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: Baxter’s 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