U.S. Opportunities in Acute Cardiac Assist Technologies

Companies Covered

Abiomed, Inc

Berlin Heart GmbH

Bioheart, Inc

Cytori Therapeutics, Inc

Getinge/Maquet Cardiovascular/Datascope

Osiris Therapeutics, Inc

Teleflex Medical/Arrow International

Thoratec Corporation

Table of Contents

EXECUTIVE SUMMARY

Technology

Epidemiology and Applications

Product Markets

Intra-Aortic Balloon Pumps

Percutaneous Ventricular Assist Devices

External Ventricular Assist Devices

Cell Therapies

Companies

Summary Exhibit 1: Comparison of Major Acute Cardiac Assist Devices

Summary Exhibit 2: Conditions and Situations Potentially Requiring Acute Cardiac Assist

Summary Exhibit 3: Penetration of Selected Applications for Acute Cardiac Assist Devices, 2008-2015

Summary Exhibit 4: Acute Cardiac Assist Devices, Market Forecast by Type, 2008-2015

Summary Exhibit 5: Potential Roll Out of Cell Therapy Market for AMI

Summary Exhibit 6: Suppliers of Acute Cardiac Assist Devices by Type, 2009

1.0 OVERVIEW AND EPIDEMIOLOGY

1.1 Revascularization

1.1.1 High Risk Percutaneous Coronary Intervention

1.1.2 High Risk Cardiac Surgery

1.1.2.1 Difficulty Weaning from Cardiopulmonary Bypass

1.1.2.2 Postcardiotomy Cardiogenic Shock

1.1.2.3 Other High Risk Cardiac Surgery

1.2 Post-AMI Cardiogenic Shock

1.3 Refractory Unstable Angina

1.4 Heart Failure

1.4.1 Classification Systems

1.4.2 Etiology

14.3 Incidence and Prevalence

1.4.4 Acute Decompensation

1.5 Acute Myocarditis

1.6 High Risk AMI

Exhibit 1-1: Conditions and Situations Potentially Requiring Acute Cardiac Assist

Exhibit 1-2: Revascularizations by Type, Procedure Forecast, 2008-2013

Exhibit 1-3: High Risk PCI, Procedure Forecast, 2008-2015

Exhibit 1-4: Patients Having Difficulty Weaning from CPB, 2008-2015

Exhibit 1-5: Postcardiotomy Shock, Procedure Forecast, 2008-2015

Exhibit 1-6: Other High Risk CABG Surgery, Patient Forecast, 2008-2015

Exhibit 1-7: Hospitalizations for AMI, Patient Forecast, 1998-2015

Exhibit 1-8: Post-AMI Cardiogenic Shock, Patient Forecast, 2008-2015

Exhibit 1-9: Patients with Refractory Unstable Angina Potentially Requiring Acute Cardiac Assist, 2008-2015

Exhibit 1-10: Normal versus Enlarged Heart

Exhibit 1-11: NYHA Functional Classification of Heart Failure

Exhibit 1-12: ACC/AHA Classification of Heart Failure

Exhibit 1-13: Etiology of Heart Failure

Exhibit 1-14: Demographics and Concomitant Diseases Associated with Acute Heart Failure Syndromes in Three Registries

Exhibit 1-15: Summary of U.S. Heart Failure Epidemiology, 2006

Exhibit 1-16: U.S. Heart Failure Patients by Gender, 2008-2015

Exhibit 1-17: Heart Failure Prevalence by NYHA Classification, 2008-2015

Exhibit 1-18: Hospitalizations for Heart Failure, Total versus Primary, 2008-2015

Exhibit 1-19: Hospitalizations for Acute Myocarditis, 2008 – 2015

Exhibit 1-20: High Risk AMI, Hospital Admissions, 2008 – 2015

2.0 INTRA-AORTIC BALLOON PUMPS

2.1 Technology and Usage

2.2 Indications and Contraindications

2.2.1 Cardiac Assist Benchmark Outcomes Registry

2.2.2 Benchmark 2 Registry

2.2.3 BCIS-1

2.2.4 CRISP-AMI Trial

2.3 Potential Complications

2.4 Product Trends

2.5 Products and Suppliers

2.5.1 Abiomed

2.5.2 Getinge/Maquet Cardiovascular/Datascope

2.5.3 Teleflex Medical/Arrow International

2.6 Market Analysis

2.6.1 Applications

2.6.2 Market Forecast

2.6.3 Supplier Shares

Exhibit 2-1: Placement and Operation of Intra-Aortic Balloon Catheter

Exhibit 2-2: Indications & Contraindications for IABP Therapy

Exhibit 2-3: Benchmark Registry: Indications for IABP Therapy

Exhibit 2-4: Benchmark Registry: Complications Associated with IABP Therapy

Exhibit 2-5: Selected IABP Consoles and Balloon Catheters, 2009

Exhibit 2-6: Abiomed's iPulse IAB and Console

Exhibit 2-7: Maquet Cardiovascular CS300 Controller and Sensation 7F Catheter

Exhibit 2-8: Arrow International AutoCAT 2 WAVE and FiberOptix Catheter

Exhibit 2-9: Anatomy of Teleflex/Arrow ProActive CounterPulsation

Exhibit 2-10: IABP Targeted Applications, Procedure Forecast, 2008-2015

Exhibit 2-11: IABP Controllers and Balloon Catheters, Market Forecast, 2008-2015

Exhibit 2-12 IABP Products, Supplier Shares, 2009

3.0 PERCUTANEOUS ACUTE ASSIST DEVICES

3.1 Technology

3.2 Indications and Contraindications

3.3 Products and Suppliers

3.3.1 Abiomed

3.3.1.1 Impella 2.5

3.3.1.2 Impella LD and 5.0

3.3.1.3 Impella Mobile Console

3.3.2 A-Med Systems

3.3.3 CardiacAssist

3.3.4 CardioBridge

3.3.5 ECP GmbH

3.3.6 Levitronix

3.3.7 Lifebridge Medizintechnik GmbH

3.3.8 Orqis Medical

3.3.9 PulseCath

3.4 Market Analysis

3.4.1 Applications

3.4.2 Market Forecast

3.4.3 Supplier Shares

Exhibit 3-1: Indications and Contraindications for pVADs

Exhibit 3-2: Selected Percutaneous Ventricular Assist Products, 2009

Exhibit 3-3: Abiomed's Impella 2.5 pVAD

Exhibit 3-4: Abiomed's Impella LD and 5.0 pVADs

Exhibit 3-5: A-Med Systems' pLVAD

Exhibit 3-6: CardiacAssist TandemHeart System

Exhibit 3-7: CardioBridge Reitan Catheter Pump

Exhibit 3-8: ECP GmbH’s Expandable Catheter Pump

Exhibit 3-9: Levitronix CentriMag VAS

Exhibit 3-10: Lifebridge System

Exhibit 3-11: Orqis Medical's Cancion System

Exhibit 3-12: Orqis Exceleras System

Exhibit 3-13: PulseCath's iVac 3L

Exhibit 3-14: pVADs, Targeted Applications, Procedure Forecast, 2008-2015

Exhibit 3-15: pVADs, Market Forecast, 2008-2015

Exhibit 3-16: pVADs, Supplier Shares, 2008 & 2009

4.0 EXTERNAL ACUTE RECOVERY VADS

4.1 VAD Types

4.1.1 Pump Placement

4.1.2 Pump/Flow Type

4.2 Clinical Indications

4.3 Products and Suppliers

4.3.1 Abiomed

4.3.1.1 Blood Pumps

4.3.1.2 Cannulae

4.3.1.3 Driver Consoles

4.3.2 Berlin Heart

4.3.2.1 EXCOR

4.3.2.2 EXCOR Pediatric

4.3.2.3 Driver Consoles

4.3.3 Thoratec

4.3.3.1 Thoratec PVAD

4.3.3.2 Thoratec IVAD

4.3.3.3 Driver Consoles

4.4 Procedure Forecast

4.5 Market Forecast

4.6 Supplier Shares

Exhibit 4-1: Overview of VAD Indications

Exhibit 4-2: External Acute Recovery VAD Products and Suppliers, 2009

Exhibit 4-3: Abiomed's VAD Products

Exhibit 4-4: Berlin Heart's VAD Products

Exhibit 4-5: Thoratec's External VAD Products

Exhibit 4-6: External Acute Recovery VADs, Procedure Forecast, 2008-2015

Exhibit 4-7: External Acute Recovery VADs, Market Forecast, 2008-2015

Exhibit 4-8: External Acute Recovery VADs, Supplier Shares, 2008

5.0 CELL THERAPY

5.1 Rationale for Therapy

5.2 Process and Technology

5.3 Cell Sources

5.3.1 Embryonic Stem Cells

5.3.2 Adult Stem Cells

5.3.2.1 Adipose Tissue-Derived Stem Cells

5.3.2.2 Resident Cardiac Progenitor Cells

5.3.2.3 Umbilical Cord Blood Cells

5.3.2.4 Skeletal Myoblasts

5.3.2.5 Induced Pluripotent Stem Cells

5.4 Cell Delivery

5.5 Mechanisms of Action

5.6 Suppliers and Programs

5.6.1 Angioblast Systems

5.6.2 Bioheart

5.6.3 Cardium Therapeutics

5.6.4 Cytori Therapeutics

5.6.5 Osiris Therapeutics

5.6.6 Stempeutics

5.6.7 TCA Cellular Therapy

5.6.8 University Programs

5.6.8.1 J.W. Goethe University

5.6.8.2 Rikshospitalet University Hospital

5.6.8.3 Combination Therapy Programs

5.7 Market Opportunity

Exhibit 5-1: Circulation and Mobilization of Progenitor Cells

Exhibit 5-2: Mobilization of Progenitor Cells Following AMI

Exhibit 5-3: Cell Therapy Process and Associated Devices

Exhibit 5-4: Sources of Stem Cells

Exhibit 5-5: Methods of Cell Delivery for Cardiac Implantation

Exhibit 5-6: Comparison of Cell Delivery Approaches

Exhibit 5-7: Mechanisms of Action of Cardiac Cell Therapy

Exhibit 5-8: Cell Therapy Products and Approaches Targeting Infarct Reduction in Acute Myocardial Infarction, 2009

Exhibit 5-9: Selected Clinical Outcomes of Angioblast's Revascor MPC therapy

Exhibit 5-10: TGI 1200 Adipose Tissue Processing System

Exhibit 5-11: Frequency of Stem Cells in Adipose Tissue versus Bone Marrow

Exhibit 5-12: Cytori Therapeutics Celution System

Exhibit 5-13: Osiris Therapeutics' Prochymal for Acute Myocardial Infarction

Exhibit 5-14: Selected University Programs Targeting Stem Cell Therapy for Acute Myocardial Infarction, 2009

Exhibit 5-15: MAGIC Cell Trial and Supporting Studies Targeting Treatment of Acute Myocardial Infarction

Exhibit 5-16: Other Combination Therapy Clinical Trials Targeting Treatment of Acute Myocardial Infarction

Exhibit 5-17: Stem Cell Therapy Targeting Acute Myocardial Infarction, Addressable Market, 2008-2015

Exhibit 5-18: Stem Cell Therapy Targeting Acute Myocardial Infarction, Forecast Market by Product Type, Years 1 through 5

6.0 COMPANY PROFILES

6.1 Abiomed, Inc

6.2 Berlin Heart GmbH

6.3 Bioheart, Inc

6.4 Cytori Therapeutics, Inc

6.5 Getinge/Maquet Cardiovascular/Datascope

6.6 Osiris Therapeutics, Inc

6.7 Teleflex Medical/Arrow International

6.8 Thoratec Corporation