Blood Purification Equipment-Medical Devices Pipeline Assessment, 2017

Table of Contents

1 Table of Contents

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 12

3.4 Blood Purification Equipment-Pipeline Products by Estimated Approval Date 13

3.5 Blood Purification Equipment-Ongoing Clinical Trials 14

4 Blood Purification Equipment-Pipeline Products under Development by Companies 15

4.1 Blood Purification Equipment Companies-Pipeline Products by Stage of Development 15

4.2 Blood Purification Equipment-Pipeline Products by Stage of Development 16

5 Blood Purification Equipment Companies and Product Overview 17

5.1 Accel Diagnostics LLC Company Overview 17

5.1.1 Accel Diagnostics LLC Pipeline Products Ongoing Clinical Trials Overview 17

5.2 Aethlon Medical Inc Company Overview 18

5.2.1 Aethlon Medical Inc Pipeline Products Ongoing Clinical Trials Overview 18

5.3 Cerus Corp Company Overview 22

5.3.1 Cerus Corp Pipeline Products Ongoing Clinical Trials Overview 22

5.4 Children's Hospital Boston Company Overview 29

5.4.1 Children's Hospital Boston Pipeline Products Ongoing Clinical Trials Overview 29

5.5 CytoSorbents Corp Company Overview 31

5.5.1 CytoSorbents Corp Pipeline Products Ongoing Clinical Trials Overview 31

5.6 Ex Vivo Dynamics Inc Company Overview 44

5.6.1 Ex Vivo Dynamics Inc Pipeline Products Ongoing Clinical Trials Overview 44

5.7 Hansjorg Wyss Institute for Biologically Inspired Engineering Company Overview 45

5.7.1 Hansjorg Wyss Institute for Biologically Inspired Engineering Pipeline Products Ongoing Clinical Trials Overview 45

5.8 Immunicom Inc Company Overview 47

5.8.1 Immunicom Inc Pipeline Products Ongoing Clinical Trials Overview 47

5.9 McGowan Institute for Regenerative Medicine Company Overview 49

5.9.1 McGowan Institute for Regenerative Medicine Pipeline Products Ongoing Clinical Trials Overview 49

5.10 National University of Singapore Company Overview 50

5.10.1 National University of Singapore Pipeline Products Ongoing Clinical Trials Overview 50

5.11 NxStage Medical Inc Company Overview 51

5.11.1 NxStage Medical Inc Pipeline Products Ongoing Clinical Trials Overview 51

5.12 Spectral Medical Inc Company Overview 52

5.12.1 Spectral Medical Inc Pipeline Products Ongoing Clinical Trials Overview 52

5.13 Toray Medical Co Ltd Company Overview 55

5.13.1 Toray Medical Co Ltd Pipeline Products Ongoing Clinical Trials Overview 55

5.14 Zata Pharmaceuticals Inc Company Overview 56

5.14.1 Zata Pharmaceuticals Inc Pipeline Products Ongoing Clinical Trials Overview 56

6 Blood Purification Equipment-Recent Developments 57

6.1 Jul 17, 2017: Baxter Appoints Cathy R. Smith to its Board 57

6.2 Jul 13, 2017: CytoSorbents Awarded $1 Million STTR Phase II Contract To Advance Development of Life-Saving Universal Plasma 57

6.3 Jul 09, 2017: Biocon Receives GMP approval for Biologics Drug Substance facilities from French Regulator; Drug Product facility to be re-inspected 58

6.4 Jul 09, 2017: Biocon: Update on Inspection Audits by French health agency 58

6.5 Jun 28, 2017: Aethlon Medical Announces Fiscal 2017 Results 58

6.6 Jun 22, 2017: Haemonetics Announces Formation of Scientific Advisory Council 60

6.7 Jun 14, 2017: Aethlon Medical To Present Clinical Study Results at The BIO International Convention 60

6.8 Jun 12, 2017: Spectral's Trial Data to Be Presented at 35th Vicenza Course on AKI and CRRT 61

6.9 Jun 07, 2017: Cerus Provides Update on U.S. Platelet Additive Solution Supply 61

6.10 Jun 05, 2017: Biocon Appoints Ms. Pratima Rao as Mission Director of Biocon Foundation 62

6.11 May 30, 2017: Spectral Files Final PMA Module for Toraymyxin With FDA 62

6.12 May 30, 2017: Dr. Eric G. Mortensen, M.D., Ph.D., Clinical Trial Veteran, Joins CytoSorbents as Chief Medical Officer 63

6.13 May 25, 2017: Medtronic Reports Fourth Quarter and Fiscal Year 2017 Financial Results 64

6.14 May 23, 2017: Cerus Provides U.S. Business Update 67

6.15 May 15, 2017: First Patient Transfused in Cerus' Phase III RedeS Study Evaluating Safety and Efficacy of the INTERCEPT Red Blood Cell System 68

6.16 May 12, 2017: Spectral Announces First Quarter Results 69

6.17 May 10, 2017: Biocon statement in response to media reports on USFDA Form 483s for Biocon Limited 69

6.18 May 09, 2017: Cerus Announces Exercise of Additional BARDA Contract Options Totaling $46.6 million to Support INTERCEPT Red Blood Cell System Development 70

6.19 May 09, 2017: NxStage Reports First Quarter Financial Results 70

6.20 May 08, 2017: CytoSorbents Reports First Quarter 2017 Financial Results 71

6.21 May 08, 2017: Haemonetics Reports 4th Quarter and Fiscal Year 2017 Results and Provides Fiscal 2018 Guidance 72

6.22 May 05, 2017: CytoSorbents Announces Positive REFRESH I Trial Results 74

6.23 May 05, 2017: Biocon: Company Statement Media Reports on USFDA 483s 75

6.24 May 03, 2017: Cerus Reports First Quarter 2017 Results 75

6.25 Apr 27, 2017: Biocon Q4 FY17 Revenue Rs 974 Cr; Net Profit Rs 127 Cr; FY17 Revenue at Rs 4,079 Cr; Net Profit at Rs 612 Cr 76

6.26 Apr 26, 2017: Baxter Reports First-Quarter 2017 Results and Increases Financial Outlook for Full-Year 2017 79

6.27 Apr 24, 2017: CytoSorbents Awarded $1M Phase II SBIR Contract by U.S. Department of Defense to Advance Fungal Mycotoxin Blood Purification 81

6.28 Apr 24, 2017: Aethlon Medical Releases Shareholder Update 82

6.29 Mar 30, 2017: Spectral Announces Fourth Quarter and Fiscal 2016 Results 83

6.30 Mar 28, 2017: Cytosorbents Strengthens Intellectual Property Portfolio With New Patents Issued In The U.S., China, Japan, Russia, And Australia 84

6.31 Mar 27, 2017: CytoSorbents REFRESH I Trial Abstract Selected for Podium Presentation at the American Association for Thoracic Surgery Centennial Conference 84

6.32 Mar 22, 2017: Dr. Carl H. June, Cancer Immunotherapy Pioneer, Joins Cytosorbents Scientific Advisory Board 85

6.33 Mar 20, 2017: CytoSorb Treatment of HLH-The Parallel to Cytokine Release Syndrome in Cancer Immunotherapy 86

6.34 Mar 13, 2017: Aethlon Medical Announces The Conclusion Of Hemopurifier Clinical Study 87

6.35 Mar 08, 2017: Cytosorbents Highlights Activities At The 22nd International Conference On Advances In Critical Care Nephrology 88

6.36 Mar 07, 2017: U.S. FDA Approves Spectral's Third PMA Module for Its Toraymyxin Treatment of Endotoxemic Septic Shock 89

6.37 Mar 07, 2017: Cerus Reports Fourth Quarter and Year End 2016 Results 89

6.38 Mar 03, 2017: CytoSorbents Reports Record Quarterly and Full-Year 2016 Revenue 91

6.39 Mar 01, 2017: Aethlon Medical Announces the Grant of a European Patent Protecting Methods of Quantifying Exosomes 92

6.40 Feb 28, 2017: NxStage Reports Fourth Quarter and Full-Year 2016 Financial Results 92

6.41 Feb 23, 2017: Spectral to File Final PMA Module With the FDA for Its Toraymyxin Treatment of Endotoxemic Septic Shock 93

6.42 Feb 22, 2017: Aethlon Medical Reports Results of Cytomegalovirus, Epstein-Barr and Herpes Simplex Virus Studies 94

6.43 Feb 21, 2017: Medtronic Reports Third Quarter Financial Results 95

6.44 Feb 10, 2017: Aethlon Medical Announces Fiscal 2017 Third Quarter Results 98

6.45 Feb 08, 2017: Baxter Appoints Dr. Stephen Oesterle to Its Board 99

6.46 Feb 07, 2017: Cytosorbents To Present At The 19th Annual Bio CEO Investor Conference 100

6.47 Feb 06, 2017: Medtronic Awarded U.S. Department of Veterans Affairs National Contracts for Home Telehealth Technologies, with Three Other Vendors 100

6.48 Feb 03, 2017: NxStage Announces Appointment of Chief Medical Officer 101

6.49 Feb 01, 2017: Baxter Reports 2016 Fourth-Quarter and Full-Year Results 101

6.50 Jan 31, 2017: Immunicom Provides update on TGF-beta 104

6.51 Jan 25, 2017: Biocon Announces Changes of Key Managerial Personnel 104

6.52 Jan 24, 2017: Biocon Q3 FY17 Net Profit Up 65% at Rs 171 Crore 104

6.53 Jan 11, 2017: Aethlon Medical Provides Clinical Study Update and a Review of 2016 Accomplishments 107

6.54 Jan 10, 2017: CytoSorbents Pre-announces Q4 2016 and Full-Year 2016 Results 108

6.55 Dec 20, 2016: CytoSorbents Announces First Sales of New CytoSorb CPB Procedure Pack for Cardiac Surgery 109

6.56 Dec 19, 2016: Cerus Provides an Update on the Timeline for the INTERCEPT Blood System for Red Blood Cells in Europe 109

6.57 Dec 19, 2016: Cerus Announces Exercise Of Additional BARDA Contract Options Totaling $10,825,555 For Activities Related To Its Planned Phase Iii Trial Of The Intercept Red Blood Cell System 110

6.58 Dec 15, 2016: Aethlon Announces Initiation of Sepsis-Related Virus Study 111

6.59 Dec 12, 2016: Cytosorbents Receives $318,551 In Non-Dilutive Funding From The New Jersey Technology Business Tax Certificate Transfer Program 112

6.60 Dec 12, 2016: Arteriocyte Announces Name Change to Compass Biomedical 113

6.61 Dec 07, 2016: CytoSorb Attains Permanent, Dedicated Reimbursement Code in Core Market of Germany 113

6.62 Dec 05, 2016: Spectral Medical appoints new board member 114

6.63 Dec 01, 2016: CytoSorb Selected for NICE MedTech Innovation Briefing in the United Kingdom 114

6.64 Nov 23, 2016: Golden Meditech Announces FY2016/2017 Interim Results 115

6.65 Nov 22, 2016: First Successful Treatment of Dengue Fever and Dengue Shock Syndrome Using CytoSorb 117

6.66 Nov 22, 2016: Medtronic Reports Second Quarter Financial Results 118

6.67 Nov 17, 2016: Cytosorbents Reports Highlights From The Sepseast 2016 Critical Care Congress 121

6.68 Nov 16, 2016: Medtronic Releases FY16 Integrated Performance Report 122

6.69 Nov 15, 2016: Adrian Thomas Joins CytoSorbents to Drive Western European Sales 123

6.70 Nov 11, 2016: Spectral Announces Next Steps in Path Forward and Issues Third Quarter Results 123

6.71 Nov 10, 2016: Aethlon Medical Announces Fiscal 2017 Second Quarter Results 124

6.72 Nov 07, 2016: CytoSorb Q3 2016 Sales Reach Record $2.14M, Doubling From a Year Ago 126

6.73 Nov 03, 2016: CytoSorbents Expands Direct Sales of CytoSorb to Belgium and Luxembourg 127

6.74 Nov 03, 2016: Cerus Reports Third Quarter 2016 Results 127

6.75 Nov 03, 2016: NxStage Reports Third Quarter Financial Results; Raises Full-Year Revenue Guidance And Cuts Net Loss Guidance In Half 129

6.76 Oct 27, 2016: Heartland Blood Centers Appoints Dr. Alexander Carterson As Its Medical Director 130

6.77 Oct 27, 2016: Catherine M. Burzik Joins Haemonetics Board of Directors 130

6.78 Oct 25, 2016: Baxter Reports Third Quarter 2016 Results and Increases Financial Outlook For Full-Year 2016 131

6.79 Oct 20, 2016: Biocon Q2 FY17 Revenue Up 21%; EBITDA Up 45% 132

6.80 Oct 13, 2016: Aethlon Medical Achieves DARPA Milestones, Including Middle East Respiratory Syndrome Coronavirus (MERS-CoV) Validation 135

6.81 Oct 13, 2016: Cerus Announces First U.S. Blood Center Customer Submits Biologics License Application to the FDA to Allow for Interstate Export of INTERCEPT Platelet Components 136

6.82 Oct 11, 2016: CytoSorbents and Foxx Medical Begin Saving Lives in Chile with CytoSorb 137

6.83 Oct 10, 2016: Cerus Announces that Hemolife Fundacion Banco Nacional de Sangre Has Entered into Routine Use of the INTERCEPT Blood System 137

6.84 Oct 05, 2016: CytoSorbents Announces Positive Top-line Safety Data from REFRESH I Cardiac Surgery Trial 138

6.85 Oct 03, 2016: Spectral Announces Clinical Trial Results 139

6.86 Oct 03, 2016: International Marketing of CytoSorb Commences at European Association for Cardio-Thoracic Surgery Conference 139

6.87 Sep 29, 2016: New Cytosorbents Website Highlights Global Growth And Innovation 140

6.88 Sep 23, 2016: CytoSorbents Expands CytoSorb into Iran with Partner Arsak 140

6.89 Sep 19, 2016: Biocon Appoints Suresh Subramanian as Head of Branded Formulations (India) Business 141

6.90 Sep 15, 2016: Medtronic Names Mark Ploof Senior Vice President of Global Operations and Business Services 142

6.91 Sep 08, 2016: CytoSorbents Advances War On Sepsis with Development of CytoSorb-XL 142

6.92 Aug 29, 2016: FDA's New Recommendation For Universal Zika Risk Reduction Of Blood Components Includes Use Of Pathogen Reduction 143

6.93 Aug 25, 2016: Medtronic Reports First Quarter Financial Results 144

6.94 Aug 18, 2016: Spectral on Track With Regulatory Pathway for Novel Septic Shock Treatment 146

6.95 Aug 12, 2016: Spectral Announces Second Quarter Results 147

6.96 Aug 11, 2016: Aethlon Medical Announces Zika Virus Data 147

6.97 Aug 11, 2016: Aethlon Medical Announces Fiscal 2017 First Quarter Results 148

6.98 Aug 09, 2016: Vivek Jayaraman Appointed as Cerus Corporation's Chief Commercial Officer 149

6.99 Aug 09, 2016: CytoSorbents Achieves Fourth Consecutive Quarter of Record CytoSorb Sales 150

6.100 Aug 08, 2016: CytoSorbents Awarded $650,000 in SBIR Grant Contracts to Continue Development of Novel Hemocompatible Potassium Binding Polymers 151

6.101 Aug 04, 2016: NxStage Reports Second Quarter Financial Results And Raises Full-Year Revenue Guidance 152

6.102 Aug 04, 2016: Cerus Reports Second Quarter 2016 Results 153

6.103 Aug 01, 2016: Haemonetics Appoints Bill Burke CFO 155

6.104 Jul 26, 2016: Baxter Reports Second Quarter 2016 Results and Raises Financial Outlook for Full-Year 2016 155

7 Appendix 157

7.1 Methodology 157

7.2 About GlobalData 160

7.3 Contact Us 160

7.4 Disclaimer 160

List of Figure

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 12

Figure 4: Blood Purification Equipment-Pipeline Products by Estimated Approval Date 13

Figure 5: Blood Purification Equipment-Ongoing Clinical Trials 14

List of Table

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 12

Table 4: Blood Purification Equipment-Pipeline Products by Estimated Approval Date 13

Table 5: Blood Purification Equipment-Ongoing Clinical Trials 14

Table 6: Blood Purification Equipment Companies-Pipeline Products by Stage of Development 15

Table 7: Blood Purification Equipment-Pipeline Products by Stage of Development 16

Table 8: Accel Diagnostics LLC Pipeline Products Ongoing Clinical Trials Overview 17

Table 9: mPharesis-Product Status 17

Table 10: mPharesis-Product Description 17

Table 11: Aethlon Medical Inc Pipeline Products Ongoing Clinical Trials Overview 18

Table 12: ASEPSYS Device-Product Status 18

Table 13: ASEPSYS Device-Product Description 18

Table 14: Hemopurifier-Product Status 19

Table 15: Hemopurifier-Product Description 19

Table 16: Aethlon Medical Inc-Ongoing Clinical Trials Overview 20

Table 17: Hemopurifier-Plasma Exosome Concentration in Cancer Patients Undergoing Treatment 21

Table 18: Hemopurifier-Sepsis-related Virus Study of Aethlon Hemopurifier 21

Table 19: Cerus Corp Pipeline Products Ongoing Clinical Trials Overview 22

Table 20: INTERCEPT Blood System-Chikungunya Virus-Product Status 22

Table 21: INTERCEPT Blood System-Chikungunya Virus-Product Description 23

Table 22: INTERCEPT Blood System-Dengue Virus-Product Status 23

Table 23: INTERCEPT Blood System-Dengue Virus-Product Description 23

Table 24: INTERCEPT Blood System-Platelets-Product Status 24

Table 25: INTERCEPT Blood System-Platelets-Product Description 24

Table 26: INTERCEPT Blood System-Red Blood Cells-Product Status 24

Table 27: INTERCEPT Blood System-Red Blood Cells-Product Description 25

Table 28: INTERCEPT Blood System-Zika Virus-Product Status 25

Table 29: INTERCEPT Blood System-Zika Virus-Product Description 25

Table 30: Cerus Corp-Ongoing Clinical Trials Overview 26

Table 31: 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 27

Table 32: INTERCEPT Blood System-Zika Virus-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 33: Children's Hospital Boston Pipeline Products Ongoing Clinical Trials Overview 29

Table 34: Micromagnetic-Microfluidic Device-Product Status 29

Table 35: Micromagnetic-Microfluidic Device-Product Description 29

Table 36: Surface-Modified Circuit-Product Status 30

Table 37: Surface-Modified Circuit-Product Description 30

Table 38: CytoSorbents Corp Pipeline Products Ongoing Clinical Trials Overview 31

Table 39: BetaSorb-Product Status 31

Table 40: BetaSorb-Product Description 32

Table 41: ContrastSorb-Product Status 32

Table 42: ContrastSorb-Product Description 32

Table 43: CST 301-Product Status 33

Table 44: CST 301-Product Description 33

Table 45: CytoSorb-Product Status 33

Table 46: CytoSorb-Product Description 34

Table 47: CytoSorb-Cytokine Release Syndrome-Product Status 34

Table 48: CytoSorb-Cytokine Release Syndrome-Product Description 34

Table 49: CytoSorb-XL-Product Status 35

Table 50: CytoSorb-XL-Product Description 35

Table 51: DrugSorb-Product Status 35

Table 52: DrugSorb-Product Description 36

Table 53: HemoDefend-Product Status 36

Table 54: HemoDefend-Product Description 36

Table 55: CytoSorbents Corp-Ongoing Clinical Trials Overview 37

Table 56: 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 38

Table 57: CytoSorb-Cytokine Adsorption in Sepsis and Acute Kidney Injury 38

Table 58: CytoSorb-Cytokine Clearance with Cytoabsorbant Device During Cardiac Bypass: A Pilot Study 38

Table 59: CytoSorb-Elimination of Antibiotics During Combined Continuous Renal Replacement Therapy and Cytosorb Adsorptive Therapy in Patients with Sepsis and Acute Kidney Injury 39

Table 60: CytoSorb-Extracorporeal Elimination of Cytokines Following Abdominal-thoracic Esophagectomy-A Randomized Study : EXCESS 39

Table 61: CytoSorb-Extracorporeal Therapy for the Removal of Myoglobin Using the CytoSorb in Patients with Rhabdomyolysis 39

Table 62: CytoSorb-Immunomodulatory Effect of Extracorporeal Cytokine Adsorption in Cardiac Surgery 40

Table 63: CytoSorb-International Registry on the Use of the CytoSorb-Adsorber in ICU Patients 40

Table 64: CytoSorb-Myeloid-derived Supressor Cells in Uncomplicated Versus Complicated Patients after Cardiac Surgery 40

Table 65: CytoSorb-Pancreatitis CytoSorbents (CytoSorb) Inflammatory Cytokine Removal: A Prospective Study 41

Table 66: CytoSorb-Reduction of Inflammation Reaction to Extracorporeal Circulation in Cardiac Surgery by Interleukin Dialysis 41

Table 67: CytoSorb-Removal of Cytokine on Cardiopulmonary Bypass with CytoSorb Compared to on-and Off-pump Myocardial Revascularization 41

Table 68: CytoSorb-Removal of Cytokines During Cardiac Surgery 42

Table 69: CytoSorb-Removal of Cytokines in Patients Undergoing Cardiac Surgery with CPB (The REMOTE Study) 42

Table 70: CytoSorb-The Effect of Early Cytokine Absorption on the Systemic Inflammatory Response Syndrome and Organ Dysfunction in the First 48 Hours of Septic Shock 42

Table 71: CytoSorb-The Impact of Pre-emptive Intraoperative Use of Extracorporeal Cytokine Adsorption during Orthotopic Heart Transplantation 43

Table 72: Ex Vivo Dynamics Inc Pipeline Products Ongoing Clinical Trials Overview 44

Table 73: Blood Filter Device-Product Status 44

Table 74: Blood Filter Device-Product Description 44

Table 75: Hansjorg Wyss Institute for Biologically Inspired Engineering Pipeline Products Ongoing Clinical Trials Overview 45

Table 76: Sepsis Therapeutic Device-Improved Version-Product Status 45

Table 77: Sepsis Therapeutic Device-Improved Version-Product Description 45

Table 78: Spleen-On-A-Chip-Product Status 46

Table 79: Spleen-On-A-Chip-Product Description 46

Table 80: Immunicom Inc Pipeline Products Ongoing Clinical Trials Overview 47

Table 81: Immunopheresis Blood-Filtering Device-Product Status 47

Table 82: Immunopheresis Blood-Filtering Device-Product Description 48

Table 83: McGowan Institute for Regenerative Medicine Pipeline Products Ongoing Clinical Trials Overview 49

Table 84: Hemoadsorption Device-Sepsis-Product Status 49

Table 85: Hemoadsorption Device-Sepsis-Product Description 49

Table 86: National University of Singapore Pipeline Products Ongoing Clinical Trials Overview 50

Table 87: Microfluidic Device-Sepsis-Product Status 50

Table 88: Microfluidic Device-Sepsis-Product Description 50

Table 89: NxStage Medical Inc Pipeline Products Ongoing Clinical Trials Overview 51

Table 90: DLT Device-Sepsis-Product Status 51

Table 91: DLT Device-Sepsis-Product Description 51

Table 92: Spectral Medical Inc Pipeline Products Ongoing Clinical Trials Overview 52

Table 93: Toraymyxin PMX-20R-Product Status 52

Table 94: Toraymyxin PMX-20R-Product Description 52

Table 95: Spectral Medical Inc-Ongoing Clinical Trials Overview 53

Table 96: Toraymyxin PMX-20R-Efficacy of Polymyxin B Hemoperfusion on Severe Sepsis Secondary to Pneumonia or Urinary Tract Infection: A Single-arm Clinical Trial 54

Table 97: Toraymyxin PMX-20R-Evaluating the Use of Polymyxin B Hemoperfusion in a Prospective Non-controlled Trial in Adults 54

Table 98: Toraymyxin PMX-20R-The Effect of Endotoxin Adsorber Hemoperfusion on the Microcirculation in Patients with Severe Sepsis and Septic Shock 54

Table 99: Toray Medical Co Ltd Pipeline Products Ongoing Clinical Trials Overview 55

Table 100: Toray Leukocyte Removal Column-Product Status 55

Table 101: Toray Leukocyte Removal Column-Product Description 55

Table 102: Zata Pharmaceuticals Inc Pipeline Products Ongoing Clinical Trials Overview 56

Table 103: Anti-Pathogen Device-Product Status 56

Table 104: Anti-Pathogen Device-Product Description 56

Table 105: Glossary 159