Inspiremd Inc. · NASDAQ:NSPR
Inspiremd — Investor Presentation (May 2013)
37 slides from Inspiremd's investor presentation, May 29, 2013
Slide 1: InspireMD May 2013
D inspirel May 2013
Slide 2: Forward-Looking Statements
Forward - Looking Statements : This presentation contains “forward - looking statements . ” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words . Forwa
Slide 3: Company Description and Corporate Highlights
3 • InspireMD is a medical device company developing and commercializing its MicroNet technology for interventional cardiology and other vascular procedures • Currently commercializing the MGuard ™ Coronary Embolic Protection Stent (EPS) for the treatment of acute coronary syndromes, namely Acute My
Slide 4: Coronary Stent Market and AMI Opportunity
* Source: Health Research International, (June 2012) ** JAMA, March 2, 2005 — Vol 293, No. 9 1063 Gregg W. Stone • Inadequate outcomes, as current stents designed primarily for Stable Angina population • Distal embolization occurs in up to 73% of cases** • Majority of AMI market is outside of the U.
Slide 5: Reperfusion Impact on Infarct Size
Epicardial Myocardial TIMI Flow = Vessel patency Myocardial Blush Grade = Microvascular perfusion ST Resolution = Myocardial functionality Reperfusion will have impact on Infarct Size
Slide 6: Distal Embolization in Heart Attack Treatment
Pre Procedure Embolization Post Procedure Minor heart attack treated with a Bare Metal Stent (BMS) or Drug Eluting Stent (DES) implant Debris to flow down stream, occluding small arteries “ Distal Embolization ” Major Adverse Cardiac Event (MACE) Leading To: Causes: 6
Slide 7: Addressing the AMI Market with MGuard Coronary
Addressing the AMI Market 7 MGuard ™ Coronary combines InspireMD’ s proprietary MicroNet ™ technology, secured to proximal and distal edges of conventional stent . • Prevent distal embolization • Stabilize ruptured plaque • Improve safety outcome • Maintain standard stenting procedure • No learning
Slide 8: MicroNet Technology and Potential Applications
8 Repair Perforations Filter Emboli Advantages of technology: • Flexible structure • Minimal foreign body reaction • Does not promote thrombosis Proprietary circular knitted mesh, made of a single fiber from a biocompatible polymer, widely used in medical implantations Potential Applications of Core
Slide 9: Thrombus Trapped Behind MGuard Mesh
9 After MGuard ™ Thrombus trapped behind mesh Before Stenting Residual thrombus following aspiration …could lead to embolization when treated with BMS/DES, but with MGuard ™…
Slide 10: MASTER Trial Design
STEMI with symptom onset within 12 hours at 432 patients | 50 sites | 9 countries MGuard ™ for Acute ST Elevation Reperfusion PCI with BMS or DES PCI with MGuard Recruitment: 7/2011 – 5/2012 Follow - up: 30 days, 6 months, 1 year Primary endpoint: ST - segment resolution at 60 - 90 minutes Top Line
Slide 11: ST Resolution and One-Year Clinical Events
* TAPAS, Pieter J Vlaar ; Lancet 2008 ; 371 : 1915 – 20 15.3% 1.4% 20.0 % 2.8 % 0.0% 5.0% 10.0% 15.0% 20.0% 25.0% Cardiac Death Cardiac Death or Re-MI % of Patients 11 In STEMI, occurrence of major clinical events at 1 year is significantly related to ST resolution * < 30 % > 70 % Unsuccessful Resul
Slide 12: Complete ST Segment Resolution Results
Complete (≥ 70 %) 44.7 % Partial (> 30 % - < 70 %) 38.3 % Absent (≤30%) 17.0 % Complete (≥ 70 %) 57.8 % Partial (> 30 % - < 70 %) 25.5 % Absent (≤ 30 %) 16.7 % Relative I mprovement: 29.3 % (absolute – 13.2 %) 12 Complete ST Segment Resolution MGuard (n=204) Control (n= 206 ) P value = 0.008
Slide 13: ST-Resolution After PCI in STEMI
AMC Amsterdam (N=2124) ST - Resolution immediately post PCI is a strong predictor of long term mortality N. Verouden – Am J Cardiol 2010 ; 105 ( 12 ): 1692 - 1697 . ST - Resolution after PCI in STEMI
Slide 14: MASTER Achieved Primary Endpoint
14 Achieved Primary End P oint Superiority in TIMI Flow – 91.7 % vs. 82.9 % Superiority in ST Resolution – 57.8 % vs. 44.7 % MRI - Smaller I nfarct Size - 17.1 gm vs. 22.3 gm Mortality at 30 days occurred in 0 / 217 ( 0 %) patients in the treatment arm and in 4 / 216 ( 1.9 %) patients in the control
Slide 15: TIMI Flow Goal
Goal: Achieve 90 % TIMI 3 flow within 90 ’ Ndredepa . J Am Coll Cardiol 2008 ; 52 : 512 – 7
Slide 16: No Reflow Increases Infarct Size and Mortality
8 % 15 % 0% 2% 4% 6% 8% 10% 12% 14% 16% Infarct Size Reflow No Reflow Ndrepepa . J Am Coll Cardiol 2010 ; 55 : 2383 – 9 No Reflow increases infarct size and mortality p < 0.001
Slide 17: MASTER Trial Summary of Findings
• Superior ST Segment resolution • Improved TIMI 3 Flow/ reduced TIMI 0 - 1 occurrence • Trend toward reduced infarct size measured by MRI • Trend towards lower mortality with 0 deaths in treatment group vs. 4 deaths in control arm • What impact over time?
Slide 18: Mortality Over Time
Death - 6 months (%) 0 1 2 3 4 5 Time in Months 0 30 60 90 120 150 180 217 213 213 165 216 209 208 171 Number at risk: MGuard BMS/DES P= 0.056 HR: 0.16 [95% CI: 0.02, 1.36] 0.5% 2.8% MGuard BMS/DES Time in Days 2.8 % 0.5%
Slide 19: Secondary Endpoints
MGUARD (N= 217 ) CONTROL BMS / DES (N=216) P Value MACE 11 (5.2%) 7 (3.4%) 0.34 All cause mortality 1 (0.5%) 6 (2.8%) 0.06 Cardiac death 1 (0.5%) 5 (2.3%) 0.10 Reinfarction 3 (1.4%) 2 (0.9%) 0.66 TLR, ischemia - driven 10 (4.8%) 2 (1.0%) 0.02 TVR, ischemia - driven 13 (6.2%) 2 (1.0%) <0.01 Stent Thr
Slide 20: Commercial Strategy
• Establish Embolic Protection Stent (EPS) as new stent category • Promote MGuard ™ EPS as the preferred solution for STEMI patients • Utilize positive MASTER Trial results to push adoption and get premium reimbursement in key markets • Develop sales infrastructure to support a focused and phased se
Slide 21: Tiered Commercial Approach
• Tier 1 - Mix of direct sales agents and distributors, with focus on KOL’s/high - volume AMI centers - 14 - 18 countries, primarily Europe and Brazil • Tier 2 - Country or regional partnerships with high quality local distributors or Strategics - Scaling global reach and frequency • Tier 3 - USA 21
Slide 22: Success in Partnerships
Success in Partnerships Starbucks, Green Mountain extend partnership Starbucks, Green Mountain Coffee extend partnership with new 5-year deal (AP AssociatedPress 9 hours ago (Gem) esconmd) | tweet Blown) a4 Ben Philips Partners with Apple on Smart LED Bulb ou Ala ‘By Mary Dumon | Busines 2 Community
Slide 23: MASTER II US Pivotal Trial
Status Objective Co - primary End Points Population Chairman, PIs Approval with conditions to commence recruitment Evaluate safety and efficacy of MGuard ™ Prime Coronary vs. BMS and DES in STEMI Efficacy: Superiority in complete ST Resolution Safety: Non inferiority in death and T arget V essel MI
Slide 24: MGuard Platform Technology
Received CE Mark for Coronary Commercial • MGuard Coronary • MGuard Prime Coronary * Planned product 24 MGuard ™ Platform Technology MGuard ™ Coronary EPS MGuard ™ Carotid MGuard™ Peripheral * MGuard™ Drug Eluting * MGuard™ Cerebral * Aneurysm MGuard™ Renal * • MGuard Carotid CE Mark Approved
Slide 25: MGuard Carotid
CE Mark Approved ; Q 1 2013 25 Current Market Solution: MGuard ™ Carotid Solution: Stent + Filter Device + MGuard Embolic Protection Stent During and Post Procedure
Slide 26: IP Protects Key Attributes of MicroNet Technology
• 7 patent families • Filings in U.S. and overseas • 37 patents – 6 granted ( 1 USA), 31 pending • Stent platform: U.S. Freedom to Operate legal opinion IP Protects Key Attributes of MicroNet ™ Technology 26 Anchoring Macro Structure Drug Delivery Fiber Width
Slide 27: Manufacturing
— Use of proceeds from offering to support manufacturing expansion, global launch — Facility has completed requisite EMA inspections — Implementation of Good Manufacturing Practice (GMP) facility in process — Platform technology produced in - house, bare metal stent and catheter manufactured by thir
Slide 28: Management and Board
Eli Bar, BSc CTO • Product development • R&D infrastructure • Fully implantable VAD patent Craig Shore, MBA CFO • Pfizer , Bristol Myers Squibb, and Dunn and Bradstreet, General Electric • RIT Technologies (NASDAQ) Chaim Lotan , M.D., F.A.C.C. F.E.S.C Medical Director • Hebrew University • Hadassah
Slide 29: Scientific Advisors
Dr. Yaron Almagor • Director of Cardiac Catheterization and Interventional Cardiology Laboratories at Jesselson Heart Center, Shaare Zedek Medical Center; Jerusalem, Israel Prof. Antonio Colombo • Director of the Cardiac Catheterization • Laboratory at Columbus Hospital • Chief of Invasive Cardiolog
Slide 30: Milestones To-Date
Milestones To - Date Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 2007 2010 2011 2012 2013 MGuard CE Mark NSPR.OB Sol Barer Named Chairman 30 MASTER Recruitment MASTER Top Line MASTER Details New CEO Hired US Headquarters Carotid CE Mark NYSE MKT MGuard Prime CE Mark MASTER II IDE (FDA) Con
Slide 31: Anticipated Future Milestones
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 2013 2014 2015 2016 Anticipated Future Milestones Development Partnership I 31 MASTER Subset Analysis ( EuroPCR ) Manufacturing Expansion MASTER 12 - Month Data (TCT) Distribution Partnership I FDA Approval Peripheral CE Mark Complete MASTER II Enrollment
Slide 32: Capitalization
32 NSPR (NYSE MKT) 34.3 million Basic Shares Outstanding $ 2.80 Stock Price (5/1/2013) $ 118 million Fully Diluted Market Capitalization ( 5 / 1 / 2013 ) 7.7 million Warrants, Options and Convertible Loan Shares Q3 – $1.5M | Q2 – $1.4M | Q1 – $0.5M Revenue Growth 42 million Fully Diluted Shares Outs
Slide 33: Investment Highlights
• MGuard ™ Coronary Embolic Protection Stent designed to transform the standard of care for AMI • Initial focus is STEMI patient population • AMI market value $ 1.7 B Unmet Clinical Need • MASTER Trial ( r andomized s tudy) • Primary Endpoint: Statistical significance achieved with superior results
Slide 34: Thank You
Inspire MD Thank You
Slide 35: Appendix
Appendix inspireMD
Slide 36: Clinical Results Summary
Clinical Results Summary Clinical Trials ST Resolution Death MACE > 70% 30 days 1 year 30 days 1 year MAGICAL 61.00% 0.00% 1.80% 0.00% 1.80% Piscione 90.00% 2.20% 4.50% N/A 5.60% Weerakody N/A 0.00% 0.00% N/A 6.00% iMOS N/A 2.00% N/A 2.80% 6.80% Gaul 58.00% N/A N/A N/A N/A MICAMI N/A 0.00% N/A 0.00%
Slide 37: Detailed Analysis of Clinical Events
Detailed Analysis Clinical Events at 30 Days MGuard (n=217) Control (n=216) MACE 4 (1.8%) 5 (2.3%) - Cardiac mortality 0 (0.0%) 4 (1.9%) - Reinfarction 3 (1.4%) 2 (0.9%) - TLR, ischemia - driven 4 (1.8%) 1 (0.5%) 3 - 5 Day MRI Substudy Results MGuard (n=30) Control (n=29) Infarct mass, grams 17.1 [1