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Regenerative Medicine Markets --- Aarkstore Enterprise

Posted Nov 25 2010 6:34am

Regenerative medicine is a way of treating injured and diseased human tissue by using laboratory-grown or therapeutically-induced human tissue as a replacement. As such, astounding new advancements in the ability to repair or replace damaged human tissue and organ functions are being made. Whereas before, remedies for damaged tissue or organ functions due to congenital deformities, injuries, diseases or simple wear-and-tear relied upon either the body's ability to repair itself (or not), or a surgeon's skilled hands.

Now, the area of regenerative medicine promises to revolutionize humanity's ability to remediate countless physical maladies that have perpetually afflicted humans and other animals. Compared to a select few life forms--like the starfish--man-made solutions for tissue repair and organ replacement haven't come close to nature's solutions. And where there once was no solution even offered by nature, researchers are now at the cusp of overcoming such limitations by literally regrowing damaged tissue and restoring organ functions through the use of tissue engineering and stem cell therapy. This is the promise of regenerative medicine.

This report discusses the current state of regenerative medicine. The study provides a thorough overview of regenerative medicine sector together with analyses of the funding trends, intellectual property, market opportunities, therapeutic pipeline, research collaborations, partnership activities, and guidelines for establishing new ventures. The report enables the reader gain in-depth knowledge about ongoing tissue engineering and stem cell therapy research programs carried out in universities and other research centers. Moreover, this analysis profiles the leading companies developing regenerative medicine solutions.




Table of Contents :

TABLE OF CONTENTS

1. Overview 17
1.1 Statement of Report 17
1.2 Scope of this Report 19
1.3 Methodology 19
1.4 Executive Summary 20

2. Regenerative Medicine: An Overview of Segments 22
2.1 Tissue Engineering 22
2.1.1 Tissue-Engineered Skin 23
2.1.2 Tissue-Engineered Cartilage 23
2.1.3 Tissue-Engineered Bone 23
2.1.4 Tissue-Engineered Peripheral Nerves 24
2.1.5 Tissue-Engineered Cornea 24
2.1.6 Tissue-Engineered Blood Vessels 24
2.2 An Overview of Tissue Engineering and Regenerative Medicine (TERM) 25
2.2.1 Tissue-Engineered Products and Their Applications 26
2.2.1.1 Skin, Cartilage, Bone and Urological Applications 26
2.2.1.2 Cardiovascular Applications 27
2.2.1.3 Neurological Applications 27
2.2.1.4 Pancreas, Liver and Kidney Applications 28
2.2.1.5 Ophthalmic Applications 28
2.2.1.6 Dental Applications 28
2.2.1.7 Autologous and Allogeneic Products 28
2.2.2 Geographic Distribution of TERM Firms in the Five Focus Countries 29
2.3 Cell Therapy 32
2.3.1 Number of Patients Treated between 1988 and 2010 by Regenerative Medicine Therapies 34
2.3.2 Cell Culture Products 34
2.3.2.1 In Vitro Test Kits 36
2.3.2.2 Suppliers of Cells and Tissues 37
2.3.2.3 Suppliers of Culture Media and Reagents 38
2.3.2.4 Equipments for Stem Cell Research 38
2.3.2.5 Computer Software for Stem Cell Research 39
2.3.3 Overall Picture of Cell Therapy Industry 41
2.3.3.1 The Size of Cell Therapy Industry 41
2.3.3.2 The Age, Size and Location of Firms 42
2.3.3.3 Technology and Disease Focus 44
2.3.4 Cell Therapy Products and Companies 44
2.3.4.1 First Generation (Non-Stem Cell-based) Primary Products 46
2.3.4.2 Second Generation (Stem Cell-Based) Primary Products 47
2.3.4.3 Secondary Products 47
2.3.4.4 Products in Development 48
2.3.5 The Disease Focus of Clinical Trials 49
2.3.5.1 Stem Cell Industry Pipeline 50
2.3.6 Industry Collaboration in Stem Cell Space 52
2.3.6.1 Commercial Success in Stem Cell Industry 53
2.3.6.2 Major Shift to Stem Cells from Non-Stem Cell Technologies 53
2.3.6.3 Challenges to Commercial Development of Cell Therapies 54
2.3.6.4 Partnership of Stem Cell Companies with Large Pharmaceutical Companies 55
2.3.6.5 Strategic Approaches for Cell-Based Companies 56
2.3.6.6 The Need for Support from Large Pharmaceuticals 57
2.4 Scaffolding Biomaterials 58
2.4.1 Biomaterial Scaffolds in Regenerative Medicine 59
2.5 Growth Factors 60

3. Regenerative Medicine: The Next Evolution of Medical Treatments 62
3.1 Scope of this Chapter 62
3.2 Need for Regenerative Medicine 62
3.3 Current State of Regenerative Medicine 62
3.4 Future of Regenerative Medicine 63
3.5 Number of Products in Pipeline 63
3.6 Projected Timeline for Regenerative Medicine 67
3.7 Regenerative Medicine Products in the Market 68
3.7.1 Medtronic's Infuse Bone Graft and the LT-Cage Device 69
3.7.2 Genzyme's Carticel 69
3.7.3 Stryker's OP-1 70
3.7.4 Osyris/Nuvasive's Osteocel 71
3.7.5 RTI's Spinal Implants 71
3.7.6 Organogenesis' Apligraf 72
3.7.7 Advanced BioHealing's Dermagraft 72
3.7.8 Integra's Bilayer Matrix Wound Dressing 73
3.7.9 LifeCell's Alloderm 73
3.7.10 Cytori Therapeutics' Celution 74
3.8 Other Products of Importance in Regenerative Medicine 74
3.8.1 Tissue-Engineered Wound Healing Products 74
3.8.1.1 Oasis 75
3.8.1.2 Permacol 76
3.8.1.3 EZ-Derm 76
3.8.1.4 Matriderm 76
3.8.1.5 TransCyte 77
3.8.1.6 ICX-SKN 77
3.8.1.7 OrCel 78
3.8.1.8 Epicel 78
3.8.1.9 Myskin 78
3.8.1.10 VCT01 79
3.8.2 ICX-TRC-Hair Regeneration Therapy 79
3.8.3 Cartilage Regeneration 79
3.8.3.1 Novocart 79
3.8.3.2 BioSeed-C 80
3.8.3.3 BioSeed-Oral Bone 80
3.8.3.4 Chondrotissue 80
3.8.3.5 co.don Chondrotransplant 80
3.8.3.6 co.don Chondrotransplant DISC 80
3.8.3.7 co.don Chondrosphere 80
3.8.3.8 co.don Osteotransplant DENT 80
3.8.3.9 MACI Implant 81
3.8.3.10 Cartilink-3 81
3.8.3.11 Accell Evo3 Demineralized Bone Matrix 81
3.8.3.12 OsSatura BCP 81
3.8.4 Mozobil 81

4. Market Analysis of Regenerative Medicine Sector 82
4.1 Scope of this Chapter 82
4.1.1 Market for Regenerative Medicine Products 82
4.1.2 The Different Characteristics of Regenerative Medicine Industry in the Recent Past 85
4.1.3 Potential Market for Regenerative Medicine in the U.S. 86
4.2 Global Market for Stem Cells 87
4.3 Market for Cell Therapy in the U.S. 88
4.4 Global Market for Cord Blood Stem Cells 88
4.4.1 Public Cord Blood Banks 89
4.4.2 Private Cord Blood Banks 90

5. Business Models and Requirements for a Successful Regenerative Medicine Industry 91
5.1 Scope of this Chapter 91
5.1.1 The Limited Success Achieved by the Regenerative Medicine Products 91
5.1.2 Business Models in Regenerative Medicine 91
5.1.3 Current Model for Autologous Cell Therapies 93
5.1.4 Current Models for Allogeneic Cell Therapies 94
5.1.5 Key Factors for Successful Business Models for Cell Therapies 95
5.2 Commercial Manufacturing of Cell Therapy Products: Requirements 96
5.2.1 Elements of Commercial Manufacturing 96
5.2.1.1 Regulatory Requirements 96
5.2.1.2 Manufacturing Process Scale 96
5.2.1.3 In-House Manufacturing 97
5.2.1.4 Contract Manufacturing: Commercial and Academic 97

6. Diseases with Potential Applications for Regenerative Medicine 100
6.1 Regenerative Medicine and Diabetes 102
6.2 Regenerative Medicine for Cardiac Repair 103
6.3 Regenerative Medicine in Orthopedics 103
6.3.1 Orthobiologics in Orthopedics 103
6.3.2 Growth Factor Therapies in Orthopedics 104
6.3.3 Stem Cell Therapies in Orthopedics 104
6.4 Regenerative Medicine in Liver Diseases 104
6.4.1 Hepatocyte-Like Cells for Liver Disease 105
6.4.2 Cell Therapy for Liver Cirrhosis 105
6.4.3 CD 34+ Cells 105
6.5 Regenerative Medicine in Retinal Replacement Therapy 105
6.5.1 Retinal Transplantation 106
6.6 Regenerative Medicine in Central Nervous System (CNS) Disorders 106
6.6.1 Clinical Activity for Stem Cell Transplantation into the CNS 106

7. Current Stem Cell Research and Federal Funding in the U.S. 107
7.1 Scope of this Chapter 107
7.2 Stem Cell Policies in North America 107
7.3 Stem Cell Policies in South America 108
7.4 Stem Cell Policies in Europe 108
7.5 Stem Cell Policies in Asia/Oceania 110
7.6 Stem Cell Policies in Africa 111
7.7 Stem Cell Research and California Institute for Regenerative Medicine (CIRM)
111
7.7.1 CIRM Collaborative Funding 112
7.7.2 CIRM's funding for Clinical Applications 113
7.7.3 Early Translational Awards 113
7.7.4 CIRM's Disease Team Awards 114
7.8 Stem Cell Research Programs in Connecticut Department of Public Health 114
7.8.1 Seed Grant Awards from Connecticut Stem Cell Research Program in 2010 114
7.8.2 Established Investigator Awards from Connecticut Stem Cell Research Program in 2010 114
7.8.3 Group Project Awards from Connecticut Stem Cell Research Program in 2010 116
7.8.4 Core Facility Awards from Connecticut Stem Cell Research Program in 2010 116
7.8.5 Maryland Technology Development Corporation (TEDCO) 116
7.8.6 TEDCO's Fort Detrick Technology Transfer Initiative (FDTTI) 116
7.8.7 Johnson & Johnson Investment Fund 116
7.8.8 TEDCO's NAVAIR Technology Insertion (NAVTI) Program 116
7.8.9 TEDCO's TechStart Program 116
7.8.10 TEDCO's University Technology Development Fund (UTDF) 116
7.8.11 TEDCO's Working Capital Loan Fund 116
7.8.12 Maryland Technology Transfer and Commercialization Fund (MTTCF) 117
7.8.13 Maryland Stem Cell Research Fund 117
7.9 The New Jersey Commission on Science and Technology (NJCST) 117
7.9.1 Investigator Initiated Research Projects (IIRP) and Innovative, Developmental or Exploratory Activities (IDEA) in Stem Cell Research 118
7.9.2 Targeted Request for Applications for Investigation of iPS and Other
Derivation Approaches 119
7.9.3 Shared Facilities/Resources and Equipment/Instrumentation for Stem Cell Research 119
7.9.4 Consortia Planning Awards 119
7.9.5 Institutional Development 120
7.10 Center for Stem Cell and Regenerative Medicine 120
7.11 Global Funding for Regenerative Medicine 120
7.12 Federal Funding of Stem Cell Research in the U.S.: Past and Present 120
7.12.1 The U.S. National Institute of Health (NIH) Guidelines to hESC Research 121
7.12.2 Types of Research Ineligible for NIH Funding 121
7.12.3 NIH's Leadership in Providing Funds for Stem Cell Research 121
7.12.4 NIH Guidelines Addressing the Projected Growth of Stem Cell-related Clinical Trials 121
7.12.5 Federal Agencies Providing Funds for Stem Cell Research 122

8. Company Profiles 123
8.1 Aastrom Biosciences, Inc. 123
8.1.1 Aastrom's Clinical Trial Programs 123
8.1.1.1 Dilated Cardiomyopathy 123
8.1.1.2 Critical Limb Ischemia 123
8.1.1.3 Osteonecrosis of the Femoral Head 123
8.1.1.4 Other Bone Disorders 123
8.1.2 Product Development 124
8.1.3 Aastrom's Cell Manufacturing 124
8.1.4 Aastrom's Business Performance 124
8.2 Advanced Cell Technology, Inc. (ACT) 125
8.2.1 ACT's Cellular Reprogramming 125
8.2.2 ACT's Stem Cell Differentiation 126
8.2.2.1 ACT's Retinal Pigment Epithelium (RPE) Program 126
8.2.2.2 ACT's Hemangioblast Program 126
8.2.2.3 ACT's Adult Stem Cell Program 126
8.2.3 ACT's Intellectual Property 126
8.2.4 ACT's Business Performance 128
8.2.5 ACT's Investment in Research and Development 128
8.3 Aldagen, Inc. 129
8.3.1 Aldagen's ALD-201 129
8.3.2 Aldagen's ALD-301 129
8.4 Altrika Ltd. 129
8.4.1 Myskin 129
8.4.2 Cryoskin 130
8.4.3 Altrika's Future Products 130
8.4.3.1 Lyphoderm 130
8.4.3.2 Corneal Bandage 130
8.4.3.3 Leukodepletion Filters 131
8.5 Alseres Pharmaceuticals, Inc. 131
8.5.1 Alseres' Product Pipeline 131
8.5.1.1 Celthrin-A Rho Inhibitor 132
8.5.1.2 Inosine 132
8.5.1.3 Oncomodulin and ALSE-100 133
8.5.1.4 Altropane-PD 133
8.5.2 Alseres' Science and Technology 134
8.5.2.1 Nerve Repair Pathways 134
8.5.2.2 The Pro-Regenerative Pathway 135
8.5.2.3 The Anti-Regenerative Pathway 135
8.5.2.4 Molecular Imaging 136
8.5.2.5 Dopamine Transporter 136
8.6 Amgen, Inc. 137
8.6.1 Amgen's Marketed Products 139
8.6.1.1 Aranesp (Darbepoetin Alfa) 139
8.6.1.2 Epogen (Epoetin Alfa) 139
8.6.1.3 Neulasta (Pegfilgrastim)/Neupogen (Filgrastim) 140
8.6.1.4 Enbrel (Etanercept) 141
8.6.1.5 Sensipar (Cinacalcet) 141
8.6.1.6 Vectibix (Panitumumab) 142
8.6.1.7 Nplate (Romiplostim) 143
8.6.2 Amgen's Marketing and Distribution 143
8.6.3 Amgen's Overall Business Performance 144
8.7 Amorcyte, Inc. 145
8.7.1 Amorcyte's Technology 145
8.7.1.1 AMR-001 145
8.8 AnGes MG, Inc. 146
8.8.1 AnGes' Genetic Medicine 146
8.8.2 HGF Genetic Medicine 147
8.8.3 Hemagglutinating Virus of Japan (HVJ) Envelope Vector 147
8.8.4 NF-kB Decoy Oligodeoxynucleotide 148
8.9 Angioblast Systems, Inc. 149
8.9.1 Angioblast's Technology and Applications 149
8.9.1.1 Allogenic Adult Stem Cells 149
8.9.1.2 Protein Therapeutics 150
8.9.1.3 Gene Slicing 150
8.10 Angion Biomedica, Corp. 150
8.10.1 HGF and c-Met Signaling in Tissue Repair and Organ Regeneration 151
8.10.2 PARP-1 152
8.10.3 TGFB1 152
8.11 Ars Arthro Biotechnology, Inc. 153
8.11.1 CaReS 153
8.11.2 Fibrocell 153
8.11.3 Fibroplus 153
8.12 Arteriocyte Medical Systems, Inc. 154
8.12.1 Blood Pharming 154
8.12.2 Cardiac Ischemia 154
8.12.3 Critical Limb Ischemia 154
8.12.4 Malaria Research 155
8.12.5 Orthopedic Regenerative Medicine 155
8.12.6 Proliferative Diabetic Retinopathy 155
8.12.7 Wound Healing 155
8.13 Athersys, Inc. 156
8.13.1 Athersys' Pipeline 156
8.13.2 MultiStem for Stem Cell Therapy 156
8.13.3 MultiStem for Bone Marrow (BM) Transport Support 157
8.13.4 MultiStem for Acute Myocardial Infarction 157
8.13.5 MultiStem for Stroke 157
8.13.6 Treatments for Obesity 158
8.13.7 Histamine H3 Receptor Antagonists 158
8.13.8 Athersys' Collaborations and Partnerships 158
8.13.8.1 Collaboration with Pfizer 158
8.13.8.2 Collaboration with Angiotech 158
8.13.8.3 Collaboration with Bristol-Myers Squibb 158
8.13.9 Athersys' Research and Development 158
8.13.10 Athersys' Business Performance 159
8.14 BeFutur Biotechnologies 160
8.14.1 BeFutur's Technologies 160
8.14.1.1 Cells and Tissue Engineering 160
8.14.1.2 Serum-Free Technology 160
8.15 BioE, Inc. 160
8.15.1 BioE's Products 160
8.16 Bioheart, Inc. 161
8.16.1 Bioheart's Product Candidates 161
8.16.1.1 MyoCell 161
8.16.1.2 MyoCell SDF-1 161
8.16.1.3 TGI 1200 Cell Isolation System 161
8.16.1.4 Bioheart 3370 162
8.16.2 Bioheart's Patents and Proprietary Rights 162
8.17 BioLine Rx 162
8.17.1 BioLine's Product Pipeline 163
8.17.1.1 BL-1020 Schizophrenia 163
8.17.1.2 BL-1040 for Acute Myocardial Infarction 163
8.17.1.3 BL-5010 for Skin Lesions 163
8.17.1.4 BL-1021 for Neuropathic Pain 163
8.17.1.5 BL-2030 for Inflammation 163
8.17.1.6 BL-1023 for Parkinson's Disease 163
8.17.1.7 BL-4010 for Cancer 164
8.17.1.8 BL-4040 for Acute Kidney Failure 164
8.17.1.9 BL-5030 for Thromboembolic Diseases 164
8.17.1.10 BL-5040 for Cachexia and Inflammatory Bowel Disease 164
8.18 BIOMET 165
8.18.1 BIOMET 3i 165
8.18.2 Clotalyst Autologous Serum Collection System 165
8.18.3 BioCUE Platelet Concentration System 165
8.19 BioMimetic Therapeutics, Inc. 165
8.19.1 BioMimetic's Product Candidates 165
8.19.2 BioMimetic's Research and Development 167
8.20 BioSafe Group SA 167
8.20.1 Sepax 167
8.20.2 Sepax System in Adult Stem Cell Banking 168
8.20.3 Coolmix 168
8.20.4 SepaxNet 168
8.21 BioTime, Inc. 169
8.21.1 BioTime's Stem Cell Products for Regenerative Medicine 169
8.21.2 BioTime's Embryome Database 169
8.21.3 BioTime's Progenitor and hES Cell Lines 170
8.21.4 BioTime's hES Cells Carrying Genetic Diseases 170
8.21.5 BioTime's ESpan Cell Growth Media 170
8.21.6 BioTime's ESpy Cell Lines 170
8.21.7 BioTime's Licensed Stem Cell Technology and Stem Cell Product Development Agreements 170
8.21.7.1 Wisconsin Alumni Research Foundation 170
8.21.7.2 ACTCellerate Technology 170
8.21.7.3 The iPS Technology 171
8.21.7.4 Lifeline 171
8.21.7.5 BioTime's Stem Cell Agreement with Reproductive Genetics Institute 171
8.21.8 BioTime's Plasma Volume Expanders and Related Products 171
8.21.8.1 Hextend 171
8.21.8.2 PentaLyte 171
8.22 Biovest International, Inc. 171
8.22.1 BiovaxID Cancer Vaccine 172
8.23 BrainStorm Cell Therapeutics, Inc. 172
8.23.1 BrainStorm's Technology 172
8.23.2 BrainStorm's Stem Cell Therapy 173
8.23.3 BrainStorm Technology-NurOwn 173
8.24 Cardio3 BioSciences 174
8.24.1 Cardio3's Product Pipeline 174
8.24.1.1 C-Cure 174
8.24.1.2 C-Cure2 174
8.24.1.3 Allo-Cure 175
8.24.1.4 G-Cure 175
8.24.1.5 C-Cath 175
8.24.2 Cardio3's Investors 175
8.25 CardioPolymers, Inc. 175
8.25.1 CardioPolymer's Products 176
8.25.1.1 Algisyl-LVR 176
8.25.1.2 Plexisyl-AF 176
8.25.2 CardioPolymer's Investors 176
8.26 CaridianBCT 177
8.26.1 Trima Accel Automated Blood Collection System 177
8.26.2 Spectra Optia Apheresis System 177
8.26.3 COBE Spectra Apheresis System 177
8.26.4 Elutra Cell Separation System 178
8.26.5 Atreus Whole Blood Processing System 178
8.26.6 OrbiSac System 178
8.26.7 COBE 2991 Cell Processor 179
8.27 Cardium Therapeutics, Inc. 179
8.27.1 Cardium Biologics 180
8.27.2 Cardium's Tissue Repair Company 180
8.27.3 Cardium's Gene Activated Matrix (GAM) Technology 180
8.27.4 Cardium's Biologics and Stem Cells for Regenerative Medicine 180
8.28 Cellartis AB 180
8.28.1 Cellartis' Products 181
8.28.1.1 The hES-CMC 2D: Cardiomyocyte Monolayers 181
8.28.1.2 The hES-CMC 002: Cardiomyocyte Clusters 181
8.28.1.3 The hES-HEO 002: Hepatocyte-like Cells 182
8.28.1.4 The hES-MP 002.5: Mesenchymal Progenitors 182
8.28.1.5 The hES Cell Lines 183
8.28.1.6 SCED 461: Human ES Cells 183
8.28.1.7 Monoclonal Antibodies 183
8.28.2 Cellartis' Licensing Activities 184
8.29 Cellerix 184
8.29.1 Ontaril 184
8.29.2 Cx501 185
8.30 Celgene Corporation 185
8.30.1 Celgene's Business Performance 186
8.30.2 Celgene's Commercial Stage Products 186
8.30.2.1 Revlimid (Lenalidomide) 186
8.30.2.2 Thalomid (Thalidomide) 187
8.30.2.3 Vidaza (Azacitidine for Injection) 187
8.30.2.4 Ritalin Family of Drugs 187
8.30.2.5 Alkeran (Melphalan) 187
8.30.2.6 IMiDs Compounds 187
8.30.2.7 Oral Anti-Inflammatory Agents 188
8.30.2.8 Kinase Inhibitors 188
8.30.2.9 Cellular Therapies 188
8.31 CellSeed, Inc. 189
8.31.1 CellSeed's Epithelial Cell Sheet for Corneal Regeneration 189
8.31.2 CellSeed's Regenerated Cardiac Patch 189
8.31.3 CellSeed's Epithelial Cell Sheet for Esophageal Regeneration 189
8.31.4 CellSeed's Cell Sheet for Periodontal Tissue Regeneration 189
8.31.5 CellSeed's Regenerated Cartilage Sheet 190
8.32 Cellular Dynamics International 190
8.32.1 The iCell Cardiomyocytes 190
8.32.2 Cellular Dynamics' Technology 190
8.33 Celltrix 191
8.33.1 Credurance 191
8.34 Cerco Medical 191
8.34.1 Cerco Medical's Concept 192
8.34.2 Bio-Artificial Endocrine Pancreas 192
8.35 Cook Biotech, Inc. 192
8.35.1 Cook's Technology 193
8.35.2 Biodesign Dural Graft 193
8.35.3 Dynamatrix Oral Graft 193
8.35.4 SiS Ophthalmic 193
8.35.5 Oasis Wound Matrix 194
8.35.6 Biodesign Staple Line Reinforcement 194
8.35.7 Biodesign Hiatal Hernia Graft 194
8.35.8 ECM for Pericardial Closure 194
8.35.9 ECM for Cardiac Tissue Repair 194
8.35.10 Biodesign 8-Layer Tissue Graft 195
8.35.11 Biodesign Abdominal Lock Graft 195
8.35.12 Biodesign Hernia Graft 195
8.35.13 Biodesign Inguinal Hernia Graft 195
8.35.14 Biodesign Umbilical Hernia Graft 196
8.35.15 Biodesign Anterior Pelvic Floor Graft 196
8.35.16 Biodesign Fistula Plug 196
8.35.17 Biodesign Posterior Pelvic Floor Graft 197
8.35.18 Surgisis Biodesign Peyronie's Repair Graft 197
8.35.19 Biodesign Tension-Free Urethral Sling 197
8.35.20 Biodesign Vaginal Erosion Repair Graft 198
8.35.21 AxoGuard Nerve Protector 198
8.35.22 AxoGuard Nerve Connector 198
8.35.23 FISH Femoral Introducer Sheath and Hemostasis Device 198
8.36 Cord Blood America (CBAI), Inc. 198
8.37 Cryo-Cell International, Inc. 198
8.37.1 Cryo Cell's License Agreements 199
8.37.1.l Cryo-Cell De Mexico 199
8.37.1.2 Asia Cryo-Cell Private Limited 199
8.37.1.3 Venezuela 199
8.37.1.4 China 199
8.37.1.5 Germany 200
8.37.1.6 Nicaragua 200
8.37.1.7 Pakistan 200
8.37.2 Uses of Cord Blood Stem Cells 200
8.38 Curis, Inc. 202
8.38.1 Curis' Business Performance 203
8.38.2 Curis' Research and Development 204
8.39 Cytori Therapeutics, Inc. 204
8.39.1 Cytori's Cosmetic and Reconstructive Surgery Market 206
8.39.2 Cytori StenSource Cell Banking Market 206
8.40 Develogen AG 206
8.40.1 Develogen's Pipeline 207
8.40.1.1 DG3173-Somatostatin Analog 207
8.40.1.2 Insulin Sensitizers 207
8.40.1.3 Beta Cell Regeneration Factor 207
8.41 Effector Cell Institute, Inc (ECI) 207
8.41.1 ECI's Cell-based Drug Discovery (CDD) 207
8.41.2 ECI's Regenerative Medicine 208
8.41.3 ECI's Cancer Therapeutic Agent Development Project (EC1301) 208
8.41.4 ECI's Anti-Inflammatory Drug Development Project (FROUNT) 208
8.41.5 ECI's High Throughput Screening by Automatic TAXIScan System 209
8.41.6 ECI's Products 209
8.41.6.1 TAXIScan System 209
8.41.6.2 Cytorecon 209
8.41.6.3 TAXIScan-FL 210
8.42 Epistem plc 210
8.42.1 Epistem's Cotract Research Services in Oncology 210
8.42.2 Epistem's Xenografting Models 210
8.42.3 Epistem's Cancer Cell Assays 211
8.42.4 Epistem's Angiogenesis Models 211
8.42.5 Epistem's Colon Cancer Models (Min/+) 211
8.42.6 Epistem's Histology, IHC, ISH and Gene Expression Profiling 212
8.42.7 Epistem's In Vitro Cytotoxicity Testing 212
8.42.8 Epistem's Plucked Hair Immunohistochemistry 212
8.42.9 Epistem's Emerging Protein Therapeutics 212
8.42.10 Epistem's Biomarker Technology 213
8.43 FivePrime Therapeutics, Inc. 213
8.43.1 FivePrime's Technology 213
8.43.2 FivePrime's Collaborations 215
8.44 Forticell Bioscience, Inc. 215
8.44.1 OrCell 215
8.45 Gamidia Cell Ltd. 216
8.45.1 Gamidia's Technology 216
8.46 GeneGrafts Ltd. 216
8.46.1 GeneGrafts's Technology 217
8.47 GenVec, Inc. 217
8.47.1 GenVec's Product Programs 217
8.47.1.1 TNFerade 217
8.47.1.2 Hearing and Balance 217
8.48 Genzyme Corporation 217
8.48.1 Genzyme's Business Performance 218
8.48.2 Genzyme's Genetic Diseases Segment 219
8.48.3 Genzyme's Hematology Oncology Segment 219
8.48.4 Genzyme's Cardiometabolic and Renal Segment 220
8.48.5 Genzyme's Biosurgery Segment 220
8.48.6 Genzyme's Genetics and Diagnostics Segment 221
8.48.7 Genzyme's Pipeline 221
8.49 Geron Corporation 223
8.49.1 Geron's Major Technology Platforms 223
8.49.1.1 Role of Telomere in Cancer and Aging 223
8.49.1.2 Human Embryonic Stem Cells: Source for the Manufacturing of Therapeutic Cells 223
8.49.2 Commercial Opportunities for Geron's Major Technology Platforms 223
8.49.2.1 Oncology 223
8.49.3 Geron's Human Embryonic Stem Cell Therapies 224
8.49.4 Geron's Patents and Proprietary Technology 224
8.49.5 Geron's Business Performance 225
8.49.6 Geron's Investment in Research and Development 226
8.50 Harvest Technologies Corporation 226
8.50.1 Harvest Technologies' Products 226
8.50.1.1 SmartPReP2 APC+ 226
8.50.1.2 SmartPReP2 BMAC 227
8.51 HemaStem Therapeutics, Inc. 227
8.51.1 Cord Blood Program 227
8.52 HepaLife Technologies, Inc. 228
8.52.1 Liver Disease 228
8.52.1.1 HepaMate 228
8.53 Humacyte, Inc. 229
8.53.1 Humacyte's Products 229
8.54 Hydra Biosciences, Inc. 229
8.54.1 Hydra's Program 229
8.55 Intercytex Group plc 230
8.55.1 Vavelta-Skin Repair and Rejuvenation 230
8.55.2 SHEF-1-Stem Cell Line 231
8.55.3 CX-SKN-Skin Graft Replacement for Burns and Acute Wounds 231
8.55.4 ICX-TRC-Hair Regeneration 232
8.55.5 Cyzact-Chronic Wound Repair 232
8.56 Integra Lifesciences Holdings Corporation 232
8.56.1 Integra's Products 233
8.56.1.1 Integra's Orthopedic Product Portfolio 233
8.56.1.2 Dermal Regeneration and Engineered Wound Dressings 233
8.56.1.3 Nerve and Tendon 233
8.56.1.4 Bone Graft Substitutes for Extremity Reconstruction 233
8.56.1.5 Integra's OrthoBiologics 234
8.56.1.6 Duraplasty Products 234
8.56.2 Integra's Investment in Research and Development 234
8.56.3 Integra's Business Performance 235
8.57 International Stem Cell Corporation (ISCO) 235
8.57.1 Lifeline Cell Technology 235
8.57.2 Universal Stem Cell Bank 236
8.57.3 ISCO's Technology 236
8.58 Japan Tissue Engineering, Co., Ltd. 236
8.58.1 Autologous Cultured Epidermis 237
8.58.2 Autologous Cultured Cartilage 238
8.58.3 Autologous Cultured Corneal Epithelium 238
8.59 Karocell Tissue Engineering AB 239
8.59.1 Karocell's Autologous Cells 239
8.59.1.1 Keratinocytes 239
8.59.1.2 Melanocytes 239
8.59.1.3 Fibroblasts 239
8.59.1.4 Chondrocytes 240
8.59.1.5 Urothelial Cells 240
8.59.1.6 Karoskin 240
8.59.1.7 Karoderm 240
8.59.1.8 Cell Bank 240
8.59.2 Karocell's Research and Development 241
8.60 Kensey Nash Corporation 241
8.60.1 Biomaterials from Kensey 241
8.60.2 Kensey's Collagen Technology 241
8.60.3 Porous Tissue Matrix Technology 242
8.60.4 Kensey's Products 243
8.60.4.1 The Angio-Seal Vascular Closure Device 243
8.60.4.2 Vitoss Scaffold Foam 243
8.60.4.3 OsseoFit Porous Tissue Matrix 243
8.60.4.4 Epi-Guide Bioresorbable Barrier Matrix 244
8.61 Kiadis Pharma, BV 244
8.62 LifeCell 244
8.62.1 AlloDerm Regenerative Tissue Matrix 244
8.62.2 Strattice Reconstructive Tissue Matrix 244
8.62.3 Cymetra Micronized AlloDerm Tissue 245
8.63 MaxCyte, Inc. 245
8.63.1 Advantages of MaxCyte Platform System 245
8.63.2 MaxCyte's Collaborations 245
8.63.3 MaxCyte's Application in Immunotherapy 246
8.63.4 MaxCyte's Application in Regenerative Medicine 246
8.63.5 MaxCyte's Viral Vectors and Vaccines 246
8.63.6 MaxCyte XTS Scalable Transfection System 247
8.64 Mesoblast Ltd. 247
8.64.1 Mesoblast's Intervertebral Spinal Fusion 247
8.64.2 Lumbar Fusion 247
8.64.3 Cervical Fusion 248
8.64.4 Mesoblast's Intervertebral Disc Repair and Regeneration 248
8.64.5 Mesoblast's Product for Knee Osteoarthritis 248
8.64.6 Mesoblast's Investment in Angioblast Systems, Inc. 248
8.64.7 Angioblast's Product Candidate for Congestive Heart Failure 248
8.64.8 Angioblast's Product Candidate for Bone Marrow Transplantation 248
8.65 NanoCor Therapeutics, Inc. 249
8.65.1 NanoCor's Products 249
8.66 NeuralStem, Inc. 249
8.66.1 NeuralStem's Technology 249
8.66.2 NeuralStem's Research and Programs 250
8.66.3 NeuralStem's Intellectual Property 250
8.67 NeuroNova AB 252
8.67.1 NeroNova's Neurogenesis Qualifier-Technology 252
8.67.2 The sNN0029 252
8.67.3 The sNN0031 253
8.67.4 NeuroNova's Investors 253
8.68 Olympus Terumo Biomaterials Corporation 253
8.68.1 OSferion 60 254
8.68.2 Terudermis 254
8.68.3 Teruplug 254
8.68.4 Osferion 255
8.68.5 Boneceram P 255
8.69 Opexa Therapeutics, Inc. 255
8.69.1 Opexa's T-Cell Platform 255
8.69.2 Opexa's Stem Cell Platform 256
8.70 Organogenesis, Inc. 256
8.70.1 Products from Organogenesis 256
8.70.1.1 Apligraf 256
8.70.1.2 VCT01 257
8.70.1.3 CelTx for Oral Soft Tissue Regeneration 257
8.70.1.4 FortaGen 257
8.70.1.5 FortaPerm 257
8.70.1.6 BioSTAR 257
8.71 Orthovita, Inc. 258
8.71.1 Orthovita's Products 258
8.71.1.1 Vitoss 259
8.71.1.2 Vitoss and Bone Defect Grafting 259
8.71.1.3 Vitoss in Spinal Fusion and Grafting 259
8.71.1.4 Vitoss and Trauma 259
8.71.1.5 Vitomatrix and Dental, Periodontal, Oral and Craniomaxillofacial Defects 259
8.71.1.6 Cortoss Bone Augmentation Material 260
8.71.1.7 Cortoss and Vertebral Augmentation of Vertical Compression Fractures (VCFs) 260
8.71.1.8 Cortoss and Screw Augmentation 260
8.71.1.9 Orthovita's Aliquot Delivery System 260
8.71.2 Orthovita's Biosurgery Products 260
8.71.3 Partnership with Kensey for Vitoss Foam 261
8.71.4 Partnership with Angiotech for Vitagel and CellPaker 261
8.71.5 Partnership with Medafor for Vitasure 261
8.71.6 Orthovita's Business Performance 261
8.72 Osiris Therapeutics, Inc. 262
8.72.1 Osiris' Partnerships 262
8.72.2 Osiris' Technologies 263
8.72.3 Prochymal 263
8.72.4 Chondrogen 263
8.73 Osteotech, Inc. 264
8.73.1 Osteotech's Products 264
8.74 Pervasis Therapeutics, Inc. 265
8.74.1 Pervasis' Clinical Focus 265
8.74.2 Power of Endothelium 265
8.74.3 Therapeutic Applications of Pervasis' Products 265
8.74.3.1 Arteriovenous (AV) Access for Hemodialysis 265
8.74.3.2 Peripheral Arterial Disease 266
8.75 Pleuron 266
8.75.1 Pleuron's Technology 266
8.76 Pluristem Therapeutics, Inc. 267
8.76.1 Pluristem's PluriX 3D Bioreactor 267
8.76.2 Pluristem's PLacental eXpanded (PLX) Cells 267
8.76.3 PLX-PAD for Peripheral Artery Disease 267
8.76.4 PLX-IBD for Inflammatory Bowel Disease 267
8.76.5 PLX-MS for Multiple Sclerosis 267
8.76.6 PLX-STROKE for Ischemic Stroke 268
8.77 RegeneRx 268
8.78 ReNeuron Group plc 268
8.78.1 ReNeuron's Platform Technologies 268
8.78.2 ReNeuron's Cell Therapy Programs 270
8.78.3 ReNeuron's ReN001 for Stroke 270
8.78.4 ReNeuron's ReNcell Products 271
8.79 Revivicor, Inc. 271
8.79.1 Revivicor's Xenografting Technology 271
8.79.2 Revivicor's Islet Transplantation Technology 271
8.79.3 Revivicor's Infectious Disease Platform Technologies 272
8.80 Saneron CCEL Therapeutics, Inc. 272
8.80.1 Saneron's U-Cord-Cell Program 272
8.80.2 Saneron's Sert-Cell Program 272
8.81 Sangamo BioSciences, Inc. 272
8.81.1 Sangamo's ZFP Therapeutic Product Development Programs 273
8.81.2 ZFP Therapeutic Pre-Clinical Stage Programs 273
8.81.2.1 Neuropathic Pain (Cancer Pain) 273
8.81.2.2 Nerve Regeneration-Spinal Cord Injury (SCI) and Traumatic Brain Injury (TBI) 273
8.81.2.3 Parkinson's Disease (PD) 274
8.81.2.4 Stroke 274
8.81.2.5 ZFP Therapeutic Research Programs 274
8.81.3 Funding from Research Foundations 274
8.81.3.1 The Juvenile Diabetes Research Foundation International 274
8.81.3.2 The Michael J. Fox Foundation 274
8.81.3.3 The Bill and Melinda Gates Foundation 274
8.81.4 Sangamo's Research and Development Expenses 274
8.81.5 Sangamo's Business Performance 275
8.82 StemCells, Inc. 276
8.82.1 StemCell's Cellular Medicine Programs 276
8.82.2 StemCells' Enabling Technologies Program 277
8.82.3 StemCells' Patents, Proprietary Rights and Licenses 278
8.83 Stem Cell Authority Ltd. 279
8.83.1 The "Miracle" Mesenchymal Stem Cell-Mirachymal Stem Cells 279
8.84 Stem Cell Innovations (SCI) 279
8.84.1 SCI's Research and Development 279
8.84.2 SCI's Services 279
8.84.3 PluriCells and Derivatives 280
8.84.4 ACTIVTox 280
8.84.5 PredictivTox 280
8.84.6 Endogenous Protein Production 280
8.85 Stem Cell Sciences KK 280
8.85.1 SCS KK's Product/Service 281
8.85.1.1 CultiCell Medium for Embryonic Stem Cells 281
8.85.1.2 Contract/Sponsored Research on ES-derived Functional Cells 281
8.86 SyntheMed, Inc. 281
8.86.1 Repel-CVAdhesion Barrier 282
8.86.2 Resolve Adhesion Barrier Instillate 282
8.86.3 Repel Adhesion Barrier 282
8.86.4 SpineShield Adhesion Barrier Film 282
8.86.5 Relieve Adhesion Barrier Gel 282
8.86.6 SinusShield Adhesion Prevention Film 282
8.87 t2cure GmbH 282
8.87.1 BMCs in Regenerative Therapies 283
8.87.2 t2cure's Product Development Pipeline 283
8.88 Tengion 283
8.88.1 Tengion's Pipeline Overview 284
8.89 TiGenix 284
8.89.1 ChondroCelect 284
8.89.2 Chondromimetic 285
8.89.3 TGX002 285
8.89.4 TGX003 285
8.90 Thermogenesis Corp. 285
8.90.1 Products from Thermogenesis 285
8.90.1.1 AutoXpress Platform or AXP 285
8.90.1.2 MarrowXpress 285
8.90.1.3 BioArchive System 285
8.90.1.4 Res-Q 286
8.90.1.5 Thermoline 286
8.90.1.6 CryoSeal Fibrin Sealant (CryoSeal) System 286
8.90.2 Thermogenesis' Business Performance 286

INDEX OF FIGURES

Figure 2.1: Geographic Distribution of 73 TERM Firms in the Five Focus Countries, 2009 29
Figure 2.2: Geographic Distribution of the 15 TERM Firms in Germany, 2009 30
Figure 2.3: Geographic Distribution of the Five TERM Companies in the U.K., 2009 31
Figure 2.4: The Potential Uses of Embryonic Stem Cells 32
Figure 2.5: Cell Culture Products by Market Segment 35
Figure 2.6: Estimated Global Market for Cell and Tissue Analysis Products, 2008-2014 35
Figure 2.7: Growth in Size of Cell Therapy Industry, 2000, 2002, 2003, 2008 41
Figure 2.8: Percent Break-Up of Cell Therapy Companies by Product Type, 2008 42
Figure 2.9: Location of Primary Tissue Engineering Companies by Geography, 2008-2009 43
Figure 2.10: Breakdown of Primary Cell Therapy Products on Market by Geography, 2008-2009 45
Figure 2.11: The Geographical Distribution of Clinical Trials, 2008-2009 49
Figure 2.12: Implantation of a Hydrogel at the Site of an Injured Tissue 59
Figure 2.13: Implantation of CS-PEG Hydrogel 60
Figure 2.14: Implantation of CMP-PEG Scaffold 60
Figure 4.1: Global Market for Regenerative Medicine Products, 2008-2013 82
Figure 4.2: Estimated Market for Regenerative Cell Therapy Products for Orthopedics, 2008-2012 83
Figure 4.3: Estimated U.S. Market for Regenerative Medicine Products, 2009-2014 83
Figure 4.4: Estimated U.S. Market for Bone Grafting/Bone Replacement, 2009-2014 84
Figure 4.5: Estimated U.S. Market for Bone Growth Stimulating Substances, 2009-2014 84
Figure 4.6: Estimated U.S. Market for Regenerative Products for Cartilage Repair, 2009-2014 85
Figure 4.7: Estimated Market for Stem Cells, 2008-2012 87
Figure 4.8: Estimated Market for Cell Therapy Products in the U.S., 2009-2018 88
Figure 4.9: Estimated Global Market for Cord Blood Stem Cells, 2010-2015 89
Figure 4.10: Worldwide Growth of Public Cord Blood Banks, 2005-2009 89
Figure 4.11: Worldwide Growth of Private Cord Blood Banks, 2005-2009 90
Figure 5.1: Cell-Based Business Models 92
Figure 5.2: Current Autologous Business Models 94
Figure 5.3: Current Allogeneic Business Models 95
Figure 7.1: CIRM's Grant Awards by Category, 2009 112
Figure 7.2: CIRM's funding by Disease Application, 2009 113
Figure 7.3: CIRM's Funding by Disease Category 114
Figure 7.4: Estimated Increase in Worldwide Funding for RM Research, 2008-2018 120
Figure 8.1: Aastrom's Investment in Research and Development, 2007-2009 124
Figure 8.2: Aastrom's Business Performance, 2005-2009 125
Figure 8.3: ACT's Business Performance, 2008 and 2009 128
Figure 8.4: ACT's Investment in Research and Development, 2008 and 2009 128
Figure 8.5: Aranesp (Darbepoetin Alfa)'s Sales in the U.S. and International Market, 2007-2009 139
Figure 8.6: U.S. Market for Epogen, 2007-2009 140
Figure 8.7: Global Market for Neulasta, 2007-2009 140
Figure 8.8: Global Market for Enbrel (Etanercept), 2007-2009 141
Figure 8.9: Global Market for Sensipar (Cinacalcet), 2007-2009 142
Figure 8.10: Global Market for Vectibix (Panitumumab), 2007-2009 142
Figure 8.11: Global Market for Nplate (Romiplostim), 2007-2009 143
Figure 8.12: Amgen's Three Large Wholesale Customers, 2007-2009 144
Figure 8.13: Amgen's Overall U.S. and International Market, 2007-2008 144
Figure 8.14: Athersys' Investment and Development, 2007-2009 159
Figure 8.15: Athersys' Business Performance, 2005-2009 159
Figure 8.16: Current Capitalization of Cardio3's Investors, 2009 175
Figure 8.17: Celgene's Business Performance, 2005-2009 186
Figure 8.18: Curis' Business Performance, 2005-2009 203
Figure 8.19: Genzyme's Business Performance, 2005-2009 218
Figure 8.20: Genzyme's Percent of Revenue by Business Group, 2009 218
Figure 8.21: Geron's Business Performance, 2005-2009 225
Figure 8.22: Geron's Investment in Research and Development, 2005-2009 226
Figure 8.23: Integra's Investment in Research and Development, 2007-2009 234
Figure 8.24: Integra's Business Performance, 2005-2009 235
Figure 8.25: NeuroNova's Share Holders as of June, 2009 253
Figure 8.26: Orthovita's Business Performance, 2005-2009 262
Figure 8.27: Sangamo's Investment in Research and Development, 2007-2009 275
Figure 8.28: Sangamo's Business Performance, 2005-2009 275

INDEX OF TABLES

Table 2.1: Number of TERM Companies Identified in the Five Focus Countries, 2009 25
Table 2.2: Number of TERM Companies Developing Stem Cells Seeded to Scaffolds, 2009 25
Table 2.3: Number of Firms with Focus on Skin, Cartilage, Bone and Urological Applications, 2009 26
Table 2.4: Number of Firms Focusing on Cardiovascular Applications, 2009 27
Table 2.5: Number of Firms with a Focus on Neurological Applications, 2009 27
Table 2.6: Number of Firms Focused on Pancreas, Liver and Kidney Applications, 2009 28
Table 2.7: Number of Companies Focused on Autologous and Allogeneic Products, 2009 29
Table 2.8: Geographic Distribution of U.S. TERM Firms, 2009 30
Table 2.9: Geographic Location of 11 Out of 13 TERM Firms in Japan, 2009 31
Table 2.10: Geographic Distribution of the Three TERM Firms in Sweden, 2009 31
Table 2.11: Number of Patients Treated with Cell Therapeutics, 1988-2010 34
Table 2.12: Some Selected Suppliers of In Vitro Test Kits and Their Products 36
Table 2.13: Suppliers of Cells and Tissues 37
Table 2.14: Selected Suppliers of Media and Reagents 38
Table 2.15: Selected Providers of Equipments in Stem Cell Research 38
Table 2.16: Selected Providers of Computer Software for Stem Cell Research 40
Table 2.17: Geographical Distribution of Stem Cell-Related Tissue Engineering Companies, 2008 42
Table 2.18: Breakdown of Cell Therapy Firms by Country, 2008-2009 44
Table 2.19: Cell Therapy Products on the Market by Type and Application Area, 2008-2009 46
Table 2.20: Data on Sales and Application for Skin and Cartilage Products, 2006-2008 47
Table 2.21: Reagent Sales by Selected Stem Cell Companies, 2008 47
Table 2.22: Sales of Secondary Products, 2007 48
Table 2.23: Disease Focus of Clinical Trials, 2008-2009 50
Table 2.24: Stem Cell Products in Phase II/III Trials, 2008-2009 51
Table 2.25: Licensing Activities in Pharmaceutical and Cell Therapy Industries 56
Table 2.26: Investment Activity in Cell Therapy Sector 56
Table 2.27: Novel Partnership by Large Pharmaceuticals with Universities 57
Table 2.28: Cell Therapy Companies with Greater than Ten Million by Market Cap, 2008 58
Table 3.1: Regenerative Medicine Product Development Status, 2008 64
Table 3.2: Top Ten Regenerative Medicine Products, 2008 68
Table 3.3: Wound Healing Products 75
Table 4.1: Worldwide Estimates of Key Industry Parameters, 2007 86
Table 4.2: Potential U.S. Populations for Cell-Based Therapies 87
Table 5.1: The Required Elements of a Manufacturing Facility 97
Table 5.2: Cell Therapy CMO Qualification Audit: Points to Investigate 98
Table 6.1: Diseases with Potential Applications for Regenerative Medicine 100
Table 7.1: Stem Cell Policies in North America 107
Table 7.2: Stem Cell Policies in South America 108
Table 7.3: Stem Cell Policies in Europe 109
Table 7.4: Stem Cell Policies in Asia/Oceania 110
Table 7.5: CIRM Funded Grants To-Date 111
Table 7.6: List of Upcoming Request for Applications (RFAs) Showing Commitments from Funding Partners 113
Table 7.7: Recipients of Funds from Connecticut Stem Cell Research Program, 2009 115
Table 7.8: Maryland Stem Cell Research Fund, 2008 117
Table 7.9: NJCST's Award of Grants for Stem Cell Research, 2008 117
Table 7.10: NYSTEM's IIRP Awards, 2008 118
Table 7.11: NIH Funding for Regenerative Medicine and Stem Cell Research, 2003-2009 122
Table 7.12: NIH Funding for Various Types of Stem Cell Research, 2004-2009 122
Table 8.1: Patents Owned by ACT 127
Table 8.2: Patents Owned by ACT's Subsidiary Mytogen, Inc. 127
Table 8.3: Patents Licensed to ACT by the University of Massachusetts 127
Table 8.4: Alseres' Product Pipeline, 2009 132
Table 8.5: Amgen's Pipeline of Products 137
Table 8.6: Amgen's Approved Products 138
Table 8.7: AnGes' Current Pipeline Status, 2010 149
Table 8.8: Angioblast's Product Development Overview 150
Table 8.9: Angion's Product Pipeline 151
Table 8.10: Angion's Product Pipeline 153
Table 8.11: Arteriocyte's Product Pipeline 155
Table 8.12: Developmental Status of Athersys' Key Programs, 2010 156
Table 8.13: Bioheart's Pipeline Product Candidates 162
Table 8.14: BioLine's Product Pipeline, 2010 164
Table 8.15: BioMimetic's Current Product Candidates and Target Indications 166
Table 8.16: BioMimetic's Clinical Studies 166
Table 8.17: BioMimetic's Investment in Research and Development, 2005-2009 167
Table 8.18: BrainStorm's Intellectual Property 173
Table 8.19: Cardio3's promising Product Pipeline 174
Table 8.20: Cellerix's Product Pipeline 185
Table 8.21: Celgene's Leading Product Candidates 188
Table 8.22: Private Cord Blood Banking vs. Public Donation 202
Table 8.23: Curis' Current Research and Development Programs and Their Status 203
Table 8.24: Curis' Revenues from Research and Development, 2008 and 2009 204
Table 8.25: Regulatory Status of Celution System 205
Table 8.26: Regulatory Status of PureGraft and CelBrush 205
Table 8.27: Develogen's Pipeline Overview 207
Table 8.28: Epistem's Emerging Pipeline of Protein Therapeutics 213
Table 8.29: FivePrime's Product Pipeline 214
Table 8.30: FivePrime's Collaborations 215
Table 8.31: Gamidia's Pipeline Products 216
Table 8.32: Genzyme's Pipeline of Products 222
Table 8.33: Cancer Therapeutics and Diagnostic Products being Developed by Geron 224
Table 8.34: The hESC-derived Product Candidates Developed by Geron and its Collaborators 224
Table 8.35: Geron's Patent Portfolio 225
Table 8.36: Hydra's Product Pipeline 230
Table 8.37: Intercytex' Product Pipeline 230
Table 8.38: Kiadis' Product Pipeline 244
Table 8.39: NeuralStem's Issued and Pending Patents 251
Table 8.40: NeuroNova's Product Pipeline 252
Table 8.41: Orthovita's Existing Orthobiologic and Biosurgery Products 258
Table 8.42: Orthovita's Biosurgery Products 261
Table 8.43: Osiris' Therapeutic Product Pipeline 264
Table 8.44: Pervasis' Product Pipeline 266
Table 8.45: RegeneRx's Product Development Pipeline 268
Table 8.46: Summary of Sangamo's Current Clinical Programs 273
Table 8.47: Current Status of StemCells' Therapeutic Product Development Programs 276
Table 8.48: StemCells' Cell Culture Products 277
Table 8.49: StemCells' Patents Covering Stem and Progenitor Cells and Research Tools 278
Table 8.50: t2cure's Product Development Pipeline 283
Table 8.51: Tengion's Product Candidates Pipeline 284
Table 8.52: Thermogenisis' Business Performance by Geographic Area, 2007-2009 286

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