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Excorp Medical's Bioartificial Liver System comprises a reusable instrument, disposable tubing set and the proprietary, disposable bioartificail reactor.Once approved by regulatory agencies, Excorp Medical expects this breakthrough Bioartificial Liver System technology to be both live-saving and cost effective.Certain drugs or machines are available to substitute temporarily or long-term for many organs in the body…  no comparable substitute has been developed for the liver.The liver is the largest organ in the body and performs a variety of tasks impacting all body systems… as a result liver disease has widespread effects on virtually all other organs.Excorp Medical is currently the only company approved to conduct bioartificial liver human trials within the U.S.Currently patients must receive a liver transplant or endure prolonged hospitalization at great expense to have a chance at survival.Excorp Medical Bioartificial Liver System treatments serve as a bridge to liver regeneration and transplantExcorp Medical has developed a Bioartificial Liver System for the metabolic support of patients with compromised liver function.
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Introduction


Excorp Medical, Inc. has developed a system for the temporary metabolic support of patients in acute liver failure in a 10-year collaboration with the leading university in liver transplantation and tissue engineering, the University of Pittsburgh, Thomas E. Starzl Transplantation Institute. We have completed laboratory and preclinical studies, initiated FDA-authorized Phase I/II human clinical trials and established proof of principle for the technology.

The need is enormous ... 46,000 deaths annually from liver failure in the US and 160,000 hospital discharges where liver failure is the principal diagnosis. Other than liver transplantation, no new tools have been introduced in this particular area of medicine in many decades. Perhaps surprisingly, only about 6,500 transplants are available in the US due to a shortage of suitable organs. Over 17,000 patients are presently waiting on the liver transplant list in the US. The absence of a suitable alternative therapy means that many of these patients will die without receiving a transplant.

Four groups of patients have been identified in the US market totaling approximately 350,000 individuals who may benefit from up to 700,000 liver assist procedures using our system. These include patients in acute liver failure, those undergoing resection for primary or metastatic liver cancer and multiple organ failure. We estimate the dollar value of the US market at $7 billion.

Worldwide, the need is even greater. Driven primarily by the prevalence of viral hepatitis, liver failure is a leading cause of death in China and the Middle East. In China and Hong Kong as many as 150 million people may be chronically infected. Over 1,500,000 liver failure deaths occur annually worldwide.

Our product is an extracorporeal system, comprising a simple blood loop, which allows the equipment to continuously circulate a patient's whole blood through a bioreactor containing pig liver cells. A membrane barrier allows the pig liver cells to process the toxins accumulating in the blood as a result of liver failure but prevents direct contact with the patient’s blood. Procedures are expected to be 12 hours in duration and repeated 2-3 times during a given episode of liver failure. The clinical goal is to protect the patient's brain, heart, lungs and kidneys from the effects of the failing liver for a period long enough for the patient’s own liver to regenerate. The skills required to operate the system are not greatly different from those needed for kidney dialysis, a procedure performed millions of times per year around the world.

Our business model provides a breakthrough innovative technology, creating jobs and saving lives. We envision that the bioartificial liver bioreactors will be produced locally in each country for the benefit of its citizens.

It is our goal to make this potentially life-saving, cost-effective technology available globally.


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