Revolutionizing how advanced heart disease is treated. Alexei Marko, CEO Chris Clark, CFO November 2014

Transcription

1 Revolutionizing how advanced heart disease is treated Alexei Marko, CEO Chris Clark, CFO November 2014

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 and Canadian securities laws. 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: risks relating to regulatory requirements, including the inherent uncertainties of research and development, risks related to medical devices and clinical procedures, the Company s ability to comply with the conditions of the FDA s approval, the Company s ability to successfully receive any required local or institutional approvals, risks related to necessary enrollment of patients, the possibility of unfavorable or delayed clinical trial results, whether the FDA and other regulators will be satisfied with the results from the TIARA-I Early Feasibility Trial and further trials and studies that will be required; general economic and business conditions, both nationally and in the regions in which the Company operates; the merits and the Company s defence of the lawsuit filed by CardiAQ; our anticipated use of proceeds from any financings; a history of losses and lack of and uncertainty of revenues; ability to obtain required financing; 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. 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 except as otherwise required by applicable law. 2

3 Breakthrough products for refractory angina and mitral valve disease Collaborations with leading companies Commercial products and established revenues 3

4 3 product lines Targeting 3 significant markets Biologicial Tissue Proprietary biological tissue products for implantable medical devices Tiara Transcatheter mitral valve replacement Reducer Transcatheter device for refractory angina 4

5 Our Biological Tissue Business Working with industry leaders to improve patient care

6 Biological Tissue Proprietary process with 25+ year implant history Implantable tissue from animal pericardium Retains strength & physical characteristics of natural tissue Used in implantable medical devices including transcatheter heart valves 6

7 Biological Tissue Profitable and growing business Supports Neovasc infrastructure and internal development programs $ millions % cagr (Estimated) 7

8 Tiara Transcatheter Mitral Valve

9 Minimally invasive treatment for the most common form of valvular heart disease 9

10 Mitral Valve Regurgitation (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 Results in: shortness of breath fatigue arrhythmias fluid in lungs heart failure death 10

11 Tiara Addressable market opportunity Success of transcatheter aortic valves (TAVI) has positioned transcatheter mitral valve implantation (TMVI) as a major area of clinical/ industry interest ~4 million people suffer from MR in the US, similar population in EU ~40% have symptoms eligible for treatment ~50% of eligible patients are at high risk for surgery ~2% annual MV surgery rate EuroIntervention 2014;9:

12 Tiara A novel transcatheter Mitral Valve replacement COMPLETELY REPLACES THE DISEASED VALVE Design is specific to mitral anatomy Multiple anchors resist high dislodgment forces 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 12

13 Tiara January First Human implant of Tiara Conducted by internationally recognized team at St. Paul s Hospital, Vancouver, Canada EXCELLENT RESULTS FROM FIRST CASES No procedural complications Typically less than 20 min to enter heart through apex and implant valve Complete resolution of MR with trivial or no PVL Results presented at EuroPCR, TVT and TCT and published in JACC in

14 TIARA- I Multinational, multicenter early feasibility study in the US, Canada, EU Observational study of high-risk (operable) patients Co-Chairs of Study Committee: Dr. Martin Leon Dr. Anson Cheung Enroll up to 30 patients (~15 US, ~15 EU) Primary endpoints will be procedural success and 30-day outcomes, with additional follow-up at 3 months, 6 months, and annually thereafter Participating centers include: Columbia University Medical Center/New York-Presbyterian Hospital (New York) Lenox Hill Hospital (New York) Cedars-Sinai Medical Center (Los Angeles) St. Paul s Hospital (Vancouver) Antwerp Cardiovascular Center / ZNA Middelheim (Belgium) 14

15 Reducer Refractory Angina Therapy

16 Debilitating condition without treatment options 16

17 Refractory Angina Constant, severe chest pain ~2,000,000 refractory angina patients in each of US & EU ~10,000,000 patients/year treated for recurrent angina CAUSED BY INADEQUATE BLOOD FLOW TO AREAS OF THE HEART MUSCLE THAT CANNOT BE MANAGED THROUGH CONVENTIONAL THERAPY 17

18 Reducer 20 minute catheter-based procedure Implanted in the coronary sinus (large vein in heart) Hourglass shape modulates flow of blood in the heart to elevate CS pressure Re-distributing blood and increasing flow to ischemic areas in the endocardium Reducer modulates flow to elevate CS pressure 18

19 Reducer COSIRA study primary endpoint achieved 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 Improvement of 2 angina CCS classes (primary endpoint) occurred 2.3x more frequently in Reducer group (P =0.024) CCS is an established clinical indicator of pain and disability due to Angina Baseline 6 months 87% 81% Reducer 53% Control 31% 35% 21% 25% % 13% 13% 9% 13% CCS Class 1 CCS Class 2 CCS Class 3 CCS Class 4 CCS Class 1 CCS Class 2 CCS Class 3 CCS Class 4 19

20 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 full commercial launch 20

21 Financials Cash on hand to achieve milestones for 2014/2015 Completed C$25m financing March 2014, $6/share Current cash position ~$20m (no material debt) Listed on TSX and NASDAQ Neovasc has ~150 employees located at its facility in Vancouver, Canada and ~10 clinical and regulatory affairs employees at its Minneapolis, MN office 21

22 Looking forward Tiara Program Complete TIARA-I in 2015 Target to initiate CE mark trial in 2015 Target to initiate pivotal US trial in 2016 Reducer Program Initiate US FDA trial in 2015 Launch product in pilot sites (EU/ROW) in 2015 Tissue Business Continue to support infrastructure and development programs 22

23 Thank you Alexei Marko, CEO Chris Clark, CFO November 2014