Dialysis Accessories Pipeline Report including Stages of Development, Segments, Region and Countries, Regulatory Path and Key Companies,2022 Update

Pages: 117 Published: May 13, 2022 Report Code: GDME1356EPD

Dialysis accessories are the accessories that are used along with the machines in renal dialysis procedures. GlobalData's Medical Devices sector report, “Dialysis Accessories Pipeline Report including Stages of Development, Segments, Region and Countries, Regulatory Path and Key Companies, 2022 Update" provides comprehensive information about the Dialysis Accessories pipeline products with comparative analysis of the products at various stages of development and information about the clinical trials which are in progress.

The Dialysis Accessories report provides key information and data related to:

Extensive coverage of the Dialysis Accessories under development

Review details of major pipeline products which include product description, licensing and collaboration details and other developmental activities including pipeline territories, regulatory paths, and estimated approval dates

Reviews of major players involved in the pipeline product development.

Provides key clinical trial data related to ongoing clinical trials such as trial phase, trial status, trial start and end dates, and the number of trials of the major Dialysis Accessories pipeline products.

Review of Recent Developments in the segment / industry

The Dialysis Accessories report enables you to:

Access significant competitor information, analysis, and insights to improve your 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 Dialysis Accessories under development

Formulate market-entry and market expansion strategies

Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline

Note: Certain sections in the report may be removed or altered based on the availability and relevance of data in relation to the equipment type.

The GlobalData Differentiation

This report is prepared using data sourced from in-house databases, secondary and primary research by GlobalData's team of industry experts.

The data and analysis within this report are driven by GlobalData Medical Intelligence Center (GDMIC) database. GDMIC gives you the key information required to drive sales, investment and deal-making activity in your business. It includes the following:

• 15,000+ data tables showing market size across more than 780 medical equipment segments and 39 countries, from 2015 and forecast to 2025

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• 1,200+ companies’ revenue splits and market shares

• 1,600+ quarterly and annual medical equipment company financials

• 850+ medical equipment company SWOTs

• 28,000+ pipeline product profiles

• 56,400+ marketed product profiles

• 47,000+ clinical trials

• 41,500+ trial investigators

• 7,000+ reports on companies with products in development

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Contact us to discuss the areas of your business where you need external input, and we will work with you to identify the strongest way forward to meet your needs.

Scope

– Extensive coverage of the Dialysis Accessories under development

– The report reviews details of major pipeline products which includes, product description, licensing and collaboration details and other developmental activities

– The report reviews the major players involved in the development of Dialysis Accessories 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 Dialysis Accessories 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

  • Access Vascular Inc

    Ash Access Technology Inc

    Baxter International Inc

    Brookhaven Medical Inc

    CatheNect Medical

    Cerovations LLC

    Diavantis

    Eqalix

  • Inc.

    ExThera Medical Corp

    Fistulink Ltd.

    Fresenius Medical Care AG & Co KGaA

    Gambro Dialysatoren GmbH

    Georgia Institute of Technology

    Glomeria Therapeutics srl

    Healionics Corporation

    Indian Institute of Technology Bombay

    Innovative BioTherapies Inc

    Katharos

  • Inc.

    Laminate Medical Technologies Ltd

    Nikkiso Co Ltd

    Nipro Corp

    Northwestern University

    Novaflux Technologies

    NuVascular Technologies Inc

    Pursuit Vascular

  • Inc

    Rajamadhangi Medical Technologies Pvt Ltd

    Redsense Medical AB

    Renal Solutions Inc

    SeaStar Medical

    Silmag SA

    Simergent LLC

    Specialty Renal Products Inc

    University of California San Francisco

    University of Michigan

    University of Rochester

    University of Vermont

    Vital Access Corp

    Voyager Biomedical Inc

Table of Contents

1 Table of Contents

2 Introduction 11

2.1 Dialysis Accessories Overview 11

3 Products under Development 12

3.1 Dialysis Accessories – Pipeline Products by Stage of Development 12

3.2 Dialysis Accessories – Pipeline Products by Segment 13

3.3 Dialysis Accessories – Pipeline Products by Territory 14

3.4 Dialysis Accessories – Pipeline Products by Regulatory Path 15

3.5 Dialysis Accessories – Pipeline Products by Estimated Approval Date 16

3.6 Dialysis Accessories – Ongoing Clinical Trials 17

4 Dialysis Accessories – Pipeline Products under Development by Companies 18

4.1 Dialysis Accessories Companies – Pipeline Products by Stage of Development 18

4.2 Dialysis Accessories – Pipeline Products by Stage of Development 20

5 Dialysis Accessories Companies and Product Overview 22

5.1 Access Vascular Inc Company Overview 22

5.1.1 Access Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 22

5.2 Ash Access Technology Inc Company Overview 23

5.2.1 Ash Access Technology Inc Pipeline Products & Ongoing Clinical Trials Overview 23

5.3 Baxter International Inc Company Overview 24

5.3.1 Baxter International Inc Pipeline Products & Ongoing Clinical Trials Overview 24

5.4 Brookhaven Medical Inc Company Overview 33

5.4.1 Brookhaven Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 33

5.5 CatheNect Medical Company Overview 34

5.5.1 CatheNect Medical Pipeline Products & Ongoing Clinical Trials Overview 34

5.6 Cerovations LLC Company Overview 35

5.6.1 Cerovations LLC Pipeline Products & Ongoing Clinical Trials Overview 35

5.7 Diavantis Company Overview 36

5.7.1 Diavantis Pipeline Products & Ongoing Clinical Trials Overview 36

5.8 Eqalix, Inc. Company Overview 39

5.8.1 Eqalix, Inc. Pipeline Products & Ongoing Clinical Trials Overview 39

5.9 ExThera Medical Corp Company Overview 40

5.9.1 ExThera Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 40

5.10 Fistulink Ltd. Company Overview 41

5.10.1 Fistulink Ltd. Pipeline Products & Ongoing Clinical Trials Overview 41

5.11 Fresenius Medical Care AG & Co KGaA Company Overview 42

5.11.1 Fresenius Medical Care AG & Co KGaA Pipeline Products & Ongoing Clinical Trials Overview 42

5.12 Gambro Dialysatoren GmbH Company Overview 45

5.12.1 Gambro Dialysatoren GmbH Pipeline Products & Ongoing Clinical Trials Overview 45

5.13 Georgia Institute of Technology Company Overview 51

5.13.1 Georgia Institute of Technology Pipeline Products & Ongoing Clinical Trials Overview 51

5.14 Glomeria Therapeutics srl Company Overview 52

5.14.1 Glomeria Therapeutics srl Pipeline Products & Ongoing Clinical Trials Overview 52

5.15 Healionics Corporation Company Overview 53

5.15.1 Healionics Corporation Pipeline Products & Ongoing Clinical Trials Overview 53

5.16 Indian Institute of Technology Bombay Company Overview 54

5.16.1 Indian Institute of Technology Bombay Pipeline Products & Ongoing Clinical Trials Overview 54

5.17 Innovative BioTherapies Inc Company Overview 55

5.17.1 Innovative BioTherapies Inc Pipeline Products & Ongoing Clinical Trials Overview 55

5.18 Katharos, Inc. Company Overview 58

5.18.1 Katharos, Inc. Pipeline Products & Ongoing Clinical Trials Overview 58

5.19 Laminate Medical Technologies Ltd Company Overview 59

5.19.1 Laminate Medical Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 59

5.20 Nikkiso Co Ltd Company Overview 62

5.20.1 Nikkiso Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 62

5.21 Nipro Corp Company Overview 63

5.21.1 Nipro Corp Pipeline Products & Ongoing Clinical Trials Overview 63

5.22 Northwestern University Company Overview 64

5.22.1 Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 64

5.23 Novaflux Technologies Company Overview 65

5.23.1 Novaflux Technologies Pipeline Products & Ongoing Clinical Trials Overview 65

5.24 NuVascular Technologies Inc Company Overview 66

5.24.1 NuVascular Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 66

5.25 Pursuit Vascular, Inc Company Overview 68

5.25.1 Pursuit Vascular, Inc Pipeline Products & Ongoing Clinical Trials Overview 68

5.26 Rajamadhangi Medical Technologies Pvt Ltd Company Overview 69

5.26.1 Rajamadhangi Medical Technologies Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 69

5.27 Redsense Medical AB Company Overview 70

5.27.1 Redsense Medical AB Pipeline Products & Ongoing Clinical Trials Overview 70

5.28 Renal Solutions Inc Company Overview 71

5.28.1 Renal Solutions Inc Pipeline Products & Ongoing Clinical Trials Overview 71

5.29 SeaStar Medical Company Overview 72

5.29.1 SeaStar Medical Pipeline Products & Ongoing Clinical Trials Overview 72

5.30 Silmag SA Company Overview 76

5.30.1 Silmag SA Pipeline Products & Ongoing Clinical Trials Overview 76

5.31 Simergent LLC Company Overview 77

5.31.1 Simergent LLC Pipeline Products & Ongoing Clinical Trials Overview 77

5.32 Specialty Renal Products Inc Company Overview 78

5.32.1 Specialty Renal Products Inc Pipeline Products & Ongoing Clinical Trials Overview 78

5.33 University of California San Francisco Company Overview 79

5.33.1 University of California San Francisco Pipeline Products & Ongoing Clinical Trials Overview 79

5.34 University of Michigan Company Overview 80

5.34.1 University of Michigan Pipeline Products & Ongoing Clinical Trials Overview 80

5.35 University of Rochester Company Overview 81

5.35.1 University of Rochester Pipeline Products & Ongoing Clinical Trials Overview 81

5.36 University of Vermont Company Overview 82

5.36.1 University of Vermont Pipeline Products & Ongoing Clinical Trials Overview 82

5.37 Vital Access Corp Company Overview 83

5.37.1 Vital Access Corp Pipeline Products & Ongoing Clinical Trials Overview 83

5.38 Voyager Biomedical Inc Company Overview 84

5.38.1 Voyager Biomedical Inc Pipeline Products & Ongoing Clinical Trials Overview 84

6 Dialysis Accessories- Recent Developments 85

6.1 May 10, 2022: Baxter to Host 2022 Investor Conference 85

6.2 May 04, 2022: Nephros Announces Results for Quarter Ended March 31, 2022 85

6.3 Apr 20, 2022: Rockwell Medical to Present at Noblecon18 Investor Conference 87

6.4 Mar 23, 2022: New MHRA Guidance acknowledges the need to monitor for VND 87

6.5 Feb 23, 2022: Nephros Announces Fourth Quarter and Fiscal Year 2021 Financial Results 88

6.6 Feb 22, 2022: Asahi Kasai Names Company Veteran as New President 89

6.7 Feb 10, 2022: Baxter to Present at Citi’s 2022 Virtual Healthcare Conference 89

6.8 Feb 08, 2022: JMS Announces Financial Results for the 3rd Quarter of FYE March 2022 90

6.9 Jan 11, 2022: Nephros Announces Preliminary Results for Fourth Quarter and Fiscal Year 2021 and Revenue Guidance for 2022 91

6.10 Jan 06, 2022: Baxter to Host Fourth-Quarter 2021 Financial Results Conference Call for Investors 92

6.11 Dec 08, 2021: Dr Jens von Lackum appointed to the Management Board of B. Braun SE 92

6.12 Nov 15, 2021: Rockwell Medical Provides Third Quarter 2021 Financial and Operational Update 92

6.13 Nov 05, 2021: JMS Announces Financial Results for the Second Quarter of Fiscal Year Ending March 31, 2022 94

6.14 Nov 04, 2021: Nephros Announces Results for Quarter Ended September 30, 2021 96

6.15 Nov 03, 2021: ICU Medical Announces Third Quarter 2021 Results 98

6.16 Nov 02, 2021: Baxter to Present at Evercore ISI 4th Annual HealthCONx Conference 98

6.17 Oct 13, 2021: Baxter to Present at Credit Suisse 30th Annual Virtual Healthcare Conference 99

6.18 Sep 27, 2021: Baxter to Host Third-Quarter 2021 Financial Results Conference Call for Investors 99

6.19 Sep 15, 2021: Nephros to Present at the Virtual MicroCap Leadership Summit 99

6.20 Sep 01, 2021: Nephros Appoints Wes Lobo to Chief Commercial Officer 99

6.21 Sep 01, 2021: Optinova appoints Allan Boye as Chief Commercial Officer (CCO) 100

6.22 Aug 06, 2021: JMS Announces Financial Results for the First Quarter of Fiscal Year Ending March 31, 2022 100

6.23 Aug 05, 2021: Nephros Announces Results for Quarter Ended June 30, 2021 100

6.24 Aug 04, 2021: ICU Medical Announces Second Quarter 2021 Results 102

6.25 Jul 30, 2021: Fresenius Medical Care reports results in line with expectations for the second quarter and confirms 2021 outlook 102

6.26 Jul 29, 2021: Baxter Reports Second-Quarter 2021 Results 105

6.27 Jul 29, 2021: Rockwell Medical to Report Second Quarter 2021 Financial and Operating Results on August 16, 2021 108

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

2.0 and MedTech Innovations Summit 108

6.29 Jul 13, 2021: AngioDynamics Reports Fiscal 2021 Fourth Quarter and Full-Year Financial Results 108

6.30 Jul 08, 2021: Nephros Announces Preliminary Results for Second Quarter of 2021 110

6.31 Jun 30, 2021: B. Braun Announces Jennifer Prioleau as New Chief Legal Officer and Chief Compliance Officer 111

6.32 Jun 30, 2021: Asahi Kasei Announces Q1 2021 Financial Results 111

6.33 Jun 15, 2021: Baxter to Host Second-Quarter 2021 Financial Results Conference Call for Investors 111

6.34 May 17, 2021: Rockwell Medical Provides First Quarter 2021 Financial and Operational Update 111

7 Appendix 114

7.1 Methodology 114

7.2 About GlobalData 117

7.3 Contact Us 117

7.4 Disclaimer 117

List of Tables

Dialysis Accessories – Pipeline Products by Stage of Development 12

Dialysis Accessories – Pipeline Products by Segment 13

Dialysis Accessories – Pipeline Products by Territory 14

Dialysis Accessories – Pipeline Products by Regulatory Path 15

Dialysis Accessories – Pipeline Products by Estimated Approval Date 16

Dialysis Accessories – Ongoing Clinical Trials 17

Dialysis Accessories Companies – Pipeline Products by Stage of Development 18

Dialysis Accessories – Pipeline Products by Stage of Development 20

Access Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 22

Dialysis Port – Product Status 22

Dialysis Port – Product Description 22

Ash Access Technology Inc Pipeline Products & Ongoing Clinical Trials Overview 23

MaxFlow – Product Status 23

MaxFlow – Product Description 23

Baxter International Inc Pipeline Products & Ongoing Clinical Trials Overview 24

oXiris – Product Status 24

oXiris – Product Description 25

Point of Care Generation 1 System – Product Status 25

Point of Care Generation 1 System – Product Description 25

Point of Care Generation 2 System – Product Status 26

Point of Care Generation 2 System – Product Description 26

Baxter International Inc – Ongoing Clinical Trials Overview 27

oXiris – A Pilot Multicentre Open-Label Randomized Controlled Trial During Treatment for Acute Kidney Injury in Critically Ill Patients with Septic Shock Comparing Two Haemofilter Membrane Devices, The An69st and the Newly Available Oxiris Haemofiltration Membrane for Early Resolution of Shock As Well As Other Clinical and Technical Performance Outcomes 28

oXiris – A Randomized, Controlled Trial to Evaluate Efficacy and Safety of a Highly Selective Semipermeable Membrane (AN-69 Oxiris) in Comparison with a Semi Selective Semipermeable Membrane (Standard AN-69) in COVID-19 Associated Acute Kidney Injury: oXAKI-COV Study 28

oXiris – Antibiotic Plasma Concentrations During Continuous Renal Replacement Therapy with a High Adsorption Membrane (oXiris) 29

oXiris – Clinical Study of Microcirculatory Parameters in Septic/Septic Shock Patients Treated with Oxiris Filter 30

oXiris – Effect of Oxiris Membrane on Microcirculation Following Cardiac Surgery Under Cardiopulmonary Bypass: A Pilot Prospective Monocentric Study (Oxicard Study) 30

oXiris – Effects of Removal of Endotoxin, Cytokines, and Uremic Toxins Using Blood Purification on Patients with Severe Septic Shock 30

oXiris – Endotoxins and Cytokines Removal During Continuous Hemofiltration with oXiris 31

oXiris – Evaluation of Oxiris Membrane as a Treatment for Ischemia-reperfusion Syndrome in Cardiogenic Shock Treated with Extracorporeal Life Support (ECMO/ECLS): A Randomized Pilot Study ECMORIX 31

oXiris – Renal Replacement Therapy with a Cytokine Absorption Filter (oXiris) in Patients with Septic Shock: a Case-control Study Nested in a Cohort 31

oXiris – The Effect of a Hemoperfusion with Polyethyleneimine-coated Membrane Filter (Oxiris) in Patients with Septic Shock: A Multicenter Randomized Controlled Trial 32

oXiris – The Effects of oXiris on Systemic Inflammation, Endothelial Dysfunction and Volume Control in Cardiac Surgery Patients Undergoing Cardiopulmonary Bypass 32

Brookhaven Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 33

Hemoaccess Valve System – Product Status 33

Hemoaccess Valve System – Product Description 33

CatheNect Medical Pipeline Products & Ongoing Clinical Trials Overview 34

Peritoneal Dialysis Catheter – Product Status 34

Peritoneal Dialysis Catheter – Product Description 34

Cerovations LLC Pipeline Products & Ongoing Clinical Trials Overview 35

Contamination Resistant Interconnection Device – Product Status 35

Contamination Resistant Interconnection Device – Product Description 35

Diavantis Pipeline Products & Ongoing Clinical Trials Overview 36

Vivaxs Liva – Product Status 36

Vivaxs Liva – Product Description 36

Diavantis – Ongoing Clinical Trials Overview 37

Vivaxs Liva – Bone Anchored Port – A Novel Vascular Access for Hemodialysis Treatment 38

Eqalix, Inc. Pipeline Products & Ongoing Clinical Trials Overview 39

RenalEase – Product Status 39

RenalEase – Product Description 39

ExThera Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 40

Seraph 200 – Product Status 40

Seraph 200 – Product Description 40

Fistulink Ltd. Pipeline Products & Ongoing Clinical Trials Overview 41

Fistulink Device – Product Status 41

Fistulink Device – Product Description 41

Fresenius Medical Care AG & Co KGaA Pipeline Products & Ongoing Clinical Trials Overview 42

FX CorAL 600 – Product Status 42

FX CorAL 600 – Product Description 42

Fresenius Medical Care AG & Co KGaA – Ongoing Clinical Trials Overview 43

FX CorAL 600 – Comparison of Clinical Performance and Hemocompatibility of Dialyzers Applied During Post-dilution Online Hemodiafiltration – eMPORA III Study (Modified Polysulfone membrane) 44

Gambro Dialysatoren GmbH Pipeline Products & Ongoing Clinical Trials Overview 45

Theranova 400 Dialyzer – Product Status 45

Theranova 400 Dialyzer – Product Description 45

Theranova 500 Dialyzer – Product Status 46

Theranova 500 Dialyzer – Product Description 46

Gambro Dialysatoren GmbH – Ongoing Clinical Trials Overview 47

Theranova 400 Dialyzer – A Multicentre, Open-label, Prospective, Randomized Study to Explore the Morbimortality in Patients Dialyzed with the Theranova HDx in Comparison to On-Line – Hemodiafiltration (Study MoTHER HDx) 48

Theranova 400 Dialyzer – A Randomized, Controlled, Open-label, Parallel, Multicenter Study in Kidney Failure Patients on Hemodialysis Comparing the Theranova Dialyzer to Hemodiafiltration 48

Theranova 400 Dialyzer – A Randomized, Open-label, Cross Over Group, Single-centre Controlled Study To Evaluate The Clinical Performance Of Medium Cut-off Membrane Dialyzer Compared with High Flux Dialyzer in Removing Beta-2- Microglobulin Among Patients with End-stage Kidney Disease On Chronic Haemodialysis 48

Theranova 400 Dialyzer – Effect of Hemodiafiltration Plus MCOs on Uremic Toxins Removal 49

Theranova 400 Dialyzer – Long-term Effects of Expanded Hemodialysis in Reduction of Large Middle Molecules in Chronic Hemodialysis Patients: Potential Benefits to the Prevention of Sarcopenia 49

Theranova 400 Dialyzer – Randomized Controlled Trial of Theranova Versus High-flux Dialyzer on Preservation of Residual Renal Function in Incident Hemodialysis Patients 49

Theranova 500 Dialyzer – A Multicentre, Open-label, Prospective, Randomized Study to Explore the Morbimortality in Patients Dialyzed with the Theranova HDx in Comparison to On-Line – Hemodiafiltration (Study MoTHER HDx) 50

Georgia Institute of Technology Pipeline Products & Ongoing Clinical Trials Overview 51

Disposable Cassette Device – Dialysis – Product Status 51

Disposable Cassette Device – Dialysis – Product Description 51

Glomeria Therapeutics srl Pipeline Products & Ongoing Clinical Trials Overview 52

DesmoHD – Product Status 52

DesmoHD – Product Description 52

Healionics Corporation Pipeline Products & Ongoing Clinical Trials Overview 53

STARcuff – Product Status 53

STARcuff – Product Description 53

Indian Institute of Technology Bombay Pipeline Products & Ongoing Clinical Trials Overview 54

Dialysis Cuff – Product Status 54

Dialysis Cuff – Product Description 54

Innovative BioTherapies Inc Pipeline Products & Ongoing Clinical Trials Overview 55

Selective Cytopheretic Device Gen 2 – Pediatrics – Product Status 55

Selective Cytopheretic Device Gen 2 – Pediatrics – Product Description 55

Innovative BioTherapies Inc – Ongoing Clinical Trials Overview 56

Selective Cytopheretic Device Gen 2 – Pediatrics – A Multi-center, Pilot Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device (SCD) for the Treatment of Immunomodulatory Dysregulation Due to Pediatric Acute Kidney Injury (AKI) 57

Katharos, Inc. Pipeline Products & Ongoing Clinical Trials Overview 58

Phosphates Removing Device – Hemodialysis – Product Status 58

Phosphates Removing Device – Hemodialysis – Product Description 58

Laminate Medical Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 59

VasQ – Product Status 59

VasQ – Product Description 59

Laminate Medical Technologies Ltd – Ongoing Clinical Trials Overview 60

VasQ – A Multi-center Prospective Study to Evaluate the Safety and Effectiveness of the VasQ External Support for Arteriovenous Fistula 61

Nikkiso Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 62

Blood Volume Monitor For DCG-03 / DBG-03 – Product Status 62

Blood Volume Monitor For DCG-03 / DBG-03 – Product Description 62

Nipro Corp Pipeline Products & Ongoing Clinical Trials Overview 63

SafeTouch Dialysis CATH Plus P – Product Status 63

SafeTouch Dialysis CATH Plus P – Product Description 63

Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 64

Adjustable Banding Device – Product Status 64

Adjustable Banding Device – Product Description 64

Novaflux Technologies Pipeline Products & Ongoing Clinical Trials Overview 65

Outside-In (OI) Dialysis Filter – Product Status 65

Outside-In (OI) Dialysis Filter – Product Description 65

NuVascular Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 66

NuSpun Central Venous Catheter Cuff – Product Status 66

NuSpun Central Venous Catheter Cuff – Product Description 66

NuSpun Hemodialysis Access Graft – Product Status 67

NuSpun Hemodialysis Access Graft – Product Description 67

Pursuit Vascular, Inc Pipeline Products & Ongoing Clinical Trials Overview 68

ClearGuard HD End Cap – Product Status 68

ClearGuard HD End Cap – Product Description 68

Rajamadhangi Medical Technologies Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 69

Dialysis Cartridge – Product Status 69

Dialysis Cartridge – Product Description 69

Redsense Medical AB Pipeline Products & Ongoing Clinical Trials Overview 70

Redsense Clamp – Product Status 70

Redsense Clamp – Product Description 70

Renal Solutions Inc Pipeline Products & Ongoing Clinical Trials Overview 71

Dialysate Regeneration System – Peritoneal Dialysis – Product Status 71

Dialysate Regeneration System – Peritoneal Dialysis – Product Description 71

SeaStar Medical Pipeline Products & Ongoing Clinical Trials Overview 72

Selective Cytopheretic Device – Adult Use – Product Status 72

Selective Cytopheretic Device – Adult Use – Product Description 72

Selective Cytopheretic Device – Pediatric Use – Product Status 73

Selective Cytopheretic Device – Pediatric Use – Product Description 73

SeaStar Medical – Ongoing Clinical Trials Overview 74

Selective Cytopheretic Device – Adult Use – Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients (ERSD) 75

Selective Cytopheretic Device – Adult Use – Pilot Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device (SCD) to Treat Patients with NYHA Stage III or IV Heart Failure (HF) with Persistent Congestion and Worsening Renal Function as a Result of Cardiorenal Syndrome (CRS) That Is Resistant to Optimal Medical Therapy Including Loop Diuretics 75

Selective Cytopheretic Device – Adult Use – Pilot Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device to Treat ICU Patients with Acute or Chronic Systolic Heart Failure with Cardiorenal Syndrome(CRS) Awaiting Left Ventricular Assist Device (LVAD) Implantation 75

Silmag SA Pipeline Products & Ongoing Clinical Trials Overview 76

Cuffed Or Non-Cuffed Peritoneal Dialysis Catheter – Product Status 76

Cuffed Or Non-Cuffed Peritoneal Dialysis Catheter – Product Description 76

Simergent LLC Pipeline Products & Ongoing Clinical Trials Overview 77

Disposable Tubing Set – Product Status 77

Disposable Tubing Set – Product Description 77

Specialty Renal Products Inc Pipeline Products & Ongoing Clinical Trials Overview 78

Dialysate Regeneration Filter System – Product Status 78

Dialysate Regeneration Filter System – Product Description 78

University of California San Francisco Pipeline Products & Ongoing Clinical Trials Overview 79

Implantable Device – Percutaneous AVF – Product Status 79

Implantable Device – Percutaneous AVF – Product Description 79

University of Michigan Pipeline Products & Ongoing Clinical Trials Overview 80

Cold Dialysate Regeneration System – Product Status 80

Cold Dialysate Regeneration System – Product Description 80

University of Rochester Pipeline Products & Ongoing Clinical Trials Overview 81

Nanoporous Membrane Based Hemodialyzer – Product Status 81

Nanoporous Membrane Based Hemodialyzer – Product Description 81

University of Vermont Pipeline Products & Ongoing Clinical Trials Overview 82

Weighted Peritoneal Dialysis Catheter Anchor – Product Status 82

Weighted Peritoneal Dialysis Catheter Anchor – Product Description 82

Vital Access Corp Pipeline Products & Ongoing Clinical Trials Overview 83

Venous Window Access Device – Product Status 83

Venous Window Access Device – Product Description 83

Voyager Biomedical Inc Pipeline Products & Ongoing Clinical Trials Overview 84

ARK – Product Status 84

ARK – Product Description 84

Glossary 116

List of Figures

Dialysis Accessories – Pipeline Products by Stage of Development 12

Dialysis Accessories – Pipeline Products by Segment 13

Dialysis Accessories – Pipeline Products by Territory 14

Dialysis Accessories – Pipeline Products by Regulatory Path 15

Dialysis Accessories – Pipeline Products by Estimated Approval Date 16

Dialysis Accessories – Ongoing Clinical Trials 17

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