Neovasc Inc. TSXV: NVC

Transcription

1 Neovasc Inc. TSXV: NVC Alexei Marko, CEO Chris Clark, CFO April 2013

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. 2

3 Neovasc in Summary A Canadian small cap medical device company with existing revenues & two development products: Stage Growing Revenues Product 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 3

4 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 4

5 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 5

6 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 6

7 Reducer Clinical Results Compelling clinical data from 1 st 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 7

8 Reducer COSIRA Trial COSIRA (Coronary Sinus Reducer for Treatment of Refractory Angina) Double-blind, randomized, sham-controlled, multicenter, prospective trial patients Randomized 1:1 to blinded treatment & sham control arms Primary endpoint: 6-months Sites in Belgium, Canada, UK, Denmark, Sweden & Netherlands Complete enrollment in Q Data will support European market launch & provide pilot data for US FDA trial 8

9 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 9

10 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 10

11 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 1 st 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 11

12 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 12

13 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 13

14 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

15 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 15

16 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) 16

17 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 Q 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 Q

18 Neovasc Recap 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 18

19 Thank you 19