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U.S. Opportunities in Heart Failure Technologies

513 Pages | 167 Exhibits | Forecasts Through 2015
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Overview

Chronic heart failure (HF) remains a significant untapped market in the U.S. Although numerous innovative technologies have been investigated over the past 5 years, most have lacked the effectiveness to warrant broad adoption, or complex regulatory requirements-set against a tight capital environment-have delayed or slowed their commercialization. In addition, sophisticated ventricular assist devices and total artificial hearts target patients with advanced disease, who represent a small share of total patients. Only cardiac resynchronization therapy (CRT) has found broad acceptance, contributing 90% of revenues in 2009 based on its proven value for selected patients with systolic HF.

Unfortunately, only about 1 million of the 6 million HF patients in the U.S. are candidates for CRT therapy. About one-half of patients have diastolic disease, for which treatment largely relies on drug therapy, and patients with systolic disease who are not candidates for CRT therapy have few options for slowing their disease progression. Such patients account for a substantial share of the 4+ million annual hospitalizations for HF that tax the health delivery system. Thus, products designed to treat these underserved patients and keep them out of the hospital, such as hemodynamic monitoring implants, ultrafiltration technologies, and cell therapy, are expected to find a particularly warm reception from clinicians and payers alike. Coupled with continued growth in CRT therapy and realization of niche opportunities, the impact will be to create a chronic HF technologies market of $5 billion in 2015.

These are among some of the findings of a new, comprehensive report published by Health Research International-entitled "U.S. Opportunities in Heart Failure Technologies"-and distributed exclusively by Life Science Intelligence. This nearly 500-page report presents "must have" expert analysis of the epidemiology of chronic HF that is driving specific segments of the market, plus details on current and emerging therapeutic options. Each product market is modeled econometrically to make the report a working tool for companies purchasing it. Forecasts are provided through 2015, plus supplier shares for 2009. The econometric market models built from the demand side have been compared with supply-side data developed through detailed analyses of supplier financial reports and interviews. Among the products covered are: CRT devices, ventricular assist devices, total artificial hearts, implanted and external counterpulsation technologies, ultrafiltration systems, hemodynamic monitoring implants, neurostimulation technologies, cell and gene therapies, surgical ventricular restoration devices, and surgical cardiac support devices, among others. The report provides what we believe is the most comprehensive and accurate assessment of developments in U.S. chronic heart failure technologies and markets currently available.

Table of Contents

EXECUTIVE SUMMARY

Overview of Heart Failure Cardiac Resynchronization Therapy Ventricular Assist Devices Other Mechanical Circulatory Support Technologies. Ultrafiltration and Fluid Reduction Technologies Hemodynamic Monitoring Neuromodulation Cell and Gene Therapy Surgical Technologies Companies

Summary Exhibit 1: Device-Based Heart Failure Technologies, U.S. Market Forecast, 2008-2015 Summary Exhibit 2: Heart Failure Patients, U.S. Forecast by Total Prevalence and NYHA Functional Class, 2008-2015 Summary Exhibit 3: Cardiac Resynchronization Therapy, U.S. Market Forecast by Device Type, 2008-2015 Summary Exhibit 4: Ventricular Assist Devices, U.S. Market Forecast by Indication, 2008-2015 Summary Exhibit 5: Other Mechanical Circulatory Assist Technologies, U.S. Market Forecast by Type, 2008-2015 Summary Exhibit 6: Leading Suppliers to Heart Failure Market, 2009 1.0 HEART FAILURE OVERVIRE AND EPIDEMIOLOGY 1.1 The Heart As A Pump 1.2 Definition of Heart Failure 1.3 Types of Heart Failure 1.4 Pathophysiology of Heart Failure 1.4.1 Frank Starling Mechanism 1.4.2 Neurohormonal Activation 1.4.3 Cardiac Remodeling 1.4.4 Clinical Outcome 1.5 Clinical Manifestations of Heart Failure 1.6 Functional Classification of Heart Failure 1.7 Epidemiology of Heart Failure 1.7.1 Etiology 1.7.1.1 Coronary Artery Disease 1.7.1.2 Hypertension 1.7.1.3 Cardiomyopathy 1.7.1.3.1 Dilated Cardiomyopathy 1.7.1.3.2 Hypertrophic Cardiomyopathy 1.7.1.3.3 Restrictive Cardiomyopathy 1.7.1.4 Valvular Heart Disease 1.7.1.5 Diabetes 1.7.1.6 Atrial Fibrillation 1.7.1.7 Renal Insufficiency 1.7.1.8 Other Causes of Heart Failure 1.7.2 Risk Factors 1.7.3 Incidence & Prevalence 1.7.4 Mortality 1.7.5 Morbidity and Economic Impact 1.8 Diagnosis of Heart Failure 1.8.1 Scoring Systems 1.8.2 BNP Testing in Heart Failure 1.9 Treatment of Heart Failure 1.10 Target Populations by Therapy 1.10.1 Systolic versus Diastolic Heart Failure 1.10.2 Cardiac Resynchronization Therapy 1.10.3 Ventricular Assist Devices 1.10.4 Counterpulsation Implants 1.10.5 Heart Failure Surgery 1.10.6 Fluid Reduction (Renal Impairment) 1.10.7 Neurostimulation 1.10.8 Hemodynamic Monitoring 1.10.9 Central Sleep Apnea Exhibit 1-1: The Heart as a Pump Exhibit 1-2: Types of Heart Failure Exhibit 1-3: Pathophysiology of Intravascular Volume Homeostasis Exhibit 1-4: Comparison of Normal vs Enlarged Heart Exhibit 1-5: Effects of Neurohormonal Agents on Cardiac Remodeling Exhibit 1-6: Compensatory Mechanisms in Heart Failure Exhibit 1-7: Adverse Effects of Compensatory Mechanisms in Heart Failure Exhibit 1-8: Common Symptoms of Heart Failure Exhibit 1-9: NYHA Functional Classification of Heart Failure Exhibit 1-10: ACC/AHA Classification of Heart Failure Exhibit 1-11: Life Cycle of Heart Failure Using ACC/AHA Classification System Exhibit 1-12: Major Epidemiological Studies of Heart Failure in the U.S. Exhibit 1-13: Major Conditions Contributing to Development of Heart Failure Exhibit 1-14: Etiology of Heart Failure Exhibit 1-15: Demographics and Concomitant Diseases Associated with Acute Heart Failure Syndromes in Three Registries Exhibit 1-16: Relative Risk Factors for Development of Heart Failure Exhibit 1-17: Incidence and Prevalence of Heart Failure in U.S. Exhibit 1-18: Summary of U.S. Heart Failure Epidemiology Exhibit 1-19: U.S. Heart Failure Patient Forecast by Age and Gender, 2008-2015 Exhibit 1-20: Heart Failure Prevalence by NYHA Functional Classification, 2008-2015 Exhibit 1-21: Survival After Heart Failure in the Framingham Heart Study Exhibit 1-22: Trend in U.S. Hospital Discharges for Heart Failure, 2001-2006 Exhibit 1-23: Trend in Hospital Discharges for Heart Failure by Sex: 1979-2006 Exhibit 1-24: Estimated Direct and Indirect Costs of Heart Failure, 2010 Exhibit 1-25: Sensitivity, Specificity, and Predictive Value of Symptoms, Signs and Chest X-Ray Findings for the Presence of Heart Failure Exhibit 1-26: Scoring Systems for Heart Failure Diagnosis Exhibit 1-27: Comparison of Variables Utilized by Scoring Systems for Heart Failure Diagnosis Exhibit 1-28: ACC/AHA Guidelines for Heart Failure Treatment Exhibit 1-29: Comparison of Diastolic and Systolic Heart Failure Exhibit 1-30: Mortality of Diastolic versus Systolic Heart Failure in Selected Studies Exhibit 1-31: Prevalence of Diastolic Heart Failure in Selected Clinical Studies Exhibit 1-32: Selected Studies Estimating Heart Failure Patients with Depressed Ejection Fraction Exhibit 1-33: Heart Failure Patients with Depressed Left Ventricular Ejection Fraction and Wide QRS Complex Exhibit 1-34: Prevalence of Left Bundle Branch Block in Selected Clinical Studies Exhibit 1-35: U.S. Heart Transplant Waiting List Additions, 2000-2010 Exhibit 1-36: Estimated NYHA Class III/IV Heart Failure Patients Refractory to Optimal Medical Therapy, 2008-2015 Exhibit 1-37: Estimated Heart Failure Candidates for Fluid Reduction Therapy, 2008-2015 Exhibit 1-38: Selected Epidemiologic Studies of Central Sleep Apnea in Heart Failure Exhibit 1-39: Heart Failure Patients with Central Sleep Apnea, 2008-2015 2.0 RHYTHM MANAGEMENT IN HEART FAILURE 2.1 Cardiac Electrophysiology 2.1.1 Measuring the Heart's Electrical Activity 2.1.2 Pathophysiology of Abnormal Electrical Timing 2.2 Rhythm Management Strategies Targeting Heart Failure 2.2.1 Cardiac Resynchronization Therapy (CRT) 2.2.2 Defibrillation 2.2.3 Triventricular Pacing 2.3 Technologies 2.3.1 Description and Implantation 2.3.2 Clinical Experience 2.3.2.1 COMPANION Trial 2.3.2.2 MADIT-CRT 2.3.3 Indications 2.3.4 Issues 2.3.5 Products and Suppliers 2.3.5.1 Boston Scientific 2.3.5.2 Biotronik 2.3.5.3 EBR Systems 2.3.5.4 Medtronic 2.3.5.5 St. Jude Medical 2.3.5.6 Sorin/ELA Medical 2.4 Addressable CRT Patient Population 2.5 Procedure Forecast 2.6 Market Analysis Exhibit 2-1: Electric Conduction System of the Heart Exhibit 2-2: Rhythm Management Approaches to Heart Failure Exhibit 2-3: Lead Positions for Biventricular Pacing Exhibit 2-4: COMPANION Trial: 12 Month Outcomes Exhibit 2-5: MADIT-CRT Trial: Selected Outcomes Exhibit 2-6: Selected CRT Devices, 2010 Exhibit 2-7: Potential U.S. Patient Population for CRT, 2008-2015 Exhibit 2-8: U.S. Procedure and Market Forecast for CRT, 2008-2015 Exhibit 2-9: CRT Supplier Shares, 2009 3.0 VENTRICULAR ASSIST DEVICES 3.1 VAD Types 3.1.1 Pump Placement 3.1.2 Pump/Flow Type 3.1.2.1 Pulsatile Flow 3.1.2.2 Continuous Flow 3.1.2.2.1 Axial 3.1.2.2.2 Centrifugal 3.1.3 Device Selection 3.2 VAD Indications 3.2.1 Bridge To Transplant 3.2.2 Bridge To Decision 3.2.3 Destination Therapy 3.2.4 Therapeutic Recovery 3.2.5 VAD Contraindications 3.3 Clinical Experience 3.4 Products and Suppliers 3.4.1 Berlin Heart 3.4.1.1 EXCOR 3.4.1.2 EXCOR Pediatric 3.4.1.3 Driver Consoles 3.4.1.4 INCOR 3.4.2 BiVACOR Pty Ltd 3.4.3 Calon Cardio-Technology 3.4.4 Cleveland Heart 3.4.4.1 SmartHeart LVAD 3.4.4.2 SmartHeart RVAD 3.4.5 CircuLite 3.4.6 Evaheart Medical USA 3.4.7 HeartWare International 3.4.7.1 System Description 3.4.7.2 Clinical Experience 3.4.7.3 Regulatory Status 3.4.7.4 Pipeline Developments 3.4.8 Jarvik Heart 3.4.9 Leviticus Cardio 3.4.10 MicroMed Cardiovascular 3.4.10.1 System Description 3.4.10.2 Regulatory Status 3.4.10.3 Clinical Experience 3.4.11 MiTiHeart 3.4.12 Terumo Heart 3.4.13 Thoratec 3.4.13.1 Thoratec VAD Systems 3.4.13.1.1 Thoratec PVAD 3.4.13.1.2 Thoratec IVAD 3.4.13.1.3 Driver Options 3.3.13.2 HeartMate LVAS 3.4.13.2.1 HeartMate XVE 3.4.13.2.2 HeartMate II 3.4.13.2.3 HeartMate III 3.4.14 Ventracor 3.4.15 WorldHeart 3.4.15.1 Novacor LVAS 3.4.15.2 Levacor VAD 3.4.15.3 PediaFlow VAD 3.4.15.4 MiVAD 3.5 Reimbursement 3.6 Market Analysis 3.6.1 Procedure Forecast 3.6.1.1 Bridge To Transplant 3.6.1.2 Destination Therapy 3.6.1.3 Future Considerations 3.6.2 Market Analysis 3.6.2.1 Bridge to Transplant 3.6.2.2 Destination Therapy 3.6.3 Competitive Analysis Exhibit 3-1: Overview of Mechanical Circulatory Assist Options Exhibit 3-2: Types of Ventricular Assist Devices Exhibit 3-3: Overview of VAD Indications Exhibit 3-4: Selected Clinical Outcomes of Therapeutic Recovery Exhibit 3-5: Considerations for VAD Patient Selection Exhibit 3-6: Selected External VAD Products and Suppliers, 2010 Exhibit 3-7: Selected Implantable VAD Products and Suppliers, 2010 Exhibit 3-8: Berlin Heart's VAD Products Exhibit 3-9: BiVACOR BV Assist Exhibit 3-10: SmartHeart VADs Exhibit 3-11: CircuLite's Synergy Pocket Micro-Pump Exhibit 3-12: Evaheart Left Ventricular Assist System Exhibit 3-13: HeartWare Ventricular Assist System Exhibit 3-14: HeartWare's Miniaturized Ventricular Assist Device (MVAD) Exhibit 3-15: Jarvik Heart's Jarvik 2000 Flowmaker Exhibit 3-16: MicroMed Technology's HeartAssist 5 Exhibit 3-17: MiTiHeart LVAD Exhibit 3-18: Terumo's DuraHeart LVAS Exhibit 3-19: The Thoratec VAD System Exhibit 3-20: Thoratec's HeartMate Product Line Exhibit 3-21: Ventracor's VentrAssist LVAS Exhibit 3-22: WorldHeart's Levacor VAD Exhibit 3-23: WorldHeart's PediaFlow Pediatric VAD Exhibit 3-24: WorldHeart's MiVAD Exhibit 3-25: The History of VAD Medicare Reimbursement Exhibit 3-26: VAD-Related CPT Codes & Physician Payments Exhibit 3-27: U.S. Procedure Forecast for Ventricular Assist Devices, 2008-2015 Exhibit 3-28: U.S. Market for Ventricular Assist Devices, 2008-2015 Exhibit 3-29: U.S. Market for Ventricular Assist Devices by Type, 2009 & 2015 Exhibit 3-30: U.S. Supplier Shares for Ventricular Assist Devices, 2009 Exhibit 3-31: Implantable VAD Supplier Shares, 2009 Exhibit 3-32: External VAD Supplier Shares, 2009 4.0 OTHER MECHANICAL CIRCULATORY ASSIST TECHNOLOGIES 4.1 Total Artificial Hearts 4.1.1 History 4.1.2 Indications 4.1.3 Products and Suppliers 4.1.3.1 Abiomed 4.1.3.1.1 Device Description 4.1.3.1.2 Clinical Experience 4.1.3.1.3 Regulatory Status 4.1.3.1.4 AbioCor II 4.1.3.2 CARMAT 4.1.3.3 SynCardia Systems 4.1.3.3.1 Device Description 4.1.3.3.2 Driver Options 4.1.3.3.3 Clinical Experience 4.1.3.3.4 Regulatory Status 4.1.3.3.5 Pricing/Distribution 4.1.3.3.6 Pipeline Developments 4.1.4 Patient and Market Forecast 4.2 Counterpulsation Technologies 4.2.1 Counterpulsating Cardiac Assist Implants 4.2.1.1 Intra-Aortic Ventricular Assist Device (CardioPlus) 4.2.1.2 Extra-Aortic Counterpulsation Implants 4.2.1.2.1 Cardiak Ltd. 4.2.1.2.2 QHeart Inc./BioQ Devices Pty Ltd. 4.2.1.2.3 SCR Inc. 4.2.1.2.4 Sunshine Heart 4.2.1.3 Procedure and Market Forecast 4.2.2 External Counterpulsation Technologies 4.2.2.1 Traditional External Counterpulsation 4.2.2.1.1 Indications and Contraindications 4.2.2.1.2 Product Description 4.2.2.1.3 Clinical Experience 4.2.2.1.4 Mechanisms of Action 4.2.2.1.5 Patient Selection 4.2.2.1.6 Reimbursement 4.2.2.1.7 Products and Suppliers 4.2.2.2 Muscular Counterpulsation (Cardiola Ltd.) 4.2.2.2.1 m.pulse System 4.2.2.2.2 Clinical Experience 4.2.2.2.3 Company Background
4.2.2.3 Patient and Market Forecast 4.2.2.4 Supplier Shares Exhibit 4-1: Overview of Other Mechanical Cardiac Assist Technologies Exhibit 4-2: Selected Total Artificial Heart Products and Programs, 2010 Exhibit 4-3: Abiomed's AbioCor Implantable Replacement Heart Exhibit 4-4: CARMAT Total Artificial Heart Exhibit 4-5: SynCardia temporary Total Artificial Heart Exhibit 4-6: Selected Clinical Outcomes of the SynCardia Temporary Total Artificial Heart Exhibit 4-7: U.S. Procedure and Market Forecast for TAHs, 2008-2015 Exhibit 4-8: Selected Counterpulsating Ventricular Assist Technologies, 2010 Exhibit 4-9: Kantrowitz CardioPlus Counterpulsating Ventricular Assist Device Exhibit 4-10: Cardiak AK-Pulsator Exhibit 4-11: QHeart BioQ Cardiac Assist System Exhibit 4-12: SCR Counterpulsation Device Exhibit 4-13: Sunshine Heart C-Pulse Counterpulsation Technology Exhibit 4-14: Counterpulsating CardiacAssist Devices, Patient and Market Forecast 2012-2015 Exhibit 4-15: Schematic of External Counterpulsation Exhibit 4-16: Indications and Contraindications for ECP Exhibit 4-17: External Counterpulsation Therapy Systems Exhibit 4-18: PEECH Trial Results Exhibit 4-19: Potential Mechanisms for Clinical Effectiveness of ECP Exhibit 4-20: Selected External Counterpulsation Systems, 2010 Exhibit 4-21: Cardiola m.pulse System Exhibit 4-22: External Counterpulsation, Patient and Market Forecast, 2008-2015 5.0 HEART FAILURE SURGERY 5.1 Cardiac Transplantation 5.1.1 Transplant Statistics 5.1.2 Transplant Forecast 5.2 Dynamic Cardiomyoplasty 5.2.1 Major Limitation and Potential Solutions 5.2.2 ACC/AHA Guidelines and Clinical Prospects 5.2.3 Products and Suppliers 5.3 Left Ventricular Volume Reduction 5.3.1 Partial Left Ventriculectomy 5.3.1.1 Procedure and Indications 5.3.1.2 Clinical Experience 5.3.1.3 Procedure Volume 5.3.2 Radiofrequency Reduction (CoRepair, Inc.) 5.4 Surgical Ventricular Reconstruction and Restoration 5.4.1 Ventricular Reconstruction Techniques 5.4.2 Indications 5.4.3 SVR Technologies 5.4.3.1 BioVentrix (CHF Technologies) 5.4.3.2 CardioPolymers Inc./Lone Star Heart Inc. 5.4.3.3 Chase Medical 5.4.3.4 COR Innovations 5.4.3.5 CorRestore LLC 5.4.4 Clinical Experience with SVR 5.4.4.1 STICH Trial Results 5.4.4.2 STICH Trial Critique 5.4.5 Reimbursement 5.4.6 Procedure Trend 5.4.7 Market Analysis 5.5 Global Surgical Ventricular Reduction and Restoration 5.6 Minimally Invasive Stand-Alone Surgical Cardiac Support 5.6.1 Products 5.6.1.1 Acorn Cardiovascular 5.6.1.2 CardioKinetix 5.6.1.3 CorAssist Cardiovascular Ltd. 5.6.1.4 CorInnova 5.6.1.5 Paracor Medical 5.6.2 Procedure and Market Forecast 5.7 Cardiac Compression Exhibit 5-1: Current and Emerging Surgical Approaches to Heart Failure, 2010 Exhibit 5-2: Indications for Cardiac Transplantation Exhibit 5-3: Trend in Cardiac Transplants in U.S., 1988-2010 Exhibit 5-4: Transplants by Patient Characteristics, 1990, 2000, 2005 and 2010 Exhibit 5-5: Heart Transplant Waiting List, 2010 Exhibit 5-6: Selected Surgical Ventricular Restoration Systems, 2010 Exhibit 5-7: BioVentrix' Epicardial Left Ventricular Restoration Procedure Exhibit 5-8: CardioPolymers' Algisyl-LVR Implant and Delivery Exhibit 5-9: Chase Medical TR3ISVR System Exhibit 5-10: TR3ISVR Procedure Exhibit 5-11: CorRestore Patch Implant Exhibit 5-12: Major Criticisms of STICH Trial Exhibit 5-13: SVR, Procedure and Market Forecast, 2008-2015 Exhibit 5-14: Selected Minimally Invasive Surgical Cardiac Support Devices, 2010 Exhibit 5-15: Acorn Cardiovascular CorCap and Gen 2 CorCap Devices Exhibit 5-16: CardioKinetix' Parachute Implant and Procedure Exhibit 5-17: CorAssist ImCardia Extraventricular Device Exhibit 5-18: CorInnova CardiacSTAR Device Exhibit 5-19: Paracor Medical HeartNet Ventricular Support System Exhibit 5-20: Minimally Invasive Surgical Cardiac Support, Procedure & Market Forecast, 2013-2015 6.0 OTHER HEART FAILURE TECHNOLOGIES 6.1 Device-Based Fluid Reduction Strategies 6.1.1 Potential Risks of Chronic Diuretic Therapy 6.1.2 Technologies and Suppliers 6.1.2.1 Ultrafiltration/Aquapheresis 6.1.2.1.1 CHF Solutions 6.1.2.1.2 National Quality Care 6.1.2.2 Active Renal Infusion 6.1.2.2.1 Products and Suppliers 6.1.2.2.2 Potential Application to Heart Failure 6.1.2.3 Automated Low Flow Ascites Therapy (NovaShunt AG) 6.1.2.4 Transseptal Shunt (Atria Medical) 6.1.3 Patient and Market Forecast 6.2 Neurostimulation 6.2.1 Technologies Targeting Heart Failure 6.2.1.1 BioControl Medical 6.2.1.2 Cardiac Concepts 6.2.1.3 CVRx 6.2.1.4 Impulse Dynamics 6.2.1.5 Medtronic 6.2.1.6 Nephera 6.2.2 Market Analysis 6.3 Hemodynamic Monitoring 6.3.1 Rationale 6.3.2 Technology 6.3.3 Products and Suppliers 6.3.3.1 Boston Scientific Corporation/Remon Medical Technologies 6.3.3.2 CardioMEMS 6.3.3.3 Endotronix 6.3.3.4 Integrated Sensing Systems 6.3.3.5 Medtronic 6.3.3.6 St. Jude Medical 6.3.3.7 Vital Sensors 6.3.4 Patient and Market Forecast Exhibit 6-1: Other Device-Based Heart Failure Technologies, 2010 Exhibit 6-2: Selected Device-Based Fluid Reduction Technologies, 2010 Exhibit 6-3: CHF Solutions' Aquadex FlexFlow System Exhibit 6-4: Selected Results: UNLOAD Study Exhibit 6-5: National Quality Care Wearable Ultrafiltration System Exhibit 6-6: Active Renal Infusion Therapy Exhibit 6-7: NovaShunt AG Automated Fluid Shunt Pump Exhibit 6-8: Device-Based Fluid Reduction, Market Forecast, 2002-2008 Exhibit 6-9: Selected Neurostimulation Programs Targeting Heart Failure, 2010 Exhibit 6-10: BioControl Medical's CardioFit System Exhibit 6-11: Cardiac Concepts' RespiCardia System Exhibit 6-12: CVRx Rheos System Exhibit 6-13: Impulse Dynamic's Optimizer III System Exhibit 6-14: Timelines of Heart Failure Pressure Monitoring Prophylaxis Exhibit 6-15: Selected Hemodynamic Monitoring Implants, 2010 Exhibit 6-16: Boston Scientific's RemonCHF System Exhibit 6-17: CardioMEMS' Champion Heart Failure Pressure Management System Exhibit 6-18: Integrated Sensing Systems' Wireless Left Atrial Pressure Monitoring System Exhibit 6-19: Medtronic Chronicle Hemodynamic Monitoring Technology Exhibit 6-20: St. Jude HeartPOD Technology Exhibit 6-21: Heart Failure Hemodynamic Monitoring, Patient Forecast, 2008-2015 Exhibit 6-22: Heart Failure Hemodynamic Monitoring, Market Forecast, 2008-2015 7.0 CELL AND GENE THERAPY 7.1 Cell Transplantation Therapy 7.1.1 Approaches and Cell Types 7.1.1.1 Skeletal Myoblasts 7.1.1.1.1 Clinical Experience 7.1.1.1.2 Benefits and Limitations 7.1.1.1.3 Conclusions 7.1.1.2 Stem Cells 7.1.1.2.1 Challenges 7.1.1.2.2 Bone Marrow Stem Cells 7.1.1.2.3 Circulating Blood Stem Cells 7.1.1.2.4 Combining Stem Cell Therapy with Other Approaches 7.1.1.2.5 Clinical Experience (STAR Heart Study) 7.1.1.2.6 Developments 7.1.1.3 Cardiovascular Progenitor Cells 7.1.1.3.1 Cell Sources 7.1.1.3.2 Clinical Experience 7.1.1.3.3 Conclusions 7.1.2 Products and Suppliers 7.1.2.1 Advanced Cell Technology 7.1.2.2 Angioblast Systems, Inc. 7.1.2.3 BioCardia 7.1.2.4 Bioheart 7.1.2.5 Cell Transplants Singapore Pte. Ltd. 7.1.2.6 Juventas Therapeutics 7.1.2.7 MG Biotherapeutics LLC 7.1.2.8 RegenoCELL Therapeutics 7.1.2.9 TheraVitae Co. Ltd. 7.1.3 Addressable Market Opportunity 7.1.4 Procedure and Market Forecast 7.2 Gene Therapy 7.2.1 Molecular Targets 7.2.2 Vectors for Gene Delivery 7.2.3 Mechanisms of Cardiac Gene Delivery 7.2.4 Commercial Programs and Products 7.2.4.1 Celladon 7.2.4.1.1 MYDICAR 7.2.4.1.2 Clinical Experience (CUPID Trial) 7.2.4.2 NanoCor Therapeutics 7.2.5 Future Directions Exhibit 7-1: Comparison of Cell and Gene Therapy Approaches to Chronic Heart Failure Exhibit 7-2: Approaches to Heart Failure Cell Transplantation Exhibit 7-3: Selected Human Studies of Autologous Skeletal Myoblast-Based Cardiac Cell Transplantation Exhibit 7-4: Incidence of Arrhythmia in Autologous Skeletal Cell Transplantation Exhibit 7-5: Proposed Mechanisms of Action of Stem Cells in Cardiac Repair Exhibit 7-6: Delivery Approaches for Cardiac Cell Transplantation Therapy Exhibit 7-7: Incidence of Arrhythmias in Bone Marrow Stem Cell Transplantation Exhibit 7-8: Comparison of Major Types of Bone Marrow Stem Cells Targeting Cardiac Repair Exhibit 7-9: Selected Five-Year STAR Heart Study Outcomes Exhibit 7-10: Selected Trials of Stem Cell Transplantation for Chronic Heart Failure Exhibit 7-11: Selected Cell Based Therapies for Heart Failure, 2010 Exhibit 7-12: BioCardia Helical Biotherapeutic Catheter (Helix) Exhibit 7-13: Addressable Opportunity for Adjunctive Heart Failure Cell Therapy at Various Penetration and Pricing Levels, 2013 Exhibit 7-14: Heart Failure Cell Therapy, Procedure and Market Forecast, 2013-2015 Exhibit 7-15: Promising Gene Therapy Molecular Targets for Heart Failure Exhibit 7-16: Properties of Vector Systems for Gene Transfer Exhibit 7-17: Comparison of Cardiac Gene Transferring Approaches 8.0 COMPANY PROFILES 8.1 Advanced Cell Technology 8.2 Berlin Heart 8.3 Bioheart, Inc.
8.3 Boston Scientific Corporation 8.4 CHF Solutions/Gambro 8.5 HeartWare International 8.6 Medtronic 8.7 St. Jude Medical Inc. 8.8 SynCardia Systems Inc. 8.9 Thoratec Corporation 8.10 Vasomedical, Inc. 8.11 WorldHeart Corporation

Companies Covered

Advanced Cell Technology

Berlin Heart

Bioheart, Inc.

Boston Scientific Corporation

CHF Solutions/Gambro

HeartWare International

Medtronic

St. Jude Medical Inc.

SynCardia Systems Inc.

Thoratec Corporation

Vasomedical, Inc.

WorldHeart Corporation