Inspiremd Inc. · NASDAQ:NSPR
Inspiremd — Investor Presentation (November 2014)
22 slides from Inspiremd's investor presentation, Nov 5, 2014
Slide 1: InspireMD October 2014
October 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: Leadership
3 Leadership EXECUTIVE TEAM BOARD OF DIRECTORS Alan Milinazzo, President, CEO & Director • Medtronic • Boston Scientific Craig Shore, CFO • Pfizer • General Electric Dr. James Barry, COO • Boston Scientific • Howmedica Division of Pfizer Eli Bar, CTO • Nicast Gwen Bame, VP Corporate Development • Bo
Slide 4: 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, 2011 * JAMA, March 2 , 2005 — Vol 293 , No . 9 1063 Gregg W . Stone • Cu
Slide 5: Technology: MGuard Embolic Protection System
5 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 • MicroNet acts as safety net by offering greater surface area coverage to prevent large debris flow •
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: MGuard Clinical Experience
7 Randomized – STEMI • MICAMI (n=40) • MASTER ( n=433) 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) • iMOS Prime (n=97) MGuard Clinical
Slide 8: MASTER I: All Cause Mortality at Months
8 MASTER I: 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 HR : 0.28 [95% CI: 0.06, 1.36] P= 0.09 1.0 % 3.3 % 0% vs 1.8% (P=0.06) at 30 Days MGuard BMS/DES
Slide 9: MASTER II Update
10 MASTER II Update ▪ Enrollment discontinued in this US FDA registration trial; evaluating 30 day results ▪ Protracted FDA review on manufacturing process change delayed time to complete ▪ Enrollment was dominated by higher than anticipated DES usage ▪ Analysis of key 30 day end point data from 310
Slide 10: MASTER-OCT in collaboration with St. Jude Medical
10 MASTER - OCT - In collaboration with St. Jude Medical STATUS • Ethics Committee approvals to be complete Oct. 2014 • First patient to be enrolled in Nov. 2014 OBJECTIVE • Demonstrate increased Minimal Flow Area (MinFA) with the MGuard Prime compared to a non - mesh control stent (BMS/DES ) • Visu
Slide 11: Coronary Drug Eluting Stent Development Strategy
11 Coronary Drug Eluting Stent Development Strategy Develop two s trategic p artnerships to attach MicroNet to clinically proven FDA and/or CE marked DES . Phase I – Complete Q1 - Q2 2014 - Technical Testing And Feasibility Phase II Q4 2014 - Animal Testing (1 st candidate scheduled ) Phase III Q3 2
Slide 12: Coronary MGuard EPS Commercialization Plan
13 • 2013 revenue of $6.1 million, a 56% increase over prior year • 2014 implemented a hybrid sales strategy with direct reps in key European markets to support full re - launch of MGuard Prime in 2015 • Sales force of industry experienced professionals put into place (15 new hires in 2014) • Expand
Slide 13: Coronary MGuard EPS Commercialization Plan: Tiers
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 select Latin American and Middle East countries with favorable STEMI market factors - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Slide 14: Carotid Stent Market
15 Carotid Stent Market • Current stents not specifically designed for embolic protection • Mesh covered stent category believed to be emerging as immediate opportunity • Commercialization activity beginning Q4 2014 ROW $200 US $300 Global Carotid Market : $ 500M Source: JMP Securities, 2014
Slide 15: Carotid Solution: CGuard Embolic Prevention System
15 Carotid Solution • Reduces risk of embolization by trapping potential plaque debris and emboli against the artery wall • MicroNet acts as safety net by offering greater plaque scaffolding to prevent prolapse related to late embolization • Allows perfusion to vessel wall, does not inhibit endothel
Slide 16: CGuard Carotid Clinical Experience
16 CGuard Carotid Clinical Experience * Patients not included in CARENET • Achieved primary end point • 100 % procedural success • Z ero MACE at 30 days • 50 % fewer new ischemic lesions compared to historical non - mesh carotid artery stenting data • Average lesion volume per patient 10 times small
Slide 17: CGuard Carotid Commercialization Strategy
17 CGuard Carotid Commercialization Strategy CGuard Embolic Prevention System Commercial Activities to Complement MGuard Sales Activities Q4 2014 – Limited Market Release • Germany, Poland, Switzerland, Belgium, Italy, and Spain Q1/Q2 2015 – International Launch • Full launch of rapid exchange (RX)
Slide 18: MicroNet Product Development Pipeline
19 Therapeutic Area Stage of Development Market Size CORONARY • CE marked • MASTER I 12M data released • FDA trial halted (Q2 2014) • Second phase of DES strategy initiated $1.7B (AMI segment) CAROTID • CE marked • CARENET I data released • Limited market release 10/2014 • Global launch (ex - US) Q1
Slide 19: Milestones To-Date
20 2011 2012 2013 2014 R&D/ Clin/Reg Corporate Operational Commercial Milestones To - Date 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 Barer Named Chairm
Slide 20: Targeted Future Milestones
20 2015 2016 2017 R&D/Clin/Reg Corporate Operational Commercial Targeted Future Milestones Strategic Partnership III Strategic Partnership V Outsourced Manufacturing Facility Strategic Partnership IV Complete MGuard Prime EPS Re - Launch DES CE Mark Achieve Targeted COGS OCT Study Enrollment OCT Stu
Slide 21: Investment Summary
21 Investment Summary • Large interventional markets with favorable dynamics for new technology adoption • Proprietary platform technology addressing the multi - billion dollar global stent market with advanced integrated design – 2014 added carotid platform and enhanced coronary product platform –
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