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Regenerative Medicine Markets

2. Regenerative Medicines: An Overview of Segments 222.1 Tissue Engineering 222.1.1 Tissue-Engineered Skin 232.1.2 Tissue-Engineered Cartilage 232.1.3 Tissue-Engineered Bone 242.1.4 Tissue-Engineered Peripheral Nerves 252.1.5 Tissue-Engineered Cornea 262.1.6 Tissue-Engineered Blood Vessels 262.1.7 Progress and Promises for Tissue Engineering Industry 272.1.7.1 Key Positioning Strategies in Tissue Engineering Industry 272.1.7.2 Tissue Engineering Industry Participants 272.1.7.3 Tissue Engineering Firms by their Product Applications 282.1.7.4 Number of TEFs Focused on Skin, Cartilage, Bone and Urological Products 282.1.7.5 Number of Tissue Engineering Firms Focused on Cardiovascular Products 292.1.7.6 Number of Tissue Engineering Firms Focused on Neurological Products 302.1.7.7 Number of Tissue Engineering Firms Focusing on Pancreas, Liver and Kidney 302.1.7.8 Tissue Engineering Firms Focused on Ophthalmic Products 312.1.7.9 Tissue Engineering Firms Involved in Dental Products 312.1.7.10 Number of TEFs Involved in Autologous and Allogenic Products 312.1.7.11 Geographic Distribution of Tissue Engineering Firms in Major Markets 312.2 Cell Therapy 322.2.1 Progress in Cell Therapy Product Research 342.2.2 Commercially Available Cell Therapy Products 352.2.3 Major Cell Therapy Companies 362.2.4 Locations of Cell Therapy Companies 382.2.5 Disease Focus by Cell Therapy 392.2.6 Cell Therapy Products and Companies 392.2.6.1 Autologous Structural Products for Cartilage, Skin, Bone, etc. 412.2.7 Potential Patients for Cell Therapy in the U.S. 412.2.8 Number of Patients Treated Between 1988 and 2010 by Cell Therapy 412.2.9 Cell Therapy Pipeline 42 2.2.10 Cell Therapy Clinical Trials by Indication 432.2.10.1 Major Cell Therapy Clinical Trials for Diabetes 432.2.10.2 Progress in Clinical Trials for Diabetes 442.2.10.3 Estimated Completion Dates for Cell Therapy Clinical Trials in Diabetes 44 2.2.11 Major Four Targeted Disease Conditions for Clinical Trials 45 2.2.12 Commercial Success of Cell Therapies in Europe 46 2.2.13 Deals in Cell Therapy, 2007-2011 49 2.2.14 Commercial-Stage Cell Therapy Companies and Products 50 2.2.15 Cell Therapy Clinical Trials in the U.K. 512.2.15.1 Clinical Trials Involving Allogeneic vs. Autologous Products in the U.K. 522.2.15.2 Cell Types Involved in the U.K. Clinical Trials 532.2.15.3 U.K. Cell Therapy Clinical Trials by Indication 532.3 Cell Culture Products 542.3.1 Market for Reagents Used in Cell Culture 552.3.2 Cell Culture Media 562.3.3 Market for Sera Used in Cell Culture 572.3.3.1 Suppliers of Culture Media and Reagents 582.3.3.2 In Vitro Test Kits 592.3.3.3 Suppliers of Cells and Tissues 592.3.3.4 Equipment for Stem Cell Research 602.3.3.5 Computer Software for Stem Cell Research 622.4 Scaffolding Biomaterials 632.5 Growth Factors 64

3. Regenerative Medicine: The Next Evolution of Medical Treatment 663.1 Scope of this Chapter 663.2 Need for Regenerative Medicine 663.3 Current State of Regenerative Medicines 663.4 Future of Regenerative Medicine 673.4.1 Number of Products in Pipeline 683.5 Projected Timeline for Regenerative Medicine 723.6 Selected Regenerative Medicine Products in the Market 723.6.1 Medtronic's Infuse Bone Graft and LT-Cage Device 733.6.2 Genzyme's Corticel 733.6.3 OP-1 from Stryker 753.6.4 Osteocel from Osyris/Nuvasive 753.6.5 Spinal Implants from RTI Biologics 763.6.6 Apligraf from Organogenesis 763.6.7 Dermograft from Advanced BioHealing 763.6.8 Integra's Bilayer Matrix for Wound Dressing 773.6.9 Alloderm from LifeCell 77 3.6.10 Celution from Cytori Therapeutics 78 3.6.11 Other Products of Importance in Regenerative Medicine 78 3.6.12 Tissue-Engineered Wound Healing Products 783.6.12.1 Oasis 793.6.12.2 Permacol 793.6.12.3 EZ-Derm 793.6.12.4 Matriderm 803.6.12.5 TransCyte 803.6.12.6 ICX-SKN 803.6.12.7 OrCel 813.6.12.8 Epicel 813.6.12.9 Myskin 823.6.12.10 VCT01 82 3.6.13 ICX-TRC—Hair Regeneration Therapy 82 3.6.14 Cartilage Regeneration 823.6.14.1 Novocart 823.6.14.2 BioSeed-C 833.6.14.3 BioSeed—Oral Bone 833.6.14.4 Chondrotissue 833.6.14.5 co.don Chondrotransplant 833.6.14.6 co.don Chondrotransplant DISC 833.6.14.7 co.don Chondrosphere 833.6.14.8 co.don Osteotransplant DENT 843.6.14.9 MACI Implant 843.6.14.10 Cartilink-3 843.6.14.11 Accell Evo3 Demineralized Bone Matrix 843.6.14.12 OsSatura BCP 84 3.6.15 Mozobil 843.7 Clinical Milestones in RM Sector, 2011-2012 843.7.1 GINTUIT ( March 2012) 843.7.2 Ixmyelocel-T ( February 2012) 843.7.3 Autologous CD34+ Stem Cells ( February 2012) 853.7.4 HuCNS-SC ( February 2012) 853.7.5 DeNovo ET ( February 2012) 853.7.6 Retinal Pigment Epithelium Cells ( January 2012) 853.7.7 AMR-001 ( January 2012) 853.7.8 Avance Nerve Graft ( January 2012) 853.7.9 Adipose-Derived Stem Cells to Treat Myocardial Ischemia ( January 2012) 86 3.7.10 T-Cells Resistant to HIV ( January 2012) 86 3.7.11 Tissue-Engineered Windpipe ( November 2011) 86 3.7.12 Revascor ( November 2011) 86 3.7.13 ReN001 Stem Cell Therapy ( September 2011) 86 3.7.14 HP802-247 Allogeneic Cell Suspension for Leg Ulcers ( August 2011) 86 3.7.15 ALD-301 for Critical Limb Ischemia ( May 2011) 86 3.7.16 JVS-100 for Heart Failure ( April 2011) 87 3.7.17 MultiStem for Ulcerative Colitis ( March 2011) 87 3.7.18 HuCNS-SC Human Neural Stem Cells ( March 2011) 873.8 Accelerated Pace of Deals in RM Sector 873.8.1 Acquisitions and Partnerships 873.8.1.1 Shire's Acquisition of Advanced BioHealing, Inc. ( May 2011) 873.8.1.2 Terumo Americas Holding's Acquisition of Harvest Technologies (April 2011) 873.8.1.3 Sanofi's Acquisition of Genzyme Corporation ( February 2011) 873.8.1.4 NeoStem's Acquisition of Progenitor Cell Therapy, LLC ( January 2011) 873.8.1.5 Strategic Alliance between Mesoblast and Cephalon, Inc. ( December 2011) 883.8.2 Notable Financings 883.8.2.1 Financing to AlloCure, Inc. ( April 2012) 883.8.2.2 Financing to Promethera Biosciences ( March 2012) 883.8.2.3 Financing to In Vivo Therapeutics Holdings Corp. ( February 2012) 883.8.2.4 Financing to Organovo ( March 2012) 883.8.2.5 Financing to Cytomedix, Inc. ( February 2012) 883.8.2.6 Financing to Fate Therapeutics, Inc. ( May 2011) 883.8.2.7 Financing to Cellular Dynamics International, Inc. ( April 2011) 893.8.2.8 Financing to Cytori Therapeutics ( December 2010) 893.8.2.9 Overview of Capital Formation in RM Industry 89

4. Recent Advances in Regenerative Medicine and Stem Cell Research 904.1 Bioengineered Autologous Vein 904.2 Stem Cell Treatment for Spinal Cord Injury 904.3 Repairing Damaged Retina 904.4 A Possible Cure for Deafness 914.5 Clinical Trials for Stem Cell Therapies for CNS Disorders by StemCells, Inc. 914.6 First Clinical Use of Bioengineered Vascular Graft Made from Autologous Stem Cells 924.6.1 Recent Developments in Stem Cell Therapy in Cardiology 924.6.2 Recent Developments in Acute MI 924.6.3 Chronic Ischemic Cardiomyopathy and Heart Failure 944.6.4 Stem Cells and Neurodegenerative Diseases 954.7 Disease Modeling: The Use of Inducible Cells 964.7.1 Modeling Disease with iPS Cells 964.7.2 Modeling Disease with Direct Neuronal Conversion 974.8 Stem Cell Transplants 974.8.1 Recent Developments in Ophthalmologic Stem Cell Transplantation Therapies 984.8.2 Stem Cell Types for Eye Disease Clinical Trials 984.8.2.1 Pluripotent Stem Cells 994.8.2.2 Neural Stem Cells 994.8.2.3 RPE Stem Cells 994.8.2.4 Limbal Stem Cells 994.8.2.5 Umbilical Cord Stem Cells 994.8.2.6 Bone Marrow Stem Cells 994.8.2.7 Pluripotent Stem Cells for Retinal and RPE Degeneration 994.8.2.8 Patch of hESC-Derived RPE Monolayer 1004.8.2.9 Patient-Derived RPE 1004.8.2.10 NSCs for AMD 1004.8.2.11 UCSCs for RP and AMD 1014.8.2.12 Bone Marrow Stem Cells for Photoreceptor Diseases 1014.8.2.13 Corneal Repair 1014.8.2.14 Bioengineered Eye Tissues 1014.9 Regenerative Strategies in the Treatment of Diabetes 1014.9.1 Cell-Based Therapy for Diabetes 1024.9.2 Embryonic Stem Cells and Induced Pluripotent Cells 102

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