Full Press Release Details
CytoSorbents Announces Availability of Preliminary
Data Abstracts from Two Endocarditis Studies, including the REMOVE study, to be Presented at the EACTS Conference
MONMOUTH JUNCTION, N.J.,
October 7, 2021 - 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
About CytoSorbents Corporation (NASDAQ: CTSO)
Corporation is a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood
purification. Its flagship product, CytoSorb ,
is approved in the European Union with distribution in 68 countries around the world as an extracorporeal cytokine adsorber designed
to reduce the "cytokine storm" or "cytokine release syndrome" seen in common critical illnesses that may result
in massive inflammation, organ failure and patient death. These are conditions where the risk of death can be extremely high, yet few
to no effective treatments exist. CytoSorb is also being used during and after cardiothoracic surgery to remove inflammatory mediators
that can lead to post-operative complications, including multiple organ failure. More than 143,000 CytoSorb devices have been delivered
to date. CytoSorb was originally introduced into the European Union under CE-Mark as a first-in-kind cytokine adsorber. Additional
CE-Mark label expansions were received for the removal of bilirubin and myoglobin in clinical conditions such as liver disease and trauma,
respectively, and both ticagrelor and rivaroxaban
during cardiothoracic surgery. CytoSorb has also received FDA
Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with imminent or confirmed
respiratory failure. The DrugSorb-ATR Antithrombotic Removal System, which is based on the same polymer technology as CytoSorb,
has also been granted FDA Breakthrough Designation for the removal
of ticagrelor, as well as FDA Breakthrough Designation for the
removal of the direct oral anticoagulant (DOAC) drugs, rivaroxaban and apixaban, in a cardiopulmonary bypass circuit during urgent cardiothoracic
CytoSorbents' purification technologies
are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids
by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of more than $39.5
million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart,
Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command
(USAF/AFMC), and others. The Company has numerous marketed products and products under development based upon this unique blood purification
technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending,
including ECOS-300CY , CytoSorb-XL , HemoDefend-RBC , HemoDefend-BGA , VetResQ , K+ontrol ,
DrugSorb , DrugSorb-ATR , ContrastSorb, and others. For more information, please visit the Company's websites
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