Sector Landscapes: Neuromodulation by Medical Alley Association

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

List of Contributors PLEASE DIRECT CORRESPONDENCE TO:

Cheryl Matter, PhD, Vice President of Intelligence & Research, LifeScience Alley cmatter@lifesciencealley.org | 952.746.3817 Anastasia N. Zink, PhD Candidate, Graduate Program in Neuroscience, UMN Research Lead Amanda K. Weber, LifeScience Alley Design Consultant Visualization + Design LifeScience Alley's intelligence and research work is generously supported by our Foundational and Sustaining Members.

Foundational Members

Sustaining Members

About LifeScience Alley LifeScience Alley is a global leader in enabling health technology and care organizations to innovate, succeed and influence the evolution of healthcare. By influencing policy, 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.

EXECUTIVE SUMMARY 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 productâ&#x20AC;&#x2122;s life-cycle, including pre-clinical research, product development and commercialization. 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. Minnesotaâ&#x20AC;&#x2122;s early and continued foothold in

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.)

the medical device industry provides a mature foundation, open for innovation and entrepreneurship in neuromodulation. KEY FINDINGS + 27 companies with major operations in Minnesota with more than 40 FDAregistered 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 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

A fast growing segment of healthcare is the neuromodulation industry MARKET

DEVICES

INDICATIONS

MAJOR PLAYERS

[2] NEUROMODULATION IN MINNESOTA

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

IMPLANTABLE & MINIMALLY INVASIVE SYSTEMS

NON-SURGICAL STIMULATION SYSTEMS

SUPPORTING ENTERPRISE

SUPPORTING INFRASTRUCTURE

[3] FUTURE FORECAST OF NEUROMODULATION INDUSTRY IN MINNESOTA

EMERGING TECHNOLOGY

UNMET NEEDS

MARKET CLIMATE

CONCLUDING SUMMARY

ACKNOWLEDGEMENTS

[4] NEUROMODULATION RESOURCES DIRECTORY

[5] CLINICAL, SURGICAL, RESEARCH & BUSINESS DIRECTORY

LIST OF FIGURES FIGURE 1.

FDA Neuromodulation Trials Open Worldwide by Subsector

FIGURE 2.

Global Locations of Major Neuromodulation Companies

FIGURE 3.

Neuromodulation Global Revenue Fiscal Year 2013

FIGURE 4.

Indications Approved and Under Investigation

FIGURE 5.

Minnesota Companies by Anatomical Target

FIGURE 6.

Cumulative Growth of Neurosurgery & Neuromodulation in Minnesota

1. GLOBAL OVERVIEW OF NEUROMODULATION INDUSTRY

1,0

BRAIN: TRANSCRANIAL ELECTRICAL STIMULATION // 9%

BRAIN: DEEP BRAIN STIMULATION // 16%

BRAIN: TRANSCRANIAL MAGNETIC STIMULATION // 29%

BRAIN // 54%

SPINAL CORD STIMULATION // 10%

NEUROMUSCULAR ELECTRICAL STIMULATION + TRANSCUTANEOUS ELECTRICAL STIMULATION // 23%

PERIPHERAL NERVE STIMULATION // 9%

COCHLEAR // 4%

Sector Landscapes: Neuromodulation | LifeScience Alley

TRIA

FIGURE 1. FDA NEUROMODULATION TRIALS OPEN WORLDWIDE BY SUBSECTOR

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 pacemakerinspired prototypes. MARKET Minnesota-based companies were the first to commercialize devices for Deep Brain Stimulation (DBS), Spinal Cord Stimulation (SCS), and Peripheral Nerve Stimulation (PNS). Minnesota-based companies continue to hold a substantial (72%) share of the $3.5 billion global market, which is estimated to reach $6-7 billion by 2018.1,2 The neuromodulation market is dominated by three medical device giants - Medtronic, Boston Scientific and St. Jude Medical - all of which have headquarters or significant operations in the state of Minnesota. Greatbatch is responsible for manufacturing critical components contained in 95% of Active Implantable Medical Devices (AIMD) and has multiple operations in Minnesota. The major players have successful histories of independently developing or acquiring technologies for neuromodulation therapies and associated surgical operations. Significant industry activity is focused on: + Expanding approved indications for existing platforms. + Producing or acquiring de-risked technology for new patient markets. + Developing novel delivery systems specialized for unique anatomical targets.

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

Section 1 | Global Overview of Neuromodulation Industry

DEVICES Neuromodulation therapies are available in implantable, minimally invasive and non-surgical options. Implantable devices for brain stimulation deliver electricity deeply via ‘depth’ electrodes or cortical electrode arrays placed on the brain surface. Similar technology is used for spinal cord stimulation, as well as peripheral nerve targeting. Implanted-drug pumps that deliver small molecules to the central nervous system via the intrathecal space also achieve targeted neuromodulation. Minimally invasive neuromodulation can be achieved by transcutaneous stimulation through small needle-like electrodes and is typically restricted to spinal and superficial nerve stimulation. Non-surgical or non-invasive devices act through a variety of modalities. Electrical stimulation delivered to muscles and wounds by paddle-style electrodes placed topically are used to prevent atrophy, increase blood flow, reduce pain and edema. Neuromodulation of the brain and spinal cord can be achieved through electrical direct or alternating current, ultrasound, and magnetic fields.

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

Sector Landscapes: Neuromodulation | LifeScience Alley

FIGURE 2. GLOBAL LOCATIONS OF MAJOR NEUROMODULATION COMPANIES

MEDTRONIC BOSTON SCIENTIFIC ST. JUDE MEDICAL CYBERONICS

FIGURE 3. NEUROMODULATION GLOBAL REVENUE FISCAL YEAR 2013

MEDTRONIC BOSTON SCIENTIFIC ST. JUDE MEDICAL CYBERONICS

Sales office and representative locations excluded from map.

Section 1 | Global Overview of Neuromodulation Industry

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

â&#x20AC;&#x153;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.â&#x20AC;? William Murray, President & CEO, Medical Device Innovation Consortium (MDIC)

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

Sector Landscapes: Neuromodulation | LifeScience Alley

FIGURE 4. INDICATIONS APPROVED AND UNDER INVESTIGATION

FDA STATUS

DEEP BRAIN STIMULATION (DBS)

SPINAL CORD STIMULATION (SCS)

PERIPHERAL NERVE STIMULATION (PNS)

APPROVED INDICATIONS

INVESTIGATIONAL INDICATIONS

Parkinson's disease, essential tremor and epilepsy

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

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

165 indications Bacterial 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 diseases and Wounds and injuries

Obstructive sleep apnea, central sleep apnea, hypertension, obesity, incontinence, heart failure and migraine

120 indications 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 and Wounds and injuries

Section 1 | Global Overview of Neuromodulation Industry

MAJOR PLAYERS Medtronic

(Minneapolis,

–

operational

headquarters) holds a dominant presence in the national and global neuromodulation market. The company upholds a reputation for developing first-in-class products and acquiring IP in areas that complement or expand existing capabilities. Neuromodulation operations are based in Fridley, MN, and will remain there following the upcoming merger with Covidien. Device

Therapy

Indications

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

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 (*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*

Sector Landscapes: Neuromodulation | LifeScience Alley

St. Jude Medical, Inc., (St. Paul, MN) is a leading producer of medical technology for treating cardiac and neurological disorders. St. Jude Medical has a history of developing innovative technology and successful partnerships with companies to commercialize de-risked technology. R&D operations are focused in California and Texas, with efforts spanning cardiovascular disease, chronic pain and neurological diseases. Device

Therapy

Indications (*CE/IDE)

Libra™, Brio™

Deep Brain Stimulation

Movement disorders*

Prodigy™ *, Eon™, Protégé™

Spinal Cord Stimulation

Pain*

Genesis™

Optic Nerve Stimulation

Chronic migraine*

Greatbatch, Inc., (Plano, TX) is a leading developer and manufacturer of medical device systems and critical components for the neuromodulation, orthopedics and cardiovascular markets. The company is known for inventing the now ubiquitous lithium-powered batteries, first used in implantable pacemakers. Today, 95% of commercially available AIMDs are designed with Greatbatch materials. The last year saw expanded operations in Minnesota for medical device manufacturing (Greatbatch Medical) and internal product development (QiG Group). The 2014 acquisition of CCC Medical increased international OEM capabilities. Device

Therapy

Indications

Algostim™, Algovita™

Spinal Cord Stimulation

Chronic pain

Section 1 | Global Overview of Neuromodulation Industry

2. NEUROMODULATION IN MINNESOTA

FIGURE 5. MINNESOTA COMPANIES BY ANATOMICAL TARGET

Sector Landscapes: Neuromodulation | LifeScience Alley

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

COMPANIES TARGETING SPINAL CORD Boston Scientific Greatbatch Medical Mainstay Medical Medtronic St. Jude Medical

COMPANIES TARGETING NERVES Advanced Bionics

Holaira

BioControl Medical

Inspire Medical Systems

Boston Scientific

Medi-Stim

Cardionomic

Medtronic

Chattanooga Group

Novum Therapeutics

Cogentix Medical

Respicardia

(Uroplasty)

CVRx Empi Enopace Biomedical EnteroMedics

SPR Therapeutics St. Jude Medical Uni-Patch WR Medical Electronics

Envoy Medical

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

Minnesota supports a thriving and diverse ecosystem for neuromodulation enterprise. There are 28 companies with headquarters or significant operations in MN responsible for producing at least 40 stimulation systems across all platform areas. Another 37+ companies work in the surrounding space, offering contract based expertise in IP, design, engineering, surgery, quality, regulatory, finance, manufacturing, patient data and clinical testing. Minnesota established itself early as a source of 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 2014 Sources: Life Science Investments 2014 Sources: National Institute of Health Awards 2014 Sources: National Science Foundation Awards TOTAL 2014 AMOUNT

$430 M $446 M $155 M $1,031 M

Minnesota's global positioning in the neuromodulation industry is well-established. Having grown on the shoulders of the cardiac pacemaker industry, neuromodulation has deep roots in Minnesota and a wide reach. Greg Molnar, PhD, Director of Medtronic's Neuroscience Discovery Division, commented that â&#x20AC;&#x153;You naturally have new geographies with pre-existing people and efforts. [It] makes sense to leave it there and leverage the global nature of it. Still, Medtronicâ&#x20AC;&#x2122;s R&D headquarters 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 emphasized that the announcement to retain neuromodulation operations in SOURCE: www.startribune.com/local/minneapolis/288484351.html?page=1&c=y SOURCE: www.projectreporter.nih.gov/reporter.cfm; http://www.nsf.gov/awardsearch 3 SOURCE: LifeScience Alley, Minnesota Life Science Investment Activity: 2014 Annual Report. 1 2

Sector Landscapes: Neuromodulation | LifeScience Alley

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 corporations. The Twin Cities are known for excellence in engineering and medicine, consistently outranking other metro areas in medical device patents and inventive patents.1 To promote early stage ventures in healthcare and medical technology, a variety of startup incubator spaces and accelerators complement community- and member-based programs geared toward education and network expansion for entrepreneurs working with biomedical technology. In addition to the major players and supporting industry, the University of Minnesota and Mayo Clinic fund clinical research programs, hire world class scientists and provide unparalleled facilities. Both employ locally-sourced personnel with years of success in the medical device industry to provide structured systems for IP development, commercialization and licensing. FIGURE 6. CUMULATIVE GROWTH OF NEUROSURGERY & NEUROMODULATION IN MN 70 60 50 40

MAYO CLINIC, DEPT. OF NEUROSURGERY, EST. 1919

UMN, DEPT. OF NEUROSURGERY, EST. 1937

2014

1980

1965

1940

1915

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

Section 2 | Neuromodulation in Minnesota

IMPLANTABLE & MINIMALLY INVASIVE SYSTEMS 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 promising, however, one entrepreneur with decades of experience in neuromodulation 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 significant 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 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 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 neuromodulation expertise is built primarily upon mergers with two Minnesota neuromodulation businesses, Enpath and Quan Emerteq, in 2007. Although headquarters relocated from New York to Texas in 2012, ties to the Twin Cities remain strong. 16

Sector Landscapes: Neuromodulation | LifeScience Alley

Peripheral Nerve Stimulation (PNS): Peripheral nerves are attractive targets for neuromodulation-based therapies due to relatively easy surgical 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 midsized 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 vagalnerve stimulation for weight loss and is exploring efficacy in related metabolic disorders. PMA status was granted by FDA in January 2015, contingent upon a 5-year Phase IV follow-up study. Inspire Medical Systems, Inc., spun out of Medtronic to produce the Inspire® Upper Airway Stimulation device for stimulating the hypoglossal nerve to treat Obstructive Sleep Apnea. FDA awarded PMA status in April 2014.

Section 2 | Neuromodulation in Minnesota

NON-SURGICAL STIMULATION SYSTEMS Non-surgical Neuromodulation: Methods that achieve neuromodulation via non-invasive or non-surgical means are the subject of more than half (61%) of all FDA trials currently open worldwide. Significantly more trials are targeting the brain (38%) than peripheral nerves (23%). While under active clinical investigation, non-surgical neuromodulation devices 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 depression 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 nonsurgical orthopedic rehabilitation device producer in the U.S. Two significant acquisitions include Minnesota-based companies, EMPI and Chattanooga Group, with the latter maintaining operations in the state. Minnesota’s MediStim, also produces full electrotherapy systems and garments for portable devices.

"Minnesota is a Disneyland for medical devices." John Linehan, PhD, Clinical Professor of Biomedical Engineering, Northwestern University

Sector Landscapes: Neuromodulation | LifeScience Alley

SUPPORTING ENTERPRISE Medical Device Manufacturing: Minnesota produced the first FDAapproved neurostimulation devices and continues to be a global leader in active implantable medical devices. The Minneapolis - St. Paul metropolitan area is the nationâ&#x20AC;&#x2122;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). Evergreen Medical Technologies, Inc. specializes in active implantable medical device development, manufacturing, testing and clinical insight. The majority of clientele (60%) is local. Known for electromedical engineering expertise, 90% of contract efforts focus on neuromodulation products. Greatbatch Medical provides a wide variety of contract medical device development and manufacturing services. The company also designs and manufactures critical electromedical technologies to enhance the reliability and performance of medical devices and procedures, including batteries, device headers and enclosures, leads, coated electrodes and more.

Minnetronix, Inc., is a medical technology and innovation company, specializing in electronic and electromechanical devices. Minnetronix provides ideas, innovation, and strategic guidance, as well as design, development and manufacturing services to medical device companies. 1

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

Section 2 | Neuromodulation in Minnesota

SUPPORTING INFRASTRUCTURE 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 neurosurgery departments early in the twentieth century, providing an easily accessible source of expertise for developing and testing implantable technology. See Neuromodulation Directory for listing of clinicians and research centers. Talent & Workforce: The population of Minnesota is highly educated and has access to numerous specialized training programs from certificate to doctorate. Overall, Minnesota boasts one of the highest literacy rates in the United States. Education is consistently supported by the state 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 complementary services and expertise to the neuromodulation sector. UnitedHealth Group is the world’s largest healthcare and insurance provider. UnitedHealth is headquartered in Minnetonka, MN, and reports over 20 other facilities in the state. The leading healthcare investment bank, Piper Jaffray, is headquartered in downtown Minneapolis, offering both financial analysis and investing opportunities. Multiple accelerators and co-working spaces are available for healthcare endeavors, both early stage and growing, including Healthcare.mn and TreeHouse Health.

"Minnesota is the best place to find people who know the neuromodulation business and can grow it." John Swoyer, Executive Director of Product Development, QiG Group

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

Sector Landscapes: Neuromodulation | LifeScience Alley

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

Alley

spends

significant

efforts

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

public-private

partnership

among

industry

stakeholders, governmental agencies and patient / physician groups. The MDIC is presently working with the FDA to establish standardized safety guidelines for stimulation parameters in nerve tissue. BioAM LLC, in Rochester, MN, is a community-based organization promoting economic development in life sciences through education and networking. BioAM works with regional organizations like Destination Medical Center to elevate activities in healthcare and medicine across the state. The MN Neuromodulation Consortium was established in January 2015 to provide a centralized access point to the regionâ&#x20AC;&#x2122;s extensive collection of resources and expertise in neuromodulation.

Section # | Text Section 2 | Neuromodulation in Minnesota

3. FUTURE FORECAST OF NEUROMODULATION INDUSTRY

EMERGING TECHNOLOGY 'Closed-loop' Systems: Recent advancements in neuroscience, electrical engineering and bio-sensors have enabled ‘closed-loop’ systems, capable of sensing ongoing brain or nerve activity and incorporating it into 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 optogenetics 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 iterations due to limited acceptance of gene therapy in humans. Non-Surgical: While challenges to commercialization remain, nonsurgical options are gaining traction. Transcranial electrical, magnetic and 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 developing small, portable devices to deliver small electrical charges to ‘superficial’ nerves near the surface of the body, e.g., via the ear canal like Novum Therapeutics.

"LifeScience Alley is great because they continue to build connections and focus on issues of the day." Todd Langevin, President & COO, Functional Neuromodulation

Sector Landscapes: Neuromodulation | LifeScience Alley

UNMET NEEDS Therapeutics: Medical diseases and disorders that affect the nervous system are diverse in nature and widespread across demographics. Finding successful treatment options is often challenged by the complex nature of the diseases and limited understanding of symptomatology and etiology, as is the case with many psychiatric and neurodegenerative 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 neurological interventions. Metabolic disorders, like obesity and type 2 diabetes, are growing at epidemic proportions and present significant patient needs. Inflammation treatments are another area of great commercial potential. Urinary and fecal incontinence is a major untapped market that will soon be filled by implantable neuromodulation devices that are under clinical investigation by numerous sponsors. Prosthetics: In amputees and trauma victims, neuromodulation is aiding recovery following injury by promoting regrowth of severed nerves or spinal cords. Prosthetic limbs are being developed with biomimetic â&#x20AC;&#x2DC;skinâ&#x20AC;&#x2122;, 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.

Section 3 | Future Forecast of Neuromodulation Industry

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

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

1 2

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

Sector Landscapes: Neuromodulation | LifeScience Alley

ACKNOWLEDGEMENTS We would like to thank all of the neuromodulation and neuroscience experts in local industry and academia who shared their insights and thoughts during the preparation of this report. This work would not have been possible without their assistance. The following experts and executives were consulted during the creation of this report: David Anderson Senior Vice President of R&D, St. Jude Medical, Inc. Bryce Beverlin II, PhD Medical Devices Center Innovation Fellow, University of Minnesota Charles Billington, MD Professor, Department of Medicine, University of Minnesota Dori Henderson, PhD Program Manager, MnDRIVE Brain Conditions Initiative, University of Minnesota Thomas Gunderson Senior Financial Analyst, Piper Jaffray Companies Matthew Johnson, PhD Assistant Professor, Department of Biomedical Engineering, University of Minnesota Robert Kieval, PhD Executive Vice President & CTO (Founder), CVRx, Inc. Mark Knudson, PhD President & CEO, EnteroMedics, Inc.

Section 3 | Future Forecast of Neuromodulation Industry

Todd Langevin President & COO, Functional Neuromodulation, Ltd. Gregory Molnar, PhD Director of Neuroscience & Discovery, Medtronic. William Murray President & CEO, Medical Device Innovation Consortium (MDIC) Randall Nelson President, Evergreen Medical Technologies Tay Netoff, PhD Assistant Professor, Department of Biomedical Engineering, University of Minnesota David Rhees, PhD Executive Director, The Bakken Museum Barry Rittberg, MD Assistant Professor, Department of Psychiatry, University of Minnesota John Swoyer Executive Director of Product Development, QiG Group David Wechter Senior R&D Engineer, Neuromodulation, Boston Scientific Corporation

4. NEUROMODULATION RESOURCE DIRECTORY

Section # | Text

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 Scientific Corporation

Marlbourough, MA St. 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, MN Vista, 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 stimulation 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.

Sector Landscapes: Neuromodulation | LifeScience Alley

NEUROMODULATION DEVICES Company

City, State

Founded Summary

Inspire Medical Systems, Inc.

Maple Grove, MN

2007

Sells Inspire® for Obstructive Sleep Apnea.

Mainstay Medical, Inc.

Dublin, Ireland Plymouth, 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, Ireland Minneapolis, MN

1949

Develops and commercializes diverse neuromodulation device portfolio

Monteris Medical, Inc.

Plymouth, MN Winnipeg, Canada

1999

NeuroBlate® System for MRI-guided neurosurgical 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, development, and manufacturing.

QiG Group

Blaine, MN

2008

Neurostimulation 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.

Section 4 | Neuromodulation Resources Directory

DESIGN, DEVELOPMENT & MANUFACTURING - DEVICES & COMPONENTS Company

City, State

Founded Summary

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

2004

Electromedical 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

Algovitaâ&#x201E;˘ & Algostimâ&#x201E;˘ 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

2011

Research, design, development, prototyping, & manufacturing for medical device components. Coalition of independent Minnesota companies offering expertise to get new medical devices to the market.

Medical Device Resource Group

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.

Sector Landscapes: Neuromodulation | LifeScience Alley

DESIGN, DEVELOPMENT & MANUFACTURING - DEVICES & COMPONENTS Company

City, State

Founded Summary

PMT Corporation

Chanhassen, MN

1979

RCRI, Inc.

Products for neurosurgery, orthopedics, and plastic & reconstructive surgery. Regulatory and clinical CRO that combines operation excellence and strategic consulting in medical device, IVD, Biologics and combination product spaces. Contract research organization specializing in preclinical services for medical devices, pharmaceuticals, biologics, and combination products. Contract research partner with preclinical models for evaluation of various cardiovascular, gastrointestinal and other devices.

Surpass, Inc.

Osceola, WI

TOXIKON, Inc.

Minnetonka, MN

1977

Company

City, State

Founded Summary

ev3 Inc. (Covidien, Ltd.)

Plymouth, MN

2000

Medical devices for neurosurgery applications.

IMRIS Inc.

Minnetonka, MN Winnipeg, Canada

2005

Multiple product lines for image guided neurosurgery solutions.

Monteris Medical, Inc.

Plymouth, MN Winnipeg, Canada

1999

Medical devices for MRI-guided neurosurgical ablation.

1982

Medical device development for neurosurgery application

NEUROSURGERY EQUIPMENT

Summit Medical, Inc. St. Paul, MN (Shore Capital Partners LLC)

NEUROMODULATION DEVICES Company

City, State

Founded Summary

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.

1982

Medical device manufacturing, regulatory, quality, engineering, sales, and marketing.

Summit Medical, Inc. St. Paul, MN (Shore Capital Partners LLC)

Section 4 | Neuromodulation Resources Directory

NEUROMODULATION DEVICES Company

City, State

Founded Summary

Teren Med, Inc.

Minneapolis, MN

2008

Electromedical equipment manufacturer.

Worrell Design, Inc.

Minneapolis, MN

1976

Product design, development, and strategy.

Company

City, State

Founded Summary

Bay City Capital LLC

San Francisco, CA

1997

Life sciences investment firm.

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

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.

FINANCE

Sector Landscapes: Neuromodulation | LifeScience Alley

FINANCE Company

City, State

Founded Summary

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, MA San 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.

INTELLECTUAL PROPERTY - MEDICAL DEVICE Company

City, State

Founded Summary

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.

Section 4 | Neuromodulation Resources Directory

INTELLECTUAL PROPERTY - MEDICAL DEVICE Company

City, State

Founded Summary

BioAM

Rochester, MN

Engages with local entrepreneurs & connects them with people & resources.

CoCo - MSP (Google for Entrepreneurs)

St. Paul, MN Minneapolis, 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

OTHER - SUPPORTING INFRASTRUCTURE

Company

City, State

Founded Summary

CoCo - MSP (Google for Entrepreneurs)

St. Paul, MN Minneapolis, 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 universitydeveloped technology.

Sector Landscapes: Neuromodulation | LifeScience Alley

OTHER - SUPPORTING INFRASTRUCTURE Company

City, State

Founded Summary

UMN - Office for Technology Commercialization (OTC)

Minneapolis, MN

Facilitates transfer of university research to licensees for the development of new products and services.

Section 4 | Neuromodulation Resources Directory

5. CLINICAL, SURGICAL, RESEARCH & BUSINESS DIRECTORY

Section # | Text

CLINICAL EXPERTISE: ABLATION Organization

City, State

Contact Name

Contact Info

Mayo Clinic, Department of Anesthesiology & Pain Medicine

Rochester, MN

Samuel J. Asirvatham, MD 507. 284. 2511 Neurovascular & PNS

CLINICAL EXPERTISE: DEPRESSION Organization

City, State

Contact Name

Contact Info

University of Minnesota, Department of Psychiatry

Minneapolis, MN

Barry Rittburg, MD - DBS, VNS, TMS

rittb001@umn.edu

CLINICAL EXPERTISE: EPILEPSY Organization

City, State

Contact Name

Contact Info

Mayo Clinic, Department of Neurosurgery & Otorhinolaryngology

Rochester, MN

Jamie J. Van Gompel, MD - DBS

507.284.8008

CLINICAL EXPERTISE: EPILEPSY Organization

City, State

Contact Name

Contact Info

Mayo Clinic, Department of Neurosurgery

Rochester, MN

Kendall H. Lee, MD, PhD DBS

lee.kendall@mayo.edu

Mayo Clinic, Department of Neurosurgery

Rochester, MN

Squire (Matt) M. Stead, MD, 507.284.7341 PhD - DBS

CLINICAL EXPERTISE: MOVEMENT DISORDERS Organization

City, State

Contact Name

University of Minnesota, Department of Neurology

Minneapolis, MN

David Rottenberg, MSc, MD rotte001@umn.edu - DBS

University of Minnesota, Department of Neurology

Minneapolis, MN

Anthony Santiago, MD DBS

asantiag@umn.edu

University of Minnesota, Department of Neurology

Minneapolis, MN

Jerrold Vitek, MD - DBS

vitek004@umn.edu

Sector Landscapes: Neuromodulation | LifeScience Alley

Contact Info

CLINICAL EXPERTISE: MOVEMENT DISORDERS Organization

City, State

Contact Name

Contact Info

University of Minnesota, Department of Neurosurgery

Minneapolis, MN

Michael C. Park, MD - DBS

mcpark@umn.edu

Mayo Clinic, Department of Neurology

Rochester, MN

Anhar Hassan, MB, BCh DBS

hassan.anhar@mayo.edu

Mayo Clinic, Department of Neurosurgery

Rochester, MN

Kendall H. Lee, MD, PhD DBS

lee.kendall@mayo.edu

Mayo Clinic, Department of Psychiatry and Psychology

Rochester, MN

Julie A. Fields, PhD, LP DBS

fields.julie@mayo.edu

Mayo Clinic, Department of Neurosurgery

Rochester, MN

Squire (Matt) M. Stead, MD, 507.284.7341 PhD - DBS

Mayo Clinic, Department of Neurology

Rochester, MN

Bryan T. Klassen, MD - DBS klassen.bryan@mayo.edu

University of Minnesota, Department of Biomedical Engineering

Minneapolis, MN

Dr. Matthew D. Johnson DBS (pre-clinical)

john5101@umn.edu

Organization

City, State

Contact Name

Contact Info

University of Minnesota, Department of Medicine

Minneapolis, MN

Charles Billington, MD VNS

billi005@umn.edu

Organization

City, State

Contact Name

Contact Info

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

mcpark@umn.edu

Mayo Clinic, Department of Anesthesiology & Pain Medicine

Rochester, MN

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

507.284.2511

CLINICAL EXPERTISE: OBESITY

CLINICAL EXPERTISE: PAIN

Section 5 | Clinical, Surgical, Research & Business Directory

CLINICAL EXPERTISE: PAIN Organization

City, State

Contact Name

Contact Info

Mayo Clinic, Department of Anesthesiology & Pain Medicine

Rochester, MN

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

507.284.2511

Mayo Clinic, Department of Anesthesiology & Pain Medicine

Rochester, MN

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

507.284.2511

Mayo Clinic, Department of Anesthesiology & Pain Medicine

Rochester, MN

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

507.284.2511

CLINICAL EXPERTISE: PSYCHIATRIC DISORDERS Organization

City, State

Contact Name

Contact Info

University of Minnesota, Department of Psychiatry

Minneapolis, MN

Barry Rittburg, MD - DBS, VNS, TMS

rittb001@umn.edu

Mayo Clinic, Department of Neurosurgery

Rochester, MN

Kendall H. Lee, MD, PhD DBS

lee.kendall@mayo.edu

Mayo Clinic, Department of Neurosurgery

Rochester, MN

Susannah J. Tye, PhD DBS

507.284.8008

Organization

City, State

Contact Name

Contact Info

University of Minnesota, Program in Physical Therapy

Minneapolis, MN

James R. Carey, PhD, PT, FAPTA - TMS, fMRI

carey007@umn.edu

University of Minnesota, Brain Plasticity Laboratory

Minneapolis, MN

Teresa Jacobson Kimberley, tjk@umn.edu PhD, PT - TMS, fMRI

University of Minnesota, Brain Plasticity Laboratory

Minneapolis, MN

Bernadette Gillick, PhD, MS, gillick@umn.edu PT - TMS, fMRI

University of Minnesota, Brain Plasticity Laboratory

Minneapolis, MN

Wynn Legon, PhD TMS, tACS / tDCS, and wlegon@umn.edu Ultrasound Stimulation, fMRI

CLINICAL EXPERTISE: STROKE

Sector Landscapes: Neuromodulation | LifeScience Alley

CLINICAL EXPERTISE: STROKE Organization

City, State

Contact Name

Contact Info

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

Minneapolis, MN

Bin He, PhD - TMS, tDCS

binhe@umn.edu

Organization

City, State

Contact Name

Contact Info

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

yorek001@umn.edu

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

Minneapolis, MN

612.626.6688

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

Minneapolis, MN

612.624.6666

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

Minneapolis, MN

612.672.7422

Organization

City, State

Contact Name

Contact Info

Mayo Clinic, Traumatic Brain Injury Program

Rochester, MN

Nicole L. Dernbach

tbims@mayo.edu

Minneapolis, MN

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

princess.osei-bonsu@ va.gov

SURGICAL EXPERTISE

CLINICAL CENTERS

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

Section 5 | Clinical, Surgical, Research & Business Directory

CLINICAL CENTERS Organization

City, State

Contact Name

Contact Info

Mayo Clinic, Alzeimer's Disease Research Center

Rochester, MN

mayoadc@mayo.edu

Mayo Clinic, Diabetes Center

Rochester, MN

John Miles, MD

miles.john@mayo.edu

Mayo Clinic, Migraine Research Program

Rochester, MN

migraineresearch program@mayo.edu

Minnesota Obesity Center

St. Paul, MN

Dr. Catherine C. Welch, Program Coordinator

mnoc@tc.umn.edu

University of Minnesota, Brain Plasticity Laboratory

Minneapolis, MN

612.626.4096

Mayo Clinic, CT Clinical Trials Innovation Center

Rochester, MN

ctcic@mayo.edu

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

Minneapolis, MN

memclin@umn.edu

City, State

Contact Name

Contact Info

University of Minnesota, Center Minneapolis, MN for Magnetic Resonance Research

Deb Morgan, Executive Assistant

deb@cmrr.umn.edu

University of Minnesota, Center for Clinical Imaging Research

Minneapolis, MN

ccir@umn.edu

Mayo Clinic, Center for Advanced Imaging Research

Rochester, MN

Stephen J. Riederer, PhD

riederer@mayo.edu

City, State

Contact Name

Contact Info

612.625.3394

IMAGING CENTERS Organization

RESEARCH CENTERS Organization

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

Sector Landscapes: Neuromodulation | LifeScience Alley

RESEARCH CENTERS Organization

City, State

Contact Name

Contact Info

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

Minneapolis, MN

612.625.8446

University of Minnesota, Biomedical Functional Imaging and Minneapolis, MN Neuroengineering Laboratory

612.626.1114

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

507.255.7101

University of Minnesota, Clinical and Translational Science Institute

Minneapolis, MN

Rosalyn Segal, Administrative Director

rsegal@umn.edu

Mayo Clinic, Evidence-Based Practice Research Program

Rochester, MN

507.266.1829

Fairview Research Administration

St. Paul, MN

research@fairview.org Helpline: 612.672.7692

University of Minnesota, Neuromodulation Research and Technology Laboratory

Minneapolis, MN

Dr. Matthew D. Johnson

john5101@umn.edu

iem@umn.edu

University of Minnesota, Institute Minneapolis, MN for Engineering University of Minnesota, Center for Applied and Translational Sensory Science (CATSS)

Minneapolis, MN

University of Minnesota, Center for Neuroengineering

Minneapolis, MN

cne@umn.edu

University of Minnesota, Center for Design in Health

Minneapolis, MN

Kathleen A. Harder, PhD, Director

kharder@umn.edu

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

Minneapolis, MN

Amy Wicklund, Administrator bsc@umn.edu

catss@umn.edu

University of Minnesota, Institute Minneapolis, MN for Translational Neuroscience

Rosalyn Segal, Administrative Director

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

Tim Ebner, PhD, Co-Director ebner001@umn.edu Harry Orr, PhD, Co-Director orrxx002@umn.edu

rsegal@umn.edu

Section 5 | Clinical, Surgical, Research & Business Directory

RESEARCH CENTERS Organization

City, State

Contact Name

Contact Info

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

Minneapolis, MN

Tim Ebner, PhD, Research Lead

ebner001@umn.edu

University of Minnesota, Medical Devices Center (MDC)

Minneapolis, MN

Greg Peterson, Innovation Collaborator

gkpeters@umn.edu

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

City, State

Contact Info

Summary

Medical Device Innovation Consortium (MDIC)

St. Louis Park, MN

952.314.1255

Public-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

info@neurotechindustry. Accelerates neurotechnology research, org development and commercialization.

Chicago, IL

cwelber@ neuromodulation.org

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

San Francisco, CA

ins@neuromodulation. com

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

North American Neuromodulation Society (NANS) The International Neuromodulation Society (INS)

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

City, State

Contact Info

Summary

NeuroInsights

San Francisco, CA

Provides neurotech industry info@neuroinsights.com newsletters, market reports, investment conferences and advisory.

Neurotech Reports

San Francisco, CA

415.546.1259

Offers information about neurotech field and future developments that will affect VC, research, and start-ups.