sector landscapes: neuromodulation

About LifeScience AlleyLifeScience Alley is a global leader in enabling health technology and care organizations to innovate, succeed and influence the evolution of healthcare. By influencing policy, delivering actionable information and intelligence and connecting members with critical resources, we work to ensure that Minnesota's Medical Alley remains the world's strongest health technology community.

SECTOR LANDSCAPES: NEUROMODULATIONCopyright © 2015 by LifeScience Alley. All rights reserved.

About Sector Landscapes PublicationsThe Sector Landscapes provide in depth analysis of emerging and established industry sectors in Minnesota. The reports highlight global industry insights, Minnesota core and supporting assets, unique positioning, company lists and industry trends. Identified sector areas include: neuromodulation, cardiac active implantables, tissue based products, research tools, animal health, diagnostics, vascular technologies,and digital health.

List of Contributors

PLEASE DIRECT CORRESPONDENCE TO:

Cheryl Matter, PhD, Vice President of Intelligence & Research, LifeScience [email protected] | 952.746.3817

Anastasia N. Zink, PhD Candidate, Graduate Program in Neuroscience, UMNResearch Lead

Amanda K. Weber, LifeScience Alley Design ConsultantVisualization + Design

LifeScience Alley's intelligence and research work is generously supported by our Foundational and Sustaining Members.

Foundational Members

Sustaining Members

Three Minnesota companies were awarded their first Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) approval from the FDA for neuromodulation 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 active implantable technology and electrotherapeutics. Technical expertise is available for all stages of a product’s life-cycle, including pre-clinical research, product development and commer-cialization. The Mayo Clinic and University of Minnesota are leading research institutions that attract world-class scientists and clinicians. Both institutions invest competitively in active programming to engage industry partnerships and promote technology commercialization. Minnesota’s early and continued foothold in the medical device industry provides a mature foundation, open for innovation and entrepre-neurship in neuromodulation.

EXECUTIVE SUMMARY

The global market for neuromodulation devices is strong and projected to double by 2018, reaching $6-7 billion.1,2 Minnesota-based Medtronic and St. Jude Medical account for 72% of worldwide sales. (See page 5 for an in depth look into neuromodulation revenue.)

+ 27 companies with major operations in Minnesota with more than 40 FDA-registered neuromodulation devices.

+ 42 companies providing products and services.

+ 25+ research and clinical centers for neuromodulation and related expertise.

+ $1 billion in federal research funding and life science investments in 2014.3,4

+ Minnesota is ranked 1st in US for: electromedical manufacturing employment;5 medical device patents;6 and PMA / 510(k) awards from FDA for complex neurological devices.7

KEY FINDINGS

1 Global Neurostimulation/Neuromodulation Market. MicroMarketMonitor (Feb. 2015).2 The Market for Neurotechnology: 2014-2018. NeuroTechReports (March 2014).

3 NSF & NIH Reports (Jan. 2015).4 LifeScience Alley, Minnesota Life Science Investment Activity: 2014 Annual Report.

5,6 Deed.gov.7 LifeScience Alley, Alley Insights (April 2015).

[1] GLOBAL OVERVIEW OF NEUROMODULATION INDUSTRY 1

A fast growing segment of healthcare is the neuromodulation industry

MARKET 3

DEVICES 4

INDICATIONS 6

MAJOR PLAYERS 8

[2] NEUROMODULATION IN MINNESOTA 11

The Neuromodulation Industry has a strong history in Minnesota and currently boasts 28 companies with more than 40 stimulation systems.

OVERVIEW OF MINNESOTA INDUSTRY 14

IMPLANTABLE & MINIMALLY INVASIVE SYSTEMS 18

NON-SURGICAL STIMULATION SYSTEMS 20

SUPPORTING ENTERPRISE 21

SUPPORTING INFRASTRUCTURE 22

[3] FUTURE FORECAST OF NEUROMODULATION INDUSTRY IN MINNESOTA

23

EMERGING TECHNOLOGY 24

UNMET NEEDS 25

MARKET CLIMATE 26

CONCLUDING SUMMARY 26

ACKNOWLEDGEMENTS 27

[4] NEUROMODULATION RESOURCES DIRECTORY 29

[5] CLINICAL, SURGICAL, RESEARCH & BUSINESS DIRECTORY 39

LIST OF FIGURES

FIGURE 1. FDA Neuromodulation Trials Open Worldwide by Subsector 2

FIGURE 2. Global Locations of Major Neuromodulation Companies 5

FIGURE 3. Neuromodulation Global Revenue Fiscal Year 2013 5

FIGURE 4. Indications Approved and Under Investigation 7

FIGURE 5. Minnesota Companies by Anatomical Target 12

FIGURE 6. Cumulative Growth of Neurosurgery & Neuromodulation in Minnesota 15

GLOBAL OVERVIEW OF NEUROMODULATIONINDUSTRY

1.

2 Sector Landscapes: Neuromodulation | LifeScience Alley

FIGURE 1. FDA NEUROMODULATION TRIALS OPEN WORLDWIDE BY SUBSECTOR

CO

CH

LEAR

// 4%

PERIPH

ERA

L NER

VE STIMU

LATION

// 9%

SPINA

L CO

RD

STIMU

LATION

// 10%

BR

AIN

// 54%

BR

AIN

: TRA

NSC

RA

NIA

L MA

GN

ETIC STIM

ULATIO

N // 29%

BR

AIN

: DEEP B

RA

IN STIM

ULATIO

N // 16%

BR

AIN

: TRA

NSC

RA

NIA

L ELECTR

ICA

L STIMU

LATION

// 9%

NEU

RO

MU

SCU

LAR

ELECTR

ICA

L STIMU

LATION

+ TR

AN

SCU

TAN

EOU

S ELECTR

ICA

L STIMU

LATION

// 23%

1 ,014 TRI ALS

3Section 1 | Global Overview of Neuromodulation Industry

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.

Minnesota-based companies were the first to commercialize devices for Deep Brain Stimulation (DBS), Spinal Cord Stimulation (SCS), and Peripheral Nerve Stimulation (PNS). Minnesota-based companies continue to hold a substantial (72%) share of the $3.5 billion global market, which is estimated to reach $6-7 billion by 2018.1,2

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

MARKET

Significant industry activity is focused on:

1 SOURCE: Global Neurostimulation / Neuromodulation Market. MicroMarketMonitor (Feb 2015).2 SOURCE: The Market for Neurotechnology: 2014-2018. NeuroTechReport.com (Mar 2014).

+ 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.


Neuromodulation therapies are available in implantable, minimally invasive and non-surgical options.

Implantable devices for brain stimulation deliver electricity deeply via ‘depth’ electrodes or cortical electrode arrays placed on the brain surface. Similar technology is used for spinal cord stimulation, as well as peripheral nerve targeting. Implanted-drug pumps that deliver small molecules to the central nervous system via the intrathecal space also achieve targeted neuromodulation.

Minimally invasive neuromodulation can be achieved by transcuta-neous stimulation through small needle-like electrodes and is typically restricted to spinal and superficial nerve stimulation.

Non-surgical or non-invasive devices act through a variety of modalities. Electrical stimulation delivered to muscles and wounds by paddle-style electrodes placed topically are used to prevent atrophy, increase blood flow, reduce pain and edema. Neuromodulation of the brain and spinal cord can be achieved through electrical direct or alternating current, ultrasound, and magnetic fields.

DEVICES

“[Minnesota's] become a local mecca for neuromodulation just in the entities here: Medtronic, Mayo Clinic, the University of Minnesota. You have state money. You have university focus. You have hiring of people with that specialty. 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."

Greg Molnar, Director of Neuroscience Discovery Division, Medtronic

Section 1 | Global Overview of Neuromodulation Industry 5

FIGURE 2. GLOBAL LOCATIONS OF MAJOR NEUROMODULATION COMPANIES 1

FIGURE 3. NEUROMODULATION GLOBAL REVENUE FISCAL YEAR 2013

ST. JUDE MEDICAL

CYBERONICS

BOSTON SCIENTIFIC

MEDTRONIC

1 Sales office and representative locations excluded from map.

MEDTRONIC

BOSTON SCIENTIFIC

ST. JUDE MEDICAL

CYBERONICS


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

Neuromodulation devices are registered in over 1000 on-going FDA-regulated clinical trials worldwide. These trials are investigating over 1300 indications, including metabolic disorders, inflammation, migraine and psychiatric disorders.1 Categories or types of indications under investigation for the three major types of commercial platforms are listed in Figure 4 on the following page.

INDICATIONS

1 SOURCE: www.clinicaltrials.gov, searched Jan 20, 2014.

“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)


FDA STATUS APPROVED INDICATIONS INVESTIGATIONAL INDICATIONS

DEEP BRAIN STIMULATION (DBS)

Parkinson's disease, essential tremor and epilepsy

133 indicationsBehaviors 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,Skin and connective tissue diseases,Substance related disorders,Symptoms and general pathology,Viral diseasesand Wounds and injuries

SPINAL CORD STIMULATION (SCS)

Chronic pain due to failed back syndrome, chronic regional pain syndrome, peripheral neuropathy and ischemic pain

165 indicationsBacterial and fungal diseases,Behaviors and mental disorders,Blood and lymph conditions,Cancers and other neoplasms,Ear / nose / and throat disease,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 diseasesand Wounds and injuries

PERIPHERAL NERVE STIMULATION (PNS)

Obstructive sleep apnea,central sleep apnea,hypertension,obesity,incontinence,heart failureand migraine

120 indicationsBehaviors 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 conditionsand Wounds and injuries

FIGURE 4. INDICATIONS APPROVED AND UNDER INVESTIGATION


MAJOR PLAYERS

Medtronic (Minneapolis, MN – operational headquarters) holds a dominant presence in the national and global neuromodulation market. The

company upholds a reputation for developing first-in-class products and acquiring IP in areas that complement or expand existing capabilities. Neuromodulation operations are based in Fridley, MN, and will remain there following the upcoming merger with Covidien.

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.

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

Entera® Gastric Electrical Stimulation

Nausea / vomiting from gastroparesis

InterStim® Sacal Neuromodulation Systems

Overactive bladder, Bowel incontinence, Urinary retention

AdaptiveStim® +SureScan®

Spinal Cord Stimulation - MRI compatible Chronic pain

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*


St. Jude Medical, Inc., (St. Paul, MN) is a leading producer of medical technology for treating cardiac

and neurological disorders. St. Jude Medical has a history of developing innovative technology and successful partnerships with companies to commercialize de-risked technology. R&D operations are focused in California and Texas, with efforts spanning cardiovascular disease, chronic pain and neurological diseases.

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 (GreatbatchMedical) and internal product development (QiG Group). The 2014 acquisition of CCC Medical increased international OEM capabilities.

Device Therapy Indications (*CE/IDE)

Libra™, Brio™ Deep Brain Stimulation Movement disorders*

Prodigy™ *, Eon™, Protégé™

Spinal Cord Stimulation Pain*

Genesis™ Optic Nerve Stimulation Chronic migraine*

Device Therapy Indications

Algostim™, Algovita™ Spinal Cord Stimulation Chronic pain

NEUROMODULATION IN MINNESOTA

2.


FIGURE 5. MINNESOTA COMPANIES BY ANATOMICAL TARGET

13Section # | Text

Boston ScientificFunctional NeuromodulationMedtronicMonteris MedicalSt. Jude Medical

COMPANIES TARGETING BRAIN

Boston ScientificGreatbatch MedicalMainstay MedicalMedtronicSt. Jude Medical

COMPANIES TARGETING SPINAL CORD

Advanced BionicsBioControl MedicalBoston ScientificCardionomicChattanooga GroupCogentix Medical (Uroplasty)

CVRxEmpiEnopace BiomedicalEnteroMedicsEnvoy Medical

HolairaInspire Medical SystemsMedi-StimMedtronicNovum TherapeuticsRespicardiaSPR TherapeuticsSt. Jude MedicalUni-PatchWR Medical Electronics

COMPANIES TARGETING NERVES

See Neuromodulation Resource Directory (p. 29) for summary and contact information of companies listed above and additional businesses providing supporting goods and services.


Minnesota supports a thriving and diverse ecosystem for neuro-modulation enterprise. There are 28 companies with headquarters or significant operations in MN responsible for producing at least 40 stimu-lation systems across all platform areas. Another 37+ companies work in the surrounding space, offering contract based expertise in IP, design, engineering, surgery, quality, regulatory, finance, manufacturing, patient data and clinical testing. Minnesota established itself early as a source of neurological expertise and continues to show rapid growth of new enterprise.

Funding for the life sciences is on the up and holding firm. In 2014, the state attracted over $1 billion for research and enterprise in the life sciences. More than 1000 federal research grants worth $740.6 million were awarded, up 5.2% from 2013.1,2 2014 also saw a six-year high of $430 million invested in life science businesses, with $320 million going to medical device companies.3

Minnesota's global positioning in the neuromodulation industry is well-established. Having grown on the shoulders of the cardiac pace-maker industry, neuromodulation has deep roots in Minnesota and a wide reach. Greg Molnar, PhD, Director of Medtronic's Neuroscience Discovery Division, commented that “You naturally have new geogra-phies with pre-existing people and efforts. [It] makes sense to leave it there and leverage the global nature of it. Still, Medtronic’s R&D head-quarters for neuromodulation are here in Minnesota. At the end of the day, the convergence of all that information and activity comes together to business and decisions based here in Minneapolis." Molnar empha-sized that the announcement to retain neuromodulation operations in

2014 Sources: Life Science Investments $430 M2014 Sources: National Institute of Health Awards $446 M2014 Sources: National Science Foundation Awards $155 MTOTAL 2014 AMOUNT $1,031 M

1 SOURCE: www.startribune.com/local/minneapolis/288484351.html?page=1&c=y2 SOURCE: www.projectreporter.nih.gov/reporter.cfm; http://www.nsf.gov/awardsearch3 SOURCE: LifeScience Alley, Minnesota Life Science Investment Activity: 2014 Annual Report.

15Section 2 | Neuromodulation in Minnesota

Minnesota following the Covidien merger, the largest in medical device history, is a clear indicator of the value of having such a critical mass of industry activity in Minnesota.

Regional activity in neuromodulation is strong across the spectrum, from pre-clinical and basic research to startups and established corpo-rations. The Twin Cities are known for excellence in engineering and medicine, consistently outranking other metro areas in medical device patents and inventive patents.1 To promote early stage ventures in healthcare and medical technology, a variety of startup incubator spaces and accelerators complement community- and member-based programs geared toward education and network expansion for entre-preneurs working with biomedical technology. In addition to the major players and supporting industry, the University of Minnesota and Mayo Clinic fund clinical research programs, hire world class scientists and provide unparalleled facilities. Both employ locally-sourced personnel with years of success in the medical device industry to provide struc-tured systems for IP development, commercialization and licensing.

1 SOURCE: www.mn.gov/deed, Compare MN and metropolitan areas.

1915

1965

1940

1980

2014

10

20

30

40

50

60

70

FIGURE 6. CUMULATIVE GROWTH OF NEUROSURGERY & NEUROMODULATION IN MN

MAYO CLINIC, DEPT. OF NEUROSURGERY, EST. 1919

UMN, DEPT. OF NEUROSURGERY, EST. 1937


Deep Brain Stimulation (DBS): Medtronic’s Activa™ system is the leading device option for treating Parkinson’s disease and essential tremor (Humanitarian Device Exempt status for Dystonia and Obsessive Compulsive Disorder). Boston Scientific is the other leading provider of a DBS system, Vercise™, approved for successful treatment of PD. While St. Jude Medical awaits FDA approval of their DBS systems, Libra, LibraXP and Brio, they are approved for treatment of Parkinson’s and dystonia in Europe and Australia. Early success in Parkinson’s is prom-ising, however, one entrepreneur with decades of experience in neu-romodulation noted 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 sig-nificant interest. Functional Neuromodulation is using Medtronic’s DBS platform in Phase I/II clinical trials for early stage Alzheimer’s disease. Multiple unsuccessful attempts at using DBS to treat depression attest to the substantial efforts being made to break into new disease applications and address significant unmet clinical needs.

Spinal Cord Stimulation (SCS): Medtronic, St. Jude Medical and Boston Scientific all produce FDA approved SCS devices to treat chronic back pain. Medtronic’s AdaptiveStim™ and SureScan™systems offer a dis-tinct 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 com-mercially 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 pro-ducing electromedical components, received FDA PMA approval of their first fully-functioning stimulation platform, Algovita™, in late-2015. Greatbatch's neuromodulation product development is performed by its subsidary, the QiG Group, located in Blaine, MN. Greatbatch's neuro-modulation expertise is built primarily upon mergers with two Minnesota neuromodulation businesses, Enpath and Quan Emerteq, in 2007. Although headquarters relocated from New York to Texas in 2012, ties to the Twin Cities remain strong.

IMPLANTABLE & MINIMALLY INVASIVE SYSTEMS


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

Cogentix Medical Inc., (Uroplasty) produces the Urgent® PC Neuromodulation System for sacral nerve stimulation to treat overactive bladder. PMA

status was awarded in 2005. Present efforts are focused on improving reimbursement.

CVRx developed and produces Barostim neo™, a first in-class implantable device for restoring cardiac and vascular function via the sympathetic nervous

system. HDE status was awarded for hypertension in December 5 and FDA approval for heart failure is anticipated in the future.

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 Medtronicto produce the Inspire® Upper Airway Stimulation device for stimulating the hypoglossal nerve to treat

Obstructive Sleep Apnea. FDA awarded PMA status in April 2014.


Non-surgical Neuromodulation: Methods that achieve neuromodula-tion via non-invasive or non-surgical means are the subject of more than half (61%) of all FDA trials currently open worldwide. Significantly more trials are targeting the brain (38%) than peripheral nerves (23%). While under active clinical investigation, non-surgical neuromodulation devices 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 Magnetic Stimulation (TMS) and Functional Ultrasound Stimulation. Major research efforts are directed toward stroke recovery and dystonia. Clinicians are also exploring applications in treatment-resistant depres-sion and rehabilitation following brain-related trauma. The center recently expanded due to notable funding awards from MnDRIVE and National Institutes of Health.

Neuromuscular Electrical Stimulation and Transcutaneous Electrical

Nerve Stimulation (NMES / TENS): DJO Global is the largest non-surgical orthopedic rehabilitation device producer in the U.S. Two sig-nificant acquisitions include Minnesota-based companies, EMPI and Chattanooga Group, with the latter maintaining operations in the state. Minnesota’s MediStim, also produces full electrotherapy systems and garments for portable devices.

NON-SURGICAL STIMULATION SYSTEMS

"Minnesota is a Disneyland for medical devices."

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


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

Medical Device Development: Notable operations span medical device R&D, IP, prototype production, sterilization, project management, regulatory, commercialization and finance (see Neuromodulation Resources Directory, page 31).

SUPPORTING ENTERPRISE

1 SOURCE: LifeScience Alley Patent Report: 2010-2014 .2 SOURCE: LifeScience Alley Workforce Report.

Evergreen Medical Technologies, Inc. specializes in active implantable medical device development, manufacturing, testing and clinical insight. The

majority of clientele (60%) is local. Known for electromedical engineering expertise, 90% of contract efforts focus on neuromodulation products.

Minnetronix, Inc., is a medical technology and innovation company, specializing in electronic and electromechanical devices. Minnetronix provides

ideas, innovation, and strategic guidance, as well as design, development and manufacturing services to medical device companies.

Greatbatch Medical provides a wide variety of contract medical device development and manu-facturing 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.


Clinical & Surgical Expertise: Minnesota has been the site for over 80 neuromodulation clinical trials.1 Minnesota’s expertise in clinical trials parallels the interests of the companies and organizations within the area. Mayo Clinic and the University of Minnesota established neuro-surgery departments early in the twentieth century, providing an easily accessible source of expertise for developing and testing implantable technology. See Neuromodulation Directory for listing of clinicians and research centers.

Talent & Workforce: The population of Minnesota is highly educated and has access to numerous specialized training programs from certifi-cate to doctorate. Overall, Minnesota boasts one of the highest literacy rates in the United States. Education is consistently supported by the state legislature and local programming. The University of Minnesota is ranked in the top 25 research universities in the world by the Center for Measuring University Performance. The 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 neuromodulation sector. UnitedHealth Group is the world’s largest healthcare and insurance pro-vider. 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, offer-ing both financial analysis and investing opportunities. Multiple accel-erators and co-working spaces are available for healthcare endeavors, both early stage and growing, including Healthcare.mn and TreeHouse Health.

SUPPORTING INFRASTRUCTURE

1 SOURCE: www.clinicaltrials.gov, searched Jan 20, 2014.

"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

21Section # | Text

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

The MN Neuromodulation Consortium was established in January 2015 to provide a centralized access point to the region’s extensive collection of resources and expertise in neuromodulation.

LifeScience Alley spends significant efforts advocating for federal and state legislation that promotes a profitable business climate. These

efforts produced the Angel Tax Credit, now offering up to $15 million in tax credits in 2015. LifeScience Alley also provides industry intelligence, programming and business referral opportunities to specifically address challenges faced in the health technology and medical device industries.

The Medical Device Innovation Consortium (MDIC)aims to advance regulatory science through its public-private partnership among industry

stakeholders, governmental agencies and patient / physician groups. The MDIC is presently working with the FDA to establish standardized safety guidelines for stimulation parameters in nerve tissue.

BioAM LLC, in Rochester, MN, is a community-based organization promoting economic development in life sciences through education and networking.

BioAM works with regional organizations like Destination Medical Center to elevate activities in healthcare and medicine across the state.

Section 2 | Neuromodulation in Minnesota

FUTUREFORECAST OFNEUROMODULATIONINDUSTRY

3.


'Closed-loop' Systems: Recent advancements in neuroscience, electri-cal engineering and bio-sensors have enabled ‘closed-loop’ systems, capable of sensing ongoing brain or nerve activity and incorporating it into stimulation parameters for optimized therapeutic efficacy in real-time.California-based Neuropace’s RNS® System is the first to the U.S. market with this technology, although many efforts are underway to make this technology the gold standard of care.

Pre-Clinical: Powerful pre-clinical capabilities are provided by optoge-netics and pharmacosynthetics, which make use of genetics to achieve selective cellular and anatomical targeting. The delivery of light and syn-thetic small molecules, respectively, is used to achieve neuromodula-tion. Both approaches are making major strides at the bench but are not used therapeutically in their present iterations due to limited acceptance of gene therapy in humans.

Non-Surgical: While challenges to commercialization remain, nonsurgi-cal options are gaining traction. Transcranial electrical, magnetic and ultrasound stimulation have demonstrated clinical efficacy but are sig-nificantly limited by high energy demands, large device size and ease of use. These modalities often require daily or weekly clinical visits to receive treatment, posing considerable geographic limitation to patient access. Some groups are addressing these limitations by developing small, portable devices to deliver small electrical charges to ‘superficial’ nerves near the surface of the body, e.g., via the ear canal like Novum Therapeutics.

EMERGING TECHNOLOGY

"LifeScience Alley is great because they continue to build connections and focus on issues of the day."

Todd Langevin, President & COO, Functional Neuromodulation

25Section 3 | Future Forecast of Neuromodulation Industry

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

Beyond classical nervous system disorders, diseases of peripheral tissues often have a neurological component or could benefit from neuro-logical interventions. Metabolic disorders, like obesity and type 2 diabe-tes, are growing at epidemic proportions and present significant patient needs. Inflammation treatments are another area of great commercial potential. Urinary and fecal incontinence is a major untapped market that will soon be filled by implantable neuromodulation devices that are under clinical investigation by numerous sponsors.

Prosthetics: In amputees and trauma victims, neuromodulation is aiding recovery following injury by promoting regrowth of severed nerves or spinal cords. Prosthetic limbs are being developed with biomimetic ‘skin’, capable of sensing temperature and pressure, which are paired with brain-computer interfaces to restore feeling and mobility. Much of the development work in this area is funded by the U.S. Department of Defense, with a focus on the veteran population.

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

UNMET NEEDS


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

Early safety demonstrations and lasting patient successes in treating pain and Parkinson’s disease continue to bolster physician support for SCS and DBS, respectively. Manufacturers of FDA-approved stimulation systems are able to provide entrepreneurs with verified technology for early-phase investigations, ultimately leading to lower cost, lower risk clinical trials.

MARKET CLIMATE

Minnesota is a powerful global center for the Neuromodulation Industry. Minnesota established a strong lead in neuromodulation therapies due to early success in cardiac stimulation. Talent and technology is easily transferred to a wide range of active implantable medical devices. The Twin Cities metropolitan area is home to small and large companies working in the neuromodulation space. The historic legacy serves the area well, providing emerging enterprises with talent, expertise and financing. Smaller ventures run the risk of being overshadowed by major players but can easily take advantage of the close proximity by accessing corporate talent on a consulting basis and leveraging connections for favorable exit strategies.

CONCLUDING SUMMARY

1 SOURCE: Global Neurostimulation / Neuromodulation Market. MicroMarketMonitor. (Feb 2015).2 SOURCE: The Market for Neurotechnology: 2014 - 2018. NeuroTechReports.com. (Mar 2014).

27Section 3 | Future Forecast of Neuromodulation Industry

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 AndersonSenior Vice President of R&D, St. Jude Medical, Inc.

Bryce Beverlin II, PhDMedical Devices Center Innovation Fellow, University of Minnesota

Charles Billington, MDProfessor, Department of Medicine, University of Minnesota

Dori Henderson, PhDProgram Manager, MnDRIVE Brain Conditions Initiative, University of Minnesota

Thomas GundersonSenior Financial Analyst, Piper Jaffray Companies

Matthew Johnson, PhDAssistant Professor, Department of Biomedical Engineering, University of Minnesota

Robert Kieval, PhDExecutive Vice President & CTO (Founder), CVRx, Inc.

Mark Knudson, PhDPresident & CEO, EnteroMedics, Inc.

ACKNOWLEDGEMENTS

Todd LangevinPresident & COO, Functional Neuromodulation, Ltd.

Gregory Molnar, PhDDirector of Neuroscience & Discovery, Medtronic.

William MurrayPresident & CEO, Medical Device Innovation Consortium (MDIC)

Randall NelsonPresident, Evergreen Medical Technologies

Tay Netoff, PhDAssistant Professor, Department of Biomedical Engineering, University of Minnesota

David Rhees, PhDExecutive Director, The Bakken Museum

Barry Rittberg, MDAssistant Professor, Department of Psychiatry, University of Minnesota

John SwoyerExecutive Director of Product Development, QiG Group

David WechterSenior R&D Engineer, Neuromodulation, Boston Scientific Corporation

29Section # | Text

NEUROMODULATIONRESOURCEDIRECTORY

4.


NEUROMODULATION DEVICES

Company City, State Founded Summary

Advanced Bionics Hopkins, MN 2009 Produces cochlear implant for hearing loss.

BioControl Medical Ltd. Minneapolis, MN 1999 Produces the CardioFit System for vagal nerve stimulation to treat heart failure.

Boston ScientificCorporation

Marlbourough, MASt. Paul, MN 1979 Develops and commercializes a diverse

neuromodulation device portfolio.

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

CerebralRx Ltd. Minneapolis, MN 2010 Device for neuromodulating terminal branches of cardiac plexus.

Chattanooga Group, Inc. St. Paul, MNVista, CA 1947 World's largest manufacturer of TENS /

NMES rehabilitation equipment.

Cogentix Medical, Inc. Hopkins, MN 1987 Urgent® PC Neuromodulation System for percutaneous tibial nerve stimulation.

CVRx, Inc. Minneapolis, MN 2001 Barostim neo™ for barostim receptor stimu-lation in the carotid artery.

Empi, Inc. St. Paul, MN - Non-invasive electrical stimulation (TENS / NMES) devices.

EnteroMedics, Inc. St. Paul, MN 2002 vBloc Maestro® Rechargeale System for vagal nerve blocking.

Envoy Medical Corp. St. Paul, MN 1995 Middle-ear implant for nerve-related hearing loss, Esteem.

Functional Neuromodulation Ltd. Minneapolis, MN 1995 Developing DBS to treat mild Alzheimer's

disease.

Greatbatch Medical(Greatbatch, Inc.) Plymouth, MN 1970 Algovita™ & Algostim™ spinal cord

stimulation systems for chronic pain.

Holaira Medical, Inc. Plymouth, MN 2008 Device for Targeted Lung Denervation to reduce overactive airway nerve activity.

31Section 4 | Neuromodulation Resources Directory



Inspire Medical Systems, Inc. Maple Grove, MN 2007 Sells Inspire® for Obstructive Sleep Apnea.

Mainstay Medical, Inc. Dublin, IrelandPlymouth, MN 2008 ReActiv8™ implantable spinal stimulation

device for chronic low back pain.

Medi-Stim, Inc. Wabasha, MN 1984 Non-invasive electrotherapy products to treat neural & muscular pain.

Medtronic. Dublin, IrelandMinneapolis, MN 1949 Develops and commercializes diverse

neuromodulation device portfolio

Monteris Medical, Inc. Plymouth, MNWinnipeg, Canada 1999 NeuroBlate® System for MRI-guided neuro-

surgical ablation.

Novum Therapeutics, Inc. Minneapolis, MN 2013 Nocturne™ non-invasive neuromodulation for Obstructive Sleep Apnea.

Pepin Manufacturing, Inc. Lake City, MN 1993 Contract-based product design, develop-ment, and manufacturing.

QiG Group Blaine, MN 2008Neurostimulation systems including implantable pulse generators, leads and programmers.

Respicardia, Inc. Hopkins, MN 2006 Remedē® System for phrenic nerve stimulation of the diaphragm.

SPR Therapeutics LLC Minneapolis, MN 2010 Smartpatch & Micropulse PNS systems for interventional pain management.

St. Jude Medical, Inc. St. Paul, MN 1976 Develops and commercializes a diverse neuromodulation device portfolio.

Uni-Patch (Covidien, Ltd.) Wabasha, MN 1978 Produces non-implantable electrodes and

garments.

WR Medical Electronics Co. Maplewood, MN 1962 Hilger Silverstein Facial Nerve Stimulators for facial paralysis.


DESIGN, DEVELOPMENT & MANUFACTURING - DEVICES & COMPONENTS


Advanced Medical Electronics Corporation Maple Grove, MN 1990 Product-focused research and development

company specializing in medical devices.

Cymbet Corporation Elk River, MN 2000 Rechargeable, thin film & solid state batteries for microelectronic systems.

Devicix LLC Eden Prairie, MN 2004Electromedical device design, engineering, prototyping, development, regulatory, & commercialization.

Donatelle Medical New Brighton, MN 1967 Medical device development, manufacturing, & commercialization.

Evergreen Medical Technologies, Inc. St. Paul, MN 2006

Electromedical device design, engineering, prototyping, development, certification, and regulatory expertise.

Greatbatch Medical(Greatbatch, Inc.) Plymouth, MN 1970 Algovita™ & Algostim™ spinal cord

stimulation systems for chronic pain.

Heraeus Medical Components LLC St. Paul, MN 1851 Delivers from ingot to complex engineered

assembly.

Matrix MedTech, Inc. Maple Grove, MN 2011Research, design, development, prototyping, & manufacturing for medical device components.

Medical Device Resource Group

Coalition of independent Minnesota companies offering expertise to get new medical devices to the market.

Minnetronix, Inc. St. Paul, MN 1996 Medical device design, manufacturing, & IP.

Nortech Systems, Inc. Maple Grove, MN 1981 Electronics manufactuing services for medical device industry & others.

North American Science Associates, Inc. (NAMSA) Minneapolis, MN 1967 Medical research organization - regulatory,

laboratory, clinical & compliance services.

Omnetics Connector Corp. Minneapolis, MN 1984 Micro & nano connectors for military, commercial, and medical applications.

Pepin Manufacturing, Inc. Lake City, MN 1993 Custom electrodes for electrotherapy. R&D, design, and manufacturing expertise.




Smiths Medical ASD Inc.(Smiths Group) St. Paul, MN 1983 Clinical & technical support services for

multi-national medical device studies.

Stellar Technologies, Inc. Brooklyn Park, MN 1991 Development, qualification, and component manufacturing of medical products.

Summit Medical, Inc.(Shore Capital Partners LLC) St. Paul, MN 1982 Medical device manufacturing, regulatory,

quality, engineering, sales, and marketing.


PMT Corporation Chanhassen, MN 1979 Products for neurosurgery, orthopedics, and plastic & reconstructive surgery.

RCRI, Inc.

Regulatory and clinical CRO that combines operation excellence and strategic consulting in medical device, IVD, Biologics and combination product spaces.

Surpass, Inc. Osceola, WI

Contract research organization specializing in preclinical services for medical devices, pharmaceuticals, biologics, and combination products.

TOXIKON, Inc. Minnetonka, MN 1977

Contract research partner with preclinical models for evaluation of various cardiovascular, gastrointestinal and other devices.

DESIGN, DEVELOPMENT & MANUFACTURING - DEVICES & COMPONENTS

NEUROSURGERY EQUIPMENT


ev3 Inc.(Covidien, Ltd.) Plymouth, MN 2000 Medical devices for neurosurgery

applications.

IMRIS Inc. Minnetonka, MNWinnipeg, Canada 2005 Multiple product lines for image guided

neurosurgery solutions.

Monteris Medical, Inc. Plymouth, MNWinnipeg, Canada 1999 Medical devices for MRI-guided

neurosurgical ablation.

Summit Medical, Inc.(Shore Capital Partners LLC) St. Paul, MN 1982 Medical device development for

neurosurgery application


FINANCE


Bay City Capital LLC San Francisco, CA 1997 Life sciences investment firm.

Brain Trust Accelerator Fund, L.P. Burlingame, CA 2006

Early stage investments that address diagnosis & treatment of brain-related diseases.

Craig-Hallum Capital Group LLC Minneapolis, MN 1997 Institutional investment banking firm for

health technology and medical devices.

Gopher Angels LLC Minneapolis, MN - Network of accredited investors seeking to invest capital in early stage MN businesses.

Greatbatch Medical(Greatbatch, Inc.) Plymouth, MN 1970 Invests in targeted technology &

acquisitions.

Neuro Device Innovations (NDI) Medical LLC Minneapolis, MN 2002 Hybrid VC & commercialization firm for

neurodevice technologies.

NeuroVentures Capital LLC Charlottesville, VA 2000 Invests in therapeutics & technologies to treat CNS disorders.

Oak Investment Partners Minneapolis, MN 1978 VC investments in companies developing systems & services in healthcare.

Piper Jaffray Companies Minneapolis, MN 1993 Investment banking firm with expertise in health technology & medical devices.

RAIN Source Capital St. Paul, MN 1998 Community-based network of investors, capital, and expertise.

Shore Capital Partners LLC Chicago, IL - Healthcare-focused lower middle market private equity firm.


Teren Med, Inc. Minneapolis, MN 2008 Electromedical equipment manufacturer.

Worrell Design, Inc. Minneapolis, MN 1976 Product design, development, and strategy.




Beck & Tysver PLLC Minneapolis, MN - Patent law firm specializing in software technology and medical devices.

BitLaw Legal Resource Online Directory - Free legal resource. Curates list of IP Firms in Minnesota.

Mayo Clinic Ventures Rochester, MN 1985 Works with physicians & scientists to mine inventions, ideas and discoveries.

Mueting, Raasch & Gebhardt, P.A. Minneapolis, MN - Expertise in patent law relating to electrical

& mechanical arts.

Patterson Thuente Pedersen, P.A. Minneapolis, MN 1991 Strategic solutions to complex intellectual

property matters, expertise in technology IP.

The General Counsel, Ltd. Minneapolis, MN 1985 Organization for angel investors - medical devices, diagnostics, pharma and biotech.

INTELLECTUAL PROPERTY - MEDICAL DEVICE

FINANCE


Smiths Group London, England 1851 Buys businesses that add complementary technologies and products.

Technology Partners Palo Alto, CA 1994 Builds & invests in companies focusing on life science & clean technologies.

Third Rock Ventures LLC Boston, MASan Francisco, CA - Multi-disciplinary team that brings together

science, strategy, business, and medicine.

Thomas McNerney & Partners LLC Minneapolis, MN 1992 Healthcare venture firm that invests in life

sciences & medical technology.

Twin Cities Angels Minneapolis, MN 2006 Organization for angel investors - medical devices, diagnostics, pharma and biotech.

Versant Ventures San Francisco, CA 1999 Emphasis on discovery & development of novel therapeutics.



CoCo - MSP(Google for Entrepreneurs)

St. Paul, MNMinneapolis, MN 2010 Tech hub in Google for Entrepreneurs

network. Space, funding and mentorship.

Destination Medical Center Rochester, MN - Economic development initiative to secure MN's status as a global medical destination.

Mayo Clinic Business Accelerator Rochester, MN 2013 Provides infrastructure that enables

entrepreneurism for Rochester community

Startup Venture Loft (SVL) Minneapolis, MN - Provides MN startups with space, connections, and resources.

Treehouse Health Minneapolis, MN 2013 Healthcare innovation center with emphasis on health IT and care coordination.

University Enterprise Laboratories St. Paul, MN 2006 Collaborative research center fore early

stage bio-science ventures.

UMN - Business Accelerator Program Minneapolis, MN 2012 Dynamic business mentorship-based

program.

UMN - MN-IP: MN Innovation Partnerships Minneapolis, MN - Designed to improve access to university-

developed technology.

OTHER - SUPPORTING INFRASTRUCTURE


BioAM Rochester, MN - Engages with local entrepreneurs & connects them with people & resources.

CoCo - MSP(Google for Entrepreneurs)

St. Paul, MNMinneapolis, MN 2010 Tech hub in Google for Entrepreneurs

network. Space, funding and mentorship.

Destination Medical Center Rochester, MN - Economic development initiative to secure MN's status as a global medical destination.

Mayo Clinic Business Accelerator Rochester, MN 2013 Provides infrastructure that enables

entrepreneurism for Rochester community

INTELLECTUAL PROPERTY - MEDICAL DEVICE



UMN - Office for Technology Commercialization (OTC)

Minneapolis, MN -Facilitates transfer of university research to licensees for the development of new products and services.

OTHER - SUPPORTING INFRASTRUCTURE

39Section # | Text

CLINICAL, SURGICAL, RESEARCH & BUSINESS DIRECTORY

5.


CLINICAL EXPERTISE: EPILEPSY

CLINICAL EXPERTISE: MOVEMENT DISORDERS

CLINICAL EXPERTISE: ABLATION

Organization City, State Contact Name Contact Info

Mayo Clinic, Department of Anesthesiology & Pain Medicine Rochester, MN Samuel J. Asirvatham, MD -

Neurovascular & PNS 507. 284. 2511

CLINICAL EXPERTISE: DEPRESSION


University of Minnesota, Department of Psychiatry Minneapolis, MN Barry Rittburg, MD - DBS,

VNS, TMS [email protected]

CLINICAL EXPERTISE: EPILEPSY


Mayo Clinic, Department of Neurosurgery & Otorhinolaryngology

Rochester, MN Jamie J. Van Gompel, MD - DBS 507.284.8008


Mayo Clinic, Department of Neurosurgery Rochester, MN Kendall H. Lee, MD, PhD -

DBS [email protected]

Mayo Clinic, Department of Neurosurgery Rochester, MN Squire (Matt) M. Stead, MD,

PhD - DBS 507.284.7341


University of Minnesota, Department of Neurology Minneapolis, MN David Rottenberg, MSc, MD

- DBS [email protected]

University of Minnesota, Department of Neurology Minneapolis, MN Anthony Santiago, MD -


University of Minnesota, Department of Neurology Minneapolis, MN Jerrold Vitek, MD - DBS [email protected]

41Section 5 | Clinical, Surgical, Research & Business Directory

CLINICAL EXPERTISE: MOVEMENT DISORDERS


University of Minnesota, Department of Neurosurgery Minneapolis, MN Michael C. Park, MD - DBS [email protected]

Mayo Clinic, Department of Neurology Rochester, MN Anhar Hassan, MB, BCh -




Mayo Clinic, Department of Psychiatry and Psychology Rochester, MN Julie A. Fields, PhD, LP -


Mayo Clinic, Department of Neurosurgery Rochester, MN Squire (Matt) M. Stead, MD,

PhD - DBS 507.284.7341

Mayo Clinic, Department of Neurology Rochester, MN Bryan T. Klassen, MD - DBS [email protected]

University of Minnesota, Department of Biomedical Engineering

Minneapolis, MN Dr. Matthew D. Johnson - DBS (pre-clinical) [email protected]

CLINICAL EXPERTISE: OBESITY


University of Minnesota, Department of Medicine Minneapolis, MN Charles Billington, MD -

VNS [email protected]

CLINICAL EXPERTISE: PAIN


Fairview Hospital,Spine and Brain Clinic Edina, MN Paul Gigante, MD - SCS 952.836.3695

University of Minnesota, Department of Neurosurgery Rochester, MN Michael C. Park, MD - DBS [email protected]

Mayo Clinic, Department of Anesthesiology & Pain Medicine Rochester, MN

Tim J. Lamer, MD - SCS, PNS, CNS-targeted Drug Delivery

507.284.2511


CLINICAL EXPERTISE: PSYCHIATRIC DISORDERS

CLINICAL EXPERTISE: STROKE


University of Minnesota, Department of Psychiatry Minneapolis, MN Barry Rittburg, MD - DBS,

VNS, TMS [email protected]



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

DBS 507.284.8008


University of Minnesota, Program in Physical Therapy Minneapolis, MN James R. Carey, PhD, PT,

FAPTA - TMS, fMRI [email protected]

University of Minnesota, Brain Plasticity Laboratory Minneapolis, MN Teresa Jacobson Kimberley,

PhD, PT - TMS, fMRI [email protected]

University of Minnesota, Brain Plasticity Laboratory Minneapolis, MN Bernadette Gillick, PhD, MS,

PT - TMS, fMRI [email protected]

University of Minnesota, Brain Plasticity Laboratory Minneapolis, MN

Wynn Legon, PhD - TMS, tACS / tDCS, and Ultrasound Stimulation, fMRI

[email protected]



Halena M. Gazelka, MD - SCS, PNS, CNS-targeted Drug Delivery

507.284.2511


Jason S. Eldridge, MD - SCS, PNS, CNS-targeted Drug Delivery

507.284.2511


Brenton M. Meier, MD - SCS, PNS, CNS-targeted Drug Delivery

507.284.2511

CLINICAL EXPERTISE: PAIN


CLINICAL EXPERTISE: STROKE


University of Minnesota, Department of Biomedical Engineering, Center for Neuroengineering

Minneapolis, MN Bin He, PhD - TMS, tDCS [email protected]

SURGICAL EXPERTISE


Mayo Clinic, Department of Neurosurgery Rochester, MN - 507.284.8008

Fairview Hospital, Spine and Brain Clinic Edna, MN Paul Gigante, MD - SCS 952.836.3695

University of Minnesota, Experimental Surgical Services Minneapolis, MN Stefanie B. Yorek, contact

for appointment scheduling [email protected]

University of Minnesota, Division of Gastrointestinal & Bariatric Surgery, Medical Center Department of Surgery

Minneapolis, MN - 612.625.8446

University of Minnesota, Movement Disorders & Epilepsy Surgery Center, Medical Center Department of Surgery


University of Minnesota, Neurosurgery Clinic, Medical Center Department of Surgery


University of Minnesota, Center for Minimally Invasive Surgery, Medical Center Department of Surgery


CLINICAL CENTERS


Mayo Clinic, Traumatic Brain Injury Program Rochester, MN Nicole L. Dernbach [email protected]

VA Office of Research & Development - Polytrauma / Blast-Related Injuries - Quality Enhancement Research Initiative

Minneapolis, MN

Princess Osei-Bonsu, PhD, MSPH - PBRI, Implementation Research Coordinator

[email protected]


IMAGING CENTERS


University of Minnesota, Center for Magnetic Resonance Research Minneapolis, MN Deb Morgan, Executive

Assistant [email protected]

University of Minnesota, Center for Clinical Imaging Research Minneapolis, MN - [email protected]

Mayo Clinic, Center for Advanced Imaging Research Rochester, MN Stephen J. Riederer, PhD [email protected]


Mayo Clinic, Alzeimer's Disease Research Center Rochester, MN - [email protected]

Mayo Clinic, Diabetes Center Rochester, MN John Miles, MD [email protected]

Mayo Clinic, Migraine Research Program Rochester, MN - migraineresearch

[email protected]

Minnesota Obesity Center St. Paul, MN Dr. Catherine C. Welch, Program Coordinator [email protected]

University of Minnesota, Brain Plasticity Laboratory Minneapolis, MN - 612.626.4096

Mayo Clinic, CT Clinical Trials Innovation Center Rochester, MN - [email protected]

University of Minnesota, The Memory Clinic, The N. Bud Grossman Center for Memory Research and Care

Minneapolis, MN - [email protected]

CLINICAL CENTERS

RESEARCH CENTERS


University of Minnesota, Office of the Vice President for Research Minneapolis, MN - 612.625.3394


RESEARCH CENTERS


University of Minnesota, Division of Gastrointestinal & Bariatric Surgery, Medical Center Department of Surgery


University of Minnesota, Biomedical Functional Imaging and Neuroengineering Laboratory


Mayo Clinic, Center for Clinical and Translational Science (CCaTS) Rochester, MN - 507.255.7101

University of Minnesota, Clinical and Translational Science Institute Minneapolis, MN Rosalyn Segal,

Administrative Director [email protected]

Mayo Clinic, Evidence-Based Practice Research Program Rochester, MN - 507.266.1829

Fairview Research Administration St. Paul, MN - [email protected]

Helpline: 612.672.7692

University of Minnesota, Neuromodulation Research and Technology Laboratory

Minneapolis, MN Dr. Matthew D. Johnson [email protected]

University of Minnesota, Institute for Engineering Minneapolis, MN - [email protected]

University of Minnesota, Center for Applied and Translational Sensory Science (CATSS)

Minneapolis, MN [email protected]

University of Minnesota, Center for Neuroengineering Minneapolis, MN - [email protected]

University of Minnesota, Center for Design in Health Minneapolis, MN Kathleen A. Harder, PhD,

Director [email protected]

University of Minnesota, Brain Sciences Center, Minneapolis Veterans Affairs Medical Center

Minneapolis, MN Amy Wicklund, Administrator [email protected]

University of Minnesota, Institute for Translational Neuroscience Minneapolis, MN Rosalyn Segal,

Administrative Director [email protected]

University of Minnesota, National Institute of Neurodegenerative Disorders & Stroke Center

Minneapolis, MN Tim Ebner, PhD, Co-DirectorHarry Orr, PhD, Co-Director

[email protected]@umn.edu

ADDITIONAL RESOURCES (MINNESOTA / USA / GLOBAL): POLICY, EDUCATION & ADVOCACY

ADDITIONAL RESOURCES (MINNESOTA / USA / GLOBAL): MARKET REPORTS

Organization City, State Contact Info Summary

Medical Device Innovation Consortium (MDIC)

St. Louis Park, MN 952.314.1255Public-private partnership working to advance medical device regulatory science.

Minnesota High Tech Association Minneapolis, MN 952.230.4555 Innovation and tech association that

advocates on behalf of field.

Neurotechnology Industry Organization (NIO)

San Francisco, CA [email protected]

Accelerates neurotechnology research, development and commercialization.

North American Neuromodulation Society (NANS)

Chicago, IL [email protected]

Promotes multidisciplinary collaboration among clinicians, scientists, engineers, and others to advance neuromodulation.

The International Neuromodulation Society (INS)

San Francisco, CA [email protected]

Nonprofit group of clinicians, scientists, and engineers dedicated to scientific development and awareness of neuormodulation.

Organization City, State Contact Info Summary

NeuroInsights San Francisco, CA [email protected] neurotech industry newsletters, market reports, investment conferences and advisory.

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


MnDRIVE - Brain Conditions Initiative, University of Minnesota, Office of the Vice President for Research

Minneapolis, MN Tim Ebner, PhD, Research Lead [email protected]

University of Minnesota, Medical Devices Center (MDC) Minneapolis, MN Greg Peterson,

Innovation Collaborator [email protected]

RESEARCH CENTERS

sector landscapes: neuromodulation

Documents