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United States Cardiovascular Monitoring and Diagnostic Devices Market Outlook to 2020

GDMECC0333DB / Published May 2014

© GlobalData. This report is a licensed product and is not to be copied,

reproduced, shared or resold in any form

United States Cardiovascular

Monitoring and Diagnostic Devices

Market Outlook to 2020

Reference Code: GDMECC0333DB

Publication Date: May 2014

SAMPLE





1 Table of Contents

1 Table of Contents .............................................................................................................................................. 2

1.1 List of Tables .............................................................................................................................................. 7

1.2 List of Figures ............................................................................................................................................. 8

2 Introduction........................................................................................................................................................ 9

2.1 What Is This Report About? ........................................................................................................................ 9

2.2 Cardiovascular Monitoring and Diagnostic Devices Market Segmentation ................................................... 9

2.3 Definitions of Markets Covered in the Report ............................................................................................ 10

3 Cardiovascular Monitoring and Diagnostic Devices Market, United States.................................................. 12

3.1 Cardiovascular Monitoring and Diagnostic Devices Market, United States, Revenue ($m), 2005-2012 ...... 12

3.2 Cardiovascular Monitoring and Diagnostic Devices Market, United States, Revenue ($m), 2012-2020 ...... 14

3.3 Cardiovascular Monitoring and Diagnostic Devices Market, United States, Volume (Units), 2005-2012 ..... 16

3.4 Cardiovascular Monitoring and Diagnostic Devices Market, United States, Volume (Units), 2012-2020 ..... 18

3.5 Cardiovascular Monitoring and Diagnostic Devices Market, United States, Average Price ($), 2005-2020 . 20

3.6 Cardiovascular Monitoring and Diagnostic Devices Market, United States, Distribution Share by Revenue ($m), 2011-2012 ................................................................................................................................................... 22

3.7 Cardiovascular Monitoring and Diagnostic Devices Market, United States, Company Share by Revenue ($m), 2011-2012 ................................................................................................................................................... 23

4 Overview of Key Companies in United States, Cardiovascular Monitoring and Diagnostic Devices Market 25

4.1 GE Healthcare .......................................................................................................................................... 25

4.1.1 Company Overview ............................................................................................................................... 25

4.2 Philips Healthcare ..................................................................................................................................... 25


4.3 CareFusion Corporation ............................................................................................................................ 25


4.4 Welch Allyn Inc. ........................................................................................................................................ 26


4.5 OSI Systems, Inc. ..................................................................................................................................... 26


4.6 Opto Circuits India Limited ........................................................................................................................ 26


4.7 Schiller AG ............................................................................................................................................... 27


4.8 Mortara Instrument, Inc. ............................................................................................................................ 27


4.9 Nihon Kohden Corporation ........................................................................................................................ 27


4.10 Fukuda Denshi Co., Ltd. ........................................................................................................................... 28

4.10.1 Company Overview ........................................................................................................................... 28

5 Cardiovascular Monitoring and Diagnostic Devices Market Pipeline Products ........................................... 29

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6 Financial Deals Landscape ............................................................................................................................. 31

6.1 Acquisition ................................................................................................................................................ 31

6.1.1 Digirad Acquires Telerhythmics For US$4 Million .................................................................................. 31

6.1.2 St. Jude Medical To Acquire CardioMEMS ............................................................................................ 33

6.2 Asset Transactions ................................................................................................................................... 35

6.2.1 BioTelemetry Completes Acquisition Of Cardiac Patient Services Business From Biomedical Systems For US$8.6 Million ............................................................................................................................................. 35

6.2.2 Mortara Instrument To Acquire Diagnostic Cardiology Product Line Of Cardiac Science For US$21 Million 37

6.3 Debt Offerings .......................................................................................................................................... 39

6.3.1 Edwards Lifesciences Completes Public Offering Of Notes Due 2018 For US$600 Million ..................... 39

6.4 Equity Offerings ........................................................................................................................................ 41

6.4.1 CardioDx Postpones IPO ...................................................................................................................... 41

6.4.2 Bioheart Completes Private Placement Of Shares ................................................................................. 43

6.4.3 Bioheart Announces Private Placement Of Shares For US$2 Million ..................................................... 44

6.5 Partnerships ............................................................................................................................................. 45

6.5.1 Millar Instruments Enters Into Distribution Agreement With CD Leycom ................................................ 45

6.5.2 Cardionet, Imec, And Delta Enter Into Agreement To Develop Cardiac Monitoring Products .................. 46

6.5.3 Everist Genomics Enters Into Licensing Agreement With Rutgers For Cardiovascular Disease Monitoring Sensor Technology ............................................................................................................................................ 47

6.5.4 Infraredx Enters Into Co-Development Agreement With Philips ............................................................. 48

6.5.5 Lifewatch Services Enters Into Technology Integration Agreement With Perminova ............................... 49

6.5.6 Compumed Entres Into Technology Integration Agreement With GE Healthcare ................................... 50

6.6 Private Equity ........................................................................................................................................... 51

6.6.1 ICU Medical Drops The Sale Of The Company...................................................................................... 51

6.6.2 Tenex Capital Acquires Roscoe Medical ............................................................................................... 53

6.6.3 HealthEdge Investment Fund II Acquires Majority Stake In LifeSync, Maker Of Wireless Electrocardiogram Data Communications System .............................................................................................. 54

6.7 Venture Financing ..................................................................................................................................... 55

6.7.1 InfoBionic Raises US$17 Million In First Tranche Of Series B Financing ................................................ 55

6.7.2 Cardiox Raises US$3.2 Million In Venture Financing ............................................................................. 57

6.7.3 Cheetah Medical Raises US$9 Million In Venture Financing .................................................................. 58

6.7.4 Cardiac Insight Raises US$2 Million In Venture Financing ..................................................................... 60

6.7.5 Eso-Technologies Raises US$0.6 Million In Series A Financing ............................................................ 61

6.7.6 Nipro Invests US$25 Million In Infraredx ................................................................................................ 63

6.7.7 Rijuven Raises US$0.3 Million In Venture Financing ............................................................................. 65

6.7.8 Cardiac Insight Raises US$1.3 Million In Venture Financing .................................................................. 66

6.7.9 Topera Raises US$25 Million In Series C Financing .............................................................................. 67

6.7.10 iRhythm Technologies Raises US$16 Million In Series D Financing ................................................... 68

6.7.11 Cheetah Medical Raises US$14.4 Million In Extended Series C Financing ........................................ 70

6.7.12 Endotronix Raises US$1.2 Million In Venture Financing ..................................................................... 71

6.7.13 Cardiox Raises US$9.4 Million In Venture Financing ......................................................................... 72

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6.7.14 Cardiox Raises US$0.4 Million In Venture Financing ......................................................................... 73

6.7.15 Angel Medical Systems Raises US$27.5 Million In Initial Closing Of Venture Financing Round .......... 74

6.7.16 iRhythm Technologies Raises US$1.5 Million In Venture Financing ................................................... 75

6.7.17 iRhythm Technologies Raises US$3.5 Million In Venture Financing ................................................... 76

6.7.18 Rijuven Raises US$0.5 Million In Venture Financing .......................................................................... 78

6.7.19 Aviir Raises US$5 Million In Venture Financing ................................................................................. 79

6.7.20 Cardiac Insight Raises US$0.3 Million In Venture Financing .............................................................. 81

6.7.21 Inovise Medical Raises US$0.4 Million In Venture Financing ............................................................. 82

6.7.22 Rijuven Raises US$0.9 Million In Venture Financing .......................................................................... 83

7 Recent Developments...................................................................................................................................... 84

7.1 Corporate Communications....................................................................................................................... 84

7.1.1 Apr 08, 2014: Ventripoint Corporate Update and Resignation of Director ............................................... 84

7.1.2 Feb 12, 2014: ICU Medical Names Vivek Jain as New Chief Executive Officer and Chairman ............... 84

7.1.3 Jan 31, 2014: AMAG Pharmaceuticals Announces Issuance of New U.S. Patent for Ferumoxytol ......... 85

7.1.4 Dec 19, 2013: Bioheart Reports Update on CEO ................................................................................... 85

7.1.5 Nov 22, 2013: Voyage Care Acquires Ingleby Care ............................................................................... 85

7.1.6 Nov 18, 2013: Bioheart's President/CEO Mike Tomas Named Chair of the eMerge Innovate Advisory Board of eMerge Americas ................................................................................................................................ 86

7.1.7 Oct 21, 2013: ICU Medical Announces Management Transition ............................................................ 87

7.1.8 Sep 23, 2013: Bioheart Boosts Team with Regulatory, Finance and Administrative Expertise Three New Key Positions Added .......................................................................................................................................... 88

7.1.9 Sep 19, 2013: Atherotech Diagnostics Lab Bolsters Research Efforts with Addition of Abate as Chief Clinical Officer ................................................................................................................................................... 88

7.1.10 Sep 13, 2013: Arrhythmia Research Technology Announces Resignation of CFO and Appointment of New Principal Financial Officer........................................................................................................................... 89

7.1.11 Aug 28, 2013: Sheldon T. Anderson Elected to the Board of Directors of Bioheart, Inc....................... 89

7.1.12 Aug 01, 2013: CardioNet Holding Company Structure Effective ......................................................... 90

7.1.13 Jul 23, 2013: Vincent Caponi Joins Welch Allyn Board of Directors .................................................... 90

7.1.14 Jun 04, 2013: Cheetah Medical Appoints Chris Hutchison As CEO .................................................... 91

7.2 Financial Announcements ......................................................................................................................... 91

7.2.1 Apr 16, 2014: Osteoarthritis Study shows ActiPatch Therapy Significantly Relieves Knee Pain .............. 91

7.2.2 Mar 27, 2014: Vasomedical Announces Financial Results for Fourth Quarter and Full Year for 2013 ..... 93

7.2.3 Feb 12, 2014: ICU Medical Announces Fourth Quarter and Fiscal Year 2013 Results ........................... 95

7.2.4 Jan 20, 2014: Pulmonary Embolism Trial Comparing Endovascular Ultrasound to Standard of Care Anticoagulation Published in the American Heart Association‘s Journal, Circulation ........................................... 96

7.2.5 Nov 19, 2013: Arrhythmia Research Technology Announces Third Quarter 2013 Results ...................... 97

7.2.6 Nov 14, 2013: Vasomedical Recorded 33% Year-over-year Growth in Revenue for the Third Quarter of 2013 98

7.2.7 Nov 05, 2013: Vasomedical to Report Third Quarter 2013 Results on November 14, 2013 .................... 99

7.2.8 Nov 05, 2013: BioTelemetry Reports Third Quarter 2013 Financial Results ........................................... 99

7.2.9 Oct 29, 2013: BioTelemetry to Release Third Quarter 2013 Earnings Results on November 5, 2013 ... 100

7.2.10 Oct 21, 2013: ICU Medical Reports Third Quarter 2013 Results ...................................................... 101

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7.2.11 Oct 16, 2013: ICU Medical Announces Time of Third Quarter 2013 Earnings Call ............................ 102

7.2.12 Oct 08, 2013: Arrhythmia Research Technology Announces Second Quarter 2013 Results ............. 102

7.2.13 Oct 02, 2013: Arrhythmia Research Technology Announces Updated Preliminary Second Quarter Results 103

7.2.14 Aug 20, 2013: First Databank Acquires Design Clinicals, Medication Reconciliation Solutions Provider 104

7.2.15 Aug 20, 2013: Arrhythmia Research Technology, Inc. Announces Delay in Finalizing Second Quarter Results 106

7.2.16 Aug 13, 2013: Vasomedical Announces Financial Results for the Second Quarter of 2013 .............. 106

7.2.17 Aug 06, 2013: Vasomedical to Report Second Quarter 2013 Results on August 13, 2013 ................ 107

7.2.18 Jul 30, 2013: CardioNet Reports Second Quarter 2013 Financial Results ........................................ 108

7.2.19 Jul 23, 2013: CardioNet to Release Second Quarter 2013 Earnings Results on July 30, 2013 ......... 109

7.2.20 Jul 18, 2013: ICU Medical Reports Second Quarter 2013 Results.................................................... 109

7.2.21 Jun 28, 2013: Arrhythmia Research Technology, Inc. Announces First Quarter 2013 Results .......... 110

7.2.22 Jun 17, 2013: Takeda Announces Availability Of Nesina In US Pharmacies..................................... 111

7.2.23 Jun 03, 2013: Arrhythmia Reports Revenue Of $20.6m In 2012 ....................................................... 112

7.2.24 May 15, 2013: Vasomedical Reports Revenue Of $7.3m In Q1 2013 ............................................... 113

7.2.25 May 09, 2013: Bioheart Reports Q1 2013 Results ........................................................................... 114

7.2.26 May 07, 2013: PLC Systems Presents Clinical Data Of RenalGuard System At 60th International Conference Of Israel Heart Society .................................................................................................................. 115

7.3 Government and Public Interest .............................................................................................................. 117

7.3.1 Jan 06, 2014: ICU Medical to Present at the 32nd Annual J.P. Morgan Healthcare Conference ........... 117

7.3.2 Jan 02, 2014: Topera to Present at the 32nd Annual J.P. Morgan Healthcare Conference ................... 117

7.3.3 Dec 31, 2013: Bioheart to Present at Vail Symposium's Winter Program on Cell Therapy .................... 117

7.3.4 Dec 02, 2013: ZOLL Summit 2014 Call for Presentations .................................................................... 117

7.3.5 Nov 25, 2013: Topera to Present at the 25th Annual Piper Jaffray Health Conference ......................... 118

7.3.6 Nov 21, 2013: ICU Medical to Present at the Piper Jaffray 25th Annual Healthcare Conference .......... 118

7.3.7 Oct 23, 2013: Additional dedicated trainer hospital established in the USA .......................................... 118

7.3.8 Aug 09, 2013: IMRIS CEO Jay D. Miller to present at Canaccord Genuity 33rd Annual Global Growth Conference ...................................................................................................................................................... 118

7.4 Legal And Regulatory ............................................................................................................................. 119

7.4.1 Apr 17, 2014: Boston Heart Granted New York Laboratory Permit for Diagnostic Testing .................... 119

7.5 Other Significant Developments .............................................................................................................. 119

7.5.1 Feb 24, 2014: AliveCor Offers Integration With Practice Fusion's Electronic Health Records Platform . 119

7.5.2 Feb 20, 2014: Boston Heart Diagnostics Awarded $1.0 Million in Tax Incentives from the Massachusetts Life Sciences Center ........................................................................................................................................ 120

7.5.3 Dec 04, 2013: BioTelemetry, Inc. Announces Reduction to Medicare Reimbursement for Remote Cardiac Monitoring Services ......................................................................................................................................... 121

7.5.4 Dec 02, 2013: Bioheart Announces Agreement With StemMD to Provide Bioheart Therapies to Its Network 121

7.5.5 Nov 18, 2013: AliveCor transforms Heart Monitor into eHealth Service ................................................ 121

7.5.6 Nov 15, 2013: Millar Appointed Exclusive US Distributor of CD Leycom INCA Pressure-Volume Loop System 122

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7.5.7 Oct 25, 2013: Bioheart Announces Agreement With Anosis to Distribute Products in the Middle East .. 123

7.5.8 Oct 16, 2013: Bioheart Announces Contract With African-Middle East Medical to Begin Distributing Stem Cell Products in Uganda .................................................................................................................................. 123

7.5.9 Oct 09, 2013: $2 Million Awarded to Sutter Health, IBM and Geisinger Health System to Study Heart Failure Prediction ............................................................................................................................................. 123

7.5.10 Aug 23, 2013: Arrhythmia Research Technology Receives NYSE MKT LLC Exchange Compliance Notice 125

7.5.11 Jul 09, 2013: Behrman Capital Portfolio Company Atherotech Completes Recapitalization .............. 125

7.6 Product News ......................................................................................................................................... 125

7.6.1 Apr 16, 2014: AtCor Medical Receives Patent in USA ......................................................................... 125

7.6.2 Mar 27, 2014: First Patients Enrolled in Medtronic Clinical Study Designed to Identify Patients at High Risk for Sudden Cardiac Arrest in Developing Countries .................................................................................. 126

7.6.3 Mar 17, 2014: Vasomedical Announces Biox's MobiCare Wireless Patient Monitors Receives Marketing Approval in China ............................................................................................................................................ 127

7.6.4 Feb 13, 2014: New Data Support Use of iRhythm's ZIO Service to Identify Cardiac Arrhythmias in Stroke and TIA Patients .............................................................................................................................................. 127

7.6.5 Jan 22, 2014: UCLA researchers develop risk calculator to predict survival in heart failure patients ..... 128

7.6.6 Jan 06, 2014: FDA Reclassifies ECP Devices for Refractory Angina as Class II .................................. 130

7.6.7 Jan 02, 2014: ZIO Service Identifies Significantly More Cardiac Arrhythmias Than the Traditional Holter Monitor, According to Study Published Online in the American Journal of Medicine .......................................... 130

7.6.8 Nov 25, 2013: Independent Multi-Center Clinical Study Shows the Use of Topera‘s 3D Mapping System Improved Long-Term Outcomes for Atrial Fibrillation Patients .......................................................................... 131

7.6.9 Nov 18, 2013: AliveCor Transforms Heart Monitor into eHealth Service ............................................... 132

7.6.10 Oct 07, 2013: MDxHealth‘s Prostate Cancer Test Meets Endpoints In DOCUMENT Trial ................ 133

7.6.11 Aug 23, 2013: AliveCor Launches New Feature to Enhance Visual Quality of ECG ......................... 135

7.6.12 May 14, 2013: iCardiac Releases StudyView Module for iClinica 4G Cardiac Safety Software Platform 135

7.7 Research And Development ................................................................................................................... 136

7.7.1 Jun 04, 2013: Immunicum's Intuvax Is Registered As Brand In EU At Office for Harmonization in the Internal Market ................................................................................................................................................. 136

7.8 Strategy And Business Planning ............................................................................................................. 136

7.8.1 Nov 25, 2013: Bioheart Announces New Clinical Site in Mexico .......................................................... 136

7.8.2 Nov 06, 2013: Welch Allyn Establishes New Regional Headquarters, Operations Center in The Netherlands ..................................................................................................................................................... 137

7.8.3 Nov 04, 2013: Bioheart Announces Agreement With Global Stem Cell Group to Provide Bioheart Therapies and Training .................................................................................................................................... 138

7.8.4 Jul 25, 2013: First Injection of Dotarem in US Performed at Cincinnati Children's Hospital Medical Center 138

7.8.5 Jul 02, 2013: Apogenix Strengthens Patent Position for Apocept In Europe And Canada ..................... 139

8 Appendix ........................................................................................................................................................ 141

8.1 Research Methodology ........................................................................................................................... 142

8.1.1 Coverage ............................................................................................................................................ 142

8.1.2 Secondary Research........................................................................................................................... 142

8.1.3 Primary Research ............................................................................................................................... 143

8.1.4 Market Modeling and Forecasting ....................................................................................................... 144

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8.1.5 Company Share Analysis .................................................................................................................... 147

8.1.6 Distribution Share Analysis ................................................................................................................. 148

8.2 Expert Panel ........................................................................................................................................... 148

8.3 GlobalData Consulting ............................................................................................................................ 149

8.5 Disclaimer ............................................................................................................................................... 149

1.1 List of Tables

Table 1: Cardiovascular Monitoring and Diagnostic Devices Market, United States, Revenue ($m), USD Constant, Historic, 2005-

2012 ........................................................................................................................................................................................ 13

Table 2: Cardiovascular Monitoring and Diagnostic Devices Market, United States, Revenue ($m), USD Constant, Forecast,

2012-2020 ................................................................................................................................................................................ 15

Table 3: Cardiovascular Monitoring and Diagnostic Devices Market, United States, Volume (Units), Historic, 2005-2012 ........... 17

Table 4: Cardiovascular Monitoring and Diagnostic Devices Market, United States, Volume (Units), Forecast, 2012-2020 ......... 19

Table 5: Cardiovascular Monitoring and Diagnostic Devices Market, United States, Average Price ($), Historic, 2005-2012 ....... 20

Table 6: Cardiovascular Monitoring and Diagnostic Devices Market, United States, Average Price ($), Forecast, 2012-2020 ..... 21

Table 7: Cardiovascular Monitoring and Diagnostic Devices Market, United States, Distribution Share by Revenue ($m), USD

Constant, 2011-2012 ................................................................................................................................................................ 22

Table 8: Cardiovascular Monitoring and Diagnostic Devices Market, United States, Company Share by Revenue ($m), USD

Constant, 2011-2012 ................................................................................................................................................................ 24

Table 9: Cardiovascular Monitoring and Diagnostic Devices Market Pipeline Products .............................................................. 29

Table 10: Digirad Acquires Telerhythmics For US$4 Million...................................................................................................... 31

Table 11: St. Jude Medical To Acquire CardioMEMS ............................................................................................................... 33

Table 12: BioTelemetry Completes Acquisition Of Cardiac Patient Services Business From Biomedical Systems For US$8.6

Million ...................................................................................................................................................................................... 35

Table 13: Mortara Instrument To Acquire Diagnostic Cardiology Product Line Of Cardiac Science For US$21 Million ................ 37

Table 14: Edwards Lifesciences Completes Public Offering Of Notes Due 2018 For US$600 Million ......................................... 39

Table 15: CardioDx Postpones IPO ......................................................................................................................................... 41

Table 16: Bioheart Completes Private Placement Of Shares .................................................................................................... 43

Table 17: Bioheart Announces Private Placement Of Shares For US$2 Million ......................................................................... 44

Table 18: Millar Instruments Enters Into Distribution Agreement With CD Leycom .................................................................... 45

Table 19: Cardionet, Imec, And Delta Enter Into Agreement To Develop Cardiac Monitoring Products ...................................... 46

Table 20: Everist Genomics Enters Into Licensing Agreement With Rutgers For Cardiovascular Disease Monitoring Sensor

Technology .............................................................................................................................................................................. 47

Table 21: Infraredx Enters Into Co-Development Agreement With Philips ................................................................................. 48

Table 22: Lifewatch Services Enters Into Technology Integration Agreement With Perminova ................................................... 49

Table 23: Compumed Entres Into Technology Integration Agreement With GE Healthcare........................................................ 50

Table 24: ICU Medical Drops The Sale Of The Company ......................................................................................................... 51

Table 25: Tenex Capital Acquires Roscoe Medical .................................................................................................................. 53

Table 26: HealthEdge Investment Fund II Acquires Majority Stake In LifeSync, Maker Of Wireless Electrocardiogram Data

Communications System .......................................................................................................................................................... 54

Table 27: InfoBionic Raises US$17 Million In First Tranche Of Series B Financing .................................................................... 55

Table 28: Cardiox Raises US$3.2 Million In Venture Financing ................................................................................................ 57

SAMPLE





Table 29: Cheetah Medical Raises US$9 Million In Venture Financing ..................................................................................... 58

Table 30: Cardiac Insight Raises US$2 Million In Venture Financing ........................................................................................ 60

Table 31: Eso-Technologies Raises US$0.6 Million In Series A Financing ................................................................................ 61

Table 32: Nipro Invests US$25 Million In Infraredx ................................................................................................................... 63

Table 33: Rijuven Raises US$0.3 Million In Venture Financing ................................................................................................. 65

Table 34: Cardiac Insight Raises US$1.3 Million In Venture Financing ..................................................................................... 66

Table 35: Topera Raises US$25 Million In Series C Financing ................................................................................................. 67

Table 36: iRhythm Technologies Raises US$16 Million In Series D Financing .......................................................................... 68

Table 37: Cheetah Medical Raises US$14.4 Million In Extended Series C Financing ................................................................ 70

Table 38: Endotronix Raises US$1.2 Million In Venture Financing ............................................................................................ 71



Table 41: Angel Medical Systems Raises US$27.5 Million In Initial Closing Of Venture Financing Round .................................. 74

Table 42: iRhythm Technologies Raises US$1.5 Million In Venture Financing .......................................................................... 75

Table 43: iRhythm Technologies Raises US$3.5 Million In Venture Financing .......................................................................... 76


Table 45: Aviir Raises US$5 Million In Venture Financing ........................................................................................................ 79

Table 46: Cardiac Insight Raises US$0.3 Million In Venture Financing ..................................................................................... 81

Table 47: Inovise Medical Raises US$0.4 Million In Venture Financing ..................................................................................... 82


Table 49: Total Number of Primary Research Participants, Cardiovascular Devices Market, by Country ................................... 144

1.2 List of Figures

Figure 1: Cardiovascular Monitoring and Diagnostic Devices Market, United States, Revenue ($m), USD Constant, Historic,

2005-2012 ................................................................................................................................................................................ 12

Figure 2: Cardiovascular Monitoring and Diagnostic Devices Market, United States, Revenue ($m), USD Constant, Forecast,

2012-2020 ................................................................................................................................................................................ 14

Figure 3: Cardiovascular Monitoring and Diagnostic Devices Market, United States, Volume (Units), Historic, 2005-2012 .......... 16

Figure 4: Cardiovascular Monitoring and Diagnostic Devices Market, United States, Volume (Units), Forecast, 2012-2020 ........ 18

Figure 5: Cardiovascular Monitoring and Diagnostic Devices Market, United States, Company Share (%), 2012 ....................... 23

Figure 6: GlobalData Epidemiology-Based Forecasting Model ............................................................................................... 146

Figure 7: GlobalData Capital Equipment-Based Forecasting Model ........................................................................................ 147

Figure 8: Primary Interviews by Participant Type (%) ............................................................................................................. 148 SAMPLE





2 Introduction

Medical Equipment Market Reports are the ideal guide for anyone wishing to understand their market better in terms

of revenues, unit sales, distributors and competitors.

2.1 What Is This Report About?

This report provides an overview and the following information related to the country, various categories, distribution

share and competitive landscape in the market:

1. Comprehensive data related to the market revenue, unit sale, average price, company share and

distribution share.

2. Corporate-level profiles of key companies operating in the Cardiovascular Monitoring and Diagnostic

Devices market, which includes a brief overview of the company. The selection of the companies is

based on their operational presence.

3. A list of key products under development by different companies. The selection of this list is based on the

territory in which these products are being clinically investigated.

4. Key news and deals related to the Cardiovascular Monitoring and Diagnostic Devices market.

2.2 Cardiovascular Monitoring and Diagnostic Devices Market Segmentation

Cardiovascular Monitoring and Diagnostic Devices market is segmented as described below, in this report:

1. Cardiopulmonary Stress Testing Systems

2. ECG Data Management Systems

3. ECG Monitoring Equipment

4. ECG Stress Testing Systems

5. Event Monitoring Systems

6. Holter Monitoring Systems

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2.3 Definitions of Markets Covered in the Report

Cardiovascular Monitoring and Diagnostic Devices

Cardiovascular monitoring and diagnostic devices are used to detect and feedback abnormal episodes of electrical

functioning of the heart. The cardiovascular monitoring and diagnostic devices includes Cardiopulmonary Stress

Testing Systems, ECG Data Management Systems, ECG Monitoring Equipment, ECG Stress Testing Systems,

Event Monitoring Systems and Holter Monitoring Systems.

Cardiopulmonary Stress Testing Systems

Cardiopulmonary exercise or cardiopulmonary stress testing is done to non-invasively measure heart rate, cardiac

output, oxygen saturation, ventilation, and gas exchange to bring forth abnormalities not detectable at rest. The test

has been in use since over a decade to characterize a patient's primary limitation of exercise tolerance as either

cardiac or pulmonary in nature. In addition, the test also provides an assessment of the response to a specific

treatment regime. Physicians now prescribe cardiopulmonary stress test for both cardiac and pulmonary function

tests that help identify or assess conditions of the heart and lungs. One unit refers to one cardio pulmonary stress

testing system.

ECG Data Management Systems

ECG Database Management Systems are devices used to store and manage patients‘ ECG. It allows to capture and

store auditing information, report the serial ECG changes, and can communicate with other systems, such as hospital

information systems. Hospitals use ECG Data Management Systems to store and retrieve patients‘ ECG data. These

systems are integrated systems and are highly configurable to the individual hospital requirements. Multiple facilities

may share a single system. Only market for the main facility has been sized, not all facilities associated with the main

system. One unit refers to one new installation, upgrades are not considered while estimating the market size.

ECG Monitoring Equipment

Resting ECG equipment records the electrocardiogram (ECG) and is used to evaluate 10 seconds (or a specific time

interval) of electrical activity of the heart so a physician can determine the condition of a patient's heart. Resting ECG

equipment is primarily used for the 12-lead ECG test and is primarily used on a mobile cart or trolley. Resting ECG

equipment is NOT the same as ECG Bedside Patient Monitoring equipment. Single channel ECG machines are not

covered in this segment. One unit refers to one ECG monitoring equipment with more than 3 channels.

ECG Stress Testing Systems

ECG Stress Testing Systems or Tread Mill Testing (TMT) System is a diagnostic device used to record ECG of the

heart during excessive workload. The system measures the performance of the heart at various stress levels. Market

size does not include cost of treadmill. One unit refers to one ECG recorder and PC based software.

Event Monitoring Systems

Event monitors or recorders are devices which record only the abnormal events of the ECG over an extended period

of time. One unit refers to one event monitor or recorder.

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Holter Monitoring Systems

Holter monitoring systems record the ECG for a 24 or 48 hour period and are used to identify abnormal episodes of

the heart. The Holter system usually consists of a recorder, an interface circuit board, software for data analysis, and

an audio cassette or digital flash memory device for storage. One unit refers to one Holter monitoring system and a

glenoid component made of this alloy or a combination of this alloy and ultra-high molecular weight polyethylene. One

unit is one implant set.

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3 Cardiovascular Monitoring and Diagnostic Devices Market, United States

3.1 Cardiovascular Monitoring and Diagnostic Devices Market, United States, Revenue ($m), 2005-2012

Figure 1: Cardiovascular Monitoring and Diagnostic Devices Market, United States, Revenue ($m), USD Constant,

Historic, 2005-2012

Source: GlobalData

SAMPLE





Table 1: Cardiovascular Monitoring and Diagnostic Devices Market, United States, Revenue ($m), USD Constant,

Historic, 2005-2012

Category 2005 2006 2007 2008 2009 2010 2011 2012 CAGR 05-12


% Growth


% Growth


% Growth


% Growth


% Growth


% Growth

Total

% Growth

Source: GlobalData

SAMPLE





3.2 Cardiovascular Monitoring and Diagnostic Devices Market, United States, Revenue ($m), 2012-2020

Figure 2: Cardiovascular Monitoring and Diagnostic Devices Market, United States, Revenue ($m), USD Constant,

Forecast, 2012-2020

Source: GlobalData

SAMPLE





Table 2: Cardiovascular Monitoring and Diagnostic Devices Market, United States, Revenue ($m), USD Constant,

Forecast, 2012-2020

Category 2012 2013 2014 2015 2016 2017 2018 2019 2020 CAGR 12-20


% Growth


% Growth


% Growth


% Growth

Cardiopulmonary Stress Testing

Systems

% Growth


% Growth

Total

% Growth

Source: GlobalData

SAMPLE





3.3 Cardiovascular Monitoring and Diagnostic Devices Market, United States, Volume (Units), 2005-2012

Figure 3: Cardiovascular Monitoring and Diagnostic Devices Market, United States, Volume (Units), Historic, 2005-2012

Source: GlobalData

SAMPLE





Table 3: Cardiovascular Monitoring and Diagnostic Devices Market, United States, Volume (Units), Historic, 2005-2012

Category 2005 2006 2007 2008 2009 2010 2011 2012 CAGR 05-12


% Growth


% Growth


% Growth


% Growth


% Growth


% Growth

Total

% Growth

Source: GlobalData

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Page 141

8 Appendix

The data and analysis within this report are driven by Medical eTrack. Medical eTrack gives you the key information

required to drive sales, investment and deal-making activity in your business. It includes the following:

15,000+ data tables showing market size across more than 780 medical equipment segments and 15 countries,

from 2005 and forecast to 2020

6,000+ primary expert interviews, conducted annually to ensure data and report quality

1,100+ medical equipment conference reports

1,000+ industry-leading reports per annum, covering growing sectors, market trends, investment opportunities

and competitive landscape

600+ analysis reports, covering market and pipeline product analysis, by indication; medical equipment trends

and issues, and investment and M&A trends worth over $3m

50,000+ medical equipment company profiles

2,000+ private, emerging and technology start-up company profiles

4,000+ company profiles of medical equipment manufacturers in China and India

2,000+ company profiles of medical equipment manufacturers in Japan

825+ companies‘ revenue splits and market shares

1,100+ quarterly and annual medical equipment company financials

700+ medical equipment company SWOTs

11,700+ pipeline product profiles

14,000+ marketed product profiles

16,900+ clinical trials

17,000+ trial investigators

18,000+ new product patents

3,700+ reports on companies with products in development

21,500+ reports on deals in the medical equipment industry

1,300+ surgical and diagnostic procedures by therapy area

50+ key healthcare indicators by country

For more information or to receive a free demonstration of the service, please visit:

http://www.medicaletrack.com/ContactUs.aspx?Id=RequestDemo

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8.1 Research Methodology

GlobalData‘s dedicated research and analysis teams consist of experienced professionals with advanced statistical

expertise and marketing, market research and consulting backgrounds in the medical devices industry.

GlobalData adheres to the codes of practice of the European Pharmaceutical Marketing Research Association

(http://www.ephmra.org/).

All GlobalData databases are continuously updated and revised.

8.1.1 Coverage

The objective of updating GlobalData‘s coverage is to ensure that it represents the most up-to-date vision of the

industry possible.

Changes to the industry taxonomy are built on the basis of extensive research of company, association and

competitor sources.

Company coverage is based on three key factors: revenue; product and media attention; and innovation and market

potential.

The estimated revenue of all major companies, both private and public, are gathered and used to prioritize coverage.

GlobalData aims to cover all major news events and deals in the medical devices industry, updated on a daily basis.

The coverage is further streamlined and strengthened with additional input from GlobalData‘s expert panel.

8.1.2 Secondary Research

The research process begins with extensive secondary research using internal and external sources to gather all

relevant data and information pertaining to a particular market model for a particular country. The secondary research

sources that are typically referred to include, but are not limited to:

Company websites, annual reports, financial reports, broker reports, investor presentations and SEC filings

Industry trade journals, scientific journals and other technical literature

Association and healthcare organization websites

PubMed, Medscape and other relevant services which compile extensive reviews of clinical literature

Internal proprietary databases

Relevant patent and regulatory databases

National government documents, statistical databases and market reports

Procedure registries

News articles, press releases and web-casts specific to the companies operating in the market

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8.1.3 Primary Research

GlobalData conducts interviews with industry participants and commentators in order to validate its data and analysis.

A typical research interview fulfills the following functions:

Provides first-hand information on market size, market trends, growth trends, competitive landscape and

future outlook

Helps to validate and strengthen secondary research findings

Further develops the analysis team‘s expertise and market understanding

Primary research involves email correspondence, telephone interviews and face-to-face interviews for each market,

category, segment and sub-segment across a range of geographies.

The participants who typically take part in such a process include, but are not limited to:

o Industry participants: CEOs, VPs, marketing/product managers, market intelligence managers and

national sales managers

o Distributors, paramedics and representatives from hospital stores, laboratories and pharmacies

o Outside experts: investment bankers, valuation experts and research analysts that specialize in specific

medical equipment markets

o Key opinion leaders: physicians and surgeons that specialize in the therapeutic areas in which the

medical device is used

The market data was validated based on the inputs from 1,771 primary research participants. The primary research

participants included stakeholders from demand side such as the cardiovascular surgeons, as well as participants

from the supply side such as the marketing managers, sales managers and product managers of companies

manufacturing/marketing cardiovascular devices.

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Table 49: Total Number of Primary Research Participants, Cardiovascular Devices Market, by Country

Country Total Number of Primary Research Participants

United States 136

United Kingdom 120

Germany 128

France 153

Italy 121

Spain 134

Brazil 128

China 79

India 173

Russia 89

Japan 88

Australia 122

Canada 111

Mexico 90

South Korea 99

Total 1,771

Source: GlobalData

8.1.4 Market Modeling and Forecasting

GlobalData uses an epidemiology-based treatment flow model and capital equipment-based model to estimate and

forecast market size.

Epidemiology-Based Market Model and Forecasting

The epidemiology-based forecasting model uses epidemiology data gathered from research publications and primary

interviews with physicians to establish the target patient population and treatment flow pattern for individual diseases

and therapies. The data covers prevalence, incidence, diseased population, diagnosed population, and treatment

population.

The market forecast begins with the general population, the size of which varies depending on the indication.

Prevalence is the percentage of the total population that suffers from a particular disease or condition.

Incidence is the number of new cases of a condition, symptom, death or injury that develop during a specific

time period, such as one year.

The diseased population is the population suffering from a particular disease or condition.

The diagnosed population is the population that has been diagnosed with a particular disease or condition,

expressed as a percentage of the prevalence population.

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The treatment population is the percentage of the population that has been diagnosed with a particular

disease or condition.

Device uptake is the percentage of the treatment population using a particular device, determined based on

the primary responses and the information available in secondary sources.

The epidemiology-based forecasting model for a medical device is used to:

Determine the patient segment using a particular device or procedure

Determine the frequency of usage of a particular device depending on the patient type, which further helps to

determine the absolute unit sales of a device in a year

The market for any medical device is directly proportional to the volume of units sold and the price per unit.

Market size = volumes of units sold X ASP (Average Selling Price)

The volume of units sold is calculated from the number of patients using or that has been implanted with the device.

Data on treatment rate, diagnosis and surgical treatment rate, if unavailable from research publications, is gathered

from interviews with physicians and used to estimate the patient volume for the disease under consideration.

The ASP of a device is mostly gathered from primary and secondary sources. ASP is the price at which a device is

available in a target country to an end-user. For capital equipment, the end-user is typically considered to be the

healthcare setting. For implants and consumables purchased by patients, the end-user is the patient.

Factors such as company share, reimbursement, company type (local/domestic or multinational) are taken into

consideration during ASP analysis, which uses the following sources:

Company websites

Annual reports/industry reports

Press releases

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Epidemiology-Based Forecasting Model

Capital Equipment-Based Market Model and Forecasting

The capital equipment-based forecasting model is based on the installed base, replacements and new sales of a

specific type of capital equipment in healthcare facilities such as hospitals, clinics and diagnostic centers. The

installed base is calculated from the average number of units per facility. Sales for a particular year are arrived at by

calculating the number of replacement units and new units (additional and first-time purchases). Secondary sources

and interviews with supply-side participants and key opinion leaders from healthcare facilities are used to arrive at

installed base and unit sales for a particular year. The factors typically affecting the forecast growth rates are:

Growth in the number of healthcare facilities

Healthcare spending and government programs and initiatives

Migration from low-end equipment to high-end equipment

Growth in the diagnosed population and treatment population

Figure 6: GlobalData Epidemiology-Based Forecasting Model

Source: GlobalData

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Capital Equipment-Based Forecasting Model

8.1.5 Company Share Analysis

Company shares are calculated by analyzing a company‘s sales in a particular market. In the case of public

companies, annual reports and regulatory filings, investor presentations, earnings call transcripts and broker reports

are used to determine a company‘s revenue in a particular market and in a particular geography.

In the case of the private companies, company share data is gathered mostly from primary interviews and secondary

sources. Company share analysis is based on primary interviews with:

Supply side (manufacturers)

Procurement side

Distributors

Hospital purchasing groups

Demand side (surgeons/specialists)

Figure 7: GlobalData Capital Equipment-Based Forecasting Model

Source: GlobalData

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The benefits of this approach are:

High number of respondents to validate and from which to derive accurate company shares

Broad view from the supply, demand, and procurement side

Prevents biased opinions being reproduced

Demand-side interviews with key opinion leaders help to understand their preferences for the devices of

specific companies, strengthening company share estimates

Primary Interviews by Participant Type

Figure 8: Primary Interviews by Participant Type (%)

The final company share data is based on input from the supply side, the procurement side and the demand side, as

well as secondary sources. Please note that market share for companies that are included under the ‗Others‘

category is not tracked on an individual basis.

8.1.6 Distribution Share Analysis

Distribution share information is gathered using a combination of secondary and primary research. It is supported by

primary interviews because the availability of secondary data is limited in most cases.

8.2 Expert Panel

GlobalData uses a panel of experts to cross-verify its databases and forecasts.

GlobalData‘s expert panel comprises marketing managers, product specialists, international sales managers from

medical device companies, academics from research universities, key opinion leaders from hospitals, consultants

from venture capital funds and distributors/suppliers of medical equipment and supplies.

Historic data and forecasts are relayed to GlobalData‘s expert panel for feedback and adjusted accordingly.

50

25

25

Procurement side Supply side Demand side

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8.3 GlobalData Consulting

We hope that the data and analysis in this brief will help you to make informed and imaginative business decisions. If

you have further requirements, GlobalData‘s consulting team may be able to help you. GlobalData offers tailor-made

analytical and advisory services to drive your key strategic decisions.

8.5 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.

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