Synthetic Bone Graft Substitutes Pipeline Report including Stages of Development, Segments, Region and Countries, Regulatory Path and Key Companies, 2022 Update

Pages: 146 Published: June 24, 2022 Report Code: GDME1392EPD

Synthetic bone graft substitutes are used as substitutes to autograft and allograft bone. Major types of synthetic bone substitutes include calcium sulfate, calcium phosphate, tricalcium phosphate (TCP), and coralline hydroxyapatite. The second-generation products include bioactive glass, collagen-containing and polymer-based bone substitutes. Products available in the form of granules, paste, pellets, or strips are all tracked here.

The Synthetic Bone Graft Substitutes Pipeline research report provides comprehensive information about the synthetic bone graft 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.

What is the territory outlook in the synthetic bone graft substitutes pipeline products market?

The US, Europe, Taiwan, the UK, Australia, China, and Japan have products in the pipeline. As of June 2022, the US has the highest number of products in the pipeline out of them all.

Synthetic bone graft substitutes pipeline products market, by territory

Synthetic bone graft substitutes pipeline products market, by territory

For more territory insights, download a free report sample

What are the regulatory paths for the synthetic bone graft substitutes pipeline products market?

The regulatory path followed by the synthetic bone graft substitutes pipeline products are 510(k), CE, PMA, TGA, BOPA, UKCA, de novo, Ninsho, and NMPA. The majority of products follow the 510(k) pathway to enter the market.

Synthetic bone graft substitutes pipeline products market, by regulatory path

Synthetic bone graft substitutes pipeline products market, by regulatory path

For more regulatory path insights, download a free report sample

What are the key companies in the synthetic bone graft substitutes pipeline products market?

Some of the key companies in the synthetic bone graft substitutes pipeline products market are Acuitive Technologies Inc, Anika Therapeutics Inc, Baxter International Inc, Agenta Biotechnologies Inc (Inactive), Amend Surgical, Inc., Berkeley Advanced Biomaterials Inc, Bio2 Technologies Inc, BioGend Therapeutics Co Ltd, Biomatlante SA, and Biorez Inc.

Acuitive Technologies Inc

Acuitive Technologies Inc is a developer of surgical medical devices designed to help in surgeries. It is headquartered in Allendale, New Jersey, the US.

Anika Therapeutics Inc

Anika Therapeutics Inc develops, manufactures, and markets therapeutic products for degenerative orthopedic diseases and traumatic conditions. It offers solutions for ortho-biologics, dermal, ophthalmic, surgical, and veterinary applications. Anika has research and manufacturing facilities in Bedford, Massachusetts. The company offers products through distributors in Latin America, Canada, Europe, the Middle East, and Asia. It is headquartered in Massachusetts, the US.

Baxter International Inc

Baxter International Inc is a provider of a range of healthcare products, including dialysis in acute and chronic conditions, sterile intravenous solutions, generic injectable pharmaceuticals, parenteral nutrition therapies, infusion systems and devices, inhaled anesthetics, and surgical hemostat and sealant products. The company has operations in the Americas, the Middle East, Africa, Europe, and Asia-Pacific. Baxter is headquartered in Deerfield, Illinois, the US.

Market report scope

Key territories The US, Europe, Taiwan, The UK, Australia, China, and Japan
Key regulatory paths 510(k), CE, PMA, TGA, BOPA, UKCA, de novo, Ninsho, and NMPA
Key companies Acuitive Technologies Inc, Anika Therapeutics Inc, Baxter International Inc, Berkeley Advanced Biomaterials Inc, Bio2 Technologies Inc, Agenta Biotechnologies Inc (Inactive), Amend Surgical, Inc., BioGend Therapeutics Co Ltd, Biomatlante SA, and Biorez Inc

This report provides:

  • Extensive coverage of the synthetic bone graft substitutes under development.
  • Details of major pipeline products which includes, product description, licensing and collaboration details and other developmental activities.
  • Major players involved in the development of synthetic bone graft substitutes and list all their pipeline projects.
  • Coverage of pipeline products based on various stages of development ranging from early development to approved/issued stage.
  • Key clinical trial data of ongoing trials specific to pipeline products.
  • Recent developments in the segment/industry.

Reasons to Buy

  • Formulate significant competitor information, analysis, and insights to improve R&D strategies.
  • Identify emerging players with potentially strong product portfolio and create effective counter strategies to gain competitive advantage.
  • Identify and understand important and diverse types of synthetic bone graft 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.

Key Players

Acuitive Technologies Inc

Agenta Biotechnologies Inc (Inactive)

Amend Surgical, Inc.

Anika Therapeutics Inc

Baxter International Inc

Berkeley Advanced Biomaterials Inc

Bio2 Technologies Inc

BioGend Therapeutics Co Ltd

Biomatlante SA

Biorez Inc

Bone Solutions Inc

BoneGrafix, Inc.

BoneSupport AB

Calcitec, Inc.

Dimension Inx LLC

DSM Biomedical BV

Elute Inc

Eskisehir Osmangazi University

EternoGen Aesthetics LLC

Graftys SA

Innovoss Inc. (Inactive)

IRCCS San Raffaele Hospital

Isto Biologics

King’s College London

Maxigen Biotech Inc

National Center of Innovation for Biomaterials in Orthopaedic Research

National University of Science and Technology MiSiS

OrthoMedex LLC

PolyPid Ltd

Polytechnic University of Catalonia

Promimic AB

ReCaPP

RepRegen Ltd. (Inactive)

Revivicor Inc

Sanara MedTech Inc

Scil Technology GmbH

SDIP Innovations Pty Ltd

SIRAKOSS Ltd

Sofregen Medical Inc

Soteira Inc

Sree Chitra Tirunal Institute for Medical Sciences & Technology

SurGenTec LLC

University of California San Diego

University of Edinburgh

Wright Medical Group NV

Xtant Medical Holdings Inc

Table of Contents

1 Table of Contents 3

|1.1 List of Tables 7

|1.2 List of Figures 11

2 Introduction 12

2.1 Synthetic Bone Graft Substitutes Overview 12

3 Products under Development 13

3.1 Synthetic Bone Graft Substitutes – Pipeline Products by Stage of Development 13

3.2 Synthetic Bone Graft Substitutes – Pipeline Products by Territory 14

3.3 Synthetic Bone Graft Substitutes – Pipeline Products by Regulatory Path 15

3.4 Synthetic Bone Graft Substitutes – Pipeline Products by Estimated Approval Date 16

3.5 Synthetic Bone Graft Substitutes – Ongoing Clinical Trials 17

4 Synthetic Bone Graft Substitutes – Pipeline Products under Development by Companies 18

4.1 Synthetic Bone Graft Substitutes Companies – Pipeline Products by Stage of Development 18

4.2 Synthetic Bone Graft Substitutes – Pipeline Products by Stage of Development 20

5 Synthetic Bone Graft Substitutes Companies and Product Overview 22

5.1 Acuitive Technologies Inc Company Overview 22

5.1.1 Acuitive Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 22

5.2 Agenta Biotechnologies Inc (Inactive) Company Overview 23

5.2.1 Agenta Biotechnologies Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 23

5.3 Amend Surgical, Inc. Company Overview 24

5.3.1 Amend Surgical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 24

5.4 Anika Therapeutics Inc Company Overview 25

5.4.1 Anika Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 25

5.5 Baxter International Inc Company Overview 30

5.5.1 Baxter International Inc Pipeline Products & Ongoing Clinical Trials Overview 30

5.6 Berkeley Advanced Biomaterials Inc Company Overview 31

5.6.1 Berkeley Advanced Biomaterials Inc Pipeline Products & Ongoing Clinical Trials Overview 31

5.7 Bio2 Technologies Inc Company Overview 33

5.7.1 Bio2 Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 33

5.8 BioGend Therapeutics Co Ltd Company Overview 36

5.8.1 BioGend Therapeutics Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 36

5.9 Biomatlante SA Company Overview 41

5.9.1 Biomatlante SA Pipeline Products & Ongoing Clinical Trials Overview 41

5.10 Biorez Inc Company Overview 42

5.10.1 Biorez Inc Pipeline Products & Ongoing Clinical Trials Overview 42

5.11 BonAlive Biomaterials Ltd. Company Overview 43

5.11.1 BonAlive Biomaterials Ltd. Pipeline Products & Ongoing Clinical Trials Overview 43

5.12 Bone Solutions Inc Company Overview 44

5.12.1 Bone Solutions Inc Pipeline Products & Ongoing Clinical Trials Overview 44

5.13 BoneGrafix, Inc. Company Overview 47

5.13.1 BoneGrafix, Inc. Pipeline Products & Ongoing Clinical Trials Overview 47

5.14 BoneSupport AB Company Overview 48

5.14.1 BoneSupport AB Pipeline Products & Ongoing Clinical Trials Overview 48

5.15 Calcitec, Inc. Company Overview 53

5.15.1 Calcitec, Inc. Pipeline Products & Ongoing Clinical Trials Overview 53

5.16 Daewoong Pharmaceutical Co Ltd Company Overview 54

5.16.1 Daewoong Pharmaceutical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 54

5.17 Dimension Inx LLC Company Overview 55

5.17.1 Dimension Inx LLC Pipeline Products & Ongoing Clinical Trials Overview 55

5.18 DSM Biomedical BV Company Overview 56

5.18.1 DSM Biomedical BV Pipeline Products & Ongoing Clinical Trials Overview 56

5.19 Elute Inc Company Overview 57

5.19.1 Elute Inc Pipeline Products & Ongoing Clinical Trials Overview 57

5.20 Eskisehir Osmangazi University Company Overview 58

5.20.1 Eskisehir Osmangazi University Pipeline Products & Ongoing Clinical Trials Overview 58

5.21 EternoGen Aesthetics LLC Company Overview 61

5.21.1 EternoGen Aesthetics LLC Pipeline Products & Ongoing Clinical Trials Overview 61

5.22 Graftys SA Company Overview 62

5.22.1 Graftys SA Pipeline Products & Ongoing Clinical Trials Overview 62

5.23 Industrie Biomediche Insubri SA Company Overview 64

5.23.1 Industrie Biomediche Insubri SA Pipeline Products & Ongoing Clinical Trials Overview 64

5.24 Innovoss Inc. (Inactive) Company Overview 65

5.24.1 Innovoss Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 65

5.25 IRCCS San Raffaele Hospital Company Overview 66

5.25.1 IRCCS San Raffaele Hospital Pipeline Products & Ongoing Clinical Trials Overview 66

5.26 Isto Biologics Company Overview 67

5.26.1 Isto Biologics Pipeline Products & Ongoing Clinical Trials Overview 67

5.27 King’s College London Company Overview 68

5.27.1 King’s College London Pipeline Products & Ongoing Clinical Trials Overview 68

5.28 Maxigen Biotech Inc Company Overview 69

5.28.1 Maxigen Biotech Inc Pipeline Products & Ongoing Clinical Trials Overview 69

5.29 National Center of Innovation for Biomaterials in Orthopaedic Research Company Overview 70

5.29.1 National Center of Innovation for Biomaterials in Orthopaedic Research Pipeline Products & Ongoing Clinical Trials Overview 70

5.30 National University of Science and Technology MiSiS Company Overview 71

5.30.1 National University of Science and Technology MiSiS Pipeline Products & Ongoing Clinical Trials Overview 71

5.31 OrthoMedex LLC Company Overview 72

5.31.1 OrthoMedex LLC Pipeline Products & Ongoing Clinical Trials Overview 72

5.32 PolyPid Ltd Company Overview 73

5.32.1 PolyPid Ltd Pipeline Products & Ongoing Clinical Trials Overview 73

5.33 Polytechnic University of Catalonia Company Overview 74

5.33.1 Polytechnic University of Catalonia Pipeline Products & Ongoing Clinical Trials Overview 74

5.34 Promimic AB Company Overview 75

5.34.1 Promimic AB Pipeline Products & Ongoing Clinical Trials Overview 75

5.35 ReCaPP Company Overview 76

5.35.1 ReCaPP Pipeline Products & Ongoing Clinical Trials Overview 76

5.36 RepRegen Ltd. (Inactive) Company Overview 77

5.36.1 RepRegen Ltd. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 77

5.37 Revivicor Inc Company Overview 79

5.37.1 Revivicor Inc Pipeline Products & Ongoing Clinical Trials Overview 79

5.38 Sanara MedTech Inc Company Overview 80

5.38.1 Sanara MedTech Inc Pipeline Products & Ongoing Clinical Trials Overview 80

5.39 Scil Technology GmbH Company Overview 81

5.39.1 Scil Technology GmbH Pipeline Products & Ongoing Clinical Trials Overview 81

5.40 SDIP Innovations Pty Ltd Company Overview 82

5.40.1 SDIP Innovations Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 82

5.41 SIRAKOSS Ltd Company Overview 83

5.41.1 SIRAKOSS Ltd Pipeline Products & Ongoing Clinical Trials Overview 83

5.42 Sofregen Medical Inc Company Overview 86

5.42.1 Sofregen Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 86

5.43 Soteira Inc Company Overview 88

5.43.1 Soteira Inc Pipeline Products & Ongoing Clinical Trials Overview 88

5.44 Sree Chitra Tirunal Institute for Medical Sciences & Technology Company Overview 89

5.44.1 Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview 89

5.45 SurGenTec LLC Company Overview 90

5.45.1 SurGenTec LLC Pipeline Products & Ongoing Clinical Trials Overview 90

5.46 University of California San Diego Company Overview 91

5.46.1 University of California San Diego Pipeline Products & Ongoing Clinical Trials Overview 91

5.47 University of Edinburgh Company Overview 92

5.47.1 University of Edinburgh Pipeline Products & Ongoing Clinical Trials Overview 92

5.48 Wright Medical Group NV Company Overview 93

5.48.1 Wright Medical Group NV Pipeline Products & Ongoing Clinical Trials Overview 93

5.49 Xtant Medical Holdings Inc Company Overview 94

5.49.1 Xtant Medical Holdings Inc Pipeline Products & Ongoing Clinical Trials Overview 94

6 Synthetic Bone Graft Substitutes- Recent Developments 95

6.1 Jun 10, 2022: Anika to Participate in the Sidoti Small Cap Virtual Investor Conference 95

6.2 Jun 08, 2022: Baxter to Host Second-Quarter 2022 Financial Results Conference Call for Investors 95

6.3 May 27, 2022: Medtronic reports full year and fourth quarter fiscal year 2022 financial results 95

6.4 May 26, 2022: Medtronic reports full year and fourth quarter fiscal year 2022 financial results announces 8% dividend increase 95

6.5 May 25, 2022: Baxter Highlights Business Strategies and Innovation at 2022 Investor Conference 95

6.6 May 25, 2022: ATEC to Host Investor Day, May 25, 2022 96

6.7 May 19, 2022: ATEC to Participate in Upcoming Investor Events 96

6.8 May 16, 2022: Zimmer Biomet Announces Appointment of New Chief Accounting Officer 96

6.9 May 10, 2022: Baxter to Host 2022 Investor Conference 96

6.10 May 09, 2022: Anika to Participate in the UBS Global Healthcare Conference 2022 97

6.11 May 05, 2022: ATEC Reports First Quarter 2022 Financial Results and Increases Full-Year Revenue Guidance 97

6.12 May 05, 2022: Anika Reports First Quarter Fiscal 2022 Financial Results 98

6.13 May 04, 2022: NuVasive Announces First Quarter 2022 Financial Results 101

6.14 May 03, 2022: Zimmer Biomet Announces First Quarter 2022 Financial Results 103

6.15 Apr 21, 2022: ATEC to Report First Quarter 2022 Financial Results on May 5, 2022 104

6.16 Apr 07, 2022: Anika to Issue First Quarter 2022 Financial Results on Thursday, May 5, 2022 105

6.17 Apr 05, 2022: ATEC to Host Investor Day on May 25, 2022 105

6.18 Apr 04, 2022: Anika to Participate in the 21st Annual Needham Virtual Healthcare Conference 105

6.19 Mar 28, 2022: ATEC to Participate in the Needham Virtual Healthcare Conference 105

6.20 Mar 10, 2022: Anika to Participate in the Canaccord Genuity Musculoskeletal Conference 106

6.21 Mar 08, 2022: Anika Reports Fourth Quarter and Year-End 2021 Financial Results 106

6.22 Mar 01, 2022: Atec Reports Fourth Quarter and Full Year 2021 Financial Results and Recent Corporate Highlights 107

6.23 Feb 22, 2022: Sanara MedTech Announces Unaudited Preliminary Results for the Fourth Quarter and Full Year 2021 108

6.24 Feb 10, 2022: ATEC to Participate in Upcoming Investor Conferences 109

6.25 Feb 10, 2022: Baxter to Present at Citi’s 2022 Virtual Healthcare Conference 109

6.26 Feb 08, 2022: Anika to Issue Fourth Quarter and Year-End 2021 Financial Results on Tuesday, March 8, 2022 109

6.27 Feb 07, 2022: Zimmer Biomet Announces Fourth Quarter and Full-Year 2021 Financial Results 110

6.28 Feb 07, 2022: ATEC to Report Fourth Quarter and Fiscal Year 2021 Financial Results on March 1, 2022 111

6.29 Jan 21, 2022: Zimmer Biomet Announces Filing of Form 10 Registration Statement in Connection with Planned Spinoff of ZimVie; ZimVie to Host Investor Day on February 7 111

6.30 Jan 11, 2022: Integra LifeSciences Reports Preliminary Fourth Quarter and Full-Year 2021 Revenue and Plans $125 Million Share Repurchase 112

6.31 Jan 10, 2022: ATEC Announces Preliminary 2021 Revenue Results and 2022 Guidance 113

6.32 Jan 07, 2022: Collagen Matrix Names Tony Orsini Chief Operating Officer 113

6.33 Jan 06, 2022: ATEC to Participate in the Virtual Needham Growth Conference 114

6.34 Jan 06, 2022: Baxter to Host Fourth-Quarter 2021 Financial Results Conference Call for Investors 114

6.35 Jan 04, 2022: Medtronic Chairman and CEO Geoff Martha to speak at J.P. Morgan healthcare conference 114

6.36 Dec 22, 2021: Sanara MedTech Announces the Retirement of J. Michael Carmena and Appointment of Eric Tanzberger to its Board of Directors 114

6.37 Dec 15, 2021: Sanara MedTech Announces the Appointment of Roszell Mack III to its Board of Directors 115

6.38 Nov 18, 2021: NuVasive to Present at Piper Sandler 33rd Annual Virtual Healthcare Conference 115

6.39 Nov 18, 2021: Zimmer Biomet to Present at Evercore ISI’s 4th Annual HealthCONx Conference 116

6.40 Nov 18, 2021: Anika to Participate in Upcoming Investor Conferences 116

6.41 Nov 09, 2021: NuVasive Announces Third Quarter 2021 Financial Results 116

6.42 Nov 04, 2021: Anika Reports Third Quarter 2021 Financial Results 117

6.43 Nov 03, 2021: Zimmer Biomet to Present at Stifel’s 2021 Virtual Healthcare Conference 120

6.44 Nov 02, 2021: Baxter to Present at Evercore ISI 4th Annual HealthCONx Conference 120

6.45 Nov 01, 2021: ATEC to Participate in Upcoming Investor Conferences 121

6.46 Nov 01, 2021: Anika Appoints Sheryl Conley to Board of Directors 121

6.47 Oct 21, 2021: ATEC to Report Third Quarter Financial Results on November 4, 2021 122

6.48 Oct 18, 2021: Anika to Issue Third Quarter 2021 Financial Results on Thursday, November 4, 2021 122

6.49 Oct 14, 2021: Spineway Announces Increase of 2021 9 months revenue 122

6.50 Oct 13, 2021: Baxter to Present at Credit Suisse 30th Annual Virtual Healthcare Conference 123

6.51 Sep 28, 2021: Globus Medical to Participate in North American Spine Society Annual Meeting 123

6.52 Sep 27, 2021: Baxter to Host Third-Quarter 2021 Financial Results Conference Call for Investors 124

6.53 Sep 13, 2021: SPINEWAY 2021 half-year results 124

6.54 Sep 07, 2021: Anika to Participate in the Morgan Stanley 19th Annual Global Healthcare Conference 125

6.55 Sep 02, 2021: Integra LifeSciences Announces Participation In Upcoming Investor Conferences 126

6.56 Aug 03, 2021: Zimmer Biomet Announces Second Quarter 2021 Financial Results 126

6.57 Aug 03, 2021: Alphatec Reports Second Quarter Financial Results 127

6.58 Jul 29, 2021: Baxter Reports Second-Quarter 2021 Results 128

6.59 Jul 29, 2021: Baxter to Present at UBS Genomics

2.0 and MedTech Innovations Summit 130

6.60 Jul 28, 2021: Integra LifeSciences Reports Second Quarter 2021 Financial Results 131

6.61 Jul 28, 2021: LifeNet Health features revolutionary biologics for wounds at APMA Annual Scientific Meeting 133

6.62 Jul 28, 2021: NuVasive Announces Second Quarter 2021 Financial Results 134

6.63 Jul 27, 2021: Stryker reports second quarter 2021 operating results 137

6.64 Jul 26, 2021: ATEC Appoints Beth Altman to Board of Directors 138

6.65 Jul 19, 2021: Anika to Issue Second Quarter 2021 Financial Results on Thursday, August 5, 2021 139

6.66 Jul 16, 2021: Globus Medical Schedules Second Quarter Earnings Release and Conference Call 139

6.67 Jul 12, 2021: ATEC Announces Select Preliminary Second Quarter 2021 Financial Results 140

6.68 Jul 08, 2021: FDA: Potential biocompatibility concerns with nuvasive specialized orthopedics’ precice devices – letter to health care providers 140

7 Appendix 143

7.1 Methodology 143

7.2 About GlobalData 145

7.3 Contact Us 146

7.4 Disclaimer 146

List of Tables

Synthetic Bone Graft Substitutes – Pipeline Products by Stage of Development 13

Synthetic Bone Graft Substitutes – Pipeline Products by Territory 14

Synthetic Bone Graft Substitutes – Pipeline Products by Regulatory Path 15

Synthetic Bone Graft Substitutes – Pipeline Products by Estimated Approval Date 16

Synthetic Bone Graft Substitutes – Ongoing Clinical Trials 17

Synthetic Bone Graft Substitutes Companies – Pipeline Products by Stage of Development 18

Synthetic Bone Graft Substitutes – Pipeline Products by Stage of Development 20

Acuitive Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 22

Citrefoam – Product Status 22

Citrefoam – Product Description 22

Agenta Biotechnologies Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 23

B-247 Cranial Bone Graft Implant – Product Status 23

B-247 Cranial Bone Graft Implant – Product Description 23

Amend Surgical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 24

Biomimetic Bone – Product Status 24

Biomimetic Bone – Product Description 24

Anika Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 25

Hyalobone – Product Status 25

Hyalobone – Product Description 25

Hyalofast – Product Status 26

Hyalofast – Product Description 26

Hyalograft C Autograft – Product Status 26

Hyalograft C Autograft – Product Description 27

Anika Therapeutics Inc – Ongoing Clinical Trials Overview 28

Hyalofast – A Prospective, Randomized, Active Treatment-controlled, Evaluator-blinded Multicenter Study to Establish the Superiority of Hyalofast with BMAC in the Treatment of Articular Knee Cartilage Defect Lesions in Comparison to Control 29

Hyalofast – A Study on the Safety and Effectiveness of Improved Microfracture Techniques Using Temperature Sensitive Polymer Hydrogel for Femoral and Cartilage Defects– Prospective, Randomize, Single–center 29

Hyalofast – Cartilage Repair Using a Hyaluronic Acid-based Scaffold with Bone Marrow Aspirate Compared with Microfracture for Focal Articular Cartilage Damage of the Hip: A Randomized Controlled Trial 29

Baxter International Inc Pipeline Products & Ongoing Clinical Trials Overview 30

Synthetic Bone Graft – Spinal – Product Status 30

Synthetic Bone Graft – Spinal – Product Description 30

Berkeley Advanced Biomaterials Inc Pipeline Products & Ongoing Clinical Trials Overview 31

CPA Ceramics – Product Status 31

CPA Ceramics – Product Description 31

HAP Ceramics – Product Status 32

HAP Ceramics – Product Description 32

Bio2 Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 33

Vitrium – Hammertoe Correction – Product Status 33

Vitrium – Hammertoe Correction – Product Description 33

Vitrium – Radial Osteotomy – Product Status 34

Vitrium – Radial Osteotomy – Product Description 34

Vitrium – Wrist Fracture Revision – Product Status 34

Vitrium – Wrist Fracture Revision – Product Description 35

BioGend Therapeutics Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 36

OIF – Non-Union Bone Fracture – Product Status 36

OIF – Non-Union Bone Fracture – Product Description 36

OIF/ß-TCP – Block Form – Product Status 37

OIF/ß-TCP – Block Form – Product Description 37

OIF/ß-TCP – Granular Form – Product Status 37

OIF/ß-TCP – Granular Form – Product Description 38

BioGend Therapeutics Co Ltd – Ongoing Clinical Trials Overview 39

OIF/ß-TCP – Granular Form – A Randomized, Evaluator-blinded, Controlled Study to Evaluate the Safety and Clinical Performance of OIF/ß-TCP in Patients with Open Tibial Fractures in Need of Bone Grafting 40

Biomatlante SA Pipeline Products & Ongoing Clinical Trials Overview 41

Osteoconductive Resorbable Composite – Product Status 41

Osteoconductive Resorbable Composite – Product Description 41

Biorez Inc Pipeline Products & Ongoing Clinical Trials Overview 42

L-C Ligament – Product Status 42

L-C Ligament – Product Description 42

BonAlive Biomaterials Ltd. Pipeline Products & Ongoing Clinical Trials Overview 43

S53P4 BonAlive Granules – Product Status 43

S53P4 BonAlive Granules – Product Description 43

Bone Solutions Inc Pipeline Products & Ongoing Clinical Trials Overview 44

Osteocrete – Bone Anchor – Product Status 44

Osteocrete – Bone Anchor – Product Description 44

OsteoCrete – Cranial – Product Status 45

OsteoCrete – Cranial – Product Description 45

OsteoCrete – Maxillofacial – Product Status 45

OsteoCrete – Maxillofacial – Product Description 46

OsteoCrete – Non Load Bearing Spine – Product Status 46

OsteoCrete – Non Load Bearing Spine – Product Description 46

BoneGrafix, Inc. Pipeline Products & Ongoing Clinical Trials Overview 47

Solid Bone Block – Product Status 47

Solid Bone Block – Product Description 47

BoneSupport AB Pipeline Products & Ongoing Clinical Trials Overview 48

Cerament + Bisphosphonate – Product Status 48

Cerament + Bisphosphonate – Product Description 48

Cerament|G – Product Status 49

Cerament|G – Product Description 49

Gelatin/Cerament – Product Status 49

Gelatin/Cerament – Product Description 50

BoneSupport AB – Ongoing Clinical Trials Overview 51

Cerament|G – CERAMENTTM|G and V in the Management of Hip and Knee Arthroplasty Revisions (Revision Arthroplasty Italy) 52

Cerament|G – Evaluation of the Efficiency of the Bone Substitute Cerament-G Locally Delivering Gentamicin in the Treatment of Chronic Osteomyelitis of Long Bones: Randomized Multicentre Study in the CRIOAc Network – CONVICTION Study 52

Cerament|G – Two-stage Treatment of Large Bone Defects with Cerament G and Cerament V plus Auto and/or Allograft Using the Masquelet Technique as Salvage Therapy after Bone Resection in Patients with Septic Pseudarthrosis 52

Calcitec, Inc. Pipeline Products & Ongoing Clinical Trials Overview 53

Corticell – Product Status 53

Corticell – Product Description 53

Daewoong Pharmaceutical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 54

Bongros HA – Product Status 54

Bongros HA – Product Description 54

Dimension Inx LLC Pipeline Products & Ongoing Clinical Trials Overview 55

Hyperelastic Bone – Product Status 55

Hyperelastic Bone – Product Description 55

DSM Biomedical BV Pipeline Products & Ongoing Clinical Trials Overview 56

Structural Synthetic Bone Graft – Product Status 56

Structural Synthetic Bone Graft – Product Description 56

Elute Inc Pipeline Products & Ongoing Clinical Trials Overview 57

EP Granules With Tobramycin – Product Status 57

EP Granules With Tobramycin – Product Description 57

Eskisehir Osmangazi University Pipeline Products & Ongoing Clinical Trials Overview 58

Antimicrobial Synthetic Bone Graft – Product Status 58

Antimicrobial Synthetic Bone Graft – Product Description 58

Eskisehir Osmangazi University – Ongoing Clinical Trials Overview 59

Antimicrobial Synthetic Bone Graft – The Use of Antimicrobial Synthetic Bone Grafts in the Treatment of Bone Infection 60

EternoGen Aesthetics LLC Pipeline Products & Ongoing Clinical Trials Overview 61

Collagen Scaffold – Orthopedic Procedures – Product Status 61

Collagen Scaffold – Orthopedic Procedures – Product Description 61

Graftys SA Pipeline Products & Ongoing Clinical Trials Overview 62

GRFT-M04 – Product Status 62

GRFT-M04 – Product Description 62

GRFT-R02 – Product Status 63

GRFT-R02 – Product Description 63

Industrie Biomediche Insubri SA Pipeline Products & Ongoing Clinical Trials Overview 64

SmartBonePep – Product Status 64

SmartBonePep – Product Description 64

Innovoss Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 65

Synthetic Bone Material – Product Status 65

Synthetic Bone Material – Product Description 65

IRCCS San Raffaele Hospital Pipeline Products & Ongoing Clinical Trials Overview 66

Tissue Repair Composite Scaffold – Product Status 66

Tissue Repair Composite Scaffold – Product Description 66

Isto Biologics Pipeline Products & Ongoing Clinical Trials Overview 67

InQu Bone Graft Extender And Substitute – Chondral Defects – Product Status 67

InQu Bone Graft Extender And Substitute – Chondral Defects – Product Description 67

King’s College London Pipeline Products & Ongoing Clinical Trials Overview 68

Synthetic Bone Composite – Product Status 68

Synthetic Bone Composite – Product Description 68

Maxigen Biotech Inc Pipeline Products & Ongoing Clinical Trials Overview 69

MaxiSetin – Product Status 69

MaxiSetin – Product Description 69

National Center of Innovation for Biomaterials in Orthopaedic Research Pipeline Products & Ongoing Clinical Trials Overview 70

Composite Bone Graft Substitute – Product Status 70

Composite Bone Graft Substitute – Product Description 70

National University of Science and Technology MiSiS Pipeline Products & Ongoing Clinical Trials Overview 71

Hybrid Bone Implant – Product Status 71

Hybrid Bone Implant – Product Description 71

OrthoMedex LLC Pipeline Products & Ongoing Clinical Trials Overview 72

Cancellous Bone Allograft – Product Status 72

Cancellous Bone Allograft – Product Description 72

PolyPid Ltd Pipeline Products & Ongoing Clinical Trials Overview 73

D-Plex1000 – Product Status 73

D-Plex1000 – Product Description 73

Polytechnic University of Catalonia Pipeline Products & Ongoing Clinical Trials Overview 74

Bone Regeneration Foam – Product Status 74

Bone Regeneration Foam – Product Description 74

Promimic AB Pipeline Products & Ongoing Clinical Trials Overview 75

HAnano Bone – Product Status 75

HAnano Bone – Product Description 75

ReCaPP Pipeline Products & Ongoing Clinical Trials Overview 76

ReCapp Putty – Product Status 76

ReCapp Putty – Product Description 76

RepRegen Ltd. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 77

Bone Graft Substitute – Load Bearing – Product Status 77

Bone Graft Substitute – Load Bearing – Product Description 77

StronBone-P – Product Status 78

StronBone-P – Product Description 78

Revivicor Inc Pipeline Products & Ongoing Clinical Trials Overview 79

Tendon – ACL Repair – Product Status 79

Tendon – ACL Repair – Product Description 79

Sanara MedTech Inc Pipeline Products & Ongoing Clinical Trials Overview 80

Bone Void Filler – Product Status 80

Bone Void Filler – Product Description 80

Scil Technology GmbH Pipeline Products & Ongoing Clinical Trials Overview 81

ST01 Bone Graft Substitute Material – Product Status 81

ST01 Bone Graft Substitute Material – Product Description 81

SDIP Innovations Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 82

JAZBI – Product Status 82

JAZBI – Product Description 82

SIRAKOSS Ltd Pipeline Products & Ongoing Clinical Trials Overview 83

MaxSi Graft Granules – Product Status 83

MaxSi Graft Granules – Product Description 83

MaxSi Graft Putty – Product Status 84

MaxSi Graft Putty – Product Description 84

Osteo3 ZP Putty – Product Status 84

Osteo3 ZP Putty – Product Description 85

Sofregen Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 86

SeriACL Scaffold – Product Status 86

SeriACL Scaffold – Product Description 86

SeriCuff Scaffold – Product Status 87

SeriCuff Scaffold – Product Description 87

Soteira Inc Pipeline Products & Ongoing Clinical Trials Overview 88

Nanotechnology Bone Biomaterial – Spinal Repair – Product Status 88

Nanotechnology Bone Biomaterial – Spinal Repair – Product Description 88

Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview 89

Bioceramic Cage – Product Status 89

Bioceramic Cage – Product Description 89

SurGenTec LLC Pipeline Products & Ongoing Clinical Trials Overview 90

OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft – Product Status 90

OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft – Product Description 90

University of California San Diego Pipeline Products & Ongoing Clinical Trials Overview 91

Synthetic Bone Graft – Product Status 91

Synthetic Bone Graft – Product Description 91

University of Edinburgh Pipeline Products & Ongoing Clinical Trials Overview 92

Shapeable Foam – Bone Repair – Product Status 92

Shapeable Foam – Bone Repair – Product Description 92

Wright Medical Group NV Pipeline Products & Ongoing Clinical Trials Overview 93

Augment Rotator Cuff Graft – Product Status 93

Augment Rotator Cuff Graft – Product Description 93

Xtant Medical Holdings Inc Pipeline Products & Ongoing Clinical Trials Overview 94

Monetite Granules Based Bone Graft – Product Status 94

Monetite Granules Based Bone Graft – Product Description 94

Glossary 145

List of Figures

Synthetic Bone Graft Substitutes – Pipeline Products by Stage of Development 13

Synthetic Bone Graft Substitutes – Pipeline Products by Territory 14

Synthetic Bone Graft Substitutes – Pipeline Products by Regulatory Path 15

Synthetic Bone Graft Substitutes – Pipeline Products by Estimated Approval Date 16

Synthetic Bone Graft Substitutes – Ongoing Clinical Trials 17

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