Inspiremd Inc. · NASDAQ:NSPR
Inspiremd — Investor Presentation (September 2013)
35 slides from Inspiremd's investor presentation, Sep 10, 2013
Slide 1: InspireMD September 2013
September 2013 v50 - 46 NYSE MKT: NSPR
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 overview
An emerging medical device company developing and commercializing advanced stent technology for interventional cardiology and other vascular procedures • NYSE MKT: NSPR • Stock Price (9/3/13): $2.12 • Shares Outstanding: 34.3 Million • Total Cash (3/31/13): $2.5 Million – Does not include net procee
Slide 4: Investment highlights
• 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) – MGuard ™ is the only stand alone stent technology proven to demonstr
Slide 5: Current stent technology limitations and MGuard
• Current stent technology: – Targets the Stable Angina patient (i.e. general chest pain from poor blood flow through the blood vessels in the heart) – Unstable Angina patients (i.e. AMI) represent complex clinical problem not addressed by current stent technologies • InspireMD’s MGuard ™ is a game
Slide 6: Treating AMI
Treating AMI 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: 6
Slide 7: Stent and embolic protection in a single device
• 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 days – MicroNet ™ acts as safety net by offerin
Slide 8: MicroNet technology
Proprietary circular knitted mesh wraps around stent to protect patient from plaque debris flowing downstream upon deployment Advantages of MicroNet ™: • Made of a single fiber from a biocompatible polymer, widely used in medical implantations • Flexible structure • Does not promote thrombosis ™ 8
Slide 9: Target indications, development stage and market size
Target Indication Stage of Development Market Size Coronary STEMI / AMI • 12 - month data to be released in October • Commercialization prep ongoing in anticipation of 12 - month data • CE mark received • Seeking FDA approval by 2016 • AMI Segment: $1.7B Coronary Drug Eluting • Planned product • Tot
Slide 10: Clinical program
Coronary EPS • 6 single - center studies in Europe and South America – Consistent positive clinical outcomes • MASTER Trial ( M Guard ™ for A cute ST E levation R eperfusion) – Multi - center, randomized clinical trial – Improved mortality, results confirmed* • MASTER II (for FDA approval) – Began e
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 Lin
Slide 12: MASTER trial results
• Achieved p rimary e nd point – Superiority in ST Resolution – 57.8% vs. 44.7 % • Reduction in mortality rate at 6 - months: – Occurred in 1/217 (0.5%) patients with MGuard ™ – Occurred in 6/216 (2.8%) patients with BMS or DES • Reduced Infarct size* – 17.1gm ( MGuard ™) vs 22.3gm (BMS/DES) 12 *MRI
Slide 13: Mortality at 6 months
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% 13
Slide 14: MASTER II trial
• Status: First patient recruited i n July 2013 • Objective: Evaluate safety and efficacy of MGuard ™ Prime Coronary vs. BMS and DES in STEMI • Co - Primary Endpoints: – Efficacy: Superiority in complete ST Resolution – Safety : Non inferiority in death and Target Vessel MI • Design: Multi - center
Slide 15: Regulatory and commercial strategy
™ • Received CE Mark for AMI indication; expect to submit for FDA approval post - MASTER II trial • Establishing Embolic Protection Stent (EPS) as a new stent category as the preferred solution for STEMI patients • Developing sales infrastructure to support a focused and phased selling approach in s
Slide 16: Selectively scaling global reach
™ Selectively scaling global reach and frequency 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 • Country or regional partnerships with high quality local distributors or Str
Slide 17: Manufacturing
• Platform technology ( MicroNet ™) produced in - house • Bare metal stent and catheter manufactured by third - party • Final product assembled at InspireMD facility, including attachment of proprietary mesh sleeve to the stent • Recently consolidated facilities to capture additional margin • Additi
Slide 18: Milestones 2010-2013
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2010 2011 2012 2013 NSPR.OB Sol Barer Named Chairman 18 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) Conditional Approval MASTER Subset Analysis ( Eu
Slide 19: Upcoming milestones 2013-2016
` Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 2013 2014 2015 2016 Strategic Partnership II 19 Carotid First in Man Peripheral CE Mark Complete MASTER II Enrollment Strategic Partnership III MASTER II Results Outsourced Manufacturing Facility Strategic Partnership IV Strategic Partnership FDA Filing MASTE
Slide 20: Intellectual property
• 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: 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 22: 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 23: Investment highlights
• 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) – MGuard ™ is the only stand alone stent technology proven to demonstr
Slide 24: Thank You
Inspire MD Thank You
Slide 25: Appendix
2 Appendix inspireMD.
Slide 26: 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
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: MASTER trial takeaways
• 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? 28
Slide 29: One-year clinical events
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 Throm
Slide 30: Complete ST segment resolution
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%) 30 Complete ST Segment Resolution MGuard (n=204) Control (n=206) P value = 0.008
Slide 31: ST resolution and 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 31 In STEMI, occurrence of major clinical events at 1 year is significantly related to ST resolution * < 30 % > 70 % Unsuccessful Result
Slide 32: TIMI flow goal
Goal: Achieve 90% TIMI 3 flow within 90’ Ndredepa . J Am Coll Cardiol 2008;52:512 – 7 32
Slide 33: ST resolution predicts long-term mortality
AMC Amsterdam (N= 2124 ) N. Verouden – Am J Cardiol 2010 ; 105 ( 12 ): 1692 - 1697 . ST - Resolution after PCI in STEMI 33 ST - Resolution immediately post PCI is a strong predictor of long term mortality
Slide 34: 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 34
Slide 35: Reperfusion and infarct size
Epicardial Myocardial TIMI Flow = Vessel patency Myocardial Blush Grade = Microvascular perfusion ST Resolution = Myocardial functionality Reperfusion will have impact on Infarct Size 35