MONMOUTH JUNCTION, N.J., Nov. 10, 2014 /PRNewswire/ -- CytoSorbents Corporation (CTSO), a blood purification company commercializing its CE Mark approved CytoSorb® extracorporeal cytokine adsorber in 19 countries worldwide, announced that following significant due diligence, it has entered into an initial partnership agreement with a leading global medical device company in cardiac surgery and other cardiovascular diseases, to use CytoSorb® intra-operatively during cardiac surgery in France. France is the second largest medical device market and one of the highest volume cardiac surgery markets in the European Union.
Under the terms of the agreement, the partnership will commence with an initial six-month market evaluation period to determine various market parameters, to obtain clinical data, and to build key opinion leader support in France. Following a successful evaluation, the parties plan to jointly determine how to expand upon both the size and geographic footprint of its partnership.
There are approximately 1.5 million cardiac surgeries performed worldwide each year for indications such as coronary artery bypass graft (CABG) surgery, heart valve replacement, congenital defect repair, and heart-lung transplant. During the majority of these surgeries, the heart and lungs are stopped, and blood is shunted to a heart-lung machine that both oxygenates and pumps blood to the rest of the body in a process called cardiopulmonary bypass. When placed into a parallel blood circuit in the heart-lung machine, CytoSorb® works to remove a broad range of inflammatory mediators, such as cytokines, that are generated during surgery and that could lead to post-operative inflammation and dangerous complications such as circulatory, lung and kidney failure. This major new innovation in cardiac surgery holds the promise to improve patient safety while decreasing serious complications and their high associated costs, particularly in those undergoing complex cardiothoracic procedures.
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents, commented, "While we are unable to disclose the specific details about the partner at this time, we are pleased to begin working with this top-four world leader in cardiac surgery. Cardiac surgery is a large and strategically important market opportunity for CytoSorbents. This partnership enables us to work with an organization that has a long history of bringing cutting-edge technology and innovation, like CytoSorb®, to the market."
Dr. Robert Bartlett, Chief Medical Officer of CytoSorbents and cardiothoracic surgeon stated, "Cardiac surgery can generate a plethora of inflammatory mediators such as cytokines, activated complement, and plasma free hemoglobin. There has not been an easy and convenient way to reduce these substances. CytoSorb® is ideally suited for intra-operative use during cardiac surgery and we believe it has the potential to significantly improve the way cardiopulmonary bypass is performed throughout the world. CytoSorb® installs easily into a heart-lung machine bypass circuit within a few minutes, works seamlessly and silently with the machine and the operating room workflow, and unlike other technologies, does not require management of another blood pump or machine. These are all important aspects to both the cardiac surgeon and the cardiac perfusionist."
Mr. Chris Cramer, Vice President of Business Development, CytoSorbents stated "In the initial phase of this partnership, CytoSorbents will work closely with an outstanding organization that has influenced the modern design of nearly all of the equipment used during cardiac surgery. The focus will be to collaborate with the company and with some of the top cardiac surgery professionals in France to build the foundation for an expanded partnership and future growth in the country and abroad."
About CytoSorbents Corporation
CytoSorbents Corporation is an immunotherapy company using blood purification to modulate 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 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 U.S. 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/
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 letter 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 31, 2014, 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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