CytoSorbents Announces the "CytoSorb Therapy in COVID-19 ICU Patients" (CTC) Registry Is Actively Enrolling
CytoSorbents Corporation (NASDAQ: CTSO) announced the launch of its 'CytoSorb Therapy in COVID-19 ICU Patients' (CTC) Registry, aimed at collecting clinical outcomes data on critically-ill COVID-19 patients treated with its CytoSorb technology. The registry, which is actively enrolling patients at multiple U.S. centers, including the University of Chicago Medicine, seeks to improve the understanding and effectiveness of CytoSorb therapy in managing cytokine storms. The technology has received FDA Emergency Use Authorization for specific applications in COVID-19 patients.
- CytoSorb therapy has received FDA Emergency Use Authorization for critically-ill COVID-19 patients.
- The CTC Registry will provide valuable clinical data to improve treatment practices.
- Increased engagement from multiple U.S. medical centers enhances potential insights into patient outcomes.
- CytoSorb has not received full FDA approval for treating COVID-19, limiting its use to emergency authorization.
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
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