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

Renal dialysis equipment like dialysis machines, dialysis accessories, and vascular access devices for hemodialysis are intended to provide an artificial replacement for lost kidney function due to renal failure.

The renal dialysis equipment pipeline product market report provides key information and data related to extensive coverage of the renal dialysis equipment under development. The report has provided 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.

What are the market dynamics in the renal dialysis equipment pipeline products market?

As of April 2022, the inactive stage had the most pipeline products followed by the clinical stage, early development stage, in-approval stage, pre-clinical stage, and indeterminate stage. Q4 of 2026 has the greatest number of approval dates for the pipeline products. Based on the trial status, most of the products in the Renal Dialysis Equipment pipeline products market are in the ongoing, recruiting stage.

What is the territory outlook of the renal dialysis equipment pipeline products market?

The US, Europe, Australia, China, Canada, India, Israel, Japan, New Zealand, Singapore, the UK, Brazil, Argentina, Bermuda, Colombia, Costa Rica, Ecuador, El Salvador, Italy, Chile, France, Germany, South Africa, South Korea, Taiwan, the UAE, Pakistan, and Mexico have products in the pipeline. As of April 2022, the US has the highest number of products in the pipeline out of them all.

Renal dialysis equipment pipeline products market, by territory

Renal dialysis equipment pipeline products market, by territory

For more territory insights, download a free report sample

Which are the key companies in the renal dialysis equipment pipeline products market?

Some of the key companies in the renal dialysis equipment market are Access Vascular Inc, AngioDynamics Inc, Angiotech Pharmaceuticals Inc, Ariste Medical LLC, Ash Access Technology Inc, Advanced Dialysis Methods Ltd., Advent Access Pte Ltd, Aperture Biomedical LLC, Baxter International Inc, Biosurfaces Inc, Bioteque Corp, BOA Biomedical Inc, and Brookhaven Medical Inc. 

Access Vascular Inc

Access Vascular Inc develops and manufactures hydrogel-based devices. The company’s devices use the hydrogel-based biomaterial to reduce the body’s thrombotic response and subsequent clinical complications. Access Vascular is headquartered in Bedford, Massachusetts, the US.

AngioDynamics Inc

AngioDynamics Inc 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, products for dialysis, angioplasty, drainage, thrombolysis and embolization, venous products, and renal therapy products. Its products find application in interventional radiology, interventional cardiology, and minimally-invasive diagnosis and treatment of cancer and peripheral vascular disease. AngioDynamics is headquartered in Latham, New York, the US.

Angiotech Pharmaceuticals Inc

Angiotech Pharmaceuticals Inc is a surgical specialist corporation that offers medical devices. The corporation’s products include QUILL devices, surgical sutures, microsurgical knives, ophthalmic instruments, specialty products, BIOSENTRY systems, OEM products, LOOK sutures, and Sharpoint ophthalmic microsurgical knives and sutures. It also provides ophthalmology medicine, plastic surgery medicine, orthopedics medicine, urology medicine, dental medicine, veterinary medicine, and private label finished goods, among others. Angiotech Pharmaceuticals is headquartered in Vancouver, British Columbia, Canada.

Ariste Medical LLC

Ariste Medical LLC is a medical device company that develops drug eluting surgical implants. The company develops drug-eluting tunneled dialysis catheters for hemodialysis, drug-eluting mesh for hernia repair, and drug-eluting vascular graft for peripheral bypass. It also develops drug-eluting mesh, drug-eluting tunneled dialysis catheters, and drug-eluting vascular grafts. Ariste’s products help in addressing common causes of device failure including infection, thrombosis, and restenosis. The company is headquartered in Memphis, Tennessee, the US.

Ash Access Technology Inc

Ash Access Technology Inc is a medical device company that provides therapeutic solutions and equipment for vascular access diseases. The company offers antimicrobial and antithrombotic therapy against both gram-positive and negative strains of bacteria and tunneled central venous catheters for hemodialysis. It offers product formulation, efficacy and safety studies, pivotal, PMA trials, prototype development, and clinical testing services. Ash Access is headquartered in Lafayette, Indiana, the US.

Market report scope

Key territories The US, Europe, Australia, China, Canada, India, Israel, Japan, New Zealand, Singapore, the UK, Brazil, Argentina, Bermuda, Colombia, Costa Rica, Ecuador, El Salvador, Italy, Chile, France, Germany, South Africa, South Korea, Taiwan, the UAE, Pakistan, and Mexico
Key companies Access Vascular Inc, AngioDynamics Inc, Angiotech Pharmaceuticals Inc, Ariste Medical LLC, Ash Access Technology Inc, Advanced Dialysis Methods Ltd., Advent Access Pte Ltd, Aperture Biomedical LLC, Baxter International Inc, Biosurfaces Inc, Bioteque Corp, BOA Biomedical Inc, and Brookhaven Medical Inc

Market Scope

This report provides:

  • Extensive coverage of the renal dialysis equipment 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 renal dialysis equipment 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.
  • 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 counterstrategies to gain a competitive advantage.
  • Identify and understand important and diverse types of Renal dialysis equipment 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

Advanced Dialysis Methods Ltd.

Advent Access Pte Ltd

AngioDynamics Inc

Angiotech Pharmaceuticals Inc

Aperture Biomedical LLC

Ariste Medical LLC

Ash Access Technology Inc

Baxter International Inc

Biosurfaces Inc

Bioteque Corp

BOA Biomedical Inc

Brookhaven Medical Inc

Byonyks

CatheNect Medical

Cerovations LLC

Chemica Technologies Inc

Chrysalis Medical Inc

Columbia University

CR Bard Inc

CVS Kidney Care

Cytograft Tissue Engineering Inc (Inactive)

Debiotech SA

Diality Inc

Diavantis

Districlass Medical SA

Ellen Medical Devices Pty Ltd

Emory University

Eqalix Inc

ExThera Medical Corp

Fistulink Ltd.

Fresenius Medical Care AG & Co KGaA

Fresenius Medical Care Holdings Inc

Fresenius Medical Care Russia

Gambro Dasco SpA

Gambro Dialysatoren GmbH

Gambro Renal Products Inc

Georgia Institute of Technology

Glomeria Therapeutics srl

Haemair Ltd

Healionics Corporation

Hemotek Medical Inc

Humacyte Inc

Indian Institute of Technology Bombay

Infomed SA

InnAVasc Medical Inc

Innovative BioTherapies Inc

Katharos, Inc.

Koronis Biomedical Technologies Corporation

Laminate Medical Technologies Ltd

LiberDi Ltd

Mar Cor Purification Inc

Marvao Medical Devices Ltd

Medtronic Plc

Minnesota Health Solutions Corporation

Nanodialysis BV

NanoVasc, Inc.

Neokidney Development BV

Nephros Inc

Nicast Ltd

Nikkiso Co Ltd

Nipro Corp

Northwestern University

Novaflux Technologies

NuVascular Technologies Inc

NxStage Medical Inc

Occlutech International AB

Oxford Biomaterials Ltd

Padmaseetha Technologies Pvt Ltd

Phase One Medical LLC

Phraxis, Inc.

Physiologas Technologies Inc

Pursuit Vascular, Inc

Qidni Labs Inc

Quanta Dialysis Technologies Ltd

Rajamadhangi Medical Technologies Pvt Ltd

Rambam Health Care Campus

Redsense Medical AB

RegenMedTX LLC

Renal Solutions Inc

SeaStar Medical

Senexis Limited (Inactive)

Silmag SA

Simergent LLC

Southern Illinois University Carbondale

Specialty Renal Products Inc

Stent Tek Ltd

TEI Biosciences Inc

Thorn Technologies LLC

Triomed AB

University of Arizona

University of California

University of California San Francisco

University of Colorado

University of Limerick

University of Michigan

University of Rochester

University of Texas Southwestern Medical Center

University of Vermont

Vanderbilt University

Vascoscope BV

Vascudyne Inc

Vascular Genesis

Verasonics, Inc.

Vital Access Corp

Vizio Medical Devices

Voyager Biomedical Inc

Xeltis AG

Xerem Medical Ltd

Table of Contents

1 Table of Contents

2 Introduction 19

2.1 Renal Dialysis Equipment Overview 19

3 Products under Development 21

3.1 Renal Dialysis Equipment – Pipeline Products by Stage of Development 21

3.2 Renal Dialysis Equipment – Pipeline Products by Segment 22

3.3 Renal Dialysis Equipment – Pipeline Products by Territory 24

3.4 Renal Dialysis Equipment – Pipeline Products by Regulatory Path 26

3.5 Renal Dialysis Equipment – Pipeline Products by Estimated Approval Date 27

3.6 Renal Dialysis Equipment – Ongoing Clinical Trials 28

4 Renal Dialysis Equipment – Pipeline Products under Development by Companies 29

4.1 Renal Dialysis Equipment Companies – Pipeline Products by Stage of Development 29

4.2 Renal Dialysis Equipment – Pipeline Products by Stage of Development 33

5 Renal Dialysis Equipment Companies and Product Overview 37

5.1 Access Vascular Inc Company Overview 37

5.1.1 Access Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 37

5.2 Advanced Dialysis Methods Ltd. Company Overview 39

5.2.1 Advanced Dialysis Methods Ltd. Pipeline Products & Ongoing Clinical Trials Overview 39

5.3 Advent Access Pte Ltd Company Overview 40

5.3.1 Advent Access Pte Ltd Pipeline Products & Ongoing Clinical Trials Overview 40

5.4 AngioDynamics Inc Company Overview 41

5.4.1 AngioDynamics Inc Pipeline Products & Ongoing Clinical Trials Overview 41

5.5 Angiotech Pharmaceuticals Inc Company Overview 43

5.5.1 Angiotech Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 43

5.6 Aperture Biomedical LLC Company Overview 44

5.6.1 Aperture Biomedical LLC Pipeline Products & Ongoing Clinical Trials Overview 44

5.7 Ariste Medical LLC Company Overview 45

5.7.1 Ariste Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 45

5.8 Ash Access Technology Inc Company Overview 46

5.8.1 Ash Access Technology Inc Pipeline Products & Ongoing Clinical Trials Overview 46

5.9 Baxter International Inc Company Overview 48

5.9.1 Baxter International Inc Pipeline Products & Ongoing Clinical Trials Overview 48

5.10 Biosurfaces Inc Company Overview 59

5.10.1 Biosurfaces Inc Pipeline Products & Ongoing Clinical Trials Overview 59

5.11 Bioteque Corp Company Overview 60

5.11.1 Bioteque Corp Pipeline Products & Ongoing Clinical Trials Overview 60

5.12 BOA Biomedical Inc Company Overview 61

5.12.1 BOA Biomedical Inc Pipeline Products & Ongoing Clinical Trials Overview 61

5.13 Brookhaven Medical Inc Company Overview 64

5.13.1 Brookhaven Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 64

5.14 Byonyks Company Overview 65

5.14.1 Byonyks Pipeline Products & Ongoing Clinical Trials Overview 65

5.15 CatheNect Medical Company Overview 66

5.15.1 CatheNect Medical Pipeline Products & Ongoing Clinical Trials Overview 66

5.16 Cerovations LLC Company Overview 67

5.16.1 Cerovations LLC Pipeline Products & Ongoing Clinical Trials Overview 67

5.17 Chemica Technologies Inc Company Overview 68

5.17.1 Chemica Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 68

5.18 Chrysalis Medical Inc Company Overview 69

5.18.1 Chrysalis Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 69

5.19 Columbia University Company Overview 70

5.19.1 Columbia University Pipeline Products & Ongoing Clinical Trials Overview 70

5.20 CR Bard Inc Company Overview 71

5.20.1 CR Bard Inc Pipeline Products & Ongoing Clinical Trials Overview 71

5.21 CVS Kidney Care Company Overview 72

5.21.1 CVS Kidney Care Pipeline Products & Ongoing Clinical Trials Overview 72

5.22 Cytograft Tissue Engineering Inc (Inactive) Company Overview 75

5.22.1 Cytograft Tissue Engineering Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 75

5.23 Debiotech SA Company Overview 76

5.23.1 Debiotech SA Pipeline Products & Ongoing Clinical Trials Overview 76

5.24 Diality Inc Company Overview 78

5.24.1 Diality Inc Pipeline Products & Ongoing Clinical Trials Overview 78

5.25 Diavantis Company Overview 79

5.25.1 Diavantis Pipeline Products & Ongoing Clinical Trials Overview 79

5.26 Districlass Medical SA Company Overview 82

5.26.1 Districlass Medical SA Pipeline Products & Ongoing Clinical Trials Overview 82

5.27 Ellen Medical Devices Pty Ltd Company Overview 83

5.27.1 Ellen Medical Devices Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 83

5.28 Emory University Company Overview 84

5.28.1 Emory University Pipeline Products & Ongoing Clinical Trials Overview 84

5.29 Eqalix, Inc. Company Overview 85

5.29.1 Eqalix, Inc. Pipeline Products & Ongoing Clinical Trials Overview 85

5.30 ExThera Medical Corp Company Overview 86

5.30.1 ExThera Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 86

5.31 Fistulink Ltd. Company Overview 87

5.31.1 Fistulink Ltd. Pipeline Products & Ongoing Clinical Trials Overview 87

5.32 Fresenius Medical Care AG & Co KGaA Company Overview 88

5.32.1 Fresenius Medical Care AG & Co KGaA Pipeline Products & Ongoing Clinical Trials Overview 88

5.33 Fresenius Medical Care Holdings Inc Company Overview 93

5.33.1 Fresenius Medical Care Holdings Inc Pipeline Products & Ongoing Clinical Trials Overview 93

5.34 Gambro Dasco SpA Company Overview 95

5.34.1 Gambro Dasco SpA Pipeline Products & Ongoing Clinical Trials Overview 95

5.35 Gambro Dialysatoren GmbH Company Overview 96

5.35.1 Gambro Dialysatoren GmbH Pipeline Products & Ongoing Clinical Trials Overview 96

5.36 Georgia Institute of Technology Company Overview 102

5.36.1 Georgia Institute of Technology Pipeline Products & Ongoing Clinical Trials Overview 102

5.37 Glomeria Therapeutics srl Company Overview 104

5.37.1 Glomeria Therapeutics srl Pipeline Products & Ongoing Clinical Trials Overview 104

5.38 Haemair Ltd Company Overview 106

5.38.1 Haemair Ltd Pipeline Products & Ongoing Clinical Trials Overview 106

5.39 Healionics Corporation Company Overview 107

5.39.1 Healionics Corporation Pipeline Products & Ongoing Clinical Trials Overview 107

5.40 Hemotek Medical Inc Company Overview 110

5.40.1 Hemotek Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 110

5.41 Humacyte Inc Company Overview 111

5.41.1 Humacyte Inc Pipeline Products & Ongoing Clinical Trials Overview 111

5.42 Indian Institute of Technology Bombay Company Overview 116

5.42.1 Indian Institute of Technology Bombay Pipeline Products & Ongoing Clinical Trials Overview 116

5.43 Infomed SA Company Overview 117

5.43.1 Infomed SA Pipeline Products & Ongoing Clinical Trials Overview 117

5.44 InnAVasc Medical Inc Company Overview 121

5.44.1 InnAVasc Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 121

5.45 Innovative BioTherapies Inc Company Overview 124

5.45.1 Innovative BioTherapies Inc Pipeline Products & Ongoing Clinical Trials Overview 124

5.46 Katharos, Inc. Company Overview 127

5.46.1 Katharos, Inc. Pipeline Products & Ongoing Clinical Trials Overview 127

5.47 Koronis Biomedical Technologies Corporation Company Overview 128

5.47.1 Koronis Biomedical Technologies Corporation Pipeline Products & Ongoing Clinical Trials Overview 128

5.48 Laminate Medical Technologies Ltd Company Overview 129

5.48.1 Laminate Medical Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 129

5.49 LiberDi Ltd Company Overview 132

5.49.1 LiberDi Ltd Pipeline Products & Ongoing Clinical Trials Overview 132

5.50 Mar Cor Purification Inc Company Overview 135

5.50.1 Mar Cor Purification Inc Pipeline Products & Ongoing Clinical Trials Overview 135

5.51 Marvao Medical Devices Ltd Company Overview 136

5.51.1 Marvao Medical Devices Ltd Pipeline Products & Ongoing Clinical Trials Overview 136

5.52 Medtronic Plc Company Overview 137

5.52.1 Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 137

5.53 Minnesota Health Solutions Corporation Company Overview 139

5.53.1 Minnesota Health Solutions Corporation Pipeline Products & Ongoing Clinical Trials Overview 139

5.54 Nanodialysis BV Company Overview 140

5.54.1 Nanodialysis BV Pipeline Products & Ongoing Clinical Trials Overview 140

5.55 NanoVasc, Inc. Company Overview 141

5.55.1 NanoVasc, Inc. Pipeline Products & Ongoing Clinical Trials Overview 141

5.56 Neokidney Development BV Company Overview 142

5.56.1 Neokidney Development BV Pipeline Products & Ongoing Clinical Trials Overview 142

5.57 Nephros Inc Company Overview 143

5.57.1 Nephros Inc Pipeline Products & Ongoing Clinical Trials Overview 143

5.58 Nicast Ltd Company Overview 144

5.58.1 Nicast Ltd Pipeline Products & Ongoing Clinical Trials Overview 144

5.59 Nikkiso Co Ltd Company Overview 145

5.59.1 Nikkiso Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 145

5.60 Nipro Corp Company Overview 148

5.60.1 Nipro Corp Pipeline Products & Ongoing Clinical Trials Overview 148

5.61 Northwestern University Company Overview 149

5.61.1 Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 149

5.62 Novaflux Technologies Company Overview 151

5.62.1 Novaflux Technologies Pipeline Products & Ongoing Clinical Trials Overview 151

5.63 NuVascular Technologies Inc Company Overview 152

5.63.1 NuVascular Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 152

5.64 NxStage Medical Inc Company Overview 154

5.64.1 NxStage Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 154

5.65 Occlutech International AB Company Overview 156

5.65.1 Occlutech International AB Pipeline Products & Ongoing Clinical Trials Overview 156

5.66 Oxford Biomaterials Ltd Company Overview 157

5.66.1 Oxford Biomaterials Ltd Pipeline Products & Ongoing Clinical Trials Overview 157

5.67 Padmaseetha Technologies Pvt Ltd Company Overview 158

5.67.1 Padmaseetha Technologies Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 158

5.68 Phase One Medical LLC Company Overview 159

5.68.1 Phase One Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 159

5.69 Phraxis, Inc. Company Overview 161

5.69.1 Phraxis, Inc. Pipeline Products & Ongoing Clinical Trials Overview 161

5.70 Physiologas Technologies Inc Company Overview 162

5.70.1 Physiologas Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 162

5.71 Pursuit Vascular, Inc Company Overview 163

5.71.1 Pursuit Vascular, Inc Pipeline Products & Ongoing Clinical Trials Overview 163

5.72 Qidni Labs Inc Company Overview 164

5.72.1 Qidni Labs Inc Pipeline Products & Ongoing Clinical Trials Overview 164

5.73 Quanta Dialysis Technologies Ltd Company Overview 165

5.73.1 Quanta Dialysis Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 165

5.74 Rajamadhangi Medical Technologies Pvt Ltd Company Overview 166

5.74.1 Rajamadhangi Medical Technologies Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 166

5.75 Rambam Health Care Campus Company Overview 167

5.75.1 Rambam Health Care Campus Pipeline Products & Ongoing Clinical Trials Overview 167

5.76 Redsense Medical AB Company Overview 168

5.76.1 Redsense Medical AB Pipeline Products & Ongoing Clinical Trials Overview 168

5.77 RegenMedTX LLC Company Overview 169

5.77.1 RegenMedTX LLC Pipeline Products & Ongoing Clinical Trials Overview 169

5.78 Renal Solutions Inc Company Overview 170

5.78.1 Renal Solutions Inc Pipeline Products & Ongoing Clinical Trials Overview 170

5.79 SeaStar Medical Company Overview 171

5.79.1 SeaStar Medical Pipeline Products & Ongoing Clinical Trials Overview 171

5.80 Senexis Limited (Inactive) Company Overview 175

5.80.1 Senexis Limited (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 175

5.81 Silmag SA Company Overview 176

5.81.1 Silmag SA Pipeline Products & Ongoing Clinical Trials Overview 176

5.82 Simergent LLC Company Overview 178

5.82.1 Simergent LLC Pipeline Products & Ongoing Clinical Trials Overview 178

5.83 Southern Illinois University Carbondale Company Overview 181

5.83.1 Southern Illinois University Carbondale Pipeline Products & Ongoing Clinical Trials Overview 181

5.84 Specialty Renal Products Inc Company Overview 182

5.84.1 Specialty Renal Products Inc Pipeline Products & Ongoing Clinical Trials Overview 182

5.85 Stent Tek Ltd Company Overview 184

5.85.1 Stent Tek Ltd Pipeline Products & Ongoing Clinical Trials Overview 184

5.86 TEI Biosciences Inc Company Overview 185

5.86.1 TEI Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 185

5.87 Thorn Technologies LLC Company Overview 186

5.87.1 Thorn Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 186

5.88 Triomed AB Company Overview 187

5.88.1 Triomed AB Pipeline Products & Ongoing Clinical Trials Overview 187

5.89 University of Arizona Company Overview 189

5.89.1 University of Arizona Pipeline Products & Ongoing Clinical Trials Overview 189

5.90 University of California Company Overview 190

5.90.1 University of California Pipeline Products & Ongoing Clinical Trials Overview 190

5.91 University of California San Francisco Company Overview 191

5.91.1 University of California San Francisco Pipeline Products & Ongoing Clinical Trials Overview 191

5.92 University of Colorado Company Overview 193

5.92.1 University of Colorado Pipeline Products & Ongoing Clinical Trials Overview 193

5.93 University of Limerick Company Overview 194

5.93.1 University of Limerick Pipeline Products & Ongoing Clinical Trials Overview 194

5.94 University of Michigan Company Overview 195

5.94.1 University of Michigan Pipeline Products & Ongoing Clinical Trials Overview 195

5.95 University of Rochester Company Overview 196

5.95.1 University of Rochester Pipeline Products & Ongoing Clinical Trials Overview 196

5.96 University of Texas Southwestern Medical Center Company Overview 197

5.96.1 University of Texas Southwestern Medical Center Pipeline Products & Ongoing Clinical Trials Overview 197

5.97 University of Vermont Company Overview 198

5.97.1 University of Vermont Pipeline Products & Ongoing Clinical Trials Overview 198

5.98 Vanderbilt University Company Overview 199

5.98.1 Vanderbilt University Pipeline Products & Ongoing Clinical Trials Overview 199

5.99 Vascoscope BV Company Overview 200

5.99.1 Vascoscope BV Pipeline Products & Ongoing Clinical Trials Overview 200

5.100 Vascudyne Inc Company Overview 201

5.100.1 Vascudyne Inc Pipeline Products & Ongoing Clinical Trials Overview 201

5.101 Vascular Genesis Company Overview 204

5.101.1 Vascular Genesis Pipeline Products & Ongoing Clinical Trials Overview 204

5.102 Verasonics, Inc. Company Overview 205

5.102.1 Verasonics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 205

5.103 Vital Access Corp Company Overview 206

5.103.1 Vital Access Corp Pipeline Products & Ongoing Clinical Trials Overview 206

5.104 Vizio Medical Devices Company Overview 207

5.104.1 Vizio Medical Devices Pipeline Products & Ongoing Clinical Trials Overview 207

5.105 Voyager Biomedical Inc Company Overview 208

5.105.1 Voyager Biomedical Inc Pipeline Products & Ongoing Clinical Trials Overview 208

5.106 Xeltis AG Company Overview 209

5.106.1 Xeltis AG Pipeline Products & Ongoing Clinical Trials Overview 209

5.107 Xerem Medical Ltd Company Overview 212

5.107.1 Xerem Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 212

6 Renal Dialysis Equipment- Recent Developments 213

6.1 Mar 31, 2022: Renalytix Reports Financial Results for Second Quarter of Fiscal Year 2022 213

6.2 Mar 29, 2022: Miromatrix Moves into New Headquarters Complete with In-House Manufacturing Capabilities 214

6.3 Mar 23, 2022: New MHRA Guidance acknowledges the need to monitor for VND 215

6.4 Mar 17, 2022: Miromatrix to Report Fourth Quarter and Full Year 2021 Financial Results 215

6.5 Mar 16, 2022: Ascend Clinical Chooses Category leaders, DeLorean AI and SambaNova, to Advance Renal Care with AI 215

6.6 Mar 01, 2022: Miromatrix Names Jim Douglas as New Chief Financial Officer 216

6.7 Feb 24, 2022: Teleflex Announces Fourth Quarter and Full-Year 2021 Financial Results 217

6.8 Feb 23, 2022: Nephros Announces Fourth Quarter and Fiscal Year 2021 Financial Results 218

6.9 Feb 22, 2022: Asahi Kasai Names Company Veteran as New President 220

6.10 Feb 16, 2022: Satellite Healthcare Announces Opening of New Regional Office in Denver 220

6.11 Feb 15, 2022: Satellite Healthcare enters Southeast U.S., expanding access to industry-leading comprehensive kidney care 220

6.12 Feb 10, 2022: Baxter to Present at Citi’s 2022 Virtual Healthcare Conference 221

6.13 Feb 08, 2022: JMS Announces Financial Results for the 3rd Quarter of FYE March 2022 221

6.14 Jan 31, 2022: Poly Medicure Announces Statement of Unaudited Standalone Financial Results for the Quarter and Nine Months Ended December 31 2021 223

6.15 Jan 13, 2022: NanoVibronix Expands Board of Directors with Appointment of Two New Independent Directors 224

6.16 Jan 11, 2022: Nephros Announces Preliminary Results for Fourth Quarter and Fiscal Year 2021 and Revenue Guidance for 2022 224

6.17 Jan 07, 2022: Renalytix Appoints Jean M. Casner as Chief Human Resources Officer 224

6.18 Jan 06, 2022: Baxter to Host Fourth-Quarter 2021 Financial Results Conference Call for Investors 225

6.19 Jan 04, 2022: Medtronic Chairman and CEO Geoff Martha to speak at J.P. Morgan healthcare conference 225

6.20 Jan 04, 2022: American Diabetes Association and Renalytix partner to prioritize kidney health in type 2 diabetes population 226

6.21 Dec 17, 2021: Renalytix Announces Result of AGM 226

6.22 Dec 08, 2021: Renalytix Reports Financial Results for First Quarter of Fiscal Year 2022 229

6.23 Dec 08, 2021: Dr Jens von Lackum appointed to the Management Board of B. Braun SE 230

6.24 Nov 19, 2021: Renalytix Announces Publication of Annual Report 2021 & Notice of AGM 231

6.25 Nov 18, 2021: Teleflex to Participate in the 33rd Annual Virtual Piper Sandler Healthcare Conference 231

6.26 Nov 15, 2021: Rockwell Medical Provides Third Quarter 2021 Financial and Operational Update 232

6.27 Nov 08, 2021: Boston Scientific Announces Upcoming Conference Schedule 233

6.28 Nov 05, 2021: JMS Announces Financial Results for the Second Quarter of Fiscal Year Ending March 31, 2022 234

6.29 Nov 04, 2021: Nephros Announces Results for Quarter Ended September 30, 2021 235

6.30 Nov 04, 2021: Satellite Healthcare develops program to safely transition patients to dialysis at home 237

6.31 Nov 03, 2021: ICU Medical Announces Third Quarter 2021 Results 238

6.32 Nov 02, 2021: Baxter to Present at Evercore ISI 4th Annual HealthCONx Conference 239

6.33 Nov 01, 2021: Poly Medicure announces Unaudited Financial Results Standalone & Consolidated for the Second quarter and half year ended on 30th September 2021 239

6.34 Oct 28, 2021: Teleflex Reports Third Quarter 2021 Results and Full Year Outlook 239

6.35 Oct 28, 2021: Merit Medical Reports Results For Quarter Ended September 30, 2021 243

6.36 Oct 27, 2021: Boston Scientific Announces Results For Third Quarter 2021 244

6.37 Oct 21, 2021: Renalytix Reports Full Year Fiscal 2021 Results 248

6.38 Oct 14, 2021: Teleflex Announces Third Quarter 2021 Earnings Conference Call Information 250

6.39 Oct 13, 2021: Baxter to Present at Credit Suisse 30th Annual Virtual Healthcare Conference 251

6.40 Oct 05, 2021: Merit Medical Systems to Announce Third Quarter Results on October 28, 2021 251

6.41 Oct 01, 2021: Satellite Healthcare Expands Scope and Impact of Brand Leadership Team 251

6.42 Sep 29, 2021: Somatus Names New Operations and Finance Executives to Accelerate Nationwide Access to Better Kidney Care 252

6.43 Sep 27, 2021: Baxter to Host Third-Quarter 2021 Financial Results Conference Call for Investors 252

6.44 Sep 15, 2021: Nephros to Present at the Virtual MicroCap Leadership Summit 252

6.45 Sep 09, 2021: Merit Medical Systems to Announce First Quarter Results on April 29, 2021 253

6.46 Sep 09, 2021: Boston Scientific Announces 2021 Investor Day Meeting 253

6.47 Sep 01, 2021: Teleflex to Present at the Morgan Stanley 19th Annual Global Healthcare Conference 253

6.48 Sep 01, 2021: Nephros Appoints Wes Lobo to Chief Commercial Officer 253

6.49 Sep 01, 2021: Optinova appoints Allan Boye as Chief Commercial Officer (CCO) 254

6.50 Aug 30, 2021: Renalytix Appoints Daniel J. Levangie to its Board of Directors 254

6.51 Aug 26, 2021: Teleflex to Present at the Wells Fargo 2021 Virtual Healthcare Conference 255

6.52 Aug 17, 2021: NanoVibronix Announces Results of Annual Meeting of Stockholders Held 255

6.53 Aug 06, 2021: JMS Announces Financial Results for the First Quarter of Fiscal Year Ending March 31, 2022 255

6.54 Aug 05, 2021: Nephros Announces Results for Quarter Ended June 30, 2021 255

6.55 Aug 04, 2021: ICU Medical Announces Second Quarter 2021 Results 257

6.56 Jul 30, 2021: Fresenius Medical Care reports results in line with expectations for the second quarter and confirms 2021 outlook 257

6.57 Jul 29, 2021: Baxter Reports Second-Quarter 2021 Results 260

6.58 Jul 29, 2021: Rockwell Medical to Report Second Quarter 2021 Financial and Operating Results on August 16, 2021 263

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

2.0 and MedTech Innovations Summit 263

6.60 Jul 29, 2021: Poly Medicure announce Unaudited Quarterly Financial Results(Standalone & Consolidated) For The Quarter Ended

30.06.2021 263

6.61 Jul 29, 2021: Poly Medicure Announces Un-Audited Financial Results for the First Quarter ended on 30th June 2021 264

6.62 Jul 13, 2021: AngioDynamics Reports Fiscal 2021 Fourth Quarter and Full-Year Financial Results 264

6.63 Jul 09, 2021: Merit Medical Systems to Announce Second Quarter Results on July 29, 2021 266

6.64 Jul 08, 2021: Nephros Announces Preliminary Results for Second Quarter of 2021 266

6.65 Jul 01, 2021: Renalytix announce Directorate Change 266

6.66 Jun 30, 2021: B. Braun Announces Jennifer Prioleau as New Chief Legal Officer and Chief Compliance Officer 267

6.67 Jun 30, 2021: Asahi Kasei Announces Q1 2021 Financial Results 267

6.68 Jun 24, 2021: Renalytix AI: Change of name 267

6.69 Jun 15, 2021: Renalytix Reports Financial Results for Third Quarter of Fiscal Year 2021 268

6.70 Jun 15, 2021: Baxter to Host Second-Quarter 2021 Financial Results Conference Call for Investors 269

6.71 Jun 10, 2021: Satellite Healthcare Names Chief Medical Officer for New Value-Based Care Division 269

6.72 Jun 10, 2021: Renalytix to Report Financial Results for Fiscal Third Quarter 2021 and Provide Corporate Update 270

6.73 Jun 09, 2021: Somatus aims to address health disparities in kidney care through innovative research partnerships and access to exclusive data 270

6.74 May 24, 2021: Boston Scientific to Participate in Bernstein’s 37th Annual Strategic Decisions Conference 270

6.75 May 17, 2021: Rockwell Medical Provides First Quarter 2021 Financial and Operational Update 271

6.76 May 12, 2021: JMS Announces Financial Results for the Fiscal Year Ended March 31, 2021 272

6.77 May 06, 2021: ICU Medical Announces First Quarter 2021 Results 274

6.78 May 06, 2021: Nephros Announces Results for Quarter Ended March 31, 2021 275

6.79 Apr 29, 2021: Teleflex Reports First Quarter 2021 Results 276

7 Appendix 281

7.1 Methodology 281

7.2 About GlobalData 284

7.3 Contact Us 284

7.4 Disclaimer 284

List of Tables

Renal Dialysis Equipment – Pipeline Products by Stage of Development 21

Renal Dialysis Equipment – Pipeline Products by Segment 23

Renal Dialysis Equipment – Pipeline Products by Territory 25

Renal Dialysis Equipment – Pipeline Products by Regulatory Path 26

Renal Dialysis Equipment – Pipeline Products by Estimated Approval Date 27

Renal Dialysis Equipment – Ongoing Clinical Trials 28

Renal Dialysis Equipment Companies – Pipeline Products by Stage of Development 29

Renal Dialysis Equipment – Pipeline Products by Stage of Development 33

Access Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 37

Dialysis Catheter – Product Status 37

Dialysis Catheter – Product Description 37

Dialysis Port – Product Status 38

Dialysis Port – Product Description 38

Advanced Dialysis Methods Ltd. Pipeline Products & Ongoing Clinical Trials Overview 39

Vibro-Care – Product Status 39

Vibro-Care – Product Description 39

Advent Access Pte Ltd Pipeline Products & Ongoing Clinical Trials Overview 40

av-Guardian – Product Status 40

av-Guardian – Product Description 40

AngioDynamics Inc Pipeline Products & Ongoing Clinical Trials Overview 41

Acuswift – Product Status 41

Acuswift – Product Description 41

Next Generation Dialysis Device – Product Status 42

Next Generation Dialysis Device – Product Description 42

Angiotech Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 43

5-FU Anti-Infective HemoStream Dialysis Catheter – Product Status 43

5-FU Anti-Infective HemoStream Dialysis Catheter – Product Description 43

Aperture Biomedical LLC Pipeline Products & Ongoing Clinical Trials Overview 44

Vascular Access Device – Hemodialysis – Product Status 44

Vascular Access Device – Hemodialysis – Product Description 44

Ariste Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 45

Drug Eluting Tunneled Dialysis Catheter – Product Status 45

Drug Eluting Tunneled Dialysis Catheter – Product Description 45

Ash Access Technology Inc Pipeline Products & Ongoing Clinical Trials Overview 46

MaxFlow – Product Status 46

MaxFlow – Product Description 46

SureFlow – Product Status 47

SureFlow – Product Description 47

Baxter International Inc Pipeline Products & Ongoing Clinical Trials Overview 48

CWP 800 Mini – Product Status 48

CWP 800 Mini – Product Description 48

Non PVC CAPD – Product Status 49

Non PVC CAPD – Product Description 49

oXiris – Product Status 49

oXiris – Product Description 50

Point of Care Generation 1 System – Product Status 50

Point of Care Generation 1 System – Product Description 50

Point of Care Generation 2 System – Product Status 51

Point of Care Generation 2 System – Product Description 51

PrisMax 2 System – Product Status 51

PrisMax 2 System – Product Description 52

Baxter International Inc – Ongoing Clinical Trials Overview 53

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 54

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 54

oXiris – Antibiotic Plasma Concentrations During Continuous Renal Replacement Therapy with a High Adsorption Membrane (oXiris) 55

oXiris – Clinical Study of Microcirculatory Parameters in Septic/Septic Shock Patients Treated with Oxiris Filter 56

oXiris – Effect of Oxiris Membrane on Microcirculation Following Cardiac Surgery Under Cardiopulmonary Bypass: A Pilot Prospective Monocentric Study (Oxicard Study) 56

oXiris – Effects of Removal of Endotoxin, Cytokines, and Uremic Toxins Using Blood Purification on Patients with Severe Septic Shock 56

oXiris – Endotoxins and Cytokines Removal During Continuous Hemofiltration with oXiris 57

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 57

oXiris – Renal Replacement Therapy with a Cytokine Absorption Filter (oXiris) in Patients with Septic Shock: a Case-control Study Nested in a Cohort 57

oXiris – The Effect of a Hemoperfusion with Polyethyleneimine-coated Membrane Filter (Oxiris) in Patients with Septic Shock: A Multicenter Randomized Controlled Trial 58

oXiris – The Effects of oXiris on Systemic Inflammation, Endothelial Dysfunction and Volume Control in Cardiac Surgery Patients Undergoing Cardiopulmonary Bypass 58

Biosurfaces Inc Pipeline Products & Ongoing Clinical Trials Overview 59

NuSpun Vascular Graft – Product Status 59

NuSpun Vascular Graft – Product Description 59

Bioteque Corp Pipeline Products & Ongoing Clinical Trials Overview 60

Fold-Proof Dialysis Catheter – Product Status 60

Fold-Proof Dialysis Catheter – Product Description 60

BOA Biomedical Inc Pipeline Products & Ongoing Clinical Trials Overview 61

GARNET Device – Product Status 61

GARNET Device – Product Description 61

BOA Biomedical Inc – Ongoing Clinical Trials Overview 62

GARNET Device – Feasibility of Hemodialysis with the GARNET Device in Chronic Hemodialysis Patients with a Bloodstream Infection 63

Brookhaven Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 64

Hemoaccess Valve System – Product Status 64

Hemoaccess Valve System – Product Description 64

Byonyks Pipeline Products & Ongoing Clinical Trials Overview 65

Robo-Kidney – Product Status 65

Robo-Kidney – Product Description 65

CatheNect Medical Pipeline Products & Ongoing Clinical Trials Overview 66

Peritoneal Dialysis Catheter – Product Status 66

Peritoneal Dialysis Catheter – Product Description 66

Cerovations LLC Pipeline Products & Ongoing Clinical Trials Overview 67

Contamination Resistant Interconnection Device – Product Status 67

Contamination Resistant Interconnection Device – Product Description 67

Chemica Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 68

Portable Hemodialysis System – Product Status 68

Portable Hemodialysis System – Product Description 68

Chrysalis Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 69

Hemodialysis Catheter – Product Status 69

Hemodialysis Catheter – Product Description 69

Columbia University Pipeline Products & Ongoing Clinical Trials Overview 70

Hemodialysis Access Flow Restrictor Device – Product Status 70

Hemodialysis Access Flow Restrictor Device – Product Description 70

CR Bard Inc Pipeline Products & Ongoing Clinical Trials Overview 71

Glidepath LE – Product Status 71

Glidepath LE – Product Description 71

CVS Kidney Care Pipeline Products & Ongoing Clinical Trials Overview 72

HemoCare Hemodialysis System – Product Status 72

HemoCare Hemodialysis System – Product Description 72

CVS Kidney Care – Ongoing Clinical Trials Overview 73

HemoCare Hemodialysis System – An Open Label Study to HemoCare Hemodialysis System for Home Hemodialysis Prior to Market Authorization 74

HemoCare Hemodialysis System – Clinical Evaluation of the HemoCare Hemodialysis System for Home Nocturnal Hemodialysis 74

Cytograft Tissue Engineering Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 75

Lifeline TEBV – AV Shunt – Product Status 75

Lifeline TEBV – AV Shunt – Product Description 75

Debiotech SA Pipeline Products & Ongoing Clinical Trials Overview 76

DialEase – Product Status 76

DialEase – Product Description 76

Renal Expres – Product Status 77

Renal Expres – Product Description 77

Diality Inc Pipeline Products & Ongoing Clinical Trials Overview 78

Dharma – Product Status 78

Dharma – Product Description 78

Diavantis Pipeline Products & Ongoing Clinical Trials Overview 79

Vivaxs Liva – Product Status 79

Vivaxs Liva – Product Description 79

Diavantis – Ongoing Clinical Trials Overview 80

Vivaxs Liva – Bone Anchored Port – A Novel Vascular Access for Hemodialysis Treatment 81

Districlass Medical SA Pipeline Products & Ongoing Clinical Trials Overview 82

DIALCAN – Product Status 82

DIALCAN – Product Description 82

Ellen Medical Devices Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 83

Solar-Powered Dialysis Machine – Product Status 83

Solar-Powered Dialysis Machine – Product Description 83

Emory University Pipeline Products & Ongoing Clinical Trials Overview 84

KIDS CRRT – Product Status 84

KIDS CRRT – Product Description 84

Eqalix, Inc. Pipeline Products & Ongoing Clinical Trials Overview 85

RenalEase – Product Status 85

RenalEase – Product Description 85

ExThera Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 86

Seraph 200 – Product Status 86

Seraph 200 – Product Description 86

Fistulink Ltd. Pipeline Products & Ongoing Clinical Trials Overview 87

Fistulink Device – Product Status 87

Fistulink Device – Product Description 87

Fresenius Medical Care AG & Co KGaA Pipeline Products & Ongoing Clinical Trials Overview 88

FX CorAL 600 – Product Status 88

FX CorAL 600 – Product Description 88

Hemodialysis System – Blood Clotting – Product Status 89

Hemodialysis System – Blood Clotting – Product Description 89

Ultrafiltration Device – Product Status 89

Ultrafiltration Device – Product Description 90

Fresenius Medical Care AG & Co KGaA – Ongoing Clinical Trials Overview 91

FX CorAL 600 – Comparison of Clinical Performance and Hemocompatibility of Dialyzers Applied During Post-dilution Online Hemodiafiltration – eMPORA III Study (Modified Polysulfone membrane) 92

Fresenius Medical Care Holdings Inc Pipeline Products & Ongoing Clinical Trials Overview 93

Hospital Renal Replacement Device – Product Status 93

Hospital Renal Replacement Device – Product Description 93

Portable Table Top HD Machine – Product Status 94

Portable Table Top HD Machine – Product Description 94

Gambro Dasco SpA Pipeline Products & Ongoing Clinical Trials Overview 95

Artis Dialysis System – Product Status 95

Artis Dialysis System – Product Description 95

Gambro Dialysatoren GmbH Pipeline Products & Ongoing Clinical Trials Overview 96

Theranova 400 Dialyzer – Product Status 96

Theranova 400 Dialyzer – Product Description 96

Theranova 500 Dialyzer – Product Status 97

Theranova 500 Dialyzer – Product Description 97

Gambro Dialysatoren GmbH – Ongoing Clinical Trials Overview 98

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) 99

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 99

Theranova 400 Dialyzer – Effect of Hemodiafiltration Plus MCOs on Uremic Toxins Removal 99

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 100

Theranova 400 Dialyzer – Randomized Controlled Trial of Theranova Versus High-flux Dialyzer on Preservation of Residual Renal Function in Incident Hemodialysis Patients 100

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) 101

Georgia Institute of Technology Pipeline Products & Ongoing Clinical Trials Overview 102

Disposable Cassette Device – Dialysis – Product Status 102

Disposable Cassette Device – Dialysis – Product Description 102

Pediatric Renal Dialysis Device – Product Status 103

Pediatric Renal Dialysis Device – Product Description 103

Glomeria Therapeutics srl Pipeline Products & Ongoing Clinical Trials Overview 104

DesmoHD – Product Status 104

DesmoHD – Product Description 104

Smart Hemo – Product Status 105

Smart Hemo – Product Description 105

Haemair Ltd Pipeline Products & Ongoing Clinical Trials Overview 106

Extracorporeal Membrane Oxygenation (ECMO) Device – Product Status 106

Extracorporeal Membrane Oxygenation (ECMO) Device – Product Description 106

Healionics Corporation Pipeline Products & Ongoing Clinical Trials Overview 107

STARcuff – Product Status 107

STARcuff – Product Description 107

STARgraft AV+ – Product Status 108

STARgraft AV+ – Product Description 108

STARport – Product Status 108

STARport – Product Description 109

Hemotek Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 110

V-Needle – Product Status 110

V-Needle – Product Description 110

Humacyte Inc Pipeline Products & Ongoing Clinical Trials Overview 111

HUMACYL – End Stage Renal Disease – Product Status 111

HUMACYL – End Stage Renal Disease – Product Description 111

HumaGraft – Product Status 112

HumaGraft – Product Description 112

Humacyte Inc – Ongoing Clinical Trials Overview 113

HumaGraft – A Phase II Assessment of Humacyte’s Human Acellular Vessel in Patients Needing Vascular Access for Dialysis 114

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 114

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 114

HUMACYL – 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 115

HUMACYL – 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 115

HUMACYL – End Stage Renal Disease – Individual Patient Expanded Access for Human Acellular Vessel (HAV) 115

Indian Institute of Technology Bombay Pipeline Products & Ongoing Clinical Trials Overview 116

Dialysis Cuff – Product Status 116

Dialysis Cuff – Product Description 116

Infomed SA Pipeline Products & Ongoing Clinical Trials Overview 117

DIMI Home Hemodialysis Device – Product Status 117

DIMI Home Hemodialysis Device – Product Description 117

DIMI PD System – Product Status 118

DIMI PD System – Product Description 118

Infomed SA – Ongoing Clinical Trials Overview 119

DIMI Home Hemodialysis Device – A Prospective Multicenter, Open Label, Non-randomized, Cross-over Study Evaluating the Use of the DIMI Renal Replacement Therapy (RRT) System In-center by Trained Dialysis Nurses and In-home by Trained Care Partners and Patients with End Stage Renal Disease (ESRD) Who are on Stable Dialysis Regimens 120

InnAVasc Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 121

InnAVasc Arteriovenous Graft Surgical Implant – Product Status 121

InnAVasc Arteriovenous Graft Surgical Implant – Product Description 121

InnAVasc Medical Inc – Ongoing Clinical Trials Overview 122

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 123

Innovative BioTherapies Inc Pipeline Products & Ongoing Clinical Trials Overview 124

Selective Cytopheretic Device Gen 2 – Pediatrics – Product Status 124

Selective Cytopheretic Device Gen 2 – Pediatrics – Product Description 124

Innovative BioTherapies Inc – Ongoing Clinical Trials Overview 125

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) 126

Katharos, Inc. Pipeline Products & Ongoing Clinical Trials Overview 127

Phosphates Removing Device – Hemodialysis – Product Status 127

Phosphates Removing Device – Hemodialysis – Product Description 127

Koronis Biomedical Technologies Corporation Pipeline Products & Ongoing Clinical Trials Overview 128

Continuous Renal Replacement Therapy Device – Product Status 128

Continuous Renal Replacement Therapy Device – Product Description 128

Laminate Medical Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 129

VasQ – Product Status 129

VasQ – Product Description 129

Laminate Medical Technologies Ltd – Ongoing Clinical Trials Overview 130

VasQ – A Multi-center Prospective Study to Evaluate the Safety and Effectiveness of the VasQ External Support for Arteriovenous Fistula 131

LiberDi Ltd Pipeline Products & Ongoing Clinical Trials Overview 132

Smart Peritoneal Dialysis System – Product Status 132

Smart Peritoneal Dialysis System – Product Description 132

LiberDi Ltd – Ongoing Clinical Trials Overview 133

Smart Peritoneal Dialysis System – A Single Arm, Prospective, Open Label, Cross-over, Multi-center Study to Evaluate the Safety, Feasibility and Usability of the Intelligent Dialysis Assistant (IDA) 134

Mar Cor Purification Inc Pipeline Products & Ongoing Clinical Trials Overview 135

Sentri Central Water System – Product Status 135

Sentri Central Water System – Product Description 135

Marvao Medical Devices Ltd Pipeline Products & Ongoing Clinical Trials Overview 136

NexSite Hemodialysis Catheter – Product Status 136

NexSite Hemodialysis Catheter – Product Description 136

Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 137

HD Multi-Pass System – Product Status 137

HD Multi-Pass System – Product Description 137

HDS – Hemodialysis System – Product Status 138

HDS – Hemodialysis System – Product Description 138

Minnesota Health Solutions Corporation Pipeline Products & Ongoing Clinical Trials Overview 139

Dialysis Access Dysfunction Treatment Device – Product Status 139

Dialysis Access Dysfunction Treatment Device – Product Description 139

Nanodialysis BV Pipeline Products & Ongoing Clinical Trials Overview 140

Portable Hemodialysis Device – Product Status 140

Portable Hemodialysis Device – Product Description 140

NanoVasc, Inc. Pipeline Products & Ongoing Clinical Trials Overview 141

NanoVasc Polyurethane Graft – Product Status 141

NanoVasc Polyurethane Graft – Product Description 141

Neokidney Development BV Pipeline Products & Ongoing Clinical Trials Overview 142

Neokidney 2.0 – Product Status 142

Neokidney 2.0 – Product Description 142

Nephros Inc Pipeline Products & Ongoing Clinical Trials Overview 143

EndoPur Endotoxin 40” Filter – Product Status 143

EndoPur Endotoxin 40” Filter – Product Description 143

Nicast Ltd Pipeline Products & Ongoing Clinical Trials Overview 144

Improved Version Of The AVflo Vascular Access Graft – Product Status 144

Improved Version Of The AVflo Vascular Access Graft – Product Description 144

Nikkiso Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 145

Artificial Kidneys – Product Status 145

Artificial Kidneys – Product Description 145

Blood Volume Monitor For DCG-03 / DBG-03 – Product Status 146

Blood Volume Monitor For DCG-03 / DBG-03 – Product Description 146

Next Generation Dialysis Machine – Product Status 146

Next Generation Dialysis Machine – Product Description 147

Nipro Corp Pipeline Products & Ongoing Clinical Trials Overview 148

SafeTouch Dialysis CATH Plus P – Product Status 148

SafeTouch Dialysis CATH Plus P – Product Description 148

Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 149

Adjustable Banding Device – Product Status 149

Adjustable Banding Device – Product Description 149

Hemodialysis Needle – Product Status 150

Hemodialysis Needle – Product Description 150

Novaflux Technologies Pipeline Products & Ongoing Clinical Trials Overview 151

Outside-In (OI) Dialysis Filter – Product Status 151

Outside-In (OI) Dialysis Filter – Product Description 151

NuVascular Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 152

NuSpun Central Venous Catheter Cuff – Product Status 152

NuSpun Central Venous Catheter Cuff – Product Description 152

NuSpun Hemodialysis Access Graft – Product Status 153

NuSpun Hemodialysis Access Graft – Product Description 153

NxStage Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 154

Next Generation Critical Care System – Product Status 154

Next Generation Critical Care System – Product Description 154

NxStage System One – Peritoneal Dialysis – Product Status 155

NxStage System One – Peritoneal Dialysis – Product Description 155

Occlutech International AB Pipeline Products & Ongoing Clinical Trials Overview 156

Dialysis Prosthesis Device – Product Status 156

Dialysis Prosthesis Device – Product Description 156

Oxford Biomaterials Ltd Pipeline Products & Ongoing Clinical Trials Overview 157

SpiderGraft – Product Status 157

SpiderGraft – Product Description 157

Padmaseetha Technologies Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 158

mCAPD – Product Status 158

mCAPD – Product Description 158

Phase One Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 159

Goldilocks Valved Hemodialysis Catheter – Product Status 159

Goldilocks Valved Hemodialysis Catheter – Product Description 159

Reversus Hemodialysis Catheter – Product Status 160

Reversus Hemodialysis Catheter – Product Description 160

Phraxis, Inc. Pipeline Products & Ongoing Clinical Trials Overview 161

Phraxis InterGraft – Product Status 161

Phraxis InterGraft – Product Description 161

Physiologas Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 162

Home Dialysis Machine – Product Status 162

Home Dialysis Machine – Product Description 162

Pursuit Vascular, Inc Pipeline Products & Ongoing Clinical Trials Overview 163

ClearGuard HD End Cap – Product Status 163

ClearGuard HD End Cap – Product Description 163

Qidni Labs Inc Pipeline Products & Ongoing Clinical Trials Overview 164

Implantable Renal Replacement Therapy Device – Product Status 164

Implantable Renal Replacement Therapy Device – Product Description 164

Quanta Dialysis Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 165

Advanced Haemodialysis System – Nocturnal Use – Product Status 165

Advanced Haemodialysis System – Nocturnal Use – Product Description 165

Rajamadhangi Medical Technologies Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 166

Dialysis Cartridge – Product Status 166

Dialysis Cartridge – Product Description 166

Rambam Health Care Campus Pipeline Products & Ongoing Clinical Trials Overview 167

Peritoneal Dialysis Device – Product Status 167

Peritoneal Dialysis Device – Product Description 167

Redsense Medical AB Pipeline Products & Ongoing Clinical Trials Overview 168

Redsense Clamp – Product Status 168

Redsense Clamp – Product Description 168

RegenMedTX LLC Pipeline Products & Ongoing Clinical Trials Overview 169

Neo-Vessel Replacement – Vascular Access Graft – Product Status 169

Neo-Vessel Replacement – Vascular Access Graft – Product Description 169

Renal Solutions Inc Pipeline Products & Ongoing Clinical Trials Overview 170

Dialysate Regeneration System – Peritoneal Dialysis – Product Status 170

Dialysate Regeneration System – Peritoneal Dialysis – Product Description 170

SeaStar Medical Pipeline Products & Ongoing Clinical Trials Overview 171

Selective Cytopheretic Device – Adult Use – Product Status 171

Selective Cytopheretic Device – Adult Use – Product Description 171

Selective Cytopheretic Device – Pediatric Use – Product Status 172

Selective Cytopheretic Device – Pediatric Use – Product Description 172

SeaStar Medical – Ongoing Clinical Trials Overview 173

Selective Cytopheretic Device – Adult Use – Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients (ERSD) 174

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 174

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 174

Senexis Limited (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 175

Dialysis Related Amyloidosis Device – Product Status 175

Dialysis Related Amyloidosis Device – Product Description 175

Silmag SA Pipeline Products & Ongoing Clinical Trials Overview 176

Cuffed Or Non-Cuffed Peritoneal Dialysis Catheter – Product Status 176

Cuffed Or Non-Cuffed Peritoneal Dialysis Catheter – Product Description 176

Silicone Hemodialysis Catheter Kit – Product Status 177

Silicone Hemodialysis Catheter Kit – Product Description 177

Simergent LLC Pipeline Products & Ongoing Clinical Trials Overview 178

Archimedes System – Product Status 178

Archimedes System – Product Description 178

Disposable Tubing Set – Product Status 179

Disposable Tubing Set – Product Description 179

Faraday – Product Status 179

Faraday – Product Description 180

Southern Illinois University Carbondale Pipeline Products & Ongoing Clinical Trials Overview 181

Material Retrieval Device – Product Status 181

Material Retrieval Device – Product Description 181

Specialty Renal Products Inc Pipeline Products & Ongoing Clinical Trials Overview 182

Dialysate Regeneration Filter System – Product Status 182

Dialysate Regeneration Filter System – Product Description 182

Second-Generation HDF System – Product Status 183

Second-Generation HDF System – Product Description 183

Stent Tek Ltd Pipeline Products & Ongoing Clinical Trials Overview 184

ePATH AVF Device – Product Status 184

ePATH AVF Device – Product Description 184

TEI Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 185

Biologic Vascular Graft – Product Status 185

Biologic Vascular Graft – Product Description 185

Thorn Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 186

Neocare Peritoneal Dialysis Machine – Product Status 186

Neocare Peritoneal Dialysis Machine – Product Description 186

Triomed AB Pipeline Products & Ongoing Clinical Trials Overview 187

Carry Life Renal – Product Status 187

Carry Life Renal – Product Description 187

Carry Life UF – Product Status 188

Carry Life UF – Product Description 188

University of Arizona Pipeline Products & Ongoing Clinical Trials Overview 189

Percutaneous Vascular Anastomosis Device – Dialysis – Product Status 189

Percutaneous Vascular Anastomosis Device – Dialysis – Product Description 189

University of California Pipeline Products & Ongoing Clinical Trials Overview 190

Smart Dialysis Catheter – Product Status 190

Smart Dialysis Catheter – Product Description 190

University of California San Francisco Pipeline Products & Ongoing Clinical Trials Overview 191

iHemo Dialysis System – Product Status 191

iHemo Dialysis System – Product Description 191

Implantable Device – Percutaneous AVF – Product Status 192

Implantable Device – Percutaneous AVF – Product Description 192

University of Colorado Pipeline Products & Ongoing Clinical Trials Overview 193

Nanocomposite Material Vascular Graft – Product Status 193

Nanocomposite Material Vascular Graft – Product Description 193

University of Limerick Pipeline Products & Ongoing Clinical Trials Overview 194

Prolong AV Graft – Product Status 194

Prolong AV Graft – Product Description 194

University of Michigan Pipeline Products & Ongoing Clinical Trials Overview 195

Cold Dialysate Regeneration System – Product Status 195

Cold Dialysate Regeneration System – Product Description 195

University of Rochester Pipeline Products & Ongoing Clinical Trials Overview 196

Nanoporous Membrane Based Hemodialyzer – Product Status 196

Nanoporous Membrane Based Hemodialyzer – Product Description 196

University of Texas Southwestern Medical Center Pipeline Products & Ongoing Clinical Trials Overview 197

PercSac – Product Status 197

PercSac – Product Description 197

University of Vermont Pipeline Products & Ongoing Clinical Trials Overview 198

Weighted Peritoneal Dialysis Catheter Anchor – Product Status 198

Weighted Peritoneal Dialysis Catheter Anchor – Product Description 198

Vanderbilt University Pipeline Products & Ongoing Clinical Trials Overview 199

Hemocartridge – Product Status 199

Hemocartridge – Product Description 199

Vascoscope BV Pipeline Products & Ongoing Clinical Trials Overview 200

Vascoscope – Hemodialysis – Product Status 200

Vascoscope – Hemodialysis – Product Description 200

Vascudyne Inc Pipeline Products & Ongoing Clinical Trials Overview 201

TRUE Vascular Graft – Hemodialysis – Product Status 201

TRUE Vascular Graft – Hemodialysis – Product Description 201

Vascudyne Inc – Ongoing Clinical Trials Overview 202

TRUE Vascular Graft – Hemodialysis – Preliminary Safety of The TRUE Vascular Graft for Hemodialysis Access: TRUE HD I Study 203

Vascular Genesis Pipeline Products & Ongoing Clinical Trials Overview 204

The Vascular Genesis AVs – Product Status 204

The Vascular Genesis AVs – Product Description 204

Verasonics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 205

Transcutaneous Ultrasound Device – Product Status 205

Transcutaneous Ultrasound Device – Product Description 205

Vital Access Corp Pipeline Products & Ongoing Clinical Trials Overview 206

Venous Window Access Device – Product Status 206

Venous Window Access Device – Product Description 206

Vizio Medical Devices Pipeline Products & Ongoing Clinical Trials Overview 207

Ambulatory Wearable Device – Product Status 207

Ambulatory Wearable Device – Product Description 207

Voyager Biomedical Inc Pipeline Products & Ongoing Clinical Trials Overview 208

ARK – Product Status 208

ARK – Product Description 208

Xeltis AG Pipeline Products & Ongoing Clinical Trials Overview 209

Xeltis Hemodialysis Access Graft – Product Status 209

Xeltis Hemodialysis Access Graft – Product Description 209

Xeltis AG – Ongoing Clinical Trials Overview 210

Xeltis Hemodialysis Access Graft – First-in-Human (FIH) Study of the Xeltis Hemodialysis Access Graft (aXess) 211

Xerem Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 212

Hemodialysis Implant – Product Status 212

Hemodialysis Implant – Product Description 212

Glossary 283

List of Figures

Renal Dialysis Equipment – Pipeline Products by Stage of Development 21

Renal Dialysis Equipment – Pipeline Products by Segment 22

Renal Dialysis Equipment – Pipeline Products by Territory 24

Renal Dialysis Equipment – Pipeline Products by Regulatory Path 26

Renal Dialysis Equipment – Pipeline Products by Estimated Approval Date 27

Renal Dialysis Equipment – Ongoing Clinical Trials 28

Frequently Asked Questions

The US, Europe, Australia, China, Canada, India, Israel, Japan, New Zealand, Singapore, the UK, Brazil, Argentina, Bermuda, Colombia, Costa Rica, Ecuador, El Salvador, Italy, Chile, France, Germany, South Africa, South Korea, Taiwan, the UAE, Pakistan, and Mexico have products in the pipeline.

Some of the key companies in the renal dialysis equipment market are Access Vascular Inc, AngioDynamics Inc, Angiotech Pharmaceuticals Inc, Ariste Medical LLC, Ash Access Technology Inc, Advanced Dialysis Methods Ltd., Advent Access Pte Ltd, Aperture Biomedical LLC, Baxter International Inc, Biosurfaces Inc, Bioteque Corp, BOA Biomedical Inc, and Brookhaven Medical Inc.

Key regulatory paths used in the renal dialysis equipment pipeline product market are 510(k), CE, TGA, MDL, Ninsho, NMPA, PMA, HSA, ICAC, MIDATC, HDE Approvals, BOPA, ANVISA, de novo, BLA, INVIMA, UKCA.

The renal dialysis equipment pipeline product market report offers information on pipeline products of several companies including Access Vascular Inc, Advanced Dialysis Methods Ltd., Advent Access Pte Ltd, AngioDynamics Inc, Angiotech Pharmaceuticals Inc, Aperture Biomedical LLC, Ariste Medical LLC, Ash Access Technology Inc, Baxter International Inc, Biosurfaces Inc, Bioteque Corp, BOA Biomedical Inc, Brookhaven Medical Inc, Byonyks, and CatheNect Medical.

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