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Neovasc Inc. TSXV: NVC Alexei Marko, CEO Chris Clark, CFO April - - PowerPoint PPT Presentation
Neovasc Inc. TSXV: NVC Alexei Marko, CEO Chris Clark, CFO April - - PowerPoint PPT Presentation
Neovasc Inc. TSXV: NVC Alexei Marko, CEO Chris Clark, CFO April 2013 Forward-Looking Statements Statements contained herein that are not based on historical or current fact, including without limitation statements containing the words
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Neovasc in Summary
A Canadian small cap medical device company with existing revenues & two development products:
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Stage Product Growing Revenues Implantable biological tissue & services for transcatheter heart valves & other applications Late Stage Neovasc Reducer™ for treatment of refractory angina (CE marked) Early Stage Neovasc Tiara™ in preclinical development for treatment of mitral valve disease
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Reducer Product
Treats Refractory Angina
- Angina – Constant and severs heart pain caused by inadequate blood flow to
heart muscle
- Refractory – Angina that cannot be managed through conventional drug,
catheter or surgical therapy
- Large & growing population of untreatable patients
– Improved cardiac care leads to less mortality & more patients with advanced/end-stage disease
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Reducer Method of Action
Venous back pressure causes more uniform distribution of blood flow through heart muscle
- Forces more blood
into ischemic areas
- Relieves angina
Reducer modulates outflow of blood from coronary veins, increasing blood flow to ischemic areas Reducer implanted in coronary sinus vein
Blood flow takes path of least resistance
- Majority of blood flows
around ischemic areas
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Reducer Procedure
- Based on 1950’s surgical Beck Procedure
- Reported excellent results but is no longer performed due to invasiveness
- Reducer achieves same narrowing using modern non-surgical catheter-
based techniques
- Reducer procedure takes 20 minutes; patient discharged within 24 hours
- Safely provides treatment for an otherwise untreatable patient
CORONARY SINUS
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Reducer Clinical Results
Compelling clinical data from 1st human trial (15 patients, 3 centers)
- 6-month data published in May 2007 JACC demonstrated safety & significant
improvement of angina symptoms
- 3-year follow-up data confirms excellent long-term safety & treatment
durability (presented at ACC, March 2010)
Average CCS Class Average Echo-Dobutamine Results Average Thalium SPECT Severity
Baseline 6-mos 3-yrs Baseline 6-mos 3-yrs Baseline 6-mos 3-yrs
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Reducer COSIRA Trial
COSIRA (Coronary Sinus Reducer for Treatment of Refractory Angina) Double-blind, randomized, sham-controlled, multicenter, prospective trial
- 110-124 patients
- Randomized 1:1 to blinded treatment & sham control arms
- Primary endpoint: Efficacy @ 6-months
- Sites in Belgium, Canada, UK, Denmark, Sweden & Netherlands
- Complete enrollment in Q1 2013
Data will support European market launch & provide pilot data for US FDA trial
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Reducer Timeline & Market Opportunity
Europe
- CE mark received November 2011
- Complete COSIRA enrollment in Apr/May 2013
- Collect additional clinical data through registries initiated in Europe & Israel
- Launch with distribution partner(s) following completion of COSIRA
United States
- FDA IDE trial to be initiated following completion of COSIRA study
Market size
- ~2,000,000 existing “no option” refractory angina patients in US & Europe
- ~400,000 new “no option” patients diagnosed annually
- ~1,000,000 patients/year treated for “recurrent” angina
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Biological Tissue and Services
Neovasc is a turnkey solution for industry partners developing medical devices that incorporate pericardial tissue Tissue
- Proprietary process creates implantable, biocompatible tissue from animal
pericardium that retains strength & physical characteristics of natural tissue
- Developed specifically for fabricating surgical heart valves
- 20+ year implant history, FDA-cleared, CE-marked, EDQM-certified
- State-of-the-art laboratories & manufacturing facilities
Services
- Tissue supply
- Development & prototyping services
- Pilot & commercial manufacturing
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Transcatheter Heart Valve Applications
Neovasc is the leading independent supplier of biological leaflet material & related services to companies developing transcatheter heart valves
- 2011 sales of 1st generation transcatheter aortic valves $600M
- 2012 sales estimated $900M
- Next generation devices reach commercialization in 2013/14
- Wider use expected as valves improve
- Currently supplying multiple programs
- Broad services from simple tissue supply to full OEM valve manufacturing
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Tiara Mitral Valve Replacement
- Neovasc is developing Tiara, a novel transcatheter device for the treatment
- f mitral regurgitation (MR)
- MR is serious & widespread condition that can cause significant disability or
death
- Significant portion of those with MR are non-surgical candidates
- Tiara is a minimally-invasive device - delivered using a catheter inserted
through apex of heart to replace the diseased mitral valve
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Tiara Key Features
- Design is specific to mitral anatomy & matches natural shape of mitral
annulus
- Resists high dislodgment forces during systole
- Exerts minimal radial force on mitral annulus
- Does not inhibit LV function or obstruct LVOT
- Preserves native structures in LV (chordae, papillary muscles)
- Implantation does not require rapid pacing & can be completed in less than 5
minutes after obtaining apical access
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Tiara Development Timeline
- Multiple patent applications filed
- Refined valves & transapical delivery systems developed
- Preclinical testing underway (bench, acute / chronic animal)
- Durability (accelerated wear) testing underway
- Clinical technique developed & refined through multiple animal implants
- Expert medical advisory team assembled & active
- Target first human implantation in 2013
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Tiara Market Opportunity
- Success of transcatheter aortic valves has positioned transcatheter mitral
valve replacement as major area of industry/clinical interest
- 600,000 new patients per year with MR in US & EU
- Only 20% of diagnosed patients currently undergo surgery
- Minimally invasive mitral valve replacement market potential estimated
at >$1B
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Clinical Opinion Leaders
Leaders in interventional cardiology are assisting Neovasc programs
- Dr. Shmuel Banai (Tel Aviv Medical Center)
- Dr. Elazer Edelman (Harvard – MIT, Cambridge)
- Dr. Tim Henry (Minneapolis Heart Institute)
- Dr. Marc Jolicoeur (Montreal Heart Institute)
- Dr. Martin Leon (Columbia University Medical Center, NYC)
- Dr. William O’Neill (Miller School of Medicine, University of Miami)
- Dr. Jean-Francois Tanguay (Montreal Heart Institute)
- Dr. Stefan Verheye (Antwerp Cardiovascular Institute)
- Dr. Chris White (Ochsner Medical Center, New Orleans)
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Neovasc Looking Forward
Continued growth of tissue business
- Steady growth in 2013
- Upside potential as customers’ products commercialize in 2014 forward
Complete COSIRA trial for Reducer & pilot launch in Europe
- Complete COSIRA enrollment in Apr/May 2013
- Release full efficacy data after 6-month follow up in Q4 2013
- Continue controlled EU release through REDUCE registries
- Strategic partnership for wider EU launch in 2014
- Develop plan for FDA approval and US market entry with Partner
Continued development of Tiara
- Target first human study of Tiara in Q4 2013
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Neovasc Recap
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Product leader in 3 separate fields
- Neovasc Tissue – Growing revenues & significant strategic value
- Neovasc Reducer – CE marked & efficacy data in 2013
- Neovasc Tiara – Successful acute animal studies & rapid advance to clinical
stage in 2013 Corporate Summary
- Clean corporate structure 45.9m share issued, 55.8m fully diluted
- Revenue growth of 50% over the last 4 years
- $5.8m cash on hand at December 2012
- Additional $4.2m from maturing in-the-money warrants and options in 2013
- Key investors including Frost Group, Gagnon Securities and Peregrine
Ventures Public small cap opportunity in rapidly growing transcatheter valve space
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