|CytoSorbents Corporation (OTCBB: CTSO), a critical care focused company using blood purification to treat life-threatening illnesses in the intensive care unit, announced today that the United States Food and Drug Administration (FDA) has granted approval to begin a U.S.-based human pilot study using CytoSorb® for the treatment of rhabdomyolysis as a result of trauma under an Investigational Device Exemption (IDE). Rhabdomyolysis is caused by the massive release of myoblobin from severely injured skeletal muscle that can lead to kidney failure. The study was initiated by and will be funded by the U.S. Air Force. CytoSorbents is the official sponsor of the study, and expects the study to begin this year.
Dr. Phillip Chan, MD, PhD, Chief Executive Officer stated, “This major announcement is a significant milestone for CytoSorbents for many reasons:
- This will be the first human CytoSorb® study to begin in critically ill patients in the United States. We are confident that CytoSorb® treatment will be easy to implement, after now having safely completed more than 1,000 human treatments, mostly in Europe, including a number of treatments in trauma patients.
- The U.S. Air Force is funding this study, a major benefit to the Company. The trial will be conducted by experienced clinical researchers from both the U.S. Air Force and Army. Along with our previously established Trauma Advisory Board, we will have a wealth of experience to draw upon for this trial.
- This collaboration expands our relationship with the U.S. Department of Defense to now include the U.S. Air Force, the U.S. Army, and the Defense Advanced Research Projects Agency (DARPA). Our collective goal is to develop our technologies for the treatment of life-threatening conditions such as sepsis, burn injury, trauma and rhabdomyolysis, to protect our wounded warfighters and civilians alike. We greatly appreciate the ongoing interest and support of these respective agencies.
- As part of the IDE application process, the FDA has reviewed the CytoSorb® treatment safety data from the European Sepsis Trial. We believe this early review of the European Sepsis Trial safety data will help streamline our future discussions with the FDA about a planned U.S. pivotal trial in sepsis.
- Finally, this study will expand the CytoSorb® clinical trial experience to now include trials in sepsis and in trauma patients with rhabdomyolysis. If successful, the trauma and rhabdomyolysis application could represent yet another avenue to seek CytoSorb® approval in the U.S. CytoSorb® is currently approved in the European Union and has been used successfully in treating a variety of conditions, including sepsis, lung injury, influenza, burn injury, trauma, liver failure, and others.”
Based on statistics from the National Trauma Institute, trauma accounts for 42 million emergency department visits, 2 million hospital admissions, and more than 170,000 deaths in the U.S. each year. In severe trauma patients, crush injury and ischemia can lead to rhabdomyolysis – the destruction and breakdown of muscle tissue, releasing intracellular myoglobin into the blood. High levels of myoglobin are toxic to the kidneys and can precipitate acute kidney injury and kidney failure, which significantly increases the risk of death in trauma injury. CytoSorb® has demonstrated the ability to efficiently remove myoglobin in pre-clinical testing and will be evaluated on its ability to reduce myoglobin levels in human trauma patients with rhabdomyolysis when used with standard of care therapy, compared to standard of care therapy alone.
About CytoSorbents Corporation
CytoSorbents is a critical care focused therapeutic device company using blood purification to modulate the immune system and fight multiple organ failure in 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 adsorption. CytoSorb®, the Company’s flagship product, is approved in the European Union as a safe and effective extracorporeal cytokine filter, designed to reduce the “cytokine storm” that could otherwise cause massive inflammation, organ failure and death in common critical illnesses such as sepsis, burn injury, trauma, lung injury, and pancreatitis. These are conditions where the mortality is extremely high, yet no effective treatments exist. CytoSorbents has numerous products under development based upon the same underlying blood purification technology including HemoDefend™, ContrastSorb, DrugSorb, and others. Additional information is available for download on the Company’s website: http://www.cytosorbents.com.
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. Forward-looking statements in this press release are not promises or guarantees and are subject to risks and uncertainties that could cause our actual results to differ materially from those anticipated. These statements are based on management’s current expectations and assumptions and are naturally subject to uncertainty and changes in circumstances. We caution you not to place undue reliance upon any such forward-looking statements. Actual results may differ materially from those expressed or implied by the statements herein. CytoSorbents Corporation and CytoSorbents, Inc believe that its primary risk factors include, but are not limited to: obtaining government regulatory approvals; ability to successfully develop commercial operations; dependence on key personnel; acceptance of the Company’s medical devices in the marketplace; the outcome of potential litigation; compliance with governmental regulations; reliance on research and testing facilities of various universities and institutions; the ability to obtain adequate and timely financing in the future when needed; product liability risks; limited manufacturing experience; limited marketing, sales and distribution experience; market acceptance of the Company’s products; competition; unexpected changes in technologies and technological advances; and other factors detailed in the Company’s Form 10-K filed with the SEC on April 3, 2013, which is available at http://www.sec.gov.