July 23, 2008 -- The U.S. Food and Drug Administration (FDA) has given Exalenz Bioscience Ltd. (Modiin, Israel) (TASE:EXEN) approval to begin Phase III clinical trials for its BreathID diagnostic system. BreathID, which incorporates proprietary technologies such as MCS (Molecular Correlation Spectroscopy), enables the assessment of liver function (hepatic impairment), gastric emptying, and the detection of the Helicobacter pylori bacteria.
According to the Israeli news outlet Globes, Exalenz will begin the trial in next month and conclude in March 2009; the trial will include 412 patients at 12 large medical centers in the U.S. as well as at Hadassah Medical Organization in Jerusalem.
Exalenz believes that this is the largest clinical trial of its kind ever conducted by an Israeli company. The trial aims to replicate the results of its 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.
