The company will test its BreathID diagnostic device.
Exalenz Bioscience Ltd. (TASE:EXEN) has obtained US Food and Drug Administration (FDA) approval to begin the Phase III clinical trial for the company's BreathID diagnostic device for liver damage. The company will begin the trial in August, and is due to complete it by March 2009.
The trial will include 412 patients at 12 large medical centers in the US as well as at Hadassah Medical Organization in Jerusalem. Exalenz says that it believes that this is the largest clinical trial of its kind ever conducted by an Israeli company. The trial aims at replicating the results of the Phase II clinical trial in Israel and Europe, which was completed a few months ago.
Exalenz estimates the potential market for its BreathID diagnostic device for liver damage at hundreds of millions of dollars.
Published by Globes [online], Israel business news - www.globes-online.com - on July 20, 2008
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