On October 1, 2003, Vital Therapies, a new company formed to acquire the assets of VitaGen and continue the development of ELAD (Extracorporeal Liver Assist Device), acquired venture-backed VitaGen, a provider of external artificial human liver therapy.Formerly known as Hepatix Inc. in 2001 Vitagen began using wireless devices to manage randomization for a series of clinical trials for an artificial liver system called the Extracorporeal Liver Assist Device (ELAD). The ELAD contains live human liver cells and can support a patient's liver functions for up to 10 days, by which time hopefully he will have had the needed transplant. Vitagen's clinical trials were in high demand, and doctors needed to know which patients involved in the trials were receiving the ELAD treatment and which were in a control group. Using a software program developed by Synteract, a contract research organization in Encinitas, Calif., and the SAS Institute in Cary, N.C., doctors were able to access randomization codes (tracking which patients are treated with the new device and which with standard treatment) via handheld devices over a wireless connection, saving vital time. Before the applications were developed, doctors used phone, fax or e-mail to access up-to-date information, which was maintained by Synteract. Now, instead of lugging laptops from room to room, doctors can do their job anywhere as long as they have a Palm VII with them. In November 1996, with a private placement of $12.5M, firm still called Hepatix relocated to La Jolla CA from Houston TX after Chapter 11 emergence. Hepatix, Inc. was among those companies developing organic-synthetic hybrid technologies. The company's ELAD (extracorporeal liver assist device) is touted as the first artificial liver and the first medical device to incorporate immortalized human hepatocytes. The ELAD consists of two parts: the Bioassist System, which pumps the blood, and the ELAD cartridge, which contains the cloned (immortal) human hepatocytes that assume liver function. In design, the ELAD works much like a traditional kidney dialysis machine. In practice, it does much more. The cloned liver cells not only filter toxins from the plasma but also secrete albumin proteins and clotting factors like a normal liver. Even though human cells are used, tissue types do not require matching. Immune response is prevented by a semipermeable membrane that separates the ELAD's cells from the patient's blood cells and immunoglobins. Smaller molecules, like toxins and nutrients, can pass through the membrane. These blood toxins are filtered out, while the nutrients from the patient's own sera can sustain the artificial liver cells indefinitely. ELAD therapy is intended for patients with fulminant hepatic failure and will be used as a bridge to recovery or transplant.
