Healthcare Industry News:  coronavirus 

Devices Regulatory

 News Release - March 31, 2020

CytoSorb(R) Receives Marketing Approval in Mexico with Commercialization to Commence with Partner Fresenius Medical Care

CytoSorb® can now be used in Mexico to treat patients with a wide range of conditions including complications from severe COVID-19 infection

MONMOUTH JUNCTION, N.J., March 31, 2020 -- (Healthcare Sales & Marketing Network) -- CytoSorbents Corporation (NASDAQ: CTSO) a critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat cytokine storm and deadly inflammation in critically-ill and cardiac surgery patients around the world, announced that its CytoSorb cytokine adsorber has been approved to be marketed and sold in Mexico by the country's health authority, COFEPRIS. COFEPRIS, or the Federal Committee for Protection from Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios) is responsible for regulating the importation of medical devices into the country.

As previously announced, Fresenius Medical Care (FMC) maintains the exclusive rights to distribute CytoSorb for acute care and other hospital applications in Mexico. These include indications where cytokines (e.g. sepsis, endocarditis, acute respiratory distress syndrome), bilirubin (e.g. liver disease), or myoglobin (e.g. trauma) are elevated. With this approval, commercial promotional activities and sales of CytoSorb may now officially commence in Mexico.

Mr. Ignacio Castañón, President of Fresenius Medical Care Mexico commented, "Each year in Mexico, hyperinflammatory conditions such as septic shock, severe lung injury, trauma, and acute flares of chronic liver disease lead to a staggering human and economic toll due to a lack of effective therapies. We are very excited to now bring CytoSorb to doctors and patients throughout Mexico that are dealing with these conditions on a daily basis, particularly now as the number of hospital admissions due to COVID-19 pneumonia are expected to rise dramatically. The FMC Mexico team has been preparing the market and we are ready to go. We hope to have a positive impact on patient care in Mexico with CytoSorb."

Mr. Vincent Capponi, Chief Operating Officer of CytoSorbents, stated, "We are pleased to have successfully achieved the registration of CytoSorb in Mexico and plan to fulfill initial orders from FMC this quarter. Given the COVID-19 pandemic, the approval is timely, providing physicians in Mexico access to an additional tool to fight cytokine storm and inflammation, common themes in those infected with COVID-19. We are excited to expand our existing relationship with Fresenius to now include Mexico. Through the acquisition of NxStage and Xenios, Fresenius has increased its intensive care unit footprint in North America to serve those critically-ill patients that require continuous renal replacement therapy (CRRT) and extracorporeal membrane oxygenation (ECMO). Both modalities are commonly used with CytoSorb. We look forward to supporting FMC in a successful market launch of CytoSorb in Mexico."

Mr. Chris Cramer, Vice President of Business Development at CytoSorbents stated, "This approval takes on an even greater importance now, as the number of serious COVID-19 infections in Mexico continues to rise. We are pleased that FMC Mexico can now promote and make CytoSorb available to physicians throughout the country for a wide variety of acute care and other hospital-based conditions. Having worked closely together in Europe for the past several years, we plan to leverage that extensive experience to help FMC's outstanding sales organization in Mexico to rapidly bring CytoSorb to the market."

Mexico is home to over 129 million people and is the second-largest medical device market in Latin America after Brazil and the 18th largest economic market in the world. Throughout the country, there is an increasing burden of illness and rising healthcare costs associated with deadly inflammatory conditions such as sepsis. Additionally, there is a growing demand for CRRT treatments for acute kidney injury (AKI) and cytokine removal in intensive care unit patients. In particular, there is a significant unmet need in patients suffering from infection and septic shock, systemic inflammation, Acute Respiratory Distress Syndrome (ARDS), liver failure, burn injury, and trauma. Healthcare in Mexico varies from the most basic primary health care, offered free by the state, to highly specialized, high-tech health services available in both the public and private sectors. According to OECD (Organization for Economic Co-operation and Development) Health Statistics, healthcare expenditure in 2018 as a percentage of GDP was 5.5% for Mexico.

Mexico has reported approximately 1,100 COVID-19 infections, with 28 deaths to date. These numbers are expected to increase exponentially in the coming weeks as the coronavirus pandemic spreads across North America. As a precautionary measure due to the anticipated rise of cases, Mexico's Deputy Health Minister, Hugo Lopez-Gatell, has urged all residents to stay at home for a month to slow down the spread of the coronavirus.

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 nearly $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), the U.S. Army, U.S. Special Operations Command (USSOCOM), the U.S. Air Force, 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 CytoSorb-XL™, HemoDefend™, VetResQ™, K+ontrol™, ContrastSorb, DrugSorb, and others. For more information, please visit the Company's websites at and 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 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 5, 2020, 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, 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.

Source: CytoSorbents

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