Neovasc Inc. Alexei Marko, CEO Chris Clark, CFO June 2014
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: third-party claims regarding our intellectual property, continued success of clinical trials, general economic and business conditions, both nationally and in the regions in which the Company operates; history of losses and lack of and uncertainty of revenues, ability to obtain required financing, receipt of regulatory approval of product candidates, ability to properly integrate newly acquired businesses, 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 and the Securities and Exchange Commission, including in the Company's annual information form. Although the Company believes that expectations conveyed by the forward-looking statements are reasonable based on the information available to it on the date such statements were made, no assurances can be given as to the future results, approvals or achievements. 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 to reflect events or circumstances after the date of this presentation or to reflect the occurrence of unanticipated events except as otherwise required by applicable law. 2
Company Overview • Develop products to treat heart disease through industry partnerships and internal programs • Collaborate with leading companies and MD’s globally to bring new products to market • Product development/commercial manufacturing facilities located in Vancouver, Canada • Approximately ~150 employees –(~100 Production, ~35 R&D,~15 Support) 3
Product Overview – Three Lines 1. Tissue, Development and Manufacturing (TD&M) Business • Work with industry customers to develop, supply and manufacture products incorporating our proprietary biological tissue • Funds Neovasc infrastructure and generates cash to support internal development programs 4
Product Overview – Three Lines 2. Tiara™ Transcatheter Mitral Valve •First human implant-January 2014 •Recognized as a leading program 3. Reducer™ Refractory Angina Device •CE Mark received •Controlled efficacy trial completed •Entering early commercialization 5
TD&M Business 6
TD&M Products – Biological Tissue • Proprietary process creates implantable tissue from animal pericardium that retains strength & physical characteristics of natural tissue • Used in implantable medical devices including transcatheter heart valves • 25+ year implant history, FDA-cleared, CE-marked, EDQM-certified 7
TD&M Business – Strategy Provide a turnkey service to customers developing medical devices incorporating pericardial tissue Support customers at all phases of their programs, from inception through to commercialization 8
TD&M Business – Tactics • Supply generic implantable tissue (non-sterile / sterile) Early Product • Supply custom tissue (species, shape, thickness, sterility etc.) Development • Provide R&D assistance in the development of devices & Support incorporating tissue • Fabricate initial prototypes for proof of concept testing • Fabricate R&D prototypes for design evaluation / validation (R&D lab, white room, or clean room) • Undertake product performance evaluation and testing (hydrodynamic performance, wear testing, etc.) • Manufacture controlled prototypes for pre-clinical evaluation (acute / chronic animal studies) • Provide sterilization services as needed (validated if required) • Pilot manufacture of devices for clinical study / regulatory • Support for transfer to commercial manufacture and related regulatory validations • Supply of commercial quality tissue or tissue subassemblies in Commercial commercial quantities Supply • Manufacture of finished sterile product in commercial quantities 9
TD&M Business – Results • Supports Neovasc infrastructure for cardiovascular device development and commercial manufacture • Generates funding for internal development programs • Solid revenue growth since 2008 (~50% annual) 14 12 10 8 6 Revenues (C$M) 4 2 0 2008 2009 2010 2011 2012 2013 10
Tiara™ – Transcatheter Mitral Valve 11
Tiara Mitral Valve Replacement • Tiara is a novel transcatheter valve for the treatment of functional Mitral Regurgitation (MR) • MR occurs when the valve that separates the atrium from the ventricle on the left side of the heart does not close properly allowing blood to flow back into the atrium during systole Mitral regurgitation Valve does not fully close 12
Tiara Market Opportunity Success of transcatheter aortic valves (TAVI) has positioned transcatheter mitral valve implantation (TMVI) as a major area of clinical/industry interest • ~4.1 million people suffer from MR in the US • ~50% of eligible patients at high risk for surgery • ~2% annual MV surgery rate EuroIntervention 2014;9:1133-1135 13
Tiara Key Features • Completely replaces the diseased valve • Design is specific to mitral anatomy • Anchors resist high dislodgment forces (systole) • Exerts minimal radial force on mitral annulus • Does not obstruct LVOT and preserves LV function • Quick and repeatable implantation procedure • Transapical delivery via 2” incision between ribs • No need for cardiac bypass 14
Tiara First Clinical Experience • January 2014 - First Human implant of Tiara conducted by internationally recognized team at St. Paul’s Hospital, Vancouver, Canada • Initial procedures completed under compassionate use (Health Canada) regulatory approvals 15
Tiara First Clinical Results • Excellent acute results from first two cases, with no procedural complications • Less than 20 min required to enter heart through apex and implant valve • Complete resolution of MR with trivial or no PVL • Detailed results presented at EuroPCR in May 2014 16
Tiara – Next Steps • Prepare regulatory applications for feasibility studies • Initiate multicenter feasibility study in Canada / EU • Investigate inclusion of US sites under US FDA Early Feasibility Study program • Expand size matrix • Upon positive feasibility studies, initiate CE mark study in 2015 17
Reducer™ – Refractory Angina Therapy 18
Reducer Market – Refractory Angina Constant, severe heart pain caused by inadequate blood flow to areas of the heart muscle that cannot be managed through conventional therapy. • ~2,000,000 existing “no option” refractory angina patients in US & Europe • ~400,000 new “no option” patients/year diagnosed • ~1,000,000 patients/year treated for “recurrent” angina 19
Reducer Procedure • Reducer is implanted in the coronary sinus (large vein in heart) in 20 minute catheter-based procedure • Reducer’s hourglass shape modulates flow of blood in the heart to elevate CS pressure, increasing flow to ischemic areas in the endocardium Reducer modulates flow to elevate CS pressure 20
Reducer Mechanism of Action • Advanced disease creates areas of ischemic myocardium causing angina pain • Elevated CS pressure causes vessels to dilate, increasing blood flow to ischemic areas Elevated pressure in coronary sinus due to Reducer Improved blood flow to ischemic area Elevated CS pressure 21
Reducer COSIRA Study Double-blind, randomized, sham-controlled, multicenter prospective trial • N = 104 patients (in EU and Canada) • Patients randomized 1:1 to blinded treatment & sham control arms • Primary endpoint (achieved) was � 2 class reduction in CCS angina score at 6 months Full data set presented at ACC in March 2014 22
Reducer COSIRA Study Results Improvement of � 2 angina CCS classes (primary endpoint) occurred 2.3x more frequently in Reducer group (P =0.024) 6 months Baseline 87% 53% 81% 35% 31% 25% 21% 13% 13% 19% 9% 13% 0 0 0 0 CCS CCS CCS Class 1 CCS CCS Class 2 CCS Class 1 CCS Class 3 Class 2 CCS Class 4 Class 3 Class 4 Reducer Control 23
Reducer – Next Steps • Expand enrollment in European Registries • Initiate US IDE Study required for FDA approval • Introduce product into pilot centers in Europe • Explore partnerships for EU commercial launch 24
Recommend
More recommend
