Liver Filter OKd for Clinical Tests
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A small Los Angeles company received Food and Drug Administration approval this week to begin limited clinical trials of a device that purifies the blood of patients suffering from liver failure, the firm said Friday.
The device, created by Arbios Systems Inc., is a disposable cylindrical filter made of a bundle of hollow fibers and can be installed in a kidney dialysis machine.
The process is similar to kidney dialysis: A patient’s blood is pumped through a machine to remove harmful substances that build up in the blood when the liver isn’t working properly.
The filter -- named Sepet, for selective plasma filtration therapy -- cleanses the blood of toxins that are associated with a failing liver and diminish the organ’s ability to heal itself, said Dr. Jacek Rozga, a co-founder of Arbios and a research scientist at Cedars-Sinai Medical Center in Los Angeles.
The two medical centers where the tests will be conducted -- Cedars-Sinai and Albert Einstein Medical Center in Philadelphia -- still have to approve Arbios’ plan for conducting the trials. The tests will involve 15 patients who are suffering from a chronic liver condition.
Arbios was founded in 2000 by Rozga and Dr. Achilles Demetriou, chairman of the surgery department at Cedars-Sinai. (Arbios is short for artificial biological systems.) The company, which has no products on the market, reported a net loss of $3.3 million last year on revenue of $72,030, which came from government grants.
Arbios’ stock rose 19 cents, or 12.6%, to $1.70 in over-the- counter trading.