Slide 1: March 2014 NYSE MKT: NSPR
March 2014 NYSE MKT: NSPR
Slide 2: Forward-looking statements
2 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 . Forward - looking statements are n
Slide 3: Emerging medical device company developing advanced stent technology
3 An emerging medical device company developing and commercializing advanced stent technology for interventional cardiology and other vascular procedures InspireMD NYSE MKT: NSPR Stock Price (2/28/14): $3.13 52 Week Range: $1.80 - 3.80 Shares Outstanding (2/28/14): 34.9 M Market Capitalization $109
Slide 4: Leadership
4 Leadership EXECUTIVE TEAM BOARD OF DIRECTORS Alan Milinazzo , President, CEO & Director • Medtronic • Boston Scientific Craig Shore, CFO • Pfizer • General Electric Eli Bar, CTO • Nicast Gwen Bame , VP Corporate Development • Boston Scientific • Covidien David Blossom, VP Global Marketing & Strate
Slide 5: Global Market Values
5 Global Market Values • Current stents not specifically designed for AMI • Distal embolization occurs in up to 73% of cases* • Majority of AMI market is outside of the U.S. (~60%) Source: Health Research International, (June 2012) * JAMA, March 2, 2005 — Vol 293, No. 9 1063 Gregg W. Stone • Current
Slide 6: Current Coronary Problem
6 Current Coronary Problem Pre Procedure Embolization Post Procedure Minor heart attack treated with a Bare Metal Stent (BMS) or Drug Eluting Stent (DES) implant Debris can flow down stream, occluding small arteries “ Distal Embolization ” Cardiac Mortality and Morbidity Leading To: Causes:
Slide 7: Technology: MGuard Embolic Protection System
7 Technology MGuard Embolic Protection System Combines stent and embolic protection in a single device • Reduces risk of embolization by capturing potentially harmful debris against the artery wall • Micro - particles then slowly re - enter the artery in a non - harmful way over approximately 30 day
Slide 8: Clinical Experience and MASTER I Trial Highlights
8 Randomized – STEMI • MICAMI (n=40) • MASTER (n=432) Single Arm – Vein Grafts & Native Vessels • FIM (n=41) • INSPIRE (n=30) Single Arm – STEMI (& ACS) • MAGICAL (n=60) • PISCIONE(n=105) • WEERACKODY (n=51) • PREIS (n=24) • ROMAGUERA (n=56) • ANTHOPOULOS (n=73) Clinical Experience * Majority with M
Slide 9: All Cause Mortality at Months
9 All Cause Mortality at 12 Months Death (%) 0 1 2 3 4 5 Months 0 1 2 3 4 5 6 7 8 9 10 11 12 P= 0.09 HR: 0.28 [95% CI: 0.06, 1.36] 1.0% 3.3% MGuard BMS/DES
Slide 10: MASTER II: US FDA PMA Trial
10 MASTER II: US FDA PMA Trial STATUS • First patient recruited in Q3 2013 • International sites fully activated Q1 2014 • Anticipated enrollment completion end of 2014 OBJECTIVE • Evaluate safety and efficacy of MGuard Prime Coronary vs. BMS and DES in STEMI CO - PRIMARY ENDPOINTS • Efficacy: Super
Slide 11: Commercial strategy by tier
Tier 1 • Mix of direct sales representatives, agents and distributors, with focus on KOL’s/high - volume AMI centers • 14 - 18 countries, primarily Europe and Brazil - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Tier 2
Slide 12: Product Development Pipeline
12 Therapeutic Area Stage of Development Market Size Coronary • CE mark received • 12 - month MASTER I randomized data available October 2013 • FDA trial initiated • DES phase I initiated • AMI Segment: $1.7B Carotid • CE mark received • CARENET enrollment Q2 2014 • Total Carotid: $500M Peripheral V
Slide 13: Coronary Drug Eluting Stent Development Strategy
13 Coronary Drug Eluting Stent Development Strategy Strategic Partnership : Attach MicroNet to clinically proven CE marked DES ▪ Phase I: Technical testing and feasibility ▪ Phase II: Animal testing ▪ Phase III: Clinical strategy Q1 - Q2 2014 Phase I Q3 - Q4 2014 Phase II Q1 2015 Phase III
Slide 14: Carotid Development Program
14 Carotid Development Program CGuard Carotid Embolic Protection System • CE marked • Self - expanding nitinol stent • Wrapped in InspireMD’s MicroNet • Current Global Market: $500M CGuard CARENET Study • CGuard CARENET ( CAR otid E mbolic protection using micro NET ) study ▪ Multicenter study on th
Slide 15: Milestones To-Date
15 2010 2011 2012 2013 R&D/ Clin / Reg Corporate Operational Milestones To - Date MGuard Prime CE Mark MASTER I Recruitment MASTER I Primary Endpoint/30 Day Readout Carotid CE Mark MASTER II IDE (FDA) Trial Approval MASTER I Subset Analysis ( EuroPCR ) MASTER I 12 - Month Data (TCT) NSPR.OB Sol Bare
Slide 16: Anticipated Future Milestones
16 2014 2015 2016 R&D/ Clin / Reg Corporate Operational Commercial Anticipated Future Milestones Carotid CARENET Peripheral CE Mark Complete MASTER II Enrollment MASTER II Superiority Endpoint MGuard Prime FDA Filing DES CE Regulatory Submission Strategic Partnership I (VOLC) Strategic Partnership I
Slide 17: Investment Summary
17 Investment Summary • Appointed new, experienced management and Board members with proven track records • Proprietary platform technology addressing the multi - billion dollar global stent market – Initially targeting AMI market (i . e . heart attacks) – Early positive results with Carotid platfor
Slide 18: InspireMD
~ inspireMD