HepaMate™ is an extracorporeal cell-based bioartificial liver system. It 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. Liver cells are known to detoxify existing toxins, produce albumin and other liver-specific proteins. A patented liver cell cryopreservation process provides for safe and easy storing and distribution, a significant logistic and commercial advantage. During therapy, the patient’s plasma is separated from whole blood, exposed to the HepaMate™ bioartificial liver and returned to the patient. HepaMate™ is comprised of a blood plasma separation cartridge, a hollow-fiber bioreactor filled with proprietary porcine liver cells, a charcoal column, an oxygenator and a plasma reservoir. These components are assembled into a patented blood/plasma circulation system, which is placed on the HepaDrive™ perfusion platform.

Clinical Experience
With a total of two clinical trials involving over 200 patients, HepaLife’s bioartificial liver using cryopreserved porcine hepatocytes, is the most extensively studied extracorporeal cell-based liver support system. Results from a selective retrospective statistical analysis of these experiences in fulminant hepatic failure (FHF) patients, include:

• Demonstrated survival without a transplant
• Reduced risk of pre-transplant death in fulminant hepatic failure patients
• Helped in keeping liver failure patients alive and neurologically intact before, during and immediately after transplantation
• Improved survival in fulminant hepatic failure patients with drug-induced liver toxicity

Competititon
There are currently no cell-based liver support systems commercially available or in advanced Phase III clinical trials in the USA or Europe. HepaLife’s patented technology provides for first-mover advantage for an unmet clinical need, and includes fast-track and orphan drug status in the USA. The proprietary cryopreserved pig hepatocyte technology provides a significant advantage. The frozen cells can be stored for years, shipped and handled easily. In contrast fresh cells from cell lines or from liver tissue have a limited life time with decreasing viability and functionality. This is an important advantage for clinical and commercial success. Since cryopreserved cells are stored in cryotanks before clinical use, cell batches are released only after extensive quality and viral testing have been performed. Thawing, loading and washing of cryopreserved cells is performed at the bedside using a proprietary, FDA-approved technique. Approximately only 90 minutes are required to assemble the system, prime the blood and plasma circuits with physiological saline and process liver cells for treatment. Because of HepaDrive’s™ compact size and mobility, the therapy can potentially be provided in the intensive care unit (ICU) as well as outside of the critical care environment.

PICM-19 Stem Cell Line
The company continues to evaluate the further optimization of the proprietary PICM-19 pig embryonic liver stem cell line for potential use in a future generation of the HepaMate™ bioartificial liver system. The PICM-19 is the world's only cell line of its kind with full expansion and growth capacity, maintaining its hepatic function in repeated passage. In 2008, due to its liver-like hepatic performance, the PICM-19 liver stem cell line was chosen to be part of a scientific experiment onboard the NASA Space Shuttle “Endeavour” Mission STS 126 to investigate the differentiation and function of stem cells in space and on the ability of the human liver to regenerate during space flight and under microgravity.