Category Archives: Press Release

C O R R E C T I O N — CytoSorbents Corporation

In the news release, CytoSorbents to Host Key Opinion Leader Call on the Use of CytoSorb Blood Purification to Remove Antithrombotic Medications in Patients at Risk of Bleeding, issued 29-Jun-2020 by CytoSorbents Corporation over PR Newswire, we are advised by the company that the conference call details and webcast information has changed. To reflect this, the third hyperlink in the first paragraph has been updated. Additionally, the “Key Opinion Leader Call Details” section after the third paragraph has been updated. The complete, corrected release follows:

CytoSorbents to Host Key Opinion Leader Call on the Use of CytoSorb Blood Purification to Remove Antithrombotic Medications in Patients at Risk of Bleeding

MONMOUTH JUNCTION, N.J., July 8, 2020 /PRNewswire/ — CytoSorbents Corporation (NASDAQ:CTSO), a critical care immunotherapy leader using its CytoSorb® blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, announces that CytoSorbents will host a Key Opinion Leader call on the Use of CytoSorb to Remove Antithrombotic Medications in Patients at Risk of Bleeding, on Monday, July 13, 2020 at 11:00 AM EDT, featuring presentations by key experts:

  • Dr. C. Michael GibsonHarvard University and Baim Institute for Clinical Research, USA
  • Dr. Robert Storey – University of Sheffield, United Kingdom
  • Prof. Dr. med. Michael Schmoeckel – Asklepios-Klinik St. Georg Hamburg, Germany

Millions of patients globally are taking antithrombotic medications, or “blood thinners”, to reduce their risk of stroke and heart attacks. But when they require surgery, they risk life-threatening perioperative bleeding. The call will feature presentations from each of the distinguished speakers who will discuss the unmet medical need of managing patients on antithrombotic therapy requiring surgery.  Drs. Gibson, Storey, and Schmoeckel will be available to answer questions at the conclusion of the event.

The discussion will be focused on the use of CytoSorb to remove two of the most commonly prescribed antithrombotic agents, ticagrelor (Brilinta®, Brilique®) and rivaroxaban (Xarelto®) from the bloodstream when installed in a heart-lung machine blood circuit during cardiothoracic surgery. CytoSorb has also received FDA Breakthrough Designation to remove ticagrelor during emergent or urgent cardiothoracic surgery, representing a potential path to U.S. FDA approval. 

Key Opinion Leader Call Details (Note: New Webcast Link)
Date: Monday, July 13, 2020
Time: 11:00 AM EDT
Presentation Registration: https://lifescipartners.zoom.us/webinar/register/WN_QS3pzVugTJy6nw_yUow8SA  
Q&A Session: To ask a question during the live Q&A, please submit your request via email to questions@lifesciadvisors.com

Speaker Bios:

C. Michael Gibson, M.S., M.D.
Dr. Michael Gibson is an interventional cardiologist, cardiovascular researcher and educator who pioneered our understanding of the “open artery hypothesis” as well our understanding of the importance of restoring flow downstream in the capillary bed in the “open microvasculature hypothesis” in heart attack. He has been leading investigator in trials of thrombolytic agents, glycoprotein 2b3a inhibitor agents, thienopyridines, factor Xa inhibitors, lipid lowering agents and new devices. Gibson was named one of the world’s most widely published and cited scientists of past decade in 2014 by Thomson Reuters.

Gibson founded and led his own Academic Research Organization (PERFUSE) for 30 years, and has been principal investigator of or led core services for >120 clinical trials, the results of which have been published in leading journals. Under Gibson’s direction, PERFUSE created the master database that unified data from over many years of TIMI studies (TIMI 1-50) in nearly 100,000 patients and coordinated data analyses for the TIMI study group and functioned as the TIMI Data Coordinating Center. Gibson has led phase 1-4 clinical trials, and cardiology megatrials of over 15,000 patients which eventuated in international approval of drugs like prasugrel, rivaroxaban and betrixaban. Gibson is now CEO of the Baim Institute for Clinical Research in Boston, MA.

Gibson also founded www.wikidoc.org and www.wikipatient.org, widely viewed open source textbooks of medicine. He is Editor-In-Chief of >2,200 active contributors who have edited the content millions of times. Gibson founded www.clinicaltrialresults.org and has conducted >2,000 TV / video interviews. He has over 340K followers on twitter with millions of impressions at major meetings.

For years, Gibson has been chosen as one of Boston’s Top Doctors and U.S. News & World Report also lists Gibson as one of America’s top doctors. He has held numerous leadership positions including positions as Coronary Care Unit Director, Cardiac Catheterization Laboratory Director, Chief of Cardiology and Vice Chairman of Medicine.

Robert Storey, BM, DM, FESC
Robert Storey joined the University of Sheffield in 2002 and is currently Professor of Cardiology, Clinical Theme Lead for Cardiovascular Disease research and Director of the Cardiovascular Research Unit. In addition, Professor Storey is Academic Director and an honorary Consultant Cardiologist for the Cardiology and Cardiothoracic Surgery Directorate, Sheffield Teaching Hospitals NHS Foundation Trust. He has a special interest in the management of ischaemic heart disease, including acute coronary syndromes and coronary intervention.

Professor Storey received his BSc in biochemistry from the University of York, UK, in 1985 before going on to earn his medical degree (BM) from the University of Southampton in 1989. After completing general professional training, he trained in the fields of cardiology and internal medicine in Nottingham, completing specialist training in 2001. During that time, Professor Storey developed a keen interest in thrombosis research, studying platelet biology and pharmacology, conducting clinical research studies in patients with cardiovascular disease, and obtaining a postgraduate degree in research (DM) from the University of Nottingham. In particular, he has published original articles spanning both preclinical and clinical research fields that have supported the development of novel antiplatelet strategies, including characterization of the roles of the P2Y12 receptor and effects of novel P2Y12 inhibitors. He is in the top global 1% of highly-cited authors in clinical medicine (Clarivate Analytics).

Professor Storey served as a member of the executive committees for the DISPERSE2, PLATO and PEGASUS-TIMI 54 studies, leading the platelet function substudies for these trials, and of the steering committees for numerous other studies. He was Chair of the Working Group on Thrombosis of the European Society of Cardiology (ESC) from 2012-2014 and has been a Task Force member for ESC guidelines on chronic coronary syndromes (2019), non-ST-elevation acute coronary syndromes (2011 and 2015) and dyslipidaemias (2011).

Prof. Dr. med. Michael Schmoeckel M.A.
Professor Michael Schmoeckel is Chairman, Department of Cardiac Surgery, Asklepios-Klinik St. Georg, Hamburg, Germany, since 2009.  Professor Schmoeckel and his colleagues have been the pioneers of using CytoSorb to remove ticagrelor and rivaroxaban during emergent and urgent cardiac surgery and have published the first retrospective, observational study demonstrating a reduction in bleeding risk in patients where CytoSorb was used for this purpose intraoperatively.  He completed his preclinical training at the University of Tubingen and received his medical degree and specialty training in cardiac surgery at the Ludwig-Maximilians-University (LMU) University in Munich, Germany.  Later Professor Schmoeckel served as research fellow, Dept. of Cardiothoracic Surgery, Papworth Hospital and Imutran Ltd. and Dept. of Surgery, University of Cambridge, UK ultimately earning a PhD in transplantion.  He is also Medical Head of AK Eimsbuettel-CarioCliniC.

Professor Schmoeckel’s research and scientific interests are related to TAVI, xenotransplantation, ventricular assist devices, and heart valve reconstruction, and is widely published with 117 peer-reviewed publications.  He has served as a member in many expert groups including the “Xenotransplantation Advisory Committee” for the International Society for Heart and Lung Transplantation (ISHLT), the Expert Panel “Heart and Lung Transplantation” of the German Federal Board of Quality Control, the working group “Thoracic Organ Transplantation” of the German Society of Cardiology (DGK), and the working group “Basic Science” of the  German Society for Thoracic and Cardiovascular Surgery (DGTHG) where he also served as Chairman in 2009-11.  Professor Schmoeckel is a reviewer of many medical journals such as The Thoracic and Cardiovascular Surgeon, American Journal of Transplantation, and the Journal of Heart and Lung Transplantation.

About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in critical care immunotherapy, specializing in blood purification. Its flagship product, CytoSorb® is approved in the European Union with distribution in 65 countries around the world, as an extracorporeal cytokine adsorber designed to reduce the “cytokine storm” or “cytokine release syndrome” that could otherwise cause massive inflammation, organ failure and death in common critical illnesses. These are conditions where the risk of death is extremely high, yet no effective treatments exist. CytoSorb® has been used in more than 88,000 human treatments to date.  CytoSorb has received CE-Mark label expansions for the removal of bilirubin (liver disease), myoglobin (trauma), and both ticagrelor and rivaroxaban during cardiothoracic surgery.  CytoSorb has also received FDA Emergency Use Authorization in the United States for use in critically-ill COVID-19 patients with imminent or confirmed respiratory failure, in defined circumstances.  CytoSorb has also been granted FDA Breakthrough Designation for the removal of ticagrelor in a cardiopulmonary bypass circuit during emergent and urgent cardiothoracic surgery.

CytoSorbents’ purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of approximately $33 million from DARPA, the U.S. Army, the U.S. Department of Health and Human Services, the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), U.S. Special Operations Command (SOCOM), the U.S. Army, U.S. Special Operations Command (USSOCOM), the U.S. Air Force, Air Force Material Command (USAF/AFMC) and others. The Company has numerous products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and multiple applications pending, including CytoSorb-XL™, HemoDefend™, VetResQ™, K+ontrol™, ContrastSorb, DrugSorb, and others.  For more information, please visit the Company’s websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter.

Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release, including statements about COVID-19, our expected revenues as a result thereof, represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 5, 2020, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.

Please Click to Follow Us on Facebook and Twitter

Cytosorbents Contact:
Amy Vogel
Investor Relations
(732) 398-5394
avogel@cytosorbents.com

Investor Relations Contact:
Jeremy Feffer
LifeSci Advisors
917-749-1494
jeremy@lifesciadvisors.com

U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
ekim@rubensteinpr.com

 

SOURCE CytoSorbents Corporation

CytoSorbents to Host Key Opinion Leader Call on the Use of CytoSorb Blood Purification to Remove Antithrombotic Medications in Patients at Risk of Bleeding

MONMOUTH JUNCTION, N.J., June 29, 2020 /PRNewswire/ — CytoSorbents Corporation (NASDAQ:CTSO), a critical care immunotherapy leader using its CytoSorb® blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, announces that CytoSorbents will host a Key Opinion Leader call on the Use of CytoSorb to Remove Antithrombotic Medications in Patients at Risk of Bleeding, on Monday, July 13, 2020 at 11:00 AM EDT, featuring presentations by key experts:

  • Dr. C. Michael GibsonHarvard University and Baim Institute for Clinical Research, USA
  • Dr. Robert Storey – University of Sheffield, United Kingdom
  • Prof. Dr. med. Michael Schmoeckel – Asklepios-Klinik St. Georg Hamburg, Germany

Millions of patients globally are taking antithrombotic medications, or “blood thinners”, to reduce their risk of stroke and heart attacks. But when they require surgery, they risk life-threatening perioperative bleeding. The call will feature presentations from each of the distinguished speakers who will discuss the unmet medical need of managing patients on antithrombotic therapy requiring surgery.  Drs. Gibson, Storey, and Schmoeckel will be available to answer questions at the conclusion of the event.

The discussion will be focused on the use of CytoSorb to remove two of the most commonly prescribed antithrombotic agents, ticagrelor (Brilinta®, Brilique®) and rivaroxaban (Xarelto®) from the bloodstream when installed in a heart-lung machine blood circuit during cardiothoracic surgery. CytoSorb has also received FDA Breakthrough Designation to remove ticagrelor during emergent or urgent cardiothoracic surgery, representing a potential path to U.S. FDA approval. 

Key Opinion Leader Call Details
Date: Monday, July 13, 2020
Time: 11:00 AM EDT
Participant Dial-In: 

  • Domestic: 1-877-451-6152
  • International: 1-201-389-0879
  • UK Toll Free: 0 800 756 3429

Conference ID: 13705981
Live Presentation and Archived Webcast:
https://viavid.webcasts.com/starthere.jsp?ei=1338476&tp_key=0429b514ad
Q&A Session:  To ask a question during the live Q&A, please submit your request via email to questions@lifesciadvisors.com

Speaker Bios:

C. Michael Gibson, M.S., M.D.
Dr. Michael Gibson is an interventional cardiologist, cardiovascular researcher and educator who pioneered our understanding of the “open artery hypothesis” as well our understanding of the importance of restoring flow downstream in the capillary bed in the “open microvasculature hypothesis” in heart attack. He has been leading investigator in trials of thrombolytic agents, glycoprotein 2b3a inhibitor agents, thienopyridines, factor Xa inhibitors, lipid lowering agents and new devices. Gibson was named one of the world’s most widely published and cited scientists of past decade in 2014 by Thomson Reuters.

Gibson founded and led his own Academic Research Organization (PERFUSE) for 30 years, and has been principal investigator of or led core services for >120 clinical trials, the results of which have been published in leading journals. Under Gibson’s direction, PERFUSE created the master database that unified data from over many years of TIMI studies (TIMI 1-50) in nearly 100,000 patients and coordinated data analyses for the TIMI study group and functioned as the TIMI Data Coordinating Center. Gibson has led phase 1-4 clinical trials, and cardiology megatrials of over 15,000 patients which eventuated in international approval of drugs like prasugrel, rivaroxaban and betrixaban. Gibson is now CEO of the Baim Institute for Clinical Research in Boston, MA.

Gibson also founded www.wikidoc.org and www.wikipatient.org, widely viewed open source textbooks of medicine. He is Editor-In-Chief of >2,200 active contributors who have edited the content millions of times. Gibson founded www.clinicaltrialresults.org and has conducted >2,000 TV / video interviews. He has over 340K followers on twitter with millions of impressions at major meetings.

For years, Gibson has been chosen as one of Boston’s Top Doctors and U.S. News & World Report also lists Gibson as one of America’s top doctors. He has held numerous leadership positions including positions as Coronary Care Unit Director, Cardiac Catheterization Laboratory Director, Chief of Cardiology and Vice Chairman of Medicine.

Robert Storey, BM, DM, FESC
Robert Storey joined the University of Sheffield in 2002 and is currently Professor of Cardiology, Clinical Theme Lead for Cardiovascular Disease research and Director of the Cardiovascular Research Unit. In addition, Professor Storey is Academic Director and an honorary Consultant Cardiologist for the Cardiology and Cardiothoracic Surgery Directorate, Sheffield Teaching Hospitals NHS Foundation Trust. He has a special interest in the management of ischaemic heart disease, including acute coronary syndromes and coronary intervention.

Professor Storey received his BSc in biochemistry from the University of York, UK, in 1985 before going on to earn his medical degree (BM) from the University of Southampton in 1989. After completing general professional training, he trained in the fields of cardiology and internal medicine in Nottingham, completing specialist training in 2001. During that time, Professor Storey developed a keen interest in thrombosis research, studying platelet biology and pharmacology, conducting clinical research studies in patients with cardiovascular disease, and obtaining a postgraduate degree in research (DM) from the University of Nottingham. In particular, he has published original articles spanning both preclinical and clinical research fields that have supported the development of novel antiplatelet strategies, including characterization of the roles of the P2Y12 receptor and effects of novel P2Y12 inhibitors. He is in the top global 1% of highly-cited authors in clinical medicine (Clarivate Analytics).

Professor Storey served as a member of the executive committees for the DISPERSE2, PLATO and PEGASUS-TIMI 54 studies, leading the platelet function substudies for these trials, and of the steering committees for numerous other studies. He was Chair of the Working Group on Thrombosis of the European Society of Cardiology (ESC) from 2012-2014 and has been a Task Force member for ESC guidelines on chronic coronary syndromes (2019), non-ST-elevation acute coronary syndromes (2011 and 2015) and dyslipidaemias (2011).

Prof. Dr. med. Michael Schmoeckel M.A.
Professor Michael Schmoeckel is Chairman, Department of Cardiac Surgery, Asklepios-Klinik St. Georg, Hamburg, Germany, since 2009.  Professor Schmoeckel and his colleagues have been the pioneers of using CytoSorb to remove ticagrelor and rivaroxaban during emergent and urgent cardiac surgery and have published the first retrospective, observational study demonstrating a reduction in bleeding risk in patients where CytoSorb was used for this purpose intraoperatively.  He completed his preclinical training at the University of Tubingen and received his medical degree and specialty training in cardiac surgery at the Ludwig-Maximilians-University (LMU) University in Munich, Germany.  Later Professor Schmoeckel served as research fellow, Dept. of Cardiothoracic Surgery, Papworth Hospital and Imutran Ltd. and Dept. of Surgery, University of Cambridge, UK ultimately earning a PhD in transplantion.  He is also Medical Head of AK Eimsbuettel-CarioCliniC.

Professor Schmoeckel’s research and scientific interests are related to TAVI, xenotransplantation, ventricular assist devices, and heart valve reconstruction, and is widely published with 117 peer-reviewed publications.  He has served as a member in many expert groups including the “Xenotransplantation Advisory Committee” for the International Society for Heart and Lung Transplantation (ISHLT), the Expert Panel “Heart and Lung Transplantation” of the German Federal Board of Quality Control, the working group “Thoracic Organ Transplantation” of the German Society of Cardiology (DGK), and the working group “Basic Science” of the  German Society for Thoracic and Cardiovascular Surgery (DGTHG) where he also served as Chairman in 2009-11.  Professor Schmoeckel is a reviewer of many medical journals such as The Thoracic and Cardiovascular Surgeon, American Journal of Transplantation, and the Journal of Heart and Lung Transplantation.

About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in critical care immunotherapy, specializing in blood purification. Its flagship product, CytoSorb® is approved in the European Union with distribution in 65 countries around the world, as an extracorporeal cytokine adsorber designed to reduce the “cytokine storm” or “cytokine release syndrome” that could otherwise cause massive inflammation, organ failure and death in common critical illnesses. These are conditions where the risk of death is extremely high, yet no effective treatments exist. CytoSorb® has been used in more than 88,000 human treatments to date.  CytoSorb has received CE-Mark label expansions for the removal of bilirubin (liver disease), myoglobin (trauma), and both ticagrelor and rivaroxaban during cardiothoracic surgery.  CytoSorb has also received FDA Emergency Use Authorization in the United States for use in critically-ill COVID-19 patients with imminent or confirmed respiratory failure, in defined circumstances.  CytoSorb has also been granted FDA Breakthrough Designation for the removal of ticagrelor in a cardiopulmonary bypass circuit during emergent and urgent cardiothoracic surgery.

CytoSorbents’ purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of approximately $33 million from DARPA, the U.S. Army, the U.S. Department of Health and Human Services, the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), U.S. Special Operations Command (SOCOM), the U.S. Army, U.S. Special Operations Command (USSOCOM), the U.S. Air Force, Air Force Material Command (USAF/AFMC) and others. The Company has numerous products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and multiple applications pending, including CytoSorb-XL™, HemoDefend™, VetResQ™, K+ontrol™, ContrastSorb, DrugSorb, and others.  For more information, please visit the Company’s websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter.

Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release, including statements about COVID-19, our expected revenues as a result thereof, represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 5, 2020, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.

Please Click to Follow Us on Facebook and Twitter

Cytosorbents Contact:
Amy Vogel
Investor Relations
(732) 398-5394
avogel@cytosorbents.com

Investor Relations Contact:
Jeremy Feffer
LifeSci Advisors
917-749-1494
jeremy@lifesciadvisors.com

U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
ekim@rubensteinpr.com

 

SOURCE CytoSorbents Corporation

CytoSorbents Announces Commercial Launch and Immediate Availability of CytoSorb To Treat Cytokine Storm In Many Latin American Countries As COVID-19 Cases Rise

CytoSorb is now distributed in a total of 65 countries throughout the world

MONMOUTH JUNCTION, N.J., June 24, 2020 /PRNewswire/ — CytoSorbents Corporation (NASDAQ:CTSO), a critical care immunotherapy leader using its CytoSorb® blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, announces the commercial launch and immediate availability of CytoSorb in nine Latin American countries including Colombia, Argentina, Perú, Guatemala, Ecuador, Bolivia, the Dominican Republic, El Salvador, and Costa Rica.  CytoSorb has been available in Panamá and Chile for many years, has recently received marketing approval in Mexico with initial sales, and is pending final registration in Brazil.  CytoSorb is now distributed in a total of 65 countries worldwide. This expansion is particularly timely as Central and South American countries have become “intense zones” for COVID-19 transmission, according to the World Health Organization.  In Latin American countries where CytoSorb is distributed, 2.1 million cases of COVID-19 have been reported to date, out of a total population of approximately 562 million, or approximately 0.4%, and a mortality rate of 4.6%.  This compares to 2.4 million cases in the U.S. out of a total population of 331 million, or approximately 0.7%, and a mortality rate of 5.1%.   Experts predict that COVID-19 will not stop until significant herd immunity develops with 60-70% of the world population either infected or vaccinated, suggesting the global pandemic is still in its early stages. 

In Panamá, CytoSorb has been sold commercially for over three years in a wide range of applications.  CytoSorb has been used to treat many critically-ill COVID-19 patients, and is specifically included in the Panamá COVID-19 treatment guidelines.  Dr. Nicolás Hurtado, Nephrologist and Intensivist from the National Hospital of Panamá in Panamá City, stated, “We have had 12 critical patients with COVID-19 on CytoSorb therapy and most of them responded positively.  CytoSorb is a weapon we regularly use on our patients when we see the cytokine storm approaching.”

Mr. Carlos Giron, General Manager of Servicios Quirúrgicos Guatemala, commented, “We are proud to be the exclusive distributor of CytoSorb® in Guatemala, the largest country in Central America.   Our passion is to help healthcare professionals save lives every day and strongly believe that CytoSorb will play an important role in treating a wide variety of life-threatening conditions by fighting cytokine storm and hyper-inflammation.   At this precise moment, the need is to treat sepsis in patients with COVID-19, where the numbers of new cases and deaths have been rising rapidly.  With CytoSorb now immediately available, our team is excited to begin selling the therapy through the official commercial launch and promotion of CytoSorb in the country through digital media and in person with demos, webinars, and scientific literature and case studies, among others.”  

Mr. Carlos Florez, General Manager of Fresenius Medical Care Colombia, exclusive distributor for CytoSorb in the Intensive Care segment, stated, “In Colombia’s intensive care units, hyper-inflammatory pathologies associated mainly with sepsis – such as septic shock, acute respiratory distress syndrome (ARDS), and acute kidney injury (AKI) – and trauma, are on the rise.  This not only leads to increased mortality, but also negatively impacts health system economics because of the high cost of therapies and resources dedicated to save the lives of these patients. These diseases often require a multi-systemic approach and we are very optimistic that CytoSorb therapy can adjunctively help to address these conditions and decrease both ICU stay and mortality.  In particular, in critically-ill COVID-19 patients with multi-organ failure, CytoSorb provides physicians with a new treatment option to help those suffering from cytokine storm.”

Dr. Christian Steiner, MD, Senior Vice President of Sales and Marketing at CytoSorbents stated, “We are proud and excited to work with such a strong network of professional partners.  We believe this is essential to a successful commercial launch in Central and South America, where we have big plans.  With our partners, we are also thankful that this expansion comes just in time to potentially help patients in the ongoing COVID-19 pandemic.  As a leading treatment of cytokine storm across the world, CytoSorb is now immediately available in these countries to help treat complications such as respiratory failure, shock and other organ failure, with the goal of reducing fatal outcomes.  These complications are often triggered by cytokine storm and are common to a wide variety of illnesses, including COVID-19.”

About CytoSorbents Corporation (NASDAQ: CTSO)

CytoSorbents Corporation is a leader in critical care immunotherapy, specializing in blood purification. Its flagship product, CytoSorb® is approved in the European Union with distribution in 65 countries around the world, as an extracorporeal cytokine adsorber designed to reduce the “cytokine storm” or “cytokine release syndrome” that could otherwise cause massive inflammation, organ failure and death in common critical illnesses. These are conditions where the risk of death is extremely high, yet no effective treatments exist. CytoSorb® has been used in more than 88,000 human treatments to date.  CytoSorb has received CE-Mark label expansions for the removal of bilirubin (liver disease), myoglobin (trauma) and both ticagrelor and rivaroxaban during cardiothoracic surgery.  CytoSorb has also received FDA Emergency Use Authorization in the United States for use in critically-ill COVID-19 patients with imminent or confirmed respiratory failure, in defined circumstances.  CytoSorb has also been granted FDA Breakthrough Designation for the removal of ticagrelor in a cardiopulmonary bypass circuit during emergent and urgent cardiothoracic surgery.

CytoSorbents’ purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of approximately $33 million from DARPA, the U.S. Army, the U.S. Department of Health and Human Services, the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), U.S. Special Operations Command (SOCOM), the U.S. Army, U.S. Special Operations Command (USSOCOM), the U.S. Air Force, Air Force Material Command (USAF/AFMC) and others. The Company has numerous products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and multiple applications pending, including CytoSorb-XL™, HemoDefend™, VetResQ™, K+ontrol™, ContrastSorb, DrugSorb, and others.  For more information, please visit the Company’s websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter.

Forward-Looking Statements

This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release, including statements about COVID-19, our expected revenues as a result thereof, represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 5, 2020, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws. 

Please Click to Follow Us on Facebook and Twitter

Cytosorbents Contact:
Amy Vogel
Investor Relations
(732) 398-5394
avogel@cytosorbents.com

Investor Relations Contact:
Jeremy Feffer
LifeSci Advisors
917-749-1494
jeremy@lifesciadvisors.com

U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
ekim@rubensteinpr.com

 

SOURCE CytoSorbents Corporation

CytoSorbents Awarded $2,897,172 Phase III STTR Contract to Advance HemoDefend-BGA Plasma and Whole Blood Filter to Clinical Trials

MONMOUTH JUNCTION, N.J., June 9, 2020 /PRNewswire/ — CytoSorbents Corporation (NASDAQ:CTSO), a critical care immunotherapy leader specializing in blood purification, announced today that it was awarded a Defense Health Agency Small Business Technology Transfer (STTR) Phase III contract, valued at up to $2,897,172 over 2 years, to advance its HemoDefend-BGA plasma and whole blood adsorber to human clinical trials.  The program, entitled “Development of a Highly Efficient Adsorber to Remove Anti-A and Anti-B Antibodies from Blood and Plasma for Transfusion,” is being funded by the U.S. Army Medical Research and Development Command (USAMRDC) office of the Congressionally Directed Medical Research Programs (CDMRP).  This follows the successful completion of Phase I and II STTR contracts of approximately $1.15 million with researchers at Penn State University, previously funded by the U.S. Army Medical Research Acquisition Activity (USAMRAA) and the U.S. Army Medical Research and Material Command (USAMRMC).

Plasma and whole blood are life-saving blood products, particularly in civilian and combat trauma where the loss of blood, or hemorrhage, is the leading cause of preventable deaths.  However, these products have limitations due to the presence of anti-A and anti-B antibodies in the blood plasma that can cause hemolytic transfusion reactions in an incompatible recipient.

The HemoDefend-BGA filter is part of the HemoDefend™ family of blood transfusion filters, and is fundamentally different from the HemoDefend-RBC filter for packed red blood cells. The HemoDefend-BGA filter is designed to enable “universal plasma”, or plasma that can be administered to anyone regardless of blood type, and to improve the safety of whole blood transfusions, by the rapid and efficient removal of anti-A and anti-B antibodies from these two blood products.  An advanced HemoDefend-BGA prototype was developed previously under the prior STTR Phase II program.

Dr. Maryann Gruda, PhD, Principal Investigator and Director of Biology of CytoSorbents stated, “We are excited to take this next major step in the development of the HemoDefend-BGA adsorber. A tremendous amount of effort and innovation has gone into the current prototype that has exceeded program performance expectations.  With this new funding, we plan to optimize our prototype and scale-up manufacturing to produce commercial-grade materials. This will facilitate advancement of the HemoDefend-BGA adsorber through pre-clinical testing to human clinical trials, with the goal of potential U.S. FDA regulatory approval.  If successful, we expect the HemoDefend-BGA adsorber to expand the availability of universal plasma and whole blood that may help to save warfighter and civilian lives.”

Dr. Phillip Chan, MD, PhD, Chief Executive Officer of CytoSorbents stated, “The development of a simple device that efficiently reduces the level of anti-A and anti-B antibodies in whole blood and plasma to low titer is a major milestone in our collaboration with the U.S. military.  We are grateful for U.S. Army support and proud to contribute to this important program.  We plan to work aggressively to make this technology commercially available as soon as possible.”

Plasma is the straw-colored, cell-free portion of whole blood.  It contains a wide range of important substances such as electrolytes, hormones, proteins such as albumin, clotting factors, and antibodies. The transfusion of plasma, or plasma-derived products, is used widely to help save the lives of trauma and bleeding victims, septic and other critically-ill patients, and patients with life-threatening blood coagulation and autoimmune disorders.  In 2017, approximately 3.0 million units of plasma were distributed in the United States alone.  Most plasma contains blood-type specific antibodies and must be cross-matched for blood type with the intended recipient ahead of time or risk serious transfusion reactions.  The only “universal” plasma is Type AB plasma, which lack anti-A and anti-B antibodies, but is rare, accounting for less than 5.0% of potential donors.  By reducing these blood-type specific antibodies from donated plasma of all blood types, the goal is to create a cost-effective, reliable, and expanded source of “universal” plasma that can be administered immediately, without blood-typing, in a wide range of emergent and non-emergent situations.

Many studies have demonstrated that whole blood transfusion is superior in hemorrhage control and survival in severe trauma, compared to individual blood component transfusions (e.g. pRBCs, platelets, plasma).  In the military, in emergency or mass casualty situations when the demand for refrigerated blood products has exceeded the supply inventory in the combat zone, the  “Walking Blood Bank” program can be implemented, where unwounded soldiers can donate their blood to those that have fallen.  Type O whole blood is typically the universal donor type, but since it is roughly 60% plasma, anti-A and anti-B antibodies can be present at various levels that can cause potentially fatal hemolytic transfusion reactions in the recipient. Currently, the military relies on pre-screening and identification of low titer Type O donors.  By removing these antibodies from whole blood, HemoDefend-BGA may help to improve the safety of whole blood transfusion across all blood types and make the logistics of treatment much easier.

The HemoDefend-BGA Adsorber is not yet approved in the U.S. or elsewhere. This Award is supported by the Defense Health Agency STTR Program/U.S. Army Medical Research and Development Command (USAMRDC)/Congressionally Directed Medical Research Program (CDMRP) under Contract No. W81XWH-20-C-0050. Any opinions, findings and conclusions or recommendations expressed in this material are those of the author(s) and do not necessarily reflect the views of the U.S. Army Medical Research and Development Command (USAMRDC) or the U.S. Army Medical Research Acquisition Activity (USAMRAA).

About CytoSorbents Corporation (NASDAQ: CTSO)

CytoSorbents Corporation is a leader in critical care immunotherapy, specializing in blood purification. Its flagship product, CytoSorb® is approved in the European Union with distribution in 58 countries around the world, as an extracorporeal cytokine adsorber designed to reduce the “cytokine storm” or “cytokine release syndrome” that could otherwise cause massive inflammation, organ failure and death in common critical illnesses. These are conditions where the risk of death is extremely high, yet no effective treatments exist. CytoSorb® has been used in more than 88,000 human treatments to date.  CytoSorb has received FDA Emergency Use Authorization in the United States for use in critically-ill COVID-19 patients with imminent or confirmed respiratory failure, in defined circumstances.  CytoSorb has also been granted FDA Breakthrough Designation for the removal of ticagrelor in a cardiopulmonary bypass circuit during emergent and urgent cardiothoracic surgery.

CytoSorbents’ purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of approximately $33 million from DARPA, the U.S. Army, the U.S. Department of Health and Human Services, the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), Joint Program Executive Office for Chemical Biological Defense (JPEO-CBD), and others.  The Company has numerous products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and multiple applications pending, including CytoSorb-XL™, HemoDefend™, VetResQ™, K+ontrol™, ContrastSorb, DrugSorb, and others.  For more information, please visit the Company’s websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter.

Forward-Looking Statements

This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 5, 2020, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements, particularly in light of the current coronavirus pandemic, where businesses can be impacted by rapidly changing state and federal regulations, as well as the health and availability of their workforce. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.

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CytoSorbents Contact:
Amy Vogel
(732) 398-5394
avogel@cytosorbents.com

Investor Relations Contact:
Jeremy Feffer
LifeSci Advisors
917-749-1494
jeremy@lifesciadvisors.com

Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
ekim@rubensteinpr.com

 

SOURCE CytoSorbents Corporation

CytoSorbents Announces Virtual Annual Meeting

MONMOUTH JUNCTION, N.J., May 27, 2020 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat cytokine storm and deadly inflammation in critically-ill and cardiac surgery patients around the world, will host its Virtual Annual Meeting on Tuesday, June 2, 2020 at 10:00 AM EDT.  Stockholders of record will be able to virtually join and submit questions, and those that have not yet voted will be able to vote their shares electronically at the meeting.

To participate in the Virtual Annual Meeting, stockholders will need the 16-digit control number included on the “Important Notice Regarding the Availability of Proxy Materials” proxy card or voting instruction form. If you join through your brokerage firm’s website and do not have your control number, you can gain access to the meeting by logging into your brokerage firm’s website 30 minutes prior to the meeting start, selecting the shareholder communications mailbox to link through to the meeting, and the control number will automatically populate. 

The Annual Meeting webcast will begin promptly at 10:00 AM Eastern Time. We encourage stockholders to access the Annual Meeting 30 minutes prior to the start time, to allow ample time for the check-in procedures. Technicians will be ready to assist with any technical difficulties you may have accessing the virtual Annual Meeting.  A phone number where you can obtain technical assistance will be made available on the Stockholder Meeting Link 30 minutes prior to the Annual Meeting.

Annual Meeting Details:

Date:

Tuesday, June 2, 2020

Time: 

10:00 AM EDT

Stockholder Meeting Link: 

www.virtualshareholdermeeting.com/CTSO2020 

About CytoSorbents Corporation (NASDAQ: CTSO)

CytoSorbents Corporation is a leader in critical care immunotherapy, specializing in blood purification. Its flagship product, CytoSorb® is approved in the European Union with distribution in 58 countries around the world, as an extracorporeal cytokine adsorber designed to reduce the “cytokine storm” or “cytokine release syndrome” that could otherwise cause massive inflammation, organ failure and death in common critical illnesses. These are conditions where the risk of death is extremely high, yet no effective treatments exist. CytoSorb® has been used in more than 80,000 human treatments to date.  CytoSorb has received FDA Emergency Use Authorization in the United States for use in critically-ill COVID-19 patients with imminent or confirmed respiratory failure, in defined circumstances.  CytoSorb has also been granted FDA Breakthrough Designation for the removal of ticagrelor in a cardiopulmonary bypass circuit during emergent and urgent cardiothoracic surgery.

CytoSorbents’ purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of nearly $29 million from DARPA, the U.S. Army, the U.S. Department of Health and Human Services, the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), U.S. Special Operations Command (SOCOM), the U.S. Army, U.S. Special Operations Command (USSOCOM), the U.S. Air Force, Air Force Material Command (USAF/AFMC) and others. The Company has numerous products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and multiple applications pending, including CytoSorb-XL™, HemoDefend™, VetResQ™, K+ontrol™, ContrastSorb, DrugSorb, and others.  For more information, please visit the Company’s websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter.

Forward-Looking Statements

This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 5, 2020, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements, particularly in light of the current coronavirus pandemic, where businesses can be impacted by rapidly changing state and federal regulations, as well as the health and availability of their workforce. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws. 

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CytoSorbents Contact: 
Amy Vogel 
(732) 398-5394 
avogel@cytosorbents.com

Investor Relations Contact: 
Jeremy Feffer 
LifeSci Advisors 
917-749-1494 
jeremy@lifesciadvisors.com

Public Relations Contact: 
Eric Kim 
Rubenstein Public Relations 
212-805-3052 
ekim@rubensteinpr.com 

SOURCE CytoSorbents Corporation

CytoSorb® is E.U. Approved to Remove Rivaroxaban, a Leading Factor Xa Inhibitor and Novel Oral Anticoagulant, During On-Pump Cardiothoracic Surgery

Expands CytoSorb E.U. label that now includes the reduction of two major blood thinners, rivaroxaban (Xarelto®) and ticagrelor (Brilinta®), during on-pump cardiothoracic surgery with the goal of reducing serious perioperative bleeding complications

MONMOUTH JUNCTION, N.J., May 12, 2020 /PRNewswire/ — CytoSorbents Corporation (NASDAQ:CTSO), a critical care immunotherapy leader specializing in blood purification, announces that CytoSorb® is now approved and immediately available in the European Union for the removal of rivaroxaban (Xarelto®– Bayer, Jansenn/Johnson & Johnson), a widely-used Factor Xa inhibitor and novel oral anticoagulant  (NOAC), during cardiothoracic surgery requiring cardiopulmonary bypass (CPB).  With this announcement, and the E.U. approval earlier this year to remove the P2Y12 anti-platelet inhibitor, ticagrelor, for the same indication, CytoSorb is providing cardiac surgeons and perfusionists an easy-to-use and rapid new treatment option to help reduce the risk of serious and potentially fatal perioperative bleeding complications caused by these two drugs, in separate categories of blood thinners.

Mr. Vincent Capponi, Chief Operating Officer and President of CytoSorbents stated, “Rivaroxaban was the 10th top selling prescription drug by global revenue in 2018, and cumulatively, more than 40 million people worldwide have been prescribed the drug. Given the high prevalence of vascular and heart disease in these patients, it is not surprising that many patients require urgent or emergent cardiothoracic surgery each year, where rivaroxaban puts them at risk of serious bleeding complications. CytoSorb can rapidly reduce rivaroxaban during a typical coronary artery bypass graft (CABG) surgical procedure, so that waiting 2-3 days off the drug to allow the anticoagulant to be eliminated from the body is no longer necessary.  Given that CytoSorb is already being stocked in many heart centers for use during a variety of different on-pump cardiac surgery procedures, we believe it makes the decision to use CytoSorb to remove rivaroxaban relatively seamless.  Also, as the only therapy that reduces both ticagrelor and rivaroxaban, with a shelf life of 3 years at room temperature, we believe CytoSorb has the potential to negate the need to stock multiple, very expensive, and rapidly expiring biologic antidotes for different classes of anti-thrombotics that can cost more than $20,000 per dose.  We believe in time, CytoSorb has the potential to become a compelling and cost-effective standard of care for the removal of blood thinners during cardiac surgery.”

Dr. Phillip Chan, Chief Executive Officer of CytoSorbents stated, “We believe this CE Mark label expansion could be another future growth driver of sales for CytoSorb.  We plan to leverage the same marketing channels that we are using for the removal of ticagrelor during cardiac surgery with an even broader and more compelling value proposition to cardiac surgeons and perfusionists.  CytoSorb has a long history of safe and compatible usage with cardiopulmonary bypass and is now the only specifically approved therapy to remove or reverse the effects of ticagrelor and rivaroxaban during cardiothoracic surgery in the European Union and in all of the 58 countries that we serve.”  

Rivaroxaban (Xarelto®) is a commonly-used Factor Xa inhibitor and novel oral anticoagulant used to reduce the risk of blood clots in common conditions like atrial fibrillation (AFib), deep vein thrombosis (DVT), and pulmonary embolism (PE).  Rivaroxaban is also approved to reduce the risk of major cardiovascular events in conditions such as coronary artery disease (CAD) and peripheral artery disease (PAD).  Rivaroxaban is used globally, with approximately $4.5 billion in 2019 sales outside the U.S. driven by Europe and Asia, and 2019 U.S. sales of $2.3 billion.  The concern for uncontrolled bleeding in emergent surgery is increasing as the use of NOACs becomes more widespread. According to the literature, an estimated 8-10% of patients on anticoagulant therapy will require emergent surgery at some point in their lifetime.  Historically, in the case of cardiac surgery where the risk of postoperative bleeding is high, a 48-hour washout period is recommended for elective surgery. By reducing rivaroxaban during surgery, CytoSorb has the potential to eliminate the need for this delay, while decreasing the pro-thrombotic risks of being off of these agents, while also reducing bleeding complications.  For example, in a retrospective case series of patients (n=12) who required emergency cardiac surgery on rivaroxaban and could not delay surgery, the incidence of bleeding events (e.g. need for blood transfusions, re-thoracotomy rate, surgical drainage volume) and ICU and hospital time were all lower in those treated with CytoSorb compared to those that were not.

About CytoSorbents Corporation (NASDAQ: CTSO)

CytoSorbents Corporation is a leader in critical care immunotherapy, specializing in blood purification. Its flagship product, CytoSorb® is approved in the European Union with distribution in 58 countries around the world, as an extracorporeal cytokine adsorber designed to reduce the “cytokine storm” or “cytokine release syndrome” that could otherwise cause massive inflammation, organ failure and death in common critical illnesses. These are conditions where the risk of death is extremely high, yet no effective treatments exist. CytoSorb® has been used in more than 88,000 human treatments to date.  CytoSorb has received CE-Mark label expansions for the removal of bilirubin (liver disease), myoglobin (trauma) and both ticagrelor and rivaroxaban during cardiothoracic surgery.  CytoSorb has also received FDA Emergency Use Authorization in the United States for use in critically-ill COVID-19 patients with imminent or confirmed respiratory failure, in defined circumstances.  CytoSorb has also been granted FDA Breakthrough Designation for the removal of ticagrelor in a cardiopulmonary bypass circuit during emergent and urgent cardiothoracic surgery.

CytoSorbents’ purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of approximately $30 million from DARPA, the U.S. Army, the U.S. Department of Health and Human Services, the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), U.S. Special Operations Command (SOCOM), the U.S. Army, U.S. Special Operations Command (USSOCOM), the U.S. Air Force, Air Force Material Command (USAF/AFMC) and others. The Company has numerous products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and multiple applications pending, including CytoSorb-XL™, HemoDefend™, VetResQ™, K+ontrol™, ContrastSorb, DrugSorb, and others.  For more information, please visit the Company’s websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter.

Forward-Looking Statements

This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release, including statements about the market for removal of Rivaroxaban, our expected revenues as a result thereof, represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 5, 2020, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws. 

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Cytosorbents Contact:
Amy Vogel
Investor Relations
(732) 398-5394
avogel@cytosorbents.com  

Investor Relations Contact:
Jeremy Feffer
LifeSci Advisors
917-749-1494
jeremy@lifesciadvisors.com

U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
ekim@rubensteinpr.com  

SOURCE CytoSorbents Corporation

CytoSorbents Reports First Quarter 2020 Financial and Operational Results

First Quarter 2020 Total Revenue grew 68% to $8.7M and Product Sales grew 78% to $8.2M over Q1 2019

MONMOUTH JUNCTION, N.J., May 5, 2020 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader using its CytoSorb® blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, reports record financial and operational results for the quarter ending March 31, 2020.

First Quarter 2020 Financial Results:

  • Total revenue for Q1 2020 was $8.7 million, including both product sales and grant income, compared to $5.2 million in Q1 2019, a 68% increase of approximately $3.5 million
  • Product sales for Q1 2020 were $8.2 million, a 78% increase from $4.6 million for Q1 2019, and 24% sequentially over Q4 2019. On a constant exchange rate basis, Q1 2020 sales would have been $8.4 million
  • Sales growth was fueled by underlying strength in our core critical care and cardiac surgery markets, as well as demand for CytoSorb® in connection with treatment of COVID-19 patients
  • The Company entered April with its first ever sales order backlog of approximately $2.7 million, which orders are expected to be filled in Q2 2020
  • Product gross margins for Q1 2020 were 76% compared to 74% for Q1 2019 but lower from Q4 2019 due to increased costs required to rapidly scale-up CytoSorb production
  • Strong cash position of $26.4 million at March 31, 2020

First Quarter 2020 Operational Highlights:

Dr. Phillip Chan, MD, PhD, Chief Executive Officer of CytoSorbents stated, “Before COVID-19 became a pandemic, Q1 2020, our strongest quarter to date, was already looking robust, buoyed by momentum from the prior record quarter, and energized by our recently expanded commercialization team driving sales across our everyday core markets of cardiac surgery and critical care.”

Dr. Chan continued, “We began the quarter with some great news:  CE Mark approval for CytoSorb to remove ticagrelor during on-pump cardiothoracic surgery.  This allowed us to begin aggressively marketing the use of CytoSorb for this application on-label in all of the countries we serve, with the goal of reducing costly and potentially life-threatening perioperative bleeding caused by this “blood thinner” in patients who require urgent or emergent cardiac surgery.    Because of its ease of use, its efficacy in removing ticagrelor, and an established record of safety in low to high risk cardiac surgery patients, we believe CytoSorb has the potential to become the standard of care for this application in the E.U., with the potential to  significantly expand our current product revenue over time, and help drive us to profitability.  Ticagrelor has the potential to displace its rivals as the preferred anti-platelet therapy in acute coronary syndrome in-part because our therapy makes it the only reversible P2Y12 platelet inhibitor – thereby vastly improving its safety profile over the others in this patient population, we believe the market could be even greater.  We followed through with a hat trick of sorts.  In April, we received U.S. FDA Breakthrough Designation for the use of CytoSorb to reduce ticagrelor during cardiopulmonary bypass in urgent or emergent cardiac surgery.  This was an acknowledgement of the major unmet medical need that we could potentially serve, while enabling the FDA to work with us to speed the development, assessment, and regulatory review of CytoSorb for this application.  Then just recently, we announced the hiring of our new Chief Medical Officer, Dr. Ethymios “Makis” Deliargyris, MD, an experienced cardiologist and interventional cardiologist, and an industry veteran whose prior experience includes The Medicines Company. Makis is a subject matter expert in the clinical development, usage, and complications of anti-coagulants and anti-thrombotics such as ticagrelor, cangrelor, bivalirudin, and aspirin, while being well-versed in the treatment and management of critical illnesses, particularly shock – one of the hallmark effects of CytoSorb in critically-ill patients.  These developments give us much greater visibility on a potential U.S. regulatory path for approval that could be game-changing for the company.”

“Meanwhile, as China instituted unprecedented measures to try to control the spread of coronavirus, we could see the looming threat of COVID-19 coming.  Early reports of cytokine storm contributing to severity of illness and death in patients afflicted with SARS-CoV-2 infection were not a surprise.  CytoSorbents, with our flagship product CytoSorb – one of the leading therapies in Europe approved specifically to treat cytokine storm- has been one of the most vocal advocates for years proselytizing the harms of cytokine storm and the fact that an out-of-control immune response and organ failure is what really kills patients in a wide variety of life-threatening conditions seen in the intensive care unit on a daily basis, such as sepsis, trauma, acute respiratory distress syndrome (ARDS), shock, liver failure, and many others.  That it took a literal pandemic to finally drive the term “cytokine storm” into the common vernacular of journalists, government officials, investors, the lay public, and even many healthcare experts, underscores how prescient we have been and how timely CytoSorb has become.” 

Dr. Chan continued, “That said, our positioning of CytoSorb as one of the leading therapies to treat cytokine storm has led to a host of new opportunities and now more than an estimated 750 COVID-19 patients treated worldwide.  The China Medical System Holdings Ltd partnership and the listing of CytoSorb in the Italy and Panama COVID-19 treatment guidelines, were just several examples.  In Germany, where the most COVID-19 patients have now been treated with CytoSorb, there is a groundswell of clinical study activity, including randomized controlled trials, that will hopefully translate into published patient-level data that can be leveraged worldwide.  And most recently, in mid-April, CytoSorb was the first extracorporeal blood purification technology, that is compatible with the main blood pump machines used to treat critically-ill patients around the world (e.g. CRRT, hemodialysis, and ECMO), to receive FDA Emergency Use Authorization for use in critically-ill adult COVID-19 patients with imminent or confirmed respiratory failure.   For the first time, we are able to make CytoSorb commercially available to all U.S. hospitals, physicians, and patients, now with nearly 200 inquiries, 30 active hospital accounts, with CytoSorb either shipped or in use at half of these, and multiple reorders.  In the U.S., in a very short period of time, there have been approximately 25 patients treated, quite a number who have been weaned off of extracorporeal membrane oxygenation (ECMO) or mechanical ventilation.”

“We were fortunate to have begun planning and ramping production early in the quarter to meet this projected need.  We strengthened our balance sheet significantly, preparing for uncertain times, and making sure we had the financial resources to withstand the coming storm and aggressively fund production expansion.  And like other businesses, we took steps to protect our workforce while ramping production 24 hours a day, 7 days a week.  Although we are nearing full capacity now, we have the flexibility to rapidly scale production up or down as the global need requires based on whether projected second and third waves of COVID-19 infection materialize.  We ended the quarter with orders linked to the rapidly spreading COVID-19 pandemic in many of the countries we serve, and the existing physician user base that has used CytoSorb successfully in their critically-ill and cardiac surgery patients for years.  This demand was on top of the already strong results from our existing business, resulting in an exceptional quarter with our first backlog ever.”

“As one of a select group of companies thriving in these uncertain times, we believe the growth story at CytoSorbents remains remarkably bright, with so many different potential catalysts and shots on goal for our company.  To be clear, we are not a COVID-19 company.  What the pandemic has done, however, is put a spotlight on our company, our CytoSorb technology, and our core message of treating cytokine storm.  This message transcends coronavirus infection and is the same message in sepsis that kills 1 in 5 people worldwide every year; in seasonal influenza that according to the World Health Organization,  kills more people worldwide each year than COVID-19 has to date; in millions of hospitalized patients with acute exacerbations of chronic liver disease, that afflicts 1 in 11 people worldwide; in infective endocarditis cases that plague cardiac surgery programs throughout the U.S. some of which are often doing one of these surgeries a day with a patient cost that can exceed $150,000 and a high risk of death due to an explosion of heart valve infections caused by the opiate crisis and use of dirty needles with IV heroin use; and many, many others.  Because of COVID-19, we have re-introduced CytoSorb to the world, and are working to generate clinical data that will support its use in the same complications of COVID-19 infection such as shock and acute respiratory failure that are seen in other critically-ill non-COVID-19 patients, that may keep COVID-19 as a potential long-term catalyst for our business.”

Dr. Chan concluded, “I cannot begin to express my pride and gratitude to the outstanding men and women of this company, who in the depths of the COVID-19 crisis, came together, pitching in wherever needed, even when doing so put themselves and their families at risk, to ensure that we maintained the production, delivery, and access of CytoSorb to help patients around the world.  And finally, to all of the healthcare workers globally, who worked tirelessly on the front lines during the COVID-19 pandemic, putting themselves directly into harm’s way to save lives, with many making the ultimate sacrifice – the thankfulness, thoughts and prayers of a grateful world community.”

“Please join us on our earnings conference call today, details for which are below.”

Conference Call Details:
Date: Tuesday,  May 5, 2020
Time: 4:45 PM Eastern Time
Participant Dial-In:   877-451-6152
Conference ID:  13701769
Live Presentation Webcast:  http://public.viavid.com/index.php?id=139054

It is recommended that participants dial in approximately 10 minutes prior to the start of the call.  There will also be a simultaneous live webcast of the conference call that can be accessed through the following audio feed link: http://public.viavid.com/index.php?id=139054

An archived recording of the conference call will be available under the Investor Relations section of the Company’s website at http://cytosorbents.com/investor-relations/financial-results/.

Results of Operations

Comparison for the three months ended March 31, 2020 and 2019:

Revenues:

Revenue from product sales was approximately $8,156,000 for the three months ended March 31, 2020, as compared to approximately $4,577,000 for the three months ended March 31, 2019, an increase of approximately $3,579,000, or 78%. This increase was driven by an increase in direct sales of approximately $2,428,000 resulting from sales to both new customers and repeat orders from existing customers and an increase in distributor sales of approximately $1,151,000. Though difficult to quantitate, we estimate that approximately $1.5 million to $1.7 million of product sales in the first quarter of 2020 was due to the demand for CytoSorb to treat COVID-19 patients. In addition, sales were negatively impacted by approximately $237,000 as a result of the decrease in the average exchange rate of the Euro to the U.S. dollar.  For the three months ended March 31, 2020, the average exchange rate of the Euro to the U.S. dollar was $1.10 as compared to an average exchange rate of $1.13 for the three months ended March 31, 2019. 

Grant income was approximately $551,000 for the three months ended March 31, 2020 as compared to approximately $615,000 for the three months ended March 31, 2019, a decrease of approximately $64,000 or 10%.  This decrease was a result of the timing of certain grant revenue.

Total revenues were approximately $8,707,000 for the three months ended March 31, 2020, as compared to total revenues of approximately $5,192,000 for the three months ended March 31, 2019, an increase of approximately $3,515,000, or 68%.

Cost of Revenues:

For the three months ended March 31, 2020 and 2019, cost of revenue was approximately $2,385,000 and $1,739,000, respectively, an increase of approximately $646,000. Product cost of revenues increased approximately $783,000 during the three months ended March 31, 2020 as compared to the three months ended March 31, 2019 due to increased sales.  Product gross margins were approximately 76% for the three months ended March 31, 2020 and approximately 74% for the three months ended March 31, 2019, as a result of production efficiencies achieved.

Research and Development Expenses:

For the three months ended March 31, 2020, research and development expenses were approximately $1,965,000 as compared to research and development expenses of approximately $2,419,000 for the three months ended March 31, 2019.  The decrease of approximately $454,000 was due to a decrease in clinical trial and related costs of approximately $974,000, which is due primarily to the pause in our REFRESH 2-AKI study. This decrease was offset by an increase in direct labor and other costs being deployed toward grant-funded activities of approximately $137,000, which had the effect of increasing the amount of our non-reimbursable research and development costs, an increase in new product development costs of approximately $104,000, an increase in non-clinical research and development salary related costs of approximately $71,000 and an increase in non-grant related research and development costs of approximately $208,000

Legal, Financial and Other Consulting Expense:

Legal, financial and other consulting expenses were approximately $519,000 for the three months ended March 31, 2020, as compared to approximately $562,000 for the three months ended March 31, 2019.  The decrease of approximately $43,000 was due to a decrease in legal fees of approximately $97,000 and a decrease in consulting fees of approximately $9,000.  These decreases were offset by an increase in accounting fees of approximately $32,000 and an increase in employment agency fees of approximately $31,000

Selling, General and Administrative Expense:

Selling, general and administrative expenses were approximately $6,317,000 for the three months ended March 31, 2020, as compared to approximately $4,758,000 for the three months ending March 31, 2019, an increase of $1,559,000.   This increase is related to an increase in salaries, commissions and related costs of approximately $501,000, additional sales and marketing costs, which include advertising and conference attendance of approximately $47,000, an increase in royalty expenses of approximately $289,000 due to the increase in product sales, and an increase in non-cash restricted stock expense of approximately $216,000 related to restricted stock units granted to the Company’s executive officers, an increase in non-cash stock compensation expense of approximately $502,000 and an increase in office supplies and other general and administrative costs of approximately $165,000. These increases were offset by a decrease in travel and entertainment expenses of approximately $161,000.

Interest Expense, net:

For the three months ended March 31, 2020, interest expense was approximately $306,000, as compared to interest expense of approximately $205,000 for the three months ended March 31, 2019. This increase in interest expense of approximately $101,000 was primarily a result of the additional interest incurred related to the draw down of the $5,000,000 Term B Loan with Bridge Bank on July 31, 2019.

Gain (Loss) on Foreign Currency Transactions:

For the three months ended March 31, 2020, the non-cash loss on foreign currency transactions was approximately $(668,000) as compared to a loss of approximately $(393,000) for the three months ended March 31, 2019. The 2020 loss was directly related to the decrease in the exchange rate of the Euro to the U.S. dollar at March 31, 2020 as compared to December 31, 2019.  The exchange rate of the Euro to the U.S. dollar was $1.10 per Euro at March 31, 2020, as compared to $1.12 per Euro at December 31, 2019.  The 2019 loss was directly related to the decrease in the exchange rate of the Euro to the U.S. dollar at March 31, 2019 as compared to December 31, 2018. The exchange rate of the Euro to the U.S. dollar was $1.12 per Euro at March 31, 2019, as compared to $1.15 per Euro at December 31, 2018.

History of Operating Losses:

We have experienced substantial operating losses since inception. As of March 31, 2020, we had an accumulated deficit of approximately $192,242,000, which included losses of approximately $3,453,000 and $4,884,000 for the three month periods ended March 31, 2020 and 2019, respectively. Historically, losses have resulted principally from costs incurred in the research and development of our polymer technology, clinical studies, and general and administrative expenses.

Liquidity and Capital Resources

Since inception, our operations have been primarily financed through the issuance of debt and equity securities. At March 31, 2020, we had current assets of approximately $37,529,000 including cash on hand of approximately $26,389,000 and current liabilities of approximately $11,464,000. On April 14, 2020, the Company received approximately $1,093,000 in proceeds from the sale of its New Jersey Net Operating Loss carry forwards under the Technology Business Tax Certificate Transfer Program.  In addition, in early April 2020, the Company received approximately $1,917,000 in proceeds related to the sale of shares pursuant to the Open Market Sale Agreement with Jefferies LLC and B. Riley FBR, Inc.  On July 31, 2019, the Company executed an Amendment to its Loan Agreement with Bridge Bank and, simultaneous with this Amendment, received $5 million in proceeds from an additional term loan.  In addition, the Amendment extends the interest-only period of the loan through October 2020.

We believe that we have sufficient cash to fund our operations into 2021. We will need to raise additional capital to support our ongoing operations in the future. In addition, we will need to raise additional funds to support clinical trials in the U.S. and in Europe.

COVID-19 Impact on Financial Results

First quarter 2020 product revenues were positively impacted by underlying strength in our critical care and cardiac surgery business, and the use of  CytoSorb to treat critically-ill COVID-19 patients in the ICU.  Though difficult to quantitate, we estimate that approximately $1.5 million to $1.7 million of our first quarter 2020 revenues were related to COVID-19.   Given the order patterns we are currently experiencing, we expect that the COVID-19 pandemic will continue to have a positive impact on product revenues in the second quarter of 2020.   Primarily due to the demand for the CytoSorb device to treat COVID-19 patients, we had a sales backlog of approximately $2,700,000 as of March 31, 2020.

In addition, due to the EUA granted by the FDA on April 11, 2020, we began shipping CytoSorb to hospitals in the United States.  We are continuing to actively receive inquiries and orders for CytoSorb.  However, at this time, we cannot predict the overall impact this will have on our 2020 product sales.

As the impact of the COVID-19 pandemic eases, we may experience a decrease in revenue in the second half of 2020 as compared to the first half of 2020 as the impact of this catalyst for revenue growth is reduced.

Grant revenues have been negatively impacted by the COVID-19 pandemic.  Our research and development employees have either been deployed to work-from-home status or reassigned to assist production activities to increase production of CytoSorb.   This may reduce grant revenue until such time as the pandemic is over, however this is not expected to have a material impact on our financial results because of the low gross margins associated with grant activities.

There has been a worldwide slowdown in clinical trial activities as medical providers focus on COVID-19 patients and this has resulted in the temporary pause in enrollment of our TISORB study in the United Kingdom and other clinical trials in Europe.  Together with the previously disclosed pause in enrollment of our REFRESH 2-AKI trial, this has resulted in an approximately $1 million reduction in our quarterly clinical trial expenses which has a corresponding reduction in our reported operating loss and quarterly cash burn.  These clinical trial activities are expected to resume to normal levels once the pandemic is over.  

There has been an approximately $400,000 decrease in our first quarter 2020 selling, general, and administrative expenses due to the restrictions on travel and the cancelling of medical and investor conferences during the pandemic.  This is also a temporary situation.

There has been no adverse impact on our ability to access capital.  We have the ability to access capital through our ATM facility and through the equity markets, if needed.  There has also been no adverse impact on our ability to comply with the covenants associated with our debt facility with Bridge Bank.  We do not expect that this will change materially in the near future.

2020 Second Quarter Revenue Guidance

CytoSorbents has not historically given specific financial guidance on quarterly results until the quarter has been completed.  However, should current underlying order patterns continue, with strength in our core business and global demand for CytoSorb to treat COVID-19 patients, as well as our ability to continue to scale up and produce CytoSorb, we expect our second quarter 2020 product sales will exceed product sales reported in the first  quarter of 2020.   We believe the COVID-19 pandemic has increased awareness and usage of CytoSorb as a treatment of cytokine storm in many countries worldwide. We cannot predict what the lasting impact of this exposure will have on our long term business, if any, and sales of CytoSorb may return to historical levels when the pandemic is over. 

For additional information, please see the Company’s Form 10-Q for the period ended March 31, 2020 filed on May 5, 2020 on http://www.sec.gov.

About CytoSorbents Corporation (NASDAQ: CTSO)

CytoSorbents Corporation is a leader in critical care immunotherapy, specializing in blood purification. Its flagship product, CytoSorb® is approved in the European Union with distribution in 58 countries around the world, as an extracorporeal cytokine adsorber designed to reduce the “cytokine storm” or “cytokine release syndrome” that could otherwise cause massive inflammation, organ failure and death in common critical illnesses. These are conditions where the risk of death is extremely high, yet no effective treatments exist. CytoSorb® has been used in more than 88,000 human treatments to date.  CytoSorb has received FDA Emergency Use Authorization in the United States for use in critically-ill COVID-19 patients with imminent or confirmed respiratory failure, in defined circumstances.  CytoSorb has also been granted FDA Breakthrough Designation for the removal of ticagrelor in a cardiopulmonary bypass circuit during emergent and urgent cardiothoracic surgery.

CytoSorbents’ purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of approximately $30 million from DARPA, the U.S. Army, the U.S. Department of Health and Human Services, the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), U.S. Special Operations Command (SOCOM), the U.S. Army, U.S. Special Operations Command (USSOCOM), the U.S. Air Force, Air Force Material Command (USAF/AFMC) and others. The Company has numerous products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and multiple applications pending, including CytoSorb-XL™, HemoDefend™, VetResQ™, K+ontrol™, ContrastSorb, DrugSorb, and others.  For more information, please visit the Company’s websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter.

Forward-Looking Statements

This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release, including statements about our expected revenues and the impact of the COVID-19 pandemic on the Company, its operations and use of CytoSorb internationally, represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 5, 2020, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws. 

 

CYTOSORBENTS CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(amounts in thousands, except per share data)

For the Three Months Ended

3/31/20

3/31/19

Revenue:

CytoSorb sales

$

8,156

$

4,510

Other sales

67

Total product sales

8,156

4,577

  Grant income

551

615

Total revenue

8,707

5,192

Cost of revenue

2,385

1,739

Gross profit

6,322

3,453

Expenses:

Research and development

1,965

2,419

Legal, financial and other consulting   

519

561

Selling, general and administrative

6,317

4,758

Total operating expenses

8,801

7,738

Loss from operations

(2,479)

(4,285)

Other expense:

Interest expense, net

(306)

(205)

Loss on foreign currency transactions

(668)

(394)

Total other expense, net

(974)

(599)

Loss before benefit from income taxes

(3,453)

(4,884)

Benefit from income taxes

Net loss

(3,453)

(4,884)

Earnings per share:

Basic and diluted loss per share

$

(0.10)

$

(0.15)

Weighted average share outstanding

33,981,262

31,931,215

Net Loss

$

(3,453)

$

(4,884)

Other comprehensive income:

Currency translation adjustment

610

306

Comprehensive loss

$

(2,843)

$

(4,578)

 

CYTOSORBENTS CORPORATION

CONDENSED CONSOLIDATED BALANCE SHEETS

(amounts in thousands)

March 31, 2020

December 31, 2019

ASSETS:

Current Assets:

Cash and cash equivalents

$

26,389

$

12,233

Grants and accounts receivable, net

5,395

4,467

Inventories

1,967

2,114

Prepaid expenses and other current assets

3,778

2,088

    Total current assets

37,529

20,902

Property and  equipment, net

1,994

1,925

Right of use asset

970

1,071

Other assets

3,733

3,485

    TOTAL ASSETS

$

44,226

$

27,383

LIABILITIES AND STOCKHOLDERS’ EQUITY:

Current Liabilities:

Accounts payable

$

1,770

$

2,039

Current maturities of long–term debt

4,167

1,667

Lease liability – current portion

443

428

Accrued expenses and other current liabilities

5,084

5,802

Total current liabilities

11,464

9,936

Long-term debt, net of current maturities and debt
issuance costs

10,921

13,386

Lease liability, net of current portion

527

643

    TOTAL LIABILITIES

22,912

23,965

Total stockholders’ equity

21,314

3,418

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

$

44,226

$

27,383

 

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Cytosorbents Contact:
Amy Vogel
Investor Relations
(732) 398-5394
avogel@cytosorbents.com

Investor Relations Contact:
Jeremy Feffer
LifeSci Advisors
917-749-1494
jeremy@lifesciadvisors.com

U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
ekim@rubensteinpr.com  

SOURCE CytoSorbents Corporation

CytoSorbents Promotes Vincent J. Capponi to President

MONMOUTH JUNCTION, N.J., May 4, 2020 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat cytokine storm and deadly inflammation in critically-ill and cardiac surgery patients around the world, and its Chief Executive Officer, Dr. Phillip Chan, MD, PhD, announced the promotion of Chief Operating Officer Vincent J. Capponi to President and COO, effective immediately.

Dr. Phillip Chan, MD, PhD, CEO of CytoSorbents stated, “I am very pleased to announce the promotion of Vince to President and Chief Operating Officer of CytoSorbents Corporation.  Having worked closely with Vince for over a dozen years, much of the success of CytoSorbents to date is a testament to his many outstanding contributions in all aspects of the company.  In his 18 years with CytoSorbents, he has helped to manage the daily operations of the company, with a focus on manufacturing, engineering, regulatory, clinical studies, new product development and research. Vince played a pivotal role in the development and scale-up of the polymer technology from an R&D phase to commercial production, helped to spearhead the first clinical trial in septic shock patients in Germany, and  drove European Union (E.U.) CE Mark designation for CytoSorb as an extracorporeal cytokine adsorber to treat cytokine storm in many illnesses.  He further expanded market access for CytoSorb by successfully navigating three CE Mark label expansions, including the removal of myoglobin (rhabdomyolysis), bilirubin (liver dysfunction), and earlier this year, the removal of ticagrelor during on-pump cardiac surgery, with the goal of reducing costly and potentially fatal perioperative bleeding.”

Dr. Chan continued, “Most recently, Vince was instrumental in executing the regulatory strategy that led to FDA Emergency Use Authorization (EUA) of CytoSorb in adult, critically-ill, COVID-19 patients with imminent or confirmed respiratory failure, in defined circumstances, and the recent FDA Breakthrough Designation for the removal of ticagrelor during on-pump emergent and urgent cardiothoracic surgery.  In addition, his vision and leadership around the commercial production and scale-up of CytoSorb has resulted in economies of scale and major efficiency improvements in both polymer and device manufacturing, taking blended CytoSorb gross margins from 60% to 80% in Q4 2019.  This has, in turn, enabled us to rapidly respond to the increased need for CytoSorb around the globe during this COVID-19 pandemic, including here in the U.S. under the EUA.”

Dr. Chan concluded, “One of Vince’s greatest strengths stems from his favorite mantra of “plan well, execute brilliantly,” which he has proven time and time again over a career that has spanned three decades in the medical device and pharmaceutical industries.  As President and COO, Vince will continue to oversee the operations of the company, with a strong team reporting to him, but will now focus on the development of new exciting opportunities for CytoSorb and our other technologies.  A trusted colleague, I am confident that Vince will do an outstanding job.”

Mr. Vince Capponi stated, “At CytoSorbents, I have experienced what I believe is a once-in-a-lifetime opportunity:  to work with a new product concept and be part of a fantastic team to transform that idea into a life-saving therapy worldwide.  We are just beginning to see the true potential of CytoSorb and what it could mean for the future of critical care and cardiac surgery.  As President and COO, I am honored to have been given this opportunity and look forward to continuing to work with Phil and the management team, to take on new challenges, help make our corporate goals a reality, increase the overall value of our company, and most importantly, save lives.”

About CytoSorbents Corporation (NASDAQ: CTSO)

CytoSorbents Corporation is a leader in critical care immunotherapy, specializing in blood purification. Its flagship product, CytoSorb® is approved in the European Union with distribution in 58 countries around the world, as an extracorporeal cytokine adsorber designed to reduce the “cytokine storm” or “cytokine release syndrome” that could otherwise cause massive inflammation, organ failure and death in common critical illnesses. These are conditions where the risk of death is extremely high, yet no effective treatments exist. CytoSorb® has been used in more than 80,000 human treatments to date.  CytoSorb has received FDA Emergency Use Authorization in the United States for use in critically-ill COVID-19 patients with imminent or confirmed respiratory failure, in defined circumstances.  CytoSorb has also been granted FDA Breakthrough Designation for the removal of ticagrelor in a cardiopulmonary bypass circuit during emergent and urgent cardiothoracic surgery.

CytoSorbents’ purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of more than $30 million from DARPA, the U.S. Army, the U.S. Department of Health and Human Services, the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), U.S. Special Operations Command (SOCOM), the U.S. Army, U.S. Special Operations Command (USSOCOM), the U.S. Air Force, Air Force Material Command (USAF/AFMC) and others. The Company has numerous products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and multiple applications pending, including CytoSorb-XL™, HemoDefend™, VetResQ™, K+ontrol™, ContrastSorb, DrugSorb, and others.  For more information, please visit the Company’s websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter.

Forward-Looking Statements

This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, our ability to leverage designation of CytoSorb as a breakthrough device under the FDA’s  Breakthrough Devices Program in order to expedite the development, assessment, and regulatory review of CytoSorb, as well as the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 5, 2020, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements, particularly in light of the current coronavirus pandemic, where businesses can be impacted by rapidly changing state and federal regulations, as well as the health and availability of their workforce. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.

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CytoSorbents Contact:
Amy Vogel
Investor Relations
(732) 398-5394
avogel@cytosorbents.com

Investor Relations Contact:
Jeremy Feffer
LifeSci Advisors
(212) 915-2568
jeremy@lifesciadvisors.com

Public Relations Contact:
Eric Kim
Rubenstein Public Relations
(212) 805-3052
ekim@rubensteinpr.com

SOURCE CytoSorbents Corporation

CytoSorbents Receives $1.1 Million in Non-Dilutive Funding from the New Jersey Business Tax Certificate Transfer Program

Returning $1.4 Million Received from Paycheck Protection Program

MONMOUTH JUNCTION, N.J., April 29, 2020 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat cytokine storm and deadly inflammation in critically-ill and cardiac surgery patients around the world, today announced that it has received $1,092,698, net of transaction costs, in non-dilutive funding as an approved participant of the Technology Business Tax Certificate Transfer Program sponsored by the New Jersey Economic Development Authority (NJEDA).

“We are extremely grateful to the NJEDA for their continued support under this program, through which we have cumulatively received more than $4.8 million in non-dilutive funding.  This year’s funding of approximately $1.1 million was the largest in our history,” stated Dr. Phillip Chan, Chief Executive Officer of CytoSorbents. “Our company and technology have been the beneficiary of approximately $30 million in non-dilutive funding from federal and state agencies through grants, contracts, and other sources.  This has helped to advance our technologies and to develop CytoSorb as a leading therapy to treat cytokine storm in life-threatening illnesses around the world.”

Dr. Chan continued, “As a result of this funding, access to public capital markets, and our current favorable financial and operating position, we have decided to return the $1.4 million Paycheck Protection Program (PPP) loan we previously received.  We applied for this loan when the program was first announced, but we believe these funds should be deployed to small businesses in greater need of support during this difficult time.”

The New Jersey Technology Business Tax Certificate Transfer Program enables approved Technology and Biotechnology Businesses with Net Operating Losses to sell their Unused Net Operating Loss Carryover (NOL) and Unused Research and Development Tax Credits (R&D Tax Credits) for at least 80% of the value of the tax benefits to a profitable corporate taxpayer in the State of New Jersey that is not an Affiliated Business. This allows Technology and Biotechnology Businesses with Net Operating Losses to turn their tax losses and credits into cash to buy equipment or facilities, or for other Allowable Expenditures. The New Jersey Economic Development Authority (NJEDA) determines eligibility, and the New Jersey Division of Taxation determines the value of the tax benefits (NOL and R&D Tax Credits).

About CytoSorbents Corporation (NASDAQ: CTSO)

CytoSorbents Corporation is a leader in critical care immunotherapy, specializing in blood purification. Its flagship product, CytoSorb® is approved in the European Union with distribution in 58 countries around the world, as an extracorporeal cytokine adsorber designed to reduce the “cytokine storm” or “cytokine release syndrome” that could otherwise cause massive inflammation, organ failure and death in common critical illnesses. These are conditions where the risk of death is extremely high, yet no effective treatments exist. CytoSorb® has been used in more than 80,000 human treatments to date.  CytoSorb has received FDA Emergency Use Authorization in the United States for use in critically-ill COVID-19 patients with imminent or confirmed respiratory failure, in defined circumstances.  CytoSorb has also been granted FDA Breakthrough Designation for the removal of ticagrelor in a cardiopulmonary bypass circuit during emergent and urgent cardiothoracic surgery.

CytoSorbents’ purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of more than $30 million from DARPA, the U.S. Army, the U.S. Department of Health and Human Services, the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), U.S. Special Operations Command (SOCOM), the U.S. Army, U.S. Special Operations Command (USSOCOM), the U.S. Air Force, Air Force Material Command (USAF/AFMC) and others. The Company has numerous products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and multiple applications pending, including CytoSorb-XL™, HemoDefend™, VetResQ™, K+ontrol™, ContrastSorb, DrugSorb, and others.  For more information, please visit the Company’s websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter.

Forward-Looking Statements

This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, our ability to leverage designation of CytoSorb as a breakthrough device under the FDA’s  Breakthrough Devices Program in order to expedite the development, assessment, and regulatory review of CytoSorb, as well as the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 5, 2020, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements, particularly in light of the current coronavirus pandemic, where businesses can be impacted by rapidly changing state and federal regulations, as well as the health and availability of their workforce. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.

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CytoSorbents Contact:
Amy Vogel
Investor Relations
(732) 398-5394
avogel@cytosorbents.com

Investor Relations Contact:
Jeremy Feffer
LifeSci Advisors
(212) 915-2568
jeremy@lifesciadvisors.com

Public Relations Contact:
Eric Kim
Rubenstein Public Relations
(212) 805-3052
ekim@rubensteinpr.com

SOURCE CytoSorbents Corporation

CytoSorbents to Report Q1 2020 Operating and Financial Results

MONMOUTH JUNCTION, N.J., April 28, 2020 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, will report Q1 2020 financial results after the market close on Tuesday, May 5, 2020. 

CytoSorbents’ management will host a live conference call and presentation webcast that will recount both operational and financial progress during Q1 2020 followed by a question and answer session.

Conference Call Details:

Date:                  

Tuesday, May 5, 2020

Time:                      

4:45 PM Eastern

Toll Free:                        

877-451-6152

International:        

201-389-0879

Conference ID:               

13701769

Live Presentation Webcast:   

http://public.viavid.com/index.php?id=139054

It is recommended that participants dial in approximately 10 minutes prior to the start of the call.  There will also be a simultaneous live webcast of the conference call that can be accessed through the following audio feed link:  http://public.viavid.com/index.php?id=139054

An archived recording of the conference call will be available under the Investor Relations section of the Company’s website at http://cytosorbents.com/investor-relations/financial-results/ 

About CytoSorbents Corporation (NASDAQ: CTSO)

CytoSorbents Corporation is a leader in critical care immunotherapy, specializing in blood purification. Its flagship product, CytoSorb® is approved in the European Union with distribution in 58 countries around the world, as an extracorporeal cytokine adsorber designed to reduce the “cytokine storm” or “cytokine release syndrome” that could otherwise cause massive inflammation, organ failure and death in common critical illnesses. These are conditions where the risk of death is extremely high, yet no effective treatments exist. CytoSorb® has been used in more than 80,000 human treatments to date.  CytoSorb has received FDA Emergency Use Authorization in the United States for use in critically-ill COVID-19 patients with imminent or confirmed respiratory failure, in defined circumstances.  CytoSorb has also been granted FDA Breakthrough Designation for the removal of ticagrelor in a cardiopulmonary bypass circuit during emergent and urgent cardiothoracic surgery.

CytoSorbents’ purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of nearly $29 million from DARPA, the U.S. Army, the U.S. Department of Health and Human Services, the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), U.S. Special Operations Command (SOCOM), the U.S. Army, U.S. Special Operations Command (USSOCOM), the U.S. Air Force, Air Force Material Command (USAF/AFMC) and others. The Company has numerous products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and multiple applications pending, including CytoSorb-XL™, HemoDefend™, VetResQ™, K+ontrol™, ContrastSorb, DrugSorb, and others.  For more information, please visit the Company’s websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter.

Forward-Looking Statements

This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, our ability to leverage designation of CytoSorb as a breakthrough device under the FDA’s  Breakthrough Devices Program in order to expedite the development, assessment, and regulatory review of CytoSorb, as well as the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 5, 2020, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements, particularly in light of the current coronavirus pandemic, where businesses can be impacted by rapidly changing state and federal regulations, as well as the health and availability of their workforce. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws. 

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CytoSorbents Contact: 
Amy Vogel
(732) 398-5394
avogel@cytosorbents.com

Investor Relations Contact: 
Jeremy Feffer
LifeSci Advisors
917-749-1494
jeremy@lifesciadvisors.com

Public Relations Contact:
Eric Kim 
Rubenstein Public Relations
212-805-3052
ekim@rubensteinpr.com  

SOURCE CytoSorbents Corporation