CytoSorbents Corporation (NASDAQ: CTSO) is a New Jersey-based, critical care immunotherapy company specializing in blood purification to control deadly inflammation in critically-ill and cardiac surgery patients. The company’s flagship product, CytoSorb®, is approved in the European Union with distribution in 55 countries around the world, as a safe and effective 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 such as sepsis, burn injury, trauma, lung injury, and pancreatitis, as well as in cancer immunotherapy. These are conditions where the risk of death and cost of treatment are extremely high, yet no effective treatments exist. CytoSorb® is also being used during and after cardiac surgery to remove inflammatory mediators, such as cytokines and free hemoglobin, that can lead to post-operative complications, including multiple organ failure. CytoSorb® has been used safely in more than 56,000 human treatments to date.
CytoSorbents’ blood purification technologies are based on advanced, biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Each polymer bead, approximately the size of a grain of salt, contains millions of pores and channels that can be modified to remove substances as small as drugs, to substances as large as antibodies from blood. These beads are synthesized at CytoSorbents’ ISO 13485 certified manufacturing facility in New Jersey. A companion product for the animal health market that uses similar technology to CytoSorb®, called VetResQ® , is now commercially available in the United States. In addition, HemoDefend™, a packed red cell transfusion filter designed to improve the safety and quality of transfused blood, is nearing human pivotal studies in the U.S. in the second half of 2019 that are intended to support U.S. FDA approval. The Company has numerous other products under development based upon this unique blood purification technology, protected by 19 issued U.S. patents and multiple applications pending, including CytoSorb-XL, K+ontrol, ContrastSorb, DrugSorb, and others.
CytoSorb® is approved for sale in the European Union (E.U.) as an extracorporeal cytokine adsorber, designed to control deadly systemic inflammation by reducing excessive cytokines, bacterial toxins, and many other factors from blood that “fuel the fire” of inflammation. Left unchecked, this uncontrolled inflammation can lead to organ injury, organ failure, and in many cases, death of the patient. The blood purification cartridge can be used with most kinds of extracorporeal blood pumps including standard hemodialysis machines, continuous renal replacement (CRRT) machines, heart-lung machines, and extracorporeal membrane oxygenation (ECMO) machines, in any situation where cytokines are elevated. This includes a diverse range of conditions where excessive cytokines and other inflammatory toxins are driving a potentially dangerous inflammatory response. These include acute critical illnesses such as sepsis and infection, burn injury, trauma, acute respiratory distress syndrome, severe acute pancreatitis, liver failure, influenza, cytokine release syndrome in CAR T-cell immunotherapy, and complications of cardiac surgery, as well as in other more chronic diseases such as cancer, cancer cachexia, autoimmune diseases, and others. Recently, the usage label was expanded to now include the on-label reduction of bilirubin in liver disease, and myoglobin in severe trauma. CytoSorb® is also being used intra-operatively during open heart surgery in a bypass circuit in a heart-lung machine to pre-emptively reduce inflammatory mediators such as cytokines, activated complement, and plasma free hemoglobin that are generated during the surgery and can lead to post-operative inflammation and organ failure. CytoSorb® has been used in more than 56,000 human treatments to date and has been credited with saving many lives.
With registration, CytoSorb® can also be sold outside of the E.U. in countries that accept European medical device approval. CytoSorb® is being sold directly in Germany, Austria, Switzerland, Poland, Norway, Sweden, Denmark, Belgium, the Netherlands, and Luxembourg, and marketed through distributors in the United Kingdom, Italy, Spain, Portugal, the Middle East (including Saudi Arabia, the United Arab Emirates, Kuwait, Qatar, Bahrain, Oman, Yemen, Iraq, Iran, and Jordan), Israel, Turkey, Russia, Australia, New Zealand, Vietnam, Hong Kong, Panama, Chile, and many other countries.
Our strategic partner Fresenius Medical Care, the largest dialysis company in the world, is currently the exclusive distributor of CytoSorb® in France, Mexico, South Korea, Finland, and the Czech Republic for critical care applications, and is a co-marketing partner for CytoSorb® across all of our territories. Terumo Cardiovascular, a global leader in cardiac and vascular surgery, has also partnered with us to exclusively distribute CytoSorb® for cardiac surgery applications in France, Norway, Sweden, Finland, Denmark, and Iceland. CytoSorb® is currently also being sold in India, Sri Lanka, Malaysia and select emerging markets through our strategic partner, Biocon Ltd, India’s largest biopharmaceutical company. In addition, Dr. Reddy’s Laboratories, an international pharmaceutical firm, distributes CytoSorb® in South Africa.
There are more than 50 investigator-initiated studies in various stages of process in Europe and Asia using CytoSorb® in a wide variety of applications. In addition, the International CytoSorb® Registry has been established to collect and analyze treatment data from all over the world, and is being independently managed by the Center of Clinical Studies at the University of Jena, Germany.
The company has successfully completed its 46-patient randomized, controlled, U.S. based REFRESH (REduction of FREe Hemoglobin) I cardiac surgery safety and feasibility trial, using CytoSorb® intra-operatively during elective, non-emergent complex cardiac surgery. The study supported the safety and ability of the device to reduce plasma free hemoglobin and activated complement, particularly in high risk surgeries such as valve replacement surgery. The company is now conducting its pivotal 400 patient, randomized, controlled REFRESH 2-AKI trial, intended to support registration and approval of CytoSorb® in the U.S. for the initial indication of reducing acute kidney injury following cardiac surgery. In addition, the 250 patient randomized, controlled REMOVE endocarditis trial is more than halfway complete, and is being funded by the German Federal Ministry of Education and Health.
VetResQ® is commercially available in the U.S. veterinary market as a blood purification therapy targeting the reduction of toxic inflammation in critically-ill cats, dogs, and other animals suffering from infection and sepsis, trauma, pancreatitis, Leptospirosis, and other common conditions. It is also suitable for the treatment of accidental drug intoxication for hydrophobic drugs.
HemoDefend™ is a blood purification technology platform for the blood transfusion industry intended to reduce transfusion reactions and safeguard the quality and safety of blood products. The HemoDefend technology utilizes the Company’s polymer bead technology to remove many substances, such as antibodies, free hemoglobin, potassium, cytokines, bioactive lipids, and inflammatory mediators that can cause potentially serious and sometimes fatal transfusion reactions. HemoDefend-RBC, designed to purify packed red blood cells, is nearing a human pivotal trial designed to support U.S. FDA approval, and is expected to begin in the second half of 2019.
The Future of Blood Purification is Now
CytoSorb,® VetResQ,® and HemoDefend™ are just three of a number of different sorbents the Company has designed for various medical applications, including improved dialysis, the potential treatment of inflammatory and autoimmune disorders, rhabdomyolysis in trauma, removal of chemotherapy drugs during treatment of cancer with high dose regional chemotherapy, removal of IV contrast, treatment of drug intoxication, and others. Additional information is available in the Investor Relations section.
CytoSorbents and its technology has garnered more than $26 million in support from the U.S. government. DARPA, or the Defense Advanced Research Projects Agency, as part of its “Dialysis-Like Therapeutics” program to treat sepsis, awarded CytoSorbents a $3.8 million five year contract to develop cytokine and toxin binders for the program. CytoSorbents collaborated with groups such as Battelle Laboratories, Harvard’s Wyss Institute, NxStage Medical (recently acquired by Fresenius Medical Care), Massachusetts Institute of Technology, and others in this program. CytoSorbents was also awarded $1.65 million by the U.S. Army in a Phase I, Phase II and Phase II Enhancement SBIR contract to develop its blood purification technologies to treat burn injury and trauma. The Joint Program Executive Office for Chemical and Biologic Defense (JPEO-CBD) awarded CytoSorbents $1.15 million in SBIR Phase I and II contracts to develop countermeasures for fungal mycotoxin exposure. The U.S. Army Medical Research and Materiel Command (USAMRMC) awarded CytoSorbents a $150K Phase I SBIR grant to develop novel potassium binding sorbents to treat severe hyperkalemia. Also, CytoSorbents has also been awarded approximately $5.0 million in Phase I, II, and IIb bridge funding from the National Heart, Lung and Blood Institute (NHLBI), a division of the National Institutes of Health (NIH) and US Special Operations Command (USSOCOM) to further develop its HemoDefend™ technology for blood transfusions. The U.S. Army Medical Research Acquisition Activity (USAMRAA) also awarded a $1.15 million Phase I and II STTR contract to CytoSorbents to develop universal plasma.
CytoSorbents operates through its wholly-owned subsidiary, CytoSorbents Medical Inc. (fka CytoSorbents Inc.), and conducts its European business through its wholly-owned subsidiary, CytoSorbents Europe GmbH, with daughter subsidiaries in Switzerland and Poland. CytoSorbents Corporation converted from a Nevada Corporation to a Delaware Corporation in December 2014.