Synthetic Bone Graft Substitutes Pipeline by Stages of Development, Segments, Region, Regulatory Path and Key Companies

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Synthetic Bone Graft Substitutes Pipeline Market Report Overview

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. One unit volume is 10ml of synthetic bone substitutes.

The synthetic bone graft substitutes pipeline market research report provides comprehensive information about the synthetic bone graft substitutes pipeline products with comparative analysis of the products at various stages of development and information about the clinical trials which are in progress.

Key Territories The US, Europe, China, Japan, and Taiwan
Key Regulatory Paths 510(k), PMA, CE, NMPA, TGA, Ninsho, and De Novo
Leading Companies 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, and BonAlive Biomaterials Ltd

Synthetic Bone Graft Substitutes Pipeline Market Segmentation by Territories

Some of the territories in the synthetic bone graft substitutes pipeline market are the US, Europe, China, Japan, and Taiwan among others. As of May 2023, the US has the highest number of pipeline products.

Synthetic Bone Graft Substitutes Pipeline Market Analysis, by Territories, 2023 (%)

Synthetic Bone Graft Substitutes Pipeline Market Analysis, by Territories, 2023 (%)

For more territory insights into the synthetic bone graft substitutes pipeline market, download a free report sample

Synthetic Bone Graft Substitutes Pipeline Market Segmentation by Regulatory Paths

Some of the regulatory paths in the synthetic bone graft substitutes pipeline market are 510(k), PMA, CE, NMPA, TGA, Ninsho, and De Novo among others. As of May 2023, 510(k) is the most followed pathway for pipeline products.

Synthetic Bone Graft Substitutes Pipeline Market Analysis, by Regulatory Paths, 2023 (%)

Synthetic Bone Graft Substitutes Pipeline Market Analysis, by Regulatory Paths, 2023 (%)

For more regulatory path insights into the synthetic bone graft substitutes pipeline market, download a free report sample

Synthetic Bone Graft Substitutes Pipeline Market – Competitive Landscape

Some of the key companies in the synthetic bone graft substitutes pipeline market are 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, and BonAlive Biomaterials Ltd among others.

Acuitive Technologies Inc: Acuitive Technologies Inc (Acuitive Technologies) is a developer of surgical medical devices designed to help in surgeries. It is headquartered in Allendale, New Jersey, the US. Citrefoam is developed by Acuitive Technologies. It is a synthetic porous sponge intended for bone healing. It is designed to fill bone voids of various sizes and promote bone healing. It is based on CITREGEN Technology.

Segments Covered in the Report

Synthetic Bone Graft Substitutes Pipeline Market Territories Outlook

  • The US
  • Europe
  • China
  • Japan
  • Australia
  • Taiwan

Synthetic Bone Graft Substitutes Pipeline Market Regulatory Paths Outlook

  • 510(k)
  • PMA
  • CE
  • NMPA
  • TGA
  • Ninsho
  • De Novo

Scope

  • Extensive coverage of the synthetic bone graft substitutes under development
  • Reviews details of major pipeline products which includes, product description, licensing and collaboration details and other developmental activities
  • Reviews the major players involved in the development of synthetic bone graft substitutes and list all their pipeline projects
  • The coverage of pipeline products based on various stages of development ranging from Early Development to 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 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

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
BonAlive Biomaterials Ltd.
Bone Solutions Inc
BoneGrafix, Inc.
BoneSupport AB
Calcitec, Inc.
Daewoong Pharmaceutical Co Ltd
Dimension Inx LLC
DSM Biomedical BV
Elute Inc
Eskisehir Osmangazi University
EternoGen Aesthetics LLC
Graftys SA
Industrie Biomediche Insubri 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 (Inactive)
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 27

5.5.1 Baxter International Inc Pipeline Products & Ongoing Clinical Trials Overview 27

5.6 Berkeley Advanced Biomaterials Inc Company Overview 28

5.6.1 Berkeley Advanced Biomaterials Inc Pipeline Products & Ongoing Clinical Trials Overview 28

5.7 Bio2 Technologies Inc Company Overview 30

5.7.1 Bio2 Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 30

5.8 BioGend Therapeutics Co Ltd Company Overview 33

5.8.1 BioGend Therapeutics Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 33

5.9 Biomatlante SA Company Overview 38

5.9.1 Biomatlante SA Pipeline Products & Ongoing Clinical Trials Overview 38

5.10 Biorez Inc Company Overview 39

5.10.1 Biorez Inc Pipeline Products & Ongoing Clinical Trials Overview 39

5.11 BonAlive Biomaterials Ltd. Company Overview 40

5.11.1 BonAlive Biomaterials Ltd. Pipeline Products & Ongoing Clinical Trials Overview 40

5.12 Bone Solutions Inc Company Overview 41

5.12.1 Bone Solutions Inc Pipeline Products & Ongoing Clinical Trials Overview 41

5.13 BoneGrafix, Inc. Company Overview 44

5.13.1 BoneGrafix, Inc. Pipeline Products & Ongoing Clinical Trials Overview 44

5.14 BoneSupport AB Company Overview 45

5.14.1 BoneSupport AB Pipeline Products & Ongoing Clinical Trials Overview 45

5.15 Calcitec, Inc. Company Overview 50

5.15.1 Calcitec, Inc. Pipeline Products & Ongoing Clinical Trials Overview 50

5.16 Daewoong Pharmaceutical Co Ltd Company Overview 51

5.16.1 Daewoong Pharmaceutical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 51

5.17 Dimension Inx LLC Company Overview 52

5.17.1 Dimension Inx LLC Pipeline Products & Ongoing Clinical Trials Overview 52

5.18 DSM Biomedical BV Company Overview 53

5.18.1 DSM Biomedical BV Pipeline Products & Ongoing Clinical Trials Overview 53

5.19 Elute Inc Company Overview 54

5.19.1 Elute Inc Pipeline Products & Ongoing Clinical Trials Overview 54

5.20 Eskisehir Osmangazi University Company Overview 55

5.20.1 Eskisehir Osmangazi University Pipeline Products & Ongoing Clinical Trials Overview 55

5.21 EternoGen Aesthetics LLC Company Overview 56

5.21.1 EternoGen Aesthetics LLC Pipeline Products & Ongoing Clinical Trials Overview 56

5.22 Graftys SA Company Overview 57

5.22.1 Graftys SA Pipeline Products & Ongoing Clinical Trials Overview 57

5.23 Industrie Biomediche Insubri SA Company Overview 59

5.23.1 Industrie Biomediche Insubri SA Pipeline Products & Ongoing Clinical Trials Overview 59

5.24 Innovoss Inc. (Inactive) Company Overview 60

5.24.1 Innovoss Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 60

5.25 IRCCS San Raffaele Hospital Company Overview 61

5.25.1 IRCCS San Raffaele Hospital Pipeline Products & Ongoing Clinical Trials Overview 61

5.26 Isto Biologics Company Overview 62

5.26.1 Isto Biologics Pipeline Products & Ongoing Clinical Trials Overview 62

5.27 King’s College London Company Overview 63

5.27.1 King’s College London Pipeline Products & Ongoing Clinical Trials Overview 63

5.28 Maxigen Biotech Inc Company Overview 64

5.28.1 Maxigen Biotech Inc Pipeline Products & Ongoing Clinical Trials Overview 64

5.29 National Center of Innovation for Biomaterials in Orthopaedic Research Company Overview 65

5.29.1 National Center of Innovation for Biomaterials in Orthopaedic Research Pipeline Products & Ongoing Clinical Trials Overview 65

5.30 National University of Science and Technology MiSiS Company Overview 66

5.30.1 National University of Science and Technology MiSiS Pipeline Products & Ongoing Clinical Trials Overview 66

5.31 OrthoMedex LLC Company Overview 67

5.31.1 OrthoMedex LLC Pipeline Products & Ongoing Clinical Trials Overview 67

5.32 PolyPid Ltd Company Overview 68

5.32.1 PolyPid Ltd Pipeline Products & Ongoing Clinical Trials Overview 68

5.33 Polytechnic University of Catalonia Company Overview 69

5.33.1 Polytechnic University of Catalonia Pipeline Products & Ongoing Clinical Trials Overview 69

5.34 Promimic AB Company Overview 70

5.34.1 Promimic AB Pipeline Products & Ongoing Clinical Trials Overview 70

5.35 ReCaPP Company Overview 71

5.35.1 ReCaPP Pipeline Products & Ongoing Clinical Trials Overview 71

5.36 RepRegen Ltd. (Inactive) Company Overview 72

5.36.1 RepRegen Ltd. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 72

5.37 Revivicor Inc Company Overview 74

5.37.1 Revivicor Inc Pipeline Products & Ongoing Clinical Trials Overview 74

5.38 Sanara MedTech Inc Company Overview 75

5.38.1 Sanara MedTech Inc Pipeline Products & Ongoing Clinical Trials Overview 75

5.39 Scil Technology GmbH Company Overview 76

5.39.1 Scil Technology GmbH Pipeline Products & Ongoing Clinical Trials Overview 76

5.40 SDIP Innovations Pty Ltd Company Overview 77

5.40.1 SDIP Innovations Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 77

5.41 SIRAKOSS Ltd Company Overview 78

5.41.1 SIRAKOSS Ltd Pipeline Products & Ongoing Clinical Trials Overview 78

5.42 Sofregen Medical Inc Company Overview 81

5.42.1 Sofregen Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 81

5.43 Soteira Inc Company Overview 83

5.43.1 Soteira Inc Pipeline Products & Ongoing Clinical Trials Overview 83

5.44 Sree Chitra Tirunal Institute for Medical Sciences & Technology Company Overview 84

5.44.1 Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview 84

5.45 SurGenTec LLC Company Overview 85

5.45.1 SurGenTec LLC Pipeline Products & Ongoing Clinical Trials Overview 85

5.46 University of California San Diego Company Overview 86

5.46.1 University of California San Diego Pipeline Products & Ongoing Clinical Trials Overview 86

5.47 University of Edinburgh Company Overview 87

5.47.1 University of Edinburgh Pipeline Products & Ongoing Clinical Trials Overview 87

5.48 Wright Medical Group NV (Inactive) Company Overview 88

5.48.1 Wright Medical Group NV (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 88

5.49 Xtant Medical Holdings Inc Company Overview 89

5.49.1 Xtant Medical Holdings Inc Pipeline Products & Ongoing Clinical Trials Overview 89

6 Synthetic Bone Graft Substitutes- Recent Developments 90

6.1 May 11, 2023: Medtronic to announce financial results for its fourth quarter and full fiscal year 2023 90

6.2 May 08, 2023: Hoya announces consolidated financial results for the fiscal year ended March 31, 2023 90

6.3 May 04, 2023: NuVasive announces conference call and webcast of Q1 2023 results 90

6.4 May 03, 2023: Sanara MedTech announces Q1 earnings release and conference call dates 90

6.5 Apr 19, 2023: Anika to issue first quarter 2023 financial results on Tuesday, may 9, 2023 91

6.6 Apr 12, 2023: Medtronic has a layoff in California 91

6.7 Mar 29, 2023: Baxter to Host Annual Meeting of Stockholders in Virtual Format 91

6.8 Mar 28, 2023: Stryker announces Annual Meeting of Shareholders 91

6.9 Mar 16, 2023: Surgalign to Host its 2023 Annual Meeting of Shareholders on June 1, 2023 91

6.10 Mar 16, 2023: Medtronic joins in $25M funding round for home monitoring company 92

6.11 Mar 06, 2023: Anika Reports Fourth Quarter and Year-End Fiscal 2022 Financial Results 92

6.12 Feb 22, 2023: Sanara MedTech Announces Unaudited Preliminary Results for the Fourth Quarter and Full Year 2022 93

6.13 Feb 21, 2023: Anika to Issue Fourth Quarter and Year-End 2022 Financial Results on Monday, March 6, 2023 94

6.14 Feb 14, 2023: Spineway Reports Full Year 2022 Earnings 94

6.15 Feb 09, 2023: Baxter Reports Fourth-Quarter and Full-Year 2022 Results 95

6.16 Feb 09, 2023: Spineway announces 2022 annual results 97

6.17 Jan 31, 2023: Hoya Announces Fourth semi-annual financial statements 98

6.18 Jan 09, 2023: ATEC Announces Select Preliminary Financial 2022 Results, 2023 Guidance and Closing of Flexible, Non-Dilutive Debt Facility 99

6.19 Nov 23, 2022: Medtronic Reports Quarterly Earnings 101

6.20 Nov 22, 2022: Medtronic reports second quarter fiscal 2023 financial results 101

6.21 Nov 15, 2022: Medtronic Set to Announce Earnings on Tuesday 107

6.22 Nov 10, 2022: Surgalign aims to slash $30M from 2023 spending with planned layoffs 107

6.23 Nov 08, 2022: Anika Reports Third Quarter Fiscal 2022 Financial Results 107

6.24 Nov 07, 2022: NuVasive launches tube system and excavation micro for posterior spine surgery 109

6.25 Oct 25, 2022: Anika to Issue Third Quarter 2022 Financial Results on Tuesday, November 8, 2022 110

6.26 Oct 10, 2022: ATEC Announces Select Preliminary Third Quarter 2022 Financial Results and Raises Guidance 110

6.27 Oct 06, 2022: Integra LifeSciences appoints Harvinder Singh as Executive Vice President, President Of Co.”s International Business 111

6.28 Oct 06, 2022: Integra LifeSciences Announces Key Executive Appointment 111

6.29 Sep 28, 2022: PolyPid announces eligibility for European Medicines Agency centralized procedure for D-PLEX100 for the prevention of surgical site infections in abdominal surgery 111

6.30 Sep 12, 2022: NuVasive to Participate as Double Diamond Sponsor at Scoliosis Research Society Annual Meeting 112

6.31 Sep 07, 2022: Baxter to Host Third-Quarter 2022 Financial Results Conference Call for Investors 112

6.32 Sep 07, 2022: Medtronic to appear at September investor conferences 112

6.33 Sep 06, 2022: Sanara MedTech to Present at the Virtual MicroCap Leadership Summit 113

6.34 Aug 30, 2022: ATEC to Participate in Upcoming Investor Conferences 113

6.35 Aug 23, 2022: Medtronic reports first quarter fiscal 2023 financial results 113

6.36 Aug 23, 2022: Medtronic Announces Quarterly Earnings Results 116

6.37 Aug 16, 2022: Sanara MedTech Announces Second Quarter 2022 Results 119

6.38 Aug 10, 2022: Biogennix Reports Record Quarter and Half-Year Sales 120

6.39 Aug 04, 2022: ATEC Reports Second Quarter 2022 Financial Results and Increases Full-Year Revenue Guidance 120

6.40 Aug 03, 2022: Anika Reports Second Quarter Fiscal 2022 Financial Results 121

6.41 Aug 02, 2022: Zimmer Biomet Announces Second Quarter 2022 Financial Results 124

6.42 Jul 28, 2022: Smith+Nephew Second Quarter and First Half 2022 Results 125

6.43 Jul 28, 2022: Balfour Beatty teams up with Steps to Hope to raise funds for people in need 126

6.44 Jul 26, 2022: ATEC to Participate in Upcoming Investor Conferences 126

6.45 Jul 21, 2022: ATEC to Report Second Quarter 2022 Financial Results on August 4 2022 127

6.46 Jul 12, 2022: Anika to Issue Second Quarter 2022 Financial Results on Wednesday, August 3, 2022 127

6.47 Jun 27, 2022: Medtronic Board appoints Lidia Fonseca as a new director 127

6.48 Jun 10, 2022: Anika to Participate in the Sidoti Small Cap Virtual Investor Conference 128

6.49 Jun 08, 2022: Baxter to Host Second-Quarter 2022 Financial Results Conference Call for Investors 128

6.50 May 27, 2022: Medtronic reports full year and fourth quarter fiscal year 2022 financial results 128

6.51 May 26, 2022: Medtronic reports full year and fourth quarter fiscal year 2022 financial results announces 8% dividend increase 128

6.52 May 25, 2022: Baxter Highlights Business Strategies and Innovation at 2022 Investor Conference 129

6.53 May 25, 2022: ATEC to Host Investor Day, May 25, 2022 129

7 Appendix 130

7.1 Methodology 130

7.2 About GlobalData 133

7.3 Contact Us 133

7.4 Disclaimer 133

Table

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

Hyalograft C Autograft – Product Status 26

Hyalograft C Autograft – Product Description 26

Baxter International Inc Pipeline Products & Ongoing Clinical Trials Overview 27

Synthetic Bone Graft – Spinal – Product Status 27

Synthetic Bone Graft – Spinal – Product Description 27

Berkeley Advanced Biomaterials Inc Pipeline Products & Ongoing Clinical Trials Overview 28

CPA Ceramics – Product Status 28

CPA Ceramics – Product Description 28

HAP Ceramics – Product Status 29

HAP Ceramics – Product Description 29

Bio2 Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 30

Vitrium – Hammertoe Correction – Product Status 30

Vitrium – Hammertoe Correction – Product Description 30

Vitrium – Radial Osteotomy – Product Status 31

Vitrium – Radial Osteotomy – Product Description 31

Vitrium – Wrist Fracture Revision – Product Status 31

Vitrium – Wrist Fracture Revision – Product Description 32

BioGend Therapeutics Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 33

OIF – Non-Union Bone Fracture – Product Status 33

OIF – Non-Union Bone Fracture – Product Description 33

OIF/ß-TCP – Block Form – Product Status 34

OIF/ß-TCP – Block Form – Product Description 34

OIF/ß-TCP – Granular Form – Product Status 34

OIF/ß-TCP – Granular Form – Product Description 35

BioGend Therapeutics Co Ltd – Ongoing Clinical Trials Overview 36

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 37

Biomatlante SA Pipeline Products & Ongoing Clinical Trials Overview 38

Osteoconductive Resorbable Composite – Product Status 38

Osteoconductive Resorbable Composite – Product Description 38

Biorez Inc Pipeline Products & Ongoing Clinical Trials Overview 39

L-C Ligament – Product Status 39

L-C Ligament – Product Description 39

BonAlive Biomaterials Ltd. Pipeline Products & Ongoing Clinical Trials Overview 40

S53P4 BonAlive Granules – Product Status 40

S53P4 BonAlive Granules – Product Description 40

Bone Solutions Inc Pipeline Products & Ongoing Clinical Trials Overview 41

Osteocrete – Bone Anchor – Product Status 41

Osteocrete – Bone Anchor – Product Description 41

OsteoCrete – Cranial – Product Status 42

OsteoCrete – Cranial – Product Description 42

OsteoCrete – Maxillofacial – Product Status 42

OsteoCrete – Maxillofacial – Product Description 43

OsteoCrete – Non Load Bearing Spine – Product Status 43

OsteoCrete – Non Load Bearing Spine – Product Description 43

BoneGrafix, Inc. Pipeline Products & Ongoing Clinical Trials Overview 44

Solid Bone Block – Product Status 44

Solid Bone Block – Product Description 44

BoneSupport AB Pipeline Products & Ongoing Clinical Trials Overview 45

Cerament + Bisphosphonate – Product Status 45

Cerament + Bisphosphonate – Product Description 45

Cerament|G – Product Status 46

Cerament|G – Product Description 46

Gelatin/Cerament – Product Status 46

Gelatin/Cerament – Product Description 47

BoneSupport AB – Ongoing Clinical Trials Overview 48

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 49

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 49

Calcitec, Inc. Pipeline Products & Ongoing Clinical Trials Overview 50

Corticell – Product Status 50

Corticell – Product Description 50

Daewoong Pharmaceutical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 51

Bongros HA – Product Status 51

Bongros HA – Product Description 51

Dimension Inx LLC Pipeline Products & Ongoing Clinical Trials Overview 52

Hyperelastic Bone – Product Status 52

Hyperelastic Bone – Product Description 52

DSM Biomedical BV Pipeline Products & Ongoing Clinical Trials Overview 53

Structural Synthetic Bone Graft – Product Status 53

Structural Synthetic Bone Graft – Product Description 53

Elute Inc Pipeline Products & Ongoing Clinical Trials Overview 54

EP Granules With Tobramycin – Product Status 54

EP Granules With Tobramycin – Product Description 54

Eskisehir Osmangazi University Pipeline Products & Ongoing Clinical Trials Overview 55

Antimicrobial Synthetic Bone Graft – Product Status 55

Antimicrobial Synthetic Bone Graft – Product Description 55

EternoGen Aesthetics LLC Pipeline Products & Ongoing Clinical Trials Overview 56

Collagen Scaffold – Orthopedic Procedures – Product Status 56

Collagen Scaffold – Orthopedic Procedures – Product Description 56

Graftys SA Pipeline Products & Ongoing Clinical Trials Overview 57

GRFT-M04 – Product Status 57

GRFT-M04 – Product Description 57

GRFT-R02 – Product Status 58

GRFT-R02 – Product Description 58

Industrie Biomediche Insubri SA Pipeline Products & Ongoing Clinical Trials Overview 59

SmartBonePep – Product Status 59

SmartBonePep – Product Description 59

Innovoss Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 60

Synthetic Bone Material – Product Status 60

Synthetic Bone Material – Product Description 60

IRCCS San Raffaele Hospital Pipeline Products & Ongoing Clinical Trials Overview 61

Tissue Repair Composite Scaffold – Product Status 61

Tissue Repair Composite Scaffold – Product Description 61

Isto Biologics Pipeline Products & Ongoing Clinical Trials Overview 62

InQu Bone Graft Extender And Substitute – Chondral Defects – Product Status 62

InQu Bone Graft Extender And Substitute – Chondral Defects – Product Description 62

King’s College London Pipeline Products & Ongoing Clinical Trials Overview 63

Synthetic Bone Composite – Product Status 63

Synthetic Bone Composite – Product Description 63

Maxigen Biotech Inc Pipeline Products & Ongoing Clinical Trials Overview 64

MaxiSetin – Product Status 64

MaxiSetin – Product Description 64

National Center of Innovation for Biomaterials in Orthopaedic Research Pipeline Products & Ongoing Clinical Trials Overview 65

Composite Bone Graft Substitute – Product Status 65

Composite Bone Graft Substitute – Product Description 65

National University of Science and Technology MiSiS Pipeline Products & Ongoing Clinical Trials Overview 66

Hybrid Bone Implant – Product Status 66

Hybrid Bone Implant – Product Description 66

OrthoMedex LLC Pipeline Products & Ongoing Clinical Trials Overview 67

Cancellous Bone Allograft – Product Status 67

Cancellous Bone Allograft – Product Description 67

PolyPid Ltd Pipeline Products & Ongoing Clinical Trials Overview 68

D-Plex1000 – Product Status 68

D-Plex1000 – Product Description 68

Polytechnic University of Catalonia Pipeline Products & Ongoing Clinical Trials Overview 69

Bone Regeneration Foam – Product Status 69

Bone Regeneration Foam – Product Description 69

Promimic AB Pipeline Products & Ongoing Clinical Trials Overview 70

HAnano Bone – Product Status 70

HAnano Bone – Product Description 70

ReCaPP Pipeline Products & Ongoing Clinical Trials Overview 71

ReCapp Putty – Product Status 71

ReCapp Putty – Product Description 71

RepRegen Ltd. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 72

Bone Graft Substitute – Load Bearing – Product Status 72

Bone Graft Substitute – Load Bearing – Product Description 72

StronBone-P – Product Status 73

StronBone-P – Product Description 73

Revivicor Inc Pipeline Products & Ongoing Clinical Trials Overview 74

Tendon – ACL Repair – Product Status 74

Tendon – ACL Repair – Product Description 74

Sanara MedTech Inc Pipeline Products & Ongoing Clinical Trials Overview 75

Bone Void Filler – Product Status 75

Bone Void Filler – Product Description 75

Scil Technology GmbH Pipeline Products & Ongoing Clinical Trials Overview 76

ST01 Bone Graft Substitute Material – Product Status 76

ST01 Bone Graft Substitute Material – Product Description 76

SDIP Innovations Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 77

JAZBI – Product Status 77

JAZBI – Product Description 77

SIRAKOSS Ltd Pipeline Products & Ongoing Clinical Trials Overview 78

MaxSi Graft Granules – Product Status 78

MaxSi Graft Granules – Product Description 78

MaxSi Graft Putty – Product Status 79

MaxSi Graft Putty – Product Description 79

Osteo3 ZP Putty – Product Status 79

Osteo3 ZP Putty – Product Description 80

Sofregen Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 81

SeriACL Scaffold – Product Status 81

SeriACL Scaffold – Product Description 81

SeriCuff Scaffold – Product Status 82

SeriCuff Scaffold – Product Description 82

Soteira Inc Pipeline Products & Ongoing Clinical Trials Overview 83

Nanotechnology Bone Biomaterial – Spinal Repair – Product Status 83

Nanotechnology Bone Biomaterial – Spinal Repair – Product Description 83

Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview 84

Bioceramic Cage – Product Status 84

Bioceramic Cage – Product Description 84

SurGenTec LLC Pipeline Products & Ongoing Clinical Trials Overview 85

OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft – Product Status 85

OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft – Product Description 85

University of California San Diego Pipeline Products & Ongoing Clinical Trials Overview 86

Synthetic Bone Graft – Product Status 86

Synthetic Bone Graft – Product Description 86

University of Edinburgh Pipeline Products & Ongoing Clinical Trials Overview 87

Shapeable Foam – Bone Repair – Product Status 87

Shapeable Foam – Bone Repair – Product Description 87

Wright Medical Group NV (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 88

Augment Rotator Cuff Graft – Product Status 88

Augment Rotator Cuff Graft – Product Description 88

Xtant Medical Holdings Inc Pipeline Products & Ongoing Clinical Trials Overview 89

Monetite Granules Based Bone Graft – Product Status 89

Monetite Granules Based Bone Graft – Product Description 89

Glossary 132

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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