Regenerative Medicine Markets Analysis and Industry Trends

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Regenerative Medicine Markets
Published on September 2010

Report Summary

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 TriMark
Publications 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 Content

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 23
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) 24
2.2.1 Tissue-Engineered Products and Their Applications 25
2.2.1.1 Skin, Cartilage, Bone and Urological Applications 26
2.2.1.2 Cardiovascular Applications 26
2.2.1.3 Neurological Applications 27
2.2.1.4 Pancreas, Liver and Kidney Applications 27

Regenerative Medicine Markets (From Slideshare) Page 1/19


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 28
2.3 Cell Therapy 31
2.3.1 Number of Patients Treated between 1988 and 2010 by Regenerative Medicine
Therapies 33
2.3.2 Cell Culture Products 34
2.3.2.1 In vitro Test Kits 35
2.3.2.2 Suppliers of Cells and Tissues 36
2.3.2.3 Suppliers of Culture Media and Reagents 37
2.3.2.4 Equipments for Stem Cell Research 37
2.3.2.5 Computer Software for Stem Cell Research 38
2.3.3 Overall Picture of Cell Therapy Industry 40
2.3.3.1 The Size of Cell Therapy Industry 40
2.3.3.2 The Age, Size and Location of Firms 41
2.3.3.3 Technology and Disease Focus 43
2.3.4 Cell Therapy Products and Companies 43
2.3.4.1 First Generation (Non-Stem Cell-based) Primary Products 45
2.3.4.2 Second Generation (Stem Cell-based) Primary Products 46
2.3.4.3 Secondary Products 46
2.3.4.4 Products in Development 47
2.3.5 The Disease Focus of Clinical Trials 47
2.3.5.1 Stem Cell Industry Pipeline 48
2.3.6 Industry Collaboration in Stem Cell Space 50
2.3.6.1 Commercial Success in Stem Cell Industry 50
2.3.6.2 Major Shift to Stem Cells from Non-Stem Cell Technologies 51
2.3.6.3 Challenges to Commercial Development of Cell Therapies 51
2.3.6.4 Partnership of Stem Cell Companies with Large Pharmaceutical Companies
53
2.3.6.5 Strategic Approaches for Cell-based Companies 53
2.3.6.6 The Need for Support from Large Pharmaceuticals 55
2.4 Scaffolding Biomaterials 55
2.4.1 Biomaterial Scaffolds in Regenerative Medicine 56
2.5 Growth Factors 58
3. Regenerative Medicine: The Next Evolution of Medical Treatments 60
3.1 Scope of this Chapter 60
3.2 Need for Regenerative Medicine 60
3.3 Current State of Regenerative Medicine 60
3.4 Future of Regenerative Medicine 61
3.5 Number of Products in Pipeline 61
3.6 Projected Timeline for Regenerative Medicine 65
3.7 Regenerative Medicine Products in the Market 66
3.7.1 Medtronic's Infuse Bone Graft and the LT-Cage Device 66
3.7.2 Genzyme's Carticel 67
3.7.3 Stryker's OP-1 68
3.7.4 Osyris/Nuvasive's Osteocel 68
3.7.5 RTI's Spinal Implants 69



3.7.6 Organogenesis' Apligraf 69
3.7.7 Advanced BioHealing's Dermagraft 70
3.7.8 Integra's Bilayer Matrix Wound Dressing 70
3.7.9 LifeCell's Alloderm 70
3.7.10 Cytori Therapeutics' Celution 71
3.8 Other Products of Importance in Regenerative Medicine 72
3.8.1 Tissue-Engineered Wound Healing Products 72
3.8.1.1 Oasis 73
3.8.1.2 Permacol 73
3.8.1.3 EZ-Derm 73
3.8.1.4 Matriderm 73
3.8.1.5 TransCyte 74
3.8.1.6 ICX-SKN 74
3.8.1.7 OrCel 75
3.8.1.8 Epicel 75
3.8.1.9 Myskin 75
3.8.1.10 VCT01 76
3.8.2 ICX-TRC-Hair Regeneration Therapy 76
3.8.3 Cartilage Regeneration 76
3.8.3.1 Novocart 76
3.8.3.2 BioSeed-C 76
3.8.3.3 BioSeed-Oral Bone 77
3.8.3.4 Chondrotissue 77
3.8.3.5 co.don Chondrotransplant 77
3.8.3.6 co.don Chondrotransplant DISC 77
3.8.3.7 co.don Chondrosphere 77
3.8.3.8 co.don Osteotransplant DENT 77
3.8.3.9 MACI Implant 77
3.8.3.10 Cartilink-3 77
3.8.3.11 Accell Evo3 Demineralized Bone Matrix 78
3.8.3.12 OsSatura BCP 78
3.8.4 Mozobil 78
4. Market Analysis of Regenerative Medicine Sector 79
4.1.1 Market for Regenerative Medicine Products 79
4.1.2 The Different Characteristics of Regenerative Medicine Industry in the
Recent Past 82
4.1.3 Potential Market for Regenerative Medicine in the U.S 83
4.2 Global Market for Stem Cells 84
4.3 Market for Cell Therapy in the U.S. 85
4.4 Global Market for Cord Blood Stem Cells 85
4.4.1 Public Cord Blood Banks 86
4.4.2 Private Cord Blood Banks 86
5. Business Models and Requirements for a Successful Regenerative Medicine
Industry 88
5.1.1 The Limited Success Achieved by the Regenerative Medicine Products 88
5.1.2 Business Models in Regenerative Medicine 88



5.1.3 Current Model for Autologous Cell Therapies 90
5.1.4 Current Models for Allogeneic Cell Therapies 91
5.1.5 Key Factors for Successful Business Models for Cell Therapies 92
5.2 Commercial Manufacturing of Cell Therapy Products: Requirements 93
5.2.1 Elements of Commercial Manufacturing 93
5.2.1.1 Regulatory Requirements 93
5.2.1.2 Manufacturing Process Scale 93
5.2.1.3 In-House Manufacturing 94
5.2.1.4 Contract Manufacturing: Commercial and Academic 94
6. Diseases with Potential Applications for Regenerative Medicine 97
6.1 Regenerative Medicine and Diabetes 99
6.2 Regenerative Medicine for Cardiac Repair 100
6.3 Regenerative Medicine in Orthopedics 100
6.3.1 Orthobiologics in Orthopedics 100
6.3.2 Growth Factor Therapies in Orthopedics 101
6.3.3 Stem Cell Therapies in Orthopedics 101
6.4 Regenerative Medicine in Liver Diseases 101
6.4.1 Hepatocyte-like Cells for Liver Disease 102
6.4.2 Cell Therapy for Liver Cirrhosis 102
6.4.3 CD 34+ Cells 102
6.5 Regenerative Medicine in Retinal Replacement Therapy 102
6.5.1 Retinal Transplantation 102
6.6 Regenerative Medicine in Central Nervous System (CNS) Disorders 103
6.6.1 Clinical Activity for Stem Cell Transplantation into the CNS 103
7. Current Stem Cell Research and Federal Funding in the U.S. 104
7.2 Stem Cell Policies in North America 104
7.3 Stem Cell Policies in South America 105
7.4 Stem Cell Policies in Europe 105
7.5 Stem Cell Policies in Asia/Oceania 107
7.6 Stem Cell Policies in Africa 108
7.7 Stem Cell Research and California Institute for Regenerative Medicine (CIRM)
108
7.7.1 CIRM Collaborative Funding 109
7.7.2 CIRM's funding for Clinical Applications 110
7.7.3 Early Translational Awards 110
7.7.4 CIRM's Disease Team Awards 111
7.8 Stem Cell Research Programs in Connecticut Department of Public Health 111
7.8.1 Seed Grant Awards from Connecticut Stem Cell Research Program in 2010 111
7.8.2 Established Investigator Awards from Connecticut Stem Cell Research
Program in 2010 111
7.8.3 Group Project Awards from Connecticut Stem Cell Research Program in 2010
112
7.8.4 Core Facility Awards from Connecticut Stem Cell Research Program in 2010
113
7.8.5 Maryland Technology Development Corporation (TEDCO) 113
7.8.6 TEDCO's Fort Detrick Technology Transfer Initiative (FDTTI) 113
7.8.7 J&J Investment Fund 113



7.8.8 TEDCO's NAVAIR Technology Insertion (NAVTI) Program 113
7.8.9 TEDCO's TechStart Program 113
7.8.10 TEDCO's University Technology Development Fund (UTDF) 113
7.8.11 TEDCO's Working Capital Loan Fund 113
7.8.12 Maryland Technology Transfer and Commercialization Fund (MTTCF) 113
7.8.13 Maryland Stem Cell Research Fund 114
7.9 The New Jersey Commission on Science and Technology (NJCST) 114
7.9.1 Investigator Initiated Research Projects and Innovative (IIRP),
Developmental or Exploratory Activities (IDEA) in Stem Cell Research 115
7.9.2 Targeted RFA for Investigation of iPS and Other Derivation Approaches 116
7.9.3 Shared Facilities/Resources and Equipment/Instrumentation for Stem Cell
Research 116
7.9.4 Consortia Planning Awards 116
7.9.5 Institutional Development 116
7.10 Center for Stem Cell and Regenerative Medicine 116
7.11 Global Funding for Regenerative Medicine 117
7.12 Federal Funding of Stem Cell Research in the U.S.: Past and Present 117
7.12.1 The U.S. National Institute of Health (NIH) Guidelines to hESC Research
118
7.12.2 Types of Research Ineligible for NIH Funding 118
7.12.3 NIH's Leadership in Providing Funds for Stem Cell Research 118
7.12.4 NIH Guidelines Addressing the Projected Growth of Stem Cell-related
Clinical Trials 118
7.12.5 Federal Agencies Providing Funds for Stem Cell Research 118
8. Company Profiles 120
8.1 Aastrom Biosciences, Inc. 120
8.1.1 Aastrom's Clinical Trial Programs 120
8.1.1.1 Dilated Cardiomyopathy 120
8.1.1.2 Critical Limb Ischemia 120
8.1.1.3 Osteonecrosis of the Femoral Head 120
8.1.1.4 Other Bone Disorders 120
8.1.2 Product Development 121
8.1.3 Aastrom's Cell Manufacturing 121
8.1.4 Aastrom's Business Performance 121
8.2 Advanced Cell Technology, Inc. (ACT) 122
8.2.1 ACT's Cellular Reprogramming 122
8.2.2 ACT's Stem Cell Differentiation 123
8.2.2.1 ACT's Retinal Pigment Epithelium Program 123
8.2.2.2 ACT's Hemangioblast Program 123
8.2.2.3 ACT's Adult Stem Cell Program 123
8.2.3 ACT's Intellectual Property 123
8.2.4 ACT's Business Performance 124
8.2.5 ACT's Investment in Research and Development 125
8.3 Aldagen, Inc. 125
8.3.1 Aldagen's ALD-201 126
8.3.2 Aldagen's ALD-301 126
8.4 Altrika Ltd. 126
8.4.1 Myskin 126



8.4.2 Cryoskin 127
8.4.3 Altrika's Future Products 127
8.4.3.1 Lyphoderm 127
8.4.3.2 Corneal Bandage 127
8.4.3.3 Leukodepletion Filters 128
8.5 Alseres Pharmaceuticals, Inc. 128
8.5.1 Alseres' Product Pipeline 128
8.5.1.1 Celthrin-a Rho Inhibitor 129
8.5.1.2 Inosine 129
8.5.1.3 Oncomodulin and ALSE-100 130
8.5.1.4 Altropane-PD 130
8.5.2 Alseres' Science and Technology 131
8.5.2.1 Nerve Repair Pathways 131
8.5.2.2 The Pro-Regenerative Pathway 132
8.5.2.3 The Anti-Regenerative Pathway 132
8.5.2.4 Molecular Imaging 132
8.5.2.5 Dopamine Transporter 133
8.6 Amgen, Inc. 134
8.6.1 Amgen's Marketed Products 135
8.6.1.1 Aranesp (Darbepoetin Alfa) 135
8.6.1.2 Epogen (Epoetin Alfa) 136
8.6.1.3 Neulasta (Pegfilgrastim)/Neupogen (Filgrastim) 136
8.6.1.4 Enbrel (Etanercept) 137
8.6.1.5 Sensipar (cinacalcet) 138
8.6.1.6 Vectibix (Panitumumab) 138
8.6.1.7 Nplate (Romiplostim) 139
8.6.2 Amgen's Marketing and Distribution 139
8.6.3 Amgen's Overall Business Performance 140
8.7 Amorcyte, Inc. 141
8.7.1 Amorcyte's Technology 141
8.7.1.1 AMR-001 141
8.8 AnGes MG, Inc. 142
8.8.1 AnGes' Genetic Medicine 142
8.8.2 HGF Genetic Medicine 142
8.8.3 Hemagglutinating Virus of Japan (HVJ) Envelope Vector 143
8.8.4 NF kB Decoy Oligodeoxynucleotide 143
8.9 Angioblast Systems, Inc. 145
8.9.1 Angioblast's Technology and Applications 145
8.9.1.1 Allogenic Adult Stem Cells 145
8.9.1.2 Protein Therapeutics 145
8.9.1.3 Gene Slicing 145
8.10 Angion Biomedica, Corp. 146
8.10.1 HGF and c-Met Signaling in Tissue Repair and Organ Regeneration 147
8.10.2 PARP-1 147
8.10.3 TGF B1 148
8.11 Ars Arthro Biotechnology, Inc. 148
8.11.1 CaReS 148
8.11.2 Fibrocell 148



8.11.3 Fibroplus 149
8.12 Arteriocyte Medical Systems, Inc. 149
8.12.1 Blood Pharming 149
8.12.2 Cardiac Ischemia 149
8.12.3 Critical Limb Ischemia 149
8.12.4 Malaria Research 150
8.12.5 Orthopedic Regenerative Medicine 150
8.12.6 Proliferative Diabetic Retinopathy 150
8.12.7 Wound Healing 150
8.13 Athersys, Inc. 151
8.13.1 Athersys' Pipeline 151
8.13.2 MultiStem for Stem Cell Therapy 151
8.13.3 MultiStem for BM Transport Support 152
8.13.4 MultiStem for Acute Myocardial Infarction 152
8.13.5 MeriStem for Stroke 152
8.13.6 Treatments for Obesity 153
8.13.7 Histamine H3 Receptor Antagonists 153
8.13.8 Athersys' Collaborations and Partnerships 153
8.13.8.1 Collaboration with Pfizer 153
8.13.8.2 Collaboration with Angiotech 153
8.13.8.3 Collaboration with Bristol-Myers Squibb 153
8.13.9 Athersys' Research and Development 153
8.13.10 Athersys' Business Performance 154
8.14 BeFutur Biotechnologies 154
8.14.1 BeFutur's Technologies 155
8.14.1.1 Cells and Tissue Engineering 155
8.14.1.2 Serum Free Technology 155
8.15 BioE, Inc. 155
8.15.1 BioE's Products 155
8.16 Bioheart, Inc. 155
8.16.1 Bioheart's Product Candidates 156
8.16.1.1 MyoCell 156
8.16.1.2 MyoCell SDF-1 156
8.16.1.3 TGI 1200 Cell Isolation System 156
8.16.1.4 Bioheart 3370 156
8.16.2 Bioheart's Patents and Proprietary Rights 157
8.17 BioLine Rx 157
8.17.1 BioLine's Product Pipeline 157
8.17.1.1 BL-1020 Schizophrenia 157
8.17.1.2 BL-1040 for Acute Myocardial Infarction 157
8.17.1.3 BL-5010 for Skin Lesions 158
8.17.1.4 BL-1021 for Neuropathic Pain 158
8.17.1.5 BL-2030 for Inflammation 158
8.17.1.6 BL-1023 for Parkinson's disease 158
8.17.1.7 BL-4010 for Cancer 158
8.17.1.8 BL-4040 for Acute Kidney Failure 158
8.17.1.9 BL-5030 for Thromboembolic Diseases 158
8.17.1.10 BL-5040 for Cachexia and Inflammatory Bowel Disease 159



8.18 BIOMET 159
8.18.1 BIOMET 3i 159
8.18.2 Clotalyst Autologous Serum Collection System 159
8.18.3 BioCUE Platelet Concentration System 159
8.19 BioMimetic Therapeutics, Inc. 160
8.19.1 BioMimetic's Product Candidates 160
8.19.2 BioMimetic's Research and Development 161
8.20 BioSafe Group SA 161
8.20.1 Sepax 162
8.20.2 Sepax System in Adult Stem Cell Banking 162
8.20.3 Coolmix 162
8.20.4 SepaxNet 163
8.21 BioTime, Inc. 163
8.21.1 BioTime's Stem Cell Products for Regenerative Medicine 164
8.21.2 BioTime's Embryome Database 164
8.21.3 BioTime's Progenitor and hES Cell Lines 164
8.21.4 BioTime's hES Cells Carrying Genetic Diseases 164
8.21.5 BioTime's ESpan Cell Growth Media 164
8.21.6 BioTime's ESpy Cell Lines 164
8.21.7 BioTime's Licensed Stem Cell Technology and Stem Cell Product Development
Agreements 165
8.21.7.1 Wisconsin Alumni Research Foundation 165
8.21.7.2 ACTCellerate Technology 165
8.21.7.3 The iPS Technology 165
8.21.7.4 Lifeline 165
8.21.7.5 BioTime's Stem Cell Agreement with Reproductive Genetics Institute 165
8.21.8 BioTime's Plasma Volume Expanders and Related Products 165
8.21.8.1 Hextend 165
8.21.8.2 PentaLyte 166
8.22 Biovest International, Inc. 166
8.22.1 BiovaxID Cancer Vaccine 166
8.23 BrainStorm Cell Therapeutics, Inc. 166
8.23.1 BrainStorm's Technology 166
8.23.2 BrainStorm's Stem Cell Therapy 167
8.23.3 BrainStorm Technology-NurOwn 167
8.24 Cardio3 BioSciences 168
8.24.1 Cardio3's Product Pipeline 168
8.24.1.1 C-Cure 169
8.24.1.2 C-Cure2 169
8.24.1.3 Allo-Cure 169
8.24.1.4 G-Cure 169
8.24.1.5 C-Cath 169
8.24.2 Cardio3's Investors 169
8.25 CardioPolymers, Inc. 170
8.25.1 CardioPolymer's Products 170
8.25.1.1 Algisyl-LVR 170
8.25.1.2 Plexisyl-AF 171
8.25.2 CardioPolymer's Investors 171



8.26 CaridianBCT 171
8.26.1 Trima Accel Automated Blood Collection System 171
8.26.2 Spectra Optia Apheresis System 172
8.26.3 COBE Spectra Apheresis System 172
8.26.4 Elutra Cell Separation System 172
8.26.5 Atreus Whole Blood Processing System 173
8.26.6 OrbiSac System 173
8.26.7 COBE 2991 Cell Processor 173
8.27 Cardium Therapeutics, Inc. 174
8.27.1 Cardium Biologics 174
8.27.2 Cardium's Tissue Repair Company 174
8.27.3 Cardium's Gene Activated Matrix (GAM) Technology 175
8.27.4 Cardium's Biologics and Stem Cells for Regenerative Medicine 175
8.28 Cellartis AB 175
8.28.1 Cellartis' Products 175
8.28.1.1 The hES-CMC 2D: Cardiomyocyte Monolayers 175
8.28.1.2 The hES-CMC 002: Cardiomyocyte Clusters 176
8.28.1.3 The hES-HEO 002: Hepatocyte-like Cells 176
8.28.1.4 The hES-MP 002.5: Mesenchymal Progenitors 177
8.28.1.5 The hES Cell Lines 177
8.28.1.6 SCED 461: Human ES Cells 177
8.28.1.7 Monoclonal Antibodies 178
8.28.2 Cellartis' Licensing Activities 178
8.29 Cellerix 178
8.29.1 Ontaril 179
8.29.2 Cx501 179
8.30 Celgene Corporation 180
8.30.1 Celgene's Business Performance 180
8.30.2 Celgene's Commercial Stage Products 181
8.30.2.1 Revlimid (Lenalidomide) 181
8.30.2.2 Thalomid (Thalidomide) 181
8.30.2.3 Vidaza (Azacitidine for Injection) 182
8.30.2.4 Ritalin Family of Drugs 182
8.30.2.5 Alkeran (Melphalan) 182
8.30.2.6 IMiDs Compounds 182
8.30.2.7 Oral Anti-Inflammatory Agents 182
8.30.2.8 Kinase Inhibitors 182
8.30.2.9 Cellular Therapies 183
8.31 CellSeed, Inc. 183
8.31.1 CellSeed's Epithelial Cell Sheet for Corneal Regeneration 183
8.31.2 CellSeed's Regenerated Cardiac Patch 184
8.31.3 CellSeed's Epithelial Cell Sheet for Esophageal Regeneration 184
8.31.4 CellSeed's Cell Sheet for Periodontal Tissue Regeneration 184
8.31.5 CellSeed's Regenerated Cartilage Sheet 184
8.32 Cellular Dynamics International 184
8.32.1 The iCell Cardiomyocytes 185
8.32.2 Cellular Dynamics' Technology 185
8.33 Celltrix 185



8.33.1 Credurance 186
8.34 Cerco Medical 186
8.34.1 Cerco Medical's Concept 186
8.34.2 Bio-artificial Endocrine Pancreas 187
8.35 Cook Biotech, Inc. 187
8.35.1 Cook's Technology 187
8.35.2 Biodesign Dural Graft 188
8.35.3 Dynamatrix Oral Graft 188
8.35.4 SiS Ophthalmic 188
8.35.5 Oasis Wound Matrix 188
8.35.6 Biodesign Staple Line Reinforcement 188
8.35.7 Biodesign Hiatal Hernia Graft 189
8.35.8 ECM for Pericardial Closure 189
8.35.9 ECM for Cardiac Tissue Repair 189
8.35.10 Biodesign 8-Layer Tissue Graft 189
8.35.11 Biodesign Abdominal Lock Graft 189
8.35.12 Biodesign Hernia Graft 190
8.35.13 Biodesign Inguinal Hernia Graft 190
8.35.14 Biodesign Umbilical Hernia Graft 190
8.35.15 Biodesign Anterior Pelvic Floor Graft 191
8.35.16 Biodesign Fistula Plug 191
8.35.17 Biodesign Posterior Pelvic Floor Graft 191
8.35.18 Surgisis Biodesign Peyronie's Repair Graft 192
8.35.19 Biodesign Tension-free Urethral Sling 192
8.35.20 Biodesign Vaginal Erosion Repair Graft 192
8.35.21 AxoGuard Nerve Protector 193
8.35.22 AxoGuard Nerve Connector 193
8.35.23 FISH Femoral Introducer Sheath and Hemostasis Device 193
8.36 Cord Blood America (CBAI), Inc. 193
8.37 Cryo-Cell International, Inc. 193
8.37.1 Cryo Cell's License Agreements 193
8.37.1.l Cryo-Cell De Mexico 193
8.37.1.2 Asia Cryo-Cell Private Limited 194
8.37.1.3 Venezuela 194
8.37.1.4 China 194
8.37.1.5 Germany 194
8.37.1.6 Nicaragua 194
8.37.1.7 Pakistan 194
8.37.2 Uses of Cord Blood Stem Cells 195
8.38 Curis, Inc. 197
8.38.1 Curis' Business Performance 198
8.38.2 Curis' Research and Development 198
8.39 Cytori Therapeutics, Inc. 199
8.39.1 Cytori's Cosmetic and Reconstructive Surgery Market 200
8.39.2 Cytori StenSource Cell Banking Market 200
8.40 Develogen AG 201
8.40.1 Develogen's Pipeline 201
8.40.1.1 DG3173-Somatostatin Analog 201



8.40.1.2 Insulin Sensitizers 201
8.40.1.3 Beta Cell Regeneration Factor 201
8.41 Effector Cell Institute, Inc (ECI) 202
8.41.1 ECI's Cell-based Drug Discovery (CDD) 202
8.41.2 ECI's Regenerative Medicine 202
8.41.3 ECI's Cancer Therapeutic Agent Development Project (EC1301) 202
8.41.4 ECI's Anti-Inflammatory Drug Development Project (FROUNT) 203
8.41.5 ECI's High Throughput Screening by Automatic TAXIScan System 203
8.41.6 ECI's Products 204
8.41.6.1 TAXIScan System 204
8.41.6.2 Cytorecon 204
8.41.6.3 TAXIScan-FL 204
8.42 Epistem plc 205
8.42.1 Epistem's Cotract Research Services in Oncology 205
8.42.2 Epistem's Xenografting Models 205
8.42.3 Epistem's Cancer Cell Assays 205
8.42.4 Epistem's Angiogenesis Models 206
8.42.5 Epistem's Colon Cancer Models (Min/+) 206
8.42.6 Epistem's Histology, IHC, ISH and Gene Expression Profiling 206
8.42.7 Epistem's In vitro Cytotoxicity Testing 206
8.42.8 Epistem's Plucked Hair Immunohistochemistry 207
8.42.9 Epistem's Emerging Protein Therapeutics 207
8.42.10 Epistem's Biomarker Technology 207
8.43 FivePrime Therapeutics, Inc. 208
8.43.1 FivePrime's Technology 208
8.43.2 FivePrime's Collaborations 209
8.44 Forticell Bioscience, Inc. 209
8.44.1 OrCell 210
8.45 Gamidia Cell Ltd. 210
8.45.1 Gamidia's Technology 210
8.46 GeneGrafts Ltd. 211
8.46.1 Gene Graft's Technology 211
8.47 GenVec, Inc. 211
8.47.1 GenVec's Product Programs 212
8.47.1.1 TNFerade 212
8.47.1.2 Hearing and Balance 212
8.48 Genzyme Corporation 212
8.48.1 Genzyme's Business Performance 212
8.48.2 Genzyme's Genetic Diseases Segment 213
8.48.3 Genzyme's Hematology Oncology Segment 214
8.48.4 Genzyme's Cardiometabolic and Renal Segment 215
8.48.5 Genzyme's Biosurgery Segment 215
8.48.6 Genzyme's Genetics and Diagnostics Segment 216
8.48.7 Genzyme's Pipeline 216
8.49 Geron Corporation 218
8.49.1 Geron's Major Technology Platforms 218
8.49.1.1 Role of Telomere in Cancer and Aging 218
8.49.1.2 Human Embryonic Stem Cells: Source for the Manufacturing of Therapeutic



Cells 218
8.49.2 Commercial Opportunities for Geron's Major Technology Platforms 218
8.49.2.1 Oncology 218
8.49.3 Geron's Human Embryonic Stem Cell Therapies 219
8.49.4 Geron's Patents and Proprietary Technology 219
8.49.5 Geron's Business Performance 220
8.49.6 Geron's Investment in Research and Development 221
8.50 Harvest Technologies Corporation 221
8.50.1 Harvest Technologies' Products 221
8.50.1.1 SmartPReP2 APC+ 221
8.50.1.2 SmartPReP 2 BMAC 222
8.51 HemaStem Therapeutics, Inc. 222
8.51.1 Cord Blood Program 222
8.52 HepaLife Technologies, Inc. 223
8.52.1 Liver Disease 223
8.52.1.1 HepaMate 223
8.53 Humacyte, Inc. 224
8.53.1 Humacyte's Products 224
8.54 Hydra Biosciences, Inc. 224
8.54.1 Hydra's Program 224
8.55 Intercytex Group plc 225
8.55.1 Vavelta-Skin Repair and Rejuvenation 225
8.55.2 SHEF-1-Stem Cell Line 226
8.55.3 CX-SKN-Skin Graft Replacement for Burns and Acute Wounds 226
8.55.4 ICX-TRC-Hair Regeneration 227
8.55.5 Cyzact-Chronic Wound Repair 227
8.56 Integra Lifesciences Holdings Corporation 227
8.56.1 Integra's Products 228
8.56.1.1 Integra's Orthopedic Product Portfolio 228
8.56.1.2 Dermal Regeneration and Engineered Wound Dressings 228
8.56.1.3 Nerve and Tendon 228
8.56.1.4 Bone Graft Substitutes for Extremity Reconstruction 228
8.56.1.5 Integra's OrthoBiologics 229
8.56.1.6 Duraplasty Products 229
8.56.2 Integra's Investment in Research and Development 229
8.56.3 Integra's Business Performance 230
8.57 International Stem Cell Corporation (ISCO) 230
8.57.1 Lifeline Cell Technology 230
8.57.2 Universal Stem Cell Bank 231
8.57.3 ISCO's Technology 231
8.58 Japan Tissue Engineering, Co., Ltd. 231
8.58.1 Autologous Cultured Epidermis 232
8.58.2 Autologous Cultured Cartilage 232
8.58.3 Autologous Cultured Corneal Epithelium 233
8.59 Karocell Tissue Engineering AB 234
8.59.1 Karocell's Autologous Cells 234
8.59.1.1 Keratinocytes 234
8.59.1.2 Melanocytes 234



8.59.1.3 Fibroblasts 234
8.59.1.4 Chondrocytes 234
8.59.1.5 Urothelial Cells 234
8.59.1.6 Karoskin 235
8.59.1.7 Karoderm 235
8.59.1.8 Cell Bank 235
8.59.2 Karocell's Research and Development 235
8.60 Kensey Nash Corporation 235
8.60.1 Biomaterials from Kensey 236
8.60.2 Kensey's Collagen Technology 236
8.60.3 Porous Tissue Matrix Technology 237
8.60.4 Kensey's Products 237
8.60.4.1 The Angio-Seal Vascular Closure Device 237
8.60.4.2 Vitoss Scaffold Foam 238
8.60.4.3 OsseoFit Porous Tissue Matrix 238
8.60.4.4 Epi-Guide Bioresorbable Barrier Matrix 238
8.61 Kiadis Pharma, BV 238
8.62 LifeCell 239
8.62.1 AlloDerm Regenerative Tissue Matrix 239
8.62.2 Strattice Reconstructive Tissue Matrix 239
8.62.3 Cymetra Micronized AlloDerm Tissue 239
8.63 MaxCyte, Inc. 239
8.63.1 Advantages of MaxCyte Platform System 240
8.63.2 MaxCyte's Collaborations 240
8.63.3 MaxCyte's Application in Immunotherapy 240
8.63.4 MaxCyte's Application in Regenerative Medicine 241
8.63.5 MaxCyte's Viral Vectors and Vaccines 241
8.63.6 MaxCyte XTS Scalable Transfection System 241
8.64 Mesoblast Ltd. 241
8.64.1 Mesoblast's Intervertebral Spinal Fusion 242
8.64.2 Lumbar Fusion 242
8.64.3 Cervical Fusion 242
8.64.4 Mesoblast's Intervertebral Disc Repair and Regeneration 242
8.64.5 Mesoblast's Product for Knee Osteoarthritis 242
8.64.6 Mesoblast's Investment in Angioblast Systems, Inc. 242
8.64.7 Angioblast's Product Candidate for Congestive Heart Failure 243
8.64.8 Angioblast's Product Candidate for Bone Marrow Transplantation 243
8.65 NanoCor Therapeutics, Inc. 243
8.65.1 NanoCor's Products 243
8.66 NeuralStem, Inc. 243
8.66.1 NeuralStem's Technology 244
8.66.2 NeuralStem's Research and Programs 244
8.66.3 NeuralStem's Intellectual Property 245
8.67 NeuroNova AB 246
8.67.1 NeroNova's Neurogenesis Qualifier-Technology 246
8.67.2 The sNN0029 246
8.67.3 The sNN0031 247
8.67.4 NeuroNova's Investors 247



8.68 Olympus Terumo Biomaterials Corporation 247
8.68.1 OSferion 60 248
8.68.2 Terudermis 248
8.68.3 Teruplug 248
8.68.4 Osferion 249
8.68.5 Boneceram P 249
8.69 Opexa Therapeutics, Inc. 249
8.69.1 Opexa's T-Cell Platform 249
8.69.2 Opexa's Stem Cell Platform 250
8.70 Organogenesis, Inc. 250
8.70.1 Products from Organogenesis 250
8.70.1.1 Apligraf 250
8.70.1.2 VCT01 250
8.70.1.3 CelTx for Oral Soft Tissue Regeneration 251
8.70.1.4 FortaGen 251
8.70.1.5 FortaPerm 251
8.70.1.6 BioSTAR 251
8.71 Orthovita, Inc. 251
8.71.1 Orthovita's Products 252
8.71.1.1 Vitoss 252
8.71.1.2 Vitoss and Bone Defect Grafting 252
8.71.1.3 Vitoss in Spinal Fusion and Grafting 253
8.71.1.4 Vitoss and Trauma 253
8.71.1.5 Vitomatrix and Dental, Periodontal, Oral and Craniomaxillofacial
Defects 253
8.71.1.6 Cortoss Bone Augmentation Material 253
8.71.1.7 Cortoss and Vertebral Augmentation of VCFs 253
8.71.1.8 Cortoss and Screw Augmentation 253
8.71.1.9 Orthovita's Aliquot Delivery System 254
8.71.2 Orthovita's Biosurgery Products 254
8.71.3 Partnership with Kensey for Vitoss Foam 254
8.71.4 Partnership with Angiotech for Vitagel and CellPaker 254
8.71.5 Partnership with Medafor for Vitasure 255
8.71.6 Orthovita's Business Performance 255
8.72 Osiris Therapeutics, Inc. 255
8.72.1 Osiris' Partnerships 256
8.72.2 Osiris' Technologies 256
8.72.3 Prochymal 256
8.72.4 Chondrogen 257
8.73 Osteotech, Inc. 257
8.73.1 Osteotech's Products 257
8.74 Pervasis Therapeutics, Inc. 258
8.74.1 Pervasis' Clinical Focus 258
8.74.2 Power of Endothellium 258
8.74.3 Therapeutic Applications of Pervasis' Products 259
8.74.3.1 Arteriovenous (AV) Access for Hemodialysis 259
8.74.3.2 Peripheral Arterial Disease 259
8.75 Pleuron 260



8.75.1 Pleuron's Technology 260
8.76 Pluristem Therapeutics, Inc. 260
8.76.1 Pluristem's PluriX 3D Bioreactor 260
8.76.2 Pluristem's PLacental eXpanded (PLX) Cells 260
8.76.3 PLX-PAD for Peripheral Artery Disease 260
8.76.4 PLX-IBD for Inflammatory Bowel Disease 261
8.76.5 PLX-MS for Multiple Sclerosis 261
8.76.6 PLX-STROKE for Ischemic Stroke 261
8.77 RegeneRx 261
8.78 ReNeuron Group plc 261
8.78.1 ReNeuron's Platform Technologies 262
8.78.2 ReNeuron's Cell Therapy Programs 263
8.78.3 ReNeuron's ReN001 for Stroke 263
8.78.4 ReNeuron's ReNcell Products 264
8.79 Revivicor, Inc. 264
8.79.1 Revivicor's Xenografting Technology 264
8.79.2 Revivicor's Islet Transplantation Technology 264
8.79.3 Revivicor's Infectious Disease Platform Technologies 265
8.80 Saneron CCEL Therapeutics, Inc. 265
8.80.1 Saneron's U-Cord-Cell Program 265
8.80.2 Saneron's Sert-Cell Program 265
8.81 Sangamo BioSciences, Inc. 265
8.81.1 Sangamo's ZFP Therapeutic Product Development Programs 266
8.81.2 ZFP Therapeutic Pre-clinical Stage Programs 266
8.81.2.1 Neuropathic Pain (Cancer Pain) 266
8.81.2.2 Nerve Regeneration-Spinal Cord Injury (SCI) and Traumatic Brain Injury
(TBI) 266
8.81.2.3 Parkinson's Disease (PD) 267
8.81.2.4 Stroke 267
8.81.2.5 ZFP Therapeutic Research Programs 267
8.81.3 Funding from Research Foundations 267
8.81.3.1 The Juvenile Diabetes Research Foundation International 267
8.81.3.2 The Michael J. Fox Foundation 267
8.81.3.3 The Bill and Melinda Gates Foundation 267
8.81.4 Sangamo's Research and Development Expenses 267
8.81.5 Sangamo's Business Performance 268
8.82 StemCells, Inc. 268
8.82.1 StemCell's Cellular Medicine Programs 269
8.82.2 StemCells' Enabling Technologies Program 270
8.82.3 StemCells' Patents, Proprietary Rights and Licenses 270
8.83 Stem Cell Authority Ltd. 271
8.83.1 The "Miracle" Mesenchymal Stem Cell-Mirachymal Stem Cells 272
8.84 Stem Cell Innovations (SCI) 272
8.84.1 SCI's Research and Development 272
8.84.2 SCI's Services 272
8.84.3 PluriCells and Derivatives 272
8.84.4 ACTIVTox 273
8.84.5 PredictivTox 273



8.84.6 Endogenous Protein Production 273
8.85 Stem Cell Sciences KK 273
8.85.1 SCS KK's Product/Service 273
8.85.1.1 CultiCell Medium for Embryonic Stem Cells 273
8.85.1.2 Contract/Sponsored Research on ES-derived Functional Cells 274
8.86 SyntheMed, Inc. 274
8.86.1 Repel-CVAdhesion Barrier 274
8.86.2 Resolve Adhesion Barrier Instillate 274
8.86.3 Repel Adhesion Barrier 275
8.86.4 SpineShield Adhesion Barrier Film 275
8.86.5 Relieve Adhesion Barrier Gel 275
8.86.6 SinusShield Adhesion Prevention Film 275
8.87 t2cure GmbH 275
8.87.1 BMCs in Regenerative Therapies 275
8.87.2 t2cure's Product Development Pipeline 275
8.88 Tengion 276
8.88.1 Tengion's Pipeline Overview 276
8.89 TiGenix 277
8.89.1 ChondroCelect 277
8.89.2 Chondromimetic 277
8.89.3 TGX002 277
8.89.4 TGX003 277
8.90 Thermogenesis Corp. 278
8.90.1 Products from Thermogenesis 278
8.90.1.1 AutoXpress Platform or AXP 278
8.90.1.2 MarrowXpress 278
8.90.1.3 BioArchive System 278
8.90.1.4 Res-Q 278
8.90.1.5 Thermoline 278
8.90.1.6 CryoSeal Fibrin Sealant (CryoSeal) System 278
8.90.2 Thermogenesis' Business Performance 279

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
30
Figure 2.4: The Potential Uses of Embryonic Stem Cells 32
Figure 2.5: Cell Culture Products by Market Segment 34
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, 2000-2008 40
Figure 2.8: Percent Break-up of Cell Therapy Companies by Product Type, 2008 41
Figure 2.9: Location of Primary Tissue Engineering Companies by Geography,
2008-2009 42
Figure 2.10: Breakdown of Primary Cell Therapy Products on Market by Geography,
2008-2009 44



Figure 2.11: The Geographical Distribution of Clinical Trials, 2008-2009 47
Figure 2.12: Implantation of a Hydrogel at the Site of an Injured Tissue 57
Figure 2.13: Implantation of CS-PEG Hydrogel 57
Figure 2.14: Implantation of CMP-PEG Scaffold 58
Figure 4.1: Global Market for Regenerative Medicine Products, 2008-2013 79
Figure 4.2: Estimated market for Regenerative Cell Therapy Products for
Orthopedics, 2008-2012 80
Figure 4.3: Estimated U.S. Market for Regenerative Medicine Products, 2009-2014
80
Figure 4.4: Estimated U.S. Market for Bone Grafting/Bone Replacement, 2009-2014
81
Figure 4.5: Estimated U.S. Market for Bone Growth Stimulating Substances,
2009-2014 81
Figure 4.6: Estimated U.S. Market for Regenerative Products for Cartilage
Repair, 2009-2014 82
Figure 4.7: Estimated Market for Stem cells, 2008-2012 84
Figure 4.8: Estimated Market for Cell Therapy Products in the U.S., 2009-2018 85
Figure 4.9: Estimated Global Market for Cord Blood Stem Ce


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