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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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Bioartificial Liver System

The liver is the largest organ in the body and performs a variety of tasks that impact all parts of the body. As a result, liver disease has widespread effects on virtually all other organ systems. Remarkably, the liver is the only organ that can regenerate itself. Numerous attempts have been made over the past 30 years to develop a surrogate technique to provide either partial or total metabolic support for the patient with a failing liver. The technical and clinical objective is to provide a temporary liver assist until a patient's own liver regenerates or until a liver transplant can be performed.

The Excorp Medical Bioartificial Liver System comprises an extracorporeal (outside the body) process for continuously withdrawing a patient's whole venous blood, maintaining temperature, oxygenating to arterial levels, adjusting pH and perfusing a hollow fiber bioreactor charged with primary porcine hepatocytes before returning the blood to the patient. Porcine hepatocytes are obtained from qualified animals produced in a high health status herd.

Approximately 100 grams of hepatocytes are infused into the hollow fiber cartridge. Viability, oxygen consumption and other parameters are monitored to establish potency of each hepatocyte preparation and the resulting Bioreactor. The hollow fiber membrane serves as an immunoisolation barrier between the two species. High blood flows are maintained during clinical hemoperfusion with a therapeutic procedure designed to last for 12 hours. The instrument console provides control of the process, detecting potentially hazardous conditions and alerting the operator to appropriate corrective actions.

The technology is protected by issued US and European patents. The patent describes a platform technology of high-density cell culture that can be extended beyond liver cells to a wide variety of other cell types including pancreatic islets and other endocrine cells. The Company's bioartificial liver system has also been designated an "Orphan Product" by the FDA for the treatment of acute liver failure. Among the several benefits of the Orphan Drug Act, is a seven year market exclusivity following FDA marketing approval.

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