Neovasc Inc.
Alexei Marko, CEO
May 2011
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.
Neovasc at-a-Glance• Medical device company focused on innovative products to treat heart
disease and related conditions
• Two key product lines with large growth potential :
1. Neovasc Reducer™ for treatment of refractory angina
2. Implantable biological tissue and services for transcatheter heart valves and other applications
• Initial products approved in US/EU with growing revenues ($4.36M in 2010, $5M+ forecast in 2011)
• Positive cash flow in 2010 from biological tissue business
• TSX-Venture Exchange listed (TSXV: NVC)
Reducer Product
Treats Refractory Angina• Inadequate blood flow to heart muscle that cannot be managed through
conventional drug, catheter or surgical therapy
• Causes constant and severe heart pain and significant disability that negatively impacts quality of life
• Large untreatable patient population is growing as better treatments for CAD reduce mortality and increase number of patients with advanced disease
Reducer Market Opportunity• Estimated selling price $3,000 - $5,000 • ~ 2 million existing “no option” refractory angina patients in US & Europe
($6B potential market)• ~400,000 new “no option” patients diagnosed annually
($1.2B/year potential market)
• ~1 million patients/year in US & Europe undergo repeated surgeries and catheterizations to treat recurrent angina ($3B/year potential market )
Reducer Method of Action
Increased venous back pressure forces blood into ischemic areas More uniform distribution of flow throughout heart muscle
Reducer restricts outflow of blood from coronary veins, forcing oxygenated blood deeper into the heart muscle where it reaches oxygen-starved ischemic areas
Reducer
Reducer Procedure• Treating refractory angina by narrowing coronary sinus based on a surgical
procedure performed in 1960’s (Beck Procedure) • Beck Procedure reported excellent results but is no longer performed due to
invasiveness of the surgery • Neovasc Reducer achieves same narrowing, but using modern non-surgical
catheter-based techniques• Reducer procedure time ~20 minutes; patient discharged within 24 hours• Safely provides treatment for an otherwise untreatable patient
CORONARY SINUS
Reducer Clinical ResultsCompelling clinical data from first human trial (15 patients, 3 centers)
• Six-month data published in May 2007 JACC demonstrated safety and significant improvement of angina symptoms
• Three-year follow-up data confirms excellent long-term safety and durability of treatment (data 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
Reducer COSIRA Trial for CE Mark ApplicationCOSIRA (Coronary Sinus Reducer for Treatment of Refractory Angina)Double-blind, randomized, sham-controlled, multicenter, prospective trial
• 124 patients• Randomized 1:1 to blinded treatment and sham control arms• Primary endpoint: Efficacy @ 6-months• Data intended to support CE-mark application and EU launch• 3 sites in Europe (Belgium, Netherlands), 2 sites in Canada, additional sites
planned in Canada, UK and Sweden• Enrollment proceeding well – estimated completion Q3-2011
Reducer “live case” broadcast to 2010 TCT conference in Washington DC
Reducer Key Opinion Leaders
Leaders in interventional cardiology and refractory angina are working on the Reducer program
• Dr. Shmuel Banai (Tel Aviv Souraski 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. Jean-Francois Tanguay (Montreal Heart Institute)• Dr. Stefan Verheye (Antwerp Cardiovascular Institute)• Dr. Chris White (Ochsner Medical Center, New Orleans)
Reducer Commercialization Timeline
• Commercial product completed
• Europe: COSIRA to provide data for CE mark and European launch (early 2012)
• US: FDA trial and approval process (PMA) will be initiated following European CE mark approval (commence mid 2012)
Biological Tissue Products • Proprietary process creates implantable, biocompatible tissue that retains
strength and physical characteristics of natural tissue
• Developed specifically for surgical heart valve applications
• Adapted for general surgical use as a patch or reinforcement material
• FDA-cleared and CE-marked
• EDQM certified
• 20+ year positive implant history
Rapid Growth in Heart Valve Applications Neovasc is the leading independent supplier of biological leaflet material to
companies developing transcatheter heart valves.
• Clear clinical need and market support for transcatheter aortic valve therapies (TAVI)
• Acquisitions of Ventor, Corevalve, Evalve and Sadra spur rapid growth of sector
• Projected 2011 TAVI sales: ~$225M Corevalve, ~$300M Sapien
• PARTNER trial (TCT Sept 2010 / ACC April 2011) demonstrating excellent results for TAVI and potential to become standard of care
Neovasc expects continued strong growth in tissue-related revenues as our customers’ products are commercialized
Other Applications & Services
• Artificial heart components• Specialty vascular devices • Vascular surgical patches (LeMaitre
Vascular’s Xenosure™)• Surgical patches for non-vascular use
State-of-the-art facility and highly experienced team with expertise in tissue valve and vascular device development, manufacture and commercialization
• Tissue product manufacturing (including heart valves)• Product development services
2011: Looking Forward
Continued growth in revenues from tissue business (target >$5M) • Expect steady growth over next 12 months with upside potential in late
2011 and 2012 as customers’ products enter market
Complete COSIRA trial for Reducer and file CE-mark application to allow sale in Europe • Preliminary COSIRA safety study data to be presented at TCT 2011• European product launch targeted for Q2-2012
Expand activities to develop new strategic products• Activities already underway in high growth segment
Capitalization & Trading
Shares outstanding• 40.7m (issued and outstanding)• 46.1m (fully diluted)
Public listing • TSXV: NVC
Key investors• Frost Group (Dr. Phillip Frost) • Company management
Financing• 12+ months cash on hand based on current burn• May undertake financing to accelerate new projects
Thank you