CytoSorbents is now aggressively expanding CytoSorb availability, marketing, and sales opportunities across the U.S. to help address the current and expected future waves of COVID-19 infection in the country.
CytoSorbents reports the HemoDefend-BGA filter is designed to enable "universal plasma", or plasma that can be administered to anyone regardless of blood type, and to improve the safety of whole blood transfusions, by the rapid and efficient removal of anti-A and anti-B antibodies from these two blood products.
This follows the successful completion of Phase I and II STTR contracts of approximately $1.15 million with researchers at Penn State University, previously funded by the U.S. Army Medical Research Acquisition Activity (USAMRAA) and the U.S. Army Medical Research and Material Command (USAMRMC).
U.S. FDA Grants Breakthrough Designation to CytoSorb for Removal of Ticagrelor During Cardiopulmonary Bypass in Emergent and Urgent Cardiothoracic Surgery
Through Breakthrough Designation, FDA will work with CytoSorbents to expedite the development, assessment, and regulatory review of CytoSorb for the removal of ticagrelor, while maintaining statutory standards of regulatory approval (e.g., 510(k), de novo 510(k) or premarket approval (PMA)) consistent with the Agency's mission to protect and promote public health.
Under the EUA, CytoSorbents Corporation can make CytoSorb available, through commercial sales, to all hospitals in the United States for use in patients, 18 years of age or older, with confirmed COVID-19 infection who are admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure who have early acute lung injury or acute respiratory distress syndrome (ARDS), severe disease, or life-threatening illness resulting in respiratory failure, septic shock, and/or multiple organ dysfunction or failure, as described in FDA's authorization.
In this publication, Huang, et al. describe the characteristics and clinical course of hospitalized patients infected with the Wuhan coronavirus who did, or did not, require treatment in the intensive care unit.
CytoSorb® Removal of Ticagrelor Intraoperatively Results in Projected Cost Savings of Approximately $5,000 in Each Patient Undergoing Emergency Cardiac Surgery
Dr. Eric Mortensen, MD, Ph.D., Chief Medical Officer of CytoSorbents, will present data from a new study on the cost-effectiveness of CytoSorb when used intraoperatively to remove ticagrelor in patients undergoing emergency open-heart surgery. The presentation will occur at the 33rd Annual Meeting of the European Association for Cardio-Thoracic Surgery (EACTS) in Lisbon, Portugal on Saturday, October 5, 2019.