(RTTNews) - CytoSorbents Corp. (CTSO) said Monday that the United States Food and Drug Administration has granted Emergency Use Authorization or EUA of CytoSorb for use in patients with COVID-19 infection.

Under the EUA, CytoSorbents said it can make CytoSorb available through commercial sales to all hospitals in the U.S. for use in patients aged 18 years or older, with confirmed COVID-19 infection, who are admitted to the intensive care unit with confirmed or imminent respiratory failure.

These patients must have early acute lung injury or acute respiratory distress syndrome or ARDS, severe disease such as dyspnea, or life-threatening illness resulting in respiratory failure, septic shock, and multiple organ dysfunction or failure.

CytoSorbents noted that 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.

CytoSorb therapy aims to reduce cytokine storm and the deadly inflammatory response through blood purification so that this injury may be mitigated or prevented.

CytoSorb is plug-and-play compatible with the most commonly used blood purification machines or pumps in the intensive care unit used to treat COVID-19 patients, including hemoperfusion, hemodialysis, continuous renal replacement therapy or CRRT, and extracorporeal membrane oxygenation or ECMO machines.

The FDA said in the EUA letter that it has concluded the CytoSorb device may be effective at treating certain patients with confirmed COVID-19 by removing various pro-inflammatory cytokines from their blood.

The FDA believes, based on the totality of scientific evidence available, that the removal of pro-inflammatory cytokines may ameliorate cytokine storm due to the overabundance of pro-inflammatory cytokines and, in turn, provide clinical benefit.

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