Published : Jul-2018
No. of Pages : 171
1 Table of Contents 2
1.1 List of Tables 6
1.2 List of Figures 8
2 Introduction 9
2.1 Blood Purification Equipment Overview 9
3 Products under Development 10
3.1 Blood Purification Equipment - Pipeline Products by Stage of Development 10
3.2 Blood Purification Equipment - Pipeline Products by Territory 11
3.3 Blood Purification Equipment - Pipeline Products by Regulatory Path 13
3.4 Blood Purification Equipment - Pipeline Products by Estimated Approval Date 14
3.5 Blood Purification Equipment - Ongoing Clinical Trials 15
4 Blood Purification Equipment - Pipeline Products under Development by Companies 16
4.1 Blood Purification Equipment Companies - Pipeline Products by Stage of Development 16
4.2 Blood Purification Equipment - Pipeline Products by Stage of Development 17
5 Blood Purification Equipment Companies and Product Overview 18
5.1 Accel Diagnostics LLC Company Overview 18
5.2 Aethlon Medical Inc Company Overview 19
5.3 Cerus Corp Company Overview 23
5.4 Children's Hospital Boston Company Overview 30
5.5 CytoSorbents Corp Company Overview 31
5.6 Ex Vivo Dynamics Inc Company Overview 44
5.7 Good SIRS Company Overview 45
5.8 Immunicom Inc Company Overview 46
5.9 McGowan Institute for Regenerative Medicine Company Overview 47
5.10 Mediseive Ltd Company Overview 48
5.11 NxStage Medical Inc Company Overview 50
5.12 Opsonix Inc Company Overview 51
5.13 ProSorp BioTech Inc Company Overview 52
5.14 Spectral Medical Inc Company Overview 53
5.15 Toray Medical Co Ltd Company Overview 56
5.16 Zata Pharmaceuticals Inc Company Overview 57
6 Blood Purification Equipment- Recent Developments 58
6.1 Jun 15, 2018: Cerus Presents Results of European Phase 3 Chronic Anemia Study at the 23rd Congress of European Hematology Association 58
6.2 Jun 12, 2018: CytoSorbents Officially Opens New U.S. CytoSorb Manufacturing Facility 58
6.3 Jun 08, 2018: Aethlon Medical Reports Fiscal 2018 Financial Results 59
6.4 Jun 05, 2018: Medtronic Presents Strategic Growth Roadmap at 2018 Investor Day; Outlines Plan to Create Shareholder Value 60
6.5 Jun 01, 2018: Cerus Announces Presentations Highlighting INTERCEPT Blood Systems at the 35th International Congress of the International Society of Blood Transfusion 61
6.6 May 30, 2018: Spectral Provides Corporate Update 62
6.7 May 24, 2018: Medtronic Reports Fourth Quarter And Fiscal Year 2018 Financial Results 62
6.8 May 21, 2018: Baxter Highlights Business Strategies and Innovation at 2018 Investor Conference 65
6.9 May 16, 2018: Cerus Announces Additional BARDA Funding to Support Development of INTERCEPT Blood System for Red Blood Cells 66
6.10 May 14, 2018: Immunicom's Immunotherapy Product Receives U.S. FDA Breakthrough Device Designation for the Treatment of Cancer 67
6.11 May 14, 2018: CytoSorb Adds Bilirubin and Myoglobin Reduction to European Union Approved Indications for Use 68
6.12 May 11, 2018: Spectral Announces First Quarter 2018 Results 68
6.13 May 08, 2018: Haemonetics Appoints Said Bolorforosh Executive Vice President, Chief Technology Officer 69
6.14 May 08, 2018: CytoSorbents Reports Strong First Quarter 2018 Financial Results 69
6.15 May 08, 2018: Cerus Reports First Quarter 2018 Results 70
6.16 May 08, 2018: Haemonetics Reports 4th Quarter and Fiscal Year 2018 Results and Provides Fiscal 2019 Guidance 72
6.17 May 07, 2018: Medtronic Appoints Mike Weinstein As Senior Vice President Of Strategy 73
6.18 May 02, 2018: Biocon Regulatory Audit Update 74
6.19 Apr 26, 2018: Baxter Reports First-Quarter 2018 Results And Increases Financial Outlook For Full-Year 2018 74
6.20 Apr 26, 2018: Golden Meditech: Re-designation of Directors and Changes of Members of Board Committees 76
6.21 Apr 26, 2018: Biocon Q4FY18 Revenue Rs 1,237 Cr, Up 27%; EBITDA Up 30% at Rs 300 Cr; Net Profit Up 2% at Rs 130 Cr[TOPC : Pharma - Biocon Ltd] 76
6.22 Apr 25, 2018: Cerus Announces Health Canada Approval of the INTERCEPT Blood System for Platelets 80
6.23 Apr 24, 2018: CytoSorbents Enrolls First Patient into Pivotal U.S. REFRESH 2-AKI Trial Using CytoSorb During Complex Cardiac Surgery 80
6.24 Apr 16, 2018: Golden Meditech's Associate, Cellenkos Appoints Alick Sun as Corporate & Business Development SVP 81
6.25 Apr 05, 2018: Dr. Laura Mauri to Join Medtronic as Vice President, Global Clinical Research & Analytics 81
6.26 Apr 02, 2018: Cerus' RedeS Phase 3 Red Blood Cell Study Expands Into the Continental U.S. 82
6.27 Mar 29, 2018: Spectral Announces Fourth Quarter and Fiscal 2017 Results 83
6.28 Mar 19, 2018: US Food and Drug Administration (FDA) provides communication to Spectral 83
6.29 Mar 19, 2018: ExThera Medical Announces Creation of European Subsidiary 84
6.30 Mar 13, 2018: Cerus Announces the Fourth Biologics License Application (BLA) Approval for a U.S. Blood Center Customer 85
6.31 Mar 08, 2018: CytoSorbents Achieves Record Revenue and Product Sales Growth in 2017 86
6.32 Mar 08, 2018: Cerus Reports Fourth Quarter And Year End 2017 Financial Results 89
6.33 Feb 26, 2018: Robert Ward, CEO of ExThera Medical, Elected to Prestigious National Academy of Engineering 91
6.34 Feb 15, 2018: Study Shows Computer-Guided Insulin Dosing Plus More Frequent Blood Glucose Testing Leads to Better Outcomes for Patients with Diabetes 91
6.35 Feb 06, 2018: CytoSorbents to Present at the 20th Annual BIO CEO & Investor Conference 92
6.36 Feb 06, 2018: Haemonetics 3rd Quarter Fiscal 2018 Earnings 92
6.37 Feb 05, 2018: MedaPhor Group: Innovate UK grant award confirmed 94
6.38 Feb 01, 2018: New Study Demonstrates Improved Hemodynamic Stability After Heart Transplant Surgery using Intraoperative CytoSorb Blood Purification 95
6.39 Feb 01, 2018: Spectral Medical Announces the Appointment of Chief Financial Officer 96
6.40 Feb 01, 2018: Baxter Reports 2017 Fourth-Quarter and Full-Year Results 96
6.41 Feb 01, 2018: Aethlon Medical Announces Fiscal 2018 Third Quarter Results 99
6.42 Jan 30, 2018: Alex Gu Named Senior Vice President and President of Medtronic's Greater China Region 100
6.43 Jan 25, 2018: Ellen M. Zane Rejoins Haemonetics Board of Directors 101
6.44 Jan 23, 2018: Cerus Reports Positive Top-Line Results from Chronic Anemia Phase 3 Study Evaluating INTERCEPT Red Blood Cells in Thalassemia Patients 102
6.45 Jan 23, 2018: Aethlon Medical Announces Validation Completion for European Patent Protecting Methods of Quantifying Exosomes 102
6.46 Jan 18, 2018: Aethlon Medical Announces Allowance of U.S. Patent that Broadens Protection for the Aethlon Hemopurifier to Treat Viral Infections 103
6.47 Jan 10, 2018: Sabrina Martucci Johnson Joins Aethlon Medical's Board of Directors 103
6.48 Jan 08, 2018: CytoSorbents Pre-Announces Preliminary Fourth Quarter and Full Year 2017 Results and Issues Stockholder Letter 104
6.49 Jan 08, 2018: Cerus Announces Preliminary Product Revenue Results for Fourth Quarter and Full Year 2017 106
7 Appendix 168
7.1 Methodology 168
7.2 About GlobalData 171
7.3 Contact Us 171
7.4 Disclaimer 171
1.1 List of Tables
Table 1: Blood Purification Equipment - Pipeline Products by Stage of Development 10
Table 2: Blood Purification Equipment - Pipeline Products by Territory 11
Table 3: Blood Purification Equipment - Pipeline Products by Regulatory Path 13
Table 4: Blood Purification Equipment - Pipeline Products by Estimated Approval Date 14
Table 5: Blood Purification Equipment - Ongoing Clinical Trials 15
Table 6: Blood Purification Equipment Companies - Pipeline Products by Stage of Development 16
Table 7: Blood Purification Equipment - Pipeline Products by Stage of Development 17
Table 8: Accel Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 18
Table 9: mPharesis - Product Status 18
Table 10: mPharesis - Product Description 18
Table 11: Aethlon Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 19
Table 12: ASEPSYS Device - Product Status 19
Table 13: ASEPSYS Device - Product Description 19
Table 14: Hemopurifier - Product Status 20
Table 15: Hemopurifier - Product Description 20
Table 16: Aethlon Medical Inc - Ongoing Clinical Trials Overview 21
Table 17: Hemopurifier - Plasma Exosome Concentration in Cancer Patients Undergoing Treatment 22
Table 18: Hemopurifier - Sepsis-related Virus Study of Aethlon Hemopurifier 22
Table 19: Cerus Corp Pipeline Products & Ongoing Clinical Trials Overview 23
Table 20: INTERCEPT Blood System - Platelets - Product Status 23
Table 21: INTERCEPT Blood System - Platelets - Product Description 24
Table 22: INTERCEPT Blood System - Red Blood Cells - Product Status 24
Table 23: INTERCEPT Blood System - Red Blood Cells - Product Description 24
Table 24: INTERCEPT Blood System - Zika Virus - Product Status 25
Table 25: INTERCEPT Blood System - Zika Virus - Product Description 25
Table 26: Cerus Corp - Ongoing Clinical Trials Overview 26
Table 27: INTERCEPT Blood System - Platelets - A Randomized, Double-Blind, Phase I, Dose-escalation Study for the Safety of Whole Blood Treated with Amustaline (S-303) and Glutathione (GSH), a Pathogen Inactivation System, and Transfused to Anemic Adult Cancer Patients 27
Table 28: INTERCEPT Blood System - Red Blood Cells - A Randomized Controlled Study to Evaluate Efficacy and Safety of S 303 Treated Red Blood Cells (RBC) in Subjects with Thalassemia Major Requiring Chronic RBC Transfusion 28
Table 29: INTERCEPT Blood System - Red Blood Cells - A Randomized, Double-blind, Controlled, Parallel Group Study with the INTERCEPT Blood System for Red Blood Cells in Regions at Potential Risk for Zika Virus Transfusion-transmitted Infections (RedeS Study) and Treatment Use Open-label Extension Study 28
Table 30: INTERCEPT Blood System - Red Blood Cells - A Randomized, Double-Blind, Phase I, Dose-escalation Study for the Safety of Whole Blood Treated with Amustaline (S-303) and Glutathione (GSH), a Pathogen Inactivation System, and Transfused to Anemic Adult Cancer Patients 28
Table 31: INTERCEPT Blood System - Red Blood Cells - A Randomized, Double-blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures 29
Table 32: INTERCEPT Blood System - Red Blood Cells - Measurement of the Recovery and Lifespan of Red Blood Cells from Pathogen-reduced, Stored Blood Units Using Cellular Biotinylation 29
Table 33: Children's Hospital Boston Pipeline Products & Ongoing Clinical Trials Overview 30
Table 34: Immune-Modulating Extracorporeal Circuit - Product Status 30
Table 35: Immune-Modulating Extracorporeal Circuit - Product Description 30
Table 36: CytoSorbents Corp Pipeline Products & Ongoing Clinical Trials Overview 31
Table 37: BetaSorb - Product Status 31
Table 38: BetaSorb - Product Description 32
Table 39: ContrastSorb - Product Status 32
Table 40: ContrastSorb - Product Description 32
Table 41: CST 301 - Product Status 33
Table 42: CST 301 - Product Description 33
Table 43: CytoSorb - Product Status 33
Table 44: CytoSorb - Product Description 34
Table 45: CytoSorb-XL - Product Status 34
Table 46: CytoSorb-XL - Product Description 34
Table 47: DrugSorb - Product Status 35
Table 48: DrugSorb - Product Description 35
Table 49: HemoDefend - Product Status 35
Table 50: HemoDefend - Product Description 36
Table 51: CytoSorbents Corp - Ongoing Clinical Trials Overview 37
Table 52: CytoSorb - Case-observation and Compassionate Use: Use of Extracorporeal Treatment with the Cytosorb-Adsorber for the Reduction of Postoperative Hyperinflammation and SIRS After Heart-surgery with the Use of a Heart-lung-machine 39
Table 53: CytoSorb - Cytokine Adsorption in Sepsis and Acute Kidney Injury 39
Table 54: CytoSorb - Elimination of Antibiotics During Combined Continuous Renal Replacement Therapy and Cytosorb Adsorptive Therapy in Patients with Sepsis and Acute Kidney Injury 39
Table 55: CytoSorb - Extracorporeal Elimination of Cytokines Following Abdominal-thoracic Esophagectomy - A Randomized Study : EXCESS 40
Table 56: CytoSorb - Extracorporeal Therapy for the Removal of Myoglobin Using the CytoSorb in Patients with Rhabdomyolysis 40
Table 57: CytoSorb - Hemoadsorption with CytoSorb in Post-Cardiac Arrest Syndrome: a Pilot Study (The CATCH Trial: Post Cardiac Arrest Therapy with Cytosorb Hemoadsorption) 40
Table 58: CytoSorb - Immunomodulatory Effect of Extracorporeal Cytokine Adsorption in Cardiac Surgery 41
Table 59: CytoSorb - International Registry on the Use of the CytoSorb-Adsorber in ICU Patients 41
Table 60: CytoSorb - Myeloid-derived Supressor Cells in Uncomplicated Versus Complicated Patients after Cardiac Surgery 41
Table 61: CytoSorb - Pancreatitis CytoSorbents (CytoSorb) Inflammatory Cytokine Removal: A Prospective Study 42
Table 62: CytoSorb - Removal of Cytokine on Cardiopulmonary Bypass with CytoSorb Compared to on- and Off-pump Myocardial Revascularization 42
Table 63: CytoSorb - Removal of Cytokines During Cardiac Surgery 42
Table 64: CytoSorb - Removal of Cytokines in Patients Undergoing Cardiac Surgery with CPB (The REMOTE Study) 43
Table 65: CytoSorb - Revealing Mechanisms and Investigating Efficacy of Hemoadsorption for Prevention of Vasodilatory Shock in Cardiac Surgery Patients with Infective Endocarditis - A Multicentric Randomized Controlled Group Sequential Trial 43
Table 66: CytoSorb - The Impact of Pre-emptive Intraoperative Use of Extracorporeal Cytokine Adsorption during Orthotopic Heart Transplantation 43
Table 67: Ex Vivo Dynamics Inc Pipeline Products & Ongoing Clinical Trials Overview 44
Table 68: BloodGuard - Product Status 44
Table 69: BloodGuard - Product Description 44
Table 70: Good SIRS Pipeline Products & Ongoing Clinical Trials Overview 45
Table 71: Blood-Filtering Device - Product Status 45
Table 72: Blood-Filtering Device - Product Description 45
Table 73: Immunicom Inc Pipeline Products & Ongoing Clinical Trials Overview 46
Table 74: Immunopheresis Blood-Filtering Device - Product Status 46
Table 75: Immunopheresis Blood-Filtering Device - Product Description 46
Table 76: McGowan Institute for Regenerative Medicine Pipeline Products & Ongoing Clinical Trials Overview 47
Table 77: Hemoadsorption Device - Sepsis - Product Status 47
Table 78: Hemoadsorption Device - Sepsis - Product Description 47
Table 79: Mediseive Ltd Pipeline Products & Ongoing Clinical Trials Overview 48
Table 80: Magnetic Blood Filtration Device - Leukaemia - Product Status 48
Table 81: Magnetic Blood Filtration Device - Leukaemia - Product Description 48
Table 82: Magnetic Blood Filtration Device - Malaria - Product Status 49
Table 83: Magnetic Blood Filtration Device - Malaria - Product Description 49
Table 84: Magnetic Blood Filtration Device - Sepsis - Product Status 49
Table 85: Magnetic Blood Filtration Device - Sepsis - Product Description 49
Table 86: NxStage Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 50
Table 87: DLT Device - Sepsis - Product Status 50
Table 88: DLT Device - Sepsis - Product Description 50
Table 89: Opsonix Inc Pipeline Products & Ongoing Clinical Trials Overview 51
Table 90: Pathogen-Extracting Therapy Device - Product Status 51
Table 91: Pathogen-Extracting Therapy Device - Product Description 51
Table 92: ProSorp BioTech Inc Pipeline Products & Ongoing Clinical Trials Overview 52
Table 93: Blood Perfusion Device - Product Status 52
Table 94: Blood Perfusion Device - Product Description 52
Table 95: Spectral Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 53
Table 96: Toraymyxin PMX-20R - Product Status 53
Table 97: Toraymyxin PMX-20R - Product Description 53
Table 98: Spectral Medical Inc - Ongoing Clinical Trials Overview 54
Table 99: Toraymyxin PMX-20R - Efficacy of Polymyxin B Hemoperfusion on Severe Sepsis Secondary to Pneumonia or Urinary Tract Infection: A Single-arm Clinical Trial 55
Table 100: Toraymyxin PMX-20R - The Effect of Endotoxin Adsorber Hemoperfusion on the Microcirculation in Patients with Severe Sepsis and Septic Shock 55
Table 101: Toray Medical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 56
Table 102: Toray Leukocyte Removal Column - Product Status 56
Table 103: Toray Leukocyte Removal Column - Product Description 56
Table 104: Zata Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 57
Table 105: Anti - Pathogen Device - Product Status 57
Table 106: Anti - Pathogen Device - Product Description 57
Table 107: Glossary 170
1.2 List of Figures
Figure 1: Blood Purification Equipment - Pipeline Products by Stage of Development 10
Figure 2: Blood Purification Equipment - Pipeline Products by Territory 11
Figure 3: Blood Purification Equipment - Pipeline Products by Regulatory Path 13
Figure 4: Blood Purification Equipment - Pipeline Products by Estimated Approval Date 14
Figure 5: Blood Purification Equipment - Ongoing Clinical Trials 15
