cvg - medical devices 2015
TRANSCRIPT
Hosted by:
Medical Devices
CURE & CVG Collaboration:
Susan Froshauer, Ph.D. President & CEO
Mary Anne RookeExecutive Director
CVG Sponsors
Medical Devices
Moderator:
Stephen BlochGeneral Partner, Canaan Partners
Stephen Bloch, MDCanaan Partners, General Partner
Canaan Fund X - $675 Million
$4.2 Billion Under Management
58 IPOs; 110 M&As
11 Exits in 2014
Investments
Founder & CEO: Radiology Mgmt
Sciences
Medical Dir.: OmniSonics
Harvard Radiology; U. Rochester
MD; Dartmouth AB
Kauffman Fellow
MitraSpan
CVG’s Chairman Board of Directors
Medical Devices
Host’s Welcome: Paul Hermes - Covidien
3 Company Presentations to Investor Panel 5 minute Presentation by Startup Company
5 minute Q&A by Investor Panel
5 minute Pointers by Investor Panel
Keynote Speaker: David D. Wang – Covidien / Medtronic
Networking Reception & Company Showcase
Agenda:
Medical Devices
Welcome:
Paul HermesEntrepreneur in Residence, Covidien
Investor Panel:
Konstantine DrakonakisDirector
Medical Devices
Investor Panel:
Kristen KosofskyManaging Director
Medical Devices
Investor Panel:
Craig MullettAngel Investor Forum, President, Branison Group
Medical Devices
Investor Panel:
David WurzerExecutive VP & Chief Investment Officer,
Connecticut Innovations
Medical Devices
1st Company Presentation:
Neil ShahCo-Founder & CEO
Medical Devices
CONFIDENTIAL Company Overview
CONFIDENTIAL
Founding Team
14
Khaled M. Kebaish, M.D. A. Jay Khanna, M.D., MBALee H. Riley III, M.D.
Neil Shah, CEO Maxim Budyansky, CTO
CLINICAL TEAM – JOHNS HOPKINS SPINE SURGEONS
MANAGEMENT TEAM
CONFIDENTIAL
Board of Directors
Patrick O’Neill, MBA | Series A DirectorDirector of Investments at Connecticut Innovations
Paul Higham, PhD | Independent DirectorPrevious Director of R&D at Stryker Orthopaedics
Terrence Coffey | Independent DirectorPrevious VP at 2 Orthopaedic Med Device Startups
Board comprises of 5 members, including CEO and CTO
15
CONFIDENTIAL
THE SOLUTION
Overview
Avitus Harvester | Bone Graft Harvesting Device
Patients - Improve outcomes
Surgeons - Deliver gold standard
Hospitals - Increase margins
Large Market: 550,000/yr spinal fusion procedures…
$2.8 billion/yr bone graft expenditures…
BUT… no bone graft solution meets all the needs of
surgeons, hospitals & patients
16
THE PROBLEM
CONFIDENTIAL
Our Tech 1
17
Our Technology
Disposable Instrument
Patent Pending
Requires 510(k) Pathway
CONFIDENTIAL
Our Tech Entry
18
MINIMALLY
INVASIVE ENTRY
Our Technology
CONFIDENTIAL
Our Tech Method
19
COLLECTED
AUTOGRAFT
MINIMALLY
INVASIVE ENTRY
Our Technology
CONFIDENTIAL
Graft Delivered
Avitus Harvester
CONFIDENTIAL
Open Procedure
Avitus vs. Open Harvesting
Invasive: 3-9cm
PAIN POINTS
Patient Complications
Time Consuming
Cumbersome
CONFIDENTIAL
Avitus Harvester
Open Procedure
Min. Invasive: 1-2cm
Invasive: 3-9cm
Avitus vs. Open Harvesting
CONFIDENTIAL
Avitus Harvester
Min. Invasive: 1-2cm
Avitus Value Proposition
Minimally Invasive
Cost Effective
Streamlined Procedure
Deliver Gold Standard Autograft
CONFIDENTIAL 24
Top Down Market Opportunity
0
200
400
600
800
1000
1200
2015 2016 2017 2018 2019
E.U. SF + Tib + F&A
U.S. Foot & Ankle
U.S. Tibial Non-Union
U.S. Spinal Fusion
Target
Market
Size
($millions)
$957mm$1,000mm $1,055mm
Total Addressable
Market Size
World : $1.5 billion
U.S. : $1.1 billion
E.U. : $0.3 billion
$436mm
$644mm
Target Market Size
CONFIDENTIAL
Seed Round: $440K
Milestones - 2014
Working
Prototype
Product Manufacturing
& Testing
FDA
Submission
Pilot Sales
(First 100
devices)
Sales
Scale-up
Q1 2013
Works-
like/Looks-like
Final prototype
Q1 2014 Q1 2015 Q1 2016
25
CONFIDENTIAL
Seed Round: $440K
Milestones - 2015
Working
Prototype
Product Manufacturing
& Testing
FDA
Submission
Pilot Sales
(First 100
devices)
Sales
Scale-up
Q1 2013
Works-
like/Looks-like
Final prototype
Q1 2014 Q1 2015 Q1 2016
26
Federal SBIR Grant: $750,000
(non-dilutive)
Series A Round
CONFIDENTIAL
Seed Round: $440K
Milestones - 2015
Working
Prototype
Product Manufacturing
& Testing
FDA
Submission
Pilot Sales
(First 100
devices)
Sales
Scale-up
Q1 2013
Works-
like/Looks-like
Final prototype
Q1 2014 Q1 2015 Q1 2016
27
To FDA
Submission
Federal SBIR Grant: $750,000
(non-dilutive)
Series A Round
CONFIDENTIAL
Seed Round: $440K
Milestones - 2015
Working
Prototype
Product Manufacturing
& Testing
FDA
Submission
Pilot Sales
(First 100
devices)
Sales
Scale-up
Q1 2013
Works-
like/Looks-like
Final prototype
Q1 2014 Q1 2015 Q1 2016
28
To FDA
Submission
To Market
Entry
Federal SBIR Grant: $750,000
(non-dilutive)
Series A Round
CONFIDENTIAL
Milestones - 2015
Working
Prototype
Product Manufacturing
& Testing
FDA
Submission
Pilot Sales
(First 100
devices)
Sales
Scale-up
Q1 2013
Works-
like/Looks-like
Final prototype
Q1 2014 Q1 2015 Q1 2016
29
To FDA
Submission
To Market
Entry
To Completion
of Pilot Sales
Seed Round: $440KFederal SBIR Grant: $750,000
(non-dilutive)
Series A Round
CONFIDENTIAL
The Ask
30
Talento Sr. Prod Dev Engineer (Orthopaedics)
Strategic Partnerso Mid- to Large Ortho Med Device Companies
Hospitals & Surgeons
Resources to grow the business
2nd Company Presentation:
Wendy DavisFounder, CEO
Medical Devices
GestVision, Inc.
GestVision, Inc.Wendy Davis Founder & CEO
33
Preeclampsia – a Pregnancy Problem
3x more premature infants are delivered
$26B in infant care
Every 10 minutes a mom-to-be almost dies
$10B in care for preeclampsia
34
GestVision, Inc.
What is Preeclampsia?
Symptoms: high blood pressure and urine protein
Health Risk: seizures, organ failure and death
Cause: unknown
“Cure”: deliver baby ASAP, often prematurely
THE CONDITION OBGYNs LOSE SLEEP OVER
35
GestVision, Inc.
Current Impact
40% of pregnant women may show preeclampsia symptoms
15% of premature deliveries
~10% incorrect diagnosis ~5% preeclampsia
36
GestVision, Inc.
SIMPLE URINE TEST
RUN IN DOCTOR’S OFFICE
RAPID RESULTS- 1 minute
85% ACCURACY
Solution: GestAssured™ test
RESULTS: CLEAR DIAGNOSIS OF PREECLAMPSIA
37
GestVision, Inc.
Pregnancy Checkup(20 visits)
Urine Protein
More testing
Preeclampsia NOT ruled-out
Hospital
Blood Pressure
DELIVER BABY ASAP
Doctor’s Office
40%
No Definitive Diagnostic for Preeclampsia
15%
38
GestVision, Inc.
Current Methods GestAssured™ test
Pregnancy Checkup(20 visits)
Urine Protein
More testing
Preeclampsia NOT ruled-out
Hospital
Blood Pressure
DELIVER BABY ASAP
Doctor’s Office
40%
Current Methods GestAssured™ test
No Definitive Diagnostic for Preeclampsia
15%
GestVision, Inc.
Doctor’s Office
~5% Hospital
Accurate Diagnosis of Preeclampsia
39
DELIVER BABY ASAP
US Market Opportunity
US pregnancies 7 millionMaternity care doctor visits x 20Urine tests per year 140 million
Price per GestAssured™ test x $10
Total Addressable US Market $ 1.4 Billion
40
GestVision, Inc.
URINE TEST BLOOD TEST
RISK of PREECLAMPSIA
DIAGNOSISPREECLAMPSIA
Alere
Competitive Landscape
Neither available in the US
41
GestVision, Inc.
GestAssured™ test
Irina Buhimschi, MDHigh Risk Pregnancy ExpertDirector Center for Perinatal ResearchThe Research Institute Nationwide Children’s Hospital.
Licensed Yale Technology
Catalin Buhimschi, MDHigh Risk Pregnancy ExpertDirector of Maternal-Fetal Medicine Vice Chair for Research Department of Obstetrics and Gynecology The Ohio State University
Yale Intellectual Property:
• 1 Issued - US
• 1 Pending - US
• 1 Pending - Worldwide
42
GestVision, Inc.
Wendy L Davis Founder and CEOPreviously:HistoRx biotech startupAcquired by Novartis
Combined 40 years experienceR&D and Operations
Commercial and Business DevelopmentIntellectual Property
Growth Strategies
Emily MooreVP OperationsPreviously: TempTime Corp Product became Standard of care for WHO
Management Team
43
GestVision, Inc.
IncorporatedJanuary
β Prototype
2014 2015 2016
Timeline
FDA FilingDecember
FDA ClearanceFebruary -March
Product LaunchMarch 2016
Manufacturing
Capital Raise
Clinical StudiesOhio State University
International Clinical StudiesFunded by: Saving Lives at Birth
NEEDS: Team Talent in Finance, Market & Sales, Regulatory & QualityPartner Marketing & Sales, Distribution
44
GestVision, Inc.
© GestVision 2015
GestVision, Inc.
45
3rd Company Presentation:
Ilana OdessFounder, CEO
Medical Devices
For:
Date:
The Information Contained in This Presentation Has Been Provided By The Company & Any Estimates, Forecasts, Or
Other Forward-looking Statements Contained Within Have Been Prepared In Good Faith, On A Basis It Believes Is
Reasonable. Such Information Involves Significant Elements Of Subjective Judgment & Analysis, And No
Representation Or Warranty (Express Or Implied) Is Made Or Is To Be Relied Upon As A Promise Or Representation As
To The Future Performance Of The Company as Actual Results May Differ From Those Indicated In This Presentation.
Introduction Presentation
CVG and Cure
March 12, 2015
47
CONFIDENTIAL
INTRODUCTION
WOVEN IN A NUTSHELL
48
• $6.5B Market in Orthopedics (40mm Uses)
• Reduce Payer Cost & Improve Outcomes
• Address The Needs the 6 Ps
• Simple to Use
CONFIDENTIAL
MARKET
CURRENT FRACTURE TREATMENT
49
SurgeryOpen Reduction Internal Fixation (ORIF)
1
2
Goal:
Achieve Immediate Fracture Stability!
Brace, Cast
CONFIDENTIAL
MARKET
SURGICAL INTERVENTION
50
Plates & Screws Used in >279 Different Procedures
* Separate Identifiable CPT Codes per CMS
Long Bone
89 Different Procedures*
HumerusFemur
Spine
39 Different Procedures*
Cervical Spine
Craniomaxillofacial
67 Different Procedures*
Jaw
Small Bone
84 Different Procedures*
Radius Tibia
CONFIDENTIAL
Humerus Finger Clavicle
CLINICAL NEED
CLINICAL PROBLEM: LOSS OF FIXATION
51
#1 Problem = Loss of Screw Engagement(Screw Loosening / Bone Resorption / Back-out)
Loss of Screw Engagement Total Construct Failure
CONFIDENTIAL
CLINICAL NEED
EFFECTS OF LOST SCREW ENGAGEMENT
521Journal of Bone & Joint Surgery: Principles of Fixation of Osteoporotic Fractures. 2006
>15% Revision Rate1
Increased Timelines For Return to Activity/Work
Mobility Restriction
Additional Coaptation (Brace, Cast, etc)
Co-morbidity / Mortality (pneumonia, diabetes, etc)
Delayed Healing
Revision Surgery
CONFIDENTIAL
CLINICAL NEED
WHY DOES LOSS OF SCREW ENGAGEMENT OCCUR?
53
A Variety of Factors Influence Screw Engagement
2 3 4 51
Fracture Type Fracture Location AgePatient
CompliancePrior Procedures
CONFIDENTIAL
TECHNOLOGY SYSTEM SOLUTION
HOW CAN WOVEN HELP?
54
1st Solution to Focus on Improving the Implant Site (Interface)
Focus: Interface
Enhance Bone Interface
Any Existing Screw
Short and Long Term Benefits
Focus: Hardware
Expandable Screws
Rescue Screws
Cements, BSM, Grouts
Current Solutions Woven’s Solution
CONFIDENTIAL
Screw Alone Screw + Woven
TECHNOLOGY SYSTEM SOLUTION
HOW IT WORKS
55
The 1st Biotextile Designed to Enhance Screw Engagement
Short Term Long Term
Interlacing Fibers Interdigitate With Bone
Surface Area Contact
Distributed Load Transfer
Bone Ingrowth & Remodeling(Facilitates Load Sharing & Transfer)
CONFIDENTIAL
1) Strong IP Position
2) Benefit ALL Parties in
Patient Care Spectrum(The 6Ps)
3) More Exit Opportunities
BUSINESS STRATEGY
COMPETITIVE ADVANTAGES
56
Pending
Provisional
8
Issued
3
Pending
Non-Provisional
8
CONFIDENTIAL
LEADERSHIP
LEADERSHIP TEAM
57
Management Team
• 2 Exits in the Past 2 Years ($375mm in 1)
• $20B Sale of Synthes to Johnson & Johnson
• 10x Average Cash-On-Cash Returns
• Founder, Johnson & Johnson, Israel
• Former Industry Executives (CTO, CLO, VPs)
(J&J, Synthes, Medtronic, Stryker, Orthologic)
• Experienced Entrepreneurs (> 30 Companies)
CONFIDENTIAL
LEADERSHIP
LEADERSHIP
58
Management Board of Directors
Ilana Odess, Chief Executive Officer* Anthony G. Viscogliosi, Executive Chairman
Founder, Johnson & Johnson, Israel
$400mm Exit to Boston Scientific
Established $300mm JV (ICL & SQM)
BOD Chair, HDH & RealView Medical
Chair, CEO, Pres. in >14 Businesses
10 Exits & >1.5B in Exit Proceeds
Completed >240 Orthopedic Transactions
Produced 7 #1 Ranked Technologies Worldwide
Francis P. Magee, D.V.M., Chief Technology Officer Frank P. Cammisa Jr., M.D., Spine Physician Specialist
Former Chief Technology Officer, Synthes Spine
Former Chief Technology Officer, Spine Solutions
Former Chief Technology Officer, Orthologic
Developed 1st Successful Total Disc Replacement
Chief of Spine Surg Svcs, Hospital for Special Surgery
Professor of Clinical Surgery, Weill Medical College
NY Magazine - “12 Doctors Reinventing Medicine”
Medical Staff, New York Giants & NHLPA
David L. Helfet, M.D., Chief Medical Officer* J. Douglas Craft, Distribution Specialist
Chief of Ortho Trauma, HSS & NY Presbyterian
Board of Directors, Synthes
Former Chairman, AO Foundation Clinical Group
Extensive Research: >225 Papers & Books
Founder, President & CEO, Medicraft Inc.
29 Years of Distribution Experience
Top Ranked Distributor for Medtronic, Inc.
12+ Years Experience in Angel Investing
Terrance L. Carlson, Chief Legal Officer John J. Viscogliosi, Co-Founder & Operations Specialist
VP & General Counsel, Synthes
Negotiated $20B merger (Synthes & J&J)
Sr. VP, Gen Counsel & Secretary, Medtronic
Deputy Gen Counsel, AlliedSignal (Honeywell)
Chairman & CEO, Centinel Spine, Inc. (Raymedica)
Principal, Viscogliosi Bros., LLC
Co-Founder, Paradigm Spine
Founder Member of >30 Orthopedic Companies
Brandon E. Bendes, VP, Strategy & Finance
Co-managed M&A Integration$1B+ HC System
$40mm Spin-Off, Consumer Products Co.
Process Imprvmt Consultant, Huron Consulting Grp
Former Auditor of PE & VC Funds (PwC)
* Denotes Managers Who Also Are Board Members
CONFIDENTIAL
SUMMARY
SUMMARY
Address The #1 Problem With The #1 Implant In Orthopedics• Screws & Plates Used in >279 Different Types Of Procedures
• 1st Solution to Address Screw Engagement with a Biotextile
• No Direct Competitors In The Market Today
Experienced Team Has Done it Before• Board Members from the Largest Transaction in Ortho Industry History
• >15 Companies Exited
• Investors & Mgmt Team includes Top Industry Experts from Distributors, Physicians, & Executives
Competitive Advantage• 1st To Address The Screw-to-bone Interface
• Benefits ALL Parties In The Spectrum Of Care
• Testing Demonstrates Substantial Strength Enhancement
• Strong IP Portfolio With Large Pipeline
• Already Met With The FDA - 510(k) De Novo Route In Process
59
For:
Date:
The Information Contained in This Presentation Has Been Provided By The Company & Any Estimates, Forecasts, Or
Other Forward-looking Statements Contained Within Have Been Prepared In Good Faith, On A Basis It Believes Is
Reasonable. Such Information Involves Significant Elements Of Subjective Judgment & Analysis, And No
Representation Or Warranty (Express Or Implied) Is Made Or Is To Be Relied Upon As A Promise Or Representation As
To The Future Performance Of The Company as Actual Results May Differ From Those Indicated In This Presentation.
THANK YOU!
CONFIDENTIAL
FINANCE
FINANCIAL
61
Series A Raise to Complete Development for Commercialization in EU
Category Funds Proportion
Product Development $3.0 46%
Strategic Operations Regulatory, Reimbursement, QA, etc.
1.0 15%
Working Capital 1.0 15%
Early CommercializationSales & Marketing
0.8 13%
Legal, Accounting, Audit, Insurance 0.7 11%
Total Uses $6.5 100%
Series A Sources & Uses
$1 $3
$12
$33
$-
$5
$10
$15
$20
$25
$30
$35
2015E 2016P 2017P 2018P
Key Milestones:• Design Freeze
• IP Expansion
CE Mark Submission
FDA Submission
$ millions
Revenue ProjectionsUS & EU
CONFIDENTIAL
TECHNOLOGY SYSTEM SOLUTION
HOW DO WE IMPROVE SCREW ENGAGEMENT TODAY?
62
Current Methods Have Not Successfully Solved Engagement Issues
Surgeons Forced to Use Ad-Hoc Methods
Used as Bailouts
Anatomical Limitations
Potential Fracture of Surrounding Bone
Placement Accuracy (Leakage)
Not Cleared By FDA
Significant Clinical Risk
Impractical Revision Technique
Added Procedure Complexity
Rescue Screws
Bone Cement
Match-Stick TrickSmart Screw
Relocate Hole
Expanding Screws
Keynote Speaker
David D. Wang
Group VP of Business Development,
Strategy & Portfolio Management
“Past, Present & Future Investment in Medtech”
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Company Showcase
Medical Devices
Avitus Orthopaedics Neil Shah, Founder & CEOBiorasis Sagar Vaddiraju, R&D DirectorBody Biolytics Kevin Logan, Founder & CEODuraBiotech Eric Sirois, Founder & CEOGestVision Wendy Davis, Founder & CEONovatract Ellie Tandler, Founder & CEOWoven Orthopedic Ilana Odess, Founder & CEO3D United Corp. Jun Xu, Founder & CEO3Derm Liz Asai, Co-Founder & CEO
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