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Monday, 03/02/2020 7:19:11 AM

Monday, March 02, 2020 7:19:11 AM

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Excellent news today! If this study which was published today is indicative of the REMOVE trial results in Germany, which should be released around mid-year, this could bode well for the company's prospects here in the US for this indication. Positive results from REMOVE would have important implications in the U.S. where infective endocarditis is rampant due to the opiate crisis and use of dirty needles. It's possible that once armed with positive REMOVE data, CTSO could apply for Breakthrough Device Designation (replaced the previous Expedited Access Pathway or EAP designation) for the infective endocarditis indication allowing CTSO to pursue additional supporting clinical data in the US after its approval for use.

https://www.prnewswire.com/news-releases/cytosorbents-highlights-recent-publication-using-cytosorb-during-cardiac-surgery-for-infective-endocarditits-301014190.html

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