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CytoSorbents Provides Regulatory Update for DrugSorb-ATR
CytoSorbents Corporation (NASDAQ: CTSO), a leader in blood purification therapies for life-threatening conditions in the intensive care unit and cardiac surgery, today provided a regulatory update for DrugSorb™-ATR, its FDA-designated Breakthrough Device. DrugSorb-ATR is designed to reduce the severity of bleeding in patients undergoing coronary artery bypass grafting (CABG) surgery within 2 days of stopping the antiplatelet drug Brilinta® (ticagrelor, AstraZeneca), a commonly used blood thinner
About this update from Cytosorbents Corporation
[{"type":"text","content":"PRINCETON, N.J., May 1, 2025 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in blood purification therapies for life-threatening conditions in the intensive care unit and cardiac surgery, today provided a regulatory update for DrugSorb™-ATR, its FDA-designated Breakthrough Device. DrugSorb-ATR is designed to reduce the severity of bleeding in patients undergoing coronary artery bypass grafting (CABG) surgery within 2 days of stopping the antiplatelet drug Brilinta® (ticagrelor, AstraZeneca), a commonly used blood thinner.","length":562,"tagName":"p"},{"type":"image","alt":"CytoSorbents Corporation (NASDAQ: CTSO) is a leader in the treatment of life-threatening conditions using blood purification. CytoSorbents’ flagship product, CytoSorb®, is approved in the European Union and distributed in over 70 countries worldwide. CytoSorbents is conducting trials to support FDA marketing approval of DrugSorb™-ATR for antithrombotic drug removal during cardiothoracic surgery. (PRNewsfoto/CytoSorbents Corporation)","displaySize":"","headline":null,"caption":"CytoSorbents Corporation (NASDAQ: CTSO) is a leader in the treatment of life-threatening conditions using blood purification. CytoSorbents’ flagship product, CytoSorb®, is approved in the European Union and distributed in over 70 countries worldwide. CytoSorbents is conducting trials to support FDA marketing approval of DrugSorb™-ATR for antithrombotic drug removal during cardiothoracic surgery. (PRNewsfoto/CytoSorbents Corporation)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":75,"url":"https://media.zenfs.com/en/prnewswire.com/e816e81e0545c7d8b46b753e505911fd"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/9fT61Wf2yKPK1NZj2V3AsQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTEzMjtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/e816e81e0545c7d8b46b753e505911fd","width":400,"height":75}},"href":"https://mma.prnewswire.com/media/1096384/CytoSorbents_Working_To_Save_Lives_Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"On April 25, 2025, the U.S. Food and Drug Administration (FDA) issued a denial letter regarding the Company's De Novo Request for DrugSorb-ATR, identifying remaining deficiencies that must be addressed before the De Novo Request can be granted, and t...