StockGuru Spotlight on Cytosorbents Corp
(Symbol: CTSO)
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About Cytosorbents Corp:
CytoSorbents Corporation (OTCBB: CTSO; Monmouth Junction, NJ) is a publicly-traded, critical care immunotherapy company using blood purification to treat life-threatening illnesses. Its purification technology is 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. Each polymer bead 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 its ISO 13485 certified manufacturing facility in New Jersey. The technology is protected by 32 issued U.S. patents and multiple patent applications pending.
Profile from CTSO Website:
CytoSorbents Corporation (OTCBB: CTSO; Monmouth Junction, NJ) is a publicly-traded, critical care immunotherapy company using blood purification to treat life-threatening illnesses. Its purification technology is 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. Each polymer bead 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 its ISO 13485 certified manufacturing facility in New Jersey. The technology is protected by 32 issued U.S. patents and multiple patent applications pending.
CytoSorb®, the Company’s flagship product, is approved for sale in all 28 countries of the European Union (E.U.) as an extracorporeal cytokine filter, to be used in any situation where cytokines are elevated. CytoSorb® is being sold directly in Germany, Austria and Switzerland, and through distributors in the United Kingdom, Ireland and the Netherlands. With registration, it can also be sold outside of the E.U. in countries that accept European medical device approval. CytoSorb® is currently being sold in India and select emerging markets through our strategic partner, Biocon Ltd, Asia’s largest biotechnology company, and in Russia and Turkey.
CytoSorb® is approved for use in clinical situations where cytokines are elevated, and can be used for a diverse range of inflammatory conditions, including critical illnesses, cancer, cancer cachexia, and others. The goal of CytoSorb® is to modulate the immune system by removing excessive cytokines, often called “cytokine storm”, in critically-ill patients that can lead to deadly inflammation, multiple organ failure, immune dysfunction, and often death in common illnesses such as sepsis, trauma, burn injury, acute respiratory distress syndrome, and pancreatitis. CytoSorb® has demonstrated statistically significant reductions in mortality in septic patients at high risk of death.
HemoDefend™ is a development-stage 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 and inflammatory mediators that can cause potentially serious and sometimes fatal transfusion reactions.
CytoSorb® and HemoDefend™ are just two of a number of different resins 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, drug detoxification, and others. Additional information is available in the Investor Relations section.
CytoSorbents and its technology has garnered more than $15 million in support from the U.S. Government. Recently, 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 collaborates with groups such as Battelle Laboratories, Harvard’s Wyss Institute, NxStage Medical (NASDAQ: NXTM), Massachusetts Institute of Technology, and others in this program.
CytoSorbents was also awarded $1.15 million by the U.S. Army in a Phase I and Phase II SBIR contract to develop its blood purification technologies to treat burn injury and trauma. The U.S. Air Force is also funding an FDA-approved, 30 patient randomized controlled human pilot study using CytoSorb® to treat trauma patients with rhabdomyolysis that has begun. CytoSorbents was also recently awarded a $203,000 Phase I SBIR contract from the National Heart, Lung and Blood Institute (NHLBI), a division of the National Institutes of Health (NIH), to further develop its HemoDefend™ technology for blood transfusions.
CytoSorbents operates through its wholly-owned subsidiary, CytoSorbents, Inc., and conducts its European business through its wholly-owned subsidiary, CytoSorbents Europe GmbH.
About The CytoSorb Technology:
CytoSorb® – A First-in-Class Cytokine Filter Approved in the European Union
CytoSorb
CytoSorb® is a potentially breakthrough critical care immunotherapy that attempts to address one of the most challenging unmet medical needs in medicine…the ability to prevent or mitigate multiple organ failure – the leading cause of death in the intensive care unit (ICU) from any cause.
In response to life-threatening conditions such as sepsis and infection, trauma, serious burn injuries, severe lung injury, and pancreatitis, the body frequently overreacts and produces a massive excess of cytokines, or “cytokine storm”. Cytokines normally help the body cope with injury, but at these levels, cytokine storm is toxic to the body, driving severe inflammation and a cascade of pathophysiologic changes in the body that cause cell damage, organ failure and often death. It follows that reduction of cytokine storm may limit this cascade of events, thereby reducing the severity of illness, and helping patients recover and survive. Until recently, however, there were no effective ways to reduce cytokine storm broadly.
CytoSorb® is a first-in-class extracorporeal cytokine adsorber, now approved in the European Union, and broadly indicated for use in any clinical situation where cytokines are elevated. It is compatible with standard hemodialysis machines and blood pumps found in most hospitals. Blood is pumped out of the body, through the CytoSorb® cartridge that contains the company’s proprietary blood compatible porous polymer beads, and the “purified” blood is recirculated back to the patient. In a six hour period, a patient’s entire blood volume can be treated approximately 20 times.
CytoSorb® is clinically proven to reduce cytokines in the company’s multi-center, randomized, controlled European Sepsis Trial conducted in Germany. Treatment was safe and well-tolerated in more than 300 human treatments in very sick patients with the worst forms of sepsis and lung injury, and treatment has been safe in more than 3,000 human treatments overall. Early data suggests that CytoSorb® can reduce organ injury and improve survival in patients at high risk of cytokine injury, particularly those patients with very high cytokine levels, and patients older than age 65.
CytoSorb® has now been used successfully in many conditions where deadly inflammation can lead to organ injury and failure. We are seeing strong interest in the following clinical applications:
Applicatons
There are more than 150 key opinion leaders in Germany, Austria, and Switzerland (our direct sales territories) who are either using or committed to using CytoSorb in clinical practice or clinical studies. More than 30 investigator-initiated studies in a diverse set of applications are being planned, with many already enrolling patients. In the United States, the U.S. Air Force is funding a 30-patient, FDA-approved randomized controlled human trauma pilot study.
As these other independent studies progress, CytoSorbents collaborates with Dr. John Kellum at the University of Pittsburgh Medical Center, and is sponsoring clinical studies in the area of severe sepsis and septic shock, the result of an overzealous immune response to a severe infection such as pneumonia or a ruptured appendix. Severe sepsis and septic shock are collectively a top ten cause of death worldwide, afflicting approximately 27 million people annually, killing approximately 1 in 3 patients despite the best medical care. CytoSorbents is conducting clinical trials in Europe and currently has an FDA-approved IDE application to run a small sepsis trial in the U.S..
Because of the versatility of CytoSorb®, there are many other potential applications of the technology outside of critical care medicine as well. In particular, CytoSorb® has been used many times intraoperatively during open heart surgery, where the heart must be stopped in order to operate on it, while the blood is pumped outside of the body by a heart-lung machine that oxygenates the blood and pumps it back to the rest of the body. This procedure can result in the production of inflammatory mediators such as cytokines, as well as hemolysis and the release of free hemoglobin into the blood. This can result in inflammation and post-operative complications such as failure to wean from mechanical ventilation and kidney failure. There are more than 1 million open heart surgeries each year in the U.S. and E.U. combined, with an addressable market of more than $1 billion for CytoSorb®. CytoSorbents plans to initiate human trials in the U.S. using CytoSorb® in cardiac surgery to seek U.S. regulatory approval.
Another application is in cancer immunotherapy. Cancer cachexia is a wasting condition that occurs in most cancers that leads to rapid uncontrolled weight loss, anorexia, and physical debilitation. Patients lose the physical reserve needed to tolerate treatment and fight the cancer. Because CytoSorb® can remove a broad range of cytokines and other inflammatory mediators that drive cancer cachexia, it may be very helpful in this condition. CytoSorbents is exploring this application, as well as the use of CytoSorb® as a primary cancer immunotherapy to kickstart the immune system to attack cancer, with researchers at the University of Pennsylvania School of Veterinary Medicine.
CytoSorb® is being sold for clinical use in the European Union and in countries outside of the European Union that accept European CE Mark approval such as India, Russia, Turkey and others. The total addressable market for CytoSorb® in critical care applications such as sepsis, burn injury, trauma, ARDS, pancreatitis and other diseases is estimated at $10-15 Billion in the U.S. and Europe alone.
Where it is located:
7 Deer Park Drive
Suite K
Monmouth Junction, NJ
8852
United States
Key Executive Contact:
Robert Bartlett
CMO
Ninety Day Volume:
671190 (as of date of publication)
Ninety Day Dollar Volume:
$165,113
Share Information:
310699452 shares as of 2014-08-06
Corporate Information:
State Incorporated: NV
Country Incorporated: USA
Contact, Website and Social Media for Cytosorbents Corp:
Shown Where Available
Website: http://www.cytosorbents.com/
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Telephone: (732) 329-8885
Email: [email protected]
Investor Relations for Cytosorbents Corp: