CytoSorbents Gains Emergency Authorization for Covid-19 Treatment

The FDA says CytoSorbents' blood purification system 'may be effective' in fighting cytokine storms.
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Shares of CytoSorbents  (CTSO) - Get Report soared Monday after the Food and Drug Administration Friday issued an emergency use authorization for the immunotherapy company’s CytoSorb blood purification system for treating the coronavirus.

The device can now be used to treat patients in intensive care units with respiratory failure. The blood purification technology is designed to treat cytokine storms and the deadly inflammations that come with them.

Cytokine storms are an overreaction of the body’s immune system that can occur in those infected with Covid-19, the disease caused by the coronavirus.

Cytokines are small proteins released by many different cells in the body, including those of the immune system, where they direct the body’s action to fight infection and cause inflammation.

“There are no FDA approved, licensed, or cleared device treatments for Covid-19,” the FDA said in a letter to the company.

“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,” the agency added.

The FDA's emergency order doesn’t constitute formal FDA approval of a treatment, but allows the company to market its treatment to healthcare providers treating coronavirus patients. CytoSorb said its treatment has been approved overseas.

There are 70 vaccines in development globally, with three of them already in human trials, according to the World Health Organization.

Shares of CytoSorbents recently traded at $8.17, up 23.98%. The stock has soared 105% over the past three months.