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1 None Declaration of conflict of interest

2 New Long Term Circulatory Support Technology and Treatment Strategies Stephen Westaby Oxford, UK

3 Cardiac Transplantation: Facts from the UNOS Database Median survival 12.2 years Waiting list mortality 8-10% One year mortality 15% Ten year mortality 58% More than 20% transplanted die in <3 years For the 58% who die <10 years, mean survival is years Survival advantage only for UNOS Status I patients Kilic et al. Ann Thorac Surg 2012;93(3):

4 Cardiac Transplantation: Facts from the UNOS Database Predictors of transplant longevity: Age <55 years, white race and no metabolic risk factors. Young donor age and short ischemic time. Predictors of poor transplant outcome: BMI > 30 kg/m 2, diabetes, renal impairment, need for preoperative ventilation. Borderline donor heart. Kilic et al. Ann Thorac Surg 2012;93(3):

5 Survival with contemporary rotary blood pumps Jarvik Flowmaker PUMP 1 YEAR 2 YEAR LONGEST 87% 87% 7.5 years HeartMate II 85% 70% 7.2 years HeartWare HVAD 86% 78% 5.5 years INTERMACS Database % 70% HeartMate XVE % 33%

6 Preferred patient characteristics in regard to suitability for cardiac transplant or rotary blood pump Age INTERMACS profile UNOS Status Pulmonary vascular resistance BMI > 30kg/m 2 Type I Diabetes Renal Impairment (Creat >2.5 mg/dl) Right heart failure (CVP >20 mg Hg) Advanced vascular disease Previous malignancy Transplant <55 I I <2.5 Wood units Contraindication Contraindication Contraindication N/A Contraindication Contraindication LVAD < II <7.5 Wood units Acceptable Acceptable Acceptable Contraindication Acceptable Acceptable The treatments are complementary not competitive

7 Thoratec HeartMate II 281.3g (Pump body) 63 cc (Pump body) 7cc (Priming volume) Axial flow impeller with axial stator Radial flux gap motor in pump body Ceramic ball and cup bearings (both ends) 5L/min against 100 mm Hg at 12,000 rpm Survival to 7.2 years

8 HeartMate II Destination Therapy Trial Background Survival in Destination Therapy Trials 2 Initial HeartMate II Destination Therapy (DT) trial demonstrated significant improvements in outcomes compared to randomized patients with pulsatile LVADs 1 68% survival at 1 year 58% survival at 2 years Over 500 additional DT patients have been enrolled under continued access protocol (CAP) 1 Slaughter MS, Rogers JG, Milano CA et al: Advanced heart failure treated with continuous-flow left ventricular assist device. N Engl J Med Dec 3;361(23): Fang JC: Rise of Machines Left Ventricular Assist Devices as Permanent Therapy for Advanced Heart Failure N Engl J Med Dec 3;361(23): Park, S, et al Circ Heart Fail 2012.

9 HeartMate II Destination Therapy Trial Continued Access Protocol Conclusions Trend towards improving survival Fewer deaths from hemorrhagic stroke What is the magnitude of absolute survival benefit with LVAD DT therapy? Significant reductions in adverse events: Hemorrhagic stroke >50% reduction Device related infections >35% reduction Sepsis >25% reduction Both QoL measures (KCCQ and MLWHF) demonstrated significant improvement over baseline values Source: Park SJ, AHA 2010

10 Percent Survival 100 HeartMate II Improving Destination Therapy Outcomes Two Center (Advocate Christ-Duke) Results Late Experience June April 2009 (n=55) Overall Experience March April 2009 (n=93) Early experience March May 2007 (n=38) (Included in Slaughter, Rogers, Milano et al NEJM 2009) Remaining at Risk: Slaughter, Milano, Blue et al ISHLT % % Months % %

Fully Implantable HeartMate II LVAS Game-Changing Program to Advance VAD Therapy and Patient Quality of Life WiTricity Partnership Single Implanted Component: Battery, Controller, Internal TETS Coil

as a magnetic field Magnetic fields of the two coils couple tightly Enables high-efficiency, user-friendly wireless energy transfer across a distance Implanted components under development Focus on

11 Fully Implantable HeartMate II LVAS Game-Changing Program to Advance VAD Therapy and Patient Quality of Life WiTricity Partnership Single Implanted Component: Battery, Controller, Internal TETS Coil Initially configured with HeartMate II Proprietary resonant coils AC through power source coil induces a magnetic field Source coil s magnetic field induces current in the power capture coil, as well as a magnetic field Magnetic fields of the two coils couple tightly Enables high-efficiency, user-friendly wireless energy transfer across a distance Implanted components under development Focus on reduced size and reliability of electronics Advanced battery technology Custom cell technology tailored for implantable LVAD application Targeting untethered run times of ~3 hours; slow degradation for >3-year life Collaboration began in August 2010 Joint engineering team has demonstrated the ability to transfer power wirelessly to a HeartMate II LVAD Successfully started and ran the pump Currently working toward optimization of technology for incorporation into broader fully implantable HeartMate II program In development, not approved for clinical use

placement Program Status Primary Flow Paths Design freeze on pump, motor, controller Design verification and pre-clinical

12 HeartMate III Ultra-Compact, Fully Magnetically Levitated VAD Secondary Flow Paths (pum gaps) Features Full support (10L / min) in ultra-compact size Magnetic levitation Artificial Pulse Small Pocket Controller Improved, modular driveline Intrathoracic placement Program Status Primary Flow Paths Design freeze on pump, motor, controller Design verification and pre-clinical testing underway Initiate CE Mark Clinical trials mid 2013 and US trial before the end of 2013 In development, not approved for clinical use

13 Jarvik 2000 Flowmaker 90g (Pump body) 25cc (Pump body) Survival to 7.5 years Axial flow impeller with axial stator Radial flux gap motor in pump body Ceramic (Silicon Carbide) conical bearing, hybrid contact hydrodynamic bearing

14 Jarvik Flowmaker with skull pedestal power delivery

15 MicroMed HeartAssist 5 95g (Pump body) Axial flow impeller with axial stator Radial flux gap motor in pump body Ceramic (Silicon Carbide) ball and cup bearing, hybrid contact hydrodynamic bearing

16 Berlin Heart INCOR 200g (Pump body) 60cc (Pump body volume) Axial flow impeller with axial stator Radial flux gap motor in pump body Active magnetic bearings Survival to 6.5 years

17 HeartWare HVAD 145g 45cc Pump body volume Survival to 5.5 years Radial flow impeller with spiral volute Axial flux gap motor in volute housing Radial passive magnetic bearing; also provides axial bias Hydrodynamic bearing on upper surface

18 Observed Survival HVAD Survival vs. Projected Survival FDA Circulatory Systems Device Panel, April 25, % 83% 96% 71% % % % % HVAD- ADVANCE Trial SHFM Medical therapy % 20 0 HVAD Advance SHFM Medical Therapy HVAD- CAP BTT- Europe % Years

19 Biventricular support with rotary blood pumps Problems - Ability to balance systemic and pulmonary blood flow - Pump inflow position in the right ventricle

20 Biventricular support with two HeartWare VADs

21 HeartWare MVAD Axial flow impeller with spiral volute Radial flux gap[ motor in inlet cannula Axial passive magnetic bearing

body Full active magnetic levitation with

22 Terumo Duraheart 540g (Pump body) 196cc (pump body) Radial flow impeller with spiral volute Axial flux gap motor and magnetic levitation components in pump body Full active magnetic levitation with backup hydrodynamic bearing Survival to 4.5 years

23 Circulite Synergy 25g Pump body 1.9ml priming volume Mixed flow impeller with tangential radial outlet Radial flux gap motor in pump body Impeller uses ceramic ball and cup bearing with magnetic pre-load Motor is encapsulated within the pump body supported by a pair of ball race bearings at either end

Calon Cardio Technology MiniVad MiniVAD TM Radial

save space Impeller outside heart to improve efficiency

Pack & Console Strictly Confidential the contents of

Cardio-Technology Ltd and must not be communicated to

24 Calon Cardio Technology MiniVad MiniVAD TM Radial impellor with radial motor Motor in inlet cannula to save space Impeller outside heart to improve efficiency and reduce blood damage Anatomical fit Pump Battery Pack & Console Strictly Confidential the contents of this document are the intellectual property of Calon Cardio-Technology Ltd and must not be communicated to any third parties without the written consent of Calon Cardio-Technology Ltd

Reduced Size x Motor parts (red) y Impeller parts (blue) y x Motor parts (red) Impeller parts

Thoratec Heartmate II Axial flow impeller, Radial flux gap motor Large size (two body cavities

damage issues x y Motor parts (red) Impeller parts (blue) Calon MiniVAD Radial flow impeller,

25 Reduced Size x Motor parts (red) y Impeller parts (blue) y x Motor parts (red) Impeller parts (blue) Typical Axial Pump e.g. Thoratec Heartmate II Axial flow impeller, Radial flux gap motor Large size (two body cavities entered) Some blood damage issues Typical Radial Pump e.g. Heartware HVAD Radial flow impeller, Axial flux gap motor Large size outside of heart Some blood damage issues x y Motor parts (red) Impeller parts (blue) Calon MiniVAD Radial flow impeller, Radial flux gap motor VERY SMALL size outside of heart MINIMAL blood damage issues Strictly Confidential the contents of this document are the intellectual property of Calon Cardio-Technology Ltd and must not be communicated to any third parties without the written consent of Calon Cardio-Technology Ltd

26 The complete range of cardiac support Biventricular pacing, LVAD, defibrillator and stem cells

Myocardial Regeneration Therapy Cells and Assist Devices LVAD unloads the dilated LV and initially improves myocardial perfusion thus improving the environment for stem cell engraftment.

27 Myocardial Regeneration Therapy Cells and Assist Devices LVAD unloads the dilated LV and initially improves myocardial perfusion thus improving the environment for stem cell engraftment. Autologous bone marrow cells (CD105, CD34, CD133) exert predominantly paracrine effects to improve vascularity in hibernating myocardium and promote reverse remodelling. The effects are synergistic and improve native LV contractility. Improved contractility probably improves survival by reducing propensity for LV thrombus and thromboembolism.

Ventricular Assist Devices for Permanent Therapy: Current Status and Future

Ventricular Assist Devices for Permanent Therapy: Current Status and Future Prospects Francis D. Pagani MD PhD Professor of Cardiac Surgery University of Michigan April 28 th, 2012 Disclosures NHLBI and