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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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Pre-clinical Evaluation of Bioartificial Liver Support System
Plasma versus Whole Blood Perfusion
First Clinical Use of a Novel Bioartificial Liver Support
Clinical and laboratory evaluation of the safety
Bound Dilute Analysis
Oxygen Consumption in a Hollow Fiber Bioartificial Liver - Revisited

Pre-clinical Evaluation of the Excorp Medical, Inc., Bioartificial Liver Support System


John F Patzer II, PhD, George V Mazariegos, MD, FACS, Roberto Lopez, MD, Bioartificial Liver Program Investigators

Abstract

Background. Acute liver failure has no medically recognized effective therapy other than orthotopic liver transplantation. Development of bioartificial livers for support of patients with acute liver failure requires meaningful preclinical evaluation before clinical trials.

Study Design. Complete results from preclinical safety and efficacy evaluation of the Excorp Medical Bioartificial Liver Support System (BLSS) using a D-galactosamine (D-gal) canine liver failure model are presented. From a total cohort of 23 purpose-bred male hounds, 18 animals were administered a lethal dose (1.5g/kg) of D-gal. The 18 animals were divided into four treatment groups: no BLSS treatment (n=6), BLSS treatment starting at 24 to 26 hours post D-gal (n=5), BLSS treatment starting at 16 to 18 hours post D-gal (n=4), and "mock support" treatment with a BLSS system containing no hepatocytes (n=3). The animals were treated until death or death equivalent, or euthanized at 60 hours. Physiologic parameters were continuously monitored. Blood chemistries were obtained every 8 hours.

Results. Although survival times for BLSS-supported animals were significantly greater than for the unsupported group, the greatest impact on delaying progression of liver disease was time of intervention. Intervention at 16 to 18 hours post D-gal administration showed significant delay in increasing blood ammonia, lactate, and prothrombin time as compared with untreated animals. Elevated intracranial pressure was found in two of six untreated animals, but in none of the treated animals (zero of nine). Healthy animals supported by the BLSS system evidenced no significant safety problems.

Conclusions. Results suggest the BLSS impacts the course of liver failure in the animal model. Phase I clinical safety evaluation is underway. ( J Am Coll Surg 2002;195:299-310. © 2002 by the American College of Surgeons)

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