PRINCETON, N.J., Aug. 31, 2023 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a critical care therapy 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 an expanded medical device registration by the Brazilian Health Regulatory Agency (ANVISA) to treat shock.
After receiving its first ANVISA registration in September 2020 to treat cytokine storm in cardiac surgery and critical illnesses such as COVID-19 in the midst of the COVID pandemic, CytoSorb has now received an expanded ANVISA registration to also include the treatment of shock – a common and frequently fatal complication of critical illness and cardiac surgery. Shock is a persistent and rapid drop in blood pressure that deprives vital organs of adequate blood flow and oxygen that can lead to organ failure and death. To give an example of the burden of shock in critical care: Septic shock - the most serious form of sepsis, afflicts approximately one in ten patients in the ICU, where despite historical standard of care treatment which includes antibiotics, fluids, and vasopressors, approximately 40-50% will die. CytoSorb therapy helps to reverse shock, restore natural blood pressure, and stabilize the patient, representing a potentially revolutionary therapeutic advance in the treatment of this deadly condition.
CytoSorb is now commercialized in Brazil through Fresenius Medical Care (FMC) in the Critical Care segment, and by Contatti Medical in the field of Cardiac Surgery. Brazil is the 7th most populous country in the world and Latin America’s largest medical device market.
Mr. Alexandre Franco, Marketing Director of FMC Brazil, stated, “Fresenius Brazil is very proud of the registration approval of CytoSorb by ANVISA, which will help anchor our Critical Care portfolio. The use of CytoSorb, combined with other innovations we have implemented in recent years, will provide us with increasingly complete solutions in the care of severely ill patients.”
Mr. Mateus Biazus, Head of Marketing and Sales of Contatti Medical added, “There are around 60,000 cardiac surgeries per year in Brazil where surgeons may have to deal with the consequences of an overshooting inflammatory response, especially in complex and emergency procedures. Thanks to the ANVISA approval of CytoSorb, Contatti is able to offer a solution to this problem, contributing to the improvement of patient outcomes.”
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents stated, “CytoSorb is used across the world in different clinical fields and can be integrated into various extracorporeal platforms to treat life-threatening conditions. We are pleased to commercialize CytoSorb in Brazil under this expanded registration through our partners FMC and Contatti Medical, both well-established and connected experts in their respective clinical fields. Importantly, we plan to build upon the momentum of CytoSorb usage during the pandemic in Brazil, and a long track record of reversing shock in patients worldwide, to make CytoSorb broadly available to help save patient lives throughout the country.”
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its flagship product, CytoSorb®, is approved in the European Union, distributed in 75 countries worldwide, and has accumulated more than 212,000 human treatments to date, to reduce “cytokine storm” and other toxins that can cause organ failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, has received two U.S. FDA Breakthrough Device Designations to remove two separate blood thinners during cardiothoracic surgery, including ticagrelor and the direct oral anticoagulants (DOAC) apixaban and rivaroxaban, and is undergoing pivotal clinical studies. For more information, please visit the Company’s websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter.
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