MONMOUTH JUNCTION, N.J., May 25, 2021 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a critical care leader commercializing its CytoSorb® blood purification technology to treat deadly conditions in the intensive care unit (ICU) and cardiac surgery, announces that the Singapore Health Sciences Authority (HSA) has now approved registration of 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.
Mr. Vincent Capponi, President and Chief Operating Officer of CytoSorbents, stated, "We are pleased to announce the successful registration and immediate commercial availability of CytoSorb in Singapore through our distributor Humedical. Singapore is one of the wealthiest Asian countries on a per capita basis and provides its citizens with universal health coverage that can be supplemented with private insurance. Recent demographics and statistics in Singapore highlight a growing need for blood purification with CytoSorb, particularly given that 23% of all annual deaths are related to sepsis from pneumonia and urinary tract infections, the country ranks 4th in the world per capita for kidney failure and spends more than $190 million annually on dialysis treatment, the high burden of liver disease attributed to chronic viral hepatitis, alcoholism, and fatty liver, and the growing number of people on antithrombotics, such as ticagrelor - launched in Singapore in 2012 and Xarelto - approved by HSA in 2019, to reduce 1 in 3 deaths caused by cardiovascular disease each year."
Dr. Gerwin Gerke, Managing Director of Humedical (S) PTE LTD, stated, "Singapore is a center for medical excellence in Southeast Asia and is often at the forefront of adopting new medical technologies that other surrounding countries eventually follow. Based on the broad and successful usage of CytoSorb in many countries around the world, this therapy holds the promise to help treat many of the life-endangering conditions that afflict the critically ill in Singapore. We are excited to bring this innovative technology to patients and physicians in the country."
Mr. Stefan Baudis, Vice President of Global Affairs at CytoSorbents commented, "We are delighted to continue our great partnership with Humedical as our trusted commercialization partner of CytoSorb in Singapore and Malaysia. This timely registration of CytoSorb in Singapore is expected to catalyze the use of our therapy in this region."
About Humedical (S) PTE LTD
Humedical is a distributor of surgical products from leading manufacturers in the U.S., Europe, and Japan. Among our suppliers are world class companies like Medtronic, Integra Surgical, Mizuho Japan, Misonix, and others that manufacture products for neuro, ortho, and spine surgery and other surgical disciplines as well as general operating theatre supplies. The company was founded in 1990 and has a sister company covering the Malaysian market. Our customers are exclusively hospitals and specialist surgeons.
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 68 countries outside of the US, as an extracorporeal cytokine adsorber designed to reduce the "cytokine storm" or "cytokine release syndrome" that may result in massive inflammation, organ failure and death in common critical illnesses. These are conditions where the risk of death may be 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 131,000 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 $39.5 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™, DrugSorb™, ContrastSorb, 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.
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 9, 2021, 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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