MONMOUTH JUNCTION, N.J., Sept. 8, 2020 /PRNewswire/ — CytoSorbents Corporation (Nasdaq: CTSO), a critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat cytokine storm and deadly inflammation in critically-ill and cardiac surgery patients around the world, announced today that the U.S.-based “CytoSorb Therapy in COVID-19 ICU Patients,” (“CTC”) Registry, is now live and actively enrolling patients. Multiple U.S. centers are taking part in the registry, with the first patient already successfully included by the University of Chicago Medicine. The CTC registry has been designed to uniformly capture high quality, anonymized clinical outcomes data on adult, critically-ill, COVID-19 patients treated with CytoSorb under FDA Emergency Use Authorization (EUA) granted in April 2020. These data may result in one or more publications that highlight best practices on how to best treat cytokine storm in these patients with CytoSorb.
Dr. Tae H. Song, Director of the Acute Mechanical Circulatory Support and Extracorporeal Membrane Oxygenation (MCS/ECMO) program, and Surgical Director of the Lung Transplant Program at the University of Chicago stated, “The COVID-19 pandemic has had a profound impact on the use of ECMO at the University of Chicago Medicine, and at other institutions. We have been confronted with critically-ill COVID-19 patients suffering rapid decline in pulmonary function requiring ECMO support, with a limited number of proven treatment options. The CytoSorb device can be integrated into ECMO circuits to remove the inflammatory cytokines that can cause a “cytokine storm” and many harmful effects to the patient. The Food and Drug Administration issued an Emergency Use Authorization, allowing us to utilize this therapy for COVID-19 patients with severe disease. In these patients, we have seen potential benefits of the device, enabling us to wean patients from ECMO and mechanical ventilation. Now with the advent of the CytoSorb Therapy In COVID-19 (CTC) Registry, institutions around the country will be collecting de-identified clinical data from these patients, to better understand how CytoSorb therapy may be of benefit in COVID-19. We are happy to be the first center to provide data to the CTC Registry to achieve this important goal.”
Dr. Efthymios Deliargyris, Chief Medical Officer of CytoSorbents stated, “We are very thankful for the commitment of many U.S. medical centers that are using CytoSorb, to participate in the CTC Registry and to conduct clinical research, despite being on the front lines of the pandemic. Although there have been advances in understanding and treating this terrible disease, much more needs to be done. To that end, the robust infrastructure of the CTC Registry will allow speedy collection of high-resolution data from multiple U.S. institutions that will determine how CytoSorb is best being used in these patients. We are confident this strategy, along with a parallel international program, will yield actionable results to help save more lives.”
CytoSorb has been authorized by FDA under an Emergency Use Authorization (EUA) for use in COVID-19 patients, 18 years of age or older in the intensive care unit with imminent or confirmed respiratory failure. It has neither been approved nor cleared for the indication to treat patients with COVID-19 infection. The CytoSorb device is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the CytoSorb device under Section 564(b)(l) of the Act, 21 U.S.C § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in critical care immunotherapy, specializing in blood purification. Its flagship product, CytoSorb® is approved in the European Union with distribution in 65 countries around the world, as an extracorporeal cytokine adsorber designed to reduce the “cytokine storm” or “cytokine release syndrome” that could otherwise cause massive inflammation, organ failure and death in common critical illnesses. These are conditions where the risk of death is extremely high, yet no effective treatments exist. CytoSorb® has been used in more than 100,000 human treatments to date. CytoSorb has received CE-Mark label expansions for the removal of bilirubin (liver disease), myoglobin (trauma) and both ticagrelor and rivaroxaban during cardiothoracic surgery. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in critically-ill COVID-19 patients with imminent or confirmed respiratory failure, in defined circumstances. CytoSorb has also been granted FDA Breakthrough Designation for the removal of ticagrelor in a cardiopulmonary bypass circuit during emergent and urgent cardiothoracic surgery.
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 $37 million from DARPA, the U.S. Army, the U.S. Department of Health and Human Services, the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), U.S. Special Operations Command (SOCOM), the U.S. Army, the U.S. Air Force, Air Force Material Command (USAF/AFMC), and others. The Company has numerous products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and multiple applications pending, including CytoSorb-XL™, HemoDefend™, VetResQ™, K+ontrol™, ContrastSorb, DrugSorb, and others. For more information, please visit the Company’s websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter.
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release, including statements about COVID-19, our expected revenues as a result thereof, represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 5, 2020, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
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