
Based
in Boston, Massachusetts, HepaLife Technologies Inc.™,
is developing its cell-based bioartificial liver system, HepaMate™,
as a potentially lifesaving treatment for liver failure patients.
The patented technology has previously been tested in clinical
Phase I and pivotal Phase II/III studies involving more than
200 patients, making it the most clinically studied bioartificial
liver. Over 50 scientific papers and book chapters have been
published on the technology. HepaLife
expects a new pivotal Phase III clinical trial to
be successful in obtaining market approval for its HepaMate™
bioartificial liver system.
HepaMate™
Bioartificial Liver
As an extracorporeal cell-based bioartificial liver system, HepaMate™
is designed to combine blood detoxification with liver cell therapy
to provide whole liver function in patients with the most severe
forms of liver failure. A patented liver cell
cryopreservation process provides for safe and easy storing and
distribution, a significant logistic and commercial advantage.
Liver
Failure
The World Health Organization estimates that over 650 million people
worldwide are affected by some form of liver disease. In the US
alone, there are around 500,000 critical episodes of liver problems
requiring hospitalization with 80,000 deaths annually. Liver transplantation
is currently the only therapy proven to extend survival, but the
waiting list for liver transplants is extensive and many on the
list will not receive an organ. Additionally, a growing base
of hepatitis, alcohol abuse, drug overdoses, liver cancer and other
factors all clearly indicate a strong need for a bioartificial liver
support system.
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