CytoSorbents Corporation, a  critical care immunotherapy company, has been granted Emergency Use Authorization (EUA)  by the FDA for CytoSorb for use in patients with COVID-19 infection. CytoSorb is a blood purification technology to treat cytokine storm and deadly inflammation in critically-ill patients.

Under the EUA, CytoSorb can be used in patients 18 years of age or older, with confirmed COVID-19 who are admitted to the intensive care unit (ICU) with respiratory failure, early acute lung injury or acute respiratory distress syndrome (ARDS), severe disease, or life-threatening illness resulting in respiratory failure, septic shock, and/or multiple organ dysfunction or failure.

Patients with COVID-19 infection often exhibit a cytokine storm with severe hyperinflammation that can contribute to worsened injury to vital organs like the lungs, heart, and the kidneys. The goal of CytoSorb therapy is to reduce cytokine storm and the deadly inflammatory response through blood purification so that this injury may be mitigated or prevented. CytoSorb is compatible with most commonly used blood purification machines or pumps in the intensive care unit.   

Mr. Vincent Capponi, Chief Operating Officer of CytoSorbents commented, “We greatly appreciate the FDA’s recognition, through this EUA, of the potential of CytoSorb and extracorporeal blood purification to help patients stricken with this terrible illness.  It was clear in this truly collaborative process with the FDA, that the Agency was committed to urgently providing physicians and patients with new treatment options in the fight against COVID-19.  We plan to continue working with the FDA to help as many patients as possible.”

According to the EUA letter, “There are no FDA approved, licensed, or cleared device treatments for COVID-19. Based on bench performance testing and reported clinical experience, FDA has concluded that the CytoSorb device may be effective at treating certain patients with confirmed COVID-19 by removing various pro-inflammatory cytokines from their blood.”