Critical care company CytoSorbents Corporation (Nasdaq:CTSO) reported on Monday the receipt of the Brazilian Health Regulatory Agency's (ANVISA) approval for CytoSorb for treating cytokine storm in cardiac surgery, COVID-19 infection and other conditions.
The company added that CytoSorb is now commercially available in Brazil via a distribution agreement with Contatti Medical, a privately-held company located in Porto Alegre, Brazil.
CytoSorb, which has been used in more than 100,000 human treatments, has received the US FDA Emergency Use Authorization in the US for use in critically-ill COVID-19 patients with imminent or confirmed respiratory failure in defined circumstances. It has received FDA Breakthrough Designation for the removal of ticagrelor in a cardiopulmonary bypass circuit during urgent cardiothoracic surgery.
According to CEO Dr Phillip Chan, the company's immediate focus is to help treat patients with life-threatening complications of COVID-19 infection, with 30,000-40,000 new coronavirus cases a day and a total of 4.5m total cases in the country, third only to the US and India.
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