The FDA designates Fresenius
Medical Care North America’s new hemodialysis system, Endexo, designed
to prevent blood clotting without the use of blood thinners, a
Breakthrough Device.
Endexo inhibits the adsorption (formation of thin
film) of protein and platelets by virtue of its polymer design made of
surface-modifying molecules.
Fresenius in-licensed global rights to Endexo from Interface Biologics in July 2010.
Breakthrough Device designation, akin to
Breakthrough Therapy status for drugs, allows for more intensive
guidance from the FDA on development, the involvement of more senior
agency personnel and priority review of the marketing application.
The company is a unit of Fresenius Medical Care AG & Co. KGaA (FMS +0.1%).
https://seekingalpha.com/news/3509151-fresenius-medical-care-hemodialysis-system-nabs-accelerated-review-status-u-s
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