non-surgical or non-invasive devices act through a variety of modalities.

Electrical stimulation delivered to muscles and wounds by paddle-style
electrodes placed topically are used to prevent atrophy, increase blood
flow, reduce pain and edema. Neuromodulation of the brain and spinal
cord can be achieved through electrical direct or alternating current, ultra-
sound, and magnetic fields.
[Minnesota's] become a local mecca for neuromodulation just

in the entities here: Medtronic, Mayo Clinic, the University of
Minnesota. You have state money. You have university focus.
You have hiring of people with that specialty. Theres a real
density of neuromodulation here. Not only are all the industry
giants physically present here but theres a lot of feeder
medical device companies supporting it, too."
Greg Molnar, Director of Neuroscience Discovery Division, Medtronic

FIGURE 2. GLOBAL LOCATIONS OF MAJOR NEUROMODULATION COMPANIES 1
MEDTRONIC
BOSTON SCIENTIFIC
ST. JUDE MEDICAL
CYBERONICS
FIGURE 3. NEUROMODULATION GLOBAL REVENUE FISCAL YEAR 2013
MEDTRONIC
BOSTON SCIENTIFIC
ST. JUDE MEDICAL
CYBERONICS
1
Sales office and representative locations excluded from map.

INDICATIONS
FDA approval of neuromodulation devices and indications is still somewhat
limited, in part due to long innovation life-cycles, clinical challenges, and
uncertainty of regulatory outcomes (Figure 1). These issues are being
addressed head-on by Minnesota's Medical Devices Innovation Consortium
and LifeScience Alley. The last two years have seen a boom in approvals
with new announcements occurring nearly monthly.
Neuromodulation devices are registered in over 1000 on-going FDA-

regulated clinical trials worldwide. These trials are investigating over 1300
indications, including metabolic disorders, inflammation, migraine, and
psychiatric disorders.1 Categories or types of indications under investigation
for the three major types of commercial platforms are listed in Figure 4 on
the following page.
Neuromodulation is an area that still has tremendous

innovation opportunities. These innovations often occur in the
clinical environment around the world. However, once you get
past the original proof-of-concept, you need an ecosystem like
we have here in Minnesota to get the product fully developed
and commercialized. This is the reason why so many new
medical device companies are formed here.
William Murray, President & CEO,
Medical Device Innovation Consortium (MDIC)
1
SOURCE: www.clinicaltrials.gov, searched Jan 20, 2014.

FIGURE 4. INDICATIONS APPROVED AND UNDER INVESTIGATION
FDA STATUS APPROVED INDICATIONS INVESTIGATIONAL INDICATIONS
133 indications
Behaviors and mental disorders,
Cancers and other neoplasms,
Diseases and abnormalities at or
before birth,
DEEP BRAIN Parkinson's disease, Ear / nose / and throat diseases,
Heart and blood diseases,
STIMULATION essential tremor,
and epilepsy Muscle / bone / and cartilage diseases,
(DBS) Nervous system diseases,
Skin and connective tissue diseases,
Substance related disorders,
Symptoms and general pathology,
Viral diseases,
and Wounds and injuries
165 indications
Bacterial and fungal diseases,
Blood and lymph conditions,
Cancers and other neoplasms,
Chronic pain due to failed Ear / nose / and throat disease,
SPINAL CORD back syndrome, Eye diseases,
chronic regional pain Heart and blood diseases,
STIMULATION syndrome, Immune system diseases,
(SCS) peripheral neuropathy, Muscle / bone / and cartilage diseases,
and ischemic pain Nervous system diseases,
Nutritional and metabolic diseases,
Skin and connective tissue diseases,
Symptoms and general pathology,
Viral diseases,
120 indications
Gland and hormone related diseases,
Obstructive sleep apnea, Heart and blood diseases,
PERIPHERAL central sleep apnea, Muscle / bone / and cartilage diseases,
hypertension, Nervous system diseases,
NERVE
obesity, Nutritional and metabolic diseases,
STIMULATION incontinence, Substance related disorders,
(PNS) heart failure, Symptoms and general pathology,
and migraine Urinary tract / sexual organs / and
pregnancy conditions,

MAJOR PLAYERS
Medtronic plc (Minneapolis, MN operational
headquarters) holds a dominant presence in the
national and global neuromodulation market. The
company upholds a reputation for developing first-in-class products and
acquiring IP in areas that complement or expand existing capabilities.
Neuromodulation operations are based in Fridley, MN, and will remain
there following the upcoming merger with Covidien.
Device Therapy Indications
Parkinson's disease, Essential

Activa Deep Brain Stimulation
Tremor, Dystonia, OCD
Intrathecal Infusion Pump Cancer pain, Chronic pain,

SynchroMed II
(Drug Delivery) Severe spasticity
Gastric Electrical Nausea / vomiting from

Entera
Stimulation gastroparesis
Sacal Neuromodulation Overactive bladder, Bowel

InterStim
Systems incontinence, Urinary retention
AdaptiveStim + Spinal Cord Stimulation -

Chronic pain
SureScan MRI compatible
Boston Scientific Corporation (Marlborough, MA)

maintains a significant share of the U.S. and global
market in neuromodulation. The company retains
active interests in Minnesota. There is considerable interaction and flow
of talent between Boston Scientifics Cardiac Rhythm Management Group,
located in Arden Hills, MN, and the neuromodulation division located in
Valencia, CA.
Device Therapy Indications (*HDE)
Vercise Deep Brain Stimulation Parkinson's disease*
Chronic pain, Orthopedic

Precision Spectra Spinal Cord Stimulation
surgery
Chronic pain, Orthopedic

Precision Plus Spinal Cord Stimulation
surgery
Vessix Renal Denervation Hypertension*

St. Jude Medical, Inc., (St. Paul, MN) is a leading
producer of medical technology for treating cardiac
and neurological disorders. St. Jude Medical has a
history of developing innovative technology and successful partnerships
with companies to commercialize de-risked technology. R&D operations
are focused in California and Texas, with efforts spanning cardiovascular
disease, chronic pain, and neurological diseases.
Device Therapy Indications (*IDE / CE)
Libra, Brio Deep Brain Stimulation Movement disorders*
Prodigy *, Eon,
Spinal Cord Stimulation Pain*
Protg
Genesis Optic Nerve Stimulation Chronic migraine*
Greatbatch, Inc., (Plano, TX) is a leading developer and

manufacturer of medical device systems and critical
components for the neuromodulation, orthopedics,
and cardiovascular markets. The company is known for inventing the now
ubiquitous lithium-powered batteries, first used in implantable pacemakers.
Today, 95% of commercially available AIMDs are designed with Greatbatch
materials. The last year saw expanded operations in Minnesota for medical
device manufacturing (Greatbatch
Medical) and internal product development (QiG Group). The 2014
acquisition of CCC Medical increased international OEM capabilities.
Device Therapy Indications (*CE)
Algostim, Algovita Spinal Cord Stimulation Chronic pain*

2. NEUROMODULATION
IN MINNESOTA
FIGURE 5. MINNESOTA COMPANIES BY ANATOMICAL TARGET
Neuromodulation | Section 2 | Neuromodulation in Minnesota 11

COMPANIES TARGETING BRAIN
Boston Scientific
Functional Neuromodulation
Medtronic
Monteris Medical
St. Jude Medical
COMPANIES TARGETING SPINAL CORD

Boston Scientific
Greatbatch Medical
Mainstay Medical
Medtronic
St. Jude Medical
COMPANIES TARGETING NERVES
Advanced Bionics Holaira

BioControl Medical Inspire Medical Systems
Boston Scientific Medi-Stim
Cardionomic Medtronic
Chattanooga Group Novum Therapeutics
Cogentix Medical Respicardia
(Uroplasty)
SPR Therapeutics
CVRx
St. Jude Medical
Empi
Uni-Patch
Enopace Biomedical
WR Medical Electronics
EnteroMedics
Envoy Medical
See Neuromodulation Resource Directory (p. 29) for summary and contact information of
companies listed above and additional businesses providing supporting goods and services.
Section # | Text 12
Minnesota supports a thriving and diverse ecosystem for neuromodulation
enterprise. There are 28 companies with headquarters or significant oper-
ations in MN responsible for producing at least 40 stimulation systems
across all platform areas. Another 37+ companies work in the surrounding
space, offering contract based expertise in IP, design, engineering,
surgery, quality, regulatory, finance, manufacturing, patient data, and
clinical testing. Minnesota established itself early as a source of neuro-
logical expertise and continues to show rapid growth of new enterprise.
Funding for the life sciences is on the up and holding firm. In 2014,
the state attracted over $1 billion for research and enterprise in the life
sciences. More than 1000 federal research grants worth $740.6 million
were awarded, up 5.2% from 2013.1,2 2014 also saw a six-year high of
$430 million invested in life science businesses, with $320 million going to
medical device companies.3
Minnesota's global positioning in the neuromodulation industry is well-
2015 Sources: Life Science Investments $430 M

2015 Sources: National Institute of Health Awards $446 M
2015 Sources: National Science Foundation Awards $155 M
TOTAL 2015 AMOUNT $1,031 M
established. Having grown on the shoulders of the cardiac pace-maker

industry, neuromodulation has deep roots in Minnesota and a wide reach.
Greg Molnar, PhD, Director of Medtronic's Neuroscience Discovery
Division, commented that You naturally have new geographies with pre-
existing people and efforts. [It] makes sense to leave it there and leverage
the global nature of it. Still, Medtronics R&D headquarters for neuromodu-
lation are here in Minnesota. At the end of the day, the convergence of all
that information and activity comes together to business and decisions
based here in Minneapolis." Molnar emphasized that the announcement
to retain neuromodulation operations in Minnesota following the Covidien
merger, the largest in medical device history, is a clear indicator of the
value of having such a critical mass of industry activity in Minnesota.
1
SOURCE: www.startribune.com/local/minneapolis/288484351.html?page=1&c=y
2
SOURCE: www.projectreporter.nih.gov/reporter.cfm; http://www.nsf.gov/awardsearch
3
SOURCE: LifeScience Alley, Minnesota Life Science Investment Activity: 2014 Annual Report.

Regional activity in neuromodulation is strong across the spectrum, from
pre-clinical and basic research to startups and established corporations.
The Twin Cities are known for excellence in engineering and medicine,
consistently outranking other metro areas in medical device patents and
inventive patents.1 To promote early stage ventures in healthcare and
medical technology, a variety of startup incubator spaces and accel-
erators complement community- and member-based programs geared
toward education and network expansion for entrepreneurs working with
biomedical technology. In addition to the major players and supporting
industry, the University of Minnesota and Mayo Clinic fund clinical
research programs, hire world class scientists, and provide unparalleled
facilities. Both employ locally-sourced personnel with years of success in
the medical device industry to provide structured systems for IP devel-
opment, commercialization, and licensing.
FIGURE 6. CUMULATIVE GROWTH OF NEUROSURGERY & NEUROMODULATION IN MN
70
60
50
40
MAYO CLINIC, DEPT. OF
NEUROSURGERY, EST. 1919
30
UMN, DEPT. OF
NEUROSURGERY, EST. 1937
20
10
1915
1940
1965
1980
2014
1
SOURCE: www.mn.gov/deed, Compare MN and metropolitan areas.
IMPLANTABLE & MINIMALLY INVASIVE SYSTEMS
Deep Brain Stimulation (DBS): Medtronics Activa system is the
leading device option for treating Parkinsons disease and essential
tremor (Humanitarian Device Exempt status for Dystonia and Obsessive
Compulsive Disorder). Boston Scientific is the other leading provider
of a DBS system, Vercise, approved for successful treatment of PD.
While St. Jude Medical awaits FDA approval of their DBS systems, Libra,
LibraXP, and Brio, they are approved for treatment of Parkinsons and dys-
tonia in Europe and Australia. Early success in Parkinsons is promising,
however, one entrepreneur with decades of experience in neuromodula-
tion noted the Parkinsons market is reaching saturation and faces sig-
nificant competition from pharmaceutical treatment options. In light of the
aging population, neurodegenerative disorders are of significant interest.
Functional Neuromodulation is using Medtronics DBS platform in Phase I/
II clinical trials for early stage Alzheimers disease. Multiple unsuccessful
attempts at using DBS to treat depression attest to the substantial efforts
being made to break into new disease applications and address significant
unmet clinical needs.
Spinal Cord Stimulation (SCS): Medtronic, St. Jude Medical and Boston
Scientific all produce FDA approved SCS devices to treat chronic back
pain. Medtronics AdaptiveStim and SureScansystems offer a distinct
capability of MRI compatibility. Boston Scientific's Precision Plus system
recently took over a majority of the SCS market by offering 16 electrodes,
twice the number of stimulation contacts as any other commercially avail-
able product. St. Jude Medical recently received FDA approval for its
Protg implantable pulse generator, the first fully upgradeable neuro-
stimulator system. Greatbatch, well-known for producing electromedical
components, expects U.S. approval of their first fully-functioning stimu-
lation platform, Algovita, in mid-2015. Greatbatch's neuromodulation
product development is performed by its subsidary, the QiG Group, located
in Blaine, MN. Greatbatch's neuromodulation expertise is built primarily
upon mergers with two Minnesota neuromodulation businesses, Enpath
and Quan Emerteq, in 2007. Although headquarters relocated from New
York to Texas in 2012, ties to the Twin Cities remain strong.

Peripheral Nerve Stimulation (PNS): Peripheral nerves are attractive
targets for neuromodulation-based therapies due to relatively easy sur-
gical access and an established historical body of medical knowledge.
Medtronic was quick to commercialize devices in this area and recently
expanded its portfolio with the early 2015 acquisition of Uro-Solutions
percutaneous nerve stimulator to treat overactive bladder. Four mid-sized
companies headquartered in the Twin Cities (listed below) are approved
to commercially market peripheral nerve stimulation devices in the U.S.
Three of these companies received FDA approval between June 2014 and
January 2015.
Cogentix Medical Inc., (Uroplasty) produces the

Urgent PC Neuromodulation System for sacral nerve
stimulation to treat overactive bladder. PMA status was
awarded in 2005. Present efforts are focused on improving reimbursement.
CVRx developed and produces Barostim neo, a

first in-class MRI-compatible, implantable device
for restoring cardiac and vascular function via the
sympathetic nervous system. HDE status was awarded for hypertension
in December 2014 and FDA approval for heart failure is anticipated.
EnteroMedics, Inc.s vBloc Therapy, delivered

through the Maestro System, pioneered vagal-nerve
stimulation for weight loss and is exploring efficacy in
related metabolic disorders. PMA status was granted by FDA in January
2015, contingent upon a 5-year Phase IV follow-up study.
Inspire Medical Systems, Inc., spun out of Medtronic

to produce the Inspire Upper Airway Stimulation
device for stimulating the hypoglossal nerve to treat
Obstructive Sleep Apnea. FDA awarded PMA status in April 2014.

NON-SURGICAL STIMULATION SYSTEMS
Non-surgical Neuromodulation: Methods that achieve neuromodulation
via non-invasive or non-surgical means are the subject of more than half
(61%) of all FDA trials currently open worldwide. Significantly more trials
are targeting the brain (38%) than peripheral nerves (23%). While under
active clinical investigation, non-surgical neuromodulation devices repre-
sent a much smaller portion of the commercial market.
Transcranial Magnetic and Ultrasound Stimulation: The University of

Minnesotas MINCEP Epilepsy Care Center and Brain Plasticity Laboratory
are leading Minnesotas efforts in therapeutic Transcranial Magnetic
Stimulation (TMS) and Functional Ultrasound Stimulation. Major research
efforts are directed toward stroke recovery and dystonia. Clinicians are
also exploring applications in treatment-resistant depression and rehabili-
tation following brain-related trauma. The center recently expanded due to
notable funding awards from MnDRIVE and National Institutes of Health.
Neuromuscular Electrical Stimulation and Transcutaneous Electrical

Nerve Stimulation (NMES / TENS): DJO Global is the largest non-surgi-
cal orthopedic rehabilitation device producer in the U.S. Two significant
acquisitions include Minnesota-based companies, EMPI and Chattanooga
Group, with the latter maintaining operations in the state. Minnesotas
MediStim, also produces full electrotherapy systems and garments for por-
table devices.
"Minnesota is a Disneyland for medical devices."

John Linehan, PhD, Clinical Professor of Biomedical Engineering,
Northwestern University

SUPPORTING ENTERPRISE
Medical Device Manufacturing: Minnesota produced the first FDA-
approved neurostimulation devices and continues to be a global leader in
active implantable medical devices. The Minneapolis - St. Paul metropolitan
area is the nations leader in medical device patents and manufacturing
jobs.1 Within the electrotherapeutics manufacturing subsector, the Twin
Cities metro area is home to 23% of all U.S. employees and claims more
than 25% of total wages. The roughly 13,000 workers in the state are
distributed across 66 establishments, 56 of which are located in the greater
metro area.2 In addition to manufacturing, the medical device ecosystem is
flourishing and supports all phases of the neuromodulation device life-cycle.
Medical Device Development: Notable operations span medical device

R&D, IP, prototype production, sterilization, project management, regulatory,
commercialization, and finance (see Neuromodulation Resources Directory,
page 31).
Evergreen Medical Technologies, Inc. specializes

in active implantable medical device development,
manufacturing, testing, and clinical insight. The
majority of clientele (60%) is local. Known for electromedical engineering
expertise, 90% of contract efforts focus on neuromodulation products.
Greatbatch Medical provides a wide variety of contract

medical device development and manufacturing
services. The company also designs and manufactures
critical electromedical technologies to enhance the reliability and performance
of medical devices and procedures, including batteries, device headers and
enclosures, leads, coated electrodes, and more.
Minnetronix, Inc., is a medical technology and

innovation company, specializing in electronic and
electromechanical devices. Minnetronix provides
ideas, innovation, and strategic guidance, as well as design, development,
and manufacturing services to medical device companies.
1
SOURCE: mn.gov/deed, Compare MN and metropolitan areas.
2
SOURCE: www.apps.deed.state.mn.us/lmi/qcew/ResultsDisp.aspx (NAICS334510).

SUPPORTING INFRASTRUCTURE
Clinical & Surgical Expertise: Minnesota has been the site for over 80
neuromodulation clinical trials.1 Minnesotas expertise in clinical trials par-
allels the interests of the companies and organizations within the area.
Mayo Clinic and the University of Minnesota established neurosurgery
departments early in the twentieth century, providing an easily accessible
source of expertise for developing and testing implantable technology. See
Neuromodulation Directory for listing of clinicians and research centers.
Talent & Workforce: The population of Minnesota is highly educated and

has access to numerous specialized training programs from certificate to
doctorate. Overall, Minnesota boasts one of the highest literacy rates in
the United States. Education is consistently supported by the state leg-
islature and local programming. The University of Minnesota is ranked in
the top 25 research universities in the world by the Center for Measuring
University Performance. The universitys high standing is in part due to the
superior faculty and trainees affiliated with the Medical School and College
of Science & Engineering.
Healthcare: Minnesotas thriving healthcare sector provides complemen-

tary services and expertise to the neuromodulation sector. UnitedHealth
Group is the worlds largest healthcare and insurance provider. UnitedHealth
is headquartered in Minnetonka, MN, and reports over 20 other facilities in
the state. The leading healthcare investment bank, Piper Jaffray, is head-
quartered in downtown Minneapolis, offering both financial analysis and
investing opportunities. Multiple accelerators and co-working spaces are
available for healthcare endeavors, both early stage and growing, includ-
ing Healthcare.mn and TreeHouse Health.
"Minnesota is the best place to find people who know the

neuromodulation business and can grow it."
John Swoyer, Executive Director of Product Development, QiG Group
1
SOURCE: www.clinicaltrials.gov, searched Jan 20, 2014.

Supporting Organizations: Non-governmental organizations and state-
based programs are important drivers of medical device success in
Minnesota. See Neuromodulation Resources Directory (page 31) for
additional supporting organizations.
LifeScience Alley spends significant efforts

advocating for federal and state legislation that
promotes a profitable business climate. These
efforts produced the Angel Tax Credit, now offering up to $15 million in
tax credits in 2015. LifeScience Alley also provides industry intelligence,
programming, and business referral opportunities to specifically address
challenges faced in the health technology and medical device industries.
The Medical Device Innovation Consortium (MDIC)

aims to advance regulatory science through its public-
private partnership among industry stakeholders,
governmental agencies, and patient / physician groups. The MDIC is
presently working with the FDA to establish standardized safety guidelines
for stimulation parameters in nerve tissue.
BioAM LLC, in Rochester, MN, is a community-based

organization promoting economic development in life
sciences through education and networking. BioAM
works with regional organizations like Destination Medical Center to elevate
activities in healthcare and medicine across the state.
The MN Neuromodulation Consortium was established in January 2015

to provide a centralized access point to the regions extensive collection of
resources and expertise in neuromodulation.
Section
Neuromodulation | Section 2 | Neuromodulation # | Text
in Minnesota 20
3. FUTURE
FORECAST OF
NEUROMODULATION
INDUSTRY
EMERGING TECHNOLOGY
'Closed-loop' Systems: Recent advancements in neuroscience, electrical
engineering, and bio-sensors have enabled closed-loop systems, capable
of sensing ongoing brain or nerve activity and incorporating it into stimula-
tion parameters for optimized therapeutic efficacy in real-time.
California-based Neuropaces RNS System is the first to the U.S. market
with this technology, although many efforts are underway to make this
technology the gold standard of care.
Pre-Clinical: Powerful pre-clinical capabilities are provided by optogenet-

ics and pharmacosynthetics, which make use of genetics to achieve selec-
tive cellular and anatomical targeting. The delivery of light and synthetic
small molecules, respectively, is used to achieve neuromodulation. Both
approaches are making major strides at the bench but are not used ther-
apeutically in their present iterations due to limited acceptance of gene
therapy in humans.
Non-Surgical: While challenges to commercialization remain, nonsurgical

options are gaining traction. Transcranial electrical, magnetic, and ultra-
sound stimulation have demonstrated clinical efficacy but are significantly
limited by high energy demands, large device size, and ease of use. These
modalities often require daily or weekly clinical visits to receive treatment,
posing considerable geographic limitation to patient access. Some groups
are addressing these limitations by developing small, portable devices to
deliver small electrical charges to superficial nerves near the surface of
the body, e.g., via the ear canal like Novum Therapeutics.
"LifeScience Alley is great because they continue to build

connections and focus on issues of the day."
Todd Langevin, President & COO, Functional Neuromodulation
Neuromodulation l Section 3 l Future Forecast of Neuromodulation Industry 22

UNMET NEEDS
Therapeutics: Medical diseases and disorders that affect the nervous
system are diverse in nature and widespread across demographics.
Finding successful treatment options is often challenged by the complex
nature of the diseases and limited understanding of symptomatology and
etiology, as is the case with many psychiatric and neurodegenerative dis-
orders. This sets the stage for numerous potential physiological targets,
low competition in treatment-resistant diseases, and significant drive for
innovative treatments and novel technology.
Beyond classical nervous system disorders, diseases of peripheral tissues

often have a neurological component or could benefit from neurological
interventions. Metabolic disorders, like obesity and type 2 diabetes, are
growing at epidemic proportions and present significant patient needs.
Inflammation treatments are another area of great commercial potential.
Urinary and fecal incontinence is a major untapped market that will soon
be filled by implantable neuromodulation devices that are under clinical
investigation by numerous sponsors.
Prosthetics: In amputees and trauma victims, neuromodulation is aiding

recovery following injury by promoting regrowth of severed nerves or spinal
cords. Prosthetic limbs are being developed with biomimetic skin, capable
of sensing temperature and pressure, which are paired with brain-com-
puter interfaces to restore feeling and mobility. Much of the development
work in this area is funded by the U.S. Department of Defense, with a focus
on the veteran population.
Enhancements: Beyond medical applications, enhancement of healthy

individuals is of significant interest, particularly by the military and private
sector. These efforts are presently limited to non-surgical methods and
have reported improvements in attention, anxiety, and mood. Development
of these devices is unencumbered by costly pivotal trials. However, without
FDA-backing and the aid of reimbursement, devices must be marketed
to the private consumer and paid for out-of-pocket, significantly limiting
potential revenues.

MARKET CLIMATE
Market growth is strong for neuromodulation-based therapies; it is predicted
to double in the next four years.1,2 In the initial years of neurostimulation
technology, Thom Gunderson, Senior Financial Analyst at Piper Jaffray,
noted that the best and brightest talent was attracted to the success
and stability of the cardiac industry, which slowed innovation in the
neuromodulation sector. Today, neuromodulation is an open market with
great potential that is attractive to investors.
Early safety demonstrations and lasting patient successes in treating pain

and Parkinsons disease continue to bolster physician support for SCS and
DBS, respectively. Manufacturers of FDA-approved stimulation systems
are able to provide entrepreneurs with verified technology for early-phase
investigations, ultimately leading to lower cost, lower risk clinical trials.
CONCLUDING SUMMARY
Minnesota is a powerful global center for the Neuromodulation Industry.
Minnesota established a strong lead in neuromodulation therapies due
to early success in cardiac stimulation. Talent and technology is easily
transferred to a wide range of active implantable medical devices. The
Twin Cities metropolitan area is home to small and large companies
working in the neuromodulation space. The historic legacy serves the area
well, providing emerging enterprises with talent, expertise, and financing.
Smaller ventures run the risk of being overshadowed by major players but
can easily take advantage of the close proximity by accessing corporate
talent on a consulting basis and leveraging connections for favorable exit
strategies.
1
SOURCE: Global Neurostimulation / Neuromodulation Market. MicroMarketMonitor. (Feb 2015).
2
SOURCE: The Market for Neurotechnology: 2014 - 2018. NeuroTechReports.com. (Mar 2014).

ACKNOWLEDGEMENTS
We would like to thank all of the neuromodulation and neuroscience
experts in local industry and academia who shared their insights and
thoughts during the preparation of this report. This work would not have
been possible without their assistance.
The following experts and executives were consulted during the creation
of this report:
David Anderson
Senior Vice President of R&D, St. Jude Medical, Inc.
Bryce Beverlin II, PhD

Medical Devices Center Innovation Fellow, University of Minnesota
Charles Billington, MD
Professor, Department of Medicine, University of Minnesota
Dori Henderson, PhD

Program Manager, MnDRIVE Brain Conditions Initiative, University of
Minnesota
Thomas Gunderson
Senior Financial Analyst, Piper Jaffray Companies
Matthew Johnson, PhD

Assistant Professor, Department of Biomedical Engineering, University of
Minnesota
Robert Kieval, PhD

Executive Vice President & CTO (Founder), CVRx, Inc.
Mark Knudson, PhD

President & CEO, EnteroMedics, Inc.

Todd Langevin
President & COO, Functional Neuromodulation, Ltd.
Gregory Molnar, PhD

Director of Neuroscience & Discovery, Medtronic plc
William Murray
President & CEO, Medical Device Innovation Consortium (MDIC)
Randall Nelson
President, Evergreen Medical Technologies
Tay Netoff, PhD

Assistant Professor, Department of Biomedical Engineering, University of
Minnesota
David Rhees, PhD

Executive Director, The Bakken Museum
Barry Rittberg, MD
Assistant Professor, Department of Psychiatry, University of Minnesota
John Swoyer
Executive Director of Product Development, QiG Group
David Wechter
Senior R&D Engineer, Neuromodulation, Boston Scientific Corporation
4. NEUROMODULATION
RESOURCE
DIRECTORY
Section # | Text 27
NEUROMODULATION DEVICES
Company City, State Founded Summary
Advanced Bionics Hopkins, MN 2009 Produces cochlear implant for hearing loss.
Produces the CardioFit System for vagal

BioControl Medical Ltd. Minneapolis, MN 1999
nerve stimulation to treat heart failure.
Boston Scientific Marlbourough, MA Develops and commercializes a diverse

1979
Corporation St. Paul, MN neuromodulation device portfolio.
Device for neuromodulating terminal

Cardionomic, Inc. Forest Lake, MN 2011
branches of cardiac plexus.
Device for neuromodulating terminal

CerebralRx Ltd. Minneapolis, MN 2010
branches of cardiac plexus.
St. Paul, MN World's largest manufacturer of TENS /

Chattanooga Group, Inc. 1947
Vista, CA NMES rehabilitation equipment.
Urgent PC Neuromodulation System for

Cogentix Medical, Inc. Hopkins, MN 1987
percutaneous tibial nerve stimulation.
Barostim neo for barostim receptor stimu-

CVRx, Inc. Minneapolis, MN 2001
lation in the carotid artery.
Non-invasive electrical stimulation (TENS /

Empi, Inc. St. Paul, MN -
NMES) devices.
vBloc Maestro Rechargeale System for

EnteroMedics, Inc. St. Paul, MN 2002
vagal nerve blocking.
Middle-ear implant for nerve-related hearing

Envoy Medical Corp. St. Paul, MN 1995
loss, Esteem.
Functional Neuromodulation Developing DBS to treat mild Alzheimer's

Minneapolis, MN 1995
Ltd. disease.
Greatbatch Medical Algovita & Algostim spinal cord

Plymouth, MN 1970
(Greatbatch, Inc.) stimulation systems for chronic pain.
Device for Targeted Lung Denervation to

Holaira Medical, Inc. Plymouth, MN 2008
reduce overactive airway nerve activity.
Neuromodulation l Section 4 l Neuromodulation Resource Directory 28

Inspire Medical Systems,

Maple Grove, MN 2007 Sells Inspire for Obstructive Sleep Apnea.
Inc.
Dublin, Ireland ReActiv8 implantable spinal stimulation

Mainstay Medical, Inc. 2008
Plymouth, MN device for chronic low back pain.
Non-invasive electrotherapy products to

Medi-Stim, Inc. Wabasha, MN 1984
treat neural & muscular pain.
Dublin, Ireland Develops and commercializes diverse

Medtronic plc 1949
Minneapolis, MN neuromodulation device portfolio
Plymouth, MN NeuroBlate System for MRI-guided neuro-

Monteris Medical, Inc. 1999
Winnipeg, Canada surgical ablation.
Nocturne non-invasive neuromodulation

Novum Therapeutics, Inc. Minneapolis, MN 2013
for Obstructive Sleep Apnea.
Contract-based product design, develop-

Pepin Manufacturing, Inc. Lake City, MN 1993
ment, and manufacturing.
Neurostimulation systems including

QiG Group Blaine, MN 2008 implantable pulse generators, leads and
programmers.
Remed System for phrenic nerve

Respicardia, Inc. Hopkins, MN 2006
stimulation of the diaphragm.
Smartpatch & Micropulse PNS systems for

SPR Therapeutics LLC Minneapolis, MN 2010
interventional pain management.
Develops and commercializes a diverse

St. Jude Medical, Inc. St. Paul, MN 1976
neuromodulation device portfolio.
Uni-Patch Produces non-implantable electrodes and

Wabasha, MN 1978
(Covidien, Ltd.) garments.
Hilger Silverstein Facial Nerve Stimulators

WR Medical Electronics Co. Maplewood, MN 1962
for facial paralysis.

DESIGN, DEVELOPMENT & MANUFACTURING - DEVICES & COMPONENTS
Advanced Medical Product-focused research and development

Maple Grove, MN 1990
Electronics Corporation company specializing in medical devices.
Rechargeable, thin film & solid state

Cymbet Corporation Elk River, MN 2000
batteries for microelectronic systems.
Electromedical device design, engineering,

Devicix LLC Eden Prairie, MN 2004 prototyping, development, regulatory, &
commercialization.
Medical device development, manufacturing,

Donatelle Medical New Brighton, MN 1967
& commercialization.
Electromedical device design, engineering,

Evergreen Medical
St. Paul, MN 2006 prototyping, development, certification, and
Technologies, Inc.
regulatory expertise.
Greatbatch Medical Algovita & Algostim spinal cord

Plymouth, MN 1970
(Greatbatch, Inc.) stimulation systems for chronic pain.
Heraeus Medical Delivers from ingot to complex engineered

St. Paul, MN 1851
Components LLC assembly.
Research, design, development,

Matrix MedTech, Inc. Maple Grove, MN 2011 prototyping, & manufacturing for medical
device components.
Minnetronix, Inc. St. Paul, MN 1996 Medical device design, manufacturing, & IP.
Electronics manufactuing services for

Nortech Systems, Inc. Maple Grove, MN 1981
medical device industry & others.
North American Science Medical research organization - regulatory,

Associates, Inc. (NAMSA) laboratory, clinical & compliance services.
Micro & nano connectors for military,

Omnetics Connector Corp. Minneapolis, MN 1984
commercial, and medical applications.
Custom electrodes for electrotherapy. R&D,

Pepin Manufacturing, Inc. Lake City, MN 1993
design, and manufacturing expertise.
Products for neurosurgery, orthopedics, and

PMT Corporation Chanhassen, MN 1979
plastic & reconstructive surgery.

Smiths Medical ASD Inc. Clinical & technical support services for
St. Paul, MN 1983
(Smiths Group plc) multi-national medical device studies.
Development, qualification, and component

Stellar Technologies, Inc. Brooklyn Park, MN 1991
manufacturing of medical products.
Summit Medical, Inc. Medical device manufacturing, regulatory,

St. Paul, MN 1982
(Shore Capital Partners LLC) quality, engineering, sales, and marketing.
Teren Med, Inc. Minneapolis, MN 2008 Electromedical equipment manufacturer.
Worrell Design, Inc. Minneapolis, MN 1976 Product design, development, and strategy.
NEUROSURGERY EQUIPMENT
ev3 Inc. Medical devices for neurosurgery

Plymouth, MN 2000
(Covidien, Ltd.) applications.
Minnetonka, MN Multiple product lines for image guided

IMRIS Inc. 2005
Winnipeg, Canada neurosurgery solutions.
Plymouth, MN Medical devices for MRI-guided

Monteris Medical, Inc. 1999
Winnipeg, Canada neurosurgical ablation.
Summit Medical, Inc. Medical device development for

St. Paul, MN 1982
(Shore Capital Partners LLC) neurosurgery application

FINANCE
Bay City Capital LLC San Francisco, CA 1997 Life sciences investment firm.
Early stage investments that address

Brain Trust Accelerator Fund,
Burlingame, CA 2006 diagnosis & treatment of brain-related
L.P.
diseases.
Craig-Hallum Capital Group Institutional investment banking firm for

LLC health technology and medical devices.
Network of accredited investors seeking to

Gopher Angels LLC Minneapolis, MN -
invest capital in early stage MN businesses.
Greatbatch Medical Invests in targeted technology &

Plymouth, MN 1970
(Greatbatch, Inc.) acquisitions.
Neuro Device Innovations Hybrid VC & commercialization firm for

(NDI) Medical LLC neurodevice technologies.
Invests in therapeutics & technologies to

NeuroVentures Capital LLC Charlottesville, VA 2000
treat CNS disorders.
VC investments in companies developing

Oak Investment Partners Minneapolis, MN 1978
systems & services in healthcare.
Investment banking firm with expertise in

Piper Jaffray Companies Minneapolis, MN 1993
health technology & medical devices.
Community-based network of investors,

RAIN Source Capital St. Paul, MN 1998
capital, and expertise.
Healthcare-focused lower middle market

Shore Capital Partners LLC Chicago, IL -
private equity firm.
Buys businesses that add complementary

Smiths Group plc London, England 1851
technologies and products.
Builds & invests in companies focusing on

Technology Partners Palo Alto, CA 1994
life science & clean technologies.
Boston, MA Multi-disciplinary team that brings together

Third Rock Ventures LLC -
San Francisco, CA science, strategy, business, and medicine.

FINANCE
Thomas McNerney & Healthcare venture firm that invests in life

Partners LLC sciences & medical technology.
Organization for angel investors - medical

Twin Cities Angels Minneapolis, MN 2006
devices, diagnostics, pharma and biotech.
Emphasis on discovery & development of

Versant Ventures San Francisco, CA 1999
novel therapeutics.
INTELLECTUAL PROPERTY - MEDICAL DEVICE
Patent law firm specializing in software

Beck & Tysver PLLC Minneapolis, MN -
technology and medical devices.
Free legal resource. Curates list of IP Firms

BitLaw Legal Resource Online Directory -
in Minnesota.
Works with physicians & scientists to mine

Mayo Clinic Ventures Rochester, MN 1985
inventions, ideas and discoveries.
Mueting, Raasch & Expertise in patent law relating to electrical

Minneapolis, MN -
Gebhardt, P.A. & mechanical arts.
Patterson Thuente Strategic solutions to complex intellectual

Pedersen, P.A. property matters, expertise in technology IP.
Organization for angel investors - medical

The General Counsel, Ltd. Minneapolis, MN 1985
devices, diagnostics, pharma and biotech.
Engages with local entrepreneurs &

BioAM Rochester, MN -
connects them with people & resources.
CoCo - MSP St. Paul, MN Tech hub in Google for Entrepreneurs

2010
(Google for Entrepreneurs) Minneapolis, MN network. Space, funding and mentorship.
Economic development initiative to secure

Destination Medical Center Rochester, MN -
MN's status as a global medical destination.
Mayo Clinic Business Provides infrastructure that enables

Rochester, MN 2013
Accelerator entrepreneurism for Rochester community

INTELLECTUAL PROPERTY - MEDICAL DEVICE
Provides MN startups with space,

Startup Venture Loft (SVL) Minneapolis, MN -
connections, and resources.
Healthcare innovation center with emphasis

Treehouse Health Minneapolis, MN 2013
on health IT and care coordination.
University Enterprise Collaborative research center fore early

St. Paul, MN 2006
Laboratories stage bio-science ventures.
UMN - Business Dynamic business mentorship-based

Accelerator Program program.
UMN - MN-IP: MN Designed to improve access to university-

Minneapolis, MN -
Innovation Partnerships developed technology.
UMN - Office Facilitates transfer of university research

for Technology Minneapolis, MN - to licensees for the development of new
Commercialization (OTC) products and services.
OTHER - SUPPORTING INFRASTRUCTURE
CoCo - MSP St. Paul, MN Tech hub in Google for Entrepreneurs

2010
(Google for Entrepreneurs) Minneapolis, MN network. Space, funding and mentorship.
Economic development initiative to secure

Destination Medical Center Rochester, MN -
MN's status as a global medical destination.
Mayo Clinic Business Provides infrastructure that enables

Rochester, MN 2013
Accelerator entrepreneurism for Rochester community
Provides MN startups with space,

Startup Venture Loft (SVL) Minneapolis, MN -
connections, and resources.
Healthcare innovation center with emphasis

Treehouse Health Minneapolis, MN 2013
on health IT and care coordination.
University Enterprise Collaborative research center fore early

St. Paul, MN 2006
Laboratories stage bio-science ventures.
UMN - Business Dynamic business mentorship-based

Accelerator Program program.
UMN - MN-IP: MN Designed to improve access to university-

Minneapolis, MN -
Innovation Partnerships developed technology.
UMN - Office Facilitates transfer of university research

for Technology Minneapolis, MN - to licensees for the development of new
Commercialization (OTC) products and services.
5. CLINICAL,
SURGICAL,
RESEARCH
& BUSINESS
DIRECTORY
Section # | Text 36
CLINICAL EXPERTISE: ABLATION
Organization City, State Contact Name Contact Info
Mayo Clinic, Department of Samuel J. Asirvatham, MD -

Rochester, MN 507. 284. 2511
Anesthesiology & Pain Medicine Neurovascular & PNS
CLINICAL EXPERTISE: DEPRESSION
University of Minnesota, Barry Rittburg, MD - DBS,

Minneapolis, MN rittb001@umn.edu
Department of Psychiatry VNS, TMS
CLINICAL EXPERTISE: EPILEPSY

Mayo Clinic, Department
Jamie J. Van Gompel, MD
of Neurosurgery & Rochester, MN 507.284.8008
- DBS
Otorhinolaryngology
CLINICAL EXPERTISE: EPILEPSY
Mayo Clinic, Department of Kendall H. Lee, MD, PhD -

Rochester, MN lee.kendall@mayo.edu
Neurosurgery DBS
Mayo Clinic, Department of Squire (Matt) M. Stead, MD,

Rochester, MN 507.284.7341
Neurosurgery PhD - DBS
CLINICAL EXPERTISE: MOVEMENT DISORDERS
University of Minnesota, David Rottenberg, MSc, MD

Minneapolis, MN rotte001@umn.edu
Department of Neurology - DBS
University of Minnesota, Anthony Santiago, MD -

Minneapolis, MN asantiag@umn.edu
Department of Neurology DBS
University of Minnesota,
Minneapolis, MN Jerrold Vitek, MD - DBS vitek004@umn.edu
Department of Neurology
Neuromodulation l Section 5 l Clinical, Surgical, Research & Business Directory 37

CLINICAL EXPERTISE: MOVEMENT DISORDERS
Minneapolis, MN Michael C. Park, MD - DBS mcpark@umn.edu
Department of Neurosurgery
Mayo Clinic, Department of Anhar Hassan, MB, BCh -

Rochester, MN hassan.anhar@mayo.edu
Neurology DBS

Neurosurgery DBS
Mayo Clinic, Department of Julie A. Fields, PhD, LP -

Rochester, MN fields.julie@mayo.edu
Psychiatry and Psychology DBS
Mayo Clinic, Department of Squire (Matt) M. Stead, MD,

Neurosurgery PhD - DBS
Mayo Clinic, Department of

Rochester, MN Bryan T. Klassen, MD - DBS klassen.bryan@mayo.edu
Neurology
Dr. Matthew D. Johnson -
Department of Biomedical Minneapolis, MN john5101@umn.edu
DBS (pre-clinical)
Engineering
CLINICAL EXPERTISE: OBESITY
University of Minnesota, Charles Billington, MD -

Minneapolis, MN billi005@umn.edu
Department of Medicine VNS
CLINICAL EXPERTISE: PAIN
Fairview Hospital,
Edina, MN Paul Gigante, MD - SCS 952.836.3695
Spine and Brain Clinic
Rochester, MN Michael C. Park, MD - DBS mcpark@umn.edu
Department of Neurosurgery
Tim J. Lamer, MD - SCS,

Rochester, MN PNS, CNS-targeted Drug 507.284.2511
Anesthesiology & Pain Medicine
Delivery

CLINICAL EXPERTISE: PAIN

Halena M. Gazelka, MD -
Rochester, MN SCS, PNS, CNS-targeted 507.284.2511
Drug Delivery
Jason S. Eldridge, MD -
Drug Delivery
Brenton M. Meier, MD -
Drug Delivery
CLINICAL EXPERTISE: PSYCHIATRIC DISORDERS
University of Minnesota, Barry Rittburg, MD - DBS,

Minneapolis, MN rittb001@umn.edu
Department of Psychiatry VNS, TMS

Neurosurgery DBS
Mayo Clinic, Department of Susannah J. Tye, PhD -

Neurosurgery DBS
CLINICAL EXPERTISE: STROKE
University of Minnesota, James R. Carey, PhD, PT,

Minneapolis, MN carey007@umn.edu
Program in Physical Therapy FAPTA - TMS, fMRI
University of Minnesota, Teresa Jacobson Kimberley,

Minneapolis, MN tjk@umn.edu
Brain Plasticity Laboratory PhD, PT - TMS, fMRI
University of Minnesota, Bernadette Gillick, PhD, MS,

Minneapolis, MN gillick@umn.edu
Brain Plasticity Laboratory PT - TMS, fMRI
Wynn Legon, PhD -

Minneapolis, MN TMS, tACS / tDCS, and wlegon@umn.edu
Brain Plasticity Laboratory
Ultrasound Stimulation, fMRI
Department of Biomedical
Minneapolis, MN Bin He, PhD - TMS, tDCS binhe@umn.edu
Engineering, Center for
Neuroengineering

SURGICAL EXPERTISE

Rochester, MN - 507.284.8008
Neurosurgery
Fairview Hospital, Spine and

Edna, MN Paul Gigante, MD - SCS 952.836.3695
Brain Clinic
University of Minnesota, Stefanie B. Yorek, contact

Minneapolis, MN yorek001@umn.edu
Experimental Surgical Services for appointment scheduling
Division of Gastrointestinal &
Minneapolis, MN - 612.625.8446
Bariatric Surgery, Medical Center
Department of Surgery
Movement Disorders & Epilepsy
Surgery Center, Medical Center
Neurosurgery Clinic, Medical Minneapolis, MN - 612.624.6666
Center Department of Surgery
University of Minnesota, Center

for Minimally Invasive Surgery,
Medical Center Department of
Surgery

CLINICAL CENTERS
Mayo Clinic, Traumatic Brain

Rochester, MN Nicole L. Dernbach tbims@mayo.edu
Injury Program
VA Office of Research & Princess Osei-Bonsu,

Development - Polytrauma / PhD, MSPH - PBRI,
Minneapolis, MN princess.osei-bonsu@va.gov
Blast-Related Injuries - Quality Implementation Research
Enhancement Research Initiative Coordinator
Mayo Clinic, Alzeimer's Disease

Rochester, MN - mayoadc@mayo.edu
Research Center
Mayo Clinic, Diabetes Center Rochester, MN John Miles, MD miles.john@mayo.edu
Mayo Clinic, Migraine Research migraineresearchprogram@

Rochester, MN -
Program mayo.edu
Dr. Catherine C. Welch,

Minnesota Obesity Center St. Paul, MN mnoc@tc.umn.edu
Program Coordinator
University of Minnesota, Brain

Plasticity Laboratory
Mayo Clinic, CT Clinical Trials

Rochester, MN - ctcic@mayo.edu
Innovation Center
University of Minnesota, The

Memory Clinic, The N. Bud
Minneapolis, MN - memclin@umn.edu
Grossman Center for Memory
Research and Care

IMAGING CENTERS
University of Minnesota, Center Deb Morgan, Executive

Minneapolis, MN deb@cmrr.umn.edu
for Magnetic Resonance Research Assistant

Minneapolis, MN - ccir@umn.edu
for Clinical Imaging Research
Mayo Clinic, Center for Advanced

Rochester, MN Stephen J. Riederer, PhD riederer@mayo.edu
Imaging Research
Division of Gastrointestinal &
Bariatric Surgery, Medical Center
Biomedical Functional Imaging and Minneapolis, MN - 612.626.1114
Neuroengineering Laboratory
Mayo Clinic, Center for Clinical

Rochester, MN - 507.255.7101
and Translational Science (CCaTS)
University of Minnesota, Clinical Rosalyn Segal,

Minneapolis, MN rsegal@umn.edu
and Translational Science Institute Administrative Director
Mayo Clinic, Evidence-Based

Rochester, MN - 507.266.1829
Practice Research Program
Fairview Research research@fairview.org

St. Paul, MN -
Administration Helpline: 612.672.7692
Neuromodulation Research and Minneapolis, MN Dr. Matthew D. Johnson john5101@umn.edu
Technology Laboratory
University of Minnesota, Institute

Minneapolis, MN - iem@umn.edu
for Engineering

Minneapolis, MN - cne@umn.edu
for Neuroengineering

RESEARCH CENTERS
University of Minnesota, Center Kathleen A. Harder, PhD,

Minneapolis, MN kharder@umn.edu
for Design in Health Director
University of Minnesota, Brain

Sciences Center, Minneapolis Minneapolis, MN Amy Wicklund, Administrator bsc@umn.edu
Veterans Affairs Medical Center
University of Minnesota, Institute Rosalyn Segal,

Minneapolis, MN rsegal@umn.edu
for Translational Neuroscience Administrative Director
University of Minnesota, National

Tim Ebner, PhD, Co-Director ebner001@umn.edu
Institute of Neurodegenerative Minneapolis, MN
Harry Orr, PhD, Co-Director orrxx002@umn.edu
Disorders & Stroke Center
University of Minnesota, Office of

the Vice President for Research
MnDRIVE - Brain Conditions

Initiative, University of Minnesota, Tim Ebner, PhD,
Minneapolis, MN ebner001@umn.edu
Office of the Vice President for Research Lead
Research
University of Minnesota, Greg Peterson,

Minneapolis, MN gkpeters@umn.edu
Medical Devices Center (MDC) Innovation Collaborator

ADDITIONAL RESOURCES (MINNESOTA / USA / GLOBAL): POLICY, EDUCATION & ADVOCACY
Organization City, State Contact Info Summary

Medical Device Public-private partnership working to
Innovation Consortium St. Louis Park, MN 952.314.1255 advance medical device regulatory
(MDIC) science.
Minnesota High Tech Innovation and tech association that

Minneapolis, MN 952.230.4555
Association advocates on behalf of field.
Neurotechnology
info@neurotechindustry. Accelerates neurotechnology research,
Industry Organization San Francisco, CA
org development and commercialization.
(NIO)
Promotes multidisciplinary
North American
cwelber@ collaboration among clinicians,
Neuromodulation Chicago, IL
neuromodulation.org scientists, engineers, and others to
Society (NANS)
advance neuromodulation.
Nonprofit group of clinicians, scientists,
The International
ins@neuromodulation. and engineers dedicated to scientific
Neuromodulation San Francisco, CA
com development and awareness of
Society (INS) neuormodulation.
ADDITIONAL RESOURCES (MINNESOTA / USA / GLOBAL): MARKET REPORTS
Organization City, State Contact Info Summary

Provides neurotech industry
NeuroInsights San Francisco, CA info@neuroinsights.com newsletters, market reports,
investment conferences and advisory.
Offers information about neurotech

Neurotech Reports San Francisco, CA 415.546.1259 field and future developments that will
affect VC, research, and start-ups.

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SECTOR LANDSCAPES: NEUROMODULATION

Copyright 2015 by LifeScience Alley. All rights reserved.

About Sector Landscapes Publications

Anastasia N. Zink, PhD Candidate, Graduate Program in Neuroscience, UMN

Amanda K. Weber, LifeScience Alley Design Consultant

LifeScience Alley's intelligence and research work is generously supported by our

About LifeScience Alley

Three Minnesota companies were awarded their The global

+ 42 companies providing products and services.

+ 25+ research and clinical centers for neuromodulation and related

+ $1 billion in federal research funding and life science investments in

+ Minnesota is ranked 1st in US for: electromedical manufacturing

[2] NEUROMODULATION IN MINNESOTA 10

The Neuromodulation Industry has a strong history in Minnesota and

OVERVIEW OF MINNESOTA INDUSTRY 13

IMPLANTABLE & MINIMALLY INVASIVE SYSTEMS 15

NON-SURGICAL STIMULATION SYSTEMS 17

[3] FUTURE FORECAST OF NEUROMODULATION

[4] NEUROMODULATION RESOURCES DIRECTORY 27

[5] CLINICAL, SURGICAL, RESEARCH & BUSINESS

FDA Neuromodulation Trials Open Worldwide

FIGURE 2. Global Locations of Major Neuromodulation Companies 5

FIGURE 3. Neuromodulation Global Revenue Fiscal Year 2013 5

FIGURE 4. Indications Approved and Under Investigation 7

FIGURE 5. Minnesota Companies by Anatomical Target 11

Cumulative Growth of Neurosurgery & Neuromodulation

BRAIN: TRANSCRANIAL ELECTRICAL STIMULATION // 9%

The neuromodulation market is dominated by three medical device giants

Significant industry activity is focused on:

+ Producing or acquiring de-risked technology for new patient markets.

+ Developing novel delivery systems specialized for unique anatomical

Neuromodulation | Section 1 | Global Overview of Neuromodulation Industry 3

Implantable devices for brain stimulation deliver electricity deeply via

Minimally invasive neuromodulation can be achieved by transcutaneous

Non-surgical or non-invasive devices act through a variety of modalities.

[Minnesota's] become a local mecca for neuromodulation just

Neuromodulation | Section 1 | Global Overview of Neuromodulation Industry 4

FIGURE 3. NEUROMODULATION GLOBAL REVENUE FISCAL YEAR 2013

ST. JUDE MEDICAL

Neuromodulation | Section 1 | Global Overview of Neuromodulation Industry 5

Neuromodulation devices are registered in over 1000 on-going FDA-

Neuromodulation is an area that still has tremendous

Neuromodulation | Section 1 | Global Overview of Neuromodulation Industry 6

FDA STATUS APPROVED INDICATIONS INVESTIGATIONAL INDICATIONS

Neuromodulation | Section 1 | Global Overview of Neuromodulation Industry 7

Device Therapy Indications

Parkinson's disease, Essential

Intrathecal Infusion Pump Cancer pain, Chronic pain,

Gastric Electrical Nausea / vomiting from

Sacal Neuromodulation Overactive bladder, Bowel

AdaptiveStim + Spinal Cord Stimulation -

Boston Scientific Corporation (Marlborough, MA)

Device Therapy Indications (*HDE)

Vercise Deep Brain Stimulation Parkinson's disease*

Chronic pain, Orthopedic

Chronic pain, Orthopedic

Vessix Renal Denervation Hypertension*

Neuromodulation | Section 1 | Global Overview of Neuromodulation Industry 8

Device Therapy Indications (*IDE / CE)

Libra, Brio Deep Brain Stimulation Movement disorders*

Genesis Optic Nerve Stimulation Chronic migraine*

Greatbatch, Inc., (Plano, TX) is a leading developer and

Device Therapy Indications (*CE)