Inspiremd Inc. · NASDAQ:NSPR
Inspiremd — Investor Presentation (November 2013)
25 slides from Inspiremd's investor presentation, Nov 5, 2013
Slide 1: InspireMD November 2013
ireMD NYSE MKT: NSPR insp November 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: Emerging medical device company developing advanced stent technology
An emerging medical device company developing and commercializing advanced stent technology for interventional cardiology and other vascular procedures • NYSE MKT: NSPR • Stock Price (10/31/13): $2.82 • Shares Outstanding (10/21/13): 34.5 Million • Total Cash (6/30/13): $14.8 Million* * Excludes ven
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 and MGuard platform
• 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 mesh 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 released in October 2013 • Commercialization ramp anticipated • CE mark received • Seeking FDA approval by 2016 • AMI Segment: $1.7B Coronary Drug Eluting • Planned product • Total Drug Eluting: $4.0B Carotid •
Slide 10: Coronary EPS 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% (p - value = 0.008) • Reduction in mortality rate at 12 - months: – Occurred in 2/217 (1.0%) patients with MGuard ™ – Occurred in 7/216 (3.3%) patients with BMS or DES • Reduced Infarct size* – 17.1gm ( MGuard ™) vs 22.3
Slide 13: 12-month mortality
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 13
Slide 14: Efficacy by symptom onset to balloon time
Efficacy of MGuard as a Function o Symptom Onset to Balloon Time | 70% 60% z 50% = 40% B 3 30% a — 8 o0% 10% 19/ 26/ 26/ 10/ os oR: 32 B 50 26 a <120 120-239 240-359 360-479 >480 = MGuard 55.0% 58.1% 61.2% 70.0% 35.7% BMS/DES 59.4% 49.3% 52.0% 38.5% 16.1% | symptom to balloon time (minutes) inspireM
Slide 15: 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 16: Regulatory and commercialization
™ • 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 17: 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 18: 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 19: 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 19 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 ( EuroPCR ) HealthLink Partne
Slide 20: Upcoming milestones 2013-2016
` Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 2013 2014 2015 2016 Strategic Partnership II 20 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 Perip
Slide 21: 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 21 Anchoring Macro Structure Drug Delivery Fiber Width
Slide 22: 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 23: 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 24: Investment highlights 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) – MGuard ™ is the only stand alone stent technology proven to demonstr
Slide 25: Thank You
Inspire MD Thank You