MONMOUTH JUNCTION, N.J., Aug. 10, 2015 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy company commercializing its CytoSorb® extracorporeal cytokine adsorber to treat critically-ill and cardiac surgery patients in multiple countries worldwide, today announced that the Saudi Food and Drug Authority (SFDA) has approved CytoSorb® and has issued a Medical Device Marketing Authorization (MDMA) for the product. This MDMA allows CytoSorbents to market CytoSorb® in the Kingdom of Saudi Arabia with its exclusive distribution partner, Techno Orbits.
Saudi Arabia is the largest medical device market of the six member states in the Gulf Cooperation Council (GCC), and with the United Arab Emirates (UAE), accounts for 47% of the total GCC medical device market. SFDA approval facilitates the regulatory approval process in the other GCC countries, including Qatar, Kuwait, Oman, and Bahrain, as they share similar medical device regulatory requirements. It can also be leveraged in the countries of Yemen, Iraq, and Jordan, which are also covered by Techno Orbits.
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents stated, “We are pleased to have achieved this significant milestone in the Middle East. We have worked closely with Techno Orbits to reach a number of the key opinion leaders and hospitals in Saudi Arabia and the GCC. SFDA approval of CytoSorb® opens many doors to the region, allowing us to begin generating revenue, and facilitating our mission of driving adoption and saving lives.”
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 with distribution in 31 countries around the world, 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 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: https://cytosorbents.com and at www.cytosorb.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 press release 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, 2015, 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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