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Overview Cirrhosis is severe scarring of the liver and poor liver function seen at the end of chronic liver disease.
The liver performs a wide variety of vital life functions including metabolic, regulatory, detoxification and synthetic activities. Acute liver failure refers to the rapid onset of liver dysfunction in a patient without chronic liver disease. AILD is a life-threatening form of acute liver failure precipitated by the recent ingestion of alcohol.
A second form of AILD, which we refer to as non-sAAH AILD, occurs in subjects with underlying stable chronic liver disease who suffer from an episode of acute liver failure due to excessive consumption of alcohol.
The Department of Health and Human Services in the United States estimates that for 2012 the number of hospital admissions related to sAAH in the United States was approximately 95,000, with approximately 14,000 of these admissions identifying sAAH as the primary diagnosis.
A second form of acute liver failure is FHF, a relatively rare condition characterized by a rapid deterioration of liver function with altered mental state and coagulopathy in individuals without known pre-existing liver disease.
We estimate that the first two categories of SILF account for several hundred patients a year in the United States, while the third category could represent an annual population of 10,000 or more cases a year in the United States. Chronic liver failure refers to a gradual loss of liver function and is usually characterized by the presence of widespread cirrhosis, which refers to the replacement of normal liver tissue by fibrosis, scar tissue and regenerative nodules. Given the liver’s complexity, there are no simple or widely effective medical solutions to acute liver failure. The ELAD System has not been demonstrated to be safe or effective for any indication and is not available for sale in the United States or any other country.
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Alcohol increases fat mobilization from tissue reserves and reduce the oxidation of fatty acids.
The scarring is most often caused by long-term exposure to toxins such as alcohol or viral infections. The primary liver cell, the hepatocyte, is thought to be responsible for approximately 500 or more specific biologic processes. The most common early features include yellowing of the skin and eyes, mental status changes and bleeding. AILD can occur with or without chronic underlying liver disease and can manifest itself in several clinical patterns depending on the acute response of the liver to alcohol’s toxic effect.
Current standard-of-care for AILD is defined by the treating facility and typically includes the use of anti-inflammatory drugs, such as corticosteroids, and the treatment of secondary complications such as bleeding, kidney failure and hepatic coma and may include admission to an intensive care unit. In addition, approximately 305,000 hospital admissions occurred in 2012 related to alcoholic cirrhosis, alcohol liver damage not-otherwise-specified or alcoholic fatty liver, with approximately 48,000 hospital admissions identifying these conditions as the primary diagnosis. The most frequent causes include drug or toxin-induced liver injury, viral hepatitis, autoimmune disease and hypoperfusion. Primary Graft Non-Function, which occurs when a newly transplanted liver fails to function.
Small-For-Size or Split Liver Transplant occurs when the transplanted liver is functioning, but may be too small to sustain the patient, either because only a small donor liver was available, or because a live person donated a portion of their liver for transplantation.

Although liver resection can provide a cure for primary liver cancer, resection of too much tissue can lead to rapidly progressing liver failure.
As normal liver is destroyed, the organ gradually fails to perform its normal metabolic, regulatory and synthetic functions. The liver, located in the upper right side of the abdomen below the ribs, has many essential body functions, such as: production of bile, which helps to absorb dietary fats, cholesterol, and fat soluble vitamins A, D, E, and K stores sugar and vitamins for later use by the body purifying blood (removes toxins such as alcohol and bacteria) creation of blood clotting proteins Incidence of Cirrhosis According to the National Institutes of Health (NIH) cirrhosis is the 12th leading cause of death due to disease in America.
In addition, the liver also serves as a reservoir for immune cells which clear the blood of pathogens. Acute liver failure may occur from a variety of causes such as acute flares of viral hepatitis, paracetamol or acetaminophen overdose, surgical interventions, idiosyncratic drug reactions and excessive alcohol intake.
One common and well-recognized form of AILD is severe acute alcoholic hepatitis (sAAH), which is characterized by inflammation and enlargement of the liver. Since abstinence from alcohol for six months is generally considered a pre-requisite for inclusion on a liver transplant list, organ transplantation is usually not available for these patients. We believe that a subset of these patients have a form of non-sAAH AILD that may be treatable with the ELAD System. This is a life threatening medical emergency, and can lead to death if a new organ does not become available quickly. We believe the ELAD System may be able to support the patient’s liver function until the donated organ regenerates to a size large enough to become independent of external support. Currently, surgeons will typically only resect up to 50% of the liver in order to avoid death from liver failure. Unfortunately, damage from cirrhosis cannot be reversed and lost liver function can only be regained through transplantation.
In 2013, according to the United Network for Organ Sharing, fewer than 6,500 liver transplants were performed in the United States due to an insufficient number of available donor organs. As a result, the liver’s failure to perform its normal role can have devastating or fatal consequences. Despite improvements in intensive care management, mortality continues to be unacceptably high. Most subjects with sAAH are thought to have some underlying chronic changes to the liver as a result of longer-term alcohol use, although these changes may be reversible on abstention. The standard-of-care includes liver transplantation, although these patients tend to progress very rapidly and may succumb to their disease before a suitable organ is made available. We believe the ELAD System may provide patients with a bridge-to-transplant until a second liver becomes available. Moreover the ELAD System may also enable transplantation of smaller liver fragments than typically used, potentially expanding the available pool of donor organs. However, more extensive resections occasionally occur, and resection of smaller portions can also lead to liver failure. For this reason, we do not anticipate that the ELAD System will be effective for cirrhotic patients outside of the potential to bridge these patients to transplant. According to the United Network for Organ Sharing, the average billable charge for a liver transplant in 2011, including the one month before surgery and six months after surgery, was $577,100.

Causes of liver failure are numerous, and the condition is typically described in terms of rapidity of onset. Most acute liver failure patients, except active drinkers of alcohol, are considered suitable for liver transplant.
Because of the frequency with which the AILD population has been found to have some degree of preexisting liver disease, this condition is also often referred to as acute-on-chronic liver failure, or acute-on-chronic hepatitis. We believe the ELAD System may provide patients with a bridge-to-transplant, or potentially, recovery without transplantation.
We believe the ELAD System may be able to support these patients and also enable surgeons to perform larger tumor resections.
There are approximately 15,500 patients currently on the transplant waiting list and approximately 1,500 patients die while waiting each year.
When acute liver failure occurs in the presence of underlying liver disease, such as with alcohol-induced liver decompensation, the condition is sometimes referred to as acute-on-chronic liver failure. Fatty liver is caused by the excessive accumulation of fat in the liver cells, causing danger to human health. In 2013, liver disease represented the twelfth leading cause of death in the United States.
Other forms of acute liver failure include fulminant hepatic failure and surgically-induced liver failure. Outside of transplant, current therapy is defined by the treating facility and is mostly supportive and designed to manage the symptoms and complications associated with acute liver failure. In China, where viral hepatitis is endemic, liver and liver-related disease represented the fourth leading cause of death in 2011 and over 1 million cases of liver failure are estimated to occur each year in urban areas alone. It provides ways to reverse the chemical imbalances in your liver that put you at risk of developing that first cancer cell even while you can boost your metabolism by your impaired liver function and become healthier.
Obesity can be a risk factor by itself, or in combination with alcoholism and hepatitis C. The National Digestive Diseases Information Clearinghouse (NDDIC) reports that cirrhosis can develop in women who have two to three alcoholic drinks per day (includes beer and wine). For men, the amount of alcohol that puts them at risk for cirrhosis is three to four drinks daily. Hepatitis C can be contracted through sexual intercourse, or exposure to infected blood (through intravenous drug abuse and needle sharing or transfusions). Other causes of cirrhosis are: Hepatitis B The World Health Organization (WHO) reports that over two billion people are infected with hepatitis B virus world-wide. Disorders that affect the bodys ability to handle iron and copper (hemochromatosis and Wilsons disease). Medications, including prescription and over-the-counter drugs like acetaminophen, some antibiotics, and some antidepressants, can lead to cirrhosis.

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