Tissue Engineered – Skin Substitutes Pipeline Report including Stages of Development, Segments, Region and Countries, Regulatory Path and Key Companies, 2022 Update

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Tissue engineering for wound care management is the use of mechanical and chemical processing of materials to manufacture products that may substitute or replace all or some components that make up normal skin (e.g., epidermis and/or dermis, cells, and matrix).

The tissue engineered – skin substitutes pipeline market research report provides comprehensive information about the tissue engineered – skin substitutes pipeline products with a comparative analysis of the products at various stages of development and information about the clinical trials which are in progress. Moreover, the report provides information about various pipeline products and their estimated approval dates.

Tissue Engineered - Skin Substitutes Pipeline Products Market Segmentation by Territories

Some of the key territories with products in the pipeline are the US, Europe, China, South Korea, Taiwan, Japan, Kuwait, Malaysia, Mexico, and Mongolia. The US is the leading territory in the tissue engineered – skin substitutes pipeline products market followed by Europe and China.

Tissue Engineered – Skin Substitutes Pipeline Products Market Analysis by Territories

Tissue Engineered - Skin Substitutes Pipeline Products Market Analysis by Territories

For more territory insights into the tissue engineered – skin substitutes pipeline products market, download a free report sample

Tissue Engineered - Skin Substitutes Pipeline Products Market Segmentation by Regulatory Paths

The tissue engineered – skin substitutes pipeline report provides detailed insights into the pipeline products by a regulatory path including 510(k), PMA, BLA, CE, NMPA, BOPA, MDITAC, TGA, Shonin, and MDL, among others. 510(k) is the leading pathway.

Tissue Engineered – Skin Substitutes Pipeline Products Market Analysis by Regulatory Paths

Tissue Engineered - Skin Substitutes Pipeline Products Market Analysis by Regulatory Paths

For more regulatory path insights into the tissue engineered – skin substitutes pipeline products market, download a free report sample

Tissue Engineered - Skin Substitutes Pipeline Products Market Segments

The key segments in the tissue engineered – skin substitutes pipeline products market are cellular skin substitutes, acellular skin substitutes, other acellular skin substitutes, acellular skin substitutes based on amniotic membrane, and cellular skin substitutes based on amniotic membrane. Cellular skin substitutes was the leading segment.

Cellular Skin Substitutes: They contain viable cells seeded onto the matrix material. They serve as a barrier to the environment and reduce inflammation and scarring by supporting wound closure without excessive fibrosis. This segment consists of cellular skin substitutes based on amniotic membranes and other cellular skin substitutes.

Acellular Skin Substitutes: They are made of materials similar to the host extracellular matrix and function as scaffolds. Acellular biomaterials can stimulate the micro-environment to heal wounds without the regulatory and scientific challenges of cellular treatment.

Tissue Engineered – Skin Substitutes Pipeline Products Market Analysis by Segments

Tissue Engineered - Skin Substitutes Pipeline Products Market Analysis by Segments

For more segment insights into the tissue engineered – skin substitutes pipeline products market, download a free report sample

Tissue Engineered - Skin Substitutes Pipeline Products Market: Competitive Landscape

Some of the leading companies in the tissue engineered – skin substitutes pipeline products market are Acro Biomedical Co Ltd, Adept Medical Ltd, AGAM Biological Products, Amnio Technology LLC, Boston Children’s Hospital, China Regenerative Medicine International Ltd, Cutiss AG, Elanix Biotechnologies AG, Indian Institute of Technology Delhi, and Kerecis ehf.

Tissue Engineered - Skin Substitutes Pipeline Products Market Report Overview

Key Territories The US, Europe, China, South Korea, Taiwan, Japan, Kuwait, Malaysia, Mexico, and Mongolia
Key Regulatory Paths 510(k), PMA, BLA, CE, NMPA, BOPA, MDITAC, TGA, Shonin, and MDL
Key Segments Cellular Skin Substitutes, Acellular Skin Substitutes, Other Acellular Skin Substitutes, Acellular Skin Substitutes Based on Amniotic Membrane, and Cellular Skin Substitutes Based on Amniotic Membrane
Leading Companies Acro Biomedical Co Ltd, Adept Medical Ltd, AGAM Biological Products, Amnio Technology LLC, Boston Children’s Hospital, China Regenerative Medicine International Ltd, Cutiss AG, Elanix Biotechnologies AG, Indian Institute of Technology Delhi, and Kerecis ehf

Scope

  • Extensive coverage of the tissue engineered – skin substitutes 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 tissue engineered – skin substitutes and lists all their pipeline projects
  • The coverage of pipeline products is based on various stages of development ranging from early development to the 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 portfolios and create effective counter strategies to gain a competitive advantage
  • Identify and understand important and diverse types of tissue engineered – skin substitutes 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

Acro Biomedical Co Ltd
Adept Medical Ltd
AGAM Biological Products
Agenta Biotechnologies Inc (Inactive)
Amnio Technology LLC
Boston Children's Hospital
China Regenerative Medicine International Ltd
Cutiss AG
Elanix Biotechnologies AG
Indian Institute of Technology Delhi
Kerecis ehf
Lattice Biologics Ltd
LifeCell Corp
Merakris Therapeutics LLC
MiMedx Group Inc
Novadip Biosciences SA
Organogenesis Holdings Inc
Osiris Therapeutics Inc
PolarityTE Inc
PolyNovo Biomaterials Pty Ltd
Protein Genomics Inc
Purdue University
Regenicin Inc
Rensselaer Polytechnic Institute
ROKIT Healthcare Inc
Santai Biotech
Smith & Nephew Plc
SMSbiotech Inc
Sree Chitra Tirunal Institute for Medical Sciences & Technology
Stratatech Corp
Tel Aviv University
Tissue Regenix Ltd
University of Edinburgh
Vericel Corp
Worcester Polytechnic Institute
XenoTherapeutics Inc

Table of Contents

|1 Table of Contents 3

|1.1 List of Tables 6

|1.2 List of Figures 11

2 Introduction 12

2.1 Tissue Engineered – Skin Substitutes Overview 12

3 Products under Development 13

3.1 Tissue Engineered – Skin Substitutes – Pipeline Products by Stage of Development 13

3.2 Tissue Engineered – Skin Substitutes – Pipeline Products by Segment 14

3.3 Tissue Engineered – Skin Substitutes – Pipeline Products by Territory 15

3.4 Tissue Engineered – Skin Substitutes – Pipeline Products by Regulatory Path 17

3.5 Tissue Engineered – Skin Substitutes – Pipeline Products by Estimated Approval Date 18

3.6 Tissue Engineered – Skin Substitutes – Ongoing Clinical Trials 19

4 Tissue Engineered – Skin Substitutes – Pipeline Products under Development by Companies 20

4.1 Tissue Engineered – Skin Substitutes Companies – Pipeline Products by Stage of Development 20

4.2 Tissue Engineered – Skin Substitutes – Pipeline Products by Stage of Development 22

5 Tissue Engineered – Skin Substitutes Companies and Product Overview 24

5.1 Acro Biomedical Co Ltd Company Overview 24

5.1.1 Acro Biomedical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 24

5.2 Adept Medical Ltd Company Overview 27

5.2.1 Adept Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 27

5.3 AGAM Biological Products Company Overview 28

5.3.1 AGAM Biological Products Pipeline Products & Ongoing Clinical Trials Overview 28

5.4 Agenta Biotechnologies Inc (Inactive) Company Overview 29

5.4.1 Agenta Biotechnologies Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 29

5.5 Amnio Technology LLC Company Overview 31

5.5.1 Amnio Technology LLC Pipeline Products & Ongoing Clinical Trials Overview 31

5.6 Boston Children’s Hospital Company Overview 34

5.6.1 Boston Children’s Hospital Pipeline Products & Ongoing Clinical Trials Overview 34

5.7 China Regenerative Medicine International Ltd Company Overview 36

5.7.1 China Regenerative Medicine International Ltd Pipeline Products & Ongoing Clinical Trials Overview 36

5.8 Cutiss AG Company Overview 38

5.8.1 Cutiss AG Pipeline Products & Ongoing Clinical Trials Overview 38

5.9 Elanix Biotechnologies AG Company Overview 39

5.9.1 Elanix Biotechnologies AG Pipeline Products & Ongoing Clinical Trials Overview 39

5.10 Indian Institute of Technology Delhi Company Overview 41

5.10.1 Indian Institute of Technology Delhi Pipeline Products & Ongoing Clinical Trials Overview 41

5.11 Kerecis ehf Company Overview 42

5.11.1 Kerecis ehf Pipeline Products & Ongoing Clinical Trials Overview 42

5.12 Lattice Biologics Ltd Company Overview 44

5.12.1 Lattice Biologics Ltd Pipeline Products & Ongoing Clinical Trials Overview 44

5.13 LifeCell Corp Company Overview 46

5.13.1 LifeCell Corp Pipeline Products & Ongoing Clinical Trials Overview 46

5.14 Merakris Therapeutics LLC Company Overview 47

5.14.1 Merakris Therapeutics LLC Pipeline Products & Ongoing Clinical Trials Overview 47

5.15 MiMedx Group Inc Company Overview 50

5.15.1 MiMedx Group Inc Pipeline Products & Ongoing Clinical Trials Overview 50

5.16 Novadip Biosciences SA Company Overview 61

5.16.1 Novadip Biosciences SA Pipeline Products & Ongoing Clinical Trials Overview 61

5.17 Organogenesis Holdings Inc Company Overview 62

5.17.1 Organogenesis Holdings Inc Pipeline Products & Ongoing Clinical Trials Overview 62

5.18 Osiris Therapeutics Inc Company Overview 68

5.18.1 Osiris Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 68

5.19 PolarityTE Inc Company Overview 71

5.19.1 PolarityTE Inc Pipeline Products & Ongoing Clinical Trials Overview 71

5.20 PolyNovo Biomaterials Pty Ltd Company Overview 77

5.20.1 PolyNovo Biomaterials Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 77

5.21 Protein Genomics Inc Company Overview 83

5.21.1 Protein Genomics Inc Pipeline Products & Ongoing Clinical Trials Overview 83

5.22 Purdue University Company Overview 84

5.22.1 Purdue University Pipeline Products & Ongoing Clinical Trials Overview 84

5.23 Regenicin Inc Company Overview 85

5.23.1 Regenicin Inc Pipeline Products & Ongoing Clinical Trials Overview 85

5.24 Rensselaer Polytechnic Institute Company Overview 88

5.24.1 Rensselaer Polytechnic Institute Pipeline Products & Ongoing Clinical Trials Overview 88

5.25 ROKIT Healthcare Inc Company Overview 89

5.25.1 ROKIT Healthcare Inc Pipeline Products & Ongoing Clinical Trials Overview 89

5.26 Santai Biotech Company Overview 91

5.26.1 Santai Biotech Pipeline Products & Ongoing Clinical Trials Overview 91

5.27 Smith & Nephew Plc Company Overview 92

5.27.1 Smith & Nephew Plc Pipeline Products & Ongoing Clinical Trials Overview 92

5.28 SMSbiotech Inc Company Overview 93

5.28.1 SMSbiotech Inc Pipeline Products & Ongoing Clinical Trials Overview 93

5.29 Sree Chitra Tirunal Institute for Medical Sciences & Technology Company Overview 95

5.29.1 Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview 95

5.30 Stratatech Corp Company Overview 98

5.30.1 Stratatech Corp Pipeline Products & Ongoing Clinical Trials Overview 98

5.31 Tel Aviv University Company Overview 107

5.31.1 Tel Aviv University Pipeline Products & Ongoing Clinical Trials Overview 107

5.32 Tissue Regenix Ltd Company Overview 108

5.32.1 Tissue Regenix Ltd Pipeline Products & Ongoing Clinical Trials Overview 108

5.33 University of Edinburgh Company Overview 111

5.33.1 University of Edinburgh Pipeline Products & Ongoing Clinical Trials Overview 111

5.34 Vericel Corp Company Overview 112

5.34.1 Vericel Corp Pipeline Products & Ongoing Clinical Trials Overview 112

5.35 Worcester Polytechnic Institute Company Overview 114

5.35.1 Worcester Polytechnic Institute Pipeline Products & Ongoing Clinical Trials Overview 114

5.36 XenoTherapeutics Inc Company Overview 115

5.36.1 XenoTherapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 115

6 Tissue Engineered – Skin Substitutes- Recent Developments 118

6.1 May 10, 2022: Biostage Schedules Conference Call and Webcast for Q1 2022 Results 118

6.2 May 09, 2022: Anika to Participate in the UBS Global Healthcare Conference 2022 118

6.3 May 05, 2022: Anika Reports First Quarter Fiscal 2022 Financial Results 118

6.4 Apr 28, 2022: Orthofix Medical Schedules First Quarter Earnings Release and Conference Call for May 6, 2022 122

6.5 Apr 28, 2022: Smith+Nephew First Quarter 2022 Trading Update 122

6.6 Apr 08, 2022: Orthofix Announces New Business Unit President 124

6.7 Apr 07, 2022: Anika to Issue First Quarter 2022 Financial Results on Thursday, May 5, 2022 125

6.8 Apr 04, 2022: Anika to Participate in the 21st Annual Needham Virtual Healthcare Conference 125

6.9 Mar 31, 2022: Smith & Nephew announces Directorate Change 125

6.10 Mar 10, 2022: Anika to Participate in the Canaccord Genuity Musculoskeletal Conference 125

6.11 Mar 08, 2022: Anika Reports Fourth Quarter and Year-End 2021 Financial Results 125

6.12 Feb 28, 2022: MIMEDX Announces Fourth Quarter and Full Year 2021 Operating and Financial Results 127

6.13 Feb 22, 2022: Smith+nephew Announces New Chief Executive Officer 130

6.14 Feb 10, 2022: Orthofix Medical Schedules Fourth Quarter and Full Year Earnings Release and Conference Call for February 25 2022 133

6.15 Feb 08, 2022: Anika to Issue Fourth Quarter and Year-End 2021 Financial Results on Tuesday, March 8, 2022 133

6.16 Jan 25, 2022: Medprin Regenerative Medical Technologies Announces on the resignation of the company’s director and board secretary 133

6.17 Jan 10, 2022: Orthofix Announces Preliminary 2021 Fourth Quarter and Full Year Net Sales Results 134

6.18 Dec 21, 2021: Maipu Medical Announcement on Appointment of Deputy General Manager of the Company 134

6.19 Dec 14, 2021: Orthofix Announces Appointment of Thomas A. West to Board of Directors 135

6.20 Dec 03, 2021: Printing Technique creates effective skin equivalent, heals wounds 135

6.21 Nov 18, 2021: Anika to Participate in Upcoming Investor Conferences 136

6.22 Nov 05, 2021: Orthofix Reports Third Quarter 2021 Results 136

6.23 Nov 04, 2021: Anika Reports Third Quarter 2021 Financial Results 138

6.24 Nov 03, 2021: Orthofix Announces Participation in Upcoming Credit Suisse and Stifel Healthcare Conferences 141

6.25 Nov 02, 2021: MIMEDX Announces Third Quarter 2021 Operating and Financial Results 141

6.26 Nov 01, 2021: Anika Appoints Sheryl Conley to Board of Directors 143

6.27 Oct 27, 2021: Orthofix Schedules Third Quarter Earnings Release and Conference Call for November 5, 2021 144

6.28 Oct 18, 2021: Anika to Issue Third Quarter 2021 Financial Results on Thursday, November 4, 2021 144

6.29 Oct 14, 2021: SINTX Technologies Shares Q3 2021 Revenue Update 144

6.30 Oct 14, 2021: MIMEDX to Host Virtual Investor Day on December 7, 2021 145

6.31 Sep 23, 2021: Orthofix Announces Appointment of Wayne Burris to Board of Directors 145

6.32 Sep 20, 2021: Orthofix Announces Participation in Upcoming Sidoti Virtual Investor Conference 145

6.33 Sep 07, 2021: Anika to Participate in the Morgan Stanley 19th Annual Global Healthcare Conference 146

6.34 Aug 03, 2021: MIMEDX Announces Second Quarter 2021 Operating and Financial Results 146

6.35 Jul 29, 2021: Smith+Nephew Second Quarter and First Half 2021 Results 148

6.36 Jul 29, 2021: Smith & Nephew announces Half-year Report 149

6.37 Jul 28, 2021: Orthofix Schedules Second Quarter Earnings Release and Conference Call for August 6, 2021 150

6.38 Jul 20, 2021: MIMEDX to Host Second Quarter 2021 Operating and Financial Results Conference Call on August 4 150

6.39 Jul 19, 2021: Anika to Issue Second Quarter 2021 Financial Results on Thursday, August 5, 2021 151

6.40 Jul 07, 2021: Timing of Smith+Nephew Second Quarter Trading and First Half 2021 Results 151

6.41 Jun 15, 2021: New study demonstrates potential for MIMEDX Purion processed dehydrated human amnion/chorion membrane to modulate pathological scar tissue formation 151

6.42 Jun 10, 2021: Worcester Polytechnic Institute Names Andrew Aberdale Board Chair 152

7 Appendix 153

7.1 Methodology 153

7.2 About GlobalData 156

7.3 Contact Us 156

7.4 Disclaimer 156

Table

Tissue Engineered – Skin Substitutes – Pipeline Products by Stage of Development 13

Tissue Engineered – Skin Substitutes – Pipeline Products by Segment 14

Tissue Engineered – Skin Substitutes – Pipeline Products by Territory 16

Tissue Engineered – Skin Substitutes – Pipeline Products by Regulatory Path 17

Tissue Engineered – Skin Substitutes – Pipeline Products by Estimated Approval Date 18

Tissue Engineered – Skin Substitutes – Ongoing Clinical Trials 19

Tissue Engineered – Skin Substitutes Companies – Pipeline Products by Stage of Development 20

Tissue Engineered – Skin Substitutes – Pipeline Products by Stage of Development 22

Acro Biomedical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 24

ACRODDM – Product Status 24

ACRODDM – Product Description 25

ACRODDMG – Product Status 25

ACRODDMG – Product Description 25

ACRODDMP – Product Status 26

ACRODDMP – Product Description 26

Adept Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 27

Plastic Surgery Graft – Product Status 27

Plastic Surgery Graft – Product Description 27

AGAM Biological Products Pipeline Products & Ongoing Clinical Trials Overview 28

Skin Substitute – Product Status 28

Skin Substitute – Product Description 28

Agenta Biotechnologies Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 29

Implantable Mesh – Tissue Support – Product Status 29

Implantable Mesh – Tissue Support – Product Description 29

Skin Graft – Post-Burns – Product Status 30

Skin Graft – Post-Burns – Product Description 30

Amnio Technology LLC Pipeline Products & Ongoing Clinical Trials Overview 31

PalinGen Flo – Product Status 31

PalinGen Flo – Product Description 31

Amnio Technology LLC – Ongoing Clinical Trials Overview 32

PalinGen Flo – A Prospective, Multicenter, Randomized, Controlled Clinical Investigation of Palingen Flow Amniotic Tissue Allograft to Assess Safety, Tolerability, and Preliminary Efficacy for the Treatment of Chronic Lower Extremity Cutaneous Ulcers Compared to Standard of Care 33

Boston Children’s Hospital Pipeline Products & Ongoing Clinical Trials Overview 34

Biodegradable Mesostructured Polymer Membrane – Product Status 34

Biodegradable Mesostructured Polymer Membrane – Product Description 34

Fetal Tissue Engineered Patch – Product Status 35

Fetal Tissue Engineered Patch – Product Description 35

China Regenerative Medicine International Ltd Pipeline Products & Ongoing Clinical Trials Overview 36

Acellular Amniotic Membrane – Product Status 36

Acellular Amniotic Membrane – Product Description 36

Recombinant Human Acellular Dermal Matrix – Product Status 37

Recombinant Human Acellular Dermal Matrix – Product Description 37

Cutiss AG Pipeline Products & Ongoing Clinical Trials Overview 38

denovoSkin – Product Status 38

denovoSkin – Product Description 38

Elanix Biotechnologies AG Pipeline Products & Ongoing Clinical Trials Overview 39

First Cover Acute – Product Status 39

First Cover Acute – Product Description 39

First Cover Chronic – Product Status 40

First Cover Chronic – Product Description 40

Indian Institute of Technology Delhi Pipeline Products & Ongoing Clinical Trials Overview 41

Bio-Inspired Bi-Layer Polymeric Hybrid Scaffold – Product Status 41

Bio-Inspired Bi-Layer Polymeric Hybrid Scaffold – Product Description 41

Kerecis ehf Pipeline Products & Ongoing Clinical Trials Overview 42

Kerecis Omega3 – Battlefield Wounds – Product Status 42

Kerecis Omega3 – Battlefield Wounds – Product Description 42

Kerecis Omega3 – Third-Degree Burns – Product Status 43

Kerecis Omega3 – Third-Degree Burns – Product Description 43

Lattice Biologics Ltd Pipeline Products & Ongoing Clinical Trials Overview 44

MarBrane – Product Status 44

MarBrane – Product Description 45

Skin + ECM – Product Status 45

Skin + ECM – Product Description 45

LifeCell Corp Pipeline Products & Ongoing Clinical Trials Overview 46

AlloDerm Select – Non-Breast Applications – Product Status 46

AlloDerm Select – Non-Breast Applications – Product Description 46

Merakris Therapeutics LLC Pipeline Products & Ongoing Clinical Trials Overview 47

Dermacyte – Product Status 47

Dermacyte – Product Description 47

Merakris Therapeutics LLC – Ongoing Clinical Trials Overview 48

Dermacyte – A Two Part, Randomized Study of Dermacyte Amniotic Wound Care Liquid for the Treatment of Non-healing Venous Stasis Ulcers 49

MiMedx Group Inc Pipeline Products & Ongoing Clinical Trials Overview 50

AMNIOEFFECT – Product Status 50

AMNIOEFFECT – Product Description 51

AmnioFix Injectable – Achilles Tendonitis – Product Status 51

AmnioFix Injectable – Achilles Tendonitis – Product Description 51

AmnioFix Injectable – Chronic Cutaneous Ulcer – Product Status 52

AmnioFix Injectable – Chronic Cutaneous Ulcer – Product Description 52

AmnioFix Injectable – Knee OA Pain – Product Status 52

AmnioFix Injectable – Knee OA Pain – Product Description 53

AmnioFix Injectable – Plantar Fasciitis – Product Status 53

AmnioFix Injectable – Plantar Fasciitis – Product Description 53

AmnioFix Injectable – Pressure Ulcer – Product Status 54

AmnioFix Injectable – Pressure Ulcer – Product Description 54

EpiFix Amniotic Membrane Allograft – Product Status 54

EpiFix Amniotic Membrane Allograft – Product Description 55

MiMedx Group Inc – Ongoing Clinical Trials Overview 56

EpiFix Amniotic Membrane Allograft – Clinical Evaluation of EpiFix in venous leg ulcers (“VLUs”) 57

EpiFix Amniotic Membrane Allograft – Limb Salvage Through Tissue Engineering: A Novel Treatment Modality Using Dehydrated Human Amnion/Chorion Membrane 57

EpiFix Amniotic Membrane Allograft – The Registry of Cellular and Tissue Based Therapies for Chronic Wounds and Ulcers 57

AmnioFix Injectable – Plantar Fasciitis – A Phase III, Prospective, Double-blinded, Randomized Controlled Trial of the Micronized dHACM Injection as Compared to Saline Placebo Injection in the Treatment of Plantar Fasciitis 58

AmnioFix Injectable – Achilles Tendonitis – A Phase III Achilles Tendonitis Clinical Study of Investigational New Drug (IND) 59

AmnioFix Injectable – Achilles Tendonitis – A Phase III, Prospective, Double-blinded, Randomized Controlled Trial of the Micronized dHACM Injection as Compared to Saline Placebo Injection in the Treatment of Achilles Tendonitis 59

AmnioFix Injectable – Knee OA Pain – A Phase IIB, Prospective, Double-blinded, Randomized Controlled Trial of the Micronized Dehydrated Human Amnion Chorion Membrane Injection as Compared to Saline Placebo Injection in the Treatment of Osteoarthritis of the Knee 60

Novadip Biosciences SA Pipeline Products & Ongoing Clinical Trials Overview 61

NVD-X2 – Product Status 61

NVD-X2 – Product Description 61

Organogenesis Holdings Inc Pipeline Products & Ongoing Clinical Trials Overview 62

Biosynthetic Burn Wound Matrix – Product Status 62

Biosynthetic Burn Wound Matrix – Product Description 62

Dermagraft – Epidermolysis Bullosa – Product Status 63

Dermagraft – Epidermolysis Bullosa – Product Description 63

Dermagraft – Rotator Cuff Repair – Product Status 63

Dermagraft – Rotator Cuff Repair – Product Description 64

Dermagraft – Venous Leg Ulcers Repair – Product Status 64

Dermagraft – Venous Leg Ulcers Repair – Product Description 64

VCT01 – Product Status 65

VCT01 – Product Description 65

Organogenesis Holdings Inc – Ongoing Clinical Trials Overview 66

Dermagraft – Venous Leg Ulcers Repair – The Registry of Cellular and Tissue Based Therapies for Chronic Wounds and Ulcers 67

Osiris Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 68

GrafixPL CORE – Product Status 68

GrafixPL CORE – Product Description 68

GrafixPL XC – Product Status 69

GrafixPL XC – Product Description 69

Stravix Meshed – Product Status 69

Stravix Meshed – Product Description 70

Stravix PL – Product Status 70

Stravix PL – Product Description 70

PolarityTE Inc Pipeline Products & Ongoing Clinical Trials Overview 71

SkinTE – Cutaneous Ulcers – Product Status 71

SkinTE – Cutaneous Ulcers – Product Description 72

SkinTE – Diabetic Foot Ulcers – Product Status 72

SkinTE – Diabetic Foot Ulcers – Product Description 72

SkinTE – Pressure Injuries – Product Status 73

SkinTE – Pressure Injuries – Product Description 73

SkinTE – Traumatic Wounds – Product Status 73

SkinTE – Traumatic Wounds – Product Description 74

SkinTE – Venous Leg Ulcers – Product Status 74

SkinTE – Venous Leg Ulcers – Product Description 74

PolarityTE Inc – Ongoing Clinical Trials Overview 75

SkinTE – Diabetic Foot Ulcers – Closure Obtained with Vascularized Epithelial Regeneration for DFUs with SkinTE: COVER DFUs 76

PolyNovo Biomaterials Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 77

NovoSorb BTM – Full Thickness Burn – Product Status 77

NovoSorb BTM – Full Thickness Burn – Product Description 78

Novosorb BTM – Wound Dressing – Product Status 78

Novosorb BTM – Wound Dressing – Product Description 79

PolyNovo Biomaterials Pty Ltd – Ongoing Clinical Trials Overview 80

Novosorb BTM – Wound Dressing – Clinical Study Evaluating NovoSorb SynPath for the Treatment of Non-healing Diabetic Foot Ulcers 81

NovoSorb BTM – Full Thickness Burn – A Pivotal Study to Assess the Safety and Effectiveness of NovoSorb Biodegradable Temporizing Matrix (BTM) in the Treatment of Severe Burn Skin Injuries 82

NovoSorb BTM – Full Thickness Burn – Long-term Safety and Effectiveness Evaluation of Participants Treated with NovoSorb Biodegradable Temporising Matrix (BTM) for Dermal Repair: An Observational Cohort Study 82

Protein Genomics Inc Pipeline Products & Ongoing Clinical Trials Overview 83

Elastatropin – Product Status 83

Elastatropin – Product Description 83

Purdue University Pipeline Products & Ongoing Clinical Trials Overview 84

Regenerative Replacement Tissue – Laryngeal Reconstruction – Product Status 84

Regenerative Replacement Tissue – Laryngeal Reconstruction – Product Description 84

Regenicin Inc Pipeline Products & Ongoing Clinical Trials Overview 85

NovaDerm – Burns – Product Status 85

NovaDerm – Burns – Product Description 85

NovaDerm – Diabetic Foot Ulcer – Product Status 86

NovaDerm – Diabetic Foot Ulcer – Product Description 86

NovaDerm – Reconstructive Surgery – Product Status 86

NovaDerm – Reconstructive Surgery – Product Description 87

Rensselaer Polytechnic Institute Pipeline Products & Ongoing Clinical Trials Overview 88

Bioprinted Skin Graft – Product Status 88

Bioprinted Skin Graft – Product Description 88

ROKIT Healthcare Inc Pipeline Products & Ongoing Clinical Trials Overview 89

Dermal Patch Graft – Product Status 89

Dermal Patch Graft – Product Description 89

DFURegen – Product Status 90

DFURegen – Product Description 90

Santai Biotech Pipeline Products & Ongoing Clinical Trials Overview 91

3D Skin Tissue Scaffold – Product Status 91

3D Skin Tissue Scaffold – Product Description 91

Smith & Nephew Plc Pipeline Products & Ongoing Clinical Trials Overview 92

KERAGRAF – Product Status 92

KERAGRAF – Product Description 92

SMSbiotech Inc Pipeline Products & Ongoing Clinical Trials Overview 93

PEC-2S – Product Status 93

PEC-2S – Product Description 93

PEC-4I – Product Status 94

PEC-4I – Product Description 94

Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview 95

PLGC-F-HA Scaffold – Product Status 95

PLGC-F-HA Scaffold – Product Description 95

Tissue Engineered Skin Substitute – Product Status 96

Tissue Engineered Skin Substitute – Product Description 96

Xenogenic Biograft – Product Status 96

Xenogenic Biograft – Product Description 97

Stratatech Corp Pipeline Products & Ongoing Clinical Trials Overview 98

ExpressGraft – Antineoplastic – Product Status 98

ExpressGraft – Antineoplastic – Product Description 99

ExpressGraft – Sclerotic Digital Ulcers – Product Status 99

ExpressGraft – Sclerotic Digital Ulcers – Product Description 99

ExpressGraft Antimicrobial – Venous Leg Ulcers – Product Status 100

ExpressGraft Antimicrobial – Venous Leg Ulcers – Product Description 100

ExpressGraft C9T1 Skin Tissue – Product Status 100

ExpressGraft C9T1 Skin Tissue – Product Description 101

ExpressGraft Pro-Angiogenic – Diabetic Foot Ulcers – Product Status 101

ExpressGraft Pro-Angiogenic – Diabetic Foot Ulcers – Product Description 101

ExpressGraft Pro-Angiogenic – Venous Leg Ulcers – Product Status 102

ExpressGraft Pro-Angiogenic – Venous Leg Ulcers – Product Description 102

StrataGraft – Diabetic Foot Ulcers – Product Status 102

StrataGraft – Diabetic Foot Ulcers – Product Description 103

StrataGraft – Epidermolysis Bullosa – Product Status 103

StrataGraft – Epidermolysis Bullosa – Product Description 103

StrataGraft – Scar Revision – Product Status 104

StrataGraft – Scar Revision – Product Description 104

StrataGraft – Scleroderma Digital Ulcers – Product Status 104

StrataGraft – Scleroderma Digital Ulcers – Product Description 105

StrataGraft – Venous Leg Ulcer – Product Status 105

StrataGraft – Venous Leg Ulcer – Product Description 105

StrataGraft Skin Tissue – Pediatrics – Product Status 106

StrataGraft Skin Tissue – Pediatrics – Product Description 106

Tel Aviv University Pipeline Products & Ongoing Clinical Trials Overview 107

Artificial Skin Graft – Product Status 107

Artificial Skin Graft – Product Description 107

Tissue Regenix Ltd Pipeline Products & Ongoing Clinical Trials Overview 108

dCELL – Small Diameter Graft – Product Status 108

dCELL – Small Diameter Graft – Product Description 108

dCELL Human Dermis – Plastic Surgery – Product Status 109

dCELL Human Dermis – Plastic Surgery – Product Description 109

Dermapure – Acute Wounds – Product Status 109

Dermapure – Acute Wounds – Product Description 110

University of Edinburgh Pipeline Products & Ongoing Clinical Trials Overview 111

Artificial Skin – Product Status 111

Artificial Skin – Product Description 111

Vericel Corp Pipeline Products & Ongoing Clinical Trials Overview 112

Epicel – Product Status 112

Epicel – Product Description 113

Worcester Polytechnic Institute Pipeline Products & Ongoing Clinical Trials Overview 114

Extracellular Matrix Scaffold – Product Status 114

Extracellular Matrix Scaffold – Product Description 114

XenoTherapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 115

Xeno-Skin – Product Status 115

Xeno-Skin – Product Description 115

XenoTherapeutics Inc – Ongoing Clinical Trials Overview 116

Xeno-Skin – An Open-label Phase 1 Study to Evaluate the Safety and Tolerability of Xeno-Skin for Temporary Coverage of Severe and Extensive, Deep Partial and Full Thickness Burn Wounds 117

Glossary 155

Figures

Tissue Engineered – Skin Substitutes – Pipeline Products by Stage of Development 13

Tissue Engineered – Skin Substitutes – Pipeline Products by Segment 14

Tissue Engineered – Skin Substitutes – Pipeline Products by Territory 15

Tissue Engineered – Skin Substitutes – Pipeline Products by Regulatory Path 17

Tissue Engineered – Skin Substitutes – Pipeline Products by Estimated Approval Date 18

Tissue Engineered – Skin Substitutes – Ongoing Clinical Trials 19

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