Tissue Engineered - Skin Substitutes - Medical Devices Pipeline Assessment, 2017

2017-08-01
Price :
Published : Aug-2017
No. of Pages : 157
1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 6
1.2 List of Figures 8
2 Introduction 9
2.1 Tissue Engineered - Skin Substitutes Overview 9
3 Products under Development 10
3.1 Tissue Engineered - Skin Substitutes - Pipeline Products by Stage of Development 10
3.2 Tissue Engineered - Skin Substitutes - Pipeline Products by Segment 11
3.3 Tissue Engineered - Skin Substitutes - Pipeline Products by Territory 12
3.4 Tissue Engineered - Skin Substitutes - Pipeline Products by Regulatory Path 13
3.5 Tissue Engineered - Skin Substitutes - Pipeline Products by Estimated Approval Date 14
3.6 Tissue Engineered - Skin Substitutes - Ongoing Clinical Trials 15
4 Tissue Engineered - Skin Substitutes - Pipeline Products under Development by Companies 16
4.1 Tissue Engineered - Skin Substitutes Companies - Pipeline Products by Stage of Development 16
4.2 Tissue Engineered - Skin Substitutes - Pipeline Products by Stage of Development 17
5 Tissue Engineered - Skin Substitutes Companies and Product Overview 19
5.1 Adept Medical Ltd Company Overview 19
5.1.1 Adept Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 19
5.2 AGAM Biological Products Company Overview 20
5.2.1 AGAM Biological Products Pipeline Products & Ongoing Clinical Trials Overview 20
5.3 Agenta Biotechnologies Inc Company Overview 21
5.3.1 Agenta Biotechnologies Inc Pipeline Products & Ongoing Clinical Trials Overview 21
5.4 Kerecis ehf Company Overview 23
5.4.1 Kerecis ehf Pipeline Products & Ongoing Clinical Trials Overview 23
5.5 Lattice Biologics Ltd Company Overview 25
5.5.1 Lattice Biologics Ltd Pipeline Products & Ongoing Clinical Trials Overview 25
5.6 Mallinckrodt Pharmaceuticals Company Overview 27
5.6.1 Mallinckrodt Pharmaceuticals Pipeline Products & Ongoing Clinical Trials Overview 27
5.7 MiMedx Group Inc Company Overview 35
5.7.1 MiMedx Group Inc Pipeline Products & Ongoing Clinical Trials Overview 35
5.8 Organogenesis Inc Company Overview 38
5.8.1 Organogenesis Inc Pipeline Products & Ongoing Clinical Trials Overview 38
5.9 Smith & Nephew Plc Company Overview 41
5.9.1 Smith & Nephew Plc Pipeline Products & Ongoing Clinical Trials Overview 41
5.10 Sree Chitra Tirunal Institute for Medical Sciences & Technology Company Overview 42
5.10.1 Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview 42
5.11 Stratatech Corp Company Overview 44
5.11.1 Stratatech Corp Pipeline Products & Ongoing Clinical Trials Overview 44
5.12 Tel Aviv University Company Overview 48
5.12.1 Tel Aviv University Pipeline Products & Ongoing Clinical Trials Overview 48
5.13 Tissue Regenix Ltd Company Overview 49
5.13.1 Tissue Regenix Ltd Pipeline Products & Ongoing Clinical Trials Overview 49
5.14 Vericel Corp Company Overview 52
5.14.1 Vericel Corp Pipeline Products & Ongoing Clinical Trials Overview 52
5.15 Worcester Polytechnic Institute Company Overview 54
5.15.1 Worcester Polytechnic Institute Pipeline Products & Ongoing Clinical Trials Overview 54
6 Tissue Engineered - Skin Substitutes- Recent Developments 55
6.1 Jul 26, 2017: Anika Reports Strong Second Quarter 2017 Financial Results 55
6.2 Jul 18, 2017: U.S. FDA Designates Mallinckrodt's StrataGraft as Regenerative Medicine Advanced Therapy 56
6.3 Jul 13, 2017: MiMedx Announces that its Second Quarter Revenue Exceeds the Guidance Range 57
6.4 Jul 06, 2017: Lattice Biologics Announces Change in Director and Chairman of Scientific Advisory Board 57
6.5 Jul 05, 2017: MiMedx Agreement With AvKARE Expires As Planned Following Completion Of Contract Wind-Down 58
6.6 Jul 04, 2017: Appointment of Angie Risley as Non-Executive Director and Chairman Elect of the Remuneration Committee 59
6.7 Jun 26, 2017: Lattice Biologics Announces Move to Belgrade, Montana 59
6.8 Jun 09, 2017: Acera Surgical appoints new board member 59
6.9 Jun 08, 2017: Amedica Releases 2016 Preliminary Earnings Report and Business Update 60
6.10 Jun 08, 2017: Amniox Medical Enters into Agreement with Intalere 62
6.11 Jun 07, 2017: Mallinckrodt Enrolls First Patient in Phase 3 Trial of StrataGraft Regenerative Skin Tissue 62
6.12 May 31, 2017: Lattice Biologics Appoints Chief Operating Officer 64
6.13 May 30, 2017: Lattice Biologics Reports Second Quarter 2017 Highlights 64
6.14 May 11, 2017: Biostage Reports 2017 First Quarter Financial Results and Provides Business Update 65
6.15 May 08, 2017: New Clinical Evidence Continues to Support the Effectiveness and Value of AMNIOX Medical Products 66
6.16 May 05, 2017: Smith & Nephew 2017 First Quarter Trading Report 68
6.17 May 04, 2017: MiMedx EpiFix Receives Coverage From Kaiser Permanente 69
6.18 May 04, 2017: First Patient Enrolled in Mallinckrodt Phase 2 Trial of StrataGraft Regenerative Skin Tissue 70
6.19 May 04, 2017: Orthofix International Reports First Quarter 2017 Financial Results 71
6.20 May 03, 2017: Anika Reports First Quarter 2017 Financial Results 72
6.21 Apr 28, 2017: MiMedx Announces Record Results For First Quarter Of 2017 72
6.22 Apr 28, 2017: Kuros Biosciences Proposes Election of Four New Board Members 74
6.23 Apr 26, 2017: Kuros Biosciences Reports Financial Results for 2016 75
6.24 Apr 19, 2017: Amedica Announces Delayed Filing of Annual Report on Form 10-K and Receipt of Nasdaq Letter 77
6.25 Apr 18, 2017: Biostage Appoints Stephen F. Badylak DVM, PhD, MD, as Co-Chairman of Scientific Advisory Board 78
6.26 Apr 13, 2017: MiMedx Announces First Quarter 2017 Revenue to Exceed High End of Guidance 79
6.27 Apr 13, 2017: Kuros announces CEO succession 79
6.28 Apr 07, 2017: AMNIOX Highlights Three Studies Demonstrating Effectiveness of Umbilical Cord Tissue for Treating Chronic Wounds 80
6.29 Apr 06, 2017: Organogenesis Announces Presentation on Dermagraft at the 6th Stem Cell Product Development and Commercialization Conference 81
6.30 Apr 05, 2017: The Use Of MiMedx Allografts From The Company's Multiple Product Families To Be Presented At SAWC Conference 82
6.31 Mar 30, 2017: AMNIOX Study Confirms Benefits of CLARIX FLO for Plantar Fasciitis 83
6.32 Mar 23, 2017: Outcomes Data From Over 950 Severe Burn Patients Treated With Epicel Presented at the 49th Annual Meeting of the American Burn Association 83
6.33 Mar 22, 2017: PolyMedics Innovations to Sell Kerecis Omega3-rich Fish-Skin Burn Treatment in the U.S. 84
6.34 Mar 19, 2017: MiMedx Announces The Addition Of Luis A. Aguilar To Its Board Of Directors 85
6.35 Mar 09, 2017: Biostage Reports 2016 Financial Results and Provides Business Update 86
6.36 Mar 02, 2017: Lattice Biologics Reports First Quarter 2017 Highlights 88
6.37 Feb 27, 2017: Amedica Announces Results of Independent Femoral Head Wear Testing 89
6.38 Feb 27, 2017: Orthofix International Reports Fourth Quarter and Fiscal 2016 Financial Results 89
6.39 Feb 23, 2017: MiMedx Announces 2016 Record Results 90
6.40 Feb 15, 2017: Anika Reports Fourth Quarter and Full Year 2016 Financial Results 93
6.41 Feb 15, 2017: Anika Therapeutics Reports 33% Revenue Growth in Third Quarter 2011 94
6.42 Feb 09, 2017: Smith & Nephew Fourth Quarter Trading and Full Year 2016 Results 95
6.43 Feb 09, 2017: Smith & Nephew: Directorate Change 100
6.44 Jan 30, 2017: Lattice Biologics Reports Fourth Quarter and Year End 2016 Highlights 100
6.45 Jan 18, 2017: Orthofix Announces Resolution of SEC Investigations 101
6.46 Jan 12, 2017: Confirmation of CFO leaving Smith & Nephew 102
6.47 Jan 11, 2017: Shire PLC Subsidiaries to Pay $350 Million to Settle False Claims Act Allegations 102
6.48 Jan 10, 2017: DermACELL demonstrates superior clinical outcomes compared to AlloDerm in breast reconstruction 104
6.49 Jan 10, 2017: Orthofix Announces Preliminary 2016 Fourth Quarter and Full Year Net Sales Results 105
6.50 Jan 09, 2017: MiMedx Fourth Quarter 2016 Revenue in Upper Range of Guidance 106
6.51 Dec 27, 2016: MiMedx EpiFix Receives Coverage From Aetna 107
6.52 Dec 20, 2016: Vivex Biomedical Receives Level II HCPCS Q-Code for Cygnus, a Human Amniotic Tissue Allograft 108
6.53 Dec 16, 2016: MiMedx 2017 Guidance Forecasts Revenue Growth In Excess Of 21% And Operating Earnings Growth In Excess Of 90% 108
6.54 Dec 14, 2016: MTF Wound Care's AmnioBand Receives the American Podiatric Medical Association Seal of Approval 110
6.55 Dec 14, 2016: MTF Wound Care's AlloPatch Pliable Receives the American Podiatric Medical Association Seal of Approval 110
6.56 Dec 13, 2016: Orthofix Announces Appointment of Alex Lukianov to Board of Directors 111
6.57 Nov 30, 2016: Graham Baker appointed Chief Financial Officer 111
6.58 Nov 22, 2016: Amedica appoints vice president of sales and marketing 112
6.59 Nov 22, 2016: Amedica Announces New Sales Leadership and Provides Regulatory Updates 113
6.60 Nov 10, 2016: Amedica Reports Third Quarter 2016 Financial Results 114
6.61 Nov 10, 2016: Biostage Reports 2016 Third Quarter Financial Results and Provides Business Update 115
6.62 Nov 10, 2016: Derma Sciences Reports 2016 Third Quarter Financial Results 116
6.63 Nov 03, 2016: Smith & Nephew Third Quarter 2016 Trading Report 118
6.64 Nov 03, 2016: MiMedx Announces USP-NF Monograph For dHACM Allografts Has Published 120
6.65 Oct 31, 2016: Orthofix International Reports Third Quarter 2016 Financial Results 121
6.66 Oct 27, 2016: MiMedx Announces Third Quarter 2016 Results 122
6.67 Oct 26, 2016: MNIOX Highlights Study Demonstrating Improved Outcomes in Patients Treated with CLARIX Regenerative Matrix as an Adjunct to Lumbar Discectomy 125
6.68 Oct 26, 2016: Anika Reports Third Quarter 2016 Financial Results 126
6.69 Oct 19, 2016: Acelity Introduces ALLODERM SELECT DUO Regenerative Tissue Matrix 127
6.70 Oct 18, 2016: Kerecis Omega3-rich Fish-Skin Treatment for Wound Treatment to be Introduced to the Asian Market at a Major Medical Congress in Singapore 127
6.71 Oct 17, 2016: Admedus Vascucel Receives FDA Clearance For Launch In November 128
6.72 Oct 10, 2016: MiMedx Third Quarter 2016 Revenue Exceeds Upper End of Guidance 129
6.73 Oct 06, 2016: Amedica Provides Business Update 130
6.74 Oct 05, 2016: Tides Medical Showcasing New Product at SAWC 131
6.75 Oct 05, 2016: Amedica Announces Workforce Reduction 131
6.76 Sep 29, 2016: Kuros Biosciences Reports Financial Results for First Half-Year of 2016 131
6.77 Sep 19, 2016: Organogenesis Announces New Chief Financial Officer 132
6.78 Sep 16, 2016: Kerecis Wound-Treatment Product With Omega3 Fish Skin Now Eligible for Medicare Reimbursement in 45 States 133
6.79 Sep 14, 2016: TheraSkin Introduces a New 6 cm(2) Size 134
6.80 Sep 12, 2016: Scientific Study Confirms How MiMedx dHACM Allografts Effectively Promote Wound Repair 134
6.81 Sep 06, 2016: New Vendor Approval Gives Lattice Biologics Access to 39 Additional Hospitals 136
6.82 Sep 06, 2016: MiMedx Reaffirms Q3 and Full Year 2016 Guidance 136
6.83 Aug 30, 2016: MiMedx Provides Update On Clinical Trial With AmnioFix Injectable Product 137
6.84 Aug 30, 2016: MiMedx Provides Update On EpiFix BLA/PMA Compliant Chronic Wound Clinical Trial 138
6.85 Aug 29, 2016: MiMedx Awarded Six New U.S. Patents with Five Awarded for its Amniotic Membrane Allografts and One Awarded for its CollaFix Technology 139
6.86 Aug 29, 2016: Lattice Biologics Reports Third Quarter 2016 Highlights 141
6.87 Aug 25, 2016: Admedus Set To Launch Vascular Product 142
6.88 Aug 25, 2016: AlloSource Supports NASA and Jet Propulsion Laboratory on Microbial Study 143
6.89 Aug 24, 2016: Derma Sciences' AMNIOEXCEL Now Eligible for Reimbursement by Medicare Administrative Contractor NGS 143
6.90 Aug 22, 2016: MiMedx Amniotic Allografts Are Terminally Sterilized To Enhance Safety Related To Microbiological And Viral Transmission 144
6.91 Aug 19, 2016: Amedica Announces Receipt of Nasdaq Notice of Bid Price Deficiency 146
6.92 Aug 18, 2016: Derma Sciences Names Russell Olsen President of Advanced Wound Care 147
6.93 Aug 11, 2016: Biostage Reports 2016 Second Quarter Financial Results and Provides Business Update Outlining Key Near-term Milestones 147
6.94 Aug 09, 2016: Derma Sciences Reports 2016 Second Quarter Financial Results 148
6.95 Aug 01, 2016: Orthofix International Reports Second Quarter 2016 Financial Results 151
6.96 Aug 01, 2016: Lattice Biologics Gains "Preferred Vendor Status" With the Veterans Health Administration (VHA) 152
7 Appendix 154
7.1 Methodology 154
7.2 About GlobalData 157
7.3 Contact Us 157
7.4 Disclaimer 157

1.1 List of Tables
Table 1: Tissue Engineered - Skin Substitutes - Pipeline Products by Stage of Development 10
Table 2: Tissue Engineered - Skin Substitutes - Pipeline Products by Segment 11
Table 3: Tissue Engineered - Skin Substitutes - Pipeline Products by Territory 12
Table 4: Tissue Engineered - Skin Substitutes - Pipeline Products by Regulatory Path 13
Table 5: Tissue Engineered - Skin Substitutes - Pipeline Products by Estimated Approval Date 14
Table 6: Tissue Engineered - Skin Substitutes - Ongoing Clinical Trials 15
Table 7: Tissue Engineered - Skin Substitutes Companies - Pipeline Products by Stage of Development 16
Table 8: Tissue Engineered - Skin Substitutes - Pipeline Products by Stage of Development 17
Table 9: Adept Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 19
Table 10: Plastic Surgery Graft - Product Status 19
Table 11: Plastic Surgery Graft - Product Description 19
Table 12: AGAM Biological Products Pipeline Products & Ongoing Clinical Trials Overview 20
Table 13: Skin Substitute - Product Status 20
Table 14: Skin Substitute - Product Description 20
Table 15: Agenta Biotechnologies Inc Pipeline Products & Ongoing Clinical Trials Overview 21
Table 16: Implantable Mesh - Tissue Support - Product Status 21
Table 17: Implantable Mesh - Tissue Support - Product Description 21
Table 18: Skin Graft - Post-Burns - Product Status 22
Table 19: Skin Graft - Post-Burns - Product Description 22
Table 20: Kerecis ehf Pipeline Products & Ongoing Clinical Trials Overview 23
Table 21: Kerecis Omega3 Wound - Product Status 23
Table 22: Kerecis Omega3 Wound - Product Description 24
Table 23: Lattice Biologics Ltd Pipeline Products & Ongoing Clinical Trials Overview 25
Table 24: MarBrane - Product Status 25
Table 25: MarBrane - Product Description 25
Table 26: Skin + ECM - Product Status 26
Table 27: Skin + ECM - Product Description 26
Table 28: Mallinckrodt Pharmaceuticals Pipeline Products & Ongoing Clinical Trials Overview 27
Table 29: ExpressGraft Antimicrobial - Diabetic Foot Ulcers - Product Status 27
Table 30: ExpressGraft Antimicrobial - Diabetic Foot Ulcers - Product Description 28
Table 31: ExpressGraftEnhance Tissue - Product Status 28
Table 32: ExpressGraftEnhance Tissue - Product Description 28
Table 33: StrataGraft - Diabetic Foot Ulcers - Product Status 29
Table 34: StrataGraft - Diabetic Foot Ulcers - Product Description 29
Table 35: StrataGraft - Epidermolysis Bullosa - Product Status 29
Table 36: StrataGraft - Epidermolysis Bullosa - Product Description 30
Table 37: StrataGraft - Scar Revision - Product Status 30
Table 38: StrataGraft - Scar Revision - Product Description 30
Table 39: StrataGraft - Scleroderma Digital Ulcers - Product Status 31
Table 40: StrataGraft - Scleroderma Digital Ulcers - Product Description 31
Table 41: StrataGraft - Severe Burns - Product Status 31
Table 42: StrataGraft - Severe Burns - Product Description 32
Table 43: StrataGraft - Venous Leg Ulcer - Product Status 32
Table 44: StrataGraft - Venous Leg Ulcer - Product Description 32
Table 45: Mallinckrodt Pharmaceuticals - Ongoing Clinical Trials Overview 33
Table 46: StrataGraft - Severe Burns - A Phase III Open-label, Controlled, Randomized, Multicenter Study Evaluating the Efficacy and Safety of Stratagraft Skin Tissue in Promoting Autologous Skin Tissue Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements and for Which Excision and Autografts Are Clinically Indicated 34
Table 47: StrataGraft - Severe Burns - Open-label, Controlled, Randomized, Multicenter, Dose Escalation Study Evaluating the Safety, Tolerability, and Efficacy of Single or Multiple Applications of StrataGraft Skin Tissue as an Alternative to Autografting Full-thickness Complex Skin Defects 34
Table 48: MiMedx Group Inc Pipeline Products & Ongoing Clinical Trials Overview 35
Table 49: AmnioFix Injectable - Achilles Tendinitis - Product Status 35
Table 50: AmnioFix Injectable - Achilles Tendinitis - Product Description 35
Table 51: AmnioFix Injectable - Knee OA Pain - Product Status 36
Table 52: AmnioFix Injectable - Knee OA Pain - Product Description 36
Table 53: AmnioFix Injectable - Plantar Fasciitis - Product Status 36
Table 54: AmnioFix Injectable - Plantar Fasciitis - Product Description 37
Table 55: AmnioFix Injectable - Pressure Ulcer - Product Status 37
Table 56: AmnioFix Injectable - Pressure Ulcer - Product Description 37
Table 57: Organogenesis Inc Pipeline Products & Ongoing Clinical Trials Overview 38
Table 58: Dermagraft - Epidermolysis Bullosa - Product Status 38
Table 59: Dermagraft - Epidermolysis Bullosa - Product Description 38
Table 60: Dermagraft - Rotator Cuff Repair - Product Status 39
Table 61: Dermagraft - Rotator Cuff Repair - Product Description 39
Table 62: Dermagraft - Venous Leg Ulcers Repair - Product Status 39
Table 63: Dermagraft - Venous Leg Ulcers Repair - Product Description 40
Table 64: VCT01 - Product Status 40
Table 65: VCT01 - Product Description 40
Table 66: Smith & Nephew Plc Pipeline Products & Ongoing Clinical Trials Overview 41
Table 67: KERAGRAF - Product Status 41
Table 68: KERAGRAF - Product Description 41
Table 69: Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview 42
Table 70: Fibrin-PLGC Hybrid Scaffold - Product Status 42
Table 71: Fibrin-PLGC Hybrid Scaffold - Product Description 42
Table 72: Skin Graft Substitutes - Wound - Product Status 43
Table 73: Skin Graft Substitutes - Wound - Product Description 43
Table 74: Stratatech Corp Pipeline Products & Ongoing Clinical Trials Overview 44
Table 75: ExpressGraft - Antineoplastic - Product Status 44
Table 76: ExpressGraft - Antineoplastic - Product Description 45
Table 77: ExpressGraft - Sclerotic Digital Ulcers - Product Status 45
Table 78: ExpressGraft - Sclerotic Digital Ulcers - Product Description 45
Table 79: ExpressGraft Antimicrobial - Venous Leg Ulcers - Product Status 46
Table 80: ExpressGraft Antimicrobial - Venous Leg Ulcers - Product Description 46
Table 81: ExpressGraft Pro-Angiogenic - Diabetic Foot Ulcers - Product Status 46
Table 82: ExpressGraft Pro-Angiogenic - Diabetic Foot Ulcers - Product Description 47
Table 83: ExpressGraft Pro-Angiogenic - Venous Leg Ulcers - Product Status 47
Table 84: ExpressGraft Pro-Angiogenic - Venous Leg Ulcers - Product Description 47
Table 85: Tel Aviv University Pipeline Products & Ongoing Clinical Trials Overview 48
Table 86: Artificial Skin Graft - Product Status 48
Table 87: Artificial Skin Graft - Product Description 48
Table 88: Tissue Regenix Ltd Pipeline Products & Ongoing Clinical Trials Overview 49
Table 89: dCELL - Small Diameter Graft - Product Status 49
Table 90: dCELL - Small Diameter Graft - Product Description 49
Table 91: dCELL Human Dermis - Chronic Wounds - Product Status 50
Table 92: dCELL Human Dermis - Chronic Wounds - Product Description 50
Table 93: dCELL Human Dermis - Plastic Surgery - Product Status 50
Table 94: dCELL Human Dermis - Plastic Surgery - Product Description 51
Table 95: Dermapure - Acute Wounds - Product Status 51
Table 96: Dermapure - Acute Wounds - Product Description 51
Table 97: Vericel Corp Pipeline Products & Ongoing Clinical Trials Overview 52
Table 98: Epicel - Product Status 52
Table 99: Epicel - Product Description 53
Table 100: Worcester Polytechnic Institute Pipeline Products & Ongoing Clinical Trials Overview 54
Table 101: Extracellular Matrix Scaffold - Product Status 54
Table 102: Extracellular Matrix Scaffold - Product Description 54
Table 103: Glossary 156

1.2 List of Figures
Figure 1: Tissue Engineered - Skin Substitutes - Pipeline Products by Stage of Development 10
Figure 2: Tissue Engineered - Skin Substitutes - Pipeline Products by Segment 11
Figure 3: Tissue Engineered - Skin Substitutes - Pipeline Products by Territory 12
Figure 4: Tissue Engineered - Skin Substitutes - Pipeline Products by Regulatory Path 13
Figure 5: Tissue Engineered - Skin Substitutes - Pipeline Products by Estimated Approval Date 14
Figure 6: Tissue Engineered - Skin Substitutes - Ongoing Clinical Trials 15
Filed in: Medical Device
Publisher : GlobalData