Neovasc Inc. Alexei Marko, CEO Chris Clark, CFO June 2014 - - PowerPoint PPT Presentation

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)

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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

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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

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TD&M Business

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TD&M Products – Biological Tissue

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• 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

TD&M Business – Strategy

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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

TD&M Business – Tactics

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• Supply generic implantable tissue (non-sterile / sterile)
• Supply custom tissue (species, shape, thickness, sterility etc.)
• Provide R&D assistance in the development of devices

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 quantities

• Manufacture of finished sterile product in commercial quantities

Early Product Development & Support Commercial Supply

TD&M Business – Results

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• Supports Neovasc infrastructure for cardiovascular

device development and commercial manufacture

• Generates funding for internal development

programs

• Solid revenue growth since 2008 (~50% annual)

2 4 6 8 10 12 14 2008 2009 2010 2011 2012 2013

Revenues (C$M)

Tiara™ – Transcatheter Mitral Valve

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Tiara Mitral Valve Replacement

• Tiara is a novel transcatheter valve for the treatment
• f 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

12 Mitral regurgitation Valve does not fully close

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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

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

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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

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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

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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

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Reducer™ – Refractory Angina Therapy

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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

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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

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Reducer modulates flow to elevate CS pressure

Reducer Mechanism of Action

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Improved blood flow to ischemic area Elevated pressure in coronary sinus due to Reducer

Elevated CS pressure

• Advanced disease creates areas of ischemic

myocardium causing angina pain

• Elevated CS pressure causes vessels to dilate,

increasing blood flow to ischemic areas

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

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Improvement of 2 angina CCS classes (primary endpoint)

• ccurred 2.3x more frequently in Reducer group (P =0.024)

Reducer COSIRA Study Results

CCS Class 1 CCS Class 2 CCS Class 3 CCS Class 4

81% 19% 87% 13%

Baseline

CCS Class 1 CCS Class 2 CCS Class 3 CCS Class 4

31% 35% 25% 9% 13% 21% 53% 13%

Reducer Control

6 months 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

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Financials

• Completed C$25m financing March 2014, $6/share
• Current cash position ~$27m (no material debt)
• Cash on hand to achieve milestones for 2014/2015
• Listed on TSX Venture Exchange and NASDAQ

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Looking Forward

• 1. TD&M Business
• Continued revenue growth through 2014
• 2. Tiara Program
• Initiate FIM studies in second half of 2014
• Target to initiate CE mark trial in 2015
• 3. Reducer Program
• Initiate US FDA trial in 2014
• Launch product in pilot sites (EU/ROW) in 2015
• 4. New Projects
• Uniquely positioned to seize new opportunities

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Thank you