Neovasc Inc. Alexei Marko, CEO. June 2011

Transcription

1 Neovasc Inc. Alexei Marko, CEO June 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 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 Three key product lines/development projects with large growth potential: 1. Commercialized: Implantable biological tissue and services for transcatheter heart valves and other applications 2. In final EU trials: Neovasc Reducer for treatment of refractory angina 3. In development: Neovasc Tiara for treatment of mitral regurgitation 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 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

5 Reducer Market Opportunity Estimated selling price $3,000 ~ 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 Increased venous back pressure forces blood into ischemic areas More uniform distribution of flow throughout heart muscle Reducer

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 nonsurgical catheter-based techniques Reducer procedure time ~20 minutes; patient discharged within 24 hours Safely provides treatment for an otherwise untreatable patient CORONARY SINUS

8 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) 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

9 Reducer COSIRA Trial 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: 6-months Data intended to support CE-mark application and EU launch Sites in Belgium, Canada, UK, Denmark, Sweden and Netherlands Estimate completing enrollment in Q3-2011

10 Reducer Case Study Patient: 69 year old female, with multiple prior revascularizations (CABG, multiple PCIs, transcatheter aortic valve replacement). Suffering from severe refractory angina (angina with routine activities such as walking short distances or climbing stairs) Procedure: Neovasc Reducer implanted in patient s coronary sinus in September Implantation takes ~20 minutes and procedure is broadcast live to main arena of TCT 2010 conference

11 Reducer Case Study Results six months after Reducer implantation* CCS Class (Angina Score) Functional Class Dobutamine Echo Baseline III Severe angina pain when walking short distances or climbing stairs Severe postero-lateral ischemia 6 month FU I Rides her bicycle min each day No ischemia Stress Test Positive Negative Angina Medications Multiple daily medications Minimal *Data presented at EuroPCR in May 2011

12 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)

13 Reducer Commercialization Timeline Commercial product completed Europe: COSIRA to provide data for CE mark and European launch (first half 2012) US: FDA trial and approval process (PMA) will be initiated following European CE mark approval

14 Biological Tissue Products Proprietary process creates implantable, biocompatible tissue that retains strength and physical characteristics of natural tissue Developed specifically for fabricating surgical heart valves and has a 20+ year implant history for this application Adapted for general surgical use as a patch or reinforcement material FDA-cleared, CE-marked, EDQM certified State-of-the-art facility and highly experienced team with expertise in tissue valve and vascular device development, manufacture and commercialization Neovasc provides biological tissue and related services to a wide range of industry partners

15 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 valve therapies Acquisitions of Ventor, Corevalve, Evalve and Sadra spur rapid growth of sector Projected 2011 transcatheter aortic valve sales: ~$225M Corevalve, ~$300M Edwards PARTNER trial (TCT Sept 2010 / ACC April 2011) demonstrating excellent results for TAVI and potential to become standard of care for aortic valves Neovasc expects continued strong growth in tissue-related revenues as our customers products are commercialized

16 Pipeline Projects - Mitral Regurgitation Diseased mitral valve allows blood leakage back into the left atrium called mitral regurgitation or MR The condition is often severe and can lead to heart failure and death ~600,000 new MR patients annually in U.S. and Europe Conventional surgical treatments are appropriate for only about 20% of these patients leaving the majority untreated ~4 million patients in the U.S. with significant MR Due to complexity of mitral valve anatomy, development of transcatheter treatments for MR have lagged behind aortic valve replacement devices

17 Pipeline Projects Mitral Regurgitation Neovasc is in the early stage of developing a novel transcatheter device Tiara that will enable the treatment of mitral regurgitation. The Tiara device is delivered through the apex of the heart or trans-venously to restore normal function of the mitral valve while preserving the integrity of the surrounding structures of the heart. Neovasc has filed PCT patent applications protecting the Tiara technology and methodology Refined Tiara prototypes have been developed and undergone pre-clinical testing Proof of concept studies have demonstrated the feasibility and efficacy of the Tiara device in animal models Neovasc will be ramping activities on the project over the coming quarters

18 2011 / 2012: Looking Forward Continued growth in revenues from tissue business (2011 target >$5M) Expect steady growth over next 12 months with upside potential in late 2011 and 2012 as customers products are commercialized Complete COSIRA trial for Reducer Preliminary COSIRA safety study data to be presented at TCT 2011 File CE-mark application to allow sales in Europe European pilot launch targeted for Q Expand activities to develop new products Proof of concept stage complete Target first in man in 2012

19 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 Cash requirements Cash on hand for current projects New money focused entirely on pipeline projects

20 Thank you