Vascular Access Devices for Hemodialysis Pipeline by Stages of Development, Segments, Region, Regulatory Path and Key Companies

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Vascular Access Devices for Hemodialysis Pipeline Market Report Overview

Vascular Access Devices for Hemodialysis include AV Fistula Needles, Grafts, Vascular Covered Stents, and Hemodialysis Catheters. The Vascular Access Devices for Hemodialysis pipeline market research report provides comprehensive information about the Vascular Access Devices for Hemodialysis pipeline products with a comparative analysis of the products at various stages of development and information about the clinical trials that are in progress.

Key Territories ·        The US

·        China

·        Europe

·        Global

·        Australia

Key Segments ·        Grafts

·        Hemodialysis Catheters

·        AV Fistula Needles

Key Regulatory Paths ·        510(k)

·        NMPA

·        ICAC

·        TGA

·        Ninsho

Leading Companies ·        Access Vascular Inc

·        Advent Access Pte Ltd

·        AngioDynamics Inc

·        Angiotech Pharmaceuticals Inc

·        Ariste Medical LLC

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Vascular Access Devices for Hemodialysis Pipeline Market Segmentation by Segments

Some of the key segments in the Vascular Access Devices for Hemodialysis market are Grafts, Hemodialysis Catheters, and AV Fistula Needles. As of November 2023, Grafts has the highest number of pipeline products.

Grafts are strong artificial tubes inserted by surgeons underneath the skin of a patient’s forearm, upper arm, or thigh. One end of the tube connects to one of the arteries, and the other end connects to one of the veins (in the same limb). The graft may be straight or in the shape of a horseshoe.

Vascular Access Devices for Hemodialysis Pipeline Market Analysis by Segments, 2023 (%)

Vascular Access Devices for Hemodialysis Pipeline Market Analysis by Segments, 2023 (%)

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Vascular Access Devices for Hemodialysis Pipeline Market Segmentation by Territories

Some of the key territories in the Vascular Access Devices for Hemodialysis market are the US, China, Europe, Global, and Australia among others. As of November 2023, the US has the highest number of pipeline products.

Vascular Access Devices for Hemodialysis Pipeline Market Analysis by Territories, 2023 (%)

Vascular Access Devices for Hemodialysis Pipeline Market Analysis by Territories, 2023 (%)

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Vascular Access Devices for Hemodialysis Pipeline Market Segmentation by Regulatory Paths

Some of the key regulatory paths in the Vascular Access Devices for Hemodialysis pipeline market are 510(k), NMPA, ICAC, TGA, and Ninsho among others. As of November 2023, 510(k) is the most followed pathway for pipeline products in the market.

Vascular Access Devices for Hemodialysis Pipeline Market Analysis by Regulatory Paths, 2023 (%)

Vascular Access Devices for Hemodialysis Pipeline Market Analysis by Regulatory Paths, 2023 (%)

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Vascular Access Devices for Hemodialysis Pipeline Market – Competitive Landscape

Some of the key companies in the Vascular Access Devices for Hemodialysis pipeline market are:

  • Access Vascular Inc
  • Advent Access Pte Ltd
  • AngioDynamics Inc
  • Angiotech Pharmaceuticals Inc
  • Ariste Medical LLC

AngioDynamics Inc (AngioDynamics): It designs, manufactures, and markets minimal invasive and image-guided therapeutics and diagnostic devices. Its product portfolio encompasses vascular products, radiofrequency ablation and NanoKnife systems, vascular access products, angiographic products and accessories, and products for dialysis, angioplasty, drainage, thrombolysis, and embolization, besides venous products and renal therapy products. The company’s products find application in interventional radiology, interventional cardiology, and minimally invasive diagnosis and treatment of cancer and peripheral vascular disease. It sells its products through a direct sales force in the US and through a network of distributors outside the US, which include Europe, Asia, Latin America, and others. AngioDynamics is headquartered in Latham, New York, the US.

Vascular Access Devices for Hemodialysis Pipeline Market Analysis by Companies, 2023

Vascular Access Devices for Hemodialysis Pipeline Market Analysis by Companies, 2023

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Segments Covered in the Report

Vascular Access Devices for Hemodialysis Pipeline Market Segments Outlook

  • Grafts
  • Hemodialysis Catheters
  • AV Fistula Needles

Vascular Access Devices for Hemodialysis Pipeline Market Territories Outlook

  • The US
  • China
  • Europe
  • Global
  • Australia

Vascular Access Devices for Hemodialysis Pipeline Market Regulatory Paths Outlook

  • 510(k)
  • NMPA
  • ICAC
  • TGA
  • Ninsho

Scope

This report provides:

  • Extensive coverage of the Vascular Access Devices for Hemodialysis under development.
  • Review details of major pipeline products which include product description, licensing and collaboration details, and other developmental activities.
  • Reviews of major players involved in pipeline product development and lists all their pipeline projects.
  • Coverage of pipeline products based on various stages of development ranging from early development to approved/issued stage.
  • Provides key clinical trial data related to ongoing clinical 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 Vascular Access Devices for Hemodialysis 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.

Access Vascular Inc
Advent Access Pte Ltd
AngioDynamics Inc
Angiotech Pharmaceuticals Inc
Ariste Medical LLC
Ash Access Technology Inc
Biosurfaces Inc
Bioteque Corp
Chrysalis Medical Inc
Columbia University
CR Bard Inc
FreeFlow Medical Devices LLC
Healionics Corporation
Humacyte Inc
InnAVasc Medical Inc
Laminate Medical Technologies Ltd
Marvao Medical Devices Ltd
NanoVasc, Inc.
Nicast Ltd
Northwestern University
Oxford Biomaterials Ltd
Phase One Medical LLC
Phraxis, Inc.
RegenMedTX LLC
Silmag SA
TEI Biosciences Inc
University of Arizona
University of California
University of Colorado
University of Limerick
Vascoscope BV
Vascudyne Inc
Vascular Genesis
Xeltis AG

Table of Contents

1 Table of Contents 3

1.1 List of Tables 6

1.2 List of Figures 9

2 Introduction 10

2.1 Vascular Access Devices for Hemodialysis Overview 10

3 Products under Development 11

3.1 Vascular Access Devices for Hemodialysis – Pipeline Products by Stage of Development 11

3.2 Vascular Access Devices for Hemodialysis – Pipeline Products by Segment 12

3.3 Vascular Access Devices for Hemodialysis – Pipeline Products by Territory 13

3.4 Vascular Access Devices for Hemodialysis – Pipeline Products by Regulatory Path 14

3.5 Vascular Access Devices for Hemodialysis – Pipeline Products by Estimated Approval Date 15

3.6 Vascular Access Devices for Hemodialysis – Ongoing Clinical Trials 16

4 Vascular Access Devices for Hemodialysis – Pipeline Products under Development by Companies 17

4.1 Vascular Access Devices for Hemodialysis Companies – Pipeline Products by Stage of Development 17

4.2 Vascular Access Devices for Hemodialysis – Pipeline Products by Stage of Development 19

5 Vascular Access Devices for Hemodialysis Companies and Product Overview 20

5.1 Access Vascular Inc Company Overview 20

5.1.1 Access Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 20

5.2 Advent Access Pte Ltd Company Overview 21

5.2.1 Advent Access Pte Ltd Pipeline Products & Ongoing Clinical Trials Overview 21

5.3 AngioDynamics Inc Company Overview 22

5.3.1 AngioDynamics Inc Pipeline Products & Ongoing Clinical Trials Overview 22

5.4 Angiotech Pharmaceuticals Inc Company Overview 23

5.4.1 Angiotech Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 23

5.5 Ariste Medical LLC Company Overview 24

5.5.1 Ariste Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 24

5.6 Ash Access Technology Inc Company Overview 25

5.6.1 Ash Access Technology Inc Pipeline Products & Ongoing Clinical Trials Overview 25

5.7 Biosurfaces Inc Company Overview 26

5.7.1 Biosurfaces Inc Pipeline Products & Ongoing Clinical Trials Overview 26

5.8 Bioteque Corp Company Overview 27

5.8.1 Bioteque Corp Pipeline Products & Ongoing Clinical Trials Overview 27

5.9 Chrysalis Medical Inc Company Overview 28

5.9.1 Chrysalis Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 28

5.10 Columbia University Company Overview 29

5.10.1 Columbia University Pipeline Products & Ongoing Clinical Trials Overview 29

5.11 CR Bard Inc Company Overview 30

5.11.1 CR Bard Inc Pipeline Products & Ongoing Clinical Trials Overview 30

5.12 FreeFlow Medical Devices LLC Company Overview 31

5.12.1 FreeFlow Medical Devices LLC Pipeline Products & Ongoing Clinical Trials Overview 31

5.13 Healionics Corporation Company Overview 32

5.13.1 Healionics Corporation Pipeline Products & Ongoing Clinical Trials Overview 32

5.14 Humacyte Inc Company Overview 33

5.14.1 Humacyte Inc Pipeline Products & Ongoing Clinical Trials Overview 33

5.15 InnAVasc Medical Inc Company Overview 38

5.15.1 InnAVasc Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 38

5.16 Laminate Medical Technologies Ltd Company Overview 41

5.16.1 Laminate Medical Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 41

5.17 Marvao Medical Devices Ltd Company Overview 46

5.17.1 Marvao Medical Devices Ltd Pipeline Products & Ongoing Clinical Trials Overview 46

5.18 NanoVasc, Inc. Company Overview 47

5.18.1 NanoVasc, Inc. Pipeline Products & Ongoing Clinical Trials Overview 47

5.19 Nicast Ltd Company Overview 48

5.19.1 Nicast Ltd Pipeline Products & Ongoing Clinical Trials Overview 48

5.20 Northwestern University Company Overview 49

5.20.1 Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 49

5.21 Oxford Biomaterials Ltd Company Overview 50

5.21.1 Oxford Biomaterials Ltd Pipeline Products & Ongoing Clinical Trials Overview 50

5.22 Phase One Medical LLC Company Overview 51

5.22.1 Phase One Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 51

5.23 Phraxis, Inc. Company Overview 53

5.23.1 Phraxis, Inc. Pipeline Products & Ongoing Clinical Trials Overview 53

5.24 RegenMedTX LLC Company Overview 54

5.24.1 RegenMedTX LLC Pipeline Products & Ongoing Clinical Trials Overview 54

5.25 Silmag SA Company Overview 55

5.25.1 Silmag SA Pipeline Products & Ongoing Clinical Trials Overview 55

5.26 TEI Biosciences Inc Company Overview 56

5.26.1 TEI Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 56

5.27 University of Arizona Company Overview 57

5.27.1 University of Arizona Pipeline Products & Ongoing Clinical Trials Overview 57

5.28 University of California Company Overview 58

5.28.1 University of California Pipeline Products & Ongoing Clinical Trials Overview 58

5.29 University of Colorado Company Overview 59

5.29.1 University of Colorado Pipeline Products & Ongoing Clinical Trials Overview 59

5.30 University of Limerick Company Overview 60

5.30.1 University of Limerick Pipeline Products & Ongoing Clinical Trials Overview 60

5.31 Vascoscope BV Company Overview 61

5.31.1 Vascoscope BV Pipeline Products & Ongoing Clinical Trials Overview 61

5.32 Vascudyne Inc Company Overview 62

5.32.1 Vascudyne Inc Pipeline Products & Ongoing Clinical Trials Overview 62

5.33 Vascular Genesis Company Overview 65

5.33.1 Vascular Genesis Pipeline Products & Ongoing Clinical Trials Overview 65

5.34 Xeltis AG Company Overview 66

5.34.1 Xeltis AG Pipeline Products & Ongoing Clinical Trials Overview 66

6 Vascular Access Devices for Hemodialysis- Recent Developments 69

6.1 Nov 05, 2023: Teleflex Reports Third Quarter Financial Results, Full Year 2023 Outlook 69

6.2 Nov 01, 2023: Fresenius Medical Care Continues to Execute on Turnaround Plan and Raises 2023 Earnings Outlook Due to Strong Operational Performance in First Nine Months and Solid Business Outlook for The Fourth Quarter 69

6.3 Oct 04, 2023: Medtronic Names Paolo Di Vincenzo President of the Neuromodulation Business 74

6.4 Oct 03, 2023: Baxter Appoints Joel Grade Chief Financial Officer 74

6.5 Sep 29, 2023: Barry Slowey Named Vice President and Chief Sustainability Officer 75

6.6 Sep 19, 2023: Baxter to Host Third-Quarter 2023 Financial Results Conference Call for Investors 75

6.7 Sep 15, 2023: Amber Beauchamp Named Vice President of Global Human Resources 75

6.8 Sep 07, 2023: Rockwell Medical to Present at the H.C. Wainwright 25th Annual Global Investment Conference on Tuesday, September 12, 2023 76

6.9 Aug 26, 2023: Medtronic Q2 2024 Earnings Estimates Increased by William Blair 76

6.10 Aug 14, 2023: Rockwell Medical Announces Second Quarter 2023 Results 76

6.11 Aug 08, 2023: Medtronic to Announce Financial Results for its First Quarter of Fiscal Year 2024 78

6.12 Aug 03, 2023: Teleflex Reports Second Quarter Financial Results and Full Year 2023 Outlook 78

6.13 May 11, 2023: Medtronic to announce financial results for its fourth quarter and full fiscal year 2023 81

6.14 May 04, 2023: Teleflex reports first quarter financial results and full year 2023 outlook 82

6.15 Apr 26, 2023: Merit Medical reports results for first quarter March 31, 2023 83

6.16 Apr 20, 2023: Teleflex announces first quarter 2023 earnings conference call information 84

6.17 Apr 12, 2023: Medtronic has a layoff in California 84

6.18 Apr 06, 2023: Merit Medical Systems to Announce First Quarter 2023 Results on April 26, 2023 84

6.19 Mar 29, 2023: Baxter to Host Annual Meeting of Stockholders in Virtual Format 84

6.20 Mar 16, 2023: Medtronic joins in $25M funding round for home monitoring company 84

6.21 Feb 23, 2023: Teleflex Reports Fourth Quarter and Full Year 2022 Financial Results 85

6.22 Feb 21, 2023: Teleflex to Present at the 44th Annual Raymond James Institutional Investors Conference 89

6.23 Feb 09, 2023: Teleflex Announces Fourth Quarter 2022 Earnings Conference Call Information 89

6.24 Feb 09, 2023: Baxter Reports Fourth-Quarter and Full-Year 2022 Results 89

6.25 Feb 07, 2023: JMS Co Announces Financial Results for the 3rd Quarter of FYE March 2023 92

6.26 Feb 03, 2023: Merit Medical Systems to Announce Fourth Quarter and Year End 2022 Results and Issue Fiscal Year 2023 Guidance on February 22, 2023 93

6.27 Dec 13, 2022: Rockwell Medical Begins Selling its Hemodialysis Concentrates Products to New Clinics in Minnesota with its Largest Customer 93

6.28 Dec 07, 2022: Cook Medical welcomes Dr. John A. Kaufman as Chief Medical Officer 94

6.29 Nov 23, 2022: Medtronic Reports Quarterly Earnings 94

6.30 Nov 22, 2022: Medtronic reports second quarter fiscal 2023 financial results 94

7 Appendix 101

7.1 Methodology 101

7.2 About GlobalData 104

7.3 Contact Us 104

7.4 Disclaimer 104

Table

Vascular Access Devices for Hemodialysis – Pipeline Products by Stage of Development 11

Vascular Access Devices for Hemodialysis – Pipeline Products by Segment 12

Vascular Access Devices for Hemodialysis – Pipeline Products by Territory 13

Vascular Access Devices for Hemodialysis – Pipeline Products by Regulatory Path 14

Vascular Access Devices for Hemodialysis – Pipeline Products by Estimated Approval Date 15

Vascular Access Devices for Hemodialysis – Ongoing Clinical Trials 16

Vascular Access Devices for Hemodialysis Companies – Pipeline Products by Stage of Development 17

Vascular Access Devices for Hemodialysis – Pipeline Products by Stage of Development 19

Access Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 20

Dialysis Catheter – Product Status 20

Dialysis Catheter – Product Description 20

Advent Access Pte Ltd Pipeline Products & Ongoing Clinical Trials Overview 21

av-Guardian – Product Status 21

av-Guardian – Product Description 21

AngioDynamics Inc Pipeline Products & Ongoing Clinical Trials Overview 22

Acuswift – Product Status 22

Acuswift – Product Description 22

Angiotech Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 23

5-FU Anti-Infective HemoStream Dialysis Catheter – Product Status 23

5-FU Anti-Infective HemoStream Dialysis Catheter – Product Description 23

Ariste Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 24

Drug Eluting Tunneled Dialysis Catheter – Product Status 24

Drug Eluting Tunneled Dialysis Catheter – Product Description 24

Ash Access Technology Inc Pipeline Products & Ongoing Clinical Trials Overview 25

SureFlow – Product Status 25

SureFlow – Product Description 25

Biosurfaces Inc Pipeline Products & Ongoing Clinical Trials Overview 26

NuSpun Vascular Graft – Product Status 26

NuSpun Vascular Graft – Product Description 26

Bioteque Corp Pipeline Products & Ongoing Clinical Trials Overview 27

Fold-Proof Dialysis Catheter – Product Status 27

Fold-Proof Dialysis Catheter – Product Description 27

Chrysalis Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 28

Hemodialysis Catheter – Product Status 28

Hemodialysis Catheter – Product Description 28

Columbia University Pipeline Products & Ongoing Clinical Trials Overview 29

Hemodialysis Access Flow Restrictor Device – Product Status 29

Hemodialysis Access Flow Restrictor Device – Product Description 29

CR Bard Inc Pipeline Products & Ongoing Clinical Trials Overview 30

Glidepath LE – Product Status 30

Glidepath LE – Product Description 30

FreeFlow Medical Devices LLC Pipeline Products & Ongoing Clinical Trials Overview 31

TLP Coated Hemodialysis Catheter – Product Status 31

TLP Coated Hemodialysis Catheter – Product Description 31

Healionics Corporation Pipeline Products & Ongoing Clinical Trials Overview 32

STARgraft AV+ – Product Status 32

STARgraft AV+ – Product Description 32

Humacyte Inc Pipeline Products & Ongoing Clinical Trials Overview 33

Humacyl Graft – End Stage Renal Disease – Product Status 33

Humacyl Graft – End Stage Renal Disease – Product Description 33

HumaGraft – Product Status 34

HumaGraft – Product Description 34

Humacyte Inc – Ongoing Clinical Trials Overview 35

HumaGraft – A Phase II Assessment of Humacyte’s Human Acellular Vessel in Patients Needing Vascular Access for Dialysis 36

HumaGraft – A Pilot Study for Evaluation of the Safety and Efficacy of Humacyte’s Human Acellular Vascular Graft as an Above-knee Femoro-popliteal Bypass Graft in Patients with Peripheral Arterial Disease 36

HumaGraft – A Pilot Study for Evaluation of the Safety and Efficacy of Humacyte’s Human Acellular Vascular Graft for Use as a Vascular Prosthesis for Hemodialysis Access in Patients with End-stage Renal Disease 36

Humacyl Graft – End Stage Renal Disease – A Phase 3 Study to Compare the Efficacy and Safety of Humacyte’s Human Acellular Vessel with that of an Autologous Arteriovenous Fistula in Subjects with End Stage Renal Disease 37

Humacyl Graft – End Stage Renal Disease – An Assessment of Humacyte’s Human Acellular Vessel in Patients Needing Renal Replacement Therapy: A Comparison with ePTFE Grafts as Conduits for Hemodialysis: HUMANITY 37

Humacyl Graft – End Stage Renal Disease – Individual Patient Expanded Access for Human Acellular Vessel (HAV) 37

InnAVasc Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 38

InnAVasc Arteriovenous Graft Surgical Implant – Product Status 38

InnAVasc Arteriovenous Graft Surgical Implant – Product Description 38

InnAVasc Medical Inc – Ongoing Clinical Trials Overview 39

InnAVasc Arteriovenous Graft Surgical Implant – A Study to Evaluate the Safety and Effectiveness of the Innavasc Arteriovenous Graft for Hemodialysis Access in Patients with End-stage Renal Disease 40

Laminate Medical Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 41

VasQ – Product Status 42

VasQ – Product Description 43

Laminate Medical Technologies Ltd – Ongoing Clinical Trials Overview 44

VasQ – Impact of VasQ External Support Device in Maturation and Utilization of Radiocephalic Arteriovenous Fistulas: A Randomized Study 45

Marvao Medical Devices Ltd Pipeline Products & Ongoing Clinical Trials Overview 46

NexSite Hemodialysis Catheter – Product Status 46

NexSite Hemodialysis Catheter – Product Description 46

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

NanoVasc Polyurethane Graft – Product Status 47

NanoVasc Polyurethane Graft – Product Description 47

Nicast Ltd Pipeline Products & Ongoing Clinical Trials Overview 48

Improved Version Of The AVflo Vascular Access Graft – Product Status 48

Improved Version Of The AVflo Vascular Access Graft – Product Description 48

Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 49

Hemodialysis Needle – Product Status 49

Hemodialysis Needle – Product Description 49

Oxford Biomaterials Ltd Pipeline Products & Ongoing Clinical Trials Overview 50

SpiderGraft – Product Status 50

SpiderGraft – Product Description 50

Phase One Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 51

Goldilocks Valved Hemodialysis Catheter – Product Status 51

Goldilocks Valved Hemodialysis Catheter – Product Description 51

Reversus Hemodialysis Catheter – Product Status 52

Reversus Hemodialysis Catheter – Product Description 52

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

Phraxis InterGraft – Product Status 53

Phraxis InterGraft – Product Description 53

RegenMedTX LLC Pipeline Products & Ongoing Clinical Trials Overview 54

Neo-Vessel Replacement – Vascular Access Graft – Product Status 54

Neo-Vessel Replacement – Vascular Access Graft – Product Description 54

Silmag SA Pipeline Products & Ongoing Clinical Trials Overview 55

Silicone Hemodialysis Catheter Kit – Product Status 55

Silicone Hemodialysis Catheter Kit – Product Description 55

TEI Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 56

Biologic Vascular Graft – Product Status 56

Biologic Vascular Graft – Product Description 56

University of Arizona Pipeline Products & Ongoing Clinical Trials Overview 57

Percutaneous Vascular Anastomosis Device – Dialysis – Product Status 57

Percutaneous Vascular Anastomosis Device – Dialysis – Product Description 57

University of California Pipeline Products & Ongoing Clinical Trials Overview 58

Smart Dialysis Catheter – Product Status 58

Smart Dialysis Catheter – Product Description 58

University of Colorado Pipeline Products & Ongoing Clinical Trials Overview 59

Nanocomposite Material Vascular Graft – Product Status 59

Nanocomposite Material Vascular Graft – Product Description 59

University of Limerick Pipeline Products & Ongoing Clinical Trials Overview 60

Prolong AV Graft – Product Status 60

Prolong AV Graft – Product Description 60

Vascoscope BV Pipeline Products & Ongoing Clinical Trials Overview 61

Vascoscope – Hemodialysis – Product Status 61

Vascoscope – Hemodialysis – Product Description 61

Vascudyne Inc Pipeline Products & Ongoing Clinical Trials Overview 62

TRUE Vascular Graft – Hemodialysis – Product Status 62

TRUE Vascular Graft – Hemodialysis – Product Description 62

Vascudyne Inc – Ongoing Clinical Trials Overview 63

TRUE Vascular Graft – Hemodialysis – Initial Safety Study of the TRUE AVC in Hemodialysis Access (TRUE AVC I Study) 64

Vascular Genesis Pipeline Products & Ongoing Clinical Trials Overview 65

The Vascular Genesis AVs – Product Status 65

The Vascular Genesis AVs – Product Description 65

Xeltis AG Pipeline Products & Ongoing Clinical Trials Overview 66

Xeltis Hemodialysis Vascular Access Graft – Product Status 66

Xeltis Hemodialysis Vascular Access Graft – Product Description 66

Xeltis AG – Ongoing Clinical Trials Overview 67

Xeltis Hemodialysis Vascular Access Graft – First-in-Human (FIH) Study of the Xeltis Hemodialysis Access Graft (aXess) 68

Xeltis Hemodialysis Vascular Access Graft – Prospective, Non-randomized Pivotal Clinical Study to Assess the Safety and Performance of the Xeltis Hemodialysis Access Graft: aXess Pivotal Study 68

Glossary 103

Figures

Vascular Access Devices for Hemodialysis – Pipeline Products by Stage of Development 10_x000D_

Vascular Access Devices for Hemodialysis – Pipeline Products by Segment 11_x000D_

Vascular Access Devices for Hemodialysis – Pipeline Products by Territory 12_x000D_

Vascular Access Devices for Hemodialysis – Pipeline Products by Regulatory Path 13_x000D_

Vascular Access Devices for Hemodialysis – Pipeline Products by Estimated Approval Date 14_x000D_

Vascular Access Devices for Hemodialysis – Ongoing Clinical Trials 15_x000D_

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