Wound Closure Devices - Medical Devices Pipeline Assessment, 2018

2018-07-01
Price :
Published : Jul-2018
No. of Pages : 543
1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 12
1.2 List of Figures 23
2 Introduction 24
2.1 Wound Closure Devices Overview 24
3 Products under Development 27
3.1 Wound Closure Devices - Pipeline Products by Stage of Development 27
3.2 Wound Closure Devices - Pipeline Products by Segment 28
3.3 Wound Closure Devices - Pipeline Products by Territory 30
3.4 Wound Closure Devices - Pipeline Products by Regulatory Path 32
3.5 Wound Closure Devices - Pipeline Products by Estimated Approval Date 34
3.6 Wound Closure Devices - Ongoing Clinical Trials 35
4 Wound Closure Devices - Pipeline Products under Development by Companies 36
4.1 Wound Closure Devices Companies - Pipeline Products by Stage of Development 36
4.2 Wound Closure Devices - Pipeline Products by Stage of Development 41
5 Wound Closure Devices Companies and Product Overview 46
5.1 3-D Matrix Ltd Company Overview 46
5.2 Actamax Surgical Materials LLC Company Overview 50
5.3 Adhesys Medical GmbH Company Overview 53
5.4 Advanced Medical Solutions Group plc Company Overview 55
5.5 Alafair Biosciences Inc Company Overview 61
5.6 Albert Ludwigs University of Freiburg Company Overview 62
5.7 Aleo BME Inc Company Overview 63
5.8 Alumend LLC Company Overview 65
5.9 Angiotech Pharmaceuticals Inc Company Overview 66
5.10 Anika Therapeutics Inc Company Overview 68
5.11 APRUS Bio-Medical Innovations Pvt Ltd Company Overview 71
5.12 ARC Medical Devices Inc. Company Overview 72
5.13 Arch Therapeutics Inc Company Overview 73
5.14 Aura Medsystems, Inc. Company Overview 75
5.15 Baxter International Inc Company Overview 76
5.16 Bayer AG Company Overview 83
5.17 Bergen Medical Products Inc Company Overview 84
5.18 Beth Israel Deaconess Medical Center Inc Company Overview 85
5.19 BioActive Polymers in Lund AB Company Overview 86
5.20 Biomedica Management Corp Company Overview 87
5.21 Biom'Up SAS Company Overview 90
5.22 Boston University Company Overview 94
5.23 C. R. Bard Inc Company Overview 95
5.24 Calmare Therapeutics Inc Company Overview 99
5.25 CardioCommand Inc Company Overview 100
5.26 Cellphire Inc Company Overview 101
5.27 Ceramicos Para Aplicacoes Medicas SA Company Overview 105
5.28 Clemson University Company Overview 106
5.29 Cohera Medical Inc Company Overview 107
5.30 Columbia University Company Overview 112
5.31 CorMedix Inc Company Overview 113
5.32 Covalent Medical, Inc. (Inactive) Company Overview 114
5.33 Covalon Technologies Ltd Company Overview 116
5.34 Covidien plc Company Overview 118
5.35 Cresilon Inc Company Overview 119
5.36 CryoLife Inc Company Overview 121
5.37 Daewoong Pharmaceutical Co Ltd Company Overview 124
5.38 Dermtreat ApS Company Overview 129
5.39 DSM Biomedical BV Company Overview 130
5.40 Elastagen Pty Ltd Company Overview 131
5.41 Emory University Company Overview 132
5.42 Emrge LLC Company Overview 133
5.43 Endomedix Incorporated Company Overview 134
5.44 Entegrion Inc Company Overview 136
5.45 ES Vascular Ltd. Company Overview 137
5.46 Ethicon Endo-Surgery Inc Company Overview 138
5.47 Ethicon US LLC Company Overview 139
5.48 ETX Pharma Inc Company Overview 142
5.49 FzioMed Inc Company Overview 143
5.50 Gamma Therapeutics Inc Company Overview 147
5.51 GATT Technologies BV Company Overview 149
5.52 Gecko Biomedical Company Overview 152
5.53 gel-e Inc Company Overview 155
5.54 Grifols SA Company Overview 157
5.55 Haemostatix Ltd Company Overview 158
5.56 Hemostasis LLC Company Overview 160
5.57 HyperBranch Medical Technology Inc Company Overview 163
5.58 Innocoll Technologies Ltd Company Overview 165
5.59 Institute of Molecular Biology of Parana Company Overview 166
5.60 Integra LifeSciences Holdings Corp Company Overview 167
5.61 InVivo Therapeutics Corp Company Overview 170
5.62 IonMed Ltd. Company Overview 171
5.63 Johns Hopkins University Company Overview 173
5.64 KeraNetics, LLC Company Overview 174
5.65 Kollodis BioSciences Inc Company Overview 175
5.66 Kuros Biosciences AG Company Overview 177
5.67 Kytogenics Pharmaceuticals Inc Company Overview 179
5.68 Laser Tissue Welding, Inc. Company Overview 180
5.69 Latch Medical Ltd Company Overview 183
5.70 Leader Biomedical Europe BV Company Overview 184
5.71 Lenvitz Medical Solutions Pvt. Ltd. Company Overview 186
5.72 Life Care Medical Devices Ltd Company Overview 187
5.73 LifeBond Ltd Company Overview 188
5.74 Luna Innovations Inc Company Overview 193
5.75 Magen OrthoMed Ltd Company Overview 195
5.76 Maxigen Biotech Inc Company Overview 198
5.77 Medisse BV (Inactive) Company Overview 199
5.78 MiMedx Group Inc Company Overview 201
5.79 MLM Biologics Inc Company Overview 202
5.80 N8 Medical Inc Company Overview 204
5.81 Northwestern University Company Overview 205
5.82 OptMed, Inc. Company Overview 206
5.83 PetVivo Holdings Inc Company Overview 209
5.84 Pharming Group NV Company Overview 210
5.85 Polyganics BV Company Overview 211
5.86 Protein Polymer Technologies Inc (Inactive) Company Overview 214
5.87 Regenics AS Company Overview 215
5.88 Resorba GmbH Company Overview 217
5.89 Resultados y Calidad del Sistema Sanitario Publico de Andalucia Company Overview 219
5.90 Rice University Company Overview 220
5.91 Samyang Biopharmaceuticals Corp Company Overview 221
5.92 Sanofi Company Overview 222
5.93 Sea Run Holdings Inc Company Overview 224
5.94 Sealantis Ltd. Company Overview 225
5.95 Seikagaku Corp Company Overview 227
5.96 Seraffix Ltd Company Overview 228
5.97 Shanghai Haohai Biological Technology Co Ltd Company Overview 229
5.98 Sheba Medical Center Company Overview 231
5.99 St Teresa Medical Inc Company Overview 232
5.100 Surgical Energetics LLC Company Overview 234
5.101 Surgical Sealants, Inc. Company Overview 235
5.102 Teijin Pharma Ltd Company Overview 236
5.103 Texas A&M University Company Overview 237
5.104 The Medicines Company Company Overview 239
5.105 Therus Corporation Company Overview 241
5.106 Thrombotargets Corp Company Overview 242
5.107 Tissue Regenix Ltd Company Overview 246
5.108 Tribos LLC Company Overview 247
5.109 Tricol Biomedical Inc Company Overview 248
5.110 United Health Products, Inc. Company Overview 249
5.111 University of Akron Company Overview 251
5.112 University of Grenoble Alpes Company Overview 252
5.113 University of Kansas Company Overview 253
5.114 University of Pennsylvania Company Overview 254
5.115 University of Toledo Company Overview 255
5.116 Virginia Commonwealth University Company Overview 256
5.117 WNDM Medical Inc Company Overview 257
5.118 WoundZipper Inc Company Overview 258
5.119 Xcede Technologies Inc Company Overview 259
6 Wound Closure Devices- Recent Developments 264
6.1 Jun 19, 2018: Sanofi appoints Jean-Baptiste Chasseloup de Chatillon Executive Vice President, Chief Financial Officer 264
6.2 Jun 15, 2018: Arch Therapeutics Completes Enrollment and Initiates Dosing in Skin Sensitization Study 264
6.3 Jun 14, 2018: SAM XT Extremity Tourniquet Awarded JEMS Hot Product 265
6.4 Jun 07, 2018: MiMedx to restate certain historical financial statements 265
6.5 Jun 07, 2018: MiMedx Announces Executive to Lead its International Operations and Provides Update on Company's International Progress 266
6.6 Jun 06, 2018: Advanced Medical Solutions announces retirement of CFO 268
6.7 Jun 05, 2018: Johnson & Johnson Announces Progress Toward Health for Humanity Goals 268
6.8 Jun 05, 2018: Medtronic Presents Strategic Growth Roadmap at 2018 Investor Day; Outlines Plan to Create Shareholder Value 269
6.9 Jun 04, 2018: Owens & Minor Appoints Interim Chief Financial Officer, as well as a Chief Accounting Officer 270
6.10 Jun 04, 2018: Cesca Therapeutics Announces Reduction in Operating Expenses 270
6.11 May 31, 2018: Kuros Biosciences to Propose Appointment of New Board Members at AGM 271
6.12 May 31, 2018: Merit Medical Announces Leadership Change and Appointment of Interim CFO 271
6.13 May 28, 2018: Beactica Signs Three-Year Extension Agreement With Sanofi 272
6.14 May 28, 2018: Covalon Announces Major Corporate Initiatives and Second Quarter Results 272
6.15 May 25, 2018: Hollister Announces Grand Opening of New Distribution Center in Oud Gastel, Netherlands 273
6.16 May 25, 2018: Grifols culminates a year of growth and approves the distribution of a record EUR 265 million in dividends 274
6.17 May 24, 2018: EndoClot Expands GI Hemostasis Portfolio With Launch of EndoClot Adhesive 276
6.18 May 24, 2018: Medtronic Reports Fourth Quarter And Fiscal Year 2018 Financial Results 276
6.19 May 24, 2018: YIT and Hollister signed an agreement to construct the second stage of a healthcare product factory in Lithuania 279
6.20 May 23, 2018: Grifols publishes its 2017 Corporate Responsibility Report as part of its commitment to transparency 279
6.21 May 21, 2018: Seikagaku Initiates a Clinical Trial for SI-449, an Adhesion Barrier 279
6.22 May 21, 2018: Baxter Highlights Business Strategies and Innovation at 2018 Investor Conference 280
6.23 May 14, 2018: Cesca Therapeutics Reports First Quarter 2018 Financial Results 281
6.24 May 10, 2018: Partnership Agreement concluded with DEMEDIC regarding sales and marketing of absorbable local hemostat "PuraStat" in Argentina 283
6.25 May 09, 2018: Sanofi lays off 95 workers in Framingham 283
6.26 May 08, 2018: Arch Therapeutics Provides Update on Study Initiation and 510(k) 283
6.27 May 08, 2018: Arch Therapeutics Provides Update on Study Initiation and 510(k) 284
6.28 May 08, 2018: Sanofi Announces Appointment of Mr. Charles Billard as Chief Financial Officer and Key Managerial Personnel 284
6.29 May 08, 2018: ACell Names Nino Pionati Vice President, International and Business Development 285
6.30 May 08, 2018: Smith & Nephew: Change of Directorate 285
6.31 May 07, 2018: FDA permits marketing of new endoscopic device for treating gastrointestinal bleeding 285
6.32 May 07, 2018: Medtronic Appoints Mike Weinstein As Senior Vice President Of Strategy 286
6.33 May 07, 2018: Integra LifeSciences Announces Amendment and Extension of Credit Facility 287
6.34 May 07, 2018: Covalon Announces Major Sales Breakthrough - Wins Contracts with an Estimated Value of $100 Million Over a Three-Year Period 287
6.35 May 03, 2018: Smith & Nephew First Quarter 2018 Trading Report 288
6.36 May 03, 2018: Cardinal Health Announces Third-quarter Results for Fiscal Year 2018 290
6.37 May 03, 2018: Grifols increases its net profit by 7% to Euros 143 million and delivers significant growth in organic sales 291
6.38 May 02, 2018: Urgent Medical Device Recall: SAM XT Extremity Tourniquet 295
6.39 May 02, 2018: Biom'up Finalizes U.S. Commercial Organization to Support U.S. Launch of HEMOBLAST Bellows 295
6.40 May 02, 2018: CryoLife Announces First Quarter 2018 Financial Results 296
6.41 May 02, 2018: Anika Reports First Quarter 2018 Financial Results 297
6.42 May 01, 2018: United Health Products Expands Animal Testing for HemoStyp in Support of PMA Application, Human Trials to Follow 299
7 Appendix 538
7.1 Methodology 538
7.2 About GlobalData 541
7.3 Contact Us 541
7.4 Disclaimer 541

1.1 List of Tables
Table 1: Wound Closure Devices - Pipeline Products by Stage of Development 29
Table 2: Wound Closure Devices - Pipeline Products by Segment 30
Table 3: Wound Closure Devices - Pipeline Products by Territory 32
Table 4: Wound Closure Devices - Pipeline Products by Regulatory Path 34
Table 5: Wound Closure Devices - Pipeline Products by Estimated Approval Date 36
Table 6: Wound Closure Devices - Ongoing Clinical Trials 37
Table 7: Wound Closure Devices Companies - Pipeline Products by Stage of Development 38
Table 8: Wound Closure Devices - Pipeline Products by Stage of Development 43
Table 9: 3-D Matrix Ltd Pipeline Products & Ongoing Clinical Trials Overview 48
Table 10: PuraStat Hemostat - Product Status 48
Table 11: PuraStat Hemostat - Product Description 49
Table 12: TDM-511 - Product Status 49
Table 13: TDM-511 - Product Description 49
Table 14: 3-D Matrix Ltd - Ongoing Clinical Trials Overview 50
Table 15: PuraStat Hemostat - A Multi-center, Single Arm Post-market Clinical Study to Confirm Safety and Performance of PuraStat Absorbable Haemostatic Material for the Management of Bleeding in Vascular Surgery 51
Table 16: PuraStat Hemostat - Randomized Controlled Trial Comparing Purastat to Standard Therapy for Haemostasis Control During Endoscopic Submucosal Dissection 51
Table 17: Actamax Surgical Materials LLC Pipeline Products & Ongoing Clinical Trials Overview 52
Table 18: Actamax Adhesion Barrier - Product Status 52
Table 19: Actamax Adhesion Barrier - Product Description 52
Table 20: Actamax Surgical Materials LLC - Ongoing Clinical Trials Overview 53
Table 21: Actamax Adhesion Barrier - A Randomized, Controlled, Multi-center Study to Assess the Safety and Efficacy of Actamax Adhesion Barrier in Women undergoing Laparoscopic Abdominopelvic Surgery with a Myomectomy Followed by Second Look Laparoscopy (SLL) 54
Table 22: Adhesys Medical GmbH Pipeline Products & Ongoing Clinical Trials Overview 55
Table 23: CUTIS - Product Status 55
Table 24: CUTIS - Product Description 55
Table 25: VIVO - Product Status 56
Table 26: VIVO - Product Description 56
Table 27: Advanced Medical Solutions Group plc Pipeline Products & Ongoing Clinical Trials Overview 57
Table 28: LiquiBand - Product Status 57
Table 29: LiquiBand - Product Description 58
Table 30: LiquiBand Exceed - Product Status 58
Table 31: LiquiBand Exceed - Product Description 58
Table 32: LiquiBand Flow Control - Product Status 59
Table 33: LiquiBand Flow Control - Product Description 59
Table 34: Next Generation Internal Fixation And Sealant Device - Product Status 60
Table 35: Next Generation Internal Fixation And Sealant Device - Product Description 60
Table 36: Advanced Medical Solutions Group plc - Ongoing Clinical Trials Overview 61
Table 37: LiquiBand Exceed - Trial Investigating Cyanoacrylate Glue to Prevent Surgical Site Infection Following Breast Surgery 62
Table 38: Alafair Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 63
Table 39: VersaWrap Adhesion Barrier - Product Status 63
Table 40: VersaWrap Adhesion Barrier - Product Description 63
Table 41: Albert Ludwigs University of Freiburg Pipeline Products & Ongoing Clinical Trials Overview 64
Table 42: Biohybrid Membrane - Product Status 64
Table 43: Biohybrid Membrane - Product Description 64
Table 44: Aleo BME Inc Pipeline Products & Ongoing Clinical Trials Overview 65
Table 45: Dural Sealant - Product Status 65
Table 46: Dural Sealant - Product Description 65
Table 47: Surgical Adhesive - Product Status 66
Table 48: Surgical Adhesive - Product Description 66
Table 49: Topical Adhesive - Product Status 66
Table 50: Topical Adhesive - Product Description 66
Table 51: Alumend LLC Pipeline Products & Ongoing Clinical Trials Overview 67
Table 52: Tissue-Bonding Adhesive - Product Status 67
Table 53: Tissue-Bonding Adhesive - Product Description 67
Table 54: Angiotech Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 68
Table 55: Hemaseel HMN Fibrin Sealant - Product Status 68
Table 56: Hemaseel HMN Fibrin Sealant - Product Description 68
Table 57: Hemaseel Thrombin Haemostatic Agent - Product Status 69
Table 58: Hemaseel Thrombin Haemostatic Agent - Product Description 69
Table 59: Anika Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 70
Table 60: Hemostatic Patch - Product Status 70
Table 61: Hemostatic Patch - Product Description 70
Table 62: HYAFF Gel - Product Status 71
Table 63: HYAFF Gel - Product Description 71
Table 64: Hyaloglide - Product Status 71
Table 65: Hyaloglide - Product Description 72
Table 66: APRUS Bio-Medical Innovations Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 73
Table 67: Deep Wound Hemostat - Product Status 73
Table 68: Deep Wound Hemostat - Product Description 73
Table 69: ARC Medical Devices Inc. Pipeline Products & Ongoing Clinical Trials Overview 74
Table 70: Liquid Adhesion Reduction Device - Product Status 74
Table 71: Liquid Adhesion Reduction Device - Product Description 74
Table 72: Arch Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 75
Table 73: AC5 Surgical Hemostatic Device - Product Status 75
Table 74: AC5 Surgical Hemostatic Device - Product Description 75
Table 75: AC5 Surgical Hemostatic Device - Internal Use - Product Status 76
Table 76: AC5 Surgical Hemostatic Device - Internal Use - Product Description 76
Table 77: AC5 Topical Gel - Product Status 76
Table 78: AC5 Topical Gel - Product Description 76
Table 79: Aura Medsystems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 77
Table 80: LaSTR - Skin Closure Device - Product Status 77
Table 81: LaSTR - Skin Closure Device - Product Description 77
Table 82: Baxter International Inc Pipeline Products & Ongoing Clinical Trials Overview 78
Table 83: Hemopatch - Product Status 78
Table 84: Hemopatch - Product Description 79
Table 85: Tisseel Dura - Product Status 79
Table 86: Tisseel Dura - Product Description 79
Table 87: Baxter International Inc - Ongoing Clinical Trials Overview 80
Table 88: 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 (more than 5 Days - PAL) 81
Table 89: Hemopatch - A Prospective Randomized Trial of Hemopatch Versus No Hemopatch for the Intraoperative Hemostasis During Deceased Donor Renal Transplant 81
Table 90: Hemopatch - A Randomized, Controlled, Non-inferiority Study to Evaluate the Efficacy and Safety of Hemopatch Compared to TachoSil in Preventing or Reducing Postoperative Air Leaks After Pulmonary Resection 81
Table 91: Hemopatch - A Single-arm Phase II Trial of Intra-operative Application of HEMOPATCH to the Pancreatic Stump to Prevent Post-operative Pancreatic Fistula Following Distal Pancreatectomy 82
Table 92: Hemopatch - Assessment of the Usefulness of Hemopatch in Coronary Artery Bypass Graft Surgery 82
Table 93: Hemopatch - Exploratory Phase IV Randomized Single Blind Study Evaluating the Efficacy and Tolerability of Hemopatch in Improving Time of Hemostasis and Preventing Post-operative Complications After Hepatic Resection 82
Table 94: Hemopatch - Hemopatch Performance Evaluation: A Prospective Observational Registry 83

1.2 List of Figures
Figure 1: Wound Closure Devices - Pipeline Products by Stage of Development 29
Figure 2: Wound Closure Devices - Pipeline Products by Segment 30
Figure 3: Wound Closure Devices - Pipeline Products by Territory 32
Figure 4: Wound Closure Devices - Pipeline Products by Regulatory Path 34
Figure 5: Wound Closure Devices - Pipeline Products by Estimated Approval Date 36
Figure 6: Wound Closure Devices - Ongoing Clinical Trials 37
Filed in: Medical Device
Publisher : GlobalData