CytoSorbents Achieves ISO 13485 Certification of Princeton Manufacturing Facility in New Jersey

CytoSorb®, DrugSorb®-ATR, and ECOS-300CY® now cleared for manufacturing from this site

PRINCETON, N.J., Sept. 27, 2022 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced today that it has received ISO 13485 Certification of its new manufacturing facility in Princeton, New Jersey from its European Union (E.U.) notified body, clearing the way for full manufacturing of CytoSorb®, DrugSorb®-ATR, and ECOS-300CY® from this site, with capacity to add additional product lines as they are developed.

Mr. Vincent Capponi, President and Chief Operating Officer of CytoSorbents stated, "We are very excited to receive this certification, which represents another key milestone in our company development and commercialization story. Our manufacturing, engineering, quality, and regulatory teams deserve the credit for this significant accomplishment. This state-of-the-art facility expands our manufacturing capacity to support up to $350-400 million in sales of our commercialized products, and will be a key component in the regulatory application and expected commercial launch of DrugSorb-ATR in the United States."

CytoSorb is an advanced blood purification cartridge approved in the E.U. and distributed in 75 countries worldwide to remove cytokines (inflammation), bilirubin (liver failure), and myoglobin (trauma), from blood. CytoSorb is also E.U. approved to remove the antithrombotic "blood thinning" drugs, Brilinta® (ticagrelor, Astra Zeneca) and Xarelto® (rivaroxaban, Janssen, Bayer) during cardiothoracic surgery to reduce the risk of perioperative bleeding.