Presentation Transcript

1. Neovasc Inc. Alexei Marko, CEO May 2011
2. 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.
3. 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 : Neovasc Reducer™ for treatment of refractory angina Implantable biological tissueand 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)
4. Reducer Product TreatsRefractory 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
5. 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 )
6. Reducer Method of Action Reducer restricts outflow of blood from coronary veins, forcing oxygenated blood deeper into the heart muscle where it reaches oxygen-starved ischemic areas Reducer Increased venous back pressure forces blood into ischemic areas More uniform distribution of flow throughout heart muscle
7. 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
8. Average Thalium SPECT Severity Average Echo-Dobutamine Results Average CCS Class Baseline 6-mos 3-yrs Baseline 6-mos 3-yrs Baseline 6-mos 3-yrs Reducer Clinical Results Compelling 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)
9. Reducer COSIRA Trial for CE Mark Application COSIRA(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
10. 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)
11. 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 mid2012)
12. 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
13. 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
14. 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
15. 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
16. Capitalization & Trading
17. Thank you