2.3.4 Impact of Reimbursement on Procedure Coding 68

3.0 RADIOISOTOPE PRODUCTS AND TECHNOLOGY 70

3.1 TRADE-OFFS IN RADIATION SOURCES 70

3.2 ISOTOPE CHARACTERISTICS 72

3.2.1 Radiopharmaceutical Selection 76

3.2.2 Biophysical Considerations  77

TABLE OF CONTENTS 
 
 

Section     Page

3.3 RADIOISOTOPE PRODUCTION METHODS 80

3.3.1 Nuclear Reactors 82

3.3.2 Accelerators  85

3.3.3 Radionuclide Generators 86

3.4 RADIOPHARMACEUTICAL PREPARATION 87

3.4.1 Commercial Radiopharmacies 88

3.4.2 New Radiopharmaceuticals 89

4.0 CURRENT DEVELOPMENTS AND EMERGING TECHNOLOGY 91

4.1 INTRODUCTION AND OVERVIEW  92

4.1.1 Types of Brachytherapy  92

4.1.2 Brachytherapy Products and Technology  92

4.2 PROSTATE SEED IMPLANTS 94

4.2.1 Design Characteristics  94

4.2.2 Clinical Considerations 95

4.2.3 Resorbable Prostate Seeds 96

4.2.3.1 Improved Cancer Cell-Killing 97

4.2.3.2 Composition of the Resorbable Seeds 98

4.3 PARTIAL BREAST IRRADIATION  99

4.3.1 Second Generation Breast Irradiation Devices 100

4.3.2 Axxent Breast Irradiation Device 101

4.3.3 Recent Approval of Axxent for Skin and Surface Treatment 102

4.4 GYNECOLOGICAL BRACHYTHERAPY  103

4.4.1 Axxent Cervical Brachytherapy Device 103

TABLE OF CONTENTS 
 
 

Section     Page

4.4.2 Gynocyte Brachytherapy Device 104

4.5 IRRADIATED MICROSPHERE INFUSION 104

4.5.1 Treatment with SIR-Spheres 106

4.5.2 Y-90 TheraSpheres 106

4.5.3 Other Applications for Microsphere Technology 107

4.6 BRACHYTHERAPY FOR MACULAR DEGENERATION 108

4.6.1 Impetus to Use Brachytherapy for Macular Degeneration 108

4.6.2 NeoVista’s Vidion Device 109

4.6.3 Compelling Features of NeoVista's Product 110

4.6.4 Other Ophthalmic Brachytherapy Applications 110

4.7 OTHER POST-SURGICAL BRACHYTHERAPY DEVICES  112

4.7.1 GliaSite Brachytherapy for Brain Tumors 113

4.7.2 Short Term Implant Philosophy 114

4.8 ENDOVASCULAR BRACHYTHERAPY 115

4.8.1 Types of Endovascular Devices 115

4.8.2 Radiation Sources 116

4.8.3 Novoste Beta-Cath 117

4.8.4 Trade-Offs with Radioactive Stents  118

5.0  END-USER ANALYSIS  119

5.1 OVERVIEW OF THE USER ENVIRONMENT 119

5.1.1 Organization of Nuclear Medicine Departments 120

5.2 ALLOCATION OF HOSPITAL MEDICAL IMAGING EQUIPMENT 121

5.3 COMPARATIVE UTILIZATION PARAMETERS 122

TABLE OF CONTENTS 
 
 

Section     Page

5.4 DISTRIBUTION OF IMAGING PROCEDURES 125

5.4.1 Relative Diagnostic Activity 125

5.4.2 Relative Procedure Volume 128

5.4.3 Imaging Activity Index 129

5.5 IMPLEMENTATION OF BRACHYTHERAPY PROCEDURES 129

6.0 COMPANY PROFILES  132

1. INTRODUCTION  132
2. ADVANCED MEDICAL ISOTOPE CORP. (AMIC) 134
3. ANAZAO HEALTH CORPORATION 136
4. ANTISOMA LTD. (UK) 137 
5. BEST MEDICAL INTERNATIONAL 139
6. BIO-NUCLEONICS, INC. 140
7. BRACHYSCIENCES, INC. 141
8. CIANNA MEDICAL, INC. 143 
9. C.R. BARD, INC.  145 
10. CORE ONCOLOGY, INC. 146 
11. COVIDIEN, LTD.  147
12. CYTOGEN CORPORATION 149
13. GE HEALTHCARE 152 
14. GENENTECH, INC.  156 
15. HOLOGIC, INC.  158 
16. IMMUNOMEDICS, INC. 164 
17. INTUITIVE SURGICAL, INC.. 166

TABLE OF CONTENTS 
 
 

Section     Page

18. ISORAY MEDICAL, INC. 169  
19. MDS NORDION  171
20. NAS MEDICAL, INC.  175
21. NEOVISTA, INC.  177 
22. NUCLETRON BV  179
23. SIRTEX MEDICAL LTD. 182 
24. THERAGENICS CORPORATION 187 
25. VARIAN MEDICAL SYSTEMS 189
26. XOFT, INC  193 

APPENDIX

SUPPLIERS OF BRACHYTHERAPY AND 196

RADIOISOTOPE-BASED PRODUCTS  
 
 
 
 
 
 
 
 

U.S. MARKET FOR

BRACHYTHERAPY PRODUCTS

LIST OF EXHIBITS  
 
 

Exhibit    Page

1. HISTORIC AND FORECAST SALES OF BRACHYTHERAPY 15

         PRODUCTS BY PRODUCT GROUP FROM 2006-2016

2. RELATIVE PROPORTION OF BRACHYTHERAPY SALES 17

         BY PRODUCT GROUP FROM 2006-2016

3. RELATIVE GROWTH OF BRACHYTHERAPY PROCEDURES 19

         BY PRODUCT GROUP FROM 2006-2016

4. GROWTH OF BRACHYTHERAPY PROCEDURE VOLUME 21

         WITH RESPECT TO THE INCIDENCE OF DISEASE FROM 2006-2016

5. 2008 BRACHYTHERAPY SALES SUMMARY 25

         BY PROCEDURE CATEGORY AND PRODUCT TYPE

6. 2016 BRACHYTHERAPY SALES SUMMARY 27

         BY PROCEDURE CATEGORY AND PRODUCT TYPE

7. HISTORIC AND FORECAST SALES GROWTH OF BRACHYTHERAPY 31

         SEEDS FOR PROSTATE IMPLANT BY PRODUCT TYPE

         FROM 2006-2016

8. SALES VOLUME AND DISTRIBUTOR INCOME OF PROSTATE SEED 33

         SUPPLIERS, RELATIVE GROWTH AND MARKET SHARES

         IN 2007 AND 2008

9. HISTORIC AND FORECAST SALES OF BRACHYTHERAPY SEEDS 35

         BY MANUFACTURERS AND DISTRIBUTORS  FROM 2006-2016

10. HISTORIC AND FORECAST SALES OF BREAST CANCER 40

         BRACHYTHERAPY, MANUFACTURER'S UNIT SALES AND

         SALES VOLUME FROM 2006-2016

11. HISTORIC AND FORECAST SALES OF BRACHYTHERAPY DEVICES 43

         FOR GYNECOLOGY AND OTHER ACCESSIBLE CANCERS

         FROM 2006-2016

LIST OF EXHIBITS  
 
 

Exhibit    Page

12. HISTORIC AND FORECAST SALES OF BRACHYTHERAPY DEVICES 46

         FOR TREATING BRAIN CANCER GLIOMA POST-SURGICALLY,

         MANUFACTURER'S SALES VOLUME FROM 2006-2016

13. HISTORIC AND FORECAST SALES OF IRRADIATED MICROSPHERES  50

         FOR DIRECT INFUSION TO TREAT LIVER CANCER,

         MANUFACTURER'S SALES VOLUME AND MARKET SHARE

         FROM 2006-2016

14. HISTORIC AND FORECAST SALES OF ENDOVASCULAR 54

         BRACHYTHERAPY, MANUFACTURER'S SALES VOLUME

         FROM 2006-2016

15. FORECAST SALES OF BRACHYTHERAPY PRODUCTS FOR 57

         TREATING MACULAR DEGENERATION, MANUFACTURER'S SALES

         FROM 2010-2016

1. GROWTH OF BRACHYTHERAPY PROCEDURE VOLUME 63

         BY PRODUCT APPLICATION FROM 2008-2014

2. PROPORTION OF BRACHYTHERAPY PROCEDURES 64

         BY PRODUCT APPLICATION FROM 2008-2015

1. COMMON BRACHYTHERAPY ISOTOPES 71

         TYPE OF RADIATION AND TYPICAL HALF-LIFE

2. DIAGNOSTIC AND THERAPEUTIC ISOTOPES  74
1. COMPARATIVE ALLOCATION OF DIAGNOSTIC FACILITIES 123

         BY HOSPITAL BED SIZE IN 2008

2. COMPARATIVE UTILIZATION PARAMETERS 124

         FOR DIFFERENT IMAGING MODALITIES IN 2008

3. DISTRIBUTION OF HOSPITAL DIAGNOSTIC IMAGING PROCEDURES 126

         IN THE U.S. BY HOSPITAL BED SIZE IN 2008

4. RELATIVE PROCEDUREm VOLUME FOR DIFFERENT IMAGING 127

MODALITIES, PERCENTAGE RELATIONSHIP BY HOSPITAL BED SIZE

          IN 2008

5. RELATIVE ACTIVITY INDEX AMONG DIFFERENT IMAGING, 130

         MODALITIES PROCEDURES PER BED PER YEAR BY HOSPITAL

         BED SIZE IN 2008