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
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.
