Slide 1: InspireMD May 2013
inspireliD May 2013
Slide 2: Forward-Looking Statements
2 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 . For
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: 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 5: Scientific and Clinical 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 6: Coronary Stent Market 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 7: 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: 7
Slide 8: Addressing the AMI Market: MGuard Coronary
Addressing the AMI Market 8 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 9: MicroNet Technology and Potential Applications
9 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 10: Before and After MGuard Stenting
10 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 11: 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 12: ST Resolution and Clinical Outcomes in STEMI
* 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 12 In STEMI, occurrence of major clinical events at 1 year is significantly related to ST resolution * < 30 % > 70 % Unsuccessful Result
Slide 13: 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 %) 13 Complete ST Segment Resolution MGuard (n=204) Control (n=206) P value = 0.008
Slide 14: MASTER Trial 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 arm
Slide 15: 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 16: 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 16
Slide 17: MASTER II US IDE 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 18: MGuard Platform Technology
Received CE Mark for Coronary Commercial • MGuard Coronary • MGuard Prime Coronary * Planned product 18 MGuard ™ Platform Technology MGuard ™ Coronary EPS MGuard ™ Carotid MGuard™ Peripheral * MGuard™ Drug Eluting * MGuard™ Cerebral * Aneurysm MGuard™ Renal * MGuard Carotid CE Mark Approved
Slide 19: MGuard Carotid
CE Mark Approved ; Q1 2013 19 Current Market Solution: MGuard ™ Carotid Solution: Stent + Filter Device + MGuard Embolic Protection Stent During and Post Procedure
Slide 20: 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 20 Anchoring Macro Structure Drug Delivery Fiber Width
Slide 21: 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 22: 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 22 MASTER Recruitment MASTER Top Line MASTER Details New CEO Hired US Headquarters Carotid CE Mark NYSE MKT MGuard Prime CE Mark
Slide 23: 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 MASTER II IDE (FDA) Conditional Approval Development Partnership I 23 MASTER Subset Analysis ( EuroPCR ) Manufacturing Expansion MASTER 12 - Month Data (TCT) Distribution Partnership I FDA Approval Periphe
Slide 24: NSPR Capitalization
24 NSPR (NYSE MKT) 34 million Basic Shares Outstanding $2.80 Stock Price (5/1/2013) $114.52 million Fully Diluted Market Capitalization (5/1/2013) 6.9 million Warrants, Options and Convertible Loan Shares Q2 – $ 1.4M / Q1 – $ 0.5M (Up 165%) Revenue Growth 40.9 million Fully Diluted Shares Outstandin
Slide 25: 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 $1.7B Unmet Clinical Need • MASTER Trial ( r andomized s tudy) • Primary Endpoint: Statistical significance achieved with superior results •
Slide 26: Appendix
26 Appendix
Slide 27: 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 28: Detailed Analysis
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
Slide 29: Thank You
Inspire MD Thank You