Blood Purification Equipment Pipeline Report including Stages of Development, Segments, Region and Countries, Regulatory Path and Key Companies, 2021

Pages: 166 Published: November 24, 2021 Report Code: GDME1257EPD

  • Overview
  • Key Players
  • Contents
  • Tables
  • Figures
  • FAQ
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Blood Purification Equipment is to filter blood by removing the irreversibly damaged red blood cells and toxins before transfusion and reduces the occurrence of post-transfusion complications. The report provides comprehensive information about the blood purification equipment pipeline products with comparative analysis of the products at various stages of development and information about the clinical trials which are in progress.

What are the market dynamics in the blood purification equipment pipeline products?

As of November 2021, 2 pipeline products were in the approval process and 14 pipeline products were in the inactive stage. 17 pipeline products were in the pre-clinical stage and 19 pipeline products were in the clinical stage. 2 pipeline products were in the intermediate stage and only one product was found to be discontinued. The US is the leading geographic region for the blood purification equipment pipeline products with 38 pipeline products followed by Europe, Japan, China, the UK, Canada, France, Germany, Poland, Turkey, and Israel. There were 13 planned trials, 38 ongoing, recruiting trials, and 1 is ongoing, recruiting by invitation.

Which are the key players in the blood purification equipment pipeline products market?

The key players in the market are Accel Diagnostics LLC, Advanced Prenatal Therapeutics, Inc., Aethlon Medical Inc, Asahi Kasei Medical Co Ltd, Avalon GloboCare Corp, Boston Children’s Hospital, Cala Medical Ltd, Cerus Corp, Chemofilter Inc (Inactive), CytoSorbents Corp and EBO2 Inc.

Company overview:

Accel Diagnostics LLC: Accel Diagnostics LLC (Accel Diagnostics), formerly Tropical Health Systems LLC, is a medical diagnostics technology developer company. The company offers pScreen disposable test for a variety of medical conditions and pScreen-BNP blood test for diagnosis and monitoring of congestive heart failure patients with a mobile-connected pScreen device. It is also involved in the development of diagnostics of sepsis and concussion.

The product is mPharesis that is a portable dialysis-like blood purification device intended for the treatment of malaria. It is designed to remove the malaria-infected red blood cells from the patient s blood. It is based on Magnetic Separation Technology. It works by passing an extremely thin layer of blood over an array of magnets and ferromagnetic wires.

Aethlon Medical Inc: Aethlon Medical Inc (Aethlon Medical) is a developer of therapeutic technologies that address unmet needs in biodefense and global health. The company’s lead product Hemopurifier is a clinical-stage immunotherapeutic device designed to single-use removal of life-threatening viruses and exosomes from the human circulatory system that promote immune suppression. Aethelon Medical received Breakthrough Device designation from the US FDA for the treatment of life- threatening viruses with no approved therapies and for the treatment of individuals with metastatic cancer who are unresponsive to standard of care therapy. Aethlon Medical is headquartered in San Diego, California, the US.

The product is ASEPSYS Device (Anticoagulation-Free Anti-Sepsis Extracorporeal System) that is a dialysis-like device intended for hemoperfusion. It is designed to selectively clear multiple sepsis-enabling particles from blood circulation to promote recovery and prevent sepsis. It is based on Aethlon ADAPT System Technology.

Asahi Kasei Medical Co Ltd: Asahi Kasei Medical Co Ltd (Asahi Kasei), a subsidiary of Asahi Kasei Corp develops, is a medical device company. The company manufactures and commercializes medical device systems for blood treatment and purification based on advanced membrane separation and adsorption technologies. It’s product portfolio includes dialyzers (artificial kidneys) for hemodialysis treatment leukocyte reduction filters for blood transfusion therapeutic apheresis products and virus removal filters.

The product is ASEPSYS Device (Anticoagulation-Free Anti-Sepsis Extracorporeal System) that is a dialysis-like device intended for hemoperfusion. It is designed to selectively clear multiple sepsis-enabling particles from blood circulation to promote recovery and prevent sepsis. It is based on Aethlon ADAPT System Technology.

Boston Children’s Hospital: Boston Children’s Hospital (Boston Children’s) is a paediatric medical centre that provides a comprehensive range of health care services for children from birth through 21 years of age. Boston Children’s is the primary paediatric teaching affiliate of Harvard Medical School. The organization provides specialty services such as cardiovascular surgery, digestive care, blood diseases, fetal care, and others. Its Advanced Fetal Care Centre supports the needs of families and referring physicians at all steps of care for various congenital anomalies, from diagnosis and counselling through treatment and follow-up. It collaborates with other institutes such as Harvard Stem Cell Institute, MIT Health Sciences & Technology, the Broad Institute, the Autism Consortium and Boston University. Boston Children’s is headquartered in Boston, Massachusetts, the US.

Its blood filtration device is intended for the management of sepsis. It is designed to filter specific cytokines from circulating blood. It helps to understand the complex interplay of different cytokines and enables the removal of cytokines responsible for that person’s unique inflammatory response.

Cerus Corp: Cerus Corp (Cerus) is a biomedical products company that focuses on the field of blood transfusion safety. It develops and commercializes Intercept blood system, which reduces the risk of transfusion-transmitted infections by inactivating a wide range of pathogens including viruses, bacteria and parasites present in donated blood. The Intercept blood system is for use with blood components including platelets, plasma, and red blood cells. It is also used to produce PRCFC, and pathogen reduced plasma and cryoprecipitate. The company markets and sells the Intercept blood system through its direct sales force and distributors in several countries including the US, Europe, the Commonwealth of Independent States (CIS), Latin America, the Middle East, and selected countries in other regions. Cerus is headquartered in Concord, California, the US.

CytoSorbents Corp: CytoSorbents Corp (CytoSorbents), formerly MedaSorb Technologies Corp, is a critical care immunotherapy company that develops blood purification products.  Its flagship product, CytoSorb is an extracorporeal cytokine adsorber that is designed to control extreme systemic inflammation in seriously ill patients by reducing excessive cytokines and bacterial toxins. CytoSorbents’ CytoSorb is also being administered during and after cardiac surgery to prevent post-operative complications such as multiple organ failure. The company offers VetResQ, a blood purification adsorber, to support and treat excessive inflammation and toxic injury in animals. The company offers its products through a network of distributors across Europe, the Middle East and Asia Pacific.

Blood purification equipment pipeline products market, by key players

Blood purification equipment pipeline products market, by key players

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Market report scope

Key countries/regions The US, Europe, Japan, China, the UK, Canada, France, Germany, Poland, Turkey, and Israel
Key players Accel Diagnostics LLC, Advanced Prenatal Therapeutics, Inc., Aethlon Medical Inc, Asahi Kasei Medical Co Ltd, Avalon GloboCare Corp, Boston Children’s Hospital, Cala Medical Ltd, Cerus Corp, Chemofilter Inc (Inactive), CytoSorbents Corp, EBO2 Inc, Eliaz Therapeutics Inc, Ex Vivo Dynamics Inc, ExThera Medical Corp, Filtro Medical Inc, Good SIRS, HemoTune AG, Immunicom Inc, JIMRO Co Ltd, Kohane Lab, Leukocare AG, McGowan Institute for Regenerative Medicine, MediSieve Ltd, Miltenyi Biotec BV & Co KG, Nipro Corpc, Nonwovens Innovation & Research Institute Ltd, NuVascular Technologies Inc, NxStage Medical Inc, Opsonix Inc, Pall Medical Products Inc, Path Ex Inc, ProSorp BioTech Inc, Pure Biologics SA, Recombinant Technologies LLC, SanSepsis BV, Santersus AG, Sigyn Therapeutics Inc, Toray Medical Co Ltd, University of Louisville, Viatar CTC Solutions Inc, and Zata Pharmaceuticals Inc.

Scope

  • Extensive coverage of the blood purification 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 Blood Purification Equipment and list all their pipeline projects.
  • The coverage of pipeline products based on various stages of development ranging from Early Development to the 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 Blood Purification 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.

Key Players

Accel Diagnostics LLC

Advanced Prenatal Therapeutics, Inc.

Aethlon Medical Inc

Asahi Kasei Medical Co Ltd

Avalon GloboCare Corp

Boston Children’s Hospital

Cala Medical Ltd

Cerus Corp

Chemofilter Inc (Inactive)

CytoSorbents Corp

EBO2 Inc

Eliaz Therapeutics Inc

Ex Vivo Dynamics Inc

ExThera Medical Corp

Filtro Medical Inc

Good SIRS

HemoTune AG

Immunicom Inc

JIMRO Co Ltd

Kohane Lab

Leukocare AG

McGowan Institute for Regenerative Medicine

MediSieve Ltd

Miltenyi Biotec BV & Co KG

Nipro Corp

Nonwovens Innovation & Research Institute Ltd

NuVascular Technologies Inc

NxStage Medical Inc

Opsonix Inc

Pall Medical Products Inc

Path Ex Inc

ProSorp BioTech Inc

Pure Biologics SA

Recombinant Technologies LLC

SanSepsis BV

Santersus AG

Sigyn Therapeutics Inc

Toray Medical Co Ltd

University of Louisville

Viatar CTC Solutions Inc

Zata Pharmaceuticals Inc

Table of Contents

|1 Table of Contents 3

|1.1 List of Tables 6

|1.2 List of Figures 12

2 Introduction 13

2.1 Blood Purification Equipment Overview 13

3 Products under Development 14

3.1 Blood Purification Equipment – Pipeline Products by Stage of Development 14

3.2 Blood Purification Equipment – Pipeline Products by Territory 15

3.3 Blood Purification Equipment – Pipeline Products by Regulatory Path 16

3.4 Blood Purification Equipment – Pipeline Products by Estimated Approval Date 17

3.5 Blood Purification Equipment – Ongoing Clinical Trials 18

4 Blood Purification Equipment – Pipeline Products under Development by Companies 19

4.1 Blood Purification Equipment Companies – Pipeline Products by Stage of Development 19

4.2 Blood Purification Equipment – Pipeline Products by Stage of Development 21

5 Blood Purification Equipment Companies and Product Overview 23

5.1 Accel Diagnostics LLC Company Overview 23

5.1.1 Accel Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 23

5.2 Advanced Prenatal Therapeutics, Inc. Company Overview 24

5.2.1 Advanced Prenatal Therapeutics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 24

5.3 Aethlon Medical Inc Company Overview 25

5.3.1 Aethlon Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 25

5.4 Asahi Kasei Medical Co Ltd Company Overview 29

5.4.1 Asahi Kasei Medical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 29

5.5 Avalon GloboCare Corp Company Overview 30

5.5.1 Avalon GloboCare Corp Pipeline Products & Ongoing Clinical Trials Overview 30

5.6 Boston Children’s Hospital Company Overview 31

5.6.1 Boston Children’s Hospital Pipeline Products & Ongoing Clinical Trials Overview 31

5.7 Cala Medical Ltd Company Overview 32

5.7.1 Cala Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 32

5.8 Cerus Corp Company Overview 33

5.8.1 Cerus Corp Pipeline Products & Ongoing Clinical Trials Overview 33

5.9 Chemofilter Inc (Inactive) Company Overview 39

5.9.1 Chemofilter Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 39

5.10 CytoSorbents Corp Company Overview 41

5.10.1 CytoSorbents Corp Pipeline Products & Ongoing Clinical Trials Overview 41

5.11 EBO2 Inc Company Overview 60

5.11.1 EBO2 Inc Pipeline Products & Ongoing Clinical Trials Overview 60

5.12 Eliaz Therapeutics Inc Company Overview 61

5.12.1 Eliaz Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 61

5.13 Ex Vivo Dynamics Inc Company Overview 62

5.13.1 Ex Vivo Dynamics Inc Pipeline Products & Ongoing Clinical Trials Overview 62

5.14 ExThera Medical Corp Company Overview 63

5.14.1 ExThera Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 63

5.15 Filtro Medical Inc Company Overview 68

5.15.1 Filtro Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 68

5.16 Good SIRS Company Overview 69

5.16.1 Good SIRS Pipeline Products & Ongoing Clinical Trials Overview 69

5.17 HemoTune AG Company Overview 70

5.17.1 HemoTune AG Pipeline Products & Ongoing Clinical Trials Overview 70

5.18 Immunicom Inc Company Overview 71

5.18.1 Immunicom Inc Pipeline Products & Ongoing Clinical Trials Overview 71

5.19 JIMRO Co Ltd Company Overview 76

5.19.1 JIMRO Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 76

5.20 Kohane Lab Company Overview 79

5.20.1 Kohane Lab Pipeline Products & Ongoing Clinical Trials Overview 79

5.21 Leukocare AG Company Overview 80

5.21.1 Leukocare AG Pipeline Products & Ongoing Clinical Trials Overview 80

5.22 McGowan Institute for Regenerative Medicine Company Overview 81

5.22.1 McGowan Institute for Regenerative Medicine Pipeline Products & Ongoing Clinical Trials Overview 81

5.23 MediSieve Ltd Company Overview 82

5.23.1 MediSieve Ltd Pipeline Products & Ongoing Clinical Trials Overview 82

5.24 Miltenyi Biotec BV & Co KG Company Overview 87

5.24.1 Miltenyi Biotec BV & Co KG Pipeline Products & Ongoing Clinical Trials Overview 87

5.25 Nipro Corp Company Overview 90

5.25.1 Nipro Corp Pipeline Products & Ongoing Clinical Trials Overview 90

5.26 Nonwovens Innovation & Research Institute Ltd Company Overview 91

5.26.1 Nonwovens Innovation & Research Institute Ltd Pipeline Products & Ongoing Clinical Trials Overview 91

5.27 NuVascular Technologies Inc Company Overview 92

5.27.1 NuVascular Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 92

5.28 NxStage Medical Inc Company Overview 93

5.28.1 NxStage Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 93

5.29 Opsonix Inc Company Overview 94

5.29.1 Opsonix Inc Pipeline Products & Ongoing Clinical Trials Overview 94

5.30 Pall Medical Products Inc Company Overview 95

5.30.1 Pall Medical Products Inc Pipeline Products & Ongoing Clinical Trials Overview 95

5.31 Path Ex Inc Company Overview 96

5.31.1 Path Ex Inc Pipeline Products & Ongoing Clinical Trials Overview 96

5.32 ProSorp BioTech Inc Company Overview 97

5.32.1 ProSorp BioTech Inc Pipeline Products & Ongoing Clinical Trials Overview 97

5.33 Pure Biologics SA Company Overview 98

5.33.1 Pure Biologics SA Pipeline Products & Ongoing Clinical Trials Overview 98

5.34 Recombinant Technologies LLC Company Overview 99

5.34.1 Recombinant Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 99

5.35 SanSepsis BV Company Overview 100

5.35.1 SanSepsis BV Pipeline Products & Ongoing Clinical Trials Overview 100

5.36 Santersus AG Company Overview 101

5.36.1 Santersus AG Pipeline Products & Ongoing Clinical Trials Overview 101

5.37 Sigyn Therapeutics Inc Company Overview 107

5.37.1 Sigyn Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 107

5.38 Toray Medical Co Ltd Company Overview 109

5.38.1 Toray Medical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 109

5.39 University of Louisville Company Overview 116

5.39.1 University of Louisville Pipeline Products & Ongoing Clinical Trials Overview 116

5.40 Viatar CTC Solutions Inc Company Overview 117

5.40.1 Viatar CTC Solutions Inc Pipeline Products & Ongoing Clinical Trials Overview 117

5.41 Zata Pharmaceuticals Inc Company Overview 121

5.41.1 Zata Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 121

6 Blood Purification Equipment- Recent Developments 124

6.1 Nov 09, 2021: Aethlon Medical Announces Second Quarter Financial Results and Provides Corporate Update 124

6.2 Nov 02, 2021: Baxter to Present at Evercore ISI 4th Annual HealthCONx Conference 125

6.3 Oct 24, 2021: Biocon Announces Financial Results For The Quarter And Half Year Ended September 30, 2021 126

6.4 Oct 13, 2021: Baxter to Present at Credit Suisse 30th Annual Virtual Healthcare Conference 126

6.5 Oct 12, 2021: CytoSorbents Provides Preliminary Third Quarter Business Update and Revised 2021 Product Revenue Guidance 126

6.6 Oct 06, 2021: Haemonetics Sets Date for Publishing Second Quarter Fiscal Year 2022 Results: November 9, 2021 128

6.7 Sep 27, 2021: Baxter to Host Third-Quarter 2021 Financial Results Conference Call for Investors 128

6.8 Sep 22, 2021: Glycorex Transplantation- UBP product: Presentation of results at the Jahrestagung DGTI 129

6.9 Aug 13, 2021: Spectral Announces Second Quarter Results and Provides Corporate Update 129

6.10 Aug 10, 2021: ADMA Biologics advances expansion plans and opens new plasma collection center in Conyers, GA; ADMA Implements Haemonetics’ Persona Technology for NexSys Plasma Collection System 131

6.11 Aug 09, 2021: Aethlon Medical Announces First Quarter Financial Results and Provides Corporate Update 132

6.12 Aug 03, 2021: CytoSorbents Reports Second Quarter 2021 Financial and Operational Results 134

6.13 Jul 29, 2021: Baxter Reports Second-Quarter 2021 Results 139

6.14 Jul 29, 2021: Aethlon Medical to Release First Quarter Financial Results and Host Conference Call on August 9, 2021 141

6.15 Jul 29, 2021: Baxter to Present at UBS Genomics

2.0 and MedTech Innovations Summit 142

6.16 Jul 28, 2021: Jianfan Group donated 5 million yuan, China Hepatic Failure Blood Purification Diagnosis and Treatment (Yuanhang) Project was officially launched 142

6.17 Jul 22, 2021: Biocon Announces Financial Results For The Quarter Ended June 30, 2021 143

6.18 Jul 20, 2021: Cerus to Release Second Quarter 2021 Financial Results on August 3, 2021 143

6.19 Jul 13, 2021: Sigyn Therapeutics Reports Preliminary Results of Hepatic Encephalopathy Toxin Study 143

6.20 Jul 09, 2021: Haemonetics Sets Date for Publishing First Quarter Fiscal Year 2022 Results: August 11, 2021 144

6.21 Jun 30, 2021: Asahi Kasei Announces Q1 2021 Financial Results 145

6.22 Jun 24, 2021: Aethlon Medical Announces Fiscal Year End Financial Results and Provides Corporate Update 145

6.23 Jun 15, 2021: Baxter to Host Second-Quarter 2021 Financial Results Conference Call for Investors 146

6.24 Jun 08, 2021: Sigyn Therapeutics Announces Virtual Presentation at LD Micro Invitational Conference 146

6.25 May 14, 2021: Spectral Announces First Quarter Results and Provides Corporate Update 147

6.26 May 13, 2021: Haemonetics 4th Quarter Fiscal Year 2021 Earnings Release Available on Investor Relations Website 149

6.27 Apr 23, 2021: Haemonetics Sets Date for Publishing Fourth Quarter and Fiscal Year 2021 Results: May 13, 2021 150

6.28 Mar 26, 2021: Spectral Announces Fourth Quarter and Fiscal 2020 Results and Corporate Update 150

6.29 Mar 12, 2021: CytoSorbents to Present at the Oppenheimer 31st Annual Healthcare Conference 152

6.30 Mar 08, 2021: Sigyn Therapeutics to Present at the H.C. Wainwright Global Life Sciences Conference 152

6.31 Mar 02, 2021: Biocon Biologics Appoints Susheel Umesh as Chief Commercial Officer for Emerging Markets 153

6.32 Mar 02, 2021: Spectral Medical to participate at the upcoming H.C. Wainwright Global Life Sciences Conference 153

6.33 Mar 01, 2021: Aethlon Medical to Participate in Two Upcoming Healthcare Investor Conferences 154

6.34 Mar 01, 2021: CytoSorbents to Report Fiscal 2020 Operating and Financial Results 154

6.35 Feb 26, 2021: Haemonetics To Present At The Jefferies Plasma Summit 155

6.36 Feb 24, 2021: CytoSorbents to Present at the Cowen 41st Annual Health Care Conference 155

6.37 Feb 17, 2021: Medtronic Executives to Speak at Upcoming Investor Conferences 155

6.38 Feb 16, 2021: CytoSorbents to Present at the 10th Annual SVB Leerink Global Healthcare Conference 156

6.39 Feb 16, 2021: Medtronic to Announce Financial Results for Its Third Quarter of Fiscal Year 2021 156

6.40 Feb 12, 2021: Asahi Intecc announces financial results and presentation materials for the 2nd Quarter of the fiscal year ending June 2021 156

6.41 Feb 11, 2021: Cerus Corporation to Release Fourth Quarter and Full Year 2020 Financial Results on February 25, 2021 156

6.42 Feb 11, 2021: Sigyn Therapeutics Announces Force Wealth Webinar Presentation on February 16th 157

6.43 Feb 10, 2021: Aethlon Medical Announces Third Quarter Financial Results and Provides Corporate Update 157

6.44 Feb 04, 2021: Aethlon Medical to Release Third Quarter Financial Results and Host Conference Call on February 10, 2021 159

6.45 Feb 04, 2021: Cerus Corporation to Participate in Upcoming Virtual Investor Conferences 159

6.46 Feb 04, 2021: Aethlon Medical to Release Third Quarter Financial Results and Host Conference Call on February 10, 2021 159

6.47 Feb 02, 2021: Haemonetics 3rd Quarter Fiscal Year 2021 Earnings Release Available on Investor Relations Website 160

6.48 Feb 01, 2021: Asahi Holdings Australia appoints new Chairman 160

6.49 Feb 01, 2021: Spectral Medical Appoints Dr. John Kellum as Chief Medical Officer 160

6.50 Jan 21, 2021: Baxter to Present at SVB Leerink 10th Annual Global Healthcare Conference 161

6.51 Jan 21, 2021: Biocon Announces Financial Results For The Quarter And Nine Months Ended December 31, 2020 161

6.52 Jan 04, 2021: Aethlon Medical to Present at the H.C. Wainwright BioConnect 2021 Conference 161

6.53 Dec 10, 2020: CytoSorbents pays off $15M term loans and establishes new undrawn $15M loan commitment with Bridge Bank 162

7 Appendix 163

7.1 Methodology 163

7.2 About GlobalData 166

7.3 Contact Us 166

List of Tables

Blood Purification Equipment – Pipeline Products by Stage of Development 14

Blood Purification Equipment – Pipeline Products by Territory 15

Blood Purification Equipment – Pipeline Products by Regulatory Path 16

Blood Purification Equipment – Pipeline Products by Estimated Approval Date 17

Blood Purification Equipment – Ongoing Clinical Trials 18

Blood Purification Equipment Companies – Pipeline Products by Stage of Development 19

Blood Purification Equipment – Pipeline Products by Stage of Development 21

Accel Diagnostics LLC Pipeline Products & Ongoing Clinical Trials Overview 23

mPharesis – Product Status 23

mPharesis – Product Description 23

Advanced Prenatal Therapeutics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 24

Targeted Apheresis Column for Preeclampsia (TAC-PE) – Product Status 24

Targeted Apheresis Column for Preeclampsia (TAC-PE) – Product Description 24

Aethlon Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 25

ASEPSYS Device – Product Status 25

ASEPSYS Device – Product Description 25

Hemopurifier – Product Status 26

Hemopurifier – Product Description 26

Aethlon Medical Inc – Ongoing Clinical Trials Overview 27

Hemopurifier – Depleting Exosomes to Improve Response to Immune Therapy in Head and Neck Squamous Cell Cancer: An Early Feasibility Phase I Clinical Trial 28

Hemopurifier – Treatment of SARS-CoV-2 Virus Disease (COVID-19) in Humans with Hemopurifier Device 28

Asahi Kasei Medical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 29

Mysorba – Product Status 29

Mysorba – Product Description 29

Avalon GloboCare Corp Pipeline Products & Ongoing Clinical Trials Overview 30

AVA-Trap Blood Filtration System – Cytokine Storms – Product Status 30

AVA-Trap Blood Filtration System – Cytokine Storms – Product Description 30

Boston Children’s Hospital Pipeline Products & Ongoing Clinical Trials Overview 31

Blood Filtration Device – Product Status 31

Blood Filtration Device – Product Description 31

Cala Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 32

Cytoflow5 – Product Status 32

Cytoflow5 – Product Description 32

Cerus Corp Pipeline Products & Ongoing Clinical Trials Overview 33

INTERCEPT Blood System – Platelets – Product Status 33

INTERCEPT Blood System – Platelets – Product Description 34

INTERCEPT Blood System – Red Blood Cells – Product Status 34

INTERCEPT Blood System – Red Blood Cells – Product Description 34

INTERCEPT Blood System – Whole Blood – Product Status 35

INTERCEPT Blood System – Whole Blood – Product Description 35

Next Generation INTERCEPT Blood System – Product Status 35

Next Generation INTERCEPT Blood System – Product Description 36

Cerus Corp – Ongoing Clinical Trials Overview 37

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 38

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 38

INTERCEPT Blood System – Red Blood Cells – Randomized, Double-blind, Controlled, Parallel Group Study with the INTERCEPT Blood System for RBCs in Regions at Potential Risk for Zika Virus Transfusion-transmitted Infections and Treatment Use Open-label Extension Study 38

Chemofilter Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 39

ChemoFilter Device – Product Status 39

ChemoFilter Device – Product Description 39

Next-Generation ChemoFilter Device – Product Status 40

Next-Generation ChemoFilter Device – Product Description 40

CytoSorbents Corp Pipeline Products & Ongoing Clinical Trials Overview 41

BetaSorb – Product Status 41

BetaSorb – Product Description 42

ContrastSorb – Product Status 42

ContrastSorb – Product Description 42

CST 301 – Product Status 43

CST 301 – Product Description 43

CytoSorb – Product Status 43

CytoSorb – Product Description 44

CytoSorb-XL – Product Status 44

CytoSorb-XL – Product Description 45

DrugSorb-ATR – Product Status 45

DrugSorb-ATR – Product Description 45

HemoDefend BGA – Product Status 46

HemoDefend BGA – Product Description 46

HemoDefend RBC – Product Status 46

HemoDefend RBC – Product Description 47

K+ontrol – Product Status 47

K+ontrol – Product Description 47

CytoSorbents Corp – Ongoing Clinical Trials Overview 48

CytoSorb – A Prospective, Open, Multi-center, Single-arm Study to Demonstrate the Feasibility of the CytoSorb 300 mL Device to Remove Ticagrelor During Cardiopulmonary Bypass in Patients on Ticagrelor Undergoing Emergent Cardiothoracic Surgery 50

CytoSorb – A Prospective, Randomized, Multicenter, Single-blind, Controlled Study to Assess the Performance of the Cytosorb 300 ml Device for Shock Reversal in Patients with Vasoplegic Septic Shock 50

CytoSorb – An Open-label Randomized Controlled Experimental Endotoxemia Study on the Effects of the Cytokine-adsorber CytoSorb on the Development of Immunoparalysis in Humans 50

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 51

CytoSorb – Comparing the Cytokine Clearances of Pro-, and Anti-inflammatory Mediators, Chemokines and Complement in the COVID-19 Patients Treated with Cytosorb as Compared to the Same Patient Population Who Do Not Receive Blood Purification Treatment 51

CytoSorb – Cytokine Adsorption in Patients with Acute-on-chronic Liver Failure (CYTOHEP) – A Single Center, Open-label, Randomized, Controlled Intervention Trial 51

CytoSorb – Cytokine Filter Usage During Open Thoracoabdominal Aortic Aneurysm Repair- A Single-center Randomized Prospective Trial- Cytosorb and Its Impact on Open TAAA Repair Outcome 52

CytoSorb – CytoResc – CytoSorb Rescue for COVID-19 Cytokine Storm 52

CytoSorb – Cytosorb Modulation of Surgical Inflammation During LVAD Insertion 52

CytoSorb – CytoSorb Reduction of Freee Hemoglobin/Acute Kidney Injury (AKI) During Cardiac Surgery (REFRESH II Trial) 53

CytoSorb – Data Collection on the Application of Cytokine Adsorption Therapy on Patients with Acute Respiratory Failure Caused by COVID-19 53

CytoSorb – Dosing of Extracorporeal Cytokine Removal in Septic Shock (DECRISS): A Prospective, Randomized, Multicenter Clinical Trial 53

CytoSorb – Early Haemadsorption Treatment of Major Burn Trauma Patients 54

CytoSorb – ECMOsorb Trial – Impact of a VA-ECMO in Combination with CytoSorb in Critically Ill Patients with Cardiogenic Shock – A Prospective, Randomized, Blinded, Monocenter Trial 54

CytoSorb – Effectivity of Extracorporeal Cytokine Adsorption (Cytosorb) as Additive Treatment of CAR-T Cell Associated Cytokine Release (CRS) Syndrome and Encephalopathy Syndrome (CRES) 54

CytoSorb – Elimination of Antibiotics During Combined Continuous Renal Replacement Therapy and Cytosorb Adsorptive Therapy in Patients with Sepsis and Acute Kidney Injury 55

CytoSorb – Hemoadsorption with CytoSorb in Post-Cardiac Arrest Syndrome: a Pilot Study (The CATCH Trial: Post Cardiac Arrest Therapy with Cytosorb Hemoadsorption) 55

CytoSorb – Improvement of Disrupted Cerebrovascular Autoregulation in Patients in Septic Shock by Extracorporeal Reduction of Inflammatory Mediators 55

CytoSorb – International Registry on the Use of the CytoSorb-Adsorber in ICU Patients 56

CytoSorb – Monocentric Prospective Randomized Pilot Study in Patients with Kidney Failure to Evaluate the Relationship Between the Hemadsorption During and After Cardiopulmonary Bypass and the Modulation of Post-surgical Inflammatory Response 56

CytoSorb – Nephroprotection in Severe Rhabdomyolysis by Use of a Hemadsorber 56

CytoSorb – Prevention of Vasoplegia with the Use of CytoSorb 57

CytoSorb – Prospective Quality Assurance Study for the Application of Cytosorb in Patients with Cytokine Storm, Rhabdomyolysis and Acute Liver Failure 57

CytoSorb – Registry of CytoSorb Therapy in COVID-19 ICU Patients (CTC REGISTRY): Registry of Patient-level Clinical Data on CytoSorb Hemoadsorption Provided Via Integration of the CytoSorb Device Into Extracorporeal Membrane Oxygenation (ECMO), Continuous Renal Replacement Therapy (CRRT), or Hemoperfusion Extracorporeal Circuits in COVID-19 ICU Patients 57

CytoSorb – The Impact of Pre-emptive Intraoperative Use of Extracorporeal Cytokine Adsorption during Orthotopic Heart Transplantation 58

DrugSorb-ATR – Safe and Timely Antithrombotic Removal – Direct Oral Anticoagulants Apixaban & Rivaroxaban (STAR-D): A Prospective, Multicenter, Double-blind, Randomized, Study to Evaluate DrugSorb-ATR Removal of Apixaban and Rivaroxaban to Reduce Likelihood of Serious Bleeding in Patients Undergoing Urgent Cardiothoracic Surgery 59

DrugSorb-ATR – Safe and Timely Antithrombotic Removal – Ticagrelor (STAR-T): A Prospective, Multicenter, Double-blind, Randomized, Study to Evaluate Reduction in Postoperative Bleeding by Removal of Ticagrelor with the Intraoperative Use of the DrugSorb-ATR Device in Patients Undergoing On-pump Cardiothoracic Surgery within 48hrs from Last Ticagrelor Dose 59

DrugSorb-ATR – Safe and Timely Antithrombotic Removal – Direct Oral Anticoagulants [DOAC]: STAR–D 59

EBO2 Inc Pipeline Products & Ongoing Clinical Trials Overview 60

EBO2 – Product Status 60

EBO2 – Product Description 60

Eliaz Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 61

XGal-3 – Product Status 61

XGal-3 – Product Description 61

Ex Vivo Dynamics Inc Pipeline Products & Ongoing Clinical Trials Overview 62

BloodGuard – Product Status 62

BloodGuard – Product Description 62

ExThera Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 63

Seraph 100 – Product Status 63

Seraph 100 – Product Description 63

ExThera Medical Corp – Ongoing Clinical Trials Overview 64

Seraph 100 – A Pivotal, Randomized, Controlled Study to Evaluate the Efficacy of Seraph 100 in the Treatment of COVID-19 Patients 65

Seraph 100 – Blood Purification for the Treatment of Critically Ill Patients with Pathogen Associated Shock: A Multicenter, Randomized Controlled Feasibility Trial 65

Seraph 100 – Blood Purification with Seraph 100 Microbind Affinity Blood Filter for the Treatment of Severe COVID-19: An Observational Study: PURIFY-OBS-1 65

Seraph 100 – Reduction of BK Viremia in Kidney Transplant Patients Using the Seraph 100 Microbind Affinity (Seraph 100) Blood Filter 66

Seraph 100 – Registry for the Evaluation of Safety and Effectiveness of the Seraph 100 Microbind Affinity Blood Filter in the Therapy of COVID-19 Patients (COSA) 66

Seraph 100 – Safety and Effectiveness Evaluation of Seraph 100 Microbind Affinity Blood Filter (Seraph 100) in the Treatment of Patients with COVID-19 66

Seraph 100 – Safety and Performance Evaluation of Seraph 100 Microbind Affinity Blood Filter (Seraph 100) in the Reduction of Pathogen Load From the Blood in Septic Patients with Suspected, Life-threatening Bloodstream Infection 67

Seraph 100 – Seraph-100 Microbind Affinity Blood Filter for the Treatment of COVID-19 Under Emergency Use Authorization: Data Registry 67

Filtro Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 68

Endovascular ChemoFilter – Product Status 68

Endovascular ChemoFilter – Product Description 68

Good SIRS Pipeline Products & Ongoing Clinical Trials Overview 69

Blood-Filtering Device – Product Status 69

Blood-Filtering Device – Product Description 69

HemoTune AG Pipeline Products & Ongoing Clinical Trials Overview 70

HemoSystem – Product Status 70

HemoSystem – Product Description 70

Immunicom Inc Pipeline Products & Ongoing Clinical Trials Overview 71

EN-06 Blood Filtering Immunotherapy Device – Product Status 71

EN-06 Blood Filtering Immunotherapy Device – Product Description 71

LW-02 Blood-Filtering Immunotherapy Device – Product Status 72

LW-02 Blood-Filtering Immunotherapy Device – Product Description 72

Immunicom Inc – Ongoing Clinical Trials Overview 73

LW-02 Blood-Filtering Immunotherapy Device – A Multicenter, Open-label, Three-part Study to Evaluate the Safety and Effectiveness of Immunopheresis with Immunicom’s LW-02 Device in Removal of Soluble Tumor Necrosis Factor Receptors (sTNF-Rs) as Well as Clinical Efficacy in Treatment of Patients with Advanced, Refractory Triple Negative Breast Cancer (TNBC) Alone, or in Combination with Low Dose Weekly Paclitaxel plus Carboplatin Chemotherapy Versus Low Dose Weekly Paclitaxel plus Carboplatin Chemotherapy 74

LW-02 Blood-Filtering Immunotherapy Device – A Pilot Study, Single-center, Open-label, Sequentional Immuno Apheresis Plasma Volume Escalation Cohort Study of Reduction of Soluble Tumor Necrosis Factor Receptors 1 and 2 (sTNFR1/2) with or without Nivolumab in Patients with Inoperable or Metastatic Solid Tumors 74

LW-02 Blood-Filtering Immunotherapy Device – Open-label Study Evaluating the Safety and Effectiveness of Immunopheresis with the LW-02 Column Alone or in Combination with Paclitaxel or Atezolizumab in Removing Soluble Tumor Necrosis Factor Receptors to Treat Patients with Advanced, Non-small Cell Lung Cancer (NSCLC) 75

JIMRO Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 76

Adacolumn Apheresis Device – Product Status 76

Adacolumn Apheresis Device – Product Description 76

JIMRO Co Ltd – Ongoing Clinical Trials Overview 77

Adacolumn Apheresis Device – Examination of the Usefulness for the Treatment of Ulcerative Colitis through the Change of Enterobacterial Flora Derived by Adacolumn Treatment 78

Adacolumn Apheresis Device – Open Uncontrolled Investigation to Evaluate the Efficacy and Safety of the Granulocytes/ Monocytes Apheresis with the Adacolumn for the Treatment of Severe Alcoholic Hepatitis 78

Kohane Lab Pipeline Products & Ongoing Clinical Trials Overview 79

Immune-Modulating Extracorporeal Circuit – Product Status 79

Immune-Modulating Extracorporeal Circuit – Product Description 79

Leukocare AG Pipeline Products & Ongoing Clinical Trials Overview 80

CTC Apheresis Device – Product Status 80

CTC Apheresis Device – Product Description 80

McGowan Institute for Regenerative Medicine Pipeline Products & Ongoing Clinical Trials Overview 81

Hemoadsorption Device – Sepsis – Product Status 81

Hemoadsorption Device – Sepsis – Product Description 81

MediSieve Ltd Pipeline Products & Ongoing Clinical Trials Overview 82

Magnetic Blood Filtration Device – Hyperinflammation – Product Status 82

Magnetic Blood Filtration Device – Hyperinflammation – Product Description 82

Magnetic Blood Filtration Device – Leukaemia – Product Status 83

Magnetic Blood Filtration Device – Leukaemia – Product Description 83

Magnetic Blood Filtration Device – Malaria – Product Status 83

Magnetic Blood Filtration Device – Malaria – Product Description 84

Magnetic Blood Filtration Device – Sepsis – Product Status 84

Magnetic Blood Filtration Device – Sepsis – Product Description 84

MediSieve Ltd – Ongoing Clinical Trials Overview 85

Magnetic Blood Filtration Device – Malaria – Clinical Investigation of the Safety and Initial Performance of the MediSieve Magnetic Haemofiltration System in Healthy Volunteers 86

Miltenyi Biotec BV & Co KG Pipeline Products & Ongoing Clinical Trials Overview 87

Therasorb sFlt-1 – Product Status 87

Therasorb sFlt-1 – Product Description 87

Miltenyi Biotec BV & Co KG – Ongoing Clinical Trials Overview 88

Therasorb sFlt-1 – Proof-of-Concept Trial on Selective Removal of the Antiangiogenic Factor Soluble Fms-like Tyrosine Kinase-1 (sFlt-1) in Pregnant Women with Preeclampsia Via Apheresis Utilizing the Flt-1 Adsorption Column 89

Nipro Corp Pipeline Products & Ongoing Clinical Trials Overview 90

NP026 – Product Status 90

NP026 – Product Description 90

Nonwovens Innovation & Research Institute Ltd Pipeline Products & Ongoing Clinical Trials Overview 91

Blood Collection System – Product Status 91

Blood Collection System – Product Description 91

NuVascular Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 92

HIV Filter – Product Status 92

HIV Filter – Product Description 92

NxStage Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 93

DLT Device – Sepsis – Product Status 93

DLT Device – Sepsis – Product Description 93

Opsonix Inc Pipeline Products & Ongoing Clinical Trials Overview 94

Pathogen-Extracting Therapy Device – Product Status 94

Pathogen-Extracting Therapy Device – Product Description 94

Pall Medical Products Inc Pipeline Products & Ongoing Clinical Trials Overview 95

HemaTrate – Critical Limb Ischemia – Product Status 95

HemaTrate – Critical Limb Ischemia – Product Description 95

Path Ex Inc Pipeline Products & Ongoing Clinical Trials Overview 96

PATH EX Device – Product Status 96

PATH EX Device – Product Description 96

ProSorp BioTech Inc Pipeline Products & Ongoing Clinical Trials Overview 97

Blood Perfusion Device – Product Status 97

Blood Perfusion Device – Product Description 97

Pure Biologics SA Pipeline Products & Ongoing Clinical Trials Overview 98

Therapeutic Apheresis Device – Myasthenia Gravis – Product Status 98

Therapeutic Apheresis Device – Myasthenia Gravis – Product Description 98

Recombinant Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 99

Amytrapper – Product Status 99

Amytrapper – Product Description 99

SanSepsis BV Pipeline Products & Ongoing Clinical Trials Overview 100

Apheresis Filter – Product Status 100

Apheresis Filter – Product Description 100

Santersus AG Pipeline Products & Ongoing Clinical Trials Overview 101

Nucleocapture Device – Autoimmune Diseases – Product Status 101

Nucleocapture Device – Autoimmune Diseases – Product Description 101

Nucleocapture Device – Cancer – Product Status 102

Nucleocapture Device – Cancer – Product Description 102

Nucleocapture Device – COVID-19 – Product Status 102

Nucleocapture Device – COVID-19 – Product Description 103

Nucleocapture Device – Sepsis – Product Status 103

Nucleocapture Device – Sepsis – Product Description 103

Nucleocapture Device – Severe Trauma – Product Status 104

Nucleocapture Device – Severe Trauma – Product Description 104

Santersus AG – Ongoing Clinical Trials Overview 105

Nucleocapture Device – Sepsis – Safety and Efficacy Assessment of NucleoCapture Selective DNA Adsorber in Humans 106

Sigyn Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 107

Sigyn Therapy – Hepatic Encephalopathy – Product Status 107

Sigyn Therapy – Hepatic Encephalopathy – Product Description 107

Sigyn Therapy – Virus Induced Cytokine Storm – Product Status 108

Sigyn Therapy – Virus Induced Cytokine Storm – Product Description 108

Toray Medical Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 109

Dialysis Complication Treatment Column – Product Status 109

Dialysis Complication Treatment Column – Product Description 109

Epurina – Product Status 110

Epurina – Product Description 110

Filtor – Product Status 110

Filtor – Product Description 110

Respiratory Disease Treatment Column – Product Status 111

Respiratory Disease Treatment Column – Product Description 111

Toray Leukocyte Removal Column – Product Status 111

Toray Leukocyte Removal Column – Product Description 111

TORAYMYXIN PMX-20R – Product Status 112

TORAYMYXIN PMX-20R – Product Description 112

Toraymyxin – Idiopathic Pulmonary Fibrosis – Product Status 112

Toraymyxin – Idiopathic Pulmonary Fibrosis – Product Description 113

Toray Medical Co Ltd – Ongoing Clinical Trials Overview 114

TORAYMYXIN PMX-20R – A Prospective, Multicenter, Randomized, Open-label Study to Evaluate the Efficacy and Safety of PMX Cartridge in Addition to Standard Medical Care for Patients with Endotoxemic Septic Shock 115

TORAYMYXIN PMX-20R – Exploratory Study on the Efficacy and Safety of Direct Hemoperfusion Using Polymyxin B-immobilized Polystyrene Column (PMX-DHP) for COVID-19 Patients (X-CODE) 115

University of Louisville Pipeline Products & Ongoing Clinical Trials Overview 116

Ectopic Cell-Based Apheresis Device – Product Status 116

Ectopic Cell-Based Apheresis Device – Product Description 116

Viatar CTC Solutions Inc Pipeline Products & Ongoing Clinical Trials Overview 117

Viatar Therapeutic Oncopheresis System – Product Status 117

Viatar Therapeutic Oncopheresis System – Product Description 118

Viatar CTC Solutions Inc – Ongoing Clinical Trials Overview 119

Viatar Therapeutic Oncopheresis System – Evaluation of the Saftey and Efficacy of the Viatar Oncopheresis System in Removing Circulating Tumor Cells from Whole Blood 120

Zata Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 121

ZAP-System I – Product Status 121

ZAP-System I – Product Description 121

ZAP-System II – Product Status 122

ZAP-System II – Product Description 122

ZAP-System III – Product Status 122

ZAP-System III – Product Description 123

List of Figures

Blood Purification Equipment – Pipeline Products by Stage of Development 14

Blood Purification Equipment – Pipeline Products by Territory 15

Blood Purification Equipment – Pipeline Products by Regulatory Path 16

Blood Purification Equipment – Pipeline Products by Estimated Approval Date 17

Frequently Asked Questions

The US is the leading market followed by Europe, Japan, China, the UK, Canada, France, Germany, Poland, Turkey, and Israel.

The key players in the market are Accel Diagnostics LLC, Advanced Prenatal Therapeutics, Inc., Aethlon Medical Inc, Asahi Kasei Medical Co Ltd, Avalon GloboCare Corp, Boston Children’s Hospital, Cala Medical Ltd, Cerus Corp, Chemofilter Inc (Inactive), CytoSorbents Corp and EBO2 Inc.

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$12000

Can be shared globally by unlimited users within the purchasing corporation e.g. all employees of a single company

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