Exalenz to request FDA okay for diagnostic device

The firm completed a clinical trial of its liver damage identification device.

Exalenz Bioscience Ltd. (TASE:EXEN) has applied to the US Food and Drug Administration (FDA) for marketing approval of the company's BreathID device following completion of a clinical trial on 500 patients.

The trial was conducted at Hadassah Medical Organization in Ein Kerem, Kings College in London, and in Zurich. The trial aimed at diagnosing liver damage caused by cirrhosis and hepatic impairment. The BreathID diagnostic device achieved 90% accuracy compared with biopsies, which are considered the "gold standard".

Exalenz said that the BreathID system had clear advantages over biopsies of the liver for evaluating its functioning. BreathID is non-invasive, carries no risk, is very fast, and can diagnose the function of the liver as a whole, and not just the small sample used for a biopsy.

Published by Globes [online], Israel business news - www.globes-online.com - on April 2, 2008

© Copyright of Globes Publisher Itonut (1983) Ltd. 2008

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