ExThera Medical Corporation (ExThera) announced today that it has received CE Mark approval for its Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) for the reduction of pathogens during bloodstream infections (BSI). This CE Mark signifies that Seraph 100 meets the safety and performance requirements for medical devices in the European Economic Area (EEA) as an adjunct to anti-infective therapy, and it gives ExThera access to a market of 500 million people. In October 2019 ExThera plans to begin shipping Seraph 100 for clinical use in selected member states of the European Union, providing a completely new treatment option for a large, at-risk patient population. Distributors for Italy, Germany and other EU countries will be announced early in September.
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