Surgical Mesh – Medical Devices Pipeline Assessment, 2020

1 Table of Contents 2

1.1 List of Tables 5

1.2 List of Figures 6

2 Introduction 7

2.1 Surgical Mesh Overview 7

3 Products under Development 8

3.1 Surgical Mesh – Pipeline Products by Stage of Development 8

3.2 Surgical Mesh – Pipeline Products by Territory 9

3.3 Surgical Mesh – Pipeline Products by Regulatory Path 10

3.4 Surgical Mesh – Pipeline Products by Estimated Approval Date 11

3.5 Surgical Mesh – Ongoing Clinical Trials 12

4 Surgical Mesh – Pipeline Products under Development by Companies 13

4.1 Surgical Mesh Companies – Pipeline Products by Stage of Development 13

4.2 Surgical Mesh – Pipeline Products by Stage of Development 14

5 Surgical Mesh Companies and Product Overview 15

5.1 Acera Surgical, Inc. Company Overview 15

5.1.1 Acera Surgical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 15

5.2 Anika Therapeutics Inc Company Overview 16

5.2.1 Anika Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 16

5.3 Anteris Technologies Ltd Company Overview 18

5.3.1 Anteris Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 18

5.4 Aran Biomedical Company Overview 19

5.4.1 Aran Biomedical Pipeline Products & Ongoing Clinical Trials Overview 19

5.5 Biorez Inc Company Overview 20

5.5.1 Biorez Inc Pipeline Products & Ongoing Clinical Trials Overview 20

5.6 Boston Scientific Corp Company Overview 21

5.6.1 Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 21

5.7 CorMedix Inc Company Overview 25

5.7.1 CorMedix Inc Pipeline Products & Ongoing Clinical Trials Overview 25

5.8 DSM Biomedical BV Company Overview 26

5.8.1 DSM Biomedical BV Pipeline Products & Ongoing Clinical Trials Overview 26

5.9 Fibralign Corporation Company Overview 28

5.9.1 Fibralign Corporation Pipeline Products & Ongoing Clinical Trials Overview 28

5.10 Johns Hopkins University Company Overview 31

5.10.1 Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 31

5.11 Medisse BV (Inactive) Company Overview 32

5.11.1 Medisse BV (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 32

5.12 Polyganics BV Company Overview 33

5.12.1 Polyganics BV Pipeline Products & Ongoing Clinical Trials Overview 33

5.13 Refine LLC Company Overview 34

5.13.1 Refine LLC Pipeline Products & Ongoing Clinical Trials Overview 34

5.14 Retectix, LLC Company Overview 35

5.14.1 Retectix, LLC Pipeline Products & Ongoing Clinical Trials Overview 35

5.15 Samyang Biopharmaceuticals Corp Company Overview 36

5.15.1 Samyang Biopharmaceuticals Corp Pipeline Products & Ongoing Clinical Trials Overview 36

5.16 Silver Bullet Therapeutics, Inc. Company Overview 37

5.16.1 Silver Bullet Therapeutics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 37

5.17 Surgical Innovation Associates Inc Company Overview 38

5.17.1 Surgical Innovation Associates Inc Pipeline Products & Ongoing Clinical Trials Overview 38

5.18 T&R Biofab Co Ltd Company Overview 39

5.18.1 T&R Biofab Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 39

5.19 TEI Biosciences Inc Company Overview 41

5.19.1 TEI Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 41

5.20 Tela Bio Inc Company Overview 43

5.20.1 Tela Bio Inc Pipeline Products & Ongoing Clinical Trials Overview 43

5.21 Tepha Inc Company Overview 44

5.21.1 Tepha Inc Pipeline Products & Ongoing Clinical Trials Overview 44

5.22 The Electrospinning Company Ltd Company Overview 45

5.22.1 The Electrospinning Company Ltd Pipeline Products & Ongoing Clinical Trials Overview 45

5.23 University of Maryland Baltimore Company Overview 46

5.23.1 University of Maryland Baltimore Pipeline Products & Ongoing Clinical Trials Overview 46

5.24 University of Sheffield Company Overview 47

5.24.1 University of Sheffield Pipeline Products & Ongoing Clinical Trials Overview 47

5.25 University of South Florida Company Overview 48

5.25.1 University of South Florida Pipeline Products & Ongoing Clinical Trials Overview 48

6 Surgical Mesh- Recent Developments 49

6.1 Oct 20, 2020: Information for medical practitioners on pending up-classification of surgical mesh devices 49

6.2 Sep 25, 2020: Company to pay $60M for deceptive marketing with pelvic mesh 50

6.3 Jul 13, 2020: DSM appoints Cristina Monteiro new EVP People & Organization and member of the Executive Committee 50

6.4 Jul 01, 2020: DSM appoints Zhou Tao (Joe) as President DSM China 51

6.5 May 07, 2020: DSM to help accelerate Dutch Covid-19 testing by making

2.8 million nose swabs 52

6.6 Apr 14, 2020: BioCardia announces litigation financing in the case captioned Boston Scientific 53

6.7 Apr 08, 2020: Wright Medical Group announces virtual meeting alternative to physical attendance at Extraordinary General Meeting of Shareholders and change of time and location of meeting 53

6.8 Apr 08, 2020: Anika takes actions to strengthen liquidity in light of covid-19 54

6.9 Apr 06, 2020: MiMedx Group agrees to pay $6.5 million to resolve false claims act allegations of false commercial pricing disclosures 55

6.10 Mar 03, 2020: CEO Richard Twomey leaves Molnlycke 56

6.11 Feb 26, 2020: Endo reports fourth-quarter and full-year 2019 financial results 56

6.12 Feb 25, 2020: DSM appoints new EVP Materials and member of the Executive Committee 58

6.13 Feb 24, 2020: 2020 Catalyst award winner Medtronic hires Chief Inclusion and Diversity Officer 58

6.14 Feb 24, 2020: AbbVie announces extension of expiration date for exchange offers for Allergan notes 59

6.15 Feb 24, 2020: 2020 Catalyst Award Winner Medtronic hires Chief Inclusion and Diversity Officer 59

6.16 Feb 21, 2020: Coloplast – Announcement no. 2/2020 – share buyback programme 60

6.17 Feb 19, 2020: Endo names Blaise Coleman president and chief executive officer 61

6.18 Feb 19, 2020: Endo appoints Mark G. Barberio to board of directors 62

6.19 Feb 18, 2020: Medtronic reports third quarter financial results 2020 62

6.20 Feb 13, 2020: CryoLife reports fourth quarter and full year 2019 financial results 64

6.21 Feb 13, 2020: DSM reports 2019 results 65

6.22 Feb 06, 2020: Coloplast: Interim financial report, Q1 2019/20 67

6.23 Feb 05, 2020: Boston Scientific announces results for fourth quarter and full year 2019 68

6.24 Jan 20, 2020: DSM names Feike Sijbesma Honorary Chairman 69

6.25 Jan 14, 2020: Boston Scientific announces preliminary unaudited sales for the fourth quarter and full year 2019 70

6.26 Dec 20, 2019: Cook Medical applauds congressional action to repeal the medical device excise tax 71

6.27 Dec 16, 2019: MiMedx Announces addition of Peter M. Carlson 71

6.28 Dec 04, 2019: Lumeon and Medtronic partner to deliver new models of care in Europe 72

6.29 Dec 03, 2019: Collagen Solutions: Interim Results for the six months ended 30 September 2019 72

6.30 Dec 03, 2019: RTI Surgical accelerates business transformation with senior leadership appointments 74

6.31 Nov 26, 2019: MiMedx announces Securities and Exchange Commission Settlement 75

6.32 Nov 26, 2019: TGA response to federal court decision on urogynaecological mesh class action 75

6.33 Nov 26, 2019: MiMedx names William "Butch" Hulse as General Counsel and Secretary 76

6.34 Nov 26, 2019: SEC charges biotech company and executives with accounting fraud 76

6.35 Nov 19, 2019: Medtronic reports second quarter financial results for the year 2019 77

6.36 Nov 13, 2019: Collagen Solutions: Directorate Change 79

6.37 Nov 12, 2019: Cook Medical’s leadership updates in Asia-pacific reinforce focus on growth and physician relationships 80

6.38 Nov 11, 2019: BioLineRx reports third quarter 2019 financial results and provides corporate update 80

6.39 Nov 05, 2019: Surgical Innovation Associates recent series A supercharged with $2M grant from US National Cancer Institute (NCI) 82

6.40 Nov 05, 2019: Stryker signs agreement to acquire Wright Medical for $5.4bn 83

6.41 Nov 05, 2019: Coloplast delivers a strong full-year result and the company concludes that the interventional urology business remains core to its future value creation 84

6.42 Nov 05, 2019: Coloplast announced its full-year financial results 2018/19 85

7 Appendix 86

7.1 Methodology 86

7.2 About GlobalData 90

7.3 Contact Us 90

7.4 Disclaimer 90

Table 1: Surgical Mesh – Pipeline Products by Stage of Development 8

Table 2: Surgical Mesh – Pipeline Products by Territory 9

Table 3: Surgical Mesh – Pipeline Products by Regulatory Path 10

Table 4: Surgical Mesh – Pipeline Products by Estimated Approval Date 11

Table 5: Surgical Mesh – Ongoing Clinical Trials 12

Table 6: Surgical Mesh Companies – Pipeline Products by Stage of Development 13

Table 7: Surgical Mesh – Pipeline Products by Stage of Development 14

Table 8: Acera Surgical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 15

Table 9: Surgical Mesh – Orthopedic Surgery – Product Status 15

Table 10: Surgical Mesh – Orthopedic Surgery – Product Description 15

Table 11: Anika Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 16

Table 12: Hyalonect – Product Status 16

Table 13: Hyalonect – Product Description 17

Table 14: Anteris Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 18

Table 15: GyneCel – Product Status 18

Table 16: GyneCel – Product Description 18

Table 17: Aran Biomedical Pipeline Products & Ongoing Clinical Trials Overview 19

Table 18: ExtreMESH – Product Status 19

Table 19: ExtreMESH – Product Description 19

Table 20: Biorez Inc Pipeline Products & Ongoing Clinical Trials Overview 20

Table 21: 3D Surgical Mesh – Breast Reconstruction – Product Status 20

Table 22: 3D Surgical Mesh – Breast Reconstruction – Product Description 20

Table 23: Boston Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 21

Table 24: Uphold LITE Vaginal Support System – Product Status 21

Table 25: Uphold LITE Vaginal Support System – Product Description 22

Table 26: Boston Scientific Corp – Ongoing Clinical Trials Overview 23

Table 27: Uphold LITE Vaginal Support System – A Randomized Trial of Vaginal Surgery for Uterovaginal Prolapse: Vaginal Hysterectomy with Native Tissue Vault Suspension Versus Mesh Hysteropexy Suspension 24

Table 28: Uphold LITE Vaginal Support System – Cost-effectiveness Analysis and Patient Safety After Apical Prolapse Surgery by Mesh Via Different Approaches; Vaginal or Robotic-assisted: Multicenter, Prospective Parallel Cohort Study 24

Table 29: CorMedix Inc Pipeline Products & Ongoing Clinical Trials Overview 25

Table 30: CMDX-008 – Surgical Mesh – Product Status 25

Table 31: CMDX-008 – Surgical Mesh – Product Description 25

Table 32: DSM Biomedical BV Pipeline Products & Ongoing Clinical Trials Overview 26

Table 33: Bioadhesive Surgical Mesh – Tendon Repair – Product Status 26

Table 34: Bioadhesive Surgical Mesh – Tendon Repair – Product Description 26

Table 35: Meso BioMatrix – Breast Surgery – Product Status 27

Table 36: Meso BioMatrix – Breast Surgery – Product Description 27

Table 37: Fibralign Corporation Pipeline Products & Ongoing Clinical Trials Overview 28

Table 38: BioBridge Collagen Matrix – Secondary Lymphedema – Product Status 28

Table 39: BioBridge Collagen Matrix – Secondary Lymphedema – Product Description 28

Table 40: Fibralign Corporation – Ongoing Clinical Trials Overview 29

Table 41: BioBridge Collagen Matrix – Secondary Lymphedema – Prospective Evaluation of a Surgical Solution for Breast Cancer-Associated Lymphedema 30

Table 42: Johns Hopkins University Pipeline Products & Ongoing Clinical Trials Overview 31

Table 43: 3D Facial Reconstruction Pre-Form Mesh – Product Status 31

Table 44: 3D Facial Reconstruction Pre-Form Mesh – Product Description 31

Table 45: Medisse BV (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 32

Table 46: PTMC Prolapse – Product Status 32

Table 47: PTMC Prolapse – Product Description 32

Table 48: Polyganics BV Pipeline Products & Ongoing Clinical Trials Overview 33

Table 49: Surgical Mesh – Product Status 33

Table 50: Surgical Mesh – Product Description 33

Table 51: Refine LLC Pipeline Products & Ongoing Clinical Trials Overview 34

Table 52: Silhouette Refine – Product Status 34

Table 53: Silhouette Refine – Product Description 34

Table 54: Retectix, LLC Pipeline Products & Ongoing Clinical Trials Overview 35

Table 55: DuraStar Dural Substitue – Product Status 35

Table 56: DuraStar Dural Substitue – Product Description 35

Table 57: Samyang Biopharmaceuticals Corp Pipeline Products & Ongoing Clinical Trials Overview 36

Table 58: Absorbable Surgical Mesh – Product Status 36

Table 59: Absorbable Surgical Mesh – Product Description 36

Table 60: Silver Bullet Therapeutics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 37

Table 61: Galvanis Mesh – Product Status 37

Table 62: Galvanis Mesh – Product Description 37

Table 63: Surgical Innovation Associates Inc Pipeline Products & Ongoing Clinical Trials Overview 38

Table 64: DuraSorb Monofilament Mesh – Breast Reconstruction – Product Status 38

Table 65: DuraSorb Monofilament Mesh – Breast Reconstruction – Product Description 38

Table 66: T&R Biofab Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 39

Table 67: TnR Mesh – Product Status 39

Table 68: TnR Mesh – Product Description 39

Table 69: TnR Mesh Plus – Product Status 40

Table 70: TnR Mesh Plus – Product Description 40

Table 71: TEI Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 41

Table 72: SurgiMend PRS Meshed – Product Status 41

Table 73: SurgiMend PRS Meshed – Product Description 41

Table 74: Xenform Soft Tissue Repair Matrix – Product Status 42

Table 75: Xenform Soft Tissue Repair Matrix – Product Description 42

Table 76: Tela Bio Inc Pipeline Products & Ongoing Clinical Trials Overview 43

Table 77: OviTex PRS – Breast Reconstruction – Product Status 43

Table 78: OviTex PRS – Breast Reconstruction – Product Description 43

Table 79: Tepha Inc Pipeline Products & Ongoing Clinical Trials Overview 44

Table 80: TephaFLEX Absorbable Knitted Multifilament Mesh – Product Status 44

Table 81: TephaFLEX Absorbable Knitted Multifilament Mesh – Product Description 44

Table 82: The Electrospinning Company Ltd Pipeline Products & Ongoing Clinical Trials Overview 45

Table 83: Bio-Synthetic Surgical Mesh – Product Status 45

Table 84: Bio-Synthetic Surgical Mesh – Product Description 45

Table 85: University of Maryland Baltimore Pipeline Products & Ongoing Clinical Trials Overview 46

Table 86: Hybrid Mesh – Product Status 46

Table 87: Hybrid Mesh – Product Description 46

Table 88: University of Sheffield Pipeline Products & Ongoing Clinical Trials Overview 47

Table 89: Polyurethane Mesh – Product Status 47

Table 90: Polyurethane Mesh – Product Description 47

Table 91: University of South Florida Pipeline Products & Ongoing Clinical Trials Overview 48

Table 92: SiC Nanoparticle Impregnated Surgical Mesh – Product Status 48

Table 93: SiC Nanoparticle Impregnated Surgical Mesh – Product Description 48

Table 94: Glossary 89

Figure 1: Surgical Mesh – Pipeline Products by Stage of Development 8

Figure 2: Surgical Mesh – Pipeline Products by Territory 9

Figure 3: Surgical Mesh – Pipeline Products by Regulatory Path 10

Figure 4: Surgical Mesh – Pipeline Products by Estimated Approval Date 11

Figure 5: Surgical Mesh – Ongoing Clinical Trials 12