CytoSorb Achieves Registration in Brazil and Is Now Commercially Available To Treat Cytokine Storm in COVID-19 Infection and Other Conditions

Rhea-AI Summary

CytoSorbents Corporation (NASDAQ: CTSO) has announced that its blood purification technology, CytoSorb, has received medical device registration from Brazil's Health Regulatory Agency (ANVISA). This allows CytoSorb to be commercially available in Brazil for treating cytokine storm in critical illnesses and cardiac surgery, particularly amid the COVID-19 crisis. CytoSorb will be distributed by Contatti Medical, a local company with extensive experience in healthcare solutions. The partnership is expected to address the high incidence of heart disease and sepsis prevalent in Brazil.

Positive

• CytoSorb received medical device registration in Brazil, enhancing its market reach.
• Distribution in Brazil is facilitated by Contatti Medical, which has over 36 years of experience in the healthcare market.
• The launch coincides with urgent healthcare needs due to COVID-19, targeting cytokine storm treatment.

Negative

• None.

MONMOUTH JUNCTION, N.J., Sept. 21, 2020 /PRNewswire/ -- 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 CytoSorb was granted medical device registration by the Brazilian Health Regulatory Agency (ANVISA).  CytoSorb is now commercially available in Brazil to treat cytokine storm in cardiac surgery and critical illnesses such as COVID-19 infection and will be distributed by Contatti Medical.

Mr. Alessandro Pallamolla, Chief Executive Officer of Contatti Medical stated, "Contatti is a well-established company located in southern Brazil, with over 36 years of experience providing excellent solutions to the healthcare market.  We could not be happier to partner with CytoSorbents and leverage our strengths in cardiac surgery, organ transplantation, and blood bank management, to help make CytoSorb a success.  CytoSorb is an innovative therapy for critical care and cardiac surgery, with huge potential in Brazil, given the high incidence of heart disease and sepsis in the country.  In addition, the immediate availability of CytoSorb comes at a very delicate moment during the COVID-19 crisis in Brazil.   We welcome this opportunity to work with CytoSorbents and to explore together all of the possibilities in our country."

Dr. Phillip Chan, Chief Executive Officer of CytoSorbents stated, "We are pleased to announce the official registration of CytoSorb in Brazil and the launch of our partnership with Contatti Medical to distribute CytoSorb throughout the country.  We are very excited to collaborate with Contatti, whose business focus parallels ours, with an extensive network within hospitals and among physicians in Brazil.  Our immediate focus will be to help treat patients with life-threatening complications of COVID-19 infection, with 30,000-40,000 new coronavirus cases a day, and a total of 4.5 million total cases in the country to date, third only to the U.S. and India."

Brazil is the 6^th most populous country in the world with a population of 212 million people divided into 5 regions and 27 states.  Brazil has the 9^th largest global economy with a Gross Domestic Product (GDP) of $1.87 trillion (nominal).   Brazil has one of the largest public healthcare systems in the world, with universal healthcare provided to most of its citizens by the Unified Health System (SUS).  There are more than 6,100 public and private hospitals throughout the country, with over 40,000 ICU beds, and over 350,000 physicians. 

About Contatti Medical

Contatti Medical is a privately-held company located in Porto Alegre, Brazil that has been importing and distributing medical devices and disposables to the Brazilian healthcare market since 1984.  Contatti Medical provides added value products and services to health businesses that perform medium and high complexity procedures in the areas of cardiac surgery, organ transplantation, and blood bank management.                                                                                           

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 65 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 100,000 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 $37 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, 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 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 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, including statements about COVID-19, our expected revenues as a result thereof, 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. 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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Cytosorbents Contact:
Amy Vogel
Investor Relations
(732) 398-5394
avogel@cytosorbents.com   

Investor Relations Contact:
Jeremy Feffer
LifeSci Advisors
917-749-1494
jeremy@lifesciadvisors.com

U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
ekim@rubensteinpr.com 

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SOURCE CytoSorbents Corporation

FAQ

What is the significance of CytoSorbents Corporation's registration in Brazil?

The registration allows CytoSorb to be commercially available in Brazil, addressing critical health needs related to cytokine storms and COVID-19.

When was CytoSorb granted medical device registration in Brazil?

The registration was announced on September 21, 2020.

Who will distribute CytoSorb in Brazil?

Contatti Medical will handle the distribution of CytoSorb throughout Brazil.

What are the potential benefits of CytoSorb in treating COVID-19?

CytoSorb is designed to treat cytokine storms, which can lead to severe inflammation and complications in critically ill patients, especially those suffering from COVID-19.

What is the market focus following CytoSorb's launch in Brazil?

The initial focus will be on treating life-threatening complications arising from COVID-19 infection in Brazil.