CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat deadly inflammation in critically ill and cardiac surgery patients around the world, announces that the Korean Ministry of Food and Drug Safety (KMFDS) has approved CytoSorb for all equivalent European Union (E.U.) approved indications,
| MONMOUTH JUNCTION, N.J., Jan. 19, 2021 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat deadly inflammation in critically ill and cardiac surgery patients around the world, announces that the Korean Ministry of Food and Drug Safety (KMFDS) has approved CytoSorb for all equivalent European Union (E.U.) approved indications, including the reduction of cytokine storm, the reduction of bilirubin in liver disease, the reduction of myoglobin in trauma, and the removal of ticagrelor and rivaroxaban during urgent or emergent cardiothoracic surgery.
CytoSorbents (NASDAQ:CTSO) Announces Korean Approval of CytoSorb, a Treatment of Deadly Cytokine Storm and Inflammation Ms. Clare Kim, Managing Director of Fresenius Medical Care Korea commented, “In Korea, the sepsis mortality rate and incidence have increased steadily and remains a major problem in critical care. Under these circumstances, we are pleased to introduce the cytokine adsorber, CytoSorb, to healthcare professionals and patients in Korea. Fresenius Medical Care Korea remains committed to having a positive impact on the care of severely ill patients with CytoSorb.” Mr. Vincent Capponi, President and Chief Operating Officer of CytoSorbents, stated, “We are pleased to have successfully achieved approval of CytoSorb in Korea, in cooperation with our partner Fresenius Medical Care. This was the culmination of a nearly 2-year process that included an on-site audit by the KMFDS and the preparation of a full technical dossier specific to Korea’s regulatory requirements. With a world-class medical system serving a population of nearly 52 million people, the Republic of Korea is ranked as one of the leading healthcare systems in the world by the Legatum Institute. Physicians in Korea will now have the opportunity to treat patients with CytoSorb as a leading therapy to fight cytokine storm in many life-threatening conditions such as sepsis, COVID-19, and many others.” Mr. Capponi continued, “We are excited to expand the global footprint of CytoSorb, now in a total of 67 countries worldwide. In addition to exclusive distribution countries of France, the Czech Republic, and Finland, we have worked with Fresenius Medical Care this year to expand to multiple additional countries, including Colombia, Ecuador, Brazil in critical care, Mexico – with approval in March 2020, and now Korea. We believe that all of these countries have significant potential to help drive our future sales growth, and are glad to begin working with Fresenius to launch CytoSorb in this very important Asian market, with our first shipment to the country expected this month.” About CytoSorbents Corporation (NASDAQ: CTSO) CytoSorbents Corporation is a leader in critical care immunotherapy, specializing in blood purification. Its flagship product, CytoSorb® is approved in the European Union with distribution in 67 countries around the world, as an extracorporeal cytokine adsorber designed to reduce the “cytokine storm” or “cytokine release syndrome” that could otherwise cause massive inflammation, organ failure and death in common critical illnesses. 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 that can lead to post-operative complications, including multiple organ failure. CytoSorb® has been used in more than 121,000 human treatments to date. CytoSorb has received CE-Mark label expansions for the removal of bilirubin (liver disease), myoglobin (trauma) and both ticagrelor and rivaroxaban during cardiothoracic surgery. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in critically ill COVID-19 patients with imminent or confirmed respiratory failure, in defined circumstances. CytoSorb has also been granted FDA Breakthrough Designation for the removal of ticagrelor in a cardiopulmonary bypass circuit during emergent and urgent cardiothoracic surgery. 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. Its technologies have received non-dilutive grant, contract, and other funding of more than $38 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and multiple applications pending, including ECOS-300CY™, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ™, K+ontrol™, ContrastSorb, DrugSorb, and others. For more information, please visit the Company’s websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter. Forward-Looking Statements 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, including statements regarding our expectations about our cash runway, the advancement of our trials, our plans to initiate new trials, our goals to develop and commercialize CytoSorb and the timing thereof, the potential impact of COVID-19 on our operations and milestones, 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, risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 5, 2020, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, 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, particularly in light of the current coronavirus pandemic, where businesses can be impacted by rapidly changing state and federal regulations, as well as the health and availability of their workforce. 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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Company Codes: NASDAQ-SMALL:CTSO |
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