About Excorp Medical

At Excorp Medical, Inc., we have developed a system for the temporary metabolic support of patients in acute liver failure in an 8-year collaboration with the leading University in liver transplantation and tissue engineering. We have completed laboratory, preclinical and initial FDA-authorized Phase I/II human clinical studies and have established the proof of principle for the technology along with proprietary protection and sufficient clinical and technical information to enter the final stages of development and product launch.

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 5,500 transplants are available 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.

We have defined four groups of patients in this market totaling approximately 350,000 individuals who may benefit from 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.

Our product is an extracorporeal system, comprising a simple blood loop, which allows us to continuously circulate a patient's whole blood through a bioreactor containing pig liver cells. A membrane barrier separates the two species but still allows the pig liver cells to process the toxins accumulating in the blood as a result of liver failure. 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 native 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.

The technology is protected by issued US and European patents. The leading clinical indication has been granted Orphan Drug status by the US FDA. Among the several benefits of Orphan status is a 7-year market exclusivity after FDA marketing approval.

Although many attempts have been made over the years to devise such a system, at the moment, we are the only viable liver assist technology in clinical trials, globally. It is our challenge to make a life-saving cost-effective technology widely available on an expedited basis.