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CytoSorbents Corporation (OTC BB:CTSO) is an early revenue-stage, critical-care focused medical device company attempting to revolutionize the treatment of life-threatening illnesses in theintensive care unit (ICU) using blood purification. Their goal is to prevent or treat multi-organ organ failure, the leading cause of death in the ICU, with an immunomodulatory approach that removes excessive cytokines, toxins and other inflammatory mediators that can damage vital organs. The approach uses a unique biocompatible porous polymer bead technology to remove a broad range of toxins from the circulatory system and other bodily fluids that cannot be removed by standard hemodialysis or hemofiltration.
Organ Failure: focus needs to be on prevention as opposed to just treatment
Patients with critical care illnesses such as sepsis, trauma, burn injury, acute respiratory distress syndrome and pancreatitis are some of the most seriously-ill and difficult to treat patients in the hospital. Treatments that exist today are primarily supportive care therapies that help keep the patient alive, but do not actively help patients get better. As an example, in severe lung injury, patients are placed on mechanical ventilation when they can no longer breathe on their own. Mechanical ventilation prevents the patient from dying of lung failure, with the hope that the lungs will eventually heal on their own. Unfortunately, the spontaneous healing process can take weeks, assuming the patient does not die first, and is often plagued by complications such as lung injury caused by the ventilator, hospital-acquired pneumonias and other infections. Another example is severe acute pancreatitis, in which digestive enzymes and caustic fluids from the pancreas leak into the abdominal cavity and blood, causing severe tissue damage, pain, inflammation, swelling andorgan failure. This is a life-threatening condition where the only available treatment is pain control, aggressive hydration and organ-support when vital organs fail.
Despite the need for better treatments and the heavy cost to the healthcare system, little has been approved that can improve outcome in these complex diseases. One of the problems is that the attempted treatments have been too targeted. Normally, specific targeting is desirable as it can prevent unwanted adverse events but in these critical care illnesses, where the body’s entire physiology is massively deranged with multiple organ systems affected, targeted therapies are often too little, too late . These treatments, which attempt to restore balance, can themselves also be dangerous. Due to the difficulties associated with effectively managing critical care illnesses, the goal should be to prevent organ failure, as opposed to treating it after the fact. Preventing organ failure has proven a significant challenge, however, with few, if any, therapies capable of doing this. CytoSorbents’ technology is focused on doing just that (i.e. – preventing organ failure) through the removal of toxins from the blood that are the major causes of organ injury.
In critical care illnesses, the levels of inflammation driven by cytokines, toxins and other substances are so severe that if left unchecked, it would lead to widespread cell death, organ failure and ultimately patient instability and death. While hemodialysis and hemofiltration have been used to try and remove these toxins from blood, they have largely proven ineffective due to the inability to remove these larger toxins. Clinical trial data has shown that CytoSorb is one of the first technologies to be capable of reducing many of these toxins, with the goal of preventing the cascade of events that leads to organ failure. CytoSorbents’ clinical trial has shown promising data on improving organ function and survival in high-risk, critically ill septic shock and lung failure patients.
The CytoSorb device consists of a cartridge containing hemocompatible, highly porous, adsorbent polymer beads that are intended to remove toxins and other substances from blood and physiologic fluids. The cartridge incorporates industry standard connectors at either end of the device, which connect directly to an extra-corporeal circuit (bloodlines) on a stand-alone (i.e. not in series with a dialysis cartridge) basis. The extra-corporeal circuit consists of plastic tubing through which the blood flows, the CytoSorb cartridge containing adsorbent polymer beads, pressure monitoring gauges, and a blood pump (i.e. – conventional dialysis machine) to maintain blood flow. The patient,s blood is accessed through a catheter inserted into the veins. The catheter is connected to the extracorporeal circuit and the blood pump draws blood from the patient, pumps it through the cartridge and returns it back to the patient in a closed loop, recirculating system. As blood passes over the polymer beads in the cartridge, toxins (cytokines) are adsorbed from the blood. Each treatment, which lasts about six hours and processes approximately 20 – 30 blood volumes, uses a new cartridge – representing a recurrent revenue source for CytoSorbents. As CytoSorb runs on existing dialysis machines, there is no upfront capital costs to hospitals and affords CytoSorbents a large target market to sell to.
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