CytoSorbents Announces FDA Approval to Commence Initial U.S. Cardiac Surgery Study
MONMOUTH JUNCTION, N.J., Feb. 2, 2015 /PRNewswire/ — CytoSorbents Corporation (NASDAQ CM: CTSO), a critical care immunotherapy company commercializing its CytoSorb® extracorporeal cytokine adsorber to treat critically-ill and cardiac surgery patients in multiple countries worldwide, announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption (IDE) application to commence a planned U.S. cardiac surgery feasibility study. This single-arm study in 20 patients and three U.S. clinical sites represents the first part of a larger clinical trial strategy intended to support the U.S. approval of CytoSorb® for intra-operative use during cardiac surgery.
The study is designed to evaluate the safety of CytoSorb® when used intra-operatively in a heart-lung machine to reduce plasma free hemoglobin and cytokines in patients undergoing complex cardiac surgery. The length, complexity and invasiveness of these procedures cause hemolysis and inflammation, leading to high levels of plasma free hemoglobin, cytokines, activated complement, and other substances. These inflammatory mediators directly correlate with the incidence of serious post-operative complications such as kidney injury and failure. The goal of CytoSorb® is to actively remove these inflammatory and toxic substances as they are being generated during the surgery and reduce complications.
Concurrently, the Company is funding a non-interventional study amongst a broader array of U.S. cardiac surgery centers that will assess adverse event rates (e.g. incidence of acute kidney injury and respiratory failure) and levels of free hemoglobin and other inflammatory mediators in patients undergoing complex cardiac surgery. These patients will be selected using similar inclusion and exclusion criteria to the feasibility study. The data from these two studies will help to rapidly validate assumptions in this surgical patient population and help to appropriately power a U.S. pivotal cardiac surgery trial.
Dr. Gregory Di Russo, Senior Vice President of Clinical Development at CytoSorbents stated, “Pending institutional review board (IRB) approval at our selected sites, we look to rapidly execute the feasibility study and advance the non-interventional study. We plan to work with these same institutions to begin a pivotal trial in the future with critical mass. Positive data from a U.S. pivotal trial and from cardiac surgery trials ongoing in Europe may help to establish CytoSorb® as a standard component of the heart-lung machine during cardiac surgery and fill a significant unmet medical need.”
Mr. Vincent Capponi, Chief Operating Officer of CytoSorbents stated, “We are excited to begin these trials, as they underscore our commitment to seeking U.S. approval of CytoSorb® for cardiac surgery. With strong interest from leading international cardiac surgery companies, and with success in our clinical trial programs, we believe that future approval in the U.S. will help pave the way for multiple commercialization options of CytoSorb® in the US and abroad. ”
There are more than 500,000 cardiac surgeries performed in the United States, and more than 1.5 million surgeries worldwide each year for common applications such as coronary artery bypass graft (CABG) surgery, valve repair or replacement, congenital defect repair, heart/lung transplantation, implantation of left ventricular assist devices (LVAD) for heart failure, and others. This represents an estimated total addressable market of more than $1.5 billion for CytoSorb® in this indication alone, and adds to the overall $20 billion market potential of CytoSorb® for critical care applications worldwide.
About CytoSorbents Corporation
CytoSorbents Corporation is a critical care focused immunotherapy company using blood purification to control severe inflammation — with the goal of preventing or treating multiple organ failure in life-threatening illnesses. Organ failure is the cause of nearly half of all deaths in the intensive care unit, with little to improve clinical outcome. CytoSorb®, the Company’s flagship product, is approved in the European Union and marketed in 29 countries around the world, as a safe and effective extracorporeal cytokine adsorber, 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 risk of death is 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, which can lead to post-operative complications, including multiple organ failure.
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. CytoSorbents has numerous products under development based upon this unique blood purification technology, protected by 32 issued US patents and multiple applications pending, including HemoDefend™, ContrastSorb, DrugSorb, and others. Additional information is available for download on the Company’s website: http://www.cytosorbents.com/.