CytoSorbents Corporation, a critical care immunotherapy leader using its CytoSorb® blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, announced receipt of regulatory approval to begin production of CytoSorb in its new manufacturing facility in Monmouth Junction, under the company’s ISO 13485:2003 certificate.
Vincent Capponi, chief operating officer of CytoSorbents stated, “The official opening of our new facility marks a major accomplishment by our engineering and production teams that will quadruple our manufacturing capacity and help supply our rapidly growing sales of CytoSorb. The new plant has undergone extensive internal and external validation with initial test production runs and has now been added to our current ISO 13485 certification. We expect a smooth transition as we phase out our current manufacturing and begin to ramp volume production in the new facility this month.”
Capponi added, “With scaled and volume production, we expect to garner significant improvements in product gross margins that can help us achieve sustained operating profitability this year. We anticipate that 100% of CytoSorb production will originate in the new facility by the end of the third quarter of 2018. Meanwhile, we plan to utilize the current manufacturing facility, leveraging existing assets and infrastructure, to produce HemoDefend clinical devices for the planned HemoDefend U.S. pivotal trial to start in late 2018-early 2019.”
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