CytoSorbents is commercializing its E.U. approved CytoSorb blood purification technology to treat life-threatening conditions in the intensive care unit and cardiac surgery. First half 2024 product sales improved 12% from last year while product gross margins rose to 75%. The company also seeks U.S. and Canadian approval of a second product, DrugSorb-ATR, to reduce perioperative bleeding risk in patients on blood thinners during cardiac surgery. Based on the results of its pivotal U.S. and Canadian STAR-T trial, the company submitted for FDA De Novo approval on September 27, 2024.
01 Oct 2024
CTSO: CytoSorbents submits DrugSorb-ATR Marketing Application to the U.S. FDA. The company also provides Q3 2024 financial update.
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CTSO: CytoSorbents submits DrugSorb-ATR Marketing Application to the U.S. FDA. The company also provides Q3 2024 financial update.
- Published:
01 Oct 2024 -
Author:
Tom Kerr -
Pages:
17 -
CytoSorbents is commercializing its E.U. approved CytoSorb blood purification technology to treat life-threatening conditions in the intensive care unit and cardiac surgery. First half 2024 product sales improved 12% from last year while product gross margins rose to 75%. The company also seeks U.S. and Canadian approval of a second product, DrugSorb-ATR, to reduce perioperative bleeding risk in patients on blood thinners during cardiac surgery. Based on the results of its pivotal U.S. and Canadian STAR-T trial, the company submitted for FDA De Novo approval on September 27, 2024.