Cytosorbents (CTSO) Announces Availability of Preliminary Data Abstracts from Two Endocarditis Studies, including the REMOVE study, to be Presented at the EACTS Conference
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CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification, announced the public availability of preliminary data abstracts from two separate endocarditis studies, including the REMOVE study, to be presented at the upcoming European Association for Cardio-Thoracic Surgery (EACTS) annual meeting taking place in Barcelona, Spain from October 13-16, 2021, where more extensive data are expected to be made available. A summary of the abstracts are as follows:
The REMOVE ("Revealing Mechanisms and Investigating Efficiency Of Hemoadsorption for Prevention of Vasodilatory Shock in Cardiac Surgery Patients with Infective Endocarditis") investigator initiated randomized, controlled trial enrolled 288 patients with documented infective endocarditis with a EuroSCORE II (European System for Cardiac Operative Risk Evaluation II) > 3, and who required open heart valve replacement surgery, and compared the intraoperative use of CytoSorb and standard of care with standard of care alone. The investigators concluded that although intraoperative hemoadsorption reduced plasma cytokines at the end of cardiopulmonary bypass, it did not reduce the severity of post-operative organ dysfunction as observed by the change in mean SOFA (Sequential Organ Failure Assessment) score over nine days. In addition, the investigators noted no statistical difference in secondary endpoints, including 30-day mortality and durations of post-operative hemodialysis, ventilation and vasopressor therapy.
In a retrospective study entitled "Intraoperative Hemoadsorption Reduces Sepsis-related Death in All-comers Undergoing Surgery for Infective Left-sided Endocarditis," investigators from Nuremberg, Germany report results from 195 consecutive patients with left-sided endocarditis (i.e. aortic and/or mitral valve involvement) who underwent valve replacement surgery at their institution with or without intraoperative treatment with CytoSorb. A significant proportion of patients had endocarditis of a prosthetic valve (41% CytoSorb treated, 28% control). The study analyses focused on the comparison of the control cohort (n=101) who were treated prior to CytoSorb introduction at the hospital and the CytoSorb cohort (n=94) who received intraoperative CytoSorb therapy during the operation. The two groups had generally comparable baseline characteristics with a median age of 69 years, however CytoSorb treated patients had numerically higher baseline EuroSCORE II and were more frequently treated for prosthetic valve endocarditis. The use of CytoSorb was associated with significantly lower post-operative sepsis-related mortality (7.5% vs. 20% control, p=0.021) and lower levels of C-Reactive Protein (8.8 vs. 9.8 mg/dl; p=0.019) and white blood cell counts (9.8 vs. 11.7 x10-6/mcL; p=0.033) on post-operative day 1. The investigators stated that CytoSorb therapy was well-tolerated and safe and contributed to reduced sepsis-related mortality, CRP and leucocyte levels after surgery and concluded that "these data suggest that intraoperative hemoadsorption improves surgical outcomes in all-comers for left-sided infective endocarditis."
Dr. Efthymios Deliargyris, Chief Medical Officer of CytoSorbents stated, "At the current time, the available data from both studies are preliminary and limited and do not allow for in-depth evaluation. We plan to have a detailed statement once the full formal presentations are completed next week, and more complete data are made available. From a high level, CytoSorb therapy tends to work best in carefully selected patients with a high acuity of illness who are treated with the device early and for an adequate duration of time. In the case of these two endocarditis studies, important underlying differences may exist in the respective patient cohorts that could explain the reported differences in the observed benefits with the intraoperative use of CytoSorb during valve replacement surgery. In addition, in both studies, CytoSorb was only used intra-operatively, where today in many centers, CytoSorb therapy in infective endocarditis patients has advanced to be used both intraoperatively and postoperatively during recovery with reported improved benefits. Importantly, the investigators from Nuremberg reported that the intraoperative use of CytoSorb during cardiac surgery was well-tolerated and safe. We view this as a positive development that provides added reassurances for our ongoing clinical programs on intraoperative device use and are looking forward to reviewing the safety data from the REMOVE trial that we anticipate will be released during the formal presentation. We plan to work closely with the investigators of both studies to better understand the results and determine the direction for further analyses that could help identify the optimal endocarditis patient population for CytoSorb use and potentially inform the design of future endocarditis studies."
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents, stated, "Today, infective endocarditis makes up a minor part of our overall usage and revenue in cardiac surgery and we believe that CytoSorb will continue to be used in selected infective endocarditis populations. For example, prosthetic heart valve endocarditis is associated with very high mortality and is increasingly common due to the aging population with structural valvular disease and increased use of transcatheter aortic valve replacement (TAVR) and traditional open heart valve replacements. Overall, infective endocarditis is just one of many applications of our technology in cardiac surgery and is a much smaller opportunity than the removal of antithrombotic drugs during cardiothoracic surgery, for which we have specific approvals in the E.U., two U.S. FDA Breakthrough Device Designations, and is the core focus of our U.S. regulatory approval strategy."
Infective endocarditis is a potentially life-threatening infection of one or more heart valves that is usually caused when bacteria enter the bloodstream due to a systemic infection, dental care, or intravenous drug abuse and the use of dirty needles. Treatment typically involves antibiotics, but for many patients, cardiac surgery and valve replacement is the only treatment option. If left untreated, endocarditis can damage a patient's heart valves and may be fatal.
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