Neovasc Inc.
TSXV: NVC
Alexei Marko, CEO
Chris Clark, CFO
October 2013
Forward-Looking Statements
Statements contained herein that are not based on historical or current fact, including without
limitation statements containing the words “anticipates,” “believes,” “may,” “continues,” “estimates,”
“expects,” and “will” and words of similar import, constitute “forward-looking statements” within the
meaning of the U.S. Private Securities Litigation Reform Act of 1995. Such forward-looking
statements involve known and unknown risks, uncertainties and other factors that may cause the
actual results, events or developments to be materially different from any future results, events or
developments expressed or implied by such forward-looking statements. Such factors include,
among others, the following: general economic and business conditions, both nationally and in the
regions in which the Company operates; technology changes; competition; changes in business
strategy or development plans; the ability to attract and retain qualified personnel; existing
governmental regulations and changes in, or the failure to comply with, governmental regulations;
liability and other claims asserted against the Company; and other factors referenced in the
Company’s filings with Canadian securities regulators. Given these uncertainties, readers are
cautioned not to place undue reliance on such forward-looking statements. The Company does not
assume the obligation to update any forward-looking statements.
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Neovasc in Summary
A Canadian small cap medical device company with existing revenues & two
development products:
Stage
Product
Growing Revenues
Implantable biological tissue & manufacturing
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 severe 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
Reducer modulates outflow of blood from coronary veins, increasing blood flow
to ischemic areas
Blood flow takes path of
least resistance
•
Majority of blood flows
around ischemic
areas
Venous back pressure
causes more uniform
distribution of blood
flow through heart
muscle
•
Forces more blood
into ischemic areas
•
Relieves angina
Reducer
implanted in
coronary sinus
vein
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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 catheterbased 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)
• Registry Data presented at EuroPCR 2013 shows strong indications of
efficacy
Average CCS Class
Baseline
6-mos
3-yrs
Average Echo-Dobutamine Results
Baseline
6-mos
3-yrs
Average Thalium SPECT Severity
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
•
•
•
•
Enrollment completed in May 2013 (104 patients)
Randomized 1:1 to blinded treatment & sham control arms
Primary endpoint: Efficacy @ 6-months
Sites in Belgium, Canada, UK, Denmark, Sweden & Netherlands
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 May 2013, with follow up completed by end
of 2013.
• Collect additional clinical data through ongoing Registries in Europe, UK &
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
transcatheter heart valves and other 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 $550M
• 2012 sales estimated $850M
• 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
of 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 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 early 2014
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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. Anson Cheung (St. Paul’s Hospital, Vancouver)
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 (Henry Ford Hospital, Detroit MI)
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 2013 forward
Complete COSIRA trial for Reducer & pilot launch in Europe
• 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 early 2014
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Neovasc Recap
Product leader in 3 separate fields
• Neovasc Tissue and Contract Manufacturing – Growing revenues
• Neovasc Reducer – CE marked & efficacy data in 2013
• Neovasc Tiara – Advancing towards first human use
Corporate Summary
• Clean corporate structure 48.2m share issued, 57m fully diluted
• Revenue growth of 50% over the last 4 years
• ~$4m cash on hand as of October 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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Thank you
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