MONMOUTH JUNCTION, N.J. and NORTH POINT, Hong Kong, Feb. 19, 2020 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader with more than 80,000 global treatments of its CytoSorb® blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients, and China Medical System Holdings Limited (CMS) (HKG:0867), a well-established, innovation-driven specialty pharma with a focus on sales and marketing in China and Asia, entered into an agreement to bring CytoSorb to mainland China to treat critically-ill patients with COVID-19 (fka Wuhan or 2019-nCoV) coronavirus infection.
Under the terms of the agreement, CytoSorbents and CMS will partner together to earn regulatory clearance to import CytoSorb into China under the “fast-track” review process established by the National Medical Products Administration of the People’s Republic of China (NMPA) to respond to the 2019 novel coronavirus (COVID-19) pandemic. CytoSorbents will donate initial CytoSorb devices and provide product, training, and support to CMS to introduce CytoSorb initially into four hospitals in the Wuhan, China area. The therapy will be evaluated in severe COVID-19 coronavirus patients with a systemic inflammatory response who are being treated with either continuous renal replacement therapy (CRRT) or extracorporeal membrane oxygenation (ECMO). During the initial term of the agreement, CytoSorbents and CMS will explore the possibility for future commercial collaboration in China. The financial terms of the agreement have not been disclosed.
Mr. Chris Cramer, Vice President of Business Development of CytoSorbents, commented, “We are excited to collaborate with CMS to bring CytoSorb to the patients and physicians in China that are dealing with this devastating COVID-19 coronavirus pandemic. To date, this infection has killed approximately 2-3 out of every 100 patients it infects, mainly by causing severe lung injury and acute respiratory distress syndrome (ARDS), shock, and multi-organ failure. Though CytoSorb has not yet been used to specifically treat patients infected with the COVID-19 coronavirus, it has been used to help treat shock, ARDS, multi-organ failure, and other complications of cytokine storm and excessive, deadly inflammation in thousands of patients with both bacterial and viral infection and sepsis across the world.”
Dr. Huaizheng Peng, General Manager of Global Investment and Operations of CMS stated, “CMS looks forward to working with CytoSorbents to bring their innovative CytoSorb blood purification therapy to the forefront of the response to the COVID-19 pandemic. We do so with a sense of social responsibility to help those stricken at the epicenter of the outbreak, just one of the many areas in China that we serve. We believe that CytoSorb may provide physicians a powerful new approach to help patients who are suffering from severe coronavirus infection.”
The clinical features of the COVID-19 coronavirus, relationship to cytokine storm, and potential role of CytoSorb in treating patients suffering from severe coronavirus infection were described in the press release entitled, “CytoSorb, the Wuhan Coronavirus, and Cytokine Storm.” Furthermore, the use of extracorporeal therapies, such as CytoSorb, were highlighted in a recent publication in Lancet Respiratory Medicine by Drs. Claudio Ronco, Paolo Navalesi, and Jean Louis Vincent entitled, “Coronavirus epidemic: preparing for extracorporeal organ support in intensive care.” Notably the authors state, “A sepsis-like syndrome might occur frequently due to the virus itself or to a superimposed bacterial infection and in this case, since pharmacological approaches have shown poor results, new extracorporeal organ support therapies including haemoadsorption and haemoperfusion, with new sorbent cartridges designed to remove cytokines and other circulating mediators, should be considered.” These publications provide the rationale to potentially use CytoSorb, the first specifically-approved extracorporeal cytokine adsorber in the European Union, in this setting. CytoSorb is distributed in 58 countries worldwide, and is available in Hong Kong, Vietnam, Malaysia, Germany, United Kingdom, Italy France, Spain, Belgium, United Arab Emirates, India, Russia, Finland, Sri Lanka, and Australia where patients infected with the virus have been reported.
The use of CytoSorb® for the treatment of patients with severe COVID-19 coronavirus infection is considered exploratory in nature, and is currently not yet approved for commercial purposes in mainland China.
About China Medical System Holdings Limited (HKG:0867)
China Medical System Holdings Limited (“CMS”, together with its subsidiaries, the “Group”) is a well-established, innovation-driven specialty pharma with a focus on sales & marketing in China. The Group was established in 1995, and was listed on Main Board Market of the Stock Exchange of Hong Kong Limited (stock code: 867) on 28 September 2010. CMS is the object of transaction in both Shanghai-Hong Kong Stock Connect and Shenzhen-Hong Kong Stock Connect. The Group is also the largest shareholder of Chengdu Rhodiola Biological Pharmaceutical Co., Ltd., a listed company (A-share) on the Shanghai Stock Exchange.
The Group is committed to offering competitive products and services to meet China’s unmet medical needs. Over the past ten years (from 2009 to 2018), relying on a high-quality diversified product portfolio, a comprehensive and professional academic orientated promotion network, a highly efficient operation and management system and an international development perspective, the Group has achieved sustainable and rapid growth with a turnover (excluding the effect of the “two-invoices system”) compound annual growth rate (“CAGR”) of 28.1% as well as a net profit CAGR of 32.9%. In 2018, the Group’s turnover was approximately RMB 5.433 billion ($780 million USD), net profit was approximately RMB 1.845 billion ($260 million USD); total assets were approximately RMB 10.5 billion ($1.5 billion USD) and net assets were approximately RMB 8.4 billion ($1.2 billion USD). The number of employees in the Group is nearly 3,600. For more information, please see http://en.cms.net.cn
About the 2019 Novel Coronavirus (COVID-19) Outbreak
Globally, there have been more than 75,000 confirmed cases of COVID-19 infection, with approximately 2,000 deaths, of which China alone has taken the major burden of the disease. On January 30, 2020, the World Health Organization (WHO) declared the novel coronavirus outbreak a “public-health emergency of international concern”, only the fifth time it has done so, indicating this event could pose a risk to multiple countries and would require a coordinated international response. The contagiousness and growing mortality with COVID-19, coupled with the lack of specific treatments or vaccines, has created a serious health concern in China and around the world. The number of people killed by COVID-19 has already exceeded the mortality of the 2002-2003 SARS (Severe Acute Respiratory Syndrome) coronavirus outbreak in China that infected 8,098 people and killed 774 (or 1 in 10 died), and the 2012 MERS (Middle East Respiratory Syndrome) coronavirus contagion with 2,494 confirmed cases and 858 deaths to date (approximately 1 in 3 died)
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 58 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® has been used in more than 80,000 human treatments to date.
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 approximately $29 million from DARPA, the U.S. Army, the U.S. Department of Health and Human Services, the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), U.S. Special Operations Command (SOCOM), 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 CytoSorb-XL™, HemoDefend™, VetResQ™, K+ontrol™, ContrastSorb, DrugSorb, and others.
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 7, 2019, 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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