Cytosorbents Corporation (CTSO) stock is down 0.31% to $9.63 after releasing topline results from its CytoSorb Therapy in COVID-19 (CTC) multicenter registry.
FDA Emergency Use Authorization
Cytosorbents Corporation (CTSO) obtained FDA Emergency Use Authorization in April 2020 for use in severely sick COVID-19 patients, 18 years of age or older, with proven or imminent respiratory arrest, to lower pro-inflammatory cytokine levels, and can be administered with a variety of blood pumps, including ECMO.
ECMO (extracorporeal membrane oxygenation) is a system that pumps and oxygenates blood outside of the body, decreasing reliance on the lungs for gas exchange and allowing mechanical ventilator settings to be reduced to avoid ventilator-induced lung damage.
Organ Perfusion System Launch
CytoSorbents Corporation and Aferetica SRL (Italy), two pioneers in intensive care immunotherapy and blood purification, have announced the successful launch of Aferetica’sPerLifeTM ex vivo organ perfusion system for kidney and liver transplant, as well as CytoSorbents’ PerSorbTM adsorber, which removes inflammatory cells during ex vivo organ perfusion.
FDA Breakthrough Device Designation
The United States Food and Drug Administration has awarded CytoSorbents a second Breakthrough Device designation for its DrugSorb-ATR Antithrombotic Removal System.
The withdrawal of the Direct Oral Anticoagulants (DOACs) apixaban and rivaroxaban from a cardiopulmonary bypass circuit to minimize the risk of severe perioperative bleeding in urgent cardiothoracic surgery is covered by this Breakthrough Device designation. It comes after the Breakthrough Designation in April 2020, which allowed ticagrelor to be removed from the same application.
Cytosorbents’ sheet shows no debt, which is uncommon for a cash-burning growing firm, which generally has a high debt-to-equity ratio. This indicates that the firm has been functioning entirely on its funds, with no debt. This feature lowers the danger of investing in a loss-making business.