Renal Dialysis Equipment-Medical Devices Pipeline Assessment, 2016

Renal Dialysis Equipment-Medical Devices Pipeline Assessment, 2016


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Executive Summary

Renal Dialysis Equipment-Medical Devices Pipeline Assessment, 2016

Summary

GlobalData's Medical Devices sector report, "Renal Dialysis Equipment-Medical Devices Pipeline Assessment, 2016" provides an overview of Renal Dialysis Equipment currently in pipeline stage.

The report provides comprehensive information on the pipeline products with comparative analysis of the products at various stages of development. The report reviews major players involved in the pipeline product development. It also provides information about clinical trials in progress, which includes trial phase, trial status, trial start and end dates, and, the number of trials for the key Renal Dialysis Equipment pipeline products.

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

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

Scope

Extensive coverage of the Renal Dialysis Equipment under development

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

The report reviews the major players involved in the development of 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

The report provides key clinical trial data of ongoing trials specific to pipeline products

Recent developments in the segment / industry

Reasons To Buy

The report enables you to-

Formulate significant competitor information, analysis, and insights to improve R&D strategies

Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage

Identify and understand important and diverse types of 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



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Ken Research
Ankur Gupta, Head Marketing & Communications

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1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 9

1.2 List of Figures 14

2 Introduction 15

2.1 Renal Dialysis Equipment Overview 15

3 Products under Development 17

3.1 Renal Dialysis Equipment-Pipeline Products by Stage of Development 17

3.2 Renal Dialysis Equipment-Pipeline Products by Segment 18

3.3 Renal Dialysis Equipment-Pipeline Products by Territory 19

3.4 Renal Dialysis Equipment-Pipeline Products by Regulatory Path 20

3.5 Renal Dialysis Equipment-Pipeline Products by Estimated Approval Date 21

3.6 Renal Dialysis Equipment-Ongoing Clinical Trials 22

4 Renal Dialysis Equipment-Pipeline Products under Development by Companies 23

4.1 Renal Dialysis Equipment Companies-Pipeline Products by Stage of Development 23

4.2 Renal Dialysis Equipment-Pipeline Products by Stage of Development 26

5 Renal Dialysis Equipment Companies and Product Overview 29

5.1 3S BioMedical, Inc. Company Overview 29

5.1.1 3S BioMedical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 29

5.2 Advanced Dialysis Methods Ltd. Company Overview 30

5.2.1 Advanced Dialysis Methods Ltd. Pipeline Products & Ongoing Clinical Trials Overview 30

5.3 Angiotech Pharmaceuticals Inc Company Overview 31

5.3.1 Angiotech Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 31

5.4 ARISTE Medical Company Overview 33

5.4.1 ARISTE Medical Pipeline Products & Ongoing Clinical Trials Overview 33

5.5 Asahi Kasei Corp Company Overview 34

5.5.1 Asahi Kasei Corp Pipeline Products & Ongoing Clinical Trials Overview 34

5.6 Ash Access Technology Inc Company Overview 36

5.6.1 Ash Access Technology Inc Pipeline Products & Ongoing Clinical Trials Overview 36

5.7 Avenu Medical, Inc. Company Overview 38

5.7.1 Avenu Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 38

5.8 AWAK Technologies Pte Ltd Company Overview 39

5.8.1 AWAK Technologies Pte Ltd Pipeline Products & Ongoing Clinical Trials Overview 39

5.9 B. Braun Melsungen AG Company Overview 40

5.9.1 B. Braun Melsungen AG Pipeline Products & Ongoing Clinical Trials Overview 40

5.10 Baxter International Inc Company Overview 41

5.10.1 Baxter International Inc Pipeline Products & Ongoing Clinical Trials Overview 41

5.11 Blood Purification Technologies, Inc. Company Overview 48

5.11.1 Blood Purification Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 48

5.12 Brookhaven Medical Inc Company Overview 49

5.12.1 Brookhaven Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 49

5.13 CatheNect Medical Company Overview 50

5.13.1 CatheNect Medical Pipeline Products & Ongoing Clinical Trials Overview 50

5.14 Chemica Technologies Inc Company Overview 51

5.14.1 Chemica Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 51

5.15 Chrysalis Medical Weight Loss Clinic (Inactive) Company Overview 52

5.15.1 Chrysalis Medical Weight Loss Clinic (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 52

5.16 Circuport Inc Company Overview 53

5.16.1 Circuport Inc Pipeline Products & Ongoing Clinical Trials Overview 53

5.17 Control Medical Technology, LLC Company Overview 54

5.17.1 Control Medical Technology, LLC Pipeline Products & Ongoing Clinical Trials Overview 54

5.18 Cytograft Tissue Engineering Inc Company Overview 55

5.18.1 Cytograft Tissue Engineering Inc Pipeline Products & Ongoing Clinical Trials Overview 55

5.19 CytoPherx, Inc. Company Overview 57

5.19.1 CytoPherx, Inc. Pipeline Products & Ongoing Clinical Trials Overview 57

5.20 Debiotech SA Company Overview 59

5.20.1 Debiotech SA Pipeline Products & Ongoing Clinical Trials Overview 59

5.21 DEKA Research and Development Corp Company Overview 63

5.21.1 DEKA Research and Development Corp Pipeline Products & Ongoing Clinical Trials Overview 63

5.22 Dipylon Medical AB (Inactive) Company Overview 65

5.22.1 Dipylon Medical AB (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 65

5.23 ExThera Medical Corporation Company Overview 66

5.23.1 ExThera Medical Corporation Pipeline Products & Ongoing Clinical Trials Overview 66

5.24 Fistulink Ltd. Company Overview 69

5.24.1 Fistulink Ltd. Pipeline Products & Ongoing Clinical Trials Overview 69

5.25 Flow Forward Medical, LLC Company Overview 70

5.25.1 Flow Forward Medical, LLC Pipeline Products & Ongoing Clinical Trials Overview 70

5.26 Fresenius Kidney Care Company Overview 71

5.26.1 Fresenius Kidney Care Pipeline Products & Ongoing Clinical Trials Overview 71

5.27 Fresenius Medical Care AG & Co KGaA Company Overview 72

5.27.1 Fresenius Medical Care AG & Co KGaA Pipeline Products & Ongoing Clinical Trials Overview 72

5.28 Georgia Institute of Technology Company Overview 75

5.28.1 Georgia Institute of Technology Pipeline Products & Ongoing Clinical Trials Overview 75

5.29 Glomeria Therapeutics srl Company Overview 77

5.29.1 Glomeria Therapeutics srl Pipeline Products & Ongoing Clinical Trials Overview 77

5.30 Healionics Corporation Company Overview 79

5.30.1 Healionics Corporation Pipeline Products & Ongoing Clinical Trials Overview 79

5.31 Indian Institute of Technology Bombay Company Overview 80

5.31.1 Indian Institute of Technology Bombay Pipeline Products & Ongoing Clinical Trials Overview 80

5.32 Laminate Medical Technologies Ltd. Company Overview 81

5.32.1 Laminate Medical Technologies Ltd. Pipeline Products & Ongoing Clinical Trials Overview 81

5.33 Marvao Medical Devices Limited Company Overview 83

5.33.1 Marvao Medical Devices Limited Pipeline Products & Ongoing Clinical Trials Overview 83

5.34 Medtronic plc Company Overview 85

5.34.1 Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 85

5.35 Miromatrix Medical Inc Company Overview 87

5.35.1 Miromatrix Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 87

5.36 Nanodialysis BV Company Overview 88

5.36.1 Nanodialysis BV Pipeline Products & Ongoing Clinical Trials Overview 88

5.37 NanoVasc, Inc. Company Overview 89

5.37.1 NanoVasc, Inc. Pipeline Products & Ongoing Clinical Trials Overview 89

5.38 Nephros Inc Company Overview 90

5.38.1 Nephros Inc Pipeline Products & Ongoing Clinical Trials Overview 90

5.39 Nicast Ltd Company Overview 92

5.39.1 Nicast Ltd Pipeline Products & Ongoing Clinical Trials Overview 92

5.40 NuVascular Technologies Inc Company Overview 93

5.40.1 NuVascular Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 93

5.41 NxStage Medical Inc Company Overview 95

5.41.1 NxStage Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 95

5.42 Peripal AG Company Overview 98

5.42.1 Peripal AG Pipeline Products & Ongoing Clinical Trials Overview 98

5.43 PeriTec Biosciences Ltd Company Overview 99

5.43.1 PeriTec Biosciences Ltd Pipeline Products & Ongoing Clinical Trials Overview 99

5.44 Phase One Medical LLC Company Overview 100

5.44.1 Phase One Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 100

5.45 qSTAR Medical SAS Company Overview 102

5.45.1 qSTAR Medical SAS Pipeline Products & Ongoing Clinical Trials Overview 102

5.46 Quanta Dialysis Technologies Ltd Company Overview 103

5.46.1 Quanta Dialysis Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 103

5.47 Rambam Health Care Campus Company Overview 104

5.47.1 Rambam Health Care Campus Pipeline Products & Ongoing Clinical Trials Overview 104

5.48 RenalGuard Solutions, Inc. Company Overview 105

5.48.1 RenalGuard Solutions, Inc. Pipeline Products & Ongoing Clinical Trials Overview 105

5.49 Senexis Limited (Inactive) Company Overview 109

5.49.1 Senexis Limited (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 109

5.50 TEI Biosciences Inc Company Overview 110

5.50.1 TEI Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 110

5.51 Tengion Inc Company Overview 111

5.51.1 Tengion Inc Pipeline Products & Ongoing Clinical Trials Overview 111

5.52 University of California San Francisco Company Overview 113

5.52.1 University of California San Francisco Pipeline Products & Ongoing Clinical Trials Overview 113

5.53 University of Limerick Company Overview 115

5.53.1 University of Limerick Pipeline Products & Ongoing Clinical Trials Overview 115

5.54 Vanderbilt University Company Overview 116

5.54.1 Vanderbilt University Pipeline Products & Ongoing Clinical Trials Overview 116

5.55 Vital Access Corp Company Overview 118

5.55.1 Vital Access Corp Pipeline Products & Ongoing Clinical Trials Overview 118

5.56 Vivonics, Inc. Company Overview 119

5.56.1 Vivonics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 119

5.57 Vizio Medical Devices Company Overview 120

5.57.1 Vizio Medical Devices Pipeline Products & Ongoing Clinical Trials Overview 120

6 Renal Dialysis Equipment- Recent Developments 121

6.1 Nov 22, 2016: Medtronic Reports Second Quarter Financial Results 121

6.2 Nov 22, 2016: HELIOS lays foundation stone for new hospital building in Wiesbaden 123

6.3 Nov 21, 2016: New Data Presented at ASN Kidney Week Spotlight Baxter's SHARESOURCE Telehealth Platform and AMIA APD System in Supporting More Efficient Home Dialysis Care 123

6.4 Nov 17, 2016: Fresenius Medical Care Showcases Breadth and Depth of Clinical Research with Nearly 70 Abstracts Slated for Presentation at the American Society of Nephrology 2016 Kidney Week Meeting 124

6.5 Nov 17, 2016: Baxter to Present 24 Abstracts at ASN Kidney Week 2016 Focused on Elevating the Standard of Care For Dialysis Patients Globally 125

6.6 Nov 16, 2016: New Data Shows Better Outcomes, Higher Quality of Life, Lower Cost of Care, and Increased Likelihood for Transplant with More Frequent Hemodialysis Using the NxStage System One 126

6.7 Nov 16, 2016: Medtronic Releases FY16 Integrated Performance Report 127

6.8 Nov 15, 2016: NanoVibronix Provides Third Quarter 2016 Business Update 128

6.9 Nov 15, 2016: CEVA to work with Medtronic for distribution facility construction 129

6.10 Nov 14, 2016: French Study Demonstrating Safety of RenalGuard During Kidney Tranplantation Presented at International Conference on Kidney 129

6.11 Nov 14, 2016: AngioDynamics Prices Public Offering of Shares for USD32 Million 130

6.12 Nov 10, 2016: Major Study Confirms ClearGuard HD Antimicrobial Barrier Caps Significantly Reduce Catheter-Related Bloodstream Infection and Associated Hospitalizations 130

6.13 Nov 09, 2016: ICU Medical Announces Third Quarter 2016 Results 131

6.14 Nov 09, 2016: AngioDynamics Announces Addition of New Board Members 132

6.15 Nov 07, 2016: Rockwell Medical Reports Third Quarter Results 132

6.16 Nov 03, 2016: NxStage Reports Third Quarter Financial Results; Raises Full-Year Revenue Guidance And Cuts Net Loss Guidance In Half 133

6.17 Nov 02, 2016: Population-Controlled Study Shows Increased Progression of Chronic Kidney Disease and Poorer Outcomes in PCI Patients With CI-AKI 134

6.18 Nov 01, 2016: Organovo Receives Strong Customer Response for ExVive Human Kidney Tissue Launch 135

6.19 Oct 31, 2016: Increased Focus on RenalGuard and the Prevention of Contrast-Induced Nephropathy at Transcatheter Cardiovascular Therapeutics 2016 135

6.20 Oct 31, 2016: New Study Confirms the Efficacy of RenalGuard Therapy in Preventing Kidney Injury in High-Risk Patients Undergoing Procedures Requiring Contrast 136

6.21 Oct 27, 2016: Fresenius Medical Care reports strong third quarter and confirms full year guidance 137

6.22 Oct 27, 2016: Teleflex Reports Third Quarter 2016 Results 139

6.23 Oct 27, 2016: Fresenius: Continued strong sales and earnings growth; Lower end of Group earnings guidance raised 141

6.24 Oct 26, 2016: Baxters AMIA with SHARESOURCE Telehealth Platform for Home Dialysis Named a Winner of 15th Annual Chicago Innovation Awards 145

6.25 Oct 26, 2016: Boston Scientific Announces Results For Third Quarter 2016 146

6.26 Oct 26, 2016: Merit Medical Reports Sales Up 15.3% for the Quarter Ended September 30, 2016 148

6.27 Oct 25, 2016: NxStage Announces Publication of Journal Supplement with Major Clinical Reviews Supporting More Frequent Hemodialysis Therapy 148

6.28 Oct 25, 2016: Baxter Reports Third Quarter 2016 Results and Increases Financial Outlook For Full-Year 2016 149

6.29 Oct 25, 2016: Bard Announces Third Quarter Results 150

6.30 Oct 21, 2016: NxStage Highlights Innovative Nx2me Platform Data at Partners HealthCare Connected Health Symposium & Expo 2016 151

6.31 Oct 20, 2016: NanoVibronix Expands Senior Management Team and Board of Directors 152

6.32 Oct 19, 2016: Baxter's Recently Launched SHARESOURCE Telehealth System Has Securely Managed 150,000 Home Dialysis Patient Treatments Globally 153

6.33 Oct 19, 2016: Baxter's Recently Launched SHARESOURCE Telehealth System with AMIA APD system 153

6.34 Oct 10, 2016: Professor Ian Meredith To Join Boston Scientific As Executive Vice President And Global Chief Medical Officer 154

6.35 Oct 05, 2016: AngioDynamics Reports Fiscal 2017 First Quarter Results 154

6.36 Oct 03, 2016: NxStage and Satellite Healthcare Announce New Three-Year Home Hemodialysis Agreement that Includes Innovative Nx2me Platform 155

6.37 Sep 20, 2016: Quanta to Present Interim Analysis of First 255 Treatments Using SC+ at the 10th International Congress of the ISHD 156

6.38 Sep 19, 2016: Fresenius Medical Care Announces Launch of 6008 CAREsystem Into the Asia-Pacific Market 157

6.39 Sep 15, 2016: Medtronic Names Mark Ploof Senior Vice President of Global Operations and Business Services 157

6.40 Sep 09, 2016: Teleflex to Present ARROW-Clark VectorFlow Chronic Hemodialysis Catheter at the Annual Meeting and Postgraduate Course of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE), to be held in Barcelona, Spain 158

6.41 Sep 01, 2016: B. Braun Renal Therapies Division To Launch New Class of Kidney Dialyzer 158

6.42 Aug 31, 2016: Italian Study Reconfirming Safety and Effectiveness of RenalGuard Presented at 8th World Nephrology Conference 159

6.43 Aug 31, 2016: Cook Medical Names Jean-Marc Creissel Vice President of Operations in Greater China 160

6.44 Aug 25, 2016: Medtronic Reports First Quarter Financial Results 160

6.45 Aug 17, 2016: Fresenius Kabi investing nearly $250 million to expand plant near Chicago 162

6.46 Aug 11, 2016: ExThera Medical Announces Updates on Seraph Development Program to be Presented at the 2016 Military Health System Research Summit (MHSRS) 163

6.47 Aug 08, 2016: NxStage Launches First of Many NxGen Features and Capabilities 164

6.48 Aug 08, 2016: ICU Medical Announces Second Quarter 2016 Results 164

6.49 Aug 08, 2016: Rockwell Medical Reports Second Quarter Results 165

6.50 Aug 04, 2016: NxStage Reports Second Quarter Financial Results And Raises Full-Year Revenue Guidance 165

6.51 Aug 01, 2016: Fresenius Medical Care posts accelerated earnings growth in the 2nd quarter 166

7 Appendix 230

7.1 Methodology 230

7.2 About GlobalData 233

7.3 Contact Us 233

7.4 Disclaimer 233

1.2 List of Figures

Figure 1: Renal Dialysis Equipment-Pipeline Products by Stage of Development 17

Figure 2: Renal Dialysis Equipment-Pipeline Products by Segment 18

Figure 3: Renal Dialysis Equipment-Pipeline Products by Territory 19

Figure 4: Renal Dialysis Equipment-Pipeline Products by Regulatory Path 20

Figure 5: Renal Dialysis Equipment-Pipeline Products by Estimated Approval Date 21

Figure 6: Renal Dialysis Equipment-Ongoing Clinical Trials 22

1.1 List of Tables

Table 1: Renal Dialysis Equipment-Pipeline Products by Stage of Development 17

Table 2: Renal Dialysis Equipment-Pipeline Products by Segment 18

Table 3: Renal Dialysis Equipment-Pipeline Products by Territory 19

Table 4: Renal Dialysis Equipment-Pipeline Products by Regulatory Path 20

Table 5: Renal Dialysis Equipment-Pipeline Products by Estimated Approval Date 21

Table 6: Renal Dialysis Equipment-Ongoing Clinical Trials 22

Table 7: Renal Dialysis Equipment Companies-Pipeline Products by Stage of Development 23

Table 8: Renal Dialysis Equipment-Pipeline Products by Stage of Development 26

Table 9: 3S BioMedical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 29

Table 10: Resorpor Hemodialysis Graft-Product Status 29

Table 11: Resorpor Hemodialysis Graft-Product Description 29

Table 12: Advanced Dialysis Methods Ltd. Pipeline Products & Ongoing Clinical Trials Overview 30

Table 13: Vibro-Care-Product Status 30

Table 14: Vibro-Care-Product Description 30

Table 15: Angiotech Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 31

Table 16: 5-FU Anti-Infective HemoStream Dialysis Catheter-Product Status 31

Table 17: 5-FU Anti-Infective HemoStream Dialysis Catheter-Product Description 31

Table 18: Vascular Wrap-Product Status 32

Table 19: Vascular Wrap-Product Description 32

Table 20: ARISTE Medical Pipeline Products & Ongoing Clinical Trials Overview 33

Table 21: Drug Eluting Tunneled Dialysis Catheter-Product Status 33

Table 22: Drug Eluting Tunneled Dialysis Catheter-Product Description 33

Table 23: Asahi Kasei Corp Pipeline Products & Ongoing Clinical Trials Overview 34

Table 24: APS Polysulfone-membrane Artificial Kidney-New Version-Product Status 34

Table 25: APS Polysulfone-membrane Artificial Kidney-New Version-Product Description 35

Table 26: Hemodialysis Equipment-Product Status 35

Table 27: Hemodialysis Equipment-Product Description 35

Table 28: Ash Access Technology Inc Pipeline Products & Ongoing Clinical Trials Overview 36

Table 29: MaxFlow-Product Status 36

Table 30: MaxFlow-Product Description 36

Table 31: SureFlow-Product Status 37

Table 32: SureFlow-Product Description 37

Table 33: Avenu Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 38

Table 34: Ellipsys Vascular Access System-Product Status 38

Table 35: Ellipsys Vascular Access System-Product Description 38

Table 36: AWAK Technologies Pte Ltd Pipeline Products & Ongoing Clinical Trials Overview 39

Table 37: AWAK-Product Status 39

Table 38: AWAK-Product Description 39

Table 39: B. Braun Melsungen AG Pipeline Products & Ongoing Clinical Trials Overview 40

Table 40: Xevonta Dialyzer-Product Status 40

Table 41: Xevonta Dialyzer-Product Description 40

Table 42: Baxter International Inc Pipeline Products & Ongoing Clinical Trials Overview 41

Table 43: Artis Dialysis System-Product Status 41

Table 44: Artis Dialysis System-Product Description 42

Table 45: Non PVC CAPD-Product Status 42

Table 46: Non PVC CAPD-Product Description 42

Table 47: PrisMAX V1-Product Status 43

Table 48: PrisMAX V1-Product Description 43

Table 49: Theralite-Product Status 43

Table 50: Theralite-Product Description 44

Table 51: VIVIA Hemodialysis System-Product Status 44

Table 52: VIVIA Hemodialysis System-Product Description 45

Table 53: Baxter International Inc-Ongoing Clinical Trials Overview 45

Table 54: VIVIA Hemodialysis System-A Study of Sleep Patterns in Patients Performing Nocturnal Home Dialysis Utilising the VIVIA System 46

Table 55: VIVIA Hemodialysis System-U.S. Clinical Trial for VIVIA Investigational Home Hemodialysis System 47

Table 56: Artis Dialysis System-Automated Setting of Individualized Sodium Technology (ASIST)-Proof of Principle Study 47

Table 57: Blood Purification Technologies, Inc. Pipeline Products & Ongoing Clinical Trials Overview 48

Table 58: Wearable Artificial Kidney-Product Status 48

Table 59: Wearable Artificial Kidney-Product Description 48

Table 60: Brookhaven Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 49

Table 61: CreatiVasc Hemoaccess Valve System-Product Status 49

Table 62: CreatiVasc Hemoaccess Valve System-Product Description 49

Table 63: CatheNect Medical Pipeline Products & Ongoing Clinical Trials Overview 50

Table 64: PD Catheter-Product Status 50

Table 65: PD Catheter-Product Description 50

Table 66: Chemica Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 51

Table 67: Dialysis Regeneration Cartridge-Product Status 51

Table 68: Dialysis Regeneration Cartridge-Product Description 51

Table 69: Chrysalis Medical Weight Loss Clinic (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 52

Table 70: Hemodialysis Catheter-Product Status 52

Table 71: Hemodialysis Catheter-Product Description 52

Table 72: Circuport Inc Pipeline Products & Ongoing Clinical Trials Overview 53

Table 73: Circuport System-Product Status 53

Table 74: Circuport System-Product Description 53

Table 75: Control Medical Technology, LLC Pipeline Products & Ongoing Clinical Trials Overview 54

Table 76: ASPIRE Hemodialysis-Product Status 54

Table 77: ASPIRE Hemodialysis-Product Description 54

Table 78: Cytograft Tissue Engineering Inc Pipeline Products & Ongoing Clinical Trials Overview 55

Table 79: Lifeline TEBV-AV Shunt-Product Status 55

Table 80: Lifeline TEBV-AV Shunt-Product Description 56

Table 81: CytoPherx, Inc. Pipeline Products & Ongoing Clinical Trials Overview 57

Table 82: Selective Cytopheretic Device-Product Status 57

Table 83: Selective Cytopheretic Device-Product Description 57

Table 84: CytoPherx, Inc.-Ongoing Clinical Trials Overview 58

Table 85: Selective Cytopheretic Device-A Multi-center, Pilot Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device (SCD) in Pediatric Patients with Acute Kidney Injury (AKI) 58

Table 86: Debiotech SA Pipeline Products & Ongoing Clinical Trials Overview 59

Table 87: DialEase-Product Status 59

Table 88: DialEase-Product Description 60

Table 89: Miniaturized Home Hemodialysis Machine-Product Status 60

Table 90: Miniaturized Home Hemodialysis Machine-Product Description 61

Table 91: Renal Expres-Product Status 61

Table 92: Renal Expres-Product Description 62

Table 93: DEKA Research and Development Corp Pipeline Products & Ongoing Clinical Trials Overview 63

Table 94: Amia Automated PD System With Sharesource-Product Status 63

Table 95: Amia Automated PD System With Sharesource-Product Description 64

Table 96: Dipylon Medical AB (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 65

Table 97: Peripheral Microdialysis Pump Kit-Product Status 65

Table 98: Peripheral Microdialysis Pump Kit-Product Description 65

Table 99: ExThera Medical Corporation Pipeline Products & Ongoing Clinical Trials Overview 66

Table 100: Seraph 200-Product Status 66

Table 101: Seraph 200-Product Description 67

Table 102: ExThera Medical Corporation-Ongoing Clinical Trials Overview 67

Table 103: Seraph 200-Safety and Performance Evaluation of the Seraph Microbind Affinity Blood Filter for Reducing Bacteria in Patients on Hemodialysis 68

Table 104: Fistulink Ltd. Pipeline Products & Ongoing Clinical Trials Overview 69

Table 105: Fistulink Device-Product Status 69

Table 106: Fistulink Device-Product Description 69

Table 107: Flow Forward Medical, LLC Pipeline Products & Ongoing Clinical Trials Overview 70

Table 108: AFE System-Product Status 70

Table 109: AFE System-Product Description 70

Table 110: Fresenius Kidney Care Pipeline Products & Ongoing Clinical Trials Overview 71

Table 111: Portable Artificial Kidney-Product Status 71

Table 112: Portable Artificial Kidney-Product Description 71

Table 113: Fresenius Medical Care AG & Co KGaA Pipeline Products & Ongoing Clinical Trials Overview 72

Table 114: Mobile hospital Hemodialysis device-Product Status 72

Table 115: Mobile hospital Hemodialysis device-Product Description 73

Table 116: Xcorporeal Wearable Artificial Kidney-Product Status 73

Table 117: Xcorporeal Wearable Artificial Kidney-Product Description 73

Table 118: XCR-6-Product Status 74

Table 119: XCR-6-Product Description 74

Table 120: Georgia Institute of Technology Pipeline Products & Ongoing Clinical Trials Overview 75

Table 121: KIDS CRRT-Product Status 75

Table 122: KIDS CRRT-Product Description 76

Table 123: Pediatric Renal Dialysis Machine-Product Status 76

Table 124: Pediatric Renal Dialysis Machine-Product Description 76

Table 125: Glomeria Therapeutics srl Pipeline Products & Ongoing Clinical Trials Overview 77

Table 126: DesmoHD-Product Status 77

Table 127: DesmoHD-Product Description 77

Table 128: Smart Hemo-Product Status 78

Table 129: Smart Hemo-Product Description 78

Table 130: Healionics Corporation Pipeline Products & Ongoing Clinical Trials Overview 79

Table 131: STARcuff-Product Status 79

Table 132: STARcuff-Product Description 79

Table 133: Indian Institute of Technology Bombay Pipeline Products & Ongoing Clinical Trials Overview 80

Table 134: Dialysis Cuff-Product Status 80

Table 135: Dialysis Cuff-Product Description 80

Table 136: Laminate Medical Technologies Ltd. Pipeline Products & Ongoing Clinical Trials Overview 81

Table 137: VasQ-Product Status 81

Table 138: VasQ-Product Description 81

Table 139: Laminate Medical Technologies Ltd.-Ongoing Clinical Trials Overview 82

Table 140: VasQ-A Prospective, Multi Center, Study to Evaluate the Safety and Efficacy of the Laminate External Support Device for Brachiocephalic Arteriovenous Fistula 82

Table 141: Marvao Medical Devices Limited Pipeline Products & Ongoing Clinical Trials Overview 83

Table 142: NexSite Hemodialysis Catheter-Product Status 83

Table 143: NexSite Hemodialysis Catheter-Product Description 83

Table 144: Marvao Medical Devices Limited-Ongoing Clinical Trials Overview 84

Table 145: NexSite Hemodialysis Catheter-Analysis of CRBSI (Catheter-related Blood Stream Infection) Rates in Patients with a NexSite HD (Hemodialysis) Catheter 84

Table 146: Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 85

Table 147: Portable Hemodialysis System-Product Status 85

Table 148: Portable Hemodialysis System-Product Description 86

Table 149: Miromatrix Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 87

Table 150: Miro Kidney-Product Status 87

Table 151: Miro Kidney-Product Description 87

Table 152: Nanodialysis BV Pipeline Products & Ongoing Clinical Trials Overview 88

Table 153: NEPHRON+ Wearable Artificial Kidney Device-Product Status 88

Table 154: NEPHRON+ Wearable Artificial Kidney Device-Product Description 88

Table 155: NanoVasc, Inc. Pipeline Products & Ongoing Clinical Trials Overview 89

Table 156: NanoVasc Polyurethane Graft-Product Status 89

Table 157: NanoVasc Polyurethane Graft-Product Description 89

Table 158: Nephros Inc Pipeline Products & Ongoing Clinical Trials Overview 90

Table 159: HydraGuard 10 Cartridge-Product Status 90

Table 160: HydraGuard 10 Cartridge-Product Description 91

Table 161: NanoGuard 10 Cartridge-Product Status 91

Table 162: NanoGuard 10 Cartridge-Product Description 91

Table 163: Nicast Ltd Pipeline Products & Ongoing Clinical Trials Overview 92

Table 164: Improved Version Of The AVflo Vascular Access Graft-Product Status 92

Table 165: Improved Version Of The AVflo Vascular Access Graft-Product Description 92

Table 166: NuVascular Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 93

Table 167: Artificial Hemodialysis Access Graft-Product Status 93

Table 168: Artificial Hemodialysis Access Graft-Product Description 93

Table 169: NuSpun Cuff-Product Status 94

Table 170: NuSpun Cuff-Product Description 94

Table 171: NxStage Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 95

Table 172: Next Generation Critical Care System-Product Status 95

Table 173: Next Generation Critical Care System-Product Description 96

Table 174: Next Generation NxStage System One-Product Status 96

Table 175: Next Generation NxStage System One-Product Description 96

Table 176: NxStage System One-Peritoneal Dialysis-Product Status 97

Table 177: NxStage System One-Peritoneal Dialysis-Product Description 97

Table 178: Peripal AG Pipeline Products & Ongoing Clinical Trials Overview 98

Table 179: Chronic Dialysis Patient Aid-Product Status 98

Table 180: Chronic Dialysis Patient Aid-Product Description 98

Table 181: PeriTec Biosciences Ltd Pipeline Products & Ongoing Clinical Trials Overview 99

Table 182: Dialysis Graft-Product Status 99

Table 183: Dialysis Graft-Product Description 99

Table 184: Phase One Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 100

Table 185: Goldilocks Valved Hemodialysis Catheter-Product Status 100

Table 186: Goldilocks Valved Hemodialysis Catheter-Product Description 101

Table 187: Reversus Hemodialysis Catheter-Product Status 101

Table 188: Reversus Hemodialysis Catheter-Product Description 101

Table 189: qSTAR Medical SAS Pipeline Products & Ongoing Clinical Trials Overview 102

Table 190: STARport HD-Product Status 102

Table 191: STARport HD-Product Description 102

Table 192: Quanta Dialysis Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 103

Table 193: Advanced Haemodialysis System-Nocturnal Use-Product Status 103

Table 194: Advanced Haemodialysis System-Nocturnal Use-Product Description 103

Table 195: Rambam Health Care Campus Pipeline Products & Ongoing Clinical Trials Overview 104

Table 196: Peritoneal Dialysis Device-Product Status 104

Table 197: Peritoneal Dialysis Device-Product Description 104

Table 198: RenalGuard Solutions, Inc. Pipeline Products & Ongoing Clinical Trials Overview 105

Table 199: RenalGuard System-Product Status 105

Table 200: RenalGuard System-Product Description 106

Table 201: RenalGuard Solutions, Inc.-Ongoing Clinical Trials Overview 106

Table 202: RenalGuard System-A Study to Evaluate RenalGuard System Safety and Efficacy When Compared with Standard Care in the Prevention of Contrast Induced Nephropathy in the Setting of a Catheterization Laboratory 107

Table 203: RenalGuard System-Reducing Acute Kidney Injury In TAVI Patients (REDUCE Trial) 107

Table 204: RenalGuard System-Renal Insufficiency Following Contrast Media Administration Trial III (Remedial III): Renalguard System Versus Left-ventricular End-diastolic Pressure-guided Hydration in High-risk Patients for Contrast-induced Acute Kidney Injury 107

Table 205: RenalGuard System-RenalGuard System for Prevention of Contrast Induced Nephropathy-A Randomized Trial 108

Table 206: RenalGuard System-RenalGuard System to Prevent Contrast-induced Acute Kidney Injury in Japan 108

Table 207: RenalGuard System-Study to Evaluate the Use of Renalguard to Protect Patients at High Risk of AKI (STRENGTH) 108

Table 208: Senexis Limited (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 109

Table 209: Device-Dialysis Related Amyloidosis-Product Status 109

Table 210: Device-Dialysis Related Amyloidosis-Product Description 109

Table 211: TEI Biosciences Inc Pipeline Products & Ongoing Clinical Trials Overview 110

Table 212: Biologic Vascular Graft-Product Status 110

Table 213: Biologic Vascular Graft-Product Description 110

Table 214: Tengion Inc Pipeline Products & Ongoing Clinical Trials Overview 111

Table 215: Neo-Vessel Replacement-Vascular Access Graft-Product Status 111

Table 216: Neo-Vessel Replacement-Vascular Access Graft-Product Description 112

Table 217: University of California San Francisco Pipeline Products & Ongoing Clinical Trials Overview 113

Table 218: Implantable Renal Assist Device-Product Status 113

Table 219: Implantable Renal Assist Device-Product Description 114

Table 220: Portable Dialysis Machine-Product Status 114

Table 221: Portable Dialysis Machine-Product Description 114

Table 222: University of Limerick Pipeline Products & Ongoing Clinical Trials Overview 115

Table 223: Prolong AV Graft-Product Status 115

Table 224: Prolong AV Graft-Product Description 115

Table 225: Vanderbilt University Pipeline Products & Ongoing Clinical Trials Overview 116

Table 226: Bioartificial Kidney-Product Status 116

Table 227: Bioartificial Kidney-Product Description 117

Table 228: Vital Access Corp Pipeline Products & Ongoing Clinical Trials Overview 118

Table 229: Minimally Invasive Access Device-Product Status 118

Table 230: Minimally Invasive Access Device-Product Description 118

Table 231: Vivonics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 119

Table 232: Artificial Kidney-Product Status 119

Table 233: Artificial Kidney-Product Description 119

Table 234: Vizio Medical Devices Pipeline Products & Ongoing Clinical Trials Overview 120

Table 235: Ambulatory Wearable Device-Product Status 120

Table 236: Ambulatory Wearable Device-Product Description 120

Table 237: Glossary 231

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3S BioMedical, Inc., Advanced Dialysis Methods Ltd., Angiotech Pharmaceuticals Inc, ARISTE Medical, Asahi Kasei Corp, Ash Access Technology Inc, Avenu Medical, Inc., AWAK Technologies Pte Ltd, B. Braun Melsungen AG, Baxter International Inc, Blood Purification Technologies, Inc., Brookhaven Medical Inc, CatheNect Medical, Chemica Technologies Inc, Chrysalis Medical Weight Loss Clinic, Circuport Inc, Control Medical Technology, LLC, Cytograft Tissue Engineering Inc, CytoPherx, Inc., Debiotech SA, DEKA Research and Development Corp, Dipylon Medical AB, ExThera Medical Corporation, Fistulink Ltd., Flow Forward Medical, LLC, Fresenius Kidney Care, Fresenius Medical Care AG & Co KGaA, Georgia Institute of Technology, Glomeria Therapeutics srl, Healionics Corporation, Indian Institute of Technology Bombay, Laminate Medical Technologies Ltd., Marvao Medical Devices Limited, Medtronic plc, Miromatrix Medical Inc, Nanodialysis BV, NanoVasc, Inc., Nephros Inc, Nicast Ltd, NuVascular Technologies Inc, NxStage Medical Inc, Peripal AG, PeriTec Biosciences Ltd, Phase One Medical LLC, qSTAR Medical SAS, Quanta Dialysis Technologies Ltd, Rambam Health Care Campus, RenalGuard Solutions, Inc., Senexis Limited, TEI Biosciences Inc, Tengion Inc, University of California San Francisco, University of Limerick, Vanderbilt University, Vital Access Corp, Vivonics, Inc., Vizio Medical Devices

3S BioMedical, Inc., Resorpor Hemodialysis Graft; Advanced Dialysis Methods Ltd., Vibro-Care; Angiotech Pharmaceuticals Inc, 5-FU Anti-Infective HemoStream Dialysis Catheter; Angiotech Pharmaceuticals Inc, Vascular Wrap; ARISTE Medical, Drug Eluting Tunneled Dialysis Catheter; Asahi Kasei Corp, APS Polysulfone-membrane Artificial Kidney-New Version; Asahi Kasei Corp, Hemodialysis Equipment; Ash Access Technology Inc, MaxFlow; Ash Access Technology Inc, SureFlow; Avenu Medical, Inc., Ellipsys Vascular Access System; AWAK Technologies Pte Ltd, AWAK; B. Braun Melsungen AG, Xevonta Dialyzer; Baxter International Inc, Artis Dialysis System; Baxter International Inc, Non PVC CAPD; Baxter International Inc, PrisMAX V1; Baxter International Inc, Theralite; Baxter International Inc, VIVIA Hemodialysis System; Blood Purification Technologies, Inc., Wearable Artificial Kidney; Brookhaven Medical Inc, CreatiVasc Hemoaccess Valve System; CatheNect Medical, PD Catheter; Chemica Technologies Inc, Dialysis Regeneration Cartridge; Chrysalis Medical Weight Loss Clinic (Inactive), Hemodialysis Catheter; Circuport Inc, Circuport System; Control Medical Technology, LLC, ASPIRE Hemodialysis; Cytograft Tissue Engineering Inc, Lifeline TEBV-AV Shunt; CytoPherx, Inc., Selective Cytopheretic Device; Debiotech SA, DialEase; Debiotech SA, Miniaturized Home Hemodialysis Machine; Debiotech SA, Renal Expres; DEKA Research and Development Corp, Amia Automated PD System With Sharesource; Dipylon Medical AB (Inactive), Peripheral Microdialysis Pump Kit; ExThera Medical Corporation, Seraph 200; Fistulink Ltd., Fistulink Device; Flow Forward Medical, LLC, AFE System; Fresenius Kidney Care, Portable Artificial Kidney; Fresenius Medical Care AG &; Co KGaA, Mobile hospital Hemodialysis device; Fresenius Medical Care AG &; Co KGaA, Xcorporeal Wearable Artificial Kidney; Fresenius Medical Care AG &; Co KGaA, XCR-6; Georgia Institute of Technology, KIDS CRRT; Georgia Institute of Technology, Pediatric Renal Dialysis Machine; Glomeria Therapeutics srl, DesmoHD; Glomeria Therapeutics srl, Smart Hemo; Healionics Corporation, STARcuff; Indian Institute of Technology Bombay, Dialysis Cuff; Laminate Medical Technologies Ltd., VasQ; Marvao Medical Devices Limited, NexSite Hemodialysis Catheter; Medtronic plc, Portable Hemodialysis System; Miromatrix Medical Inc, Miro Kidney; Nanodialysis BV, NEPHRON+ Wearable Artificial Kidney Device; NanoVasc, Inc., NanoVasc Polyurethane Graft; Nephros Inc, HydraGuard 10 Cartridge; Nephros Inc, NanoGuard 10 Cartridge; Nicast Ltd, Improved Version Of The AVflo Vascular Access Graft; NuVascular Technologies Inc, Artificial Hemodialysis Access Graft; NuVascular Technologies Inc, NuSpun Cuff; NxStage Medical Inc, Next Generation Critical Care System; NxStage Medical Inc, Next Generation NxStage System One; NxStage Medical Inc, NxStage System One-Peritoneal Dialysis; Peripal AG, Chronic Dialysis Patient Aid; PeriTec Biosciences Ltd, Dialysis Graft; Phase One Medical LLC, Goldilocks Valved Hemodialysis Catheter; Phase One Medical LLC, Reversus Hemodialysis Catheter; qSTAR Medical SAS, STARport HD; Quanta Dialysis Technologies Ltd, Advanced Haemodialysis System-Nocturnal Use; Rambam Health Care Campus, Peritoneal Dialysis Device; RenalGuard Solutions, Inc., RenalGuard System; Senexis Limited (Inactive), Device-Dialysis Related Amyloidosis; TEI Biosciences Inc, Biologic Vascular Graft; Tengion Inc, Neo-Vessel Replacement-Vascular Access Graft; University of California San Francisco, Implantable Renal Assist Device; University of California San Francisco, Portable Dialysis Machine; University of Limerick, Prolong AV Graft; Vanderbilt University, Bioartificial Kidney; Vital Access Corp, Minimally Invasive Access Device; Vivonics, Inc., Artificial Kidney; Vizio Medical Devices, Ambulatory Wearable Device

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