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Israel Approves CytoSorb Registration, CytoSorbents Announces Gad Medical as Distributor
MONMOUTH JUNCTION, N.J., March 25, 2019 /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 Medical Device Division of the State of Israel Ministry of Health medical device regulation unit (AMAR), has granted registration of CytoSorb in Israel, clearing the way to begin selling the device in the country.
Mr. Vincent Capponi, Chief Operating Officer of CytoSorbents stated, "We are pleased to bring CytoSorb to Israel, a country well-known for its excellent medical practices, especially in critical care and cardiac surgery, and the development and adoption of new medical technologies."
CytoSorbents also announced its new Israeli distributor, Gad Medical, who will have exclusive rights to sell CytoSorb for all applications in Israel. Mr. David Frances, CEO of Gad Medical stated, "Now that CytoSorb is registered in Israel, we are excited to work with CytoSorbents on the launch of CytoSorb in the country. Gad Medical specializes in selling cardiovascular medical devices as the exclusive distributor for Terumo Cardiovascular in Israel, and distributes many new and innovative medical devices in other medical fields. Because of this, we believe we are ideally suited to promote and sell CytoSorb in the country."
Israel has a population of approximately 9 million people, and has one of the largest healthcare systems in the Middle East, spending 7.6% of its gross domestic product (GDP) on healthcare each year. Its citizens are served by 44 general hospitals and the most physicians per capita in the world. All citizens are covered by universal healthcare insurance, administered by one of four national healthcare institutes, and often supplement this universal coverage with private insurance. In 2015, the Israeli Ministry of Health estimated that sepsis was the 6th leading cause of death in the country, costing approximately $1.8 billion per year to treat. According to the Israel Heart Society, heart disease is the second leading cause of death in the country. More than 10,000 cardiothoracic surgeries are performed each year at 13 medical centers.
About Gad Medical
Founded in 2013, Gad Medical is an importing and marketing company based out of Israel specializing in the health and medical fields, focusing on innovative and cutting-edge technology devices and equipment to rapidly become market leaders. The company has an annual growth rate exceeding 50% a year, marketing a variety of products in the fields of cardiovascular, Interventional cardiology and radiology, oncology, neurology and neurosurgery, orthopedics, and pain treatment.
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 55 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. CytoSorbents is conducting its pivotal REFRESH 2-AKI trial – a multi-center, randomized controlled, clinical trial intended to support U.S. regulatory approval of CytoSorb for use in a heart-lung machine during complex cardiac surgery to reduce organ injury. CytoSorb® has been used in more than 56,000 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 nearly $26 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. 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 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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SOURCE CytoSorbents Corporation