Health Canada Authorizes CytoSorb for Use in Hospitalized COVID-19 Patients

CytoSorbents Corporation, a critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat deadly inflammation in critically ill and cardiac surgery patients around the world, announces that Health Canada has granted Medical Device Authorization for the importation, sale, and emergency use of CytoSorb in hospitalized COVID-19 patients under Interim Order (IO) ID# 316575.  CytoSorbents will collaborate with ebbtides medical, a specialty distributor of medical products throughout Canada, to ensure rapid and widespread availability of the therapy.

Mr. Steve Tymchuk, President and CEO of ebbtides medical stated, "ebbtides medical is a well-established company located in Vancouver, with over 15 years of experience in the medical/surgical industry providing excellent solutions to the healthcare market, specializing in extracorporeal life support and cardiac surgery.  We are excited to work with CytoSorbents to make CytoSorb immediately available during the COVID-19 crisis in Canada under Health Canada's COVID-19 Medical Device Authorization for Importation and Sale."

Mr. Vincent Capponi, President and Chief Operating Officer of CytoSorbents stated, "We have worked closely with Health Canada and our new Canadian distributor, ebbtides medical, to achieve this special COVID-19 authorization.  We are pleased to note that CytoSorb is now approved throughout North America for use in COVID-19 patients, and now commercially available in 67 countries worldwide.  Cases of COVID-19 have been steadily rising in Canada, with approximately 600,000 confirmed cases already.  Last month marked our first shipments of CytoSorb into Canada and we plan to work closely with ebbtides medical to deploy CytoSorb in hospitals throughout Canada to help as many patients as possible, particularly as most of the world waits for the COVID-19 vaccine.  We believe the broad usage of CytoSorb, and multiple approvals and COVID-19 authorizations around the world speak to the value of our therapy in helping to treat deadly inflammatory illnesses such as COVID-19 and many others."

An Interim Order is one of the fastest mechanisms available to the Canadian government to help make health products available to address larger-scale public health emergencies, such as the COVID-19 pandemic.  The current authorization is only valid as long as the IO is in effect. The IO is currently in effect until Fall of 2021, but may be renewed based on the ongoing public health need.  CytoSorb received U.S. FDA Emergency Use Authorization (EUA) in April 2020, and achieved marketing approval in Mexico in March 2020 as a broad extracorporeal cytokine adsorber for use in a wide variety of critical illnesses and cardiac surgery.

About ebbtides medical

With over 15 years of experience in the medical/surgical industry, ebbtides medical is a well-respected distributor of cardiac products that serve to enhance surgical outcomes within Canada. While others profess to excel at customer service, ebbtides perpetually strives to exceed customer expectations…as steady as the ebb tide.

About CytoSorbents Corporation (NASDAQ: CTSO)

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 67 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® is also being used during and after cardiac surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. CytoSorb® has been used in more than 110,000 human treatments to date.  CytoSorb has received CE-Mark label expansions for the removal of bilirubin (liver disease), myoglobin (trauma) and both ticagrelor and rivaroxaban during cardiothoracic surgery.  CytoSorb has also 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.  CytoSorb has also been granted FDA Breakthrough Designation for the removal of ticagrelor in a cardiopulmonary bypass circuit during emergent and urgent cardiothoracic surgery.

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 more than $38 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), 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 ECOS-300CY™, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ™, K+ontrol™, ContrastSorb, DrugSorb, and others.