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CytoSorbents Receives Renewal of CytoSorb® CE Mark Through May 2024 and Annual ISO 13485:2016 Certification Through September 2022
MONMOUTH JUNCTION, N.J., Aug. 15, 2019 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader using its CytoSorb® blood
About this update from Cytosorbents Corporation
[{"type":"text","content":"MONMOUTH JUNCTION, N.J., Aug. 15, 2019 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader using its CytoSorb® blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, announced that CytoSorb has received renewal of its European Union CE Mark through May 2024 and ISO 13485:2016 Full Quality Assurance System certification of its manufacturing facility through September 2022.\n\n \nMr. Vincent Capponi, Chief Operating Officer of CytoSorbents stated, \"I am happy to announce CytoSorbents successfully completed its CE Mark and ISO13485:2016 re-certification audits. These certificates cover CytoSorb and our new manufacturing facility commissioned in June 2018. The success of this renewal of the CE Mark and recent audit is a reflection of CytoSorbents' ongoing commitment to quality. I am very proud of our quality, manufacturing, and research teams that contributed to these accomplishments.\"\nDr. Phillip Chan, MD, PhD, Chief Executive Officer of CytoSorbents Corporation stated, \"We are pleased to have achieved these important milestones, enabling us to continue manufacturing, marketing and selling CytoSorb throughout all of our existing countries, and in future countries that accept E.U. regulatory approval through the next renewals. CytoSorb continues to grow in adoption and usage throughout the world, and is generating an increasing amount of new positive clinical data, because it is helping physicians stabilize and regain control of their patients in a wide variety of critical illnesses and complications of cardiac surgery. The patients that CytoSorb treats are among the sickest of the sick in the hospital, where no therapy in the past has been able to impact poor overall outcomes. We, our partners, and the growing number of physicians and healthcare workers around the world, have seen how CytoSorb is different, and are proud that CytoSorb has been used in more than 67,000 treatments, up from 46,000 a year ago, as a powerful therapy to help save lives. We are on a mission to make this therapy available to the tens of millions of patients each year who are dying or being disabled from life-threatening illnesses.\"\nDr. Chan continued, \"Having completed our strongest quarter ever in CytoSorb sales with an expansion of our bl...