Under the EUA, CytoSorbents 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 hyperinflammation that can contribute to worsened injury to vital organs like the lungs, heart, and the 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 FDA under an 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.
Based on the FDA EUA website, "The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation's public health protections against chemical, biological, radiological, and nuclear (CBRN) threats by facilitating the availability and use of medical countermeasures needed during public health emergencies. Under Section 564 of the Federal Food, Drug, and Cosmetic Act (the "Act"), the FDA commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening disease or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives."
EUA is fundamentally different from the FDA's Expanded Access Program for Medical Devices, which encompasses Emergency Use, Compassionate Use, and Treatment Investigational Device Exemptions (IDEs), all of which are limited in scope and, in the case of Compassionate Use and Treatment IDEs, require specific agency approval, often on a case-by-case basis. In contrast, EUA enables access and commercialization of therapies to hospitals nationwide, under broader guidelines for usage.
CytoSorbents Corporation is a leader in critical care immunotherapy, specializing in blood purification. Its flagship product, CytoSorb® is approved in the European Union with distribution in 58 countries around the world, as an extracorporeal cytokine adsorber designed to reduce the "cytokine storm" or "cytokine release syndrome" that could otherwise cause massive inflammation, organ failure and death in common critical illnesses. These are conditions where the risk of death is extremely high, yet no effective treatments exist. CytoSorb® has been used in more than 80,000 human treatments to date. CytoSorb has received FDA Emergency Use Authorization in the United States for use in critically-ill COVID-19 patients with imminent or confirmed respiratory failure, in defined circumstances.
CytoSorbents' purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding of nearly $29 million from DARPA, the U.S. Army, the U.S. Department of Health and Human Services, the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), U.S. Special Operations Command (SOCOM), the U.S. Army, U.S. Special Operations Command (USSOCOM), the U.S. Air Force, Air Force Material Command (USAF/AFMC) and others. The Company has numerous products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and multiple applications pending, including CytoSorb-XL™, HemoDefend™, VetResQ™, K+ontrol™, ContrastSorb, DrugSorb, and others. For more information, please visit the Company's websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter.
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