The FDA rejected a clinical trial of the BreathID non-invasive device to carry out HVPG measurements in chronic liver disease.
The US Food and Drug Administration (FDA) has rejected the clinical trial protocols of Exalenz Bioscience Ltd. (TASE:EXEN) for a clinical trial of its BreathID non-invasive device to carry out Hepatic Venous Pressure Gradient (HVPG) measurements in chronic liver disease. The FDA rejected the company's position that current methods for measuring HVPG as the "gold standard" for a clinical trial of the device.
Exalenz added that the FDA accepted the company's Hepatic Impairment Score (HIS) method, which it developed over the past several years. The company accepted the FDA's recommendation on the statistical tools needed to obtain approval on the basis of the HIS method, to the extent that they can be correlated with clinical measurements accepted by the FDA.
Exalenz's share price fell 0.2% by mid-afternoon to NIS 0.87, giving a market cap of NIS 116 million.
Published by Globes [online], Israel business news - www.globes-online.com - on May 5, 2011
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