The main reason I'm optimistic about FDA approval for Phase I Trials is that they approved the Circe sponsored (HepatAssist 2000 bioartificial liver) study that was published in Annals of Surgery, May 1997. Their device was safe. Their plan is to proceed to Phase II-III in order to prove efficacy. They use a hepatocyte filled bioreactor like we do (our device is a later generation of that device), so I would expect we'd get approval like they did.
What I think is superior about EXTI's device is the recirculating circuit consisting of an oxygenator and mixer,O2 sensor, Ph sensor and oxygenator, and this is what our Patent Pending pertains to. I would hope this technology could create an environment that keeps the cells healthier (EXTI literature refers to this as "methods for providing the proper conditions for continuous metabolism of human blood toxins by hepatocytes"--with "proper conditions" being two important words)and allows cells to be added in the needed amount (perhaps cost savings would be possible). If you wish to see the device go to exten's website where a diagram is available. This is strictly JMHO and everyone should understand this technology still needs a lot of work--so take care of your livers!
PS Vail & Beaver Creek are in pretty good shape-about 35-40inch base-but 3" of fresh was only enough to hide rocks & create "no see ums" to ding my brand new Dynastars ;.( Our return trip will be after the next storm.