CytoSorbents Corporation (CTSO)

[andy55q]

Sweden registration
Cytosorb product information was posted yesterday (2/9) on the Medical Products Agency (MPA) web site (lakemedelsverket.se). MPA is the Swedish national authority responsible for regulation and surveillance of the development, manufacturing and marketing of drugs and other medicinal products within the country. Sweden is one of the countries which Fresenius Medical Care will have the exclusive rights to distribute CytoSorb. According to the 8k that outlines the details of the Fresenius agreement, "Fresenius is obligated to register the Products with the appropriate governmental agencies for marketing approval in the Territory". Completion of these product registrations are most likely one of the reasons for the delay in the marketing launch within those respective countries.