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 23
5.3.1 Cerus Corp Pipeline Products & Ongoing Clinical Trials Overview 23
5.4 Children’s Hospital Boston Company Overview 27
5.4.1 Children’s Hospital Boston Pipeline Products & Ongoing Clinical Trials Overview 27
5.5 Circle Biologics, LLC. Company Overview 29
5.5.1 Circle Biologics, LLC. Pipeline Products & Ongoing Clinical Trials Overview 29
5.6 CytoSorbents Corp Company Overview 30
5.6.1 CytoSorbents Corp Pipeline Products & Ongoing Clinical Trials Overview 30
5.7 Hansjorg Wyss Institute for Biologically Inspired Engineering Company Overview 41
5.7.1 Hansjorg Wyss Institute for Biologically Inspired Engineering Pipeline Products & Ongoing Clinical Trials Overview 41
5.8 McGowan Institute for Regenerative Medicine Company Overview 44
5.8.1 McGowan Institute for Regenerative Medicine Pipeline Products & Ongoing Clinical Trials Overview 44
5.9 National University of Singapore Company Overview 45
5.9.1 National University of Singapore Pipeline Products & Ongoing Clinical Trials Overview 45
5.10 NxStage Medical Inc Company Overview 46
5.10.1 NxStage Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 46
5.11 Spectral Medical Inc Company Overview 48
5.11.1 Spectral Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 48
5.12 Stellarray, Inc. Company Overview 52
5.12.1 Stellarray, Inc. Pipeline Products & Ongoing Clinical Trials Overview 52
5.13 Toray Medical Co Ltd Company Overview 53
5.13.1 Toray Medical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 53
6 Blood Purification Equipment- Recent Developments 54
6.1 Dec 07, 2016: CytoSorb Attains Permanent, Dedicated Reimbursement Code in Core Market of Germany 54
6.2 Dec 05, 2016: Spectral Medical appoints new board member 54
6.3 Dec 01, 2016: CytoSorb Selected for NICE MedTech Innovation Briefing in the United Kingdom 54
6.4 Nov 23, 2016: Golden Meditech Announces FY2016/2017 Interim Results 55
6.5 Nov 22, 2016: First Successful Treatment of Dengue Fever and Dengue Shock Syndrome Using CytoSorb 57
6.6 Nov 22, 2016: Medtronic Reports Second Quarter Financial Results 58
6.7 Nov 16, 2016: Medtronic Releases FY16 Integrated Performance Report 60
6.8 Nov 11, 2016: Spectral Announces Next Steps in Path Forward and Issues Third Quarter Results 61
6.9 Nov 10, 2016: Aethlon Medical Announces Fiscal 2017 Second Quarter Results 62
6.10 Nov 07, 2016: CytoSorb Q3 2016 Sales Reach Record $2.14M, Doubling From a Year Ago 63
6.11 Nov 03, 2016: CytoSorbents Expands Direct Sales of CytoSorb to Belgium and Luxembourg 64
6.12 Nov 03, 2016: Cerus Reports Third Quarter 2016 Results 65
6.13 Nov 03, 2016: NxStage Reports Third Quarter Financial Results; Raises Full-Year Revenue Guidance And Cuts Net Loss Guidance In Half 66
6.14 Oct 27, 2016: Heartland Blood Centers Appoints Dr. Alexander Carterson As Its Medical Director 67
6.15 Oct 27, 2016: Catherine M. Burzik Joins Haemonetics Board of Directors 68
6.16 Oct 25, 2016: Baxter Reports Third Quarter 2016 Results and Increases Financial Outlook For Full-Year 2016 68
6.17 Oct 20, 2016: Biocon Q2 FY17 Revenue Up 21%; EBITDA Up 45% 69
6.18 Oct 13, 2016: Aethlon Medical Achieves DARPA Milestones, Including Middle East Respiratory Syndrome Coronavirus (MERS-CoV) Validation 72
6.19 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 72
6.20 Oct 11, 2016: CytoSorbents and Foxx Medical Begin Saving Lives in Chile with CytoSorb 73
6.21 Oct 10, 2016: Cerus Announces that Hemolife Fundación Banco Nacional de Sangre Has Entered into Routine Use of the INTERCEPT Blood System 74
6.22 Oct 05, 2016: CytoSorbents Announces Positive Top-line Safety Data from REFRESH I Cardiac Surgery Trial 74
6.23 Oct 03, 2016: Spectral Announces Clinical Trial Results 75
6.24 Oct 03, 2016: International Marketing of CytoSorb Commences at European Association for Cardio-Thoracic Surgery Conference 75
6.25 Sep 29, 2016: SwabTech Raises USD0.65 Million in Venture Financing 76
6.26 Sep 23, 2016: CytoSorbents Expands CytoSorb into Iran with Partner Arsak 76
6.27 Sep 23, 2016: CytoSorbents Enters into Distribution Agreement with Armaghan Salamat Kish 77
6.28 Sep 19, 2016: Biocon Appoints Suresh Subramanian as Head of Branded Formulations (India) Business 77
6.29 Sep 15, 2016: Medtronic Names Mark Ploof Senior Vice President of Global Operations and Business Services 77
6.30 Sep 08, 2016: CytoSorbents Advances War On Sepsis with Development of CytoSorb-XL 78
6.31 Aug 29, 2016: FDA’s New Recommendation For Universal Zika Risk Reduction Of Blood Components Includes Use Of Pathogen Reduction 79
6.32 Aug 25, 2016: Medtronic Reports First Quarter Financial Results 79
6.33 Aug 18, 2016: Spectral on Track With Regulatory Pathway for Novel Septic Shock Treatment 82
6.34 Aug 12, 2016: Spectral Announces Second Quarter Results 82
6.35 Aug 11, 2016: Aethlon Medical Announces Zika Virus Data 83
6.36 Aug 11, 2016: Aethlon Medical Announces Fiscal 2017 First Quarter Results 84
6.37 Aug 09, 2016: Vivek Jayaraman Appointed as Cerus Corporation’s Chief Commercial Officer 84
6.38 Aug 09, 2016: CytoSorbents Achieves Fourth Consecutive Quarter of Record CytoSorb Sales 85
6.39 Aug 04, 2016: NxStage Reports Second Quarter Financial Results And Raises Full-Year Revenue Guidance 86
6.40 Aug 04, 2016: Cerus Reports Second Quarter 2016 Results 87
6.41 Aug 01, 2016: Haemonetics Appoints Bill Burke CFO 88
6.42 Jul 26, 2016: Baxter Reports Second Quarter 2016 Results and Raises Financial Outlook for Full-Year 2016 88
6.43 Jul 21, 2016: Biocon Reports a Strong Q1 FY17 Revenues at Rs. 952 Crore, Up by 11%; EBITDA Up 15% to Rs. 271 Crore; Net Profit Up 17% at Rs. 147 Crore 90
6.44 Jul 20, 2016: Jafron Biomedical Prices IPO for USD68 Million 92
6.45 Jul 13, 2016: CytoSorbents Teams with Medial and Meditrade to Bring CytoSorb to Hungary, Czech Republic, Slovakia, and Poland 92
6.46 Jul 11, 2016: Cerus Provides an Update on Adoption by Blood Centers of America Members for the INTERCEPT Blood System for Platelets and Plasma 93
6.47 Jul 06, 2016: Cerus and CEI Announce Donation of INTERCEPT Blood System Kits to HEMORIO for Emergency Preparedness Ahead of the Summer Olympic Games in Rio de Janeiro 94
6.48 Jun 30, 2016: NuVasive Agrees to Settle Patent Litigation With Medtronic 95
6.49 Jun 29, 2016: Aethlon Medical Announces Fiscal 2016 Results 95
6.50 Jun 28, 2016: Aethlon Medical Files Registration Statement for Public Offering of Shares for up to USD12.5 Million 97
6.51 Jun 28, 2016: Golden Meditech Announces FY2015/2016 Annual Results 97
6.52 Jun 27, 2016: FDA Accepts Spectral’s Expanded Access Protocol for Toraymyxin 99
6.53 Jun 22, 2016: CytoSorbents Awarded $150,000 Phase I STTR Contract for Universal Plasma Development 100
6.54 Jun 22, 2016: Important Product Information Regarding the Haemonetics Leukotrap RC System with RC2D Filter 100
6.55 Jun 22, 2016: Aethlon Medical Set To Join Russell Microcap Index 101
6.56 Jun 20, 2016: Spectral Medical Announces Completion of Enrolment for Its Pivotal EUPHRATES Clinical Trial 101
6.57 Jun 19, 2016: Cerus Announces Agreement with BARDA for Potential Funding of up to Approximately $180 Million to Advance Its INTERCEPT Red Blood Cell Program 102
6.58 Jun 16, 2016: Spectral Medical Announces Acceptance of Pre-Clinical PMA Module for Toraymyxin by FDA 103
6.59 Jun 14, 2016: Aethlon Medical Announces Issuance Of Exosome Capture Patent 103
6.60 Jun 13, 2016: CytoSorbents and Palex Bring CytoSorb to Spain and Portugal 103
6.61 Jun 06, 2016: Medtronic Outlines Future Growth Vision at Investor Day 104
6.62 Jun 04, 2016: Immutrix Therapeutics Raises USD2.95 Million in Venture Financing 105
6.63 Jun 02, 2016: ExThera Medical Raises USD15.3 Million in Series B Venture Financing 105
6.64 Jun 01, 2016: CytoSorbents Announces Fresenius Medical Care Initiates Sales of CytoSorb in France, Poland and Scandinavia 105
6.65 May 31, 2016: Spectral Medical Files Expanded Access Protocol With FDA for Toraymyxin Septic Shock Treatment 105
6.66 May 31, 2016: Medtronic Reports Fourth Quarter and Fiscal Year 2016 Financial Results 106
6.67 May 27, 2016: Independent Data Safety Monitoring Board Recommends Continuation of CytoSorbents REFRESH I Trial 109
6.68 May 23, 2016: Health Canada Approves INTERCEPT Blood System for Plasma 109
6.69 May 23, 2016: 48-Week Data, Presented at the Digestive Disease Week (DDW) Meeting Today, Showed Clinical Benefit with Adacolumn in a Sub-Group of Refractory Patients with Ulcerative Colitis 110
6.70 May 18, 2016: CytoSorb Achieves Final Product Registration in Russia 111
6.71 May 12, 2016: Spectral Announces First Quarter Results 112
6.72 May 09, 2016: CytoSorbents Continues Strong Growth in Q1 2016 113
6.73 May 09, 2016: Baxter Highlights Business Strategies and Innovation at 2016 Investor Conference 115
6.74 May 09, 2016: Haemonetics Provides Fiscal 2017 Guidance 116
6.75 May 09, 2016: Haemonetics Announces Christopher Simon as President and Chief Executive Officer 117
6.76 May 06, 2016: Cerus Plans to Raise USD70 Million in Public Offering of Shares 117
6.77 May 06, 2016: CytoSorbents Establishes Swiss Subsidiary 117
6.78 May 03, 2016: Cerus Corporation Reports First Quarter 2016 Results 118
6.79 May 02, 2016: Hemopurifier Clinical Progression, USA Today on the Next Zika, Combating Bioterror & Pandemic Threats 119
6.80 May 02, 2016: Haemonetics Reports 4th Quarter Fiscal 2016 Revenue of $243 Million, Constant Currency Revenue Growth of 10% and 7% As Reported 120
6.81 Apr 14, 2016: Haemonetics Announces CFO’s Retirement 124
6.82 Mar 31, 2016: Aethlon Medical Discloses Hemopurifier Clinical Trial and Manufacturing Advancements 124
6.83 Mar 25, 2016: CytoSorbents Awarded $150,000 Phase I SBIR Contract for Fungal Mycotoxin Removal 124
6.84 Mar 16, 2016: CytoSorbents Reports on Successful 3rd International CytoSorb Users Meeting 125
6.85 Mar 16, 2016: Cerus Receives FDA Approval for Use of the INTERCEPT Blood System for Platelets Suspended in 100% Plasma 126
6.86 Mar 15, 2016: Cerus Announces the Inclusion of Pathogen Reduction Technology in FDA’s Revised Guidance Document on Bacterial Safety Standards for Platelets 126
6.87 Mar 09, 2016: Blood Centers of America Selects Cerus as its Supply Partner for Pathogen Reduction Technology 127
6.88 Mar 09, 2016: CytoSorbents Reports Record Quarterly and Full-Year 2015 Revenue 127
6.89 Mar 08, 2016: Cerus Reports Fourth Quarter and Year End 2015 Results 128
6.90 Mar 07, 2016: Spectral Commends Inclusion of Organ Dysfunction in New Expert Consensus Definitions of Sepsis and Septic Shock 130
6.91 Mar 03, 2016: Cerus Enters Into Agreement With Banco de Sangre de Servicios Mutuos for the Use of INTERCEPT Platelets in Puerto Rico to Sustain Blood Supply During Zika Epidemic 130
6.92 Mar 03, 2016: Cerus Enters Into Agreement With Banco de Sangre de Servicios Mutuos for the Use of INTERCEPT Plasma in Puerto Rico to Sustain Blood Supply During Zika Epidemic 131
6.93 Mar 01, 2016: Spectral Approaches Finish Line for Clinical and Regulatory Program 132
6.94 Feb 26, 2016: Data Presented on First CytoSorb Investigator-Initiated Septic Shock Study 132
6.95 Feb 18, 2016: CytoSorbents to Exhibit at the 45th Society of Critical Care Medicine Congress 133
6.96 Feb 16, 2016: CytoSorbents Announces 26th Symposium for Intensive Medicine and Intensive Care Agenda in Bremen, Germany 134
6.97 Feb 09, 2016: Cerus Enters Multi-Year Agreement with the American Red Cross for the Use of INTERCEPT Platelets and Plasma 134
6.98 Feb 03, 2016: Aethlon Medical Announces Dengue Virus Study Approval, Chikungunya Virus Capture Data and Completion of U.S. Principal Investigator Training 135
6.99 Feb 01, 2016: Haemonetics Reports 3rd Quarter Fiscal 2016 Revenue of $233 Million, Constant Currency Revenue Growth of 4% and 1% As Reported 136
6.100 Jan 21, 2016: CytoSorbents Appoints Dr. Volker Humbert as Senior Manager of Clinical Affairs 139
6.101 Jan 14, 2016: AABB Authorizes Use of the INTERCEPT Blood System for Platelets to Reduce the Risk of Transfusion-Associated Graft Versus Host Disease 140
6.102 Jan 12, 2016: Seacera to Acquire 51% Stake in Proligen 140
6.103 Jan 11, 2016: Spectral Medical Provides Clinical And Regulatory Update 140
6.104 Jan 05, 2016: Cerus Announces Agreement with Blood Systems for the Use of INTERCEPT Platelets and Plasma 141
6.105 Dec 21, 2015: CytoSorbents Issues EAP Update 141
7 Appendix 143
7.1 Methodology 143
7.2 About GlobalData 145
7.3 Contact Us 145
7.4 Disclaimer 146