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U.S. FDA Grants CytoSorb Emergency Use Authorization for Use in Patients with COVID-19 Infection

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Summation

  • Under the EUA, CytoSorbents Corporation can make CytoSorb available, through commercial sales, to all hospitals in the United States for use in patients, 18 years of age or older, with confirmed COVID-19 infection who are admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure who have 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, as described in FDA’s authorization and as detailed below.

CytoSorbents Corporation, a  critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat cytokine storm and deadly inflammation in critically-ill and cardiac surgery patients around the world, announced the United States Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) of CytoSorb® for use in patients with COVID-19 infection.

Under the EUA, CytoSorbents Corporation can make CytoSorb available, through commercial sales, to all hospitals in the United States for use in patients, 18 years of age or older, with confirmed COVID-19 infection who are admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure who have 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, as described in FDA’s authorization and as detailed below.

Patients with COVID-19 infection often exhibit a cytokine storm with severe hyper inflammation that can contribute to worsened injury to vital organs like the lungs, heart, and 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 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 (CRRT), and extracorporeal membrane oxygenation (ECMO) machines.

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.”

Dr. Phillip Chan, MD, PhD, Chief Executive Officer of CytoSorbents stated, “As a U.S. based company with CytoSorb device manufacturing in New Jersey, we are eager to expand the availability of CytoSorb to U.S. hospitals and patients as a treatment option to fight cytokine storm and deadly inflammation that is believed to exacerbate COVID-19 infection.  With more than 555,000 documented coronavirus infections, the U.S. leads the world with over 22,000 deaths, and emergently needs new therapies to reduce the severity of this disease.  This is important not just to reduce poor clinical outcomes and mortality, but to also alleviate the bottleneck for scarce resources such as ventilators and ECMO in the treatment of these critically ill patients.”

Dr. Chan continued, “CytoSorb has been used in critically-ill and cardiac surgery patients in more than 80,000 human treatments abroad, to help treat the same complications seen in COVID-19 patients such as lung failure, shock, and multi-organ failure.  With CRRT, and in many cases ECMO, being standard in ICUs worldwide, CytoSorb can be easily implemented with minimal training.  More than 200 COVID-19 patients have been treated with CytoSorb outside the U.S., resulting in the inclusion of CytoSorb into the COVID-19 treatment guidelines in Italy, Panama, and China.  We have now received more than 70 requests from major U.S. hospitals to use CytoSorb in COVID-19 patients.  Under the EUA, we plan to ramp the availability of CytoSorb in a controlled manner, to clinical centers that will work with us to generate data and leverage our knowledge of how to use the device most effectively.  We are pleased to collaborate with the FDA to make this possible.”

According to the EUA letter from the FDA, “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.  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,” adding that “It is reasonable to believe that the CytoSorb device may be effective in treating patients 18 years of age or older with confirmed COVID-19 admitted to the ICU with confirmed or imminent respiratory failure when used consistently with the Scope of Authorization of this letter.”

As referenced in the EUA letter, CytoSorb can be used on patients 18 years of age or older, with confirmed COVID-19 who are admitted to the ICU with confirmed or imminent respiratory failure who have any one of the following conditions:

a)   Early acute lung injury (ALI)/early acute respiratory distress syndrome (ARDS); or
b)   Severe disease, defined as: 
         1) dyspnea, 
         2) respiratory frequency ≥ 30/min, 
         3) blood oxygen saturation ≤ 93%, 
         4) partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or 
         5) lung infiltrates > 50% within 24 to 48 hours; or
c)   Life-threatening disease, defined as: 
         1) respiratory failure, 
         2) septic shock, and/or 
         3) multiple organ dysfunction or failure.

The CytoSorb device has been authorized by the FDA under a EUA. It has neither been cleared nor approved for the indication to treat patients with COVID-19 Infection.  The EUA will be effective until the declaration, that circumstances exist justifying the authorization of the emergency use of the CytoSorb device during the COVID-19 pandemic, is terminated under section 564(B)(2) of the Act, or the EUA is revoked under section 564(g) of the Act.

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