CytoSorbents and its flagship therapy, CytoSorb®, uses blood purification to treat deadly, massive uncontrolled inflammation and “cytokine storm” in a broad range of life-threatening illnesses, including COVID-19 infection
CytoSorbents Corporation (NASDAQ: CTSO) is a U.S. based medical device company that specializes in blood purification to treat deadly inflammation. Its flagship product, CytoSorb® is approved in the European Union, manufactured in the U.S., and distributed in 66 countries worldwide, as a blood purification technology to reduce “cytokine storm” and other inflammatory toxins that can otherwise cause uncontrolled massive inflammation, organ failure, and death in common critical illnesses. These are conditions where the risk of death is extremely high, yet few if any effective treatments exist. CytoSorb® has now been used in more than 110,000 human treatments to date, establishing itself as a leading therapy to safely treat cytokine storm and its complications.
Severe Inflammation and Cytokine Storm Can Kill
Inflammation is the body’s normal adaptive response to injury and infection. However, every year, millions of people die from complications of severe, uncontrolled inflammation triggered by common life-threatening conditions such as infection and sepsis, COVID-19 and influenza, trauma, surgical complications, liver failure, burn injury, and many others. This inflammation is often driven by the excessive production of cytokines, or “cytokine storm”, which are a class of more than 100 different immune system messengers that normally regulate and activate the immune response. Left unchecked, this cytokine storm and the inflammation that ensues, can rapidly kill cells and damage vital organs like the lungs, heart, and kidneys, often leading to organ failure and death. In fact, organ failure is responsible for nearly half of all deaths in the intensive care unit (ICU), and has made sepsis (the overzealous immune response to an infection) the #1 killer worldwide, contributing to 1 in every 5 deaths each year. In sepsis caused by COVID-19 infection, aggressive hyperinflammation is directly correlated with more severe lung injury, the need for mechanical ventilation, and a high risk of death.
CytoSorb® Helps Control Severe Inflammation by Reducing the “Fuel to the Fire”
CytoSorb is a powerful new broad-spectrum anti-inflammatory therapy that directly binds and reduces cytokines and a wide range of other inflammatory mediators that fuel the fire of inflammation. Within each CytoSorb cartridge are hundreds of thousands of tiny porous polymer beads roughly the size of a grain of salt. Each of these beads has millions of pores and channels that allow the bead to act like a tiny sponge and remove cytokines and other inflammatory mediators of a certain size. Treatment is very simple: after a temporary dialysis catheter is placed into a major vein, blood is pumped out of the body by a standard dialysis machine found in ICUs around the world, through the CytoSorb cartridge where cytokines and other toxins are removed, with the purified blood recirculated back into the patient over and over again. A single cartridge can treat a patient’s entire blood volume more than 70 times in a day, with a new cartridge used each day. Most patients require 1-5 cartridges, depending on the illness.
An example of how CytoSorb is used today
Use of CytoSorb in Critically Ill COVID-19 patients
Although CytoSorb is used in many different life-threatening conditions, one of the most pressing is to help treat critically ill patients with severe COVID-19 infection. The rationale of using CytoSorb in these patients is to help remove the circulating inflammatory toxins generated by SARS-CoV-2 infection that are continuously damaging the lung, ultimately giving the lungs a chance to heal. We believe this healing is the key to helping patients get off of mechanical ventilation and extracorporeal membrane oxygenation (ECMO) faster. New cases of COVID-19 are continuing to surge across the world, where CytoSorb has already been used to help treat more than 3,000 critically-ill COVID-19 patients across more than 30 countries. Treatment data that have either been published or presented at conferences demonstrate a consistent ability of CytoSorb to reduce inflammatory mediators, reverse shock, and to help improve lung function and weaning of COVID-19 patients from mechanical lung support. In April 2020, CytoSorb received U.S. Food and Drug Administration (FDA) Emergency Use Authorization for use in adult, critically-ill COVID-19 patients with imminent or confirmed respiratory failure, with now many U.S. hospitals using the therapy. The Company is working with Terumo Cardiovascular, and other independent distributors, to help co-promote CytoSorb in the U.S.
CytoSorb has received CE-Mark label expansions for the removal of bilirubin (liver disease), myoglobin (trauma), and the antithrombotic drugs, ticagrelor (Brilinta® or Brilique®) and rivaroxaban (Xarelto®), during urgent cardiothoracic surgery. CytoSorb has also been granted U.S. FDA Breakthrough Designation for the removal of ticagrelor during emergent and urgent cardiothoracic surgery.
CytoSorbents’ technologies have received non-dilutive grant, contract, and other funding of more than $38 million from the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the Defense Advanced Research Projects Agency (DARPA), the U.S. Department of Health and Human Services, the U.S. Army, Air Force, 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-RGC™, HemoDefend-BGA™, VetResQ™, K+ontrol™, ContrastSorb, DrugSorb, and others. For more information, please visit the Company’s websites at http://www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter.