With the authorization, Monmouth Junction, N.J.-based CytoSorbants is entitled to make CytoSorb commercially available to all U.S. hospitals for coronavirus patients aged 18 and older who are admitted to the intensive care unit with confirmed or imminent respiratory failure.
These patients may have early acute lung injury, acute respiratory distress syndrome, severe disease or life-threatening illness resulting in respiratory failure, septic shock and/or multiple organ dysfunction or failure, according to a news release.
CytoSorb blood purification technology is indicated for treating cytokine storm and deadly inflammation in critically ill and cardiac surgery patients.
Patients with COVID-19 often exhibit a cytokine storm with severe hyper-inflammation that can contribute to worsened injury to vital organs, CytoSorbents said in the release. CytoSorb is designed to reduce the cytokine storm and inflammatory response. The technology is compatible with common blood purification machines or pumps in the ICU, including hemoperfusion, hemodialysis, continuous renal replacement therapy and extracorporeal membrane oxygenation machines.
CytoSorbents CEO Dr. Phillip Chan said in the release that CytoSorb treated more than 200 COVID-19 patients outside the U.S., resulting in inclusion in treatment guidelines in Italy, Panama and China. He added that the company intends to ramp up the availability of the technology amid growing requests from U.S. hospitals.
“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,” CytoSorbents COO Vincent Capponi said. “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.”