CytoSorb® - A First-in-Class Cytokine Filter Approved in the European Union
CytoSorb® is a potentially breakthrough therapy that attempts to address one of the most challenging unmet medical needs in medicine…the ability to prevent or mitigate multiple organ failure - the leading cause of death in the intensive care unit (ICU) from any cause.
In response to life-threatening conditions such as sepsis and infection, trauma, serious burn injuries, severe lung injury, and pancreatitis, the body frequently overreacts and produces a massive excess of cytokines, or “cytokine storm”. Cytokines normally help the body cope with injury, but at these levels, cytokine storm is toxic to the body, driving severe inflammation and a cascade of pathophysiologic changes in the body that cause cell damage, organ failure and often death. It follows that reduction of cytokine storm may limit this cascade of events, thereby reducing the severity of illness, and helping patients recover and survive. Until recently, however, there were no effective ways to reduce cytokine storm broadly.
CytoSorb® is a first-in-class extracorporeal cytokine filter, now approved in the European Union, and broadly indicated for use in any clinical situation where cytokines are elevated. It is compatible with standard hemodialysis machines and blood pumps found in most hospitals. Blood is pumped out of the body, through the CytoSorb® cartridge that contains the company’s proprietary blood compatible porous polymer beads, and the “purified” blood is recirculated back to the patient. In a six hour period, a patient's entire blood volume can be treated approximately 20 times.
CytoSorb® is clinically proven to reduce cytokine storm in the company's multi-center, randomized, controlled European Sepsis Trial conducted in Germany. Treatment was safe and well-tolerated in more than 300 human treatments in very sick patients with the worst forms of sepsis and lung injury, and treatment has been safe in more than 650 human treatments overall. Early data suggests that CytoSorb® can reduce organ injury and improve survival in patients at high risk of cytokine injury, particularly those patients with very high cytokine levels, and patients older than age 65.
CytoSorb® is now available for sale and clinical use in the European Union. It represents one of the few treatment options available that directly tries to prevent or limit organ failure. CytoSorbents currently has an FDA-approved IDE application to run a small sepsis trial in the U.S. and will look to conduct a pivotal sepsis study in the future as a key step towards U.S. FDA approval. Severe sepsis and septic shock are collectively a top ten cause of death, afflicting approximately 18 million people annually, killing approximately 1 in 3 patients despite the best medical care. The total addressable market for CytoSorb® in critical care applications like sepsis, burn injury, trauma, ARDS, pancreatitis and other diseases is estimated at $10-15 Billion. For more information, please visit the Investor Relations section.