Exalenz Bioscience Ltd. (TASE:EXEN) today announced the final results of the Phase III clinical trial of its BreathID diagnostic kit for detecting severe liver damage.
The share rose 13.4% in morning trading to NIS 1.42, giving a market cap of NIS 115 million, after the company announced success in the secondary endpoint of the trial, although it reported two weeks ago that it had missed the primary endpoint.
The study found a strong (0.8) correlation between the Hepatic Impairment Score (HIS), developed by the company for assessing the probability of severe liver damage caused by Cirrhosis, and the risk of liver damage as measured by biopsy. This correlation was the secondary endpoint of the trial.
Exalenz CEO Steven Eitan said, "On the basis of the final results and conclusions obtained, we applied to the US Food and Drug Administration (FDA) to set a meeting for premarket approval (PMA) in order to apply for final approval to market the BreathID device in the US as a tool for assessing the probability of liver damage during 2010."
Last month, Exalenz announced that the trial of BreathID failed to achieve its primary endpoint: diagnosing severe liver damage, compared with the accuracy of biopsies of liver tissue.
The BreathID analyzes the patient's breath after digestion in order to diagnosis certain diseases.
Published by Globes [online], Israel business news - www.globes-online.com - on January 6, 2010
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