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Minnesota Capability Brief:
NEUROMODULATION
1
The Market for Neurotechnology: 2014-2018. NeuroTechReport.com (March 2014)
2
Global Neurostimulation/Neuromodulation Market. MicroMarketMonitor (Feb. 2015)
3
Evaluate MedTech Report (Oct. 2014)
4
NSF & NIH reports (Jan. 2015)
5
LifeScience Alley, Minnesota Life Science Investment Activity: 2014 Annual Report
6
https://apps.deed.state.mn.us/lmi/qcew/ResultsDisp.aspx (NAICS 334510)
7
https://apps.deed.state.mn.us/lmi/qcew/ResultsDisp.aspx
8
LifeScience Alley, Alley Insights (April 2015)
Executive Summary
Three Minnesota companies were awarded their first
Premarket Approval (PMA) or Humanitarian Device
Exemption (HDE) approval from FDA for neuromodu-
lation devices between June 2014 and January 2015.
Activity in the state spans all major target regions of
the nervous system: brain, spine, and periphery. The
Minnesota medical device ecosystem is tailored for ac-
tive implantable technology and electrotherapeutics.
Technical expertise is available for all stages of a prod-
uct’s life-cycle, including pre/clinical research, prod-
uct development, and commercialization. The Mayo
Clinic and University of Minnesota are leading research
institutions that attract world-class scientists and cli-
nicians. Both institutions invest competitively in active
programming to engage industry partnerships and pro-
mote technology commercialization. Minnesota’s early
and continued foothold in the medical device industry
provides a mature foundation, open for innovation and
entrepreneurship in neuromodulation.
Key Findings:
• 27 companies with major operations in Minnesota
		
– 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 20144,5
• 	 Minnesota is ranked 1st
in U.S. for:
		
– Electromedical manufacturing employment6
		
– Medical device patents7
		
– PMA/510(k) awards from FDA for complex
			 neurological devices8
Minnesota
Neuromodulation
Capabilities
Figure 2. MN companies by type of neuromodulation device.
Figure 1. Global revenue 2013.	
The global market for neuromodulation devices is strong and projected
to double by 2018, reaching $6-7 billion1,2
. Minnesota-based Medtronic
and St. Jude Medical account for 72% of worldwide sales3
.
1
Market
Minnesota-based compa-
nies were the first to com-
mercialize devices for Deep
Brain Stimulation (DBS),
Spinal Cord Stimulation
(SCS), and Peripheral Nerve
Stimulation (PNS). Minne-
sota-based companies con-
tinue to hold a substantial
(72%) share of the $3.5 bil-
lion global market, which is
estimated to reach $6-7 billion by 20189,10
.
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
Devices
Neuromodulation therapies are available in
implantable, minimally invasive, and non-sur-
gical options.
Implantable devices for neuromodulation of
the brain contain a programmable stimulation
unit with an internal power supply. Electricity
is delivered via ‘depth’ electrodes placed deep
in the brain or cortical electrode arrays placed
on the brain surface. Similar technology is
used for stimulating the spine and peripheral
nerves. Implanted drug pumps that deliver
small molecules directly to the cerebrospinal
fluid also achieve targeted neuromodulation.
Minimally invasive neuromodulation is achieved by
transcutaneous or percutaneous (through the skin)
stimulation via small needle-like electrodes and is
typically restricted to the spine and superficial nerves.
Non-surgical or non-invasive devices act through
many modalities. Neuromodulation of the brain and
spine are achieved through electrical direct or alter-
nating current, ultrasound, and magnetic fields. Elec-
trical stimulation is delivered to muscles and wounds
by paddle-style electrodes placed topically and often
used to treat pain and atrophy.
Figure 3. Global neuromodulation trials by subsector. Total open
trials N=1,014. Abbreviations: Neuromuscular Electrical Stimulation
(NMES), Transcutaneous Electrical Stimulation (TENS), Deep Brain
Stimulation (DBS), Transcranial Magnetic Stimulation (TMS), Tran-
scranial Electrical Stimulation (TES).
9
Global Neurostimulation/Neuromodulation Market. MicroMarketMonitor (Feb. 2015)
10
The Market for Neurotechnology: 2014-2018. NeuroTechReport.com (March 2014)
Global Overview
“Minnesota has 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. There’s a real
density of neuromodulation here. Not only are all the industry
giants physically present here but there’s a lot of feeder medical
device companies supporting it, too.”
– Gregory Molnar, PhD, Director of Neuroscience & Discovery, Medtronic plc	
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.
2
11
https://clinicaltrials.gov, searched Jan. 20, 2014.
12
https://clinicaltrials.gov, searched Jan. 20, 2014.
Indications
FDA approval of neuromodulation devices and indica-
tions is still somewhat limited (see Table 1), in part
due to long innovation life-cycles, clinical challenges,
and uncertainty of regulatory outcomes. These issues
are being addressed head-on by Minnesota’s Medical
Device Innovation Consortium (MDIC) and LifeScience
Alley. The last two years have seen a boom in approv-
als with new announcements occurring nearly monthly.
Neuromodulation devices are registered in over 1,000
ongoing FDA-regulated clinical trials worldwide11
.
These trials are investigating over 1,300 indications,
including metabolic disorders, inflammation, migraine,
and psychiatric disorders12
. Categories or types of indi-
cations under investigation for the three major types
of commercial platforms are listed in Table 1.
Table 1. Indications approved and under investigation for Deep Brain, Spinal Cord, and Peripheral Nerve Stimulation.
FDA Status
Deep Brain
Stimulation (DBS)
Spinal Cord
Stimulation (SCS)
Peripheral Nerve
Stimulation (PNS)
APPROVED
INDICATIONS
Parkinson’s disease,
Essential tremor, Epilepsy,
OCD
Chronic pain due to Failed
Back Syndrome, Chronic
Regional Pain Syndrome,
Peripheral neuropathy, and
Ischemic pain
Obstructive Sleep Apnea,
Central Sleep Apnea,
Hypertension, Obesity,
Incontinence,
Heart failure, Migraine
INVESTIGATIONAL
INDICATIONS (#)
133 165 120
INVESTIGATIONAL
INDICATIONS
(Categories)
Behaviors and mental
disorders
Cancers and other
neoplasms
Diseases and abnormalities
at or before birth
Ear, nose, and throat
diseases
Heart and blood diseases
Muscle, bone, and
cartilage diseases
Nervous system diseases
Nutritional and metabolic
diseases
Skin and connective tissue
diseases
Substance related
disorders
Symptoms and general
pathology
Viral diseases
Wounds and injuries
Bacterial and fungal
diseases
Behaviors and mental
disorders
Blood and lymph
conditions
Cancers and other
neoplasms
Ear, nose, and throat
diseases
Eye diseases
Heart and blood diseases
Immune system diseases
Muscle, bone, and
cartilage diseases
Nervous system diseases
Nutritional and metabolic
diseases
Skin and connective tissue
diseases
Symptoms and general
pathology
Viral diseases
Wounds and injuries
Behaviors and mental
disorders
Gland and hormone
related diseases
Heart and blood diseases
Muscle, bone, and
cartilage diseases
Nervous system diseases
Nutritional and metabolic
diseases
Substance related
disorders
Symptoms and general
pathology
Urinary tract, sexual
organs, and pregnancy
conditions
Wounds and injuries
3
“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)
Medtronic plc (Minneapolis, MN – operational headquarters) holds a dominant pres-
ence 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 upcom-
ing merger with Covidien.
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 Scientific’s Cardiac
Rhythm Management Group, located in Arden Hills, MN, and the neuromodulation division located in Valencia,
CA.
St. Jude Medical, Inc., (St. Paul, MN) is a leading producer of medical technol-
ogy 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.
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 inter-
national OEM capabilities.
MAJOR PLAYERS
Device Therapy Indications (*HDE)
Vercise™ Deep Brain Stimulation Parkinson’s disease*
Precision Spectra™ Spinal Cord Stimulation Chronic pain, Orthopedic surgery
Precision™
Plus Spinal Cord Stimulation Chronic pain, Orthopedic surgery
Vessix™ Renal Denervation Hypertension*
Device Therapy Indications (*IDE/CE)
Libra™
, Brio™ Deep Brain Stimulation Movement disorders*
Prodigy™*
, Eon™
, Protégé™ Spinal Cord Stimulation Pain*
Genesis™ Optic Nerve Stimulation Chronic migraine*
Device Therapy Indications (*CE)
Algostim™
, Algovita™ Spinal Cord Stimulation Chronic pain*
Device Therapy Indications
Activa® Deep Brain Stimulation
Parkinson’s disease, Essential
tremor, Dystonia, OCD
SynchroMed®
II
Intrathecal Infusion Pump (Drug
Delivery)
Cancer pain, Chronic pain,
Severe spasticity
Enterra® Gastric Electrical Stimulation Nausea/vomiting from gastroparesis
InterStim® Sacral Neuromodulation Systems
Overactive bladder, Bowel
incontinence, Urinary retention
AdaptiveStim®
+SureScan® Spinal Cord Stimulation – MRI
compatible
Chronic pain
4
See Appendix 1 for directory and contact information for companies listed above and additional businesses
providing supporting goods and services.
NEUROMODULATION IN MINNESOTA
BRAIN
Boston Scientific
Functional Neuromodulation
Medtronic
Monteris Medical
St. Jude Medical
SPINAL CORD
Boston Scientific
Greatbatch Medical
Mainstay Medical
Medtronic
St. Jude Medical
NERVES
Advanced Bionics
BioControl Medical
Boston Scientific
Cardionomic
Chattanooga Group
Cogentix Medical
(Uroplasty)
CVRx
Empi
Enopace Biomedical
EnteroMedics
Envoy Medical
Holaira
Inspire Medical Systems
Medi-Stim
Medtronic
Novum Therapeutics
Respicardia
SPR Therapeutics
St. Jude Medical
Uni-Patch
WR Medical Electronics
Figure 4. MN companies by anatomical target.
5
Minnesota supports a thriv-
ing and diverse ecosystem for
neuromodulation enterprise.
There are 27 companies with
headquarters or significant op-
erations in Minnesota respon-
sible for producing at least 40
stimulation systems across all
platform areas (Figure 2 and
Figure 3). Another 40 compa-
nies work in the surrounding
space, offering contract-based
expertise in intellectual prop-
erty (IP), design, engineering,
surgery, quality, regulatory, fi-
nance, manufacturing, patient
data, and clinical testing. Min-
nesota established itself early
as a source of neurological ex-
pertise and continues to show
rapid growth of new industry
development (Figure 5).
Funding for the life sciences is
on the rise and holding firm. In 2014, the state at-
tracted over $1 billion for research and enterprise in
the life sciences. More than 1,000 federal research
grants worth $740.6 million were awarded, up 5.2%
from 201313,14
. 2014 also saw a six-year high of $430
million invested in life science businesses, with $320
million (74%) going to medical device companies15
.
Minnesota’s
global po-
sitioning in
the neuro-
modulation
industry is
well-estab-
lished. Having grown on the shoulders of the cardiac
pacemaker industry, neuromodulation has deep roots
in Minnesota and a wide reach. Greg Molnar, PhD, Di-
rector 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. Still,
Medtronic’s R&D headquarters for neuromodulation
are in Minnesota. The convergence of all that infor-
mation and activity comes together to business and
decisions based here in Minneapolis.” Gregory Molnar,
PhD, Director of Neuroscience & Discovery, Medtronic
plc emphasized that the announcement to retain neu-
romodulation operations in Minnesota following the
Covidien merger, the largest in medical device history,
is a clear indicator of the value of having such a criti-
cal mass of industry activity in Minnesota.
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 patents16
. To
promote early stage ventures in healthcare and medi-
cal technology, a variety of startup incubator spaces
and accelerators complement community- and mem-
ber-based programs geared toward education and
network expansion for entrepreneurs working with
biomedical technology. In addition to the major play-
ers and supporting industry, the University of Minne-
sota 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 pro-
vide structured systems for IP development, commer-
cialization, and licensing.
Figure 5. Growth of neurosurgery and neuromodulation in MN.
Source (2014) Millions
Life Science Investments $430
NIH Awards $446
NSF Awards $155
TOTAL $1,031
13
http://www.startribune.com/local/minneapolis/288484351.html?page=1&c=y
14
http://projectreporter.nih.gov/reporter.cfm; http://www.nsf.gov/awardsearch/
15
LifeScience Alley, Minnesota Life Science Investment Activity: 2014 Annual Report
16
mn.gov/deed, Compare MN and metropolitan areas
“Minnesota is a Disneyland
for medical devices.”
– John Linehan, PhD, Clinical Professor of Biomedical
Engineering, Northwestern University
6
Deep Brain Stimulation (DBS)
Medtronic’s Activa®
system is the leading device op-
tion for treating Parkinson’s disease and essential
tremor (Humanitarian Device Exempt status for dys-
tonia and Obsessive Compulsive Disorder). Boston Sci-
entific is the other leading provider of a DBS system,
with Vercise™, approved for successful treatment of
Parkinson’s disease. While St. Jude Medical awaits
FDA approval of their DBS systems - Libra™, Libra XP™,
and Brio™ - they are approved for treatment of Par-
kinson’s and dystonia in Europe and Australia. Early
success in treating Parkinson’s is promising. However,
one entrepreneur with decades of experience in neu-
romodulation noted that the Parkinson’s market is
reaching saturation and faces significant competition
from pharmaceutical treatment options. In light of the
aging population, neurodegenerative disorders are of
significant interest. Functional Neuromodulation is
using Medtronic’s DBS platform in Phase I/II clinical
trials for early stage Alzheimer’s disease. Multiple un-
successful 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 pain. Medtronic’s AdaptiveStim® and
SureScan® systems 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 available product. St. Jude Medical
recently received FDA approval for its Protégé™
implantable pulse generator, the first fully
upgradeable neurostimulator system. Greatbatch,
well-known for producing electromedical compo-
nents, expects U.S. approval of their first fully-
functioning stimulation platform, Algovita™, in
mid-2015. Greatbatch’s neuromodulation product
development is performed by its subsidiary, the
QiG Group, located in Blaine, MN. Greatbatch’s
neuromodulation exper-tise is built primarily upon
mergers with two Minnesota neuromodulation bus-
inesses, 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 neuromod-
ulation-based therapies due to relatively easy surgical
access and an established historical body of medical
knowledge. Medtronic was quick to commercialize de-
vices in this area and recently expanded its portfolio
with the early 2015 acquisition of Uro-Solutions’ per-
cutaneous nerve stimulator to treat overactive blad-
der. Four mid-sized companies headquartered in the
Twin Cities (listed below) are approved to commer-
cially market peripheral nerve stimulation devices in
the U.S. Three of these companies received FDA ap-
proval between June 2014 and January 2015.
Cogentix Medical Inc., (Uroplasty) produces the Ur-
gent®
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 re-
storing cardiac and vascular function via the sympa-
thetic 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 de-
vice for stimulating the hypoglossal nerve to treat Ob-
structive Sleep Apnea. FDA awarded
PMA status in April 2014.
MINNESOTA - IMPLANTABLE &
MINIMALLY INVASIVE SYSTEMS
7
17
mn.gov/deed, Compare MN and metropolitan areas
18
https://apps.deed.state.mn.us/lmi/qcew/ResultsDisp.aspx (NAICS 334510)
19
https://apps.deed.state.mn.us/lmi/qcew/ResultsDisp.aspx (NAICS 334510)
Non-surgical Neuromodulation
Methods that achieve neuromodulation via non-inva-
sive or non-surgical means are the subject of more
than half (61%) of all FDA trials currently open world-
wide. Significantly more trials are targeting the brain
(38%) than peripheral nerves (23%). While under ac-
tive clinical investigation, non-surgical neuromodula-
tion devices represent a much smaller portion of the
commercial market.
Transcranial Magnetic and Ultrasound Stimulation
The University of Minnesota’s MINCEP Epilepsy Care
Center and Brain Plasticity Laboratory are leading
Minnesota’s efforts in therapeutic Transcranial Mag-
netic Stimulation (TMS) and Functional Ultrasound
Stimulation. Major research efforts are directed to-
ward stroke recovery and dystonia. Clinicians are
also exploring applications in treatment-resistant
depression and rehabilitation following brain-related
trauma. The center recently expanded due to notable
funding awards from MnDRIVE and NIH.
Neuromuscular Electrical Stimulation and Transcu-
taneous Electrical Nerve Stimulation (NMES/TENS)
DJO Global is the largest non-surgical orthopedic re-
habilitation device producer in the U.S. Two signifi-
cant acquisitions include Minnesota-based companies,
EMPI and Chattanooga Group, with the latter main-
taining operations in the state. Minnesota’s Medi-
Stim, also produces full electrotherapy systems and
garments for portable devices.
MINNESOTA - NON-SURGICAL
STIMULATION SYSTEMS
Medical Device Manufacturing
Minnesota produced the first FDA-approved neuro-
stimulation devices and continues to be a global
leader in active implantable medical devices. The
Minneapolis-St. Paul metropolitan area is the nation’s
leader in medical device patents and manufacturing
jobs17
. 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 wages18
. The roughly 13,000 workers in the state
are distributed across 66 establishments, 56 of which
are located in the greater metro area19
. In addition to
manufacturing, the medical device ecosystem is flour-
ishing 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 manage-
ment, regulatory, commercialization, and finance
(see Appendix 1).
Evergreen Medical Technologies, Inc. specializes
in active implantable medical device development,
manufacturing, testing, and clinical insight. The ma-
jority of clientele (60%) is local. Known for electro-
medical engineering expertise, 90% of contract efforts
focus on neuromodulation products.
Greatbatch Medical provides a wide variety of con-
tract 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 inno-
vation company, specializing in electronic and elec-
tromechanical devices. Minnetronix provides ideas,
innovation, and strategic guidance, as well as design,
development, and manufacturing services to medical
device companies.
MINNESOTA – SUPPORTING ENTERPRISE
“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
8
Clinical & Surgical Expertise
Minnesota has been the site for over 80 neuromodu-
lation clinical trials20
. Minnesota’s expertise in clini-
cal trials parallels the interests of the companies and
organizations within the area. Mayo Clinic and the
University of Minnesota established neurosurgery de-
partments early in the twentieth century, providing
an easily accessible source of expertise for developing
and testing implantable technology. See Appendix 2
for directory 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 U.S.
Education is consistently supported by the state legis-
lature and local programming. The University of Min-
nesota is ranked in the top 25 research universities in
the world by the Center for Measuring University Per-
formance. The university’s high standing is in part due
to the superior faculty and trainees affiliated with the
Medical School and College of Science & Engineering.
Healthcare
Minnesota’s thriving healthcare sector provides com-
plementary services and expertise to the neuromodu-
lation sector. UnitedHealth Group is the world’s larg-
est 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 headquartered in
downtown Minneapolis, offering both financial analy-
sis and investing opportunities. Multiple accelerators
and co-working spaces are available for healthcare
endeavors, both early stage and growing, including
Healthcare.mn and TreeHouse Health.
Supporting Organizations
Non-governmental organizations and state-based pro-
grams are important drivers of medical device success
in Minnesota. See Appendix 2 for additional support-
ing organizations.
MINNESOTA –
SUPPORTING INFRASTRUCTURE
LifeScience Alley spends significant efforts advo-
cating for federal and state legislation that pro-
motes 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 pub-
lic-private partnership among industry stakehold-
ers, governmental agencies, and patient/physician
groups. The MDIC is presently working with the FDA
to establish standardized safety guidelines for stim-
ulation parameters in nerve tissue.
BioAM, LLC, in Rochester, MN, is a community-
based organization promoting economic develop-
ment in life sciences through education and net-
working. BioAM works with regional organizations
like Destination Medical Center to elevate activities
in healthcare and medicine across the state.
The MN Neuromodulation Consortium was estab-
lished in January 2015 to provide a centralized ac-
cess point to the region’s extensive collection of
resources and expertise in neuromodulation.
20
https://clinicaltrials.gov, searched Jan. 20, 2014.
9
‘Closed-loop’ Systems
Recent advancements in neuroscience, electrical en-
gineering, and biosensors have enabled ‘closed-loop’
systems, capable of sensing ongoing brain or nerve
activity and incorporating it into stimulation param-
eters for optimized therapeutic efficacy in real-time.
California-based Neuropace’s RNS® System is the first
to 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 op-
togenetics and pharmacosynthetics, which make use
of genetics to achieve selective 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 therapeutically in their present itera-
tions due to limited acceptance of gene thera-
py in humans.
Non-surgical
While challenges to commercialization remain, non-
surgical options are gaining traction. Transcranial
electrical, magnetic, and ultrasound 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 de-
veloping small, portable devices to deliver small elec-
trical charges to ‘superficial’ nerves near the surface
of the body, e.g., via the ear canal like Novum Thera-
peutics.
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 dis-
eases and limited understanding of symptomatology
and etiology, as is the case with many psychiatric and
neurodegenerative disorders. This sets the stage for
numerous potential physiological targets, low compe-
tition 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 compo-
nent or could benefit from neurological interventions.
Metabolic disorders, like obesity and type 2 diabetes,
are growing at epidemic proportions and present sig-
nificant 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 neuromodula-
tion devices that are under clinical investigation by
numerous sponsors.
Prosthetics
In amputees and trauma victims, neuromodulation
is aiding recovery following injury by promoting re-
growth 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-computer interfaces to restore
feeling and mobility. Much of the development work
in this area is funded by the U.S. Department of De-
fense, 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 present-
ly limited to non-surgical methods and have reported
improvements in attention, anxiety, and mood. Devel-
opment 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, sig-
nificantly limiting potential revenues.
EMERGING TECHNOLOGY
UNMET NEEDS
“LifeScience Alley is great because
they continue to build connections
and focus on issues of the day.”
– Todd Langevin, President & COO, Functional Neuromodulation
10
Market growth is strong for neuromodulation-based
therapies; it is predicted to double in the next four
years21,22
. In the initial years of neurostimulation tech-
nology, Thom Gunderson, Senior Financial Analyst at
Piper Jaffray, noted that “the best and brightest tal-
ent was attracted to the success and stability of the
cardiac industry, which slowed innovation in the neu-
romodulation sector.” Today, “neuromodulation is an
open market with great potential that is attractive to
investors.”
Early safety demonstrations and lasting patient suc-
cesses in treating pain and Parkinson’s disease con-
tinue to bolster physician support for SCS and DBS,
respectively. Manufacturers of FDA-approved stimula-
tion systems are able to provide entrepreneurs with
verified technology for early-phase investigations,
ultimately leading to lower cost, lower risk clinical
trials.
Minnesota is a powerful global center for neuromodu-
lation industry. Minnesota established a strong lead
in neuromodulation therapies due to early success
in cardiac stimulation. Talent and technology is eas-
ily 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 eas-
ily take advantage of the close proximity by accessing
corporate talent on a consulting basis and leveraging
connections for favorable exit strategies.
Cheryl Matter, PhD
Vice President of Intelligence & Research, LifeScience Alley
cmatter@lifesciencealley.org
952.746.3817
Anastasia N. Zink
Research Fellow, LifeScience Alley
PhD Candidate, Graduate Program in Neuroscience, University of Minnesota
MARKET CLIMATE
SUMMARY
CONTRIBUTORS
This Capability Brief is a living document and will be updated with new information as it is discovered or
received. Please send any additional information for consideration to Cheryl Matter, PhD, Director of
Intelligence & Research, at cmatter@lifesciencealley.org or 952.746.3817.
Questions/Comments/Edits
21
Global Neurostimulation/Neuromodulation Market. MicroMarketMonitor (Feb. 2015)
22
The Market for Neurotechnology: 2014-2018. NeuroTechReport.com (March 2014)
11
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
ACKNOWLEDGEMENTS
12
Neuromodulation Devices
Advanced Bionics
(Parent Corporation: Sanova Holding A.G.)
Hopkins, MN; Stäfa, Switzerland
www.advancedbionics.com	
952.930.0686
		
Advanced Bionics produces a cochlear implant
for hearing loss.
BioControl Medical Ltd.
(Parent Corporation: Rainbow Medical)
Minneapolis, MN
www.biocontrol-medical.com	
	
BioControl Medical produces the CardioFit System
for vagal nerve stimulation to treat heart failure.
Boston Scientific Corporation		
Marlborough, MA; St. Paul, MN
www.bostonscientific.com		
508.683.4000; 651.582.4000	
Kelly Leadem
media@bsci.com
Boston Scientific develops and commercializes a
diverse neuromodulation device portfolio.
Cardionomic, Inc.
Forest Lake, MN
www.cardionomicinc.com
651.964.0170	
	
Cardionomic is developing a device for
neuromodulating the terminal branches of the
cardiac plexus to treat acute decompensated
heart failure (ADHF).
CerebralRx Ltd.
(Parent Corporation: Rainbow Medical, spinoff of
BioControl)
Minneapolis, MN
www.biocontrol-medical.com
CerebralRx produces the FitNeS Vagus Nerve
Stimulator for refractory epilepsy and other
indications.
Chattanooga Group, Inc.
(Parent Corporation: DJO, LLC)
St. Paul, MN; Vista, CA
www.djoglobal.com/our-brands/chattanooga	
Chattanooga Group is the world’s largest
manufacturer of TENS/NMES rehabilitation
equipment for treating musculoskeletal,
neurological, and soft tissue disorders.
Cogentix Medical, Inc.
(Uroplasty, Inc.)	
Hopkins, MN
www.cogentixmedical.com
866.258.2182	
	
Cogentix Medical (Uroplasty, Inc.) produces Urgent®
PC Neuromodulation System for percutaneous tibial
nerve stimulation to treat overactive bladder and
associated symptoms of urinary urgency, urinary
frequency, and urge
incontinence.
CVRx, Inc.
Minneapolis, MN
www.cvrx.com		
763.416.2840		
CVRx Inc. produces Barostim neo™ for barostim
receptor stimulation in the carotid artery to treat
hypertension and heart failure.
Empi, Inc.
(Parent Corporation: DJO, LLC)
St. Paul, MN; Clear Lake, SD
www.djoglobal.com/our-brands/empi	
651.484.9381		
Empi is a leading distributor of non-invasive
electrical stimulation (TENS/NMES) devices and
other orthopedic products used for pain
management, orthopedic rehabilitation, physical
therapy, fitness, and sport performance
enhancement.
EnteroMedics, Inc.	
St. Paul, MN
www.enteromedics.com		
651.634.3003		
EnteroMedics produces the vBloc Maestro®
Rechargeable System for vagal nerve blocking in
the treatment of obesity.
APPENDIX 1:
Neuromodulation-Related
Businesses & Resources
13
Envoy Medical Corporation	
St. Paul, MN
www.envoymedical.com	
651.361.8000	
Envoy Medical produces Esteem, a middle-ear im-
plant for moderate to severe nerve-related (sensori-
neural) hearing loss.
Functional Neuromodulation Ltd.
Minneapolis, MN
www.functionalneuromodulation.com	
info@fxneuromod.com
866.296.4040
		
Functional Neuromodulation is developing DBS to
treat mild Alzheimer’s disease.
Greatbatch Medical
(Parent Corporation: Greatbatch, Inc.)
Plymouth, MN
www.greatbatchmedical.com
763.951.8181
	
Greatbatch Medical produces the Algovita™ and
Algostim™ spinal cord stimulation systems for
chronic pain; the company also designs and
manufactures critical components for complex
medical devices and procedures.
Holaira Medical, Inc.
Plymouth, MN
www.holaira.com		
763.450.2800
Holaira Medical produces a device for Targeted Lung
Denervation (TLD) to reduce overactive airway nerve
activity for treatment of chronic obstructive
pulmonary disease (COPD).
Inspire Medical Systems, Inc.
Maple Grove, MN
www.inspiresleep.com	
763.205.7970
	
Inspire Medical Systems sells Inspire®
(stimulator,
breathing sensor, stimulation lead, remote) for
Obstructive Sleep Apnea.
Mainstay Medical, Inc.
Dublin, Ireland; Plymouth, MN
www.mainstay-medical.com
Mainstay Medical produces the ReActiv8™
implantable spinal stimulation device for chronic
low back pain.
Medi-Stim, Inc.	
Wabasha, MN
www.medi-stim.com		
651.565.2400	
Medi-Stim produces a comprehensive line of
non-invasive electrotherapy products to treat
neural and muscular pain or rehabilitative
conditions.
Medtronic plc		
Dublin, Ireland; Minneapolis, MN
www.medtronic.com	
763.514.4000
Justin Ihle, Program Manager, Public Relations,
Neuromodulation
justin.ihle@medtronic.com
		
Medtronic develops and commercializes a diverse
neuromodulation device portfolio.
Monteris Medical, Inc.
Plymouth, MN; Winnipeg, Manitoba, Canada
www.monteris.com	
763.253.4710		
Monteris Medical produces the NeuroBlate®
System for MRI-guided neurosurgical ablation.
Novum Therapeutics, Inc.
Minneapolis, MN
www.novumthera.com
763.360.2931 	
Evan Johnston, President & CEO
ejohnston@NovumThera.com		
Novum Therapeutics produces Nocturne™
non-invasive neuromodulation of cranial nerve
through the ear canal for Obstructive Sleep Apnea.
Pepin Manufacturing, Inc.
Lake City, MN
www.pepinmfg.com
651.345.5655	
Pepin Manufacturing provides contract-based
product design, development, and manufacturing.
The company also offers electrotherapy electrodes,
device components, TENS stimulation units, and
their accessories.
QiG Group
(Parent Corporation: Greatbatch, Inc.)
Blaine, MN
www.qiggroup.com
763.786.7400
QiG Group has broad capabilities and expertise in
neurostimulation systems, which typically include
implantable pulse generators, leads, and
programmers.
14
Neuromodulation Devices (Cont’d)
Respicardia, Inc.
Hopkins, MN
www.respicardia.com
952.540.4470	
Respicardia produces the Remedē®
System for
phrenic nerve stimulation of the diaphragm to treat
sleep apnea.
SPR Therapeutics, LLC
(Parent corporation: NDI Medical LLC)		
Minneapolis, MN
www.sprtherapeutics.com
info@fxneuromod.com
216.378.9108
Mark Stultz, Senior Vice President, Market
Development
info@sprtherapeutics.com
216.378.9106 x103
		
SPR Therapeutics produces Smartpatch PNS and
Micropulse PNS systems, percutaneous peripheral
nerve stimulation systems for interventional pain
management.
St. Jude Medical, Inc.
St. Paul, MN
www.sjm.com		
651.756.2000
	
St. Jude Medical develops and commercializes a
diverse neuromodulation device portfolio.
Uni-Patch
(Parent Corporation: Covidien Ltd.)
Wabasha, MN
www.uni-patch.com		
651.565.2601	
Uni-Patch produces non-implantable electrodes
and garments for use with TENS, NMES, FENS,
post-operative, interferential, and galvanic
stimulation systems.
WR Medical Electronics Co.
Maplewood, MN
www.wrmed.com
651.604.8400	
WR Medical Electronics Co. produces the Hilger,
Silverstein Facial Nerve Stimulators for
electrodiagnostic testing for facial paralysis.
Design, Development, &
Manufacturing - Devices &
Components
Advanced Medical Electronics Corporation
Maple Grove, MN
www.ame-corp.com
763.463.4814	
Advanced Medical Electronics is a product-focused
research and development company specializing in
medical devices.
Cymbet Corporation		
Elk River, MN
www.cymbet.com
763.633.1780
Cymbet Corporation specializes in rechargeable,
thin film, solid state batteries for microelectronic
systems.
Devicix, LLC
Eden Prairie, MN
www.devicix.com		
952.368.0073
Devicix provides electromedical device design,
engineering, prototyping, development, regulatory/
certification, and commercialization expertise.
Donatelle Medical		
New Brighton, MN
www.donatellemedical.com		
651.633.4200	
Donatelle Medical provides medical device
expertise in development, manufacturing, and
commercialization of cardiac rhythm management,
neuromodulation, surgery, diabetes, and spine.
Evergreen Medical Technologies, Inc.		
St. Paul, MN
www.evergreenmedtech.com
651.646.7700
Randall Nelson
Evergreen Medical Technologies provides
electromedical device design, engineering,
prototyping, development, certification, and
regulatory expertise.
Greatbatch Medical
(Parent Corporation: Greatbatch, Inc.)
Minneapolis, MN
www.greatbatchmedical.com		
612.676.7200
Greatbatch Medical designs and manufactures
critical technologies that enhance the reliability
and performance of medical devices and procedures.
15
Heraeus Medical Components, LLC
(Parent Corporation: Heraeus Holding GmbH)
St. Paul, MN
www.heraeusmedicalcomponents.com		
651.792.8500	
		
Heraeus Medical Components delivers from ingot to
complex engineered assembly.
Matrix MedTech, Inc.
Maple Grove, MN
www.matrixmedtech.com
763.331.8671 	
Scott Olson
Scott.Olson@matrixmedtech.com
	
Matrix MedTech provides research, design,
development, prototyping, and manufacturing
expertise for medical device components.
Minnetronix, Inc.
St. Paul, MN
www.minnetronix.com		
651.917.4060	
Jeremy Maniak, COO
jmaniak@minnetronix.com
Minnetronix specializes in medical device design,
manufacturing, and IP.
Nortech Systems Incorporated		
Wayzata, MN
www.nortechsys.com		
952.345.2244	
Zak Tomczak, Business Development
ztomczak@nortechsys.com
612.590.7822
	
Nortech Systems provides electronics manufacturing
services (EMS) for the medical device industry and
others.
North American Science Associates Inc. (NAMSA)	
Minneapolis, MN
www.namsa.com		
763.287.3830
NAMSA is a medical research organization providing
expert regulatory, laboratory, clinical, and
compliance services to medical device
manufacturers.
Omnetics Connector Corporation		
Minneapolis, MN
www.omnetics.com
763.572.0656	
Omnetics Connector Corporation produces micro and
nano connectors for military, commercial, and
medical applications.
Pepin Manufacturing, Inc.
Lake City, MN
www.pepinmfg.com		
651.345.5655
		
Pepin Manufacturing provides R&D, design, and
manufacturing expertise, and also specializes in
custom electrodes for electrotherapy products.
PMT Corporation
Chanhassen, MN
www.pmtcorp.com
952.470.0866		
PMT manufactures products for neurosurgery,
orthopaedics, and plastic and reconstructive surgery.
Smiths Medical ASD Inc.
(Parent Corporation: Smiths Group plc)
St. Paul, MN
www.smiths-medical.com	
OEM.Inquiries@smiths-medical.com
651.633.2556		
Smiths Medical provides clinical and technical
support services for multi-national medical device
studies and global product distribution.
Stellar Technologies, Inc.
Brooklyn Park, MN
www.stellar-technologies.com
763.493.8556
Dennis Forcelle, Director of New Technologies
dforcelle@stellar-technologies.com
763.493.8556 x103	
Stellar Technologies provides product development,
qualification, and component manufacturing of
medical products, specializing in
neurostimulation.
Summit Medical, Inc.
(Parent Corporation: Shore Capital Partners, LLC)
St. Paul, MN
www.summitmedicalusa.com
customerservice@summitmedicalusa.com
651.789.3939
Summit Medical offers expertise in medical device
manufacturing, regulatory, quality, engineering,
sales, and marketing.
Teren Med Inc.
Minneapolis, MN
814.571.3888	
Teren Med is an electromedical equipment
manufacturer.
16
Design, Development &
Manufacturing - Devices &
Components (Cont’d)
Worrell Design, Inc. 		
Minneapolis, MN
www.worrell.com
612.638.6000
		
Worrell Design provides expertise in product design,
development, and strategy.
Neurosurgery Equipment
ev3 Inc.
(Parent Corporation: Covidien Ltd.)
Plymouth, MN
www.ev3.net
customerservice@ev3.net	
763.398.7000
	
ev3 offers medical devices for neurosurgery
applications.
IMRIS Inc.
Minnetonka, MN; Winnipeg, Manitoba, Canada
www.imris.com		
763.203.6300
Sales Inquiries, 763.203.6308;
Press Inquiries, Kevin Berger
kberger@imris.com
763.203.6332	
IMRIS offers multiple product lines for image guided
neurosurgery solutions.
Monteris Medical, Inc. 		
Plymouth, MN; Winnipeg, Manitoba, Canada
www.monteris.com
info@monteris.com
763.253.4710	
	
Monteris Medical produces medical devices for
MRI-guided neurosurgical ablation.
Summit Medical, Inc.
(Parent Corporation: Shore Capital Partners, LLC)
St. Paul, MN
www.summitmedicalusa.com
customerservice@summitmedicalusa.com
651.789.3939	
Summit Medical offers expertise in medical device
development for neurosurgery applications.
Finance
Bay City Capital LLC
San Francisco, CA
www.baycitycapital.com
415.676.3830 	
Bay City Capital is a life sciences investment firm
with a global diversified strategy ranging from seed
stage to public companies, and including innovation,
restructuring opportunities, and growth investing.
Brain Trust Accelerator Fund, L.P.		
Burlingame, CA
www.braintrustvc.com
650.375.0200
John M. Reher, Managing Director
Brain Trust Accelerator Fund focuses on early stage
investments that address the diagnosis and
treatment of brain-related diseases.
Craig-Hallum Capital Group LLC
Minneapolis, MN
www.craig-hallum.com		
612.334.6300
Craig-Hallum Capital Group is an institutional
investment banking firm with expertise in health
technology and medical devices.
Gopher Angels, LLC		
Minneapolis, MN
www.gopherangels.com		
763.231.9676
David Russick, Managing Director
david.russick@russickgroup.com	
Gopher Angels is a network of accredited investors
seeking to invest capital and expertise in early stage
Minnesota businesses. The organization is a member
of the Angel Capital Association.
Greatbatch, Inc.		
Frisco, TX
www.greatbatch.com
214.618.4982 
Betsy Cowell, VP Finance and Treasurer
ecowell@greatbatch.com
Greatbatch actively invests in targeted technology
and acquisitions to drive expansion in core and
adjacent markets.
17
Neuro Device Innovations (NDI) Medical, LLC
Minneapolis, MN
www.ndimedical.com		
info@ndimedical.com
612.770.0390
Neuro Device Innovations (NDI) Medical is a hybrid
venture capital and commercialization firm
focusing exclusively on innovative neurodevice
technologies that are intended to restore lost
neurological function, prevent damage, and reduce
the painful effects of disease and injury.
NeuroVentures Capital LLC
Charlottesville, VA
www.neuroventures.com		
info@neuroventures.com
434.297.1000
NeuroVentures Capital is a specialty venture capital
firm dedicated to investing in companies focused
on discovery, development, and marketing of new
therapeutics and technologies to treat Central
Nervous System disorders.
Oak Investment Partners
Minneapolis, MN
www.oakinv.com		
612.339.9322
Oak Investment Partners is a private equity firm
focusing on venture capital investments in
companies developing systems and services in
healthcare and other industries.
Piper Jaffray Companies
Minneapolis, MN
www.piperjaffray.com		
612.303.6000
Piper Jaffray is a well-established investment
banking firm with expertise in health technology and
medical devices.
RAIN Source Capital
St. Paul, MN
www.rainsourcecapital.com		
651.632.2140
RAIN Source Capital organizes community-based
networks of investors, capital, and expertise to
benefit private investors, private companies, and
communities through leadership and ROI.
Shore Capital Partners, LLC
Chicago, IL
www.shorecp.com
info@shorecp.com		
312.348.7580
Shore Capital Partners is a healthcare-focused lower
middle market private equity firm that specializes
in partnering with companies that have between $5
and $50 million of revenue.
Smiths Group plc
London, England
www.smiths.com
T.+44 (0) 20.7808.5512 		
Peter Durman, Director, Investor Relations &
Corporate Communications
investor.relations@smiths.com
Smiths Group buys businesses that add
complementary technologies and products, expand
geographical footprint in emerging markets, or
leverage existing infrastructure to increase
shareholder returns.
Technology Partners
Palo Alto, CA
www.technologypartners.com
admin@technologypartners.com	
650.289.9001
Technology Partners builds and invests in venture
companies at all stages with a focus on life science
and clean technologies.
Third Rock Ventures, LLC
Boston, MA; San Francisco, CA
www.thirdrockventures.com
617.585.2000
Third Rock Ventures is a bi-coastal, multi-
disciplinary team that brings together the best of
science, strategy, business, and medicine.
Thomas McNerney & Partners, LLC
Minneapolis, MN
www.tm-partners.com
612.465.8660
Thomas McNerney & Partners is a healthcare venture
firm that invests in life science and medical
technology companies at all stages of development.
Twin Cities Angels
Minneapolis, MN
www.twincitiesangels.com
Twin Cities Angels provides a formal organization
for entrepreneurially-minded angel investors. Their
expertise is in medical devices, diagnostics, pharma,
and biotech.
Versant Ventures
San Francisco, CA
www.versantventures.com
415.801.8100
Versant Ventures is a leading healthcare investment
firm that invests across the healthcare sector with
an emphasis on the discovery and development of
novel therapeutics.
18
Intellectual Property -
Medical Devices
Beck & Tysver PLLC 		
Minneapolis, MN
www.becktysver.com
612.915.9633
		
Beck & Tysver is an innovative Minneapolis patent
law firm with experienced attorneys specializing in
software technology and medical devices.
BitLaw Legal Resource
Online Directory
www.bitlaw.com/links/firms.html
	
BitLaw Legal Resource is a free legal resource
focused on intellectual property; the service also
curates a list of IP Law Firms in MN.
Mayo Clinic Ventures
Rochester, MN
ventures.mayoclinic.org	
mayoclinicventures@mayo.edu
507.293.3900
Kelly Krajnik, krajnik.kelly@mayo.edu;
Andy Danielsen, danielsen.andrew@mayo.edu	
Mayo Clinic Ventures works closely with Mayo Clinic
physicians and scientists to mine inventions, ideas,
and discoveries that will truly transform healthcare.
Mueting, Raasch & Gebhardt, P.A.		
Minneapolis, MN
www.mrgs.com
612.305.1220
	
Mueting, Raasch & Gebhardt provides expertise in
all areas of patent law relating to the electrical and
mechanical arts.
Patterson Thuente Pedersen, P.A.
Minneapolis, MN
www.ptslaw.com
info@ptslaw.com
612.349.5740	
Patterson Thuente Pedersen excels at finding
strategic solutions to complex intellectual property
matters, with special expertise in technology IP.
The General Counsel, Ltd.
Minneapolis, MN
www.gcl.com
612.670.7687
Jonathan Eisenberg, Principal Attorney
jon.eisenberg@gcl.com
612.801.5659	
The General Counsel offers companies the
advantages of experienced in-house legal counsel
on an affordable, outsourced basis.
Other - Supporting Infrastructure
BioAM		
Rochester, MN
www.bioam.org
bioamroch@gmail.com
507.993.1918
BioAM is committed to engaging with local
entrepreneurs and connecting them with people and
resources their venture needs to be successful.
CoCo-MSP (Google for Entrepreneurs)
Multiple locations
www.cocomsp.com	
hello@cocomsp.com
612.545.5745
CoCo-MSP is one of nine North American tech hubs
in the Google for Entrepreneurs network providing
space, funding, and mentorship to help launch
innovative companies.
Destination Medical Center		
Rochester, MN
www.dmc.mn	
Destination Medical Center (DMC) is an innovative
economic development initiative to secure
Minnesota’s status as a global medical destination
now and in the future.
LifeScience Alley		
St. Louis Park, MN
www.lifesciencealley.org
952.542.3077
LifeScience Alley is a trade association working to
enable business success in the life science and health
technology industries by providing leadership,
advocacy, business referrals, and access to
intelligence and information.
Mayo Clinic Business Accelerator		
Rochester, MN
www.mcbusaccel.com
507.288.0208
Xavier Frigola
xfrigola@raedi.com
Mayo Clinic Business Accelerator provides
infrastructure that enables entrepreneurism for
the Rochester community.
Rochester Business Alliance 		
Rochester, NY
www.rochesterbusinessalliance.com
585.244.1800
19
Startup Venture Loft (SVL)
Minneapolis, MN
www.svl.co		
612.926.3878
Pete Kane
612.926.3878
Startup Venture Loft (SVL) is building a better
entrepreneurial ecosystem by providing Minnesota
startups with space, connections, and the resources
they need to be successful.
Treehouse Health
Minneapolis, MN
www.treehouse-health.com		
612.486.5932
TreeHouse Health is a healthcare innovation center
with an emphasis on health IT and care coordination;
it provides expertise, investment, space, networks,
and professional services.
University Enterprise Laboratories
St. Paul, MN
www.uelmn.org		
651.641.2800
Greg LaSalle
glasalle@uelmn.org
651.641.2803
University Enterprise Laboratories (UEL) is a
collaborative research center for early stage
bioscience ventures. They provide premier facilities
and services that enable innovation, growth, and
commercial success.
University of Minnesota - Business
Accelerator Program
Minneapolis, MN
diversity.umn.edu/bced/businessacceleratorprogram	
612.624.3578
Mauvalyn Bowen, PhD
bowen075@umn.edu
The University of Minnesota’s Business Accelerator
Program is a dynamic business mentorship-based
program designed to accelerate growth of early
stage, high-potential small businesses located in the
Twin Cities.
University of Minnesota - MN-IP: Minnesota
Innovation Partnerships
Minneapolis, MN
www.research.umn.edu/mn-ip	
612.625.3394
The University of Minnesota’s Minnesota Innovation
Partnerships (MN-IP) is designed to improve access to
university-developed technology while reducing the
risk and cost associated with licensing intellectual
property and sponsoring research.
University of Minnesota - Office for Technology
Commercialization (OTC)
Minneapolis, MN
www.research.umn.edu/techcomm
612.624.0550
The University of Minnesota’s Office for Technology
Commercialization (OTC) facilitates the transfer of
university research to licensees for the development
of new products and services that benefit the public
good, foster economic growth, and generate revenue
to support the University’s research and education
goals.
20
Clinical Expertise
Ablation
Samuel J. Asirvatham, MD – Neurovascular & PNS
Mayo Clinic, Department of Anesthesiology &
Pain Medicine
200 First St. SW
Rochester, MN 55905
507.284.2511
Depression
Barry Rittburg, MD – DBS, VNS, TMS
University of Minnesota, Department of Psychiatry
rittb001@umn.edu
612.273.9813
Epilepsy
Jamie J. Van Gompel, MD – DBS
Mayo Clinic, Department of Neurosurgery
& Otorhinolaryngology
200 First St. SW
Rochester, MN 55905
507.284.8008
Kendall H. Lee, MD, PhD - DBS
Mayo Clinic, Department of Neurosurgery
200 First St. SW
Rochester, MN 55905
Lee.Kendall@mayo.edu
507.284.8008
Squire (Matt) M. Stead, MD, PhD – DBS
Mayo Clinic, Department of Neurosurgery
200 First St. SW
Rochester, MN 55905
507.284.7341
Movement Disorders
David Rottenberg, MSc, MD - DBS
University of Minnesota, Department of Neurology
rotte001@umn.edu
612.467.4784
Anthony Santiago, MD – DBS
University of Minnesota, Department of Neurology
asantiag@umn.edu
612.301.1048
Jerrold Vitek, MD – DBS
University of Minnesota, Department of Neurology
vitek004@umn.edu
612.624.1903
Michael C. Park, MD - DBS
University of Minnesota, Department of Neurosurgery
200 First St. SW
Rochester, MN 55905
mcpark@umn.edu
612.626.4706
Anhar Hassan, MB, BCh – DBS
Mayo Clinic Department of Neurology
hassan.anhar@mayo.edu
507.284.2511
Kendall H. Lee, MD, PhD - DBS
Mayo Clinic, Department of Neurosurgery
200 First St. SW
Rochester, MN 55905
lee.kendall@mayo.edu
507.284.8008
Julie A. Fields, PhD, LP – DBS
Mayo Clinic, Department of Psychiatry
and Psychology
fields.julie@mayo.edu
507.284.2511
Squire (Matt) M. Stead, MD, PhD - DBS
Mayo Clinic, Department of Neurosurgery
200 First St. SW
Rochester, MN 55905
507.284.7341
Bryan T. Klassen, MD - DBS
Mayo Clinic Department of Neurology
klassen.bryan@mayo.edu
507.284.2511
Dr. Matthew D. Johnson – DBS (pre-clinical)
University of Minnesota, Department of
Biomedical Engineering
6-134 Hasselmo Hall
312 Church St SE
Minneapolis, MN 55455
john5101@umn.edu
612.626.6492
APPENDIX 2:
CLINICAL, SURGICAL, RESEARCH
& BUSINESS RESOURCES
Author’s note: List is not exhaustive and will be updated as needed.
21
Obesity
Charles Billington, MD – VNS
University of Minnesota, Department of Medicine
billi005@umn.edu
612.725.2000 x4423
Pain
Paul Gigante, MD - SCS
Spine and Brain Clinic
6545 France Ave. S., Ste 450D
Edina, MN 55435
952.836.3695
Michael C. Park, MD - DBS
University of Minnesota, Department of Neurosurgery
200 First St. SW
Rochester, MN 55905
mcpark@umn.edu
612.626.4706
Tim J. Lamer, MD – SCS, PNS, CNS-targeted
Drug Delivery
Mayo Clinic, Department of Anesthesiology
& Pain Medicine
200 First St. SW
Rochester, MN 55905
507.284.2511
Halena M. Gazelka, MD – SCS, PNS, CNS-targeted
Drug Delivery
Mayo Clinic, Department of Anesthesiology
& Pain Medicine
200 First St. SW
Rochester, MN 55905
507.284.2511
Jason S. Eldridge, MD – SCS, PNS, CNS-targeted
Drug Delivery
Mayo Clinic, Department of Anesthesiology
& Pain Medicine
200 First St. SW
Rochester, MN 55905
507.284.2511
Brenton M. Meier, MD – SCS, PNS, CNS-targeted
Drug Delivery
Mayo Clinic, Department of Anesthesiology
& Pain Medicine
200 First St. SW
Rochester, MN 55905
507.284.2511
Psychiatric Disorders
Barry Rittburg, MD – DBS, VNS, TMS
University of Minnesota, Department of Psychiatry
rittb001@umn.edu
612.273.9813
Kendall H. Lee, MD, PhD - DBS
Mayo Clinic, Department of Neurosurgery
200 First St. SW
Rochester, MN 55905
Lee.Kendall@mayo.edu
507.284.8008
Susannah J. Tye, PhD – DBS
Mayo Clinic, Department of Neurosurgery
200 First St. SW
Rochester, MN 55905
507.284.8008
Stroke
James R. Carey, PhD, PT, FAPTA – TMS, fMRI
University of Minnesota, Program in Physical Therapy
377 Children’s Rehab Center
carey007@umn.edu
612.626.2746
Teresa Jacobson Kimberley, PhD, PT - TMS, fMRI
University of Minnesota, Brain Plasticity Laboratory
tjk@umn.edu
612.626.4096
Bernadette Gillick, PhD, MS, PT – TMS, fMRI
University of Minnesota, Brain Plasticity Laboratory
gillick@umn.edu
612.626.3121
Wynn Legon, PhD - TMS, tACS/tDCS, and Ultrasound
Stimulation, fMRI
University of Minnesota, Brain Plasticity Laboratory
wlegon@umn.edu
612.626.1183
Bin He, PhD – TMS, tDCS
University of Minnesota, Department of Biomedical
Engineering, Center for Neuroengineering
6-124 Nils Hasselmo Hall
binhe@umn.edu
612.626.1115
Surgical Expertise
Mayo Clinic, Department of Neurosurgery
200 First St. SW
Rochester, MN 55905
507.284.8008
Fairview Hospital, Spine and Brain Clinic
6545 France Ave. S., Ste 450D
Edina, MN 55435
952.836.3695
22
Surgical Expertise (Cont’d)
University of Minnesota, Experimental
Surgical Services
Medical Center Department of Surgery
Stefanie B. Yorek, contact for appointment
scheduling
yorek001@umn.edu
612.625.4937
University of Minnesota, Division of Gastrointestinal
& Bariatric Surgery
Medical Center Department of Surgery
612.625.8446
University of Minnesota, Movement Disorders
& Epilepsy Surgery Center
Medical Center Department of Surgery
612.626.6688
University of Minnesota, Neurosurgery Clinic
Medical Center Department of Surgery
612.624.6666
University of Minnesota, Center for Minimally
Invasive Surgery
Medical Center Department of Surgery
612.672.7422
Clinical Centers
Mayo Clinic, Traumatic Brain Injury Program
200 First St. SW
Rochester, MN 55905
Nicole L. Dernbach
TBIMS@mayo.edu
507.255.0718
VA Office of Research & Development- Polytrauma/
Blast-Related Injuries - Quality Enhancement
Research Initiative
Princess Osei-Bonsu, PhD, MSPH - PBRI
Implementation Research Coordinator
princess.osei-bonsu@va.gov
612.467.7726
Mayo Clinic, Alzheimer’s Disease Research Center
200 First St. SW
Rochester, MN 55905
mayoadc@mayo.edu
507.284.1324
Mayo Clinic, Diabetes Center
200 First Street SW
Rochester, MN 55905
John Miles, MD
miles.john@mayo.edu
507.255.0001
Mayo Clinic, Migraine Research Program
Mayo Building, West Eighth Floor
200 First St. SW
Rochester, MN 55905
migrainersearchprogram@mayo.edu
507.266.7180
Minnesota Obesity Center
St. Paul, MN 55108
Dr. Catherine C. Welch, Program Coordinator
mnoc@tc.umn.edu
763.807.0559
University of Minnesota, Brain Plasticity Laboratory
306 Children’s Rehabilitation Center
426 Church Street SE
Minneapolis, MN 55455
612.626.4096
Mayo Clinic, CT Clinical Trials Innovation Center
200 First St. SW, Rochester, MN 55905	
CTCIC@mayo.edu
507.538.7723
University of Minnesota, The Memory Clinic
The N. Bud Grossman Center for Memory Research
and Care
5775 Wayzata Blvd in Suite #200,
Minneapolis, MN 55416
memclin@umn.edu
Clinic Appointments: 952.525.4500
Imaging Centers
University of Minnesota, Center for Magnetic
Resonance Research
2021 Sixth Street SE, Minneapolis, MN 55455
Deb Morgan, Executive Assistant
deb@cmrr.umn.edu
612.626.2001
University of Minnesota, Center for Clinical
Imaging Research
2021 Sixth Street SE, Minneapolis, MN 55455
ccir@umn.edu
612.626.6900
Mayo Clinic, Center for Advanced Imaging Research
200 First Street SW
Rochester, MN 55905
Stephen J. Riederer, PhD
riederer@mayo.edu
507.284.6209
University of Minnesota, Biomedical Functional
Imaging and Neuroengineering Laboratory
7-105 Hasselmo Hall, 312 Church St. SE,
Minneapolis, MN 55455
612.626.1114
23
Research Centers
Mayo Clinic, Center for Clinical and Translational
Science (CCaTS)
200 First Street SW
Rochester, MN 55905
507.255.7101
University of Minnesota, Clinical and Translational
Science Institute
717 Delaware Street SE, Second Floor
Minneapolis, MN 55414
ctsi@umn.edu
612.625.CTSI (2874)
Mayo Clinic, Department of Defense Medical
Research Office
Strategic Funding Office for Research
200 First St. SW
Rochester, MN 55905
Jon W. Zurn
strategicfunding@mayo.edu
507.266.4554
Mayo Clinic, Evidence-Based Practice
Research Program
Harwick Building, Room 2-54
Rochester, MN 55905
507.266.1829
Fairview Research Administration
2344 Energy Park Drive
Saint Paul, MN 55108
research@fairview.org
612.672.7690
Research Helpline: 612.672.7692
University of Minnesota, Neuromodulation Research
and Technology Laboratory
6-134 Hasselmo Hall
312 Church St SE
Minneapolis, MN 55455
Dr. Matthew D. Johnson
john5101@umn.edu
612.626.6492
University of Minnesota, Institute for Engineering
in Medicine
420 Delaware Street Southeast
725 Mayo Memorial Building, MMC 609
Minneapolis, MN 55455
iem@umn.edu
612.626.5493
University of Minnesota, Center for Neuroengineering
1-205 NHH, 312 Church Street, SE
Minneapolis, MN 55455
cne@umn.edu
612.625.7209
University of Minnesota, Center for Design in Health
1425 University Ave SE
Minneapolis, MN 55414
Kathleen A. Harder, PhD, Director
kharder@umn.edu
612.626.0026
University of Minnesota, Brain Sciences Center
Minneapolis Veterans Affairs Medical Center
One Veterans Drive
Minneapolis, MN 55417
Amy Wicklund, Administrator
bsc@umn.edu
University of Minnesota, Institute for
Translational Neuroscience
2101 6th Street SE
Minneapolis, MN 55455
Rosalyn Segal, Administrative Director
rsegal@umn.edu
612.625.6966
University of Minnesota, National Institute of
Neurodegenerative Disorders & Stroke Center
Tim Ebner, PhD, Co-Director
ebner001@umn.edu
612.626.6800
Harry Orr, PhD, Co-Director
orrxx002@umn.edu
612.625.3647
University of Minnesota, Office of the Vice President
for Research
101 Pleasant Street
Minneapolis, MN 55455
612.625.3394
MnDRIVE – Brain Conditions Initiative
University of Minnesota, Office of the Vice President
for Research
Tim Ebner, PhD, Research Lead
ebner001@umn.edu
612.626.6800
University of Minnesota, Medical Devices Center
(MDC)
Greg Peterson, Innovation Collaborator
Office Location: G217-08 Mayo Building
gkpeters@umn.edu
612.626.4615
24
Additional Resources (MN/US/Global)
Policy, Education & Advocacy
LifeScience Alley
1550 Utica Ave So, Suite 725,
St. Louis Park, MN 55416
connect@lifesciencealley.org
952.542.3077
Medical Device Innovation Consortium (MDIC)
1550 Utica Ave So, Suite 740
St. Louis Park, MN 55416
952.314.1255
Minnesota High Tech Association (MHTA)
400 South 4th Street, Suite 416
Minneapolis, MN 55415
952.230.4555
Neurotechnology Industry Organization (NIO)
Works to accelerate neurotechnology research,
development and commercialization, including
neuroscience companies, brain research institutes,
and patient advocacy groups.
North American Neuromodulation Society (NANS)
Promotes multidisciplinary collaboration among
clinicians, scientists, engineers, and others to
advance neuromodulation through education,
research, innovation and advocacy.
The International Neuromodulation Society (INS)
Nonprofit group of clinicians, scientists and
engineers dedicated to the scientific development
and awareness of neuromodulation.
Market Reports
NeuroInsights
Provides neurotech industry newsletters,
comprehensive market reports, neurotech
investment conferences and strategic advisory
services.
Neurotech Reports
Offers up-to-date and forward-looking information
about the field of neurotechnology and future
developments that will affect the venture capital,
research, and start-up communities.
25
®
Leading the conversation.
LifeScience Alley’s intelligence and research work
is generously supported by our Foundational Members.
3M | Boston Scientific | Mayo Clinic | Medtronic | St. Jude Medical

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Minnesota's Leadership in Neuromodulation

  • 1. ® Leading the conversation. Minnesota Capability Brief: NEUROMODULATION
  • 2. 1 The Market for Neurotechnology: 2014-2018. NeuroTechReport.com (March 2014) 2 Global Neurostimulation/Neuromodulation Market. MicroMarketMonitor (Feb. 2015) 3 Evaluate MedTech Report (Oct. 2014) 4 NSF & NIH reports (Jan. 2015) 5 LifeScience Alley, Minnesota Life Science Investment Activity: 2014 Annual Report 6 https://apps.deed.state.mn.us/lmi/qcew/ResultsDisp.aspx (NAICS 334510) 7 https://apps.deed.state.mn.us/lmi/qcew/ResultsDisp.aspx 8 LifeScience Alley, Alley Insights (April 2015) Executive Summary Three Minnesota companies were awarded their first Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) approval from FDA for neuromodu- lation devices between June 2014 and January 2015. Activity in the state spans all major target regions of the nervous system: brain, spine, and periphery. The Minnesota medical device ecosystem is tailored for ac- tive implantable technology and electrotherapeutics. Technical expertise is available for all stages of a prod- uct’s life-cycle, including pre/clinical research, prod- uct development, and commercialization. The Mayo Clinic and University of Minnesota are leading research institutions that attract world-class scientists and cli- nicians. Both institutions invest competitively in active programming to engage industry partnerships and pro- mote technology commercialization. Minnesota’s early and continued foothold in the medical device industry provides a mature foundation, open for innovation and entrepreneurship in neuromodulation. Key Findings: • 27 companies with major operations in Minnesota – 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 20144,5 • Minnesota is ranked 1st in U.S. for: – Electromedical manufacturing employment6 – Medical device patents7 – PMA/510(k) awards from FDA for complex neurological devices8 Minnesota Neuromodulation Capabilities Figure 2. MN companies by type of neuromodulation device. Figure 1. Global revenue 2013. The global market for neuromodulation devices is strong and projected to double by 2018, reaching $6-7 billion1,2 . Minnesota-based Medtronic and St. Jude Medical account for 72% of worldwide sales3 . 1
  • 3. Market Minnesota-based compa- nies were the first to com- mercialize devices for Deep Brain Stimulation (DBS), Spinal Cord Stimulation (SCS), and Peripheral Nerve Stimulation (PNS). Minne- sota-based companies con- tinue to hold a substantial (72%) share of the $3.5 bil- lion global market, which is estimated to reach $6-7 billion by 20189,10 . 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 Devices Neuromodulation therapies are available in implantable, minimally invasive, and non-sur- gical options. Implantable devices for neuromodulation of the brain contain a programmable stimulation unit with an internal power supply. Electricity is delivered via ‘depth’ electrodes placed deep in the brain or cortical electrode arrays placed on the brain surface. Similar technology is used for stimulating the spine and peripheral nerves. Implanted drug pumps that deliver small molecules directly to the cerebrospinal fluid also achieve targeted neuromodulation. Minimally invasive neuromodulation is achieved by transcutaneous or percutaneous (through the skin) stimulation via small needle-like electrodes and is typically restricted to the spine and superficial nerves. Non-surgical or non-invasive devices act through many modalities. Neuromodulation of the brain and spine are achieved through electrical direct or alter- nating current, ultrasound, and magnetic fields. Elec- trical stimulation is delivered to muscles and wounds by paddle-style electrodes placed topically and often used to treat pain and atrophy. Figure 3. Global neuromodulation trials by subsector. Total open trials N=1,014. Abbreviations: Neuromuscular Electrical Stimulation (NMES), Transcutaneous Electrical Stimulation (TENS), Deep Brain Stimulation (DBS), Transcranial Magnetic Stimulation (TMS), Tran- scranial Electrical Stimulation (TES). 9 Global Neurostimulation/Neuromodulation Market. MicroMarketMonitor (Feb. 2015) 10 The Market for Neurotechnology: 2014-2018. NeuroTechReport.com (March 2014) Global Overview “Minnesota has 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. There’s a real density of neuromodulation here. Not only are all the industry giants physically present here but there’s a lot of feeder medical device companies supporting it, too.” – Gregory Molnar, PhD, Director of Neuroscience & Discovery, Medtronic plc 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. 2
  • 4. 11 https://clinicaltrials.gov, searched Jan. 20, 2014. 12 https://clinicaltrials.gov, searched Jan. 20, 2014. Indications FDA approval of neuromodulation devices and indica- tions is still somewhat limited (see Table 1), in part due to long innovation life-cycles, clinical challenges, and uncertainty of regulatory outcomes. These issues are being addressed head-on by Minnesota’s Medical Device Innovation Consortium (MDIC) and LifeScience Alley. The last two years have seen a boom in approv- als with new announcements occurring nearly monthly. Neuromodulation devices are registered in over 1,000 ongoing FDA-regulated clinical trials worldwide11 . These trials are investigating over 1,300 indications, including metabolic disorders, inflammation, migraine, and psychiatric disorders12 . Categories or types of indi- cations under investigation for the three major types of commercial platforms are listed in Table 1. Table 1. Indications approved and under investigation for Deep Brain, Spinal Cord, and Peripheral Nerve Stimulation. FDA Status Deep Brain Stimulation (DBS) Spinal Cord Stimulation (SCS) Peripheral Nerve Stimulation (PNS) APPROVED INDICATIONS Parkinson’s disease, Essential tremor, Epilepsy, OCD Chronic pain due to Failed Back Syndrome, Chronic Regional Pain Syndrome, Peripheral neuropathy, and Ischemic pain Obstructive Sleep Apnea, Central Sleep Apnea, Hypertension, Obesity, Incontinence, Heart failure, Migraine INVESTIGATIONAL INDICATIONS (#) 133 165 120 INVESTIGATIONAL INDICATIONS (Categories) Behaviors and mental disorders Cancers and other neoplasms Diseases and abnormalities at or before birth Ear, nose, and throat diseases Heart and blood diseases Muscle, bone, and cartilage diseases Nervous system diseases Nutritional and metabolic diseases Skin and connective tissue diseases Substance related disorders Symptoms and general pathology Viral diseases Wounds and injuries Bacterial and fungal diseases Behaviors and mental disorders Blood and lymph conditions Cancers and other neoplasms Ear, nose, and throat diseases Eye diseases Heart and blood diseases Immune system diseases Muscle, bone, and cartilage diseases Nervous system diseases Nutritional and metabolic diseases Skin and connective tissue diseases Symptoms and general pathology Viral diseases Wounds and injuries Behaviors and mental disorders Gland and hormone related diseases Heart and blood diseases Muscle, bone, and cartilage diseases Nervous system diseases Nutritional and metabolic diseases Substance related disorders Symptoms and general pathology Urinary tract, sexual organs, and pregnancy conditions Wounds and injuries 3 “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)
  • 5. Medtronic plc (Minneapolis, MN – operational headquarters) holds a dominant pres- ence 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 upcom- ing merger with Covidien. 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 Scientific’s Cardiac Rhythm Management Group, located in Arden Hills, MN, and the neuromodulation division located in Valencia, CA. St. Jude Medical, Inc., (St. Paul, MN) is a leading producer of medical technol- ogy 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. 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 inter- national OEM capabilities. MAJOR PLAYERS Device Therapy Indications (*HDE) Vercise™ Deep Brain Stimulation Parkinson’s disease* Precision Spectra™ Spinal Cord Stimulation Chronic pain, Orthopedic surgery Precision™ Plus Spinal Cord Stimulation Chronic pain, Orthopedic surgery Vessix™ Renal Denervation Hypertension* Device Therapy Indications (*IDE/CE) Libra™ , Brio™ Deep Brain Stimulation Movement disorders* Prodigy™* , Eon™ , Protégé™ Spinal Cord Stimulation Pain* Genesis™ Optic Nerve Stimulation Chronic migraine* Device Therapy Indications (*CE) Algostim™ , Algovita™ Spinal Cord Stimulation Chronic pain* Device Therapy Indications Activa® Deep Brain Stimulation Parkinson’s disease, Essential tremor, Dystonia, OCD SynchroMed® II Intrathecal Infusion Pump (Drug Delivery) Cancer pain, Chronic pain, Severe spasticity Enterra® Gastric Electrical Stimulation Nausea/vomiting from gastroparesis InterStim® Sacral Neuromodulation Systems Overactive bladder, Bowel incontinence, Urinary retention AdaptiveStim® +SureScan® Spinal Cord Stimulation – MRI compatible Chronic pain 4
  • 6. See Appendix 1 for directory and contact information for companies listed above and additional businesses providing supporting goods and services. NEUROMODULATION IN MINNESOTA BRAIN Boston Scientific Functional Neuromodulation Medtronic Monteris Medical St. Jude Medical SPINAL CORD Boston Scientific Greatbatch Medical Mainstay Medical Medtronic St. Jude Medical NERVES Advanced Bionics BioControl Medical Boston Scientific Cardionomic Chattanooga Group Cogentix Medical (Uroplasty) CVRx Empi Enopace Biomedical EnteroMedics Envoy Medical Holaira Inspire Medical Systems Medi-Stim Medtronic Novum Therapeutics Respicardia SPR Therapeutics St. Jude Medical Uni-Patch WR Medical Electronics Figure 4. MN companies by anatomical target. 5
  • 7. Minnesota supports a thriv- ing and diverse ecosystem for neuromodulation enterprise. There are 27 companies with headquarters or significant op- erations in Minnesota respon- sible for producing at least 40 stimulation systems across all platform areas (Figure 2 and Figure 3). Another 40 compa- nies work in the surrounding space, offering contract-based expertise in intellectual prop- erty (IP), design, engineering, surgery, quality, regulatory, fi- nance, manufacturing, patient data, and clinical testing. Min- nesota established itself early as a source of neurological ex- pertise and continues to show rapid growth of new industry development (Figure 5). Funding for the life sciences is on the rise and holding firm. In 2014, the state at- tracted over $1 billion for research and enterprise in the life sciences. More than 1,000 federal research grants worth $740.6 million were awarded, up 5.2% from 201313,14 . 2014 also saw a six-year high of $430 million invested in life science businesses, with $320 million (74%) going to medical device companies15 . Minnesota’s global po- sitioning in the neuro- modulation industry is well-estab- lished. Having grown on the shoulders of the cardiac pacemaker industry, neuromodulation has deep roots in Minnesota and a wide reach. Greg Molnar, PhD, Di- rector 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. Still, Medtronic’s R&D headquarters for neuromodulation are in Minnesota. The convergence of all that infor- mation and activity comes together to business and decisions based here in Minneapolis.” Gregory Molnar, PhD, Director of Neuroscience & Discovery, Medtronic plc emphasized that the announcement to retain neu- romodulation operations in Minnesota following the Covidien merger, the largest in medical device history, is a clear indicator of the value of having such a criti- cal mass of industry activity in Minnesota. 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 patents16 . To promote early stage ventures in healthcare and medi- cal technology, a variety of startup incubator spaces and accelerators complement community- and mem- ber-based programs geared toward education and network expansion for entrepreneurs working with biomedical technology. In addition to the major play- ers and supporting industry, the University of Minne- sota 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 pro- vide structured systems for IP development, commer- cialization, and licensing. Figure 5. Growth of neurosurgery and neuromodulation in MN. Source (2014) Millions Life Science Investments $430 NIH Awards $446 NSF Awards $155 TOTAL $1,031 13 http://www.startribune.com/local/minneapolis/288484351.html?page=1&c=y 14 http://projectreporter.nih.gov/reporter.cfm; http://www.nsf.gov/awardsearch/ 15 LifeScience Alley, Minnesota Life Science Investment Activity: 2014 Annual Report 16 mn.gov/deed, Compare MN and metropolitan areas “Minnesota is a Disneyland for medical devices.” – John Linehan, PhD, Clinical Professor of Biomedical Engineering, Northwestern University 6
  • 8. Deep Brain Stimulation (DBS) Medtronic’s Activa® system is the leading device op- tion for treating Parkinson’s disease and essential tremor (Humanitarian Device Exempt status for dys- tonia and Obsessive Compulsive Disorder). Boston Sci- entific is the other leading provider of a DBS system, with Vercise™, approved for successful treatment of Parkinson’s disease. While St. Jude Medical awaits FDA approval of their DBS systems - Libra™, Libra XP™, and Brio™ - they are approved for treatment of Par- kinson’s and dystonia in Europe and Australia. Early success in treating Parkinson’s is promising. However, one entrepreneur with decades of experience in neu- romodulation noted that the Parkinson’s market is reaching saturation and faces significant competition from pharmaceutical treatment options. In light of the aging population, neurodegenerative disorders are of significant interest. Functional Neuromodulation is using Medtronic’s DBS platform in Phase I/II clinical trials for early stage Alzheimer’s disease. Multiple un- successful 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 pain. Medtronic’s AdaptiveStim® and SureScan® systems 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 available product. St. Jude Medical recently received FDA approval for its Protégé™ implantable pulse generator, the first fully upgradeable neurostimulator system. Greatbatch, well-known for producing electromedical compo- nents, expects U.S. approval of their first fully- functioning stimulation platform, Algovita™, in mid-2015. Greatbatch’s neuromodulation product development is performed by its subsidiary, the QiG Group, located in Blaine, MN. Greatbatch’s neuromodulation exper-tise is built primarily upon mergers with two Minnesota neuromodulation bus- inesses, 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 neuromod- ulation-based therapies due to relatively easy surgical access and an established historical body of medical knowledge. Medtronic was quick to commercialize de- vices in this area and recently expanded its portfolio with the early 2015 acquisition of Uro-Solutions’ per- cutaneous nerve stimulator to treat overactive blad- der. Four mid-sized companies headquartered in the Twin Cities (listed below) are approved to commer- cially market peripheral nerve stimulation devices in the U.S. Three of these companies received FDA ap- proval between June 2014 and January 2015. Cogentix Medical Inc., (Uroplasty) produces the Ur- gent® 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 re- storing cardiac and vascular function via the sympa- thetic 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 de- vice for stimulating the hypoglossal nerve to treat Ob- structive Sleep Apnea. FDA awarded PMA status in April 2014. MINNESOTA - IMPLANTABLE & MINIMALLY INVASIVE SYSTEMS 7
  • 9. 17 mn.gov/deed, Compare MN and metropolitan areas 18 https://apps.deed.state.mn.us/lmi/qcew/ResultsDisp.aspx (NAICS 334510) 19 https://apps.deed.state.mn.us/lmi/qcew/ResultsDisp.aspx (NAICS 334510) Non-surgical Neuromodulation Methods that achieve neuromodulation via non-inva- sive or non-surgical means are the subject of more than half (61%) of all FDA trials currently open world- wide. Significantly more trials are targeting the brain (38%) than peripheral nerves (23%). While under ac- tive clinical investigation, non-surgical neuromodula- tion devices represent a much smaller portion of the commercial market. Transcranial Magnetic and Ultrasound Stimulation The University of Minnesota’s MINCEP Epilepsy Care Center and Brain Plasticity Laboratory are leading Minnesota’s efforts in therapeutic Transcranial Mag- netic Stimulation (TMS) and Functional Ultrasound Stimulation. Major research efforts are directed to- ward stroke recovery and dystonia. Clinicians are also exploring applications in treatment-resistant depression and rehabilitation following brain-related trauma. The center recently expanded due to notable funding awards from MnDRIVE and NIH. Neuromuscular Electrical Stimulation and Transcu- taneous Electrical Nerve Stimulation (NMES/TENS) DJO Global is the largest non-surgical orthopedic re- habilitation device producer in the U.S. Two signifi- cant acquisitions include Minnesota-based companies, EMPI and Chattanooga Group, with the latter main- taining operations in the state. Minnesota’s Medi- Stim, also produces full electrotherapy systems and garments for portable devices. MINNESOTA - NON-SURGICAL STIMULATION SYSTEMS Medical Device Manufacturing Minnesota produced the first FDA-approved neuro- stimulation devices and continues to be a global leader in active implantable medical devices. The Minneapolis-St. Paul metropolitan area is the nation’s leader in medical device patents and manufacturing jobs17 . 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 wages18 . The roughly 13,000 workers in the state are distributed across 66 establishments, 56 of which are located in the greater metro area19 . In addition to manufacturing, the medical device ecosystem is flour- ishing 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 manage- ment, regulatory, commercialization, and finance (see Appendix 1). Evergreen Medical Technologies, Inc. specializes in active implantable medical device development, manufacturing, testing, and clinical insight. The ma- jority of clientele (60%) is local. Known for electro- medical engineering expertise, 90% of contract efforts focus on neuromodulation products. Greatbatch Medical provides a wide variety of con- tract 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 inno- vation company, specializing in electronic and elec- tromechanical devices. Minnetronix provides ideas, innovation, and strategic guidance, as well as design, development, and manufacturing services to medical device companies. MINNESOTA – SUPPORTING ENTERPRISE “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 8
  • 10. Clinical & Surgical Expertise Minnesota has been the site for over 80 neuromodu- lation clinical trials20 . Minnesota’s expertise in clini- cal trials parallels the interests of the companies and organizations within the area. Mayo Clinic and the University of Minnesota established neurosurgery de- partments early in the twentieth century, providing an easily accessible source of expertise for developing and testing implantable technology. See Appendix 2 for directory 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 U.S. Education is consistently supported by the state legis- lature and local programming. The University of Min- nesota is ranked in the top 25 research universities in the world by the Center for Measuring University Per- formance. The university’s high standing is in part due to the superior faculty and trainees affiliated with the Medical School and College of Science & Engineering. Healthcare Minnesota’s thriving healthcare sector provides com- plementary services and expertise to the neuromodu- lation sector. UnitedHealth Group is the world’s larg- est 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 headquartered in downtown Minneapolis, offering both financial analy- sis and investing opportunities. Multiple accelerators and co-working spaces are available for healthcare endeavors, both early stage and growing, including Healthcare.mn and TreeHouse Health. Supporting Organizations Non-governmental organizations and state-based pro- grams are important drivers of medical device success in Minnesota. See Appendix 2 for additional support- ing organizations. MINNESOTA – SUPPORTING INFRASTRUCTURE LifeScience Alley spends significant efforts advo- cating for federal and state legislation that pro- motes 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 pub- lic-private partnership among industry stakehold- ers, governmental agencies, and patient/physician groups. The MDIC is presently working with the FDA to establish standardized safety guidelines for stim- ulation parameters in nerve tissue. BioAM, LLC, in Rochester, MN, is a community- based organization promoting economic develop- ment in life sciences through education and net- working. BioAM works with regional organizations like Destination Medical Center to elevate activities in healthcare and medicine across the state. The MN Neuromodulation Consortium was estab- lished in January 2015 to provide a centralized ac- cess point to the region’s extensive collection of resources and expertise in neuromodulation. 20 https://clinicaltrials.gov, searched Jan. 20, 2014. 9
  • 11. ‘Closed-loop’ Systems Recent advancements in neuroscience, electrical en- gineering, and biosensors have enabled ‘closed-loop’ systems, capable of sensing ongoing brain or nerve activity and incorporating it into stimulation param- eters for optimized therapeutic efficacy in real-time. California-based Neuropace’s RNS® System is the first to 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 op- togenetics and pharmacosynthetics, which make use of genetics to achieve selective 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 therapeutically in their present itera- tions due to limited acceptance of gene thera- py in humans. Non-surgical While challenges to commercialization remain, non- surgical options are gaining traction. Transcranial electrical, magnetic, and ultrasound 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 de- veloping small, portable devices to deliver small elec- trical charges to ‘superficial’ nerves near the surface of the body, e.g., via the ear canal like Novum Thera- peutics. 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 dis- eases and limited understanding of symptomatology and etiology, as is the case with many psychiatric and neurodegenerative disorders. This sets the stage for numerous potential physiological targets, low compe- tition 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 compo- nent or could benefit from neurological interventions. Metabolic disorders, like obesity and type 2 diabetes, are growing at epidemic proportions and present sig- nificant 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 neuromodula- tion devices that are under clinical investigation by numerous sponsors. Prosthetics In amputees and trauma victims, neuromodulation is aiding recovery following injury by promoting re- growth 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-computer interfaces to restore feeling and mobility. Much of the development work in this area is funded by the U.S. Department of De- fense, 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 present- ly limited to non-surgical methods and have reported improvements in attention, anxiety, and mood. Devel- opment 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, sig- nificantly limiting potential revenues. EMERGING TECHNOLOGY UNMET NEEDS “LifeScience Alley is great because they continue to build connections and focus on issues of the day.” – Todd Langevin, President & COO, Functional Neuromodulation 10
  • 12. Market growth is strong for neuromodulation-based therapies; it is predicted to double in the next four years21,22 . In the initial years of neurostimulation tech- nology, Thom Gunderson, Senior Financial Analyst at Piper Jaffray, noted that “the best and brightest tal- ent was attracted to the success and stability of the cardiac industry, which slowed innovation in the neu- romodulation sector.” Today, “neuromodulation is an open market with great potential that is attractive to investors.” Early safety demonstrations and lasting patient suc- cesses in treating pain and Parkinson’s disease con- tinue to bolster physician support for SCS and DBS, respectively. Manufacturers of FDA-approved stimula- tion systems are able to provide entrepreneurs with verified technology for early-phase investigations, ultimately leading to lower cost, lower risk clinical trials. Minnesota is a powerful global center for neuromodu- lation industry. Minnesota established a strong lead in neuromodulation therapies due to early success in cardiac stimulation. Talent and technology is eas- ily 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 eas- ily take advantage of the close proximity by accessing corporate talent on a consulting basis and leveraging connections for favorable exit strategies. Cheryl Matter, PhD Vice President of Intelligence & Research, LifeScience Alley cmatter@lifesciencealley.org 952.746.3817 Anastasia N. Zink Research Fellow, LifeScience Alley PhD Candidate, Graduate Program in Neuroscience, University of Minnesota MARKET CLIMATE SUMMARY CONTRIBUTORS This Capability Brief is a living document and will be updated with new information as it is discovered or received. Please send any additional information for consideration to Cheryl Matter, PhD, Director of Intelligence & Research, at cmatter@lifesciencealley.org or 952.746.3817. Questions/Comments/Edits 21 Global Neurostimulation/Neuromodulation Market. MicroMarketMonitor (Feb. 2015) 22 The Market for Neurotechnology: 2014-2018. NeuroTechReport.com (March 2014) 11
  • 13. 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 ACKNOWLEDGEMENTS 12
  • 14. Neuromodulation Devices Advanced Bionics (Parent Corporation: Sanova Holding A.G.) Hopkins, MN; Stäfa, Switzerland www.advancedbionics.com 952.930.0686 Advanced Bionics produces a cochlear implant for hearing loss. BioControl Medical Ltd. (Parent Corporation: Rainbow Medical) Minneapolis, MN www.biocontrol-medical.com BioControl Medical produces the CardioFit System for vagal nerve stimulation to treat heart failure. Boston Scientific Corporation Marlborough, MA; St. Paul, MN www.bostonscientific.com 508.683.4000; 651.582.4000 Kelly Leadem media@bsci.com Boston Scientific develops and commercializes a diverse neuromodulation device portfolio. Cardionomic, Inc. Forest Lake, MN www.cardionomicinc.com 651.964.0170 Cardionomic is developing a device for neuromodulating the terminal branches of the cardiac plexus to treat acute decompensated heart failure (ADHF). CerebralRx Ltd. (Parent Corporation: Rainbow Medical, spinoff of BioControl) Minneapolis, MN www.biocontrol-medical.com CerebralRx produces the FitNeS Vagus Nerve Stimulator for refractory epilepsy and other indications. Chattanooga Group, Inc. (Parent Corporation: DJO, LLC) St. Paul, MN; Vista, CA www.djoglobal.com/our-brands/chattanooga Chattanooga Group is the world’s largest manufacturer of TENS/NMES rehabilitation equipment for treating musculoskeletal, neurological, and soft tissue disorders. Cogentix Medical, Inc. (Uroplasty, Inc.) Hopkins, MN www.cogentixmedical.com 866.258.2182 Cogentix Medical (Uroplasty, Inc.) produces Urgent® PC Neuromodulation System for percutaneous tibial nerve stimulation to treat overactive bladder and associated symptoms of urinary urgency, urinary frequency, and urge incontinence. CVRx, Inc. Minneapolis, MN www.cvrx.com 763.416.2840 CVRx Inc. produces Barostim neo™ for barostim receptor stimulation in the carotid artery to treat hypertension and heart failure. Empi, Inc. (Parent Corporation: DJO, LLC) St. Paul, MN; Clear Lake, SD www.djoglobal.com/our-brands/empi 651.484.9381 Empi is a leading distributor of non-invasive electrical stimulation (TENS/NMES) devices and other orthopedic products used for pain management, orthopedic rehabilitation, physical therapy, fitness, and sport performance enhancement. EnteroMedics, Inc. St. Paul, MN www.enteromedics.com 651.634.3003 EnteroMedics produces the vBloc Maestro® Rechargeable System for vagal nerve blocking in the treatment of obesity. APPENDIX 1: Neuromodulation-Related Businesses & Resources 13
  • 15. Envoy Medical Corporation St. Paul, MN www.envoymedical.com 651.361.8000 Envoy Medical produces Esteem, a middle-ear im- plant for moderate to severe nerve-related (sensori- neural) hearing loss. Functional Neuromodulation Ltd. Minneapolis, MN www.functionalneuromodulation.com info@fxneuromod.com 866.296.4040 Functional Neuromodulation is developing DBS to treat mild Alzheimer’s disease. Greatbatch Medical (Parent Corporation: Greatbatch, Inc.) Plymouth, MN www.greatbatchmedical.com 763.951.8181 Greatbatch Medical produces the Algovita™ and Algostim™ spinal cord stimulation systems for chronic pain; the company also designs and manufactures critical components for complex medical devices and procedures. Holaira Medical, Inc. Plymouth, MN www.holaira.com 763.450.2800 Holaira Medical produces a device for Targeted Lung Denervation (TLD) to reduce overactive airway nerve activity for treatment of chronic obstructive pulmonary disease (COPD). Inspire Medical Systems, Inc. Maple Grove, MN www.inspiresleep.com 763.205.7970 Inspire Medical Systems sells Inspire® (stimulator, breathing sensor, stimulation lead, remote) for Obstructive Sleep Apnea. Mainstay Medical, Inc. Dublin, Ireland; Plymouth, MN www.mainstay-medical.com Mainstay Medical produces the ReActiv8™ implantable spinal stimulation device for chronic low back pain. Medi-Stim, Inc. Wabasha, MN www.medi-stim.com 651.565.2400 Medi-Stim produces a comprehensive line of non-invasive electrotherapy products to treat neural and muscular pain or rehabilitative conditions. Medtronic plc Dublin, Ireland; Minneapolis, MN www.medtronic.com 763.514.4000 Justin Ihle, Program Manager, Public Relations, Neuromodulation justin.ihle@medtronic.com Medtronic develops and commercializes a diverse neuromodulation device portfolio. Monteris Medical, Inc. Plymouth, MN; Winnipeg, Manitoba, Canada www.monteris.com 763.253.4710 Monteris Medical produces the NeuroBlate® System for MRI-guided neurosurgical ablation. Novum Therapeutics, Inc. Minneapolis, MN www.novumthera.com 763.360.2931 Evan Johnston, President & CEO ejohnston@NovumThera.com Novum Therapeutics produces Nocturne™ non-invasive neuromodulation of cranial nerve through the ear canal for Obstructive Sleep Apnea. Pepin Manufacturing, Inc. Lake City, MN www.pepinmfg.com 651.345.5655 Pepin Manufacturing provides contract-based product design, development, and manufacturing. The company also offers electrotherapy electrodes, device components, TENS stimulation units, and their accessories. QiG Group (Parent Corporation: Greatbatch, Inc.) Blaine, MN www.qiggroup.com 763.786.7400 QiG Group has broad capabilities and expertise in neurostimulation systems, which typically include implantable pulse generators, leads, and programmers. 14
  • 16. Neuromodulation Devices (Cont’d) Respicardia, Inc. Hopkins, MN www.respicardia.com 952.540.4470 Respicardia produces the Remedē® System for phrenic nerve stimulation of the diaphragm to treat sleep apnea. SPR Therapeutics, LLC (Parent corporation: NDI Medical LLC) Minneapolis, MN www.sprtherapeutics.com info@fxneuromod.com 216.378.9108 Mark Stultz, Senior Vice President, Market Development info@sprtherapeutics.com 216.378.9106 x103 SPR Therapeutics produces Smartpatch PNS and Micropulse PNS systems, percutaneous peripheral nerve stimulation systems for interventional pain management. St. Jude Medical, Inc. St. Paul, MN www.sjm.com 651.756.2000 St. Jude Medical develops and commercializes a diverse neuromodulation device portfolio. Uni-Patch (Parent Corporation: Covidien Ltd.) Wabasha, MN www.uni-patch.com 651.565.2601 Uni-Patch produces non-implantable electrodes and garments for use with TENS, NMES, FENS, post-operative, interferential, and galvanic stimulation systems. WR Medical Electronics Co. Maplewood, MN www.wrmed.com 651.604.8400 WR Medical Electronics Co. produces the Hilger, Silverstein Facial Nerve Stimulators for electrodiagnostic testing for facial paralysis. Design, Development, & Manufacturing - Devices & Components Advanced Medical Electronics Corporation Maple Grove, MN www.ame-corp.com 763.463.4814 Advanced Medical Electronics is a product-focused research and development company specializing in medical devices. Cymbet Corporation Elk River, MN www.cymbet.com 763.633.1780 Cymbet Corporation specializes in rechargeable, thin film, solid state batteries for microelectronic systems. Devicix, LLC Eden Prairie, MN www.devicix.com 952.368.0073 Devicix provides electromedical device design, engineering, prototyping, development, regulatory/ certification, and commercialization expertise. Donatelle Medical New Brighton, MN www.donatellemedical.com 651.633.4200 Donatelle Medical provides medical device expertise in development, manufacturing, and commercialization of cardiac rhythm management, neuromodulation, surgery, diabetes, and spine. Evergreen Medical Technologies, Inc. St. Paul, MN www.evergreenmedtech.com 651.646.7700 Randall Nelson Evergreen Medical Technologies provides electromedical device design, engineering, prototyping, development, certification, and regulatory expertise. Greatbatch Medical (Parent Corporation: Greatbatch, Inc.) Minneapolis, MN www.greatbatchmedical.com 612.676.7200 Greatbatch Medical designs and manufactures critical technologies that enhance the reliability and performance of medical devices and procedures. 15
  • 17. Heraeus Medical Components, LLC (Parent Corporation: Heraeus Holding GmbH) St. Paul, MN www.heraeusmedicalcomponents.com 651.792.8500 Heraeus Medical Components delivers from ingot to complex engineered assembly. Matrix MedTech, Inc. Maple Grove, MN www.matrixmedtech.com 763.331.8671 Scott Olson Scott.Olson@matrixmedtech.com Matrix MedTech provides research, design, development, prototyping, and manufacturing expertise for medical device components. Minnetronix, Inc. St. Paul, MN www.minnetronix.com 651.917.4060 Jeremy Maniak, COO jmaniak@minnetronix.com Minnetronix specializes in medical device design, manufacturing, and IP. Nortech Systems Incorporated Wayzata, MN www.nortechsys.com 952.345.2244 Zak Tomczak, Business Development ztomczak@nortechsys.com 612.590.7822 Nortech Systems provides electronics manufacturing services (EMS) for the medical device industry and others. North American Science Associates Inc. (NAMSA) Minneapolis, MN www.namsa.com 763.287.3830 NAMSA is a medical research organization providing expert regulatory, laboratory, clinical, and compliance services to medical device manufacturers. Omnetics Connector Corporation Minneapolis, MN www.omnetics.com 763.572.0656 Omnetics Connector Corporation produces micro and nano connectors for military, commercial, and medical applications. Pepin Manufacturing, Inc. Lake City, MN www.pepinmfg.com 651.345.5655 Pepin Manufacturing provides R&D, design, and manufacturing expertise, and also specializes in custom electrodes for electrotherapy products. PMT Corporation Chanhassen, MN www.pmtcorp.com 952.470.0866 PMT manufactures products for neurosurgery, orthopaedics, and plastic and reconstructive surgery. Smiths Medical ASD Inc. (Parent Corporation: Smiths Group plc) St. Paul, MN www.smiths-medical.com OEM.Inquiries@smiths-medical.com 651.633.2556 Smiths Medical provides clinical and technical support services for multi-national medical device studies and global product distribution. Stellar Technologies, Inc. Brooklyn Park, MN www.stellar-technologies.com 763.493.8556 Dennis Forcelle, Director of New Technologies dforcelle@stellar-technologies.com 763.493.8556 x103 Stellar Technologies provides product development, qualification, and component manufacturing of medical products, specializing in neurostimulation. Summit Medical, Inc. (Parent Corporation: Shore Capital Partners, LLC) St. Paul, MN www.summitmedicalusa.com customerservice@summitmedicalusa.com 651.789.3939 Summit Medical offers expertise in medical device manufacturing, regulatory, quality, engineering, sales, and marketing. Teren Med Inc. Minneapolis, MN 814.571.3888 Teren Med is an electromedical equipment manufacturer. 16
  • 18. Design, Development & Manufacturing - Devices & Components (Cont’d) Worrell Design, Inc. Minneapolis, MN www.worrell.com 612.638.6000 Worrell Design provides expertise in product design, development, and strategy. Neurosurgery Equipment ev3 Inc. (Parent Corporation: Covidien Ltd.) Plymouth, MN www.ev3.net customerservice@ev3.net 763.398.7000 ev3 offers medical devices for neurosurgery applications. IMRIS Inc. Minnetonka, MN; Winnipeg, Manitoba, Canada www.imris.com 763.203.6300 Sales Inquiries, 763.203.6308; Press Inquiries, Kevin Berger kberger@imris.com 763.203.6332 IMRIS offers multiple product lines for image guided neurosurgery solutions. Monteris Medical, Inc. Plymouth, MN; Winnipeg, Manitoba, Canada www.monteris.com info@monteris.com 763.253.4710 Monteris Medical produces medical devices for MRI-guided neurosurgical ablation. Summit Medical, Inc. (Parent Corporation: Shore Capital Partners, LLC) St. Paul, MN www.summitmedicalusa.com customerservice@summitmedicalusa.com 651.789.3939 Summit Medical offers expertise in medical device development for neurosurgery applications. Finance Bay City Capital LLC San Francisco, CA www.baycitycapital.com 415.676.3830  Bay City Capital is a life sciences investment firm with a global diversified strategy ranging from seed stage to public companies, and including innovation, restructuring opportunities, and growth investing. Brain Trust Accelerator Fund, L.P. Burlingame, CA www.braintrustvc.com 650.375.0200 John M. Reher, Managing Director Brain Trust Accelerator Fund focuses on early stage investments that address the diagnosis and treatment of brain-related diseases. Craig-Hallum Capital Group LLC Minneapolis, MN www.craig-hallum.com 612.334.6300 Craig-Hallum Capital Group is an institutional investment banking firm with expertise in health technology and medical devices. Gopher Angels, LLC Minneapolis, MN www.gopherangels.com 763.231.9676 David Russick, Managing Director david.russick@russickgroup.com Gopher Angels is a network of accredited investors seeking to invest capital and expertise in early stage Minnesota businesses. The organization is a member of the Angel Capital Association. Greatbatch, Inc. Frisco, TX www.greatbatch.com 214.618.4982  Betsy Cowell, VP Finance and Treasurer ecowell@greatbatch.com Greatbatch actively invests in targeted technology and acquisitions to drive expansion in core and adjacent markets. 17
  • 19. Neuro Device Innovations (NDI) Medical, LLC Minneapolis, MN www.ndimedical.com info@ndimedical.com 612.770.0390 Neuro Device Innovations (NDI) Medical is a hybrid venture capital and commercialization firm focusing exclusively on innovative neurodevice technologies that are intended to restore lost neurological function, prevent damage, and reduce the painful effects of disease and injury. NeuroVentures Capital LLC Charlottesville, VA www.neuroventures.com info@neuroventures.com 434.297.1000 NeuroVentures Capital is a specialty venture capital firm dedicated to investing in companies focused on discovery, development, and marketing of new therapeutics and technologies to treat Central Nervous System disorders. Oak Investment Partners Minneapolis, MN www.oakinv.com 612.339.9322 Oak Investment Partners is a private equity firm focusing on venture capital investments in companies developing systems and services in healthcare and other industries. Piper Jaffray Companies Minneapolis, MN www.piperjaffray.com 612.303.6000 Piper Jaffray is a well-established investment banking firm with expertise in health technology and medical devices. RAIN Source Capital St. Paul, MN www.rainsourcecapital.com 651.632.2140 RAIN Source Capital organizes community-based networks of investors, capital, and expertise to benefit private investors, private companies, and communities through leadership and ROI. Shore Capital Partners, LLC Chicago, IL www.shorecp.com info@shorecp.com 312.348.7580 Shore Capital Partners is a healthcare-focused lower middle market private equity firm that specializes in partnering with companies that have between $5 and $50 million of revenue. Smiths Group plc London, England www.smiths.com T.+44 (0) 20.7808.5512  Peter Durman, Director, Investor Relations & Corporate Communications investor.relations@smiths.com Smiths Group buys businesses that add complementary technologies and products, expand geographical footprint in emerging markets, or leverage existing infrastructure to increase shareholder returns. Technology Partners Palo Alto, CA www.technologypartners.com admin@technologypartners.com 650.289.9001 Technology Partners builds and invests in venture companies at all stages with a focus on life science and clean technologies. Third Rock Ventures, LLC Boston, MA; San Francisco, CA www.thirdrockventures.com 617.585.2000 Third Rock Ventures is a bi-coastal, multi- disciplinary team that brings together the best of science, strategy, business, and medicine. Thomas McNerney & Partners, LLC Minneapolis, MN www.tm-partners.com 612.465.8660 Thomas McNerney & Partners is a healthcare venture firm that invests in life science and medical technology companies at all stages of development. Twin Cities Angels Minneapolis, MN www.twincitiesangels.com Twin Cities Angels provides a formal organization for entrepreneurially-minded angel investors. Their expertise is in medical devices, diagnostics, pharma, and biotech. Versant Ventures San Francisco, CA www.versantventures.com 415.801.8100 Versant Ventures is a leading healthcare investment firm that invests across the healthcare sector with an emphasis on the discovery and development of novel therapeutics. 18
  • 20. Intellectual Property - Medical Devices Beck & Tysver PLLC Minneapolis, MN www.becktysver.com 612.915.9633 Beck & Tysver is an innovative Minneapolis patent law firm with experienced attorneys specializing in software technology and medical devices. BitLaw Legal Resource Online Directory www.bitlaw.com/links/firms.html BitLaw Legal Resource is a free legal resource focused on intellectual property; the service also curates a list of IP Law Firms in MN. Mayo Clinic Ventures Rochester, MN ventures.mayoclinic.org mayoclinicventures@mayo.edu 507.293.3900 Kelly Krajnik, krajnik.kelly@mayo.edu; Andy Danielsen, danielsen.andrew@mayo.edu Mayo Clinic Ventures works closely with Mayo Clinic physicians and scientists to mine inventions, ideas, and discoveries that will truly transform healthcare. Mueting, Raasch & Gebhardt, P.A. Minneapolis, MN www.mrgs.com 612.305.1220 Mueting, Raasch & Gebhardt provides expertise in all areas of patent law relating to the electrical and mechanical arts. Patterson Thuente Pedersen, P.A. Minneapolis, MN www.ptslaw.com info@ptslaw.com 612.349.5740 Patterson Thuente Pedersen excels at finding strategic solutions to complex intellectual property matters, with special expertise in technology IP. The General Counsel, Ltd. Minneapolis, MN www.gcl.com 612.670.7687 Jonathan Eisenberg, Principal Attorney jon.eisenberg@gcl.com 612.801.5659 The General Counsel offers companies the advantages of experienced in-house legal counsel on an affordable, outsourced basis. Other - Supporting Infrastructure BioAM Rochester, MN www.bioam.org bioamroch@gmail.com 507.993.1918 BioAM is committed to engaging with local entrepreneurs and connecting them with people and resources their venture needs to be successful. CoCo-MSP (Google for Entrepreneurs) Multiple locations www.cocomsp.com hello@cocomsp.com 612.545.5745 CoCo-MSP is one of nine North American tech hubs in the Google for Entrepreneurs network providing space, funding, and mentorship to help launch innovative companies. Destination Medical Center Rochester, MN www.dmc.mn Destination Medical Center (DMC) is an innovative economic development initiative to secure Minnesota’s status as a global medical destination now and in the future. LifeScience Alley St. Louis Park, MN www.lifesciencealley.org 952.542.3077 LifeScience Alley is a trade association working to enable business success in the life science and health technology industries by providing leadership, advocacy, business referrals, and access to intelligence and information. Mayo Clinic Business Accelerator Rochester, MN www.mcbusaccel.com 507.288.0208 Xavier Frigola xfrigola@raedi.com Mayo Clinic Business Accelerator provides infrastructure that enables entrepreneurism for the Rochester community. Rochester Business Alliance Rochester, NY www.rochesterbusinessalliance.com 585.244.1800 19
  • 21. Startup Venture Loft (SVL) Minneapolis, MN www.svl.co 612.926.3878 Pete Kane 612.926.3878 Startup Venture Loft (SVL) is building a better entrepreneurial ecosystem by providing Minnesota startups with space, connections, and the resources they need to be successful. Treehouse Health Minneapolis, MN www.treehouse-health.com 612.486.5932 TreeHouse Health is a healthcare innovation center with an emphasis on health IT and care coordination; it provides expertise, investment, space, networks, and professional services. University Enterprise Laboratories St. Paul, MN www.uelmn.org 651.641.2800 Greg LaSalle glasalle@uelmn.org 651.641.2803 University Enterprise Laboratories (UEL) is a collaborative research center for early stage bioscience ventures. They provide premier facilities and services that enable innovation, growth, and commercial success. University of Minnesota - Business Accelerator Program Minneapolis, MN diversity.umn.edu/bced/businessacceleratorprogram 612.624.3578 Mauvalyn Bowen, PhD bowen075@umn.edu The University of Minnesota’s Business Accelerator Program is a dynamic business mentorship-based program designed to accelerate growth of early stage, high-potential small businesses located in the Twin Cities. University of Minnesota - MN-IP: Minnesota Innovation Partnerships Minneapolis, MN www.research.umn.edu/mn-ip 612.625.3394 The University of Minnesota’s Minnesota Innovation Partnerships (MN-IP) is designed to improve access to university-developed technology while reducing the risk and cost associated with licensing intellectual property and sponsoring research. University of Minnesota - Office for Technology Commercialization (OTC) Minneapolis, MN www.research.umn.edu/techcomm 612.624.0550 The University of Minnesota’s Office for Technology Commercialization (OTC) facilitates the transfer of university research to licensees for the development of new products and services that benefit the public good, foster economic growth, and generate revenue to support the University’s research and education goals. 20
  • 22. Clinical Expertise Ablation Samuel J. Asirvatham, MD – Neurovascular & PNS Mayo Clinic, Department of Anesthesiology & Pain Medicine 200 First St. SW Rochester, MN 55905 507.284.2511 Depression Barry Rittburg, MD – DBS, VNS, TMS University of Minnesota, Department of Psychiatry rittb001@umn.edu 612.273.9813 Epilepsy Jamie J. Van Gompel, MD – DBS Mayo Clinic, Department of Neurosurgery & Otorhinolaryngology 200 First St. SW Rochester, MN 55905 507.284.8008 Kendall H. Lee, MD, PhD - DBS Mayo Clinic, Department of Neurosurgery 200 First St. SW Rochester, MN 55905 Lee.Kendall@mayo.edu 507.284.8008 Squire (Matt) M. Stead, MD, PhD – DBS Mayo Clinic, Department of Neurosurgery 200 First St. SW Rochester, MN 55905 507.284.7341 Movement Disorders David Rottenberg, MSc, MD - DBS University of Minnesota, Department of Neurology rotte001@umn.edu 612.467.4784 Anthony Santiago, MD – DBS University of Minnesota, Department of Neurology asantiag@umn.edu 612.301.1048 Jerrold Vitek, MD – DBS University of Minnesota, Department of Neurology vitek004@umn.edu 612.624.1903 Michael C. Park, MD - DBS University of Minnesota, Department of Neurosurgery 200 First St. SW Rochester, MN 55905 mcpark@umn.edu 612.626.4706 Anhar Hassan, MB, BCh – DBS Mayo Clinic Department of Neurology hassan.anhar@mayo.edu 507.284.2511 Kendall H. Lee, MD, PhD - DBS Mayo Clinic, Department of Neurosurgery 200 First St. SW Rochester, MN 55905 lee.kendall@mayo.edu 507.284.8008 Julie A. Fields, PhD, LP – DBS Mayo Clinic, Department of Psychiatry and Psychology fields.julie@mayo.edu 507.284.2511 Squire (Matt) M. Stead, MD, PhD - DBS Mayo Clinic, Department of Neurosurgery 200 First St. SW Rochester, MN 55905 507.284.7341 Bryan T. Klassen, MD - DBS Mayo Clinic Department of Neurology klassen.bryan@mayo.edu 507.284.2511 Dr. Matthew D. Johnson – DBS (pre-clinical) University of Minnesota, Department of Biomedical Engineering 6-134 Hasselmo Hall 312 Church St SE Minneapolis, MN 55455 john5101@umn.edu 612.626.6492 APPENDIX 2: CLINICAL, SURGICAL, RESEARCH & BUSINESS RESOURCES Author’s note: List is not exhaustive and will be updated as needed. 21
  • 23. Obesity Charles Billington, MD – VNS University of Minnesota, Department of Medicine billi005@umn.edu 612.725.2000 x4423 Pain Paul Gigante, MD - SCS Spine and Brain Clinic 6545 France Ave. S., Ste 450D Edina, MN 55435 952.836.3695 Michael C. Park, MD - DBS University of Minnesota, Department of Neurosurgery 200 First St. SW Rochester, MN 55905 mcpark@umn.edu 612.626.4706 Tim J. Lamer, MD – SCS, PNS, CNS-targeted Drug Delivery Mayo Clinic, Department of Anesthesiology & Pain Medicine 200 First St. SW Rochester, MN 55905 507.284.2511 Halena M. Gazelka, MD – SCS, PNS, CNS-targeted Drug Delivery Mayo Clinic, Department of Anesthesiology & Pain Medicine 200 First St. SW Rochester, MN 55905 507.284.2511 Jason S. Eldridge, MD – SCS, PNS, CNS-targeted Drug Delivery Mayo Clinic, Department of Anesthesiology & Pain Medicine 200 First St. SW Rochester, MN 55905 507.284.2511 Brenton M. Meier, MD – SCS, PNS, CNS-targeted Drug Delivery Mayo Clinic, Department of Anesthesiology & Pain Medicine 200 First St. SW Rochester, MN 55905 507.284.2511 Psychiatric Disorders Barry Rittburg, MD – DBS, VNS, TMS University of Minnesota, Department of Psychiatry rittb001@umn.edu 612.273.9813 Kendall H. Lee, MD, PhD - DBS Mayo Clinic, Department of Neurosurgery 200 First St. SW Rochester, MN 55905 Lee.Kendall@mayo.edu 507.284.8008 Susannah J. Tye, PhD – DBS Mayo Clinic, Department of Neurosurgery 200 First St. SW Rochester, MN 55905 507.284.8008 Stroke James R. Carey, PhD, PT, FAPTA – TMS, fMRI University of Minnesota, Program in Physical Therapy 377 Children’s Rehab Center carey007@umn.edu 612.626.2746 Teresa Jacobson Kimberley, PhD, PT - TMS, fMRI University of Minnesota, Brain Plasticity Laboratory tjk@umn.edu 612.626.4096 Bernadette Gillick, PhD, MS, PT – TMS, fMRI University of Minnesota, Brain Plasticity Laboratory gillick@umn.edu 612.626.3121 Wynn Legon, PhD - TMS, tACS/tDCS, and Ultrasound Stimulation, fMRI University of Minnesota, Brain Plasticity Laboratory wlegon@umn.edu 612.626.1183 Bin He, PhD – TMS, tDCS University of Minnesota, Department of Biomedical Engineering, Center for Neuroengineering 6-124 Nils Hasselmo Hall binhe@umn.edu 612.626.1115 Surgical Expertise Mayo Clinic, Department of Neurosurgery 200 First St. SW Rochester, MN 55905 507.284.8008 Fairview Hospital, Spine and Brain Clinic 6545 France Ave. S., Ste 450D Edina, MN 55435 952.836.3695 22
  • 24. Surgical Expertise (Cont’d) University of Minnesota, Experimental Surgical Services Medical Center Department of Surgery Stefanie B. Yorek, contact for appointment scheduling yorek001@umn.edu 612.625.4937 University of Minnesota, Division of Gastrointestinal & Bariatric Surgery Medical Center Department of Surgery 612.625.8446 University of Minnesota, Movement Disorders & Epilepsy Surgery Center Medical Center Department of Surgery 612.626.6688 University of Minnesota, Neurosurgery Clinic Medical Center Department of Surgery 612.624.6666 University of Minnesota, Center for Minimally Invasive Surgery Medical Center Department of Surgery 612.672.7422 Clinical Centers Mayo Clinic, Traumatic Brain Injury Program 200 First St. SW Rochester, MN 55905 Nicole L. Dernbach TBIMS@mayo.edu 507.255.0718 VA Office of Research & Development- Polytrauma/ Blast-Related Injuries - Quality Enhancement Research Initiative Princess Osei-Bonsu, PhD, MSPH - PBRI Implementation Research Coordinator princess.osei-bonsu@va.gov 612.467.7726 Mayo Clinic, Alzheimer’s Disease Research Center 200 First St. SW Rochester, MN 55905 mayoadc@mayo.edu 507.284.1324 Mayo Clinic, Diabetes Center 200 First Street SW Rochester, MN 55905 John Miles, MD miles.john@mayo.edu 507.255.0001 Mayo Clinic, Migraine Research Program Mayo Building, West Eighth Floor 200 First St. SW Rochester, MN 55905 migrainersearchprogram@mayo.edu 507.266.7180 Minnesota Obesity Center St. Paul, MN 55108 Dr. Catherine C. Welch, Program Coordinator mnoc@tc.umn.edu 763.807.0559 University of Minnesota, Brain Plasticity Laboratory 306 Children’s Rehabilitation Center 426 Church Street SE Minneapolis, MN 55455 612.626.4096 Mayo Clinic, CT Clinical Trials Innovation Center 200 First St. SW, Rochester, MN 55905 CTCIC@mayo.edu 507.538.7723 University of Minnesota, The Memory Clinic The N. Bud Grossman Center for Memory Research and Care 5775 Wayzata Blvd in Suite #200, Minneapolis, MN 55416 memclin@umn.edu Clinic Appointments: 952.525.4500 Imaging Centers University of Minnesota, Center for Magnetic Resonance Research 2021 Sixth Street SE, Minneapolis, MN 55455 Deb Morgan, Executive Assistant deb@cmrr.umn.edu 612.626.2001 University of Minnesota, Center for Clinical Imaging Research 2021 Sixth Street SE, Minneapolis, MN 55455 ccir@umn.edu 612.626.6900 Mayo Clinic, Center for Advanced Imaging Research 200 First Street SW Rochester, MN 55905 Stephen J. Riederer, PhD riederer@mayo.edu 507.284.6209 University of Minnesota, Biomedical Functional Imaging and Neuroengineering Laboratory 7-105 Hasselmo Hall, 312 Church St. SE, Minneapolis, MN 55455 612.626.1114 23
  • 25. Research Centers Mayo Clinic, Center for Clinical and Translational Science (CCaTS) 200 First Street SW Rochester, MN 55905 507.255.7101 University of Minnesota, Clinical and Translational Science Institute 717 Delaware Street SE, Second Floor Minneapolis, MN 55414 ctsi@umn.edu 612.625.CTSI (2874) Mayo Clinic, Department of Defense Medical Research Office Strategic Funding Office for Research 200 First St. SW Rochester, MN 55905 Jon W. Zurn strategicfunding@mayo.edu 507.266.4554 Mayo Clinic, Evidence-Based Practice Research Program Harwick Building, Room 2-54 Rochester, MN 55905 507.266.1829 Fairview Research Administration 2344 Energy Park Drive Saint Paul, MN 55108 research@fairview.org 612.672.7690 Research Helpline: 612.672.7692 University of Minnesota, Neuromodulation Research and Technology Laboratory 6-134 Hasselmo Hall 312 Church St SE Minneapolis, MN 55455 Dr. Matthew D. Johnson john5101@umn.edu 612.626.6492 University of Minnesota, Institute for Engineering in Medicine 420 Delaware Street Southeast 725 Mayo Memorial Building, MMC 609 Minneapolis, MN 55455 iem@umn.edu 612.626.5493 University of Minnesota, Center for Neuroengineering 1-205 NHH, 312 Church Street, SE Minneapolis, MN 55455 cne@umn.edu 612.625.7209 University of Minnesota, Center for Design in Health 1425 University Ave SE Minneapolis, MN 55414 Kathleen A. Harder, PhD, Director kharder@umn.edu 612.626.0026 University of Minnesota, Brain Sciences Center Minneapolis Veterans Affairs Medical Center One Veterans Drive Minneapolis, MN 55417 Amy Wicklund, Administrator bsc@umn.edu University of Minnesota, Institute for Translational Neuroscience 2101 6th Street SE Minneapolis, MN 55455 Rosalyn Segal, Administrative Director rsegal@umn.edu 612.625.6966 University of Minnesota, National Institute of Neurodegenerative Disorders & Stroke Center Tim Ebner, PhD, Co-Director ebner001@umn.edu 612.626.6800 Harry Orr, PhD, Co-Director orrxx002@umn.edu 612.625.3647 University of Minnesota, Office of the Vice President for Research 101 Pleasant Street Minneapolis, MN 55455 612.625.3394 MnDRIVE – Brain Conditions Initiative University of Minnesota, Office of the Vice President for Research Tim Ebner, PhD, Research Lead ebner001@umn.edu 612.626.6800 University of Minnesota, Medical Devices Center (MDC) Greg Peterson, Innovation Collaborator Office Location: G217-08 Mayo Building gkpeters@umn.edu 612.626.4615 24
  • 26. Additional Resources (MN/US/Global) Policy, Education & Advocacy LifeScience Alley 1550 Utica Ave So, Suite 725, St. Louis Park, MN 55416 connect@lifesciencealley.org 952.542.3077 Medical Device Innovation Consortium (MDIC) 1550 Utica Ave So, Suite 740 St. Louis Park, MN 55416 952.314.1255 Minnesota High Tech Association (MHTA) 400 South 4th Street, Suite 416 Minneapolis, MN 55415 952.230.4555 Neurotechnology Industry Organization (NIO) Works to accelerate neurotechnology research, development and commercialization, including neuroscience companies, brain research institutes, and patient advocacy groups. North American Neuromodulation Society (NANS) Promotes multidisciplinary collaboration among clinicians, scientists, engineers, and others to advance neuromodulation through education, research, innovation and advocacy. The International Neuromodulation Society (INS) Nonprofit group of clinicians, scientists and engineers dedicated to the scientific development and awareness of neuromodulation. Market Reports NeuroInsights Provides neurotech industry newsletters, comprehensive market reports, neurotech investment conferences and strategic advisory services. Neurotech Reports Offers up-to-date and forward-looking information about the field of neurotechnology and future developments that will affect the venture capital, research, and start-up communities. 25
  • 27. ® Leading the conversation. LifeScience Alley’s intelligence and research work is generously supported by our Foundational Members. 3M | Boston Scientific | Mayo Clinic | Medtronic | St. Jude Medical