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liver disease The liver is the largest and most metabolically complex organ in the body. Hepatocytes comprise the bulk of the liver, and are responsible for detoxifying the blood as well as making proteins that are essential to life. In a healthy individual, the liver’s unique capability for regeneration enables the organ to combat the continuous damage to hepatocytes that results from its maintenance of the body’s detoxification and metabolism systems. Most liver disease is chronic and symptoms usually appear later in life—usually from diseases such as hepatitis, cirrhosis and cancer. With the onset of liver disease, hepatocytes are injured or die. If the injury is mild and reversible, the cells may regenerate and the patient may recover to a normal liver. However, when the injury is sustained or more severe, regeneration may be incomplete or healing may occur with the development of fibrosis or scars, which can cause cirrhosis. As the average person ages, their liver mass decreases by 30% on average, which can make a person more vulnerable to acute liver failure, whatever the cause. Loss of liver function, even when temporary or partial, can result in serious complications and the disruption of essential bodily functions due to metabolic instability such as energy supply, acid-base balance and blood coagulation. If not treated effectively and promptly, patients often become comatose and experience uncontrolled bleeding and sepsis, contributing to multiple organ failure and/or death. An unknown toxin or virus can cause a person’s liver to fail suddenly; this disease state is known as fulminant hepatic failure, or “FHF”. A similar event can cause acute episodes with chronically ill patients. VTI intends to focus the use of ELAD® therapy on treating these Acute-On-Chronic patients as well as other indications, such as Sub-Fulminant (mostly hepatitis), Acute Alcoholic Hepatitis, Split Liver and liver transplant failures. Subsequent to its first approval VTI intends to expand the use of ELAD® by running small trials for each new indication.
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