fpirc 2016 role of startups in a healthy industry · design of medical devices conference. awarded...
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FPIRC 2016Role of Startups in a Healthy Industry
Russ StraateUniversity of Minnesota
103 Companies Launched Since 2006
2 Companies Launchedin FY2017
- Ensor, Inc. 7/16- Cleanair-CARE LLP 9/16
University Start-up Pipeline
November 4, 2016
Comm
ercialization
• Evacuation Route Planning• MCT1 Cancer Treatment• Search & Recommendation Engine• Medication Therapy Management• Biomagnetic Flow Cytometer• Variable Displacement Pump• Gene Flow Prevention• Low Cost MRI• Hepatoprotective Alzheimer’s Treatment• Enhanced Immune Activity Against Tumors• ECMO Device
Parking Lot
1. Seek and docket new ideas2. Evaluate commercial potential & IP position3. Develop market analysis & financial analysis4. Develop business plan and presentation5. Negotiate business and legal terms6. Executed license to start-up
Stage Descriptions
Stage 6
Stage 2
Stage 3
Stage 4Stage 5
Biocontrol Plant Disease Mgmt
• Silica Nanoparticles• Solar Calculator• Tissue Preservation System• Anesthesia Monitoring Device• Non-toxic Skin Lotion• Vitamin K Metabolite• Biological Grafts and Valves• Alzheimer’s Diagnostic• Bee Hive Health• Metal Fiber Exhaust Filter• Pennycress Crop
10 in Stage 5 29 in Total
For the latest start-up pipeline,Google “umn start-up pipeline”
Virtual Reality Architectural Design
Supply ChainFood Safety
SoftwareWasteTreatment Biodiesel
MicrobiomProfilingStandard
Market Size
<$1B
> $1B
Business Executive
Need it
Have it
Est. Time to Revenue (yrs)
0-3 4-6 7+
Turing Tumble
Plastic Bio-refining
Glaucoma Therapy
Biomaterial FlashVolatilization
Q416
Buffer-Zone consulting
HomopolarMotor
Geo-locationMobile Survey
Tool
Q416
Probiotic Bacteria
Breast Drain Belt
Dental Mercury Recovery
Cosmetic Cleaning Material
3D Particle Measurement
Staph Vaccine
Q416
ImmunomodulatingAdjuvant
Soft MagneticDevices
ManufacturedMicro-Housing
Embryo Preservation
Snoring App
Renewable Surfactants
Q416
Hypersonic Software Support
Enhanced Immune Activity Against
Tumors
Q416
Orchard Drone
Microfluidic Device
Q416 Q416
Q416
Q416
Q416
City Infrastructure Footprinting
FY 2016Another Record Year for UMN Start-ups
UMN fiscal year
• Multi-sector• 2 Med Device• 7 Bio/Pharma• 3 Software/IT• 3 Eng/Phy Sci• 1 Food/Ag• 1 Energy & Env
• Location• 14 in Minnesota• 3 Outside Minnesota
FY ‘16 Stats
UMN Start-up Demographics
Start-ups by Sector YTD FY06 –FY16 FY16
Bio/Pharma 7 28Engineering & Phy Sci 3 12Software/IT 3 27Med Device 2 20Energy & Env 1 9Food/Agriculture 1 5Startups by Location
Reside in Minnesota 14 78Reside out of Minnesota 3 23
Total 17 101
Start-ups Created by SectorFY06 – FY16
July 8, 2016
Bio/Pharma28%
Engineering12%
Software/IT26%
Med Device20%
Energy9%
Food/Ag5%
Shawn WilhelmEnfield Technologies
Pat DillonMN-SBIR
SBIR/STTR FUNDING
• NON-DILUTIVE Seed money to fund high risk, high payoff projects with commercial/military potential - NOT A LOAN
• Small business program (1-500 employees)• 11 federal agencies = ~$2.5 billion each fiscal year• Intellectual property rights are retained by the small business• Recognition, verification and visibility by large companies, investors, etc.• Maintain control of the company• Potential leveraging tool to attract other investments (state funding, angel, early
stage and venture capital)• Potential for sole-source federal government contracts with any federal buying
office• MN-SBIR, your local resource, free, confidential one-on-one assistance from pre-
proposal to pre-award to post award.
FLUID POWER PROFILEWWW.SBIR.GOV
Ms. Pat DillonDirector, MN-SBIR, SBIR/STTR Program AssistanceFederal R&D FundingMinnesota High Tech AssociationM: (612) 230-4540C: (612) [email protected]
Twitter: @MNSBIRFacebook: MHTALinked In: minnesota-high-tech-association
MN-SBIR is funded in part through a Cooperative Agreement with the U.S. Small Business Administration, a grant from the Minnesota Department of Employment and Economic Development and in-kind support from MHTA.
CONTACT MN-SBIR
Doug JohnsonLite Run
A story of starting a pneumatic medical device company
Improved body weight support for rehabilitation gait training
Pressurized lower body suit (pneumatic) and device (pneumatic counterforce and controls) provides body weight support
Safe, comfortable gait training can improve outcomes, increase safety, reduce therapist’s burden, and reduce costs
Confidential 12
Lite Run’s mission is to help people regain their ability to stand and walk following an injury or disability, such as a stroke.
13
Unweighting Runners Medical Applications
• SBIR Phase IProposal SpecifiedMobile System
First Feasibility Trial
• Patent ApplicationRejected“it wont work”
• Patent Applications Filed
• SBIR Phase I Proposal Rejected
Early Work2009
Differential Pressure Space Suit
Developed Treadmill System
Patent Application
2010Founded Lite Run as LLC
Patent Applications
2012Self Funded Prototype
Focus GroupBusiness Plan
2013First Feasibility Trial with
Prototype
Invention! Prototype
14
2014First Patent Issued Series A Funding
Begin Product Development
With sit to stand
2015Complete Product
DevelopmentClinical Feasibility Study
22 Patients Stroke, Paraplegia, Multiple
Sclerosis, Spinal Injuries
First Patent Allowed
2016Applied for NIH Phase II Direct
NIH Conference PosterDesign of Medical Devices Conference
Awarded TREAT GrantNIH Proposal Rejected
Won NEPDC Pediatrics GrantSpace in University Enterprise Laboratories
Five Patent AllowancesBridge Loans
Building Commercial Systems
2017Clinical Trials
FDA RegistrationMarket Launch
CommercializationSeries B Funding
NEPDC and TREAT Awards to Medical Device Innovators
Jesse LitwakMedtronic
16 Litwak - Background (FPIRC Conference) | October 11, 2016
JESSE LITWAKDIRECTOR – STRATEGY & BUSINESS DEVELOPMENTMEDTRONIC CORONARY & STRUCTURAL HEARTBackground Primarily Finance and Strategy (i.e. – failed engineer) Last ~11 years in MedTech (Guidant/Boston Scientific, ATS Medical, Medtronic) Prior experience in finance and technology with Honeywell
Current Focus with Medtronic External partnerships, investments, acquisitions and divestitures Technology assessment and management of external relationships with
Innovators, Entrepreneurs, MedTech start-ups and Venture Capital firms Strategic Planning Market assessments for adjacent applications of technologies and “white-
spaces”
17 Litwak - Background (FPIRC Conference) | October 11, 2016
MEDTRONIC: A BROAD $29B PORTFOLIO BUILT THROUGH A COMBINATION OF ORGANIC AND INORGANIC INVESTMENT
$10.2B
MEDTRONIC ORGANIZATIONSTRATEGIC ALIGNMENT
18 Litwak - Background (FPIRC Conference) | October 11, 2016
Cardiac and Vascular Group Diabetes Group Restorative
Therapies Group
Minimally Invasive
Therapies Group
Aortic & Peripheral Vascular
Cardiac Rhythm and Heart Failure
Coronary and Structural Heart
Intensive Insulin Management
Non-Intensive Diabetes Therapies
Diabetes Services and Solutions
Brain Therapies
Pain Therapies
Spine/Orthopedics
Specialty Therapies
Early TechnologiesAdvanced Surgical
Technologies & General Surgical
Products
Medical Supplies, Respiratory &
Monitoring Solutions, & Venous Solutions
Revenue reflects Medtronic Fiscal 2016 ended April 29, 2016
$1.9B $7.2B $9.6B
19 Litwak - Background (FPIRC Conference) | October 11, 2016
NEW TECHNOLOGY ASSESSMENT & INVESTMENTMEDTECH PERSPECTIVE
TECHNOLOGY ASSESSMENT FUNDING SOURCES
• Is the idea novel?
• How is the IP?
• What is the market attractiveness?• Address unmet customer needs• Economic viability
• What are the risks and are they stacked?
• Technical• Clinical• Regulatory• Market Development
• Private/Angel Investors
• Public/Private Research Grants
• Loans/Debt financing• Private/Bank• Gov’t or Development Org.
• Venture Capital
• Industry/Strategic (timing…is influenced by the left side of this slide)