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Hemostats - Medical Devices Pipeline Assessment, 2016

  • March 2016
  • -
  • Global Data
  • -
  • 118 pages

Hemostats - Medical Devices Pipeline Assessment, 2016

Summary

GlobalData's Medical Devices sector report, “Hemostats - Medical Devices Pipeline Assessment, 2016" provides an overview of Hemostats currently in pipeline stage.

The report provides comprehensive information on the pipeline products with comparative analysis of the products at various stages of development. The report reviews major players involved in the pipeline product development. It also provides information about clinical trials in progress, which includes trial phase, trial status, trial start and end dates, and, the number of trials for the key Hemostats pipeline products.

This report is prepared using data sourced from in-house databases, secondary and primary research by GlobalData's team of industry experts.

*Note: Certain sections in the report may be removed or altered based on the availability and relevance of data in relation to the equipment type.

Scope

- Extensive coverage of the Hemostats under development
- The report reviews details of major pipeline products which includes, product description, licensing and collaboration details and other developmental activities
- The report reviews the major players involved in the development of Hemostats and list all their pipeline projects
- The coverage of pipeline products based on various stages of development ranging from Early Development to Approved / Issued stage
- The report provides key clinical trial data of ongoing trials specific to pipeline products
- Recent developments in the segment / industry

Reasons to buy

The report enables you to -
- Formulate significant competitor information, analysis, and insights to improve R&D strategies
- Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage
- Identify and understand important and diverse types of Hemostats under development
- Develop market-entry and market expansion strategies
- Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline
- In-depth analysis of the product’s current stage of development, territory and estimated launch date

Table Of Contents

Hemostats - Medical Devices Pipeline Assessment, 2016
1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 5
1.2 List of Figures 8
2 Introduction 9
2.1 Hemostats Overview 9
3 Products under Development 10
3.1 Hemostats - Pipeline Products by Stage of Development 10
3.2 Hemostats - Pipeline Products by Segment 11
3.3 Hemostats - Pipeline Products by Territory 12
3.4 Hemostats - Pipeline Products by Regulatory Path 13
3.5 Hemostats - Pipeline Products by Estimated Approval Date 14
3.6 Hemostats - Ongoing Clinical Trials 15
4 Hemostats - Pipeline Products under Development by Companies 16
4.1 Hemostats Companies - Pipeline Products by Stage of Development 16
4.2 Hemostats - Pipeline Products by Stage of Development 18
5 Hemostats Companies and Product Overview 20
5.1 3-D Matrix, Ltd. Company Overview 20
5.1.1 3-D Matrix, Ltd. Pipeline Products and Ongoing Clinical Trials Overview 20
5.2 Advanced Medical Solutions Group plc Company Overview 23
5.2.1 Advanced Medical Solutions Group plc Pipeline Products and Ongoing Clinical Trials Overview 23
5.3 Anika Therapeutics, Inc. Company Overview 31
5.3.1 Anika Therapeutics, Inc. Pipeline Products and Ongoing Clinical Trials Overview 31
5.4 Arch Therapeutics Inc. Company Overview 33
5.4.1 Arch Therapeutics Inc. Pipeline Products and Ongoing Clinical Trials Overview 33
5.5 Argon Medical Devices Inc. Company Overview 37
5.5.1 Argon Medical Devices Inc. Pipeline Products and Ongoing Clinical Trials Overview 37
5.6 Baxter International Inc. Company Overview 38
5.6.1 Baxter International Inc. Pipeline Products and Ongoing Clinical Trials Overview 38
5.7 Beth Israel Deaconess Medical Center, Inc. Company Overview 43
5.7.1 Beth Israel Deaconess Medical Center, Inc. Pipeline Products and Ongoing Clinical Trials Overview 43
5.8 Biomedica Management Corporation Company Overview 44
5.8.1 Biomedica Management Corporation Pipeline Products and Ongoing Clinical Trials Overview 44
5.9 Biom'Up SAS Company Overview 48
5.9.1 Biom'Up SAS Pipeline Products and Ongoing Clinical Trials Overview 48
5.10 Cellphire, Inc. Company Overview 49
5.10.1 Cellphire, Inc. Pipeline Products and Ongoing Clinical Trials Overview 49
5.11 Covalent Medical, Inc. (Inactive) Company Overview 52
5.11.1 Covalent Medical, Inc. (Inactive) Pipeline Products and Ongoing Clinical Trials Overview 52
5.12 Covalon Technologies Ltd. Company Overview 53
5.12.1 Covalon Technologies Ltd. Pipeline Products and Ongoing Clinical Trials Overview 53
5.13 CryoLife, Inc. Company Overview 56
5.13.1 CryoLife, Inc. Pipeline Products and Ongoing Clinical Trials Overview 56
5.14 Endomedix Incorporated Company Overview 60
5.14.1 Endomedix Incorporated Pipeline Products and Ongoing Clinical Trials Overview 60
5.15 Entegrion, Inc. Company Overview 62
5.15.1 Entegrion, Inc. Pipeline Products and Ongoing Clinical Trials Overview 62
5.16 Ethicon, Inc. Company Overview 63
5.16.1 Ethicon, Inc. Pipeline Products and Ongoing Clinical Trials Overview 63
5.17 Floralis S.A.S. Company Overview 64
5.17.1 Floralis S.A.S. Pipeline Products and Ongoing Clinical Trials Overview 64
5.18 Gamma Therapeutics, Inc. Company Overview 65
5.18.1 Gamma Therapeutics, Inc. Pipeline Products and Ongoing Clinical Trials Overview 65
5.19 Haemostatix Limited Company Overview 66
5.19.1 Haemostatix Limited Pipeline Products and Ongoing Clinical Trials Overview 66
5.20 Hemostasis, LLC Company Overview 69
5.20.1 Hemostasis, LLC Pipeline Products and Ongoing Clinical Trials Overview 69
5.21 KeraNetics, LLC Company Overview 71
5.21.1 KeraNetics, LLC Pipeline Products and Ongoing Clinical Trials Overview 71
5.22 LifeBond Ltd. Company Overview 72
5.22.1 LifeBond Ltd. Pipeline Products and Ongoing Clinical Trials Overview 72
5.23 Remedium Technologies Inc. Company Overview 75
5.23.1 Remedium Technologies Inc. Pipeline Products and Ongoing Clinical Trials Overview 75
5.24 Rice University Company Overview 76
5.24.1 Rice University Pipeline Products and Ongoing Clinical Trials Overview 76
5.25 Samyang Biopharmaceuticals Corporation Company Overview 78
5.25.1 Samyang Biopharmaceuticals Corporation Pipeline Products and Ongoing Clinical Trials Overview 78
5.26 Sanofi Company Overview 80
5.26.1 Sanofi Pipeline Products and Ongoing Clinical Trials Overview 80
5.27 Sea Run Holdings Inc. Company Overview 82
5.27.1 Sea Run Holdings Inc. Pipeline Products and Ongoing Clinical Trials Overview 82
5.28 St Teresa Medical, Inc. Company Overview 83
5.28.1 St Teresa Medical, Inc. Pipeline Products and Ongoing Clinical Trials Overview 83
5.29 Suneris Technologies, Inc. Company Overview 87
5.29.1 Suneris Technologies, Inc. Pipeline Products and Ongoing Clinical Trials Overview 87
5.30 The Medicines Company Company Overview 88
5.30.1 The Medicines Company Pipeline Products and Ongoing Clinical Trials Overview 88
5.31 Therus Corporation Company Overview 90
5.31.1 Therus Corporation Pipeline Products and Ongoing Clinical Trials Overview 90
5.32 Xcede Technologies, Inc. Company Overview 91
5.32.1 Xcede Technologies, Inc. Pipeline Products and Ongoing Clinical Trials Overview 91
6 Hemostats- Recent Developments 92
6.1 Feb 18, 2016: Genelife Enters into Licensing Agreement with 3-D Matrix Europe 92
6.2 Feb 17, 2016: Z-Medica Receives Expanded CE Mark for QuikClot 92
6.3 Jan 21, 2016: United Health Products Announces Optimal Government Services as UHP's Exclusive Government Distributor 92
6.4 Dec 16, 2015: Arch Therapeutics Receives Clearance to Initiate Clinical Trial in Europe 93
6.5 Dec 09, 2015: Arsenal Medical Secures Funding from U.S. Army to Advance ResQFoam Trauma Product through Regulatory Approval 93
6.6 Dec 04, 2015: Change in B. Braun Management Board 94
6.7 Dec 01, 2015: Arch Therapeutics Reports Significant Wound Healing Results in Pre-Clinical Safety Study with AC5 Surgical Hemostatic Device 94
6.8 Nov 17, 2015: CryoLife Announces Resolution of PerClot Litigation with Medafor 95
6.9 Oct 28, 2015: United Health Products' HemoStyp Now Available Through Henry Schein 95
6.10 Oct 22, 2015: CoAg Medical And Lou Ferrigno Announce StopsBleeding Product Launch 95
6.11 Oct 20, 2015: Vascular Solutions Reports Third Quarter Results-2015 96
6.12 Sep 08, 2015: Arch Therapeutics Obtains Additional Positive Safety Data for AC5 Surgical Hemostatic Device in Preclinical Toxicity Test of Sensitization 98
6.13 Aug 24, 2015: United Health Products Announces School Health as a Distributor 99
6.14 Aug 18, 2015: Dynasil Announces Xcede Technologies' Patent Application for Novel All-in-One Patch 99
6.15 Aug 05, 2015: LifeBond Raises USD27 Million in Series D Financing 99
6.16 Aug 04, 2015: Suneris CEO to Present VETIGEL at White House Demo Day 99
6.17 Jul 21, 2015: Vascular Solutions Reports Second Quarter Results 100
6.18 Jul 15, 2015: Remedium Technologies Receives FDA Clearance for Hemogrip Technology to Help Stop Bleeding 102
6.19 Jul 14, 2015: St. Teresa Medical Announces First Patient Enrolled in SURGICLOT Clinical Trial in U.K 102
6.20 Jun 26, 2015: Suneris Introduces VETIGEL as a New Wound Care Solution for Veterinarians 103
6.21 Jun 15, 2015: OxySure Systems Enters into Distribution Agreement with Z-Medica 103
6.22 Jun 09, 2015: Arch Therapeutics Obtains Additional Safety Data for Its AC5 Surgical Hemostatic Device in Successful Preclinical Toxicity Test 103
6.23 May 13, 2015: DuBiotech Welcomes Germany's B.Braun 104
6.24 Apr 30, 2015: The Medicines Company Announces FDA Approval of RAPLIXA (Fibrin Sealant), the First and Only Powdered Fibrin Sealant Ready-to-Use for Mild to Moderate Surgical Bleeding 104
6.25 Apr 28, 2015: CryoLife Begins Patient Enrolment In PerClot IDE Clinical Trial 105
6.26 Apr 21, 2015: Vascular Solutions Reports First Quarter Results 106
6.27 Apr 16, 2015: Arch Therapeutics' AC5 Compared Favorably vs. Commercially Available Combination Hemostat in Animal Study 108
6.28 Apr 14, 2015: Arch Therapeutics Announces Favorable Preclinical Data From an Independent Study of AC5 Surgical Hemostatic Device Versus a Popular Fibrin Sealant 109
6.29 Apr 07, 2015: United Health Products Announces Laboratory Test Results 110
6.30 Apr 01, 2015: Z-Medica Announces QuikClot Products Approved in California 110
6.31 Mar 27, 2015: B. Braun Group increases sales and earnings 111
6.32 Mar 25, 2015: Arch Therapeutics Announces Favorable Preclinical Data from an Independent Study of AC5 Surgical Hemostatic Device Versus a Popular Cellulose-Based Hemostatic Agent 112
6.33 Mar 23, 2015: Arch Therapeutics Announces Positive Safety Results for AC5 Surgical Hemostatic Device in Preclinical Toxicity Studies 113
6.34 Mar 13, 2015: Withdrawal of Application for the Approval of the Hemostat (TDM-621) 113
6.35 Mar 12, 2015: CryoLife Provides Update on PerClot Litigation 113
7 Appendix 115
7.1 Methodology 115
7.2 About GlobalData 117
7.3 Contact Us 118
7.4 Disclaimer 118

1.1 List of Tables
Table 1: Hemostats - Pipeline Products by Stage of Development 10
Table 2: Hemostats - Pipeline Products by Segment 11
Table 3: Hemostats - Pipeline Products by Territory 12
Table 4: Hemostats - Pipeline Products by Regulatory Path 13
Table 5: Hemostats - Pipeline Products by Estimated Approval Date 14
Table 6: Hemostats - Ongoing Clinical Trials 15
Table 7: Hemostats Companies - Pipeline Products by Stage of Development 16
Table 8: Hemostats - Pipeline Products by Stage of Development 18
Table 9: 3-D Matrix, Ltd. Pipeline Products and Ongoing Clinical Trials Overview 20
Table 10: PuraStat Hemostat - Product Status 21
Table 11: PuraStat Hemostat - Product Description 21
Table 12: TDM-511 - Product Status 22
Table 13: TDM-511 - Product Description 22
Table 14: Advanced Medical Solutions Group plc Pipeline Products and Ongoing Clinical Trials Overview 23
Table 15: Antibiotic Hemostat - Product Status 24
Table 16: Antibiotic Hemostat - Product Description 24
Table 17: GENTA-COLL Resorb - Product Status 25
Table 18: GENTA-COLL Resorb - Product Description 25
Table 19: GENTA-FOIL Resorb - Product Status 26
Table 20: GENTA-FOIL Resorb - Product Description 26
Table 21: KOLLAGEN resorb - Product Status 27
Table 22: KOLLAGEN resorb - Product Description 27
Table 23: RESORBA CELL Fibrillar - Product Status 28
Table 24: RESORBA CELL Fibrillar - Product Description 28
Table 25: RESORBA CELL forte - Product Status 29
Table 26: RESORBA CELL forte - Product Description 29
Table 27: RESORBA CELL standard - Product Status 30
Table 28: RESORBA CELL standard - Product Description 30
Table 29: Anika Therapeutics, Inc. Pipeline Products and Ongoing Clinical Trials Overview 31
Table 30: Hemostatic Patch - Product Status 32
Table 31: Hemostatic Patch - Product Description 32
Table 32: Arch Therapeutics Inc. Pipeline Products and Ongoing Clinical Trials Overview 33
Table 33: AC5 Surgical Hemostatic Device - Product Status 34
Table 34: AC5 Surgical Hemostatic Device - Product Description 34
Table 35: Arch Therapeutics Inc. - Ongoing Clinical Trials Overview 35
Table 36: AC5 Surgical Hemostatic Device - AC5 Surgical Hemostatic Device Clinical Trial in Europe 36
Table 37: Argon Medical Devices Inc. Pipeline Products and Ongoing Clinical Trials Overview 37
Table 38: Hemaseel Thrombin Haemostatic Agent - Product Status 37
Table 39: Hemaseel Thrombin Haemostatic Agent - Product Description 37
Table 40: Baxter International Inc. Pipeline Products and Ongoing Clinical Trials Overview 38
Table 41: Hemopatch - Product Status 39
Table 42: Hemopatch - Product Description 39
Table 43: Baxter International Inc. - Ongoing Clinical Trials Overview 40
Table 44: Hemopatch - A Phase II Prospective, Single Blinded, Randomized Trial of Hemopatch Compared to Standard Techniques to Achieve Air Leak Control After Complex Thoracic Surgical Procedures on High Risk Population for Prolonged Air Leak (> 5 Days - PAL) 41
Table 45: Hemopatch - A Prospective Randomized Trial of Hemopatch Versus No Hemopatch for the Intraoperative Hemostasis During Deceased Donor Renal Transplant 41
Table 46: Hemopatch - Prospective Randomized Clinical Trial to Prevent Air Leaks After Lung Resection with Hemopatch Sealing Hemostat: SEALLS (Sealing Evaluation of Air Leaks After Lung Surgery) Trial 42
Table 47: Hemopatch - Prospective, Multicenter, Open-label, Randomized, Phase III Clinical Trial of Prevention of Prolonged Air Leak after Lung Resection in High-risk Patients, Applying HEMOPATCH 42
Table 48: Beth Israel Deaconess Medical Center, Inc. Pipeline Products and Ongoing Clinical Trials Overview 43
Table 49: Portable Wound Hemostasis System - Product Status 43
Table 50: Portable Wound Hemostasis System - Product Description 43
Table 51: Biomedica Management Corporation Pipeline Products and Ongoing Clinical Trials Overview 44
Table 52: ClotFoam - Product Status 45
Table 53: ClotFoam - Product Description 45
Table 54: ClotGel - Product Status 46
Table 55: ClotGel - Product Description 46
Table 56: ClotSpray - Product Status 47
Table 57: ClotSpray - Product Description 47
Table 58: Biom'Up SAS Pipeline Products and Ongoing Clinical Trials Overview 48
Table 59: Hemoblast Bellows - Product Status 48
Table 60: Hemoblast Bellows - Product Description 48
Table 61: Cellphire, Inc. Pipeline Products and Ongoing Clinical Trials Overview 49
Table 62: Thromboderm - Product Status 50
Table 63: Thromboderm - Product Description 50
Table 64: Thrombosomes - Hemostatic Agent - Product Status 51
Table 65: Thrombosomes - Hemostatic Agent - Product Description 51
Table 66: Covalent Medical, Inc. (Inactive) Pipeline Products and Ongoing Clinical Trials Overview 52
Table 67: CovaSTAT - Product Status 52
Table 68: CovaSTAT - Product Description 52
Table 69: Covalon Technologies Ltd. Pipeline Products and Ongoing Clinical Trials Overview 53
Table 70: ColActive THP - Product Status 54
Table 71: ColActive THP - Product Description 54
Table 72: CovaStat BioActive Absorbable Hemostatic Sponge - Product Status 55
Table 73: CovaStat BioActive Absorbable Hemostatic Sponge - Product Description 55
Table 74: CryoLife, Inc. Pipeline Products and Ongoing Clinical Trials Overview 56
Table 75: PerClot - Product Status 57
Table 76: PerClot - Product Description 57
Table 77: CryoLife, Inc. - Ongoing Clinical Trials Overview 58
Table 78: PerClot - Prospective, Multicenter, Multidisciplinary, Controlled Clinical Investigation Evaluating the Safety and Efficacy of PerClot Polysaccharide Hemostatic System 59
Table 79: Endomedix Incorporated Pipeline Products and Ongoing Clinical Trials Overview 60
Table 80: Internal Hemostat - Product Status 60
Table 81: Internal Hemostat - Product Description 60
Table 82: Topical Hemostat - Product Status 61
Table 83: Topical Hemostat - Product Description 61
Table 84: Entegrion, Inc. Pipeline Products and Ongoing Clinical Trials Overview 62
Table 85: Stasix - Product Status 62
Table 86: Stasix - Product Description 62
Table 87: Ethicon, Inc. Pipeline Products and Ongoing Clinical Trials Overview 63
Table 88: Flowable thrombin - Product Status 63
Table 89: Flowable thrombin - Product Description 63
Table 90: Floralis S.A.S. Pipeline Products and Ongoing Clinical Trials Overview 64
Table 91: Bleeding Controlling Device - Product Status 64
Table 92: Bleeding Controlling Device - Product Description 64
Table 93: Gamma Therapeutics, Inc. Pipeline Products and Ongoing Clinical Trials Overview 65
Table 94: GammaTF - Product Status 65
Table 95: GammaTF - Product Description 65
Table 96: Haemostatix Limited Pipeline Products and Ongoing Clinical Trials Overview 66
Table 97: HaemoPlax - Product Status 67
Table 98: HaemoPlax - Product Description 67
Table 99: PeproStat - Product Status 68
Table 100: PeproStat - Product Description 68
Table 101: Hemostasis, LLC Pipeline Products and Ongoing Clinical Trials Overview 69
Table 102: ENT Hemostat - Product Status 69
Table 103: ENT Hemostat - Product Description 69
Table 104: Hemostatic Gel - Product Status 70
Table 105: Hemostatic Gel - Product Description 70
Table 106: KeraNetics, LLC Pipeline Products and Ongoing Clinical Trials Overview 71
Table 107: Keratin-Based Hemostat - Product Status 71
Table 108: Keratin-Based Hemostat - Product Description 71
Table 109: LifeBond Ltd. Pipeline Products and Ongoing Clinical Trials Overview 72
Table 110: Absorbable Hemostat - Product Status 72
Table 111: Absorbable Hemostat - Product Description 72
Table 112: LifePatch Heavy - Product Status 73
Table 113: LifePatch Heavy - Product Description 73
Table 114: LifePatch Surgery - Product Status 74
Table 115: LifePatch Surgery - Product Description 74
Table 116: Remedium Technologies Inc. Pipeline Products and Ongoing Clinical Trials Overview 75
Table 117: Hemogrip Spray-On Foam - Product Status 75
Table 118: Hemogrip Spray-On Foam - Product Description 75
Table 119: Rice University Pipeline Products and Ongoing Clinical Trials Overview 76
Table 120: KOD Hydrogel Hemostat - Product Status 77
Table 121: KOD Hydrogel Hemostat - Product Description 77
Table 122: Samyang Biopharmaceuticals Corporation Pipeline Products and Ongoing Clinical Trials Overview 78
Table 123: B6100 - Product Status 78
Table 124: B6100 - Product Description 78
Table 125: B6102 Hemostatic ORC - Product Status 79
Table 126: B6102 Hemostatic ORC - Product Description 79
Table 127: Sanofi Pipeline Products and Ongoing Clinical Trials Overview 80
Table 128: Lumagel - Product Status 81
Table 129: Lumagel - Product Description 81
Table 130: Sea Run Holdings Inc. Pipeline Products and Ongoing Clinical Trials Overview 82
Table 131: SEA-STAT - Product Status 82
Table 132: SEA-STAT - Product Description 82
Table 133: St Teresa Medical, Inc. Pipeline Products and Ongoing Clinical Trials Overview 83
Table 134: SURGICLOT - Product Status 83
Table 135: SURGICLOT - Product Description 83
Table 136: WRAPCLOT - Product Status 84
Table 137: WRAPCLOT - Product Description 84
Table 138: St Teresa Medical, Inc. - Ongoing Clinical Trials Overview 85
Table 139: SURGICLOT - A Multicenter Study to Assess the Safety and Performance of SurgiClot in the Treatment of Cancellous Bone Bleeding 86
Table 140: Suneris Technologies, Inc. Pipeline Products and Ongoing Clinical Trials Overview 87
Table 141: VETIGEL - Product Status 87
Table 142: VETIGEL - Product Description 87
Table 143: The Medicines Company Pipeline Products and Ongoing Clinical Trials Overview 88
Table 144: Fibropad Patch - Product Status 89
Table 145: Fibropad Patch - Product Description 89
Table 146: Therus Corporation Pipeline Products and Ongoing Clinical Trials Overview 90
Table 147: Therus Acoustic Hemostasis System - Product Status 90
Table 148: Therus Acoustic Hemostasis System - Product Description 90
Table 149: Xcede Technologies, Inc. Pipeline Products and Ongoing Clinical Trials Overview 91
Table 150: Xcede Patch - Product Status 91
Table 151: Xcede Patch - Product Description 91
Table 152: Glossary 116

1.2 List of Figures
Figure 1: Hemostats - Pipeline Products by Stage of Development 10
Figure 2: Hemostats - Pipeline Products by Segment 11
Figure 3: Hemostats - Pipeline Products by Territory 12
Figure 4: Hemostats - Pipeline Products by Regulatory Path 13
Figure 5: Hemostats - Pipeline Products by Estimated Approval Date 14
Figure 6: Hemostats - Ongoing Clinical Trials 15

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