Hemostats - Medical Devices Pipeline Assessment, 2016

Transcription

1 Hemostats - Medical Devices Pipeline Assessment, 2016

2 Hemostats - Medical Devices Pipeline Assessment, 2016 Sector Publishing Intelligence Limited (SPi) has been marketing business and market research reports from selected publishers for over five years. SPi offers a personal service to our customers with dedicated research managers who will work with you to source the best report for your needs. Based in the UK, SPi is well positioned to coordinate our customers' orders sourced from over 30 global report publishers. We are pleased to present details of this report to assist your buying decision and administrative process. You will find easy-to-use How To Buy information on the last page of this document. We look forward to being of service to you. If you have bulk and/or recurring requirements, please get in touch - we can liaise with publishers to obtain sample pages and negotiate discounts on your behalf. Phone: +44 (0) or office@sectorpublishing.com 2

3 Hemostats - Medical Devices Pipeline Assessment, 2016 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 counterstrategies 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 Additional Details Publisher : Global Data 3

4 Reference : GDME0161EPD Number of Pages : 118 Report Format : PDF Publisher Information : A leading global business intelligence provider offering advanced analytics to help clients make better, more informed decisions every day. 4

5 Table Of Contents for Hemostats - Medical Devices Pipeline Assessment, Table of Contents 1 Table of Contents List of Tables List of Figures 8 2 Introduction Hemostats Overview 9 3 Products under Development Hemostats - Pipeline Products by Stage of Development Hemostats - Pipeline Products by Segment Hemostats - Pipeline Products by Territory Hemostats - Pipeline Products by Regulatory Path Hemostats - Pipeline Products by Estimated Approval Date Hemostats - Ongoing Clinical Trials 15 4 Hemostats - Pipeline Products under Development by Companies Hemostats Companies - Pipeline Products by Stage of Development Hemostats - Pipeline Products by Stage of Development 18 5 Hemostats Companies and Product Overview D Matrix, Ltd. Company Overview D Matrix, Ltd. Pipeline Products & Ongoing Clinical Trials Overview Advanced Medical Solutions Group plc Company Overview Advanced Medical Solutions Group plc Pipeline Products & Ongoing Clinical Trials Overview Anika Therapeutics, Inc. Company Overview Anika Therapeutics, Inc. Pipeline Products & Ongoing Clinical Trials Overview Arch Therapeutics Inc. Company Overview Arch Therapeutics Inc. Pipeline Products & Ongoing Clinical Trials Overview Argon Medical Devices Inc. Company Overview Argon Medical Devices Inc. Pipeline Products & Ongoing Clinical Trials Overview Baxter International Inc. Company Overview Baxter International Inc. Pipeline Products & Ongoing Clinical Trials Overview Beth Israel Deaconess Medical Center, Inc. Company Overview Beth Israel Deaconess Medical Center, Inc. Pipeline Products & Ongoing Clinical Trials Overview Biomedica Management Corporation Company Overview Biomedica Management Corporation Pipeline Products & Ongoing Clinical Trials Overview Biom'Up SAS Company Overview Biom'Up SAS Pipeline Products & Ongoing Clinical Trials Overview Cellphire, Inc. Company Overview Cellphire, Inc. Pipeline Products & Ongoing Clinical Trials Overview Covalent Medical, Inc. (Inactive) Company Overview Covalent Medical, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview Covalon Technologies Ltd. Company Overview Covalon Technologies Ltd. Pipeline Products & Ongoing Clinical Trials Overview CryoLife, Inc. Company Overview CryoLife, Inc. Pipeline Products & Ongoing Clinical Trials Overview Endomedix Incorporated Company Overview Endomedix Incorporated Pipeline Products & Ongoing Clinical Trials Overview 60 5

6 5.15 Entegrion, Inc. Company Overview Entegrion, Inc. Pipeline Products & Ongoing Clinical Trials Overview Ethicon, Inc. Company Overview Ethicon, Inc. Pipeline Products & Ongoing Clinical Trials Overview Floralis S.A.S. Company Overview Floralis S.A.S. Pipeline Products & Ongoing Clinical Trials Overview Gamma Therapeutics, Inc. Company Overview Gamma Therapeutics, Inc. Pipeline Products & Ongoing Clinical Trials Overview Haemostatix Limited Company Overview Haemostatix Limited Pipeline Products & Ongoing Clinical Trials Overview Hemostasis, LLC Company Overview Hemostasis, LLC Pipeline Products & Ongoing Clinical Trials Overview KeraNetics, LLC Company Overview KeraNetics, LLC Pipeline Products & Ongoing Clinical Trials Overview LifeBond Ltd. Company Overview LifeBond Ltd. Pipeline Products & Ongoing Clinical Trials Overview Remedium Technologies Inc. Company Overview Remedium Technologies Inc. Pipeline Products & Ongoing Clinical Trials Overview Rice University Company Overview Rice University Pipeline Products & Ongoing Clinical Trials Overview Samyang Biopharmaceuticals Corporation Company Overview Samyang Biopharmaceuticals Corporation Pipeline Products & Ongoing Clinical Trials Overview Sanofi Company Overview Sanofi Pipeline Products & Ongoing Clinical Trials Overview Sea Run Holdings Inc. Company Overview Sea Run Holdings Inc. Pipeline Products & Ongoing Clinical Trials Overview St Teresa Medical, Inc. Company Overview St Teresa Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview Suneris Technologies, Inc. Company Overview Suneris Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview The Medicines Company Company Overview The Medicines Company Pipeline Products & Ongoing Clinical Trials Overview Therus Corporation Company Overview Therus Corporation Pipeline Products & Ongoing Clinical Trials Overview Xcede Technologies, Inc. Company Overview Xcede Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 91 6 Hemostats- Recent Developments Feb 18, 2016: Genelife Enters into Licensing Agreement with 3-D Matrix Europe Feb 17, 2016: Z-Medica Receives Expanded CE Mark for QuikClot Jan 21, 2016: United Health Products Announces Optimal Government Services as UHP's Exclusive Government Distributor Dec 16, 2015: Arch Therapeutics Receives Clearance to Initiate Clinical Trial in Europe Dec 09, 2015: Arsenal Medical Secures Funding from U.S. Army to Advance ResQFoam Trauma Product through Regulatory Approval Dec 04, 2015: Change in B. Braun Management Board Dec 01, 2015: Arch Therapeutics Reports Significant Wound Healing Results in Pre-Clinical Safety Study with AC5 Surgical Hemostatic Device Nov 17, 2015: CryoLife Announces Resolution of PerClot Litigation with Medafor Oct 28, 2015: United Health Products' HemoStyp Now Available Through Henry Schein Oct 22, 2015: CoAg Medical And Lou Ferrigno Announce StopsBleeding Product Launch 95 6

7 6.11 Oct 20, 2015: Vascular Solutions Reports Third Quarter Results Sep 08, 2015: Arch Therapeutics Obtains Additional Positive Safety Data for AC5 Surgical Hemostatic Device in Preclinical Toxicity Test of Sensitization Aug 24, 2015: United Health Products Announces School Health as a Distributor Aug 18, 2015: Dynasil Announces Xcede Technologies' Patent Application for Novel All-in-One Patch Aug 05, 2015: LifeBond Raises USD27 Million in Series D Financing Aug 04, 2015: Suneris CEO to Present VETIGEL at White House Demo Day Jul 21, 2015: Vascular Solutions Reports Second Quarter Results Jul 15, 2015: Remedium Technologies Receives FDA Clearance for Hemogrip Technology to Help Stop Bleeding Jul 14, 2015: St. Teresa Medical Announces First Patient Enrolled in SURGICLOT Clinical Trial in U.K Jun 26, 2015: Suneris Introduces VETIGEL as a New Wound Care Solution for Veterinarians Jun 15, 2015: OxySure Systems Enters into Distribution Agreement with Z-Medica Jun 09, 2015: Arch Therapeutics Obtains Additional Safety Data for Its AC5 Surgical Hemostatic Device in Successful Preclinical Toxicity Test May 13, 2015: DuBiotech Welcomes Germany s B.Braun 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 Apr 28, 2015: CryoLife Begins Patient Enrolment In PerClot IDE Clinical Trial Apr 21, 2015: Vascular Solutions Reports First Quarter Results Apr 16, 2015: Arch Therapeutics' AC5 Compared Favorably vs. Commercially Available Combination Hemostat in Animal Study Apr 14, 2015: Arch Therapeutics Announces Favorable Preclinical Data From an Independent Study of AC5 Surgical Hemostatic Device Versus a Popular Fibrin Sealant Apr 07, 2015: United Health Products Announces Laboratory Test Results Apr 01, 2015: Z-Medica Announces QuikClot Products Approved in California Mar 27, 2015: B. Braun Group increases sales and earnings 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 Mar 23, 2015: Arch Therapeutics Announces Positive Safety Results for AC5 Surgical Hemostatic Device in Preclinical Toxicity Studies Mar 13, 2015: Withdrawal of Application for the Approval of the Hemostat (TDM-621) Mar 12, 2015: CryoLife Provides Update on PerClot Litigation Appendix Methodology About GlobalData Contact Us Disclaimer 118 7

8 List Of Tables in Hemostats - Medical Devices Pipeline Assessment, 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 & Ongoing Clinical Trials Overview 20 Table 10: PuraStat Hemostat - Product Status 21 Table 11: PuraStat Hemostat - Product Description 21 Table 12: TDM Product Status 22 Table 13: TDM Product Description 22 Table 14: Advanced Medical Solutions Group plc Pipeline Products & 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 & 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 & 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 & 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 & 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 8

9 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 & 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 & 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 & 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 & 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 & Ongoing Clinical Trials Overview 52 Table 67: CovaSTAT - Product Status 52 Table 68: CovaSTAT - Product Description 52 Table 69: Covalon Technologies Ltd. Pipeline Products & 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 & 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 & 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 & Ongoing Clinical Trials Overview 62 Table 85: Stasix - Product Status 62 Table 86: Stasix - Product Description 62 Table 87: Ethicon, Inc. Pipeline Products & Ongoing Clinical Trials Overview 63 9

10 Table 88: Flowable thrombin - Product Status 63 Table 89: Flowable thrombin - Product Description 63 Table 90: Floralis S.A.S. Pipeline Products & 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 & Ongoing Clinical Trials Overview 65 Table 94: GammaTF - Product Status 65 Table 95: GammaTF - Product Description 65 Table 96: Haemostatix Limited Pipeline Products & 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 & 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 & 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 & 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 & 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 & 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 & Ongoing Clinical Trials Overview 78 Table 123: B Product Status 78 Table 124: B Product Description 78 Table 125: B6102 Hemostatic ORC - Product Status 79 Table 126: B6102 Hemostatic ORC - Product Description 79 Table 127: Sanofi Pipeline Products & 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 & 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 & 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 10

11 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 & Ongoing Clinical Trials Overview 87 Table 141: VETIGEL - Product Status 87 Table 142: VETIGEL - Product Description 87 Table 143: The Medicines Company Pipeline Products & 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 & 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 & Ongoing Clinical Trials Overview 91 Table 150: Xcede Patch - Product Status 91 Table 151: Xcede Patch - Product Description 91 Table 152: Glossary

12 List Of Figures, Charts and Diagrams in Hemostats - Medical Devices Pipeline Assessment, 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 12

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