The US Food and Drug Administration (FDA) has rejected marketing approval of the BreathID diagnostic device for liver disease developed by Exalenz Bioscience Ltd. (TASE:EXEN).
In December 2009, Exalenz reported that its BreathID device failed to achieve the primary endpoint in the Phase III clinical trial to test the device ability to diagnose liver damage compared with a biopsy. A month later, the company said that full statistical analysis for the secondary endpoint of the trial found a good 0.8 correlation between the Hepatic Impairment Score (HIS) developed by the company for assessing the probability of severe liver damage and the risk of severe liver damage as actually measured by a biopsy.
On the basis of this result, Exalenz applied to the FDA for marketing approval of the BreathID. The FDA rejected the application on the basis of the secondary endpoint results, and said that the company should conduct supplementary tests that would be based, among other things, on predetermined detailed targets.
The FDA said that Exalenz should show that the application have added value to products already approved and in medical use.
Exalenz said that, in view of the promising results obtained in various studies, it will continue the clinical trials program of the BreathID device for the diagnosis of liver damage. This program, already approved by the company, will cost NIS 1.5 million.
Exalenz's share price fell 6% by midday to NIS 0.90, giving a market cap of NIS 100 million.
Published by Globes [online], Israel business news - www.globes-online.com - on July 12, 2010
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