Cardiac Assist Devices

Cardiac Assist Devices US Analysis and Market Forecasts GDME1024CFR / Published March 2013

Executive Summary Cardiac Assist Devices: Key Metrics in US Device Markets Congestive Heart Failure Prevalence, 2012 6.1m New Incidents per Year, 2012 0.8m End-Stage Congestive Heart Failure Prevalence, 2012 US Cardiac Assist Device Market Revenue, 2012 0.3m US $758m US Market Revenue by Device Type, 2012 Intra-Aortic Balloon Pumps $139m Total Artificial Hearts $20m Ventricular Assist Device Global Revenue $598m Extracorporeal Ventricular Assist Devices 5 Intracorporeal Ventricular Assist Devices 5 Total Artificial Hearts 2 Global Events Affecting the CAD Market (2012 2019) Approval of DuraHeart (Terumo) by US FDA Approval of EvaHeart (Sun Medical) by USA FDA Approval of HeartAssist 5 (MicroMed Cardio) by US FDA Approval of Synergy (Circulite) by US FDA Approval of C-Pulse (Sunshine Heart) by US FDA Forecast US Revenue by Device Type, 2019 Level of Impact Intra-Aortic Balloon Pumps $156m Ventricular Assist Devices $1,526m Total Artificial Hearts $68m Total Source: GlobalData $1,750m The Cardiac Assist Device Market is Expected to Experience Significant Growth Through 2019 The Cardiac Assist Device (CAD) market, including Intra- Aortic Balloon Pumps (IABP), Ventricular Assist Devices (VAD), and Total Artificial Hearts (TAH), is expected to experience significant growth during the seven-year forecast period. GlobalData estimates the US market in 2012 for IABP, VAD and TAH to be $139m, $598m, and $20m respectively. All together, the Cardiac Assist Device Market is expected to grow at a Compound Annual Growth Rate (CAGR) of 12.7% to surpass $1.7 billion by 2019. The World Health Organization estimates that approximately 800,000 incident cases of Congestive Heart Failure occur each year in the US. The prevalence of CHF in the western world, where it is highest, ranges from 1% 2% and the incidence of CHF approaches 5.1 cases per 1,000 person-years. Key Drivers during the Forecast Period: Growing congestive heart failure population and shortages of donor hearts for transplantation Extensive clinical studies and device miniaturizations leading to increased adoption Growing patient awareness and rising numbers of heart centers Key Barriers during the Forecast Period: High costs make treatment unaffordable Complications associated with use still prevalent Long R&D time deters new entrants from market Page 2 GDME1024CFR / Published MAR 2013

Executive Summary Companies Working to Get Their Devices Approved in the CAD Market The most significant driver of CAD development is the lack of suitable options for an increasingly large elderly CHF population; heart transplants per annum have been steady for decades, but the population with heart failure continues to grow. Additionally, as device safety improves, physicians will look to implant devices in lesssick patients, including NYHA Class IIIB and III patients, which will only further expand the potential CAD market. The most prohibitive factor to widespread CAD adoption has been the high cost of the devices, as well as complications associated with long-term use. As device prices fall and rates of complication decrease, the CAD market will experience significant growth. Significant Growth in Target Population Incidence of other diseases that cause heart failure is also growing, including hypertension, diabetes, obesity, and coronary artery disease. According to the World Health Organization, in 2010, globally over 600 million people suffered from hypertension, which is a major cause of heart failure. According to the International Diabetes Federation, an estimated 285 million people had diabetes in 2010, which is predicted to increase to 438 million people by 2030. Similarly the population for obesity is also increasing at a rapid rate. Lifestyle factors such as smoking and alcohol intake can also greatly increase the risk of CHF. CADs are expected to be a viable option for CHF even in patients with less-advanced but progressive heart failure. Extensive Clinical Studies to Increase Adoption In recent years, there has been increased emphasis on conducting clinical trials with larger patient cohorts in order to provide sufficient evidence to convince physicians and patients of the benefits of CAD, especially for long-term use. As clinical experience with CAD amasses, reimbursement improvements and physician adoption will drive significant device sales around the world. In coming years, large populations of CHF patients will require heart transplantation, but donor availability will lead to a shortage of transplants to treat these patients. With no other options, these patients will turn to CAD to aid or replace their failing heart. People today are increasingly aware of CHF and treatment options available, especially in developed countries, which has led to an increased use of diagnostic procedures and available treatment options for end-stage heart failure. Heightened patient awareness in regards to the progressive and fatal nature of CHF has also resulted in increased patient spending to treat the condition. With a rise in accessibility to healthcare, combined with a growing population of insured patients, the CAD market will experience growth in both developed and undeveloped global markets. Older and Younger Patients to Be Treated In the Future It is expected that in the coming years, physicians will have more options for treating both elderly patients and pediatrics. Especially for young patients, the waiting time for a heart transplant can be quite long, and CAD technology offers an alternative to inotropic support during the Bridge-To-Transplantation phase. As CADs become cheaper and easier to use, the adoption of these devices will surge. Page 3 GDME1024CFR / Published MAR 2013

Executive Summary Remaining Opportunities for New Entrants Physicians around the world believe that Transcutaneous Energy Transfer (TET) technology will be the next big advancement for CAD, and a way for companies to differentiate their product from competitors. The concept of TET has existed for quite some time; however, no devices have perfected the technology. While newer iterations of VAD and TAH address many problems with coagulation, size and efficacy, issues with driveline infection have been largely ignored since the technology s inception. In fact, the rate of driveline infection is as low as it has ever been, although good practices cannot fully eliminate this drawback. Only with fully implantable devices will the risk of infection drop. Reductions of Rehospitalization Rates CHF has the highest readmission rate of any diagnosticrelated group, and since the Affordable Care Act s Hospital Readmission Reduction Program incentivizes hospitals to ensure their CHF-related rehospitalization rates meet a defined benchmark, hospitals will be eager to adopt CAD technology that can reduce rates of rehospitalization. This provides an enormous market opportunity for CAD products with low rates of rehospitalization. As such, there is enormous pressure on CAD companies to meet these newly-established high standards. It is expected that in addition to product advancements, there will be a noticeable reduction in rehospitalization rates as new guidelines for patient selection are developed. Doctors are hopeful that rehospitalization rates will eventually decrease as a result of procedural improvements, better patient selection, and reductions in device failure rates. CAD Implantation in Less-Sick Patients The current treatment paradigm for CHF patients is limited to NYHA Class IV patients; few approved options exist that are approved for Class III patients besides optimal medical management. As companies look to expand their target market by treating younger and healthier patient cohorts, their devices will need to receive FDA approval for lower NYHA classes. Current trial data does not justify VAD implantation into Class III patients; published survival with a VAD is inferior to the survival expected with medical therapy for Class III CHF. However, for patients not facing imminent death, the functional benefits of CAD implantation could provide more compelling indications than survival alone. What do Physicians Think? Adoption is on the rise around the world: I m convinced that we will use many more cardiac assist devices than now; it will rise dramatically. OUS Key Opinion Leader, January 2013 Quality of life improvements are increasing cost effectiveness: Everyone s always complaining about the fact that these implantable devices are too expensive. And they are expensive, without a doubt. That makes it a little more difficult for physicians to really include all kinds of patients. However, if quality of life is increasing, cost effectiveness will as well. Even with the high costs of the devices these days [which will stay high], cost effectiveness will be coming down in future years. OUS Key Opinion Leader, January 2013 Page 4 GDME1024CFR / Published MAR 2013

Executive Summary TAH and VAD develop separate target populations: Developing nations are looking to use CAD, too: The problem and concern with TAH is that the procedure is not recoverable; the native heart is removed. Once you put in a TAH, you must go forward with the transplantation. With VAD [support], there is the hope that the patient could recover and improve their condition. OUS Key Opinion Leader, January 2013 Expanding indications will drive future device sales: In the future, we will see older patients, more permanent devices, also younger patients who are not eligible for high urgency status on the transplant list will receive devices. Put an assist device in the patient, and wait, and then if the patient stabilizes and is good, you can transplant them. If CAD costs were to decrease to the point where they could be used in India and other developing countries, and companies could still make a profit, there is a lot of opportunity. This is especially true if [a company] is interested in developing a product in the country [ ] if a company wants to do business with a country of large scale, the numbers game, then this is the place. OUS Key Opinion Leader, February 2013 Heart transplantation is increasingly not a suitable option: Heart transplantation is becoming increasingly obsolete, and assist devices are more and more [efficient]. OUS Key Opinion Leader, January 2013 OUS Key Opinion Leader, January 2013 Page 5 GDME1024CFR / Published MAR 2013

1 Table of Contents 1 Table of Contents... 6 1.1 List of Tables... 13 1.2 List of Figures... 19 2 Introduction... 20 2.1 Catalyst... 20 3 Disease Overview Congestive Heart Failure... 22 3.1 Anatomy and Physiology... 22 3.2 Pathophysiology... 22 3.3 Types of Heart Failure... 23 3.3.1 Classification by Progression... 23 3.3.2 Classification by Location... 24 3.3.3 Classification by Pumping Mechanism... 24 3.4 Etiology... 25 3.4.1 Conditions That Cause Heart Failure... 25 3.4.2 Other Risk Factors... 26 3.5 Clinical Presentation... 30 3.5.1 Symptoms of Heart Failure... 30 3.6 Diagnosis of Heart Failure... 31 3.6.1 Stages of Heart Failure Based on Diagnosis... 33 3.7 Epidemiology... 35 3.7.1 US... 35 3.8 Epidemiology Forecast (2012 2019)... 36 3.8.1 Prevalent Cases of Congestive Heart Failure... 36 3.9 Clinical Outcomes... 36 3.9.1 Prognosis... 36 3.9.2 Surgical Risk Stratification... 37 3.10 Treatment Modalities... 38 Page 6 GDME1024CFR / Published MAR 2013

3.10.1 Medication... 39 3.10.2 Surgery... 39 3.10.3 Cardiac Assistance... 40 3.10.4 Heart Transplantation... 43 3.11 Economic Impact... 44 3.11.1 Individual Costs... 44 3.11.2 Industry Costs... 45 4 Competitive Assessment... 46 4.1 Cardiac Assist Device Market, Comparison of Key Marketed Products... 46 4.2 Ventricular Assist Devices, Comparison based on Pump Technology... 49 4.3 Ventricular Assist Devices... 50 4.3.1 Overview... 50 4.3.2 First-Generation Devices... 51 4.3.3 Second-Generation Devices... 52 4.3.4 Third-Generation Devices... 52 4.3.5 Fourth-Generation Devices... 53 4.3.6 Fifth-Generation Devices... 53 4.3.7 Sixth-Generation Devices... 53 4.3.8 Seventh-Generation Devices... 53 4.3.9 Counterpulsation Devices... 53 4.3.10 Adult Primary Implant Breakdown... 54 4.3.11 Brand-Specific Training... 54 4.4 Extracorporeal Ventricular Assist Devices... 55 4.4.1 AB5000 (Abiomed, Inc.)... 55 4.4.2 CentriMag, PediMag (Thoratec)... 57 4.4.3 Delta-Stream DP3 Pump (Medos Medizintechnik AG)... 60 4.4.4 Excor (Berlin Heart)... 61 4.4.5 PVAD (Thoratec)... 63 Page 7 GDME1024CFR / Published MAR 2013

4.4.6 RotaFlow (Maquet Cardiovascular)... 65 4.5 Intracorporeal Ventricular Assist Devices... 67 4.5.1 DuraHeart (Terumo)... 68 4.5.2 EvaHeart (Sun Medical Technology Research Corporation)... 70 4.5.3 Heart Assist 5 (MicroMed Cardiovascular, Inc.)... 72 4.5.4 HeartMate II (Thoratec)... 74 4.5.5 HVAD (HeartWare)... 78 4.5.6 Incor (Berlin Heart)... 82 4.5.7 IVAD (Thoratec)... 84 4.5.8 Jarvik 2000 (Jarvik Heart)... 86 4.6 Percutaneous Ventricular Assist Devices... 89 4.6.1 Impella (Abiomed, Inc.)... 90 4.6.2 Synergy (CircuLite)... 93 4.6.3 TandemHeart (Cardiac Assist, Inc.)... 95 4.7 Intra-Aortic Balloon Pumps... 98 4.7.1 Overview... 98 4.7.2 AutoCAT 2 Wave (Teleflex)... 100 4.7.3 CardioSave (Maquet Cardiovascular)... 102 4.7.4 CS300 (Maquet Cardiovascular)... 104 4.7.5 ivac (PulseCath)... 106 4.7.6 Xemex (Zeon)... 107 4.8 Extra-Aortic Balloon Pumps... 108 4.8.1 C-Pulse (Sunshine Heart)... 110 4.9 Total Artificial Heart... 114 4.9.1 Overview... 114 4.9.2 AbioCor (Abiomed)... 115 4.9.3 SynCardia (SynCardia Systems, Inc.)... 117 4.10 Extracorporeal Membrane Oxygenation... 119 Page 8 GDME1024CFR / Published MAR 2013

5 Unmet Needs and Opportunities... 120 5.1 Unmet Needs... 121 5.1.1 Transcutaneous Energy Transfer to Reduce Risk of Infection and Improve Lifestyle... 121 5.1.2 Anti-Coagulation to Reduce Risk of Stroke... 123 5.1.3 Thromboresistant Coatings... 123 5.1.4 Noncontact Bearing Design... 124 5.2 Opportunities... 125 5.2.1 Reduction of Rehospitalization Rates... 125 5.2.2 NYHA Class III Patients... 127 5.2.3 Destination Therapy... 128 5.2.4 Pediatrics... 130 5.2.5 Hybrid Combination Therapy... 131 5.2.6 Mitral Valve Repair... 132 6 Pipeline Products... 133 6.1 Overview... 133 6.2 Ventricular Assist Devices... 134 6.2.1 CorAide, DexAide (Teleflex)... 134 6.2.2 DuraHeart II (Terumo)... 136 6.2.3 HeartMate III (Thoratec)... 137 6.2.4 HeartMate X (Thoratec)... 138 6.2.5 MiFlow (HeartWare)... 139 6.2.6 MiTiHeart LVAD (Mohawk Innovative Technology, Inc.)... 140 6.2.7 MVAD (HeartWare)... 142 6.2.8 PediaFlow VAD (HeartWare)... 144 6.2.9 PediPump (Cleveland Clinic)... 145 6.2.10 Revolution (Vadovations, Inc.)... 146 6.2.11 s.pump (Medos Medizintechnik AG)... 147 6.3 Percutaneous Ventricular Assist Devices... 148 Page 9 GDME1024CFR / Published MAR 2013

6.3.1 HeartMate PHP (Thoratec)... 148 6.3.2 Reitan Catheter Pump (CardioBridge GmbH)... 149 6.4 Total Artificial Hearts... 151 6.4.1 AbioCor II (Abiomed, Inc.)... 151 6.4.2 Carmat TAH (Carmat)... 152 6.4.3 Golding TAH (Cleveland Clinic)... 154 6.4.4 Beatless Heart (Texas Heart Institute)... 155 6.4.5 MagScrew (Cleveland Clinic)... 157 6.4.6 ReinHeart (University of Aachen)... 158 6.4.7 Other... 158 7 Current and Future Players... 159 7.1 Company Profiles... 159 7.1.1 Abiomed, Inc.... 159 7.1.2 Berlin Heart... 161 7.1.3 CardiacAssist, Inc.... 163 7.1.4 CardioBridge... 164 7.1.5 Carmat... 165 7.1.6 CircuLite... 166 7.1.7 HeartWare International, Inc.... 167 7.1.8 Jarvik Heart... 170 7.1.9 Maquet Cardiovascular... 172 7.1.10 Medos Medizintechnik AG... 173 7.1.11 MicroMed Cardiovascular, Inc.... 174 7.1.12 MiTiHeart Corporation... 176 7.1.13 PulseCath BV... 177 7.1.14 Sunshine Heart... 178 7.1.15 SynCardia Systems, Inc.... 180 7.1.16 Teleflex Medical... 182 Page 10 GDME1024CFR / Published MAR 2013

7.1.17 Terumo... 183 7.1.18 Thoratec... 185 7.1.19 Sun Medical... 190 7.1.20 Zeon Medical... 191 7.1.21 Other... 191 8 Market Drivers, Opportunities, and Barriers... 192 8.1 Market Drivers... 193 8.1.1 Increasing Heart Failure Population... 193 8.1.2 Technological Advancements, Miniaturizations, Leading to Increased Adoption by Physicians... 194 8.1.3 Extensive Clinical Studies to Improve Adoption... 194 8.1.4 Growing Patient Awareness and Increasing Numbers of Heart Centers... 195 8.1.5 Aging Population to Drive Growth in Cardiac Assist Devices Market... 196 8.2 Market Opportunities... 198 8.2.1 Highly Under-Penetrated Market to Provide Significant Opportunity... 198 8.2.2 Shortage of Donor Hearts for Transplantation Creates Opportunity... 198 8.3 Market Barriers... 199 8.3.1 Complications Associated with CAD... 199 8.3.2 High Cost Makes Treatment Unaffordable... 199 8.3.3 Alternative Therapies... 200 8.3.4 Medical Device Tax Affects Manufacturers... 200 8.3.5 Long Research and Development of Devices may Deter New Entrants into the Market... 201 8.3.6 Complications Associated with Cardiac Assist Devices might Deter Physicians from Adoption of Their Use... 201 8.4 Mergers and Acquisitions... 201 8.4.1 Potential Sunshine Acquisition... 201 9 Country Outlook and Forecasts... 202 9.1 US... 202 Page 11 GDME1024CFR / Published MAR 2013

9.1.1 Overview... 202 9.1.2 Reimbursement... 203 9.1.3 Affordable Care Act Rehospitalization Fees... 203 9.1.4 US CAD Market Revenue, 2010 2019... 204 10 Appendix... 206 10.1 Abbreviations... 206 10.2 Bibliography... 208 10.3 Methodology... 222 10.3.1 Forecasting... 222 10.3.2 Sources Used... 222 10.3.3 Forecast Assumptions and Methods... 223 10.4 Coverage... 225 10.5 Secondary Research... 225 10.6 Forecasting Methodology... 226 10.6.1 Pricing Assumptions... 226 10.7 Physicians and Specialists Included in this Study... 227 10.8 Primary Research... 228 10.9 About the Authors... 229 10.9.1 Analysts... 229 10.9.2 Global Head of Healthcare... 230 10.10 Definitions... 231 10.11 About GlobalData... 232 10.12 Contact Us... 232 10.13 Disclaimer... 232 Page 12 GDME1024CFR / Published MAR 2013

1.1 List of Tables Table 1: New York Heart Association Scale... 34 Table 2: American College of Cardiology Scale... 34 Table 3: Prevalent Cases of Congestive Heart Failure, All Markets, Ages 45 Years, Men and Women (n), 2012 2019... 36 Table 4: Device Strategy at Time of Implant in US, 2011... 41 Table 5: Cardiac Assist Devices by Launch... 46 Table 6: Cardiac Assist Devices by Type... 49 Table 7: Product Profile AB5000... 55 Table 8: AB5000 SWOT Analysis, 2012... 56 Table 9: Product Profile CentriMag, PediMag... 58 Table 10: CentriMag, PediMag SWOT Analysis, 2012... 59 Table 11: Product Profile Delta-Stream DP3 Pump... 60 Table 12: Delta-Stream DP3 SWOT Analysis, 2012... 60 Table 13: Product Profile Excor... 61 Table 14: Excor SWOT Analysis, 2012... 62 Table 15: Product Profile PVAD... 63 Table 16: PVAD SWOT Analysis, 2012... 64 Table 17: Product Profile RotaFlow... 65 Table 18: RotaFlow SWOT Analysis, 2012... 66 Table 19: Product Profile DuraHeart... 68 Table 20: DuraHeart SWOT Analysis, 2012... 69 Table 21: Product Profile EvaHeart... 70 Table 22: EvaHeart SWOT Analysis, 2012... 71 Table 23: EvaHeart US Pivotal BTT Trial... 71 Table 24: Product Profile HeartAssist 5... 73 Table 25: HeartAssist 5 SWOT Analysis, 2012... 73 Table 26: Product Profile HeartMate II... 74 Table 27: HeartMate II SWOT Analysis, 2012... 75 Page 13 GDME1024CFR / Published MAR 2013

Table 28: REVIVE-IT... 76 Table 29: ROADMAP... 76 Table 30: REMATCH... 77 Table 31: Product Profile HVAD... 78 Table 32: HVAD SWOT Analysis, 2012... 79 Table 33: ENDURANCE... 80 Table 34: ADVANCE... 81 Table 35: Product Profile Incor... 82 Table 36: Incor SWOT Analysis, 2012... 83 Table 37: Product Profile IVAD... 84 Table 38: IVAD SWOT Analysis, 2012... 85 Table 39: Product Profile Jarvik 2000... 86 Table 40: Jarvik 2000 SWOT Analysis, 2012... 87 Table 41: Jarvik 2000 US Pivotal DT Trial... 88 Table 42: Product Profile Impella... 91 Table 43: Impella SWOT Analysis, 2012... 92 Table 44: Product Profile Synergy... 93 Table 45: Synergy SWOT Analysis, 2012... 94 Table 46: Synergy CE Mark EU Trial... 94 Table 47: Product Profile TandemHeart... 95 Table 48: TandemHeart SWOT Analysis, 2012... 96 Table 49: TandemHeart to Reduce Infarct Size (TRIS)... 97 Table 50: Product Profile AutoCAT 2 Wave... 100 Table 51: AutoCAT 2 SWOT Analysis, 2012... 101 Table 52: Product Profile CardioSave... 102 Table 53: CardioSave SWOT Analysis, 2012... 103 Table 54: Product Profile CS300... 104 Table 55: CS300 SWOT Analysis, 2012... 105 Page 14 GDME1024CFR / Published MAR 2013

Table 56: Product Profile ivac... 106 Table 57: ivac SWOT Analysis, 2012... 106 Table 58: Product Profile Xemex... 107 Table 59: Xemex SWOT Analysis, 2012... 107 Table 60: Comparing Leading CAD Products... 109 Table 61: Product Profile C-Pulse... 110 Table 62: C-Pulse SWOT Analysis, 2012... 112 Table 63: C-Pulse US Pivotal Trial... 113 Table 64: Product Profile AbioCor... 115 Table 65: AbioCor SWOT Analysis, 2012... 116 Table 66: Product Profile SynCardia... 118 Table 67: SynCardia SWOT Analysis, 2012... 119 Table 68: Risk Prediction Models... 126 Table 69: Cardiac Assist Devices in Pipeline... 133 Table 70: Product Profile CorAide, DexAide... 134 Table 71: CorAide, DexAide SWOT Analysis, 2012... 135 Table 72: Product Profile DuraHeart II... 136 Table 73: DuraHeart II SWOT Analysis, 2012... 136 Table 74: Product Profile HeartMate III... 137 Table 75: HeartMate III SWOT Analysis, 2012... 137 Table 76: Product Profile HeartMate X... 138 Table 77: HeartMate X SWOT Analysis, 2012... 138 Table 78: Product Profile MiFlow... 139 Table 79: MiFlow SWOT Analysis, 2012... 139 Table 80: Product Profile MiTiHeart Corporation... 140 Table 81: MiTiHeart SWOT Analysis, 2012... 141 Table 82: Product Profile MVAD... 142 Table 83: MVAD SWOT Analysis, 2012... 143 Page 15 GDME1024CFR / Published MAR 2013

Table 84: Product Profile PediaFlow... 144 Table 85: PediaFlow SWOT Analysis, 2012... 144 Table 86: Product Profile PediPump... 145 Table 87: PediPump SWOT Analysis, 2012... 145 Table 88: Product Profile Revolution... 146 Table 89: Revolution SWOT Analysis, 2012... 146 Table 90: Product Profile s.pump... 147 Table 91: s.pump SWOT Analysis, 2012... 147 Table 92: Product Profile HeartMate PHP... 148 Table 93: HeartMate PHP SWOT Analysis, 2012... 148 Table 94: Product Profile Reitan Catheter Pump... 149 Table 95: Reitan Catheter Pump SWOT Analysis, 2012... 150 Table 96: Product Profile AbioCor II... 151 Table 97: AbioCor II SWOT Analysis, 2012... 151 Table 98: Product Profile Carmat... 152 Table 99: Carmat SWOT Analysis, 2012... 153 Table 100: Product Profile Golding TAH... 154 Table 101: Golding TAH SWOT Analysis, 2012... 154 Table 102: Product Profile Beatless Heart... 155 Table 103: Beatless Heart SWOT Analysis, 2012... 156 Table 104: Product Profile MagScrew... 157 Table 105: MagScrew SWOT Analysis, 2012... 157 Table 106: Product Profile ReinHeart... 158 Table 107: ReinHeart SWOT Analysis, 2012... 158 Table 108: Company Profile Abiomed, Inc.... 159 Table 109: Abiomed SWOT Analysis, 2012... 160 Table 110: Company Profile Berlin Heart... 161 Table 111: Berlin Heart SWOT Analysis, 2012... 162 Page 16 GDME1024CFR / Published MAR 2013

Table 112: Company Profile Cardiac Assist... 163 Table 113: Cardiac Assist SWOT Analysis, 2012... 163 Table 114: Company Profile - CardioBridge... 164 Table 115: CardioBridge SWOT Analysis, 2012... 164 Table 116: Company Profile - Carmat... 165 Table 117: Carmat SWOT Analysis, 2012... 165 Table 118: Company Profile - CircuLite... 166 Table 119: CircuLite SWOT Analysis, 2012... 166 Table 120: Company Profile HeartWare... 168 Table 121: HeartWare SWOT Analysis, 2012... 169 Table 122: Company Profile Jarvik Heart... 170 Table 123: Jarvik Heart SWOT Analysis, 2012... 171 Table 124: Company Profile Maquet Cardiovascular... 172 Table 125: Maquet Cardiovascular SWOT Analysis, 2012... 172 Table 126: Company Profile Medos Medizintechnik AG... 173 Table 127: Medos Medizintechnik AG SWOT Analysis, 2012... 173 Table 128: Company Profile MicroMed Cardiovascular, Inc.... 174 Table 129: MicroMed Cardiovascular SWOT Analysis, 2012... 175 Table 130: Company Profile MiTiHeart Corporation... 176 Table 131: MiTiHeart Corporation SWOT Analysis, 2012... 176 Table 132: Company Profile PulseCath... 177 Table 133: PulseCath SWOT Analysis, 2012... 177 Table 134: Company Profile Sunshine Heart... 178 Table 135: Sunshine Heart SWOT Analysis, 2012... 179 Table 136: Company Profile SynCardia Systems... 180 Table 137: SynCardia Systems SWOT Analysis, 2012... 181 Table 138: Company Profile - Teleflex... 182 Table 139: Teleflex SWOT Analysis, 2012... 182 Page 17 GDME1024CFR / Published MAR 2013

Table 140: Company Profile Terumo Heart... 183 Table 141: Terumo Heart SWOT Analysis, 2012... 184 Table 142: Company Profile Thoratec... 186 Table 143: Thoratec SWOT Analysis, 2012... 189 Table 144: Company Profile Sun Medical... 190 Table 145: Sun Medical SWOT Analysis, 2012... 190 Table 146: Company Profile Zeon Medical... 191 Table 147: Zeon Medical SWOT Analysis, 2012... 191 Table 148: Heart Failure, Prevalence (% total population, n [millions]), US, 2010 2019... 193 Table 149: Population Aged 65 Years and Above as Percentage of Overall Population, Global, 1960 2050... 196 Table 150: Cardiac Assist Devices, Average Selling Price ($),US, 2012... 200 Table 151: US CAD Revenue ($m), 2010 2019... 204 Table 152: Sources of Epidemiological Data Used for the Forecast... 222 Table 153: New York Heart Association (NYHA) Class Distributions Description... 224 Page 18 GDME1024CFR / Published MAR 2013

1.2 List of Figures Figure 1: Classifications of Heart Failure... 23 Figure 2: Stages of Heart Failure Based on Diagnosis... 33 Figure 3: Treatment Modalities for Heart Failure... 38 Figure 4: Cardiac Assist Devices, Market Dynamics... 192 Figure 5: Heart Failure, Prevalence (million), US, 2010 2019... 193 Figure 6: Population Aged 65 Years and Above as Percentage of Overall Population, Global, 1960 2050... 196 Figure 7: US CAD Revenue ($m), 2010 2019... 204 Figure 8: CAD Purchases vs. Heart Transplants, US (N), 2010 2019... 205 Page 19 GDME1024CFR / Published MAR 2013

Introduction 2 Introduction Cardiac Assist Devices (CAD) are mechanical pumps that work in conjunction with a patient s heart to improve the pumping efficiency, increase the cardiac output and restore normal blood circulation. The devices are typically employed in patients suffering from end-stage Congestive Heart Failure (CHF), where the chances of survival through oral medications alone become minimal. The scarcity of donor organs has led to the development of interim interventions that utilize CADs, which comprise three segments: Ventricular Assist Devices (VAD), Intra-Aortic Balloon Pumps (IABP), and Total Artificial Hearts (TAH). These mechanical pumps are typically used for short-term purposes, allowing the heart to rest long enough that it can recuperate and return to normal and independent function. This is especially helpful for treating postcardiotomy cardiogenic shock, as these devices can provide a Bridge-To- Transplantation (BTT) or Bridge-To-Recovery (BTR) option for patients with end-stage heart failure. CADs can also be used for long-term Destination Therapy (DT) treatments in patients who are not surgical candidates for transplant but have severe heart failure. As donor hearts can be extremely difficult to get, CADs offer an alternative option for patients with critical heart failure who are waiting to receive a donor heart. 2.1 Catalyst Significant limitations and unmet needs with heart transplantation have generated considerable, continued interest in the development of CADs that are capable of supporting patients with severe CHF, either until donor hearts become available or as an alternative to heart transplantation for long-term use. These CAD devices include Ventricular Assist Devices, Intra-Aortic Balloon Pumps, and Total Artificial Hearts. While heart transplantation remains the gold standard and preferred treatment option for patients with advanced Congestive Heart Failure (CHF), the number of transplant candidates far exceeds the donor pool. The International Society for Heart and Lung Transplantation Registry 2012 Report notes a worldwide continued decrease in the number of donor hearts available. Advanced CHF patients on inotropic support have a mortality rate of 50% at three months and 94% at one year; cardiac assist devices can support these end-stage patients with significantly better survival rates. Many heart failure patients are ineligible for transplant due to old age or comorbidities; approximately 50% of patients who need a transplant are disqualified due to age. Opportunistic infection, rejection, malignancy, and graft coronary artery disease continue to be limitations to heart transplantation. Page 20 GDME1024CFR / Published MAR 2013

Introduction It has been shown that implantation of a CAD earlier on during the CHF progression can significantly slow the worsening of the condition, and in some cases even reverse the process to improve patient condition. CADs can greatly improve organ function. Destination therapy or tandem therapy, with a CAD in combination with cell transplantation, genetic treatment, or drug therapy, may be an alternative option to circumvent the shortage of donor hearts worldwide. Page 21 GDME1024CFR / Published MAR 2013

Appendix 10.11 About GlobalData GlobalData is a leading global provider of business intelligence in the Healthcare industry. GlobalData provides its clients with up-to-date information and analysis on the latest developments in medical device research, disease analysis, and clinical research and development. Our integrated business intelligence solutions include a range of interactive online databases, analytical tools, reports and forecasts. Our analysis is supported by a 24/7 client support and analyst team. GlobalData has offices in New York, Boston, London, India and Singapore. 10.13 Disclaimer All Rights Reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of the publisher, GlobalData. Page 232 GDME1024CFR / Published MAR 2013