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biotech48

12/11/17 12:10 PM

#10480 RE: Paulness #10474

From today's PR regarding the upcoming REMOVE trial " Interestingly, the REMOVE study will parallel our REFRESH 2 pivotal, registration trial in the U.S., designed to support FDA regulatory approval. The REFRESH 2 trial will also focus on the intraoperative use of CytoSorb during valve replacement surgery - but specifically excludes infective endocarditis - to reduce the incidence or severity of post-operative organ dysfunction. If successful, the two trials could rapidly lead to the use of CytoSorb as standard of care in most, if not all, open heart valve replacement surgeries, which accounts for hundreds of thousands of procedures worldwide." Some quick math shows that for each 100,000 procedures in which Cytosorb would be used would bring in $100 million in sales.