Revolutionizing how advanced heart disease is treated

Transcription

1 LEERINK Partners 5th Annual Healthcare Conference Revolutionizing how advanced heart disease is treated NASDAQ: NCVN, TSX: NVC Alexei Marko, CEO February 2016

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, plans, anticipates, intends, 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, estimates and assumptions made by management, 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 related to the potential market size for each of Tiara and Reducer, risks related to developing the 40 and 45 mm Tiara on time and on schedule, 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; 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. Should one or more of these risks, assumptions or uncertainties prove incorrect, actual results may differ materially from those described herein. 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 Commercial products and established revenues 3

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

5 Tiara Transcatheter Mitral Valve

6 Minimally invasive treatment for the most common form of valvular heart disease 6

7 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 M I T R A L R E G U RG I TAT I O N VA LV E D O E S N OT F U L LY C LO S E Results in: shortness of breath fatigue arrhythmias fluid in lungs heart failure death 7

8 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:

9 Tiara A novel transcatheter Mitral Valve replacement Fits anatomical shape of native valve Does not obstruct LVOT and preserves LV function Quick and repeatable transapical implantation procedure Simple delivery system with single thumbwheel to control deployment 35mm and 40mm size in clinical use 45mm size in preclinical testing 9

10 Tiara Excellent results from first cases First human implant conducted in 2014 by internationally recognized team at St. Paul s Hospital, Vancouver, Canada 11 patients implanted to date at 3 centers To date 30 day survival rate is 73% Treated patients with both functional and degenerative MR Patients now out to over 22 months with excellent results 10

11 TIARA- I Multinational, multicenter early feasibility study in the US, Canada, EU Observational study of high-risk (operable) patients Enroll up to 30 patients (~15 US, ~15 EU/CAN) Primary endpoints will be procedural success and 30-day outcomes, with additional follow-up at 3 months, 6 months, and annually thereafter 4 US centers, 3 Canadian Centers, 1 EU center Currently enrolling patients using 35mm and 40mm valve sizes 11

12 Tiara Next steps Continue to expand clinical program: Compassionate use cases Complete enrollment in TIARA-I CE Mark study Complete development and introduction of 45mm size Next generation refinements to device 12

13 Reducer Refractory Angina Therapy

14 Debilitating condition without treatment options 14

15 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 C AU S E D BY I N A D E Q UAT E B LO O D F LOW TO A R E A S O F T H E H E A RT M U S C L E T H AT C A N N OT B E M A N AG E D T H RO U G H CONVENTIONAL THERAPY 15

16 Reducer 20 minute catheter-based procedure Implanted in the coronary sinus (large vein in heart) Modulates flow of blood in the heart to elevate CS pressure Re-distributes blood to ischemic areas in the endocardium Reducer modulates flow to elevate CS pressure 16

17 Reducer Next steps Targeted launch in key European territories underway Expand enrollment in European Registries Initiate US IDE Study required for FDA approval 17

18 Looking forward Tiara Program Complete TIARA-I enrollment Initiate CE study in 2016 Expand portfolio with next generation and complementary products Reducer Program Gradual expansion of EU launch Begin US FDA trial in 2016 Tissue Business Continue to support infrastructure and development programs 18

19 LEERINK Partners 5th Annual Healthcare Conference Revolutionizing how advanced heart disease is treated NASDAQ: NCVN, TSX: NVC Alexei Marko, CEO February 2016