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Critical Limb Ischemia - Pipeline Review, H2 2015 Is Released

Press Release   •   Jan 27, 2016 11:45 IST

Critical Limb Ischemia - Pipeline Review, H2 2015 Summary Global Markets Direct s, Critical Limb Ischemia - Pipeline Review, H2 2015, provides an overview of the Critical Limb Ischemias therapeutic pipeline. This report provides comprehensive information on the therapeutic development for Critical Limb Ischemia, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Critical Limb Ischemia and special features on late-stage and discontinued projects. Global Markets Directs report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from Global Markets Directs proprietary databases, Company/University websites, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources, put together by Global Markets Direct s team. Drug profiles/records featured in the report undergoes periodic updation following a stringent set of processes that ensures that all the profiles are updated with the latest set of information. Additionally, processes including live news & deals tracking, browser based alert-box and clinical trials registries tracking ensure that the most recent developments are captured on a real time basis. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products. Note*: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease. Scope - The report provides a snapshot of the global therapeutic landscape of Critical Limb Ischemia - The report reviews key pipeline products under drug profile section which includes, product description, MoA and R&D brief, licensing and collaboration details & other developmental activities - The report reviews key players involved in the therapeutics development for Critical Limb Ischemia and enlists all their major and minor projects - The report summarizes all the dormant and discontinued pipeline projects - A review of the Critical Limb Ischemia products under development by companies and universities/research institutes based on information derived from company and industry-specific sources - Pipeline products coverage based on various stages of development ranging from pre-registration till discovery and undisclosed stages - A detailed assessment of monotherapy and combination therapy pipeline projects - Coverage of the Critical Limb Ischemia pipeline on the basis of target, MoA, route of administration and molecule type - Latest news and deals relating related to pipeline products Reasons to buy - Provides strategically significant competitor information, analysis, and insights to formulate effective R&D development strategies - Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage - Develop strategic initiatives by understanding the focus areas of leading companies - Identify and understand important and diverse types of therapeutics under development for Critical Limb Ischemia - Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline - Devise corrective measures for pipeline projects by understanding Critical Limb Ischemia pipeline depth and focus of Indication therapeutics - Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to enhance and expand business potential and scope - Modify the therapeutic portfolio by identifying discontinued projects and understanding the factors that drove them from pipeline.

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Table of Contents

Introduction 9

Global Markets Direct Report Coverage 9

Critical Limb Ischemia Overview 10

Therapeutics Development 11

Pipeline Products for Critical Limb Ischemia - Overview 11

Pipeline Products for Critical Limb Ischemia - Comparative Analysis 12

Critical Limb Ischemia - Therapeutics under Development by Companies 13

Critical Limb Ischemia - Therapeutics under Investigation by Universities/Institutes 15

Critical Limb Ischemia - Pipeline Products Glance 16

Late Stage Products 16

Clinical Stage Products 17

Early Stage Products 18

Critical Limb Ischemia - Products under Development by Companies 19

Critical Limb Ischemia - Products under Investigation by Universities/Institutes 21

Critical Limb Ischemia - Companies Involved in Therapeutics Development 22

AnGes MG, Inc. 22

Apceth GmbH & Co. KG 23

Athersys, Inc. 24

Caladrius Biosciences, Inc. 25

Cynata Therapeutics Limited 26

DNAVEC Corporation 27

Hemostemix Ltd 28

IntelliCell BioSciences Inc. 29

Juventas Therapeutics, Inc. 30

Kasiak Research Private Limited 31

Multi Gene Vascular Systems Ltd 32

Pharmicell Co., Ltd. 33

Pluristem Therapeutics Inc. 34

ReNeuron Group Plc 35

Stempeutics Research Private Limited 36

Targazyme, Inc. 37

TikoMed AB 38

U.S. Stem Cell, Inc. 39

Vericel Corporation 40

ViroMed Co., Ltd. 41

Critical Limb Ischemia - Therapeutics Assessment 42

Assessment by Monotherapy Products 42

Assessment by Target 43

Assessment by Mechanism of Action 45

Assessment by Route of Administration 47

Assessment by Molecule Type 49

Drug Profiles 51

ACP-01 - Drug Profile 51

Product Description 51

Mechanism of Action 51

R&D Progress 51

AdipoCell - Drug Profile 53

Product Description 53

Mechanism of Action 53

R&D Progress 53

Alecmestencel-T - Drug Profile 55

Product Description 55

Mechanism of Action 55

R&D Progress 55

ASCT-01 - Drug Profile 56

Product Description 56

Mechanism of Action 56

R&D Progress 56

Autologous Vascular Cells Therapy - Drug Profile 57

Product Description 57

Mechanism of Action 57

R&D Progress 57

beperminogene perplasmid - Drug Profile 58

Product Description 58

Mechanism of Action 58

R&D Progress 58

Cell Therapy for Critical Limb Ischemia - Drug Profile 63

Product Description 63

Mechanism of Action 63

R&D Progress 63

Cellgram for Severe Lower Limb Ischemia - Drug Profile 64

Product Description 64

Mechanism of Action 64

R&D Progress 64

CLBS-12 - Drug Profile 65

Product Description 65

Mechanism of Action 65

R&D Progress 65

DVC1-0101 - Drug Profile 66

Product Description 66

Mechanism of Action 66

R&D Progress 66

Gene Therapy for Critical Limb Ischemia and Peripheral Arterial Disease - Drug Profile 68

Product Description 68

Mechanism of Action 68

R&D Progress 68

ixmyelocel-T - Drug Profile 69

Product Description 69

Mechanism of Action 69

R&D Progress 69

JVS-100 - Drug Profile 72

Product Description 72

Mechanism of Action 72

R&D Progress 72

MultiGeneAngio - Drug Profile 74

Product Description 74

Mechanism of Action 74

R&D Progress 74

MultiStem - Drug Profile 76

Product Description 76

Mechanism of Action 76

R&D Progress 76

PLX-PAD - Drug Profile 80

Product Description 80

Mechanism of Action 80

R&D Progress 80

Protein to Agonize LRP5 and LRP6 for Myocardial Infarction and Critical Limb Ischemia - Drug Profile 84

Product Description 84

Mechanism of Action 84

R&D Progress 84

Recombinant Protein for Critical Limb Ischemia - Drug Profile 85

Product Description 85

Mechanism of Action 85

R&D Progress 85

Refacell-CLI - Drug Profile 86

Product Description 86

Mechanism of Action 86

R&D Progress 86

Rejuveinix - Drug Profile 87

Product Description 87

Mechanism of Action 87

R&D Progress 87

ReN-009 - Drug Profile 88

Product Description 88

Mechanism of Action 88

R&D Progress 88

Stem Cell Therapy for Cardiovacular Diseases - Drug Profile 89

Product Description 89

Mechanism of Action 89

R&D Progress 89

Stem Cell Therapy for Critical Limb Ischemia - Drug Profile 90

Product Description 90

Mechanism of Action 90

R&D Progress 90

Stem Cell Therapy to Activate VEGF for Critical Limb Ischemia - Drug Profile 91

Product Description 91

Mechanism of Action 91

R&D Progress 91

Stempeucel - Drug Profile 92

Product Description 92

Mechanism of Action 92

R&D Progress 92

Stromal Cell Therapy for Critical Limb Ischemia - Drug Profile 95

Product Description 95

Mechanism of Action 95

R&D Progress 95

TM-700 - Drug Profile 96

Product Description 96

Mechanism of Action 96

R&D Progress 96

TZ-101 - Drug Profile 97

Product Description 97

Mechanism of Action 97

R&D Progress 97

VM-202 - Drug Profile 99

Product Description 99

Mechanism of Action 99

R&D Progress 99

Critical Limb Ischemia - Recent Pipeline Updates 101

Critical Limb Ischemia - Dormant Projects 129

Critical Limb Ischemia - Discontinued Products 130

Critical Limb Ischemia - Product Development Milestones 131

Featured News & Press Releases 131

Oct 05, 2015: Hemostemix to Present at 2015 Stem Cell Meeting on the Mesa 131

Sep 14, 2015: Hemostemix Executes Strategic Alliance with Hemostemix Asia for Expansion of Phase-2 Clinical Trial to Taiwan 131

Aug 17, 2015: Pluristem Granted U.S. Patent for Production Methods and Use of Placental Cell Therapy in a Range of Indications 132

Aug 12, 2015: Patient Enrollment Begins in Europe in the Global Phase III Clinical Trial of HGF Gene Therapy for Critical Limb Ischemia 132

Aug 12, 2015: Japan Grants Safety Clearance to Pluristems PLX-PAD Cells for Use in Clinical Trials 133

Aug 10, 2015: Hemostemix Receives FDA Clearance for Phase-2 Clinical Trial of Lead Product ACP-01 in the United States 133

Jul 27, 2015: Hemostemix Enrolls 20th Participant and Treats 15th in International Clinical Trial for Critical Limb Ischemia 133

Jun 25, 2015: Hemostemix Enrolls Fifth Participant at Vancouver General Hospital in International Phase-2 Clinical Trial for Critical Limb Ischemia 134

Jun 18, 2015: Hemostemix Prepares Investigational New Drug Application for Review by U.S. Food and Drug Administration for Companys ACP-01 Formulation to Treat Critical Limb Ischemia 134

Jun 08, 2015: Stempeutics receives Japan process patent for its novel stem cell drug, Stempeucel 135

Appendix 136

Methodology 136

Coverage 136

Secondary Research 136

Primary Research 136

Expert Panel Validation 136

Contact Us 136

Disclaimer 137

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