Exalenz Bioscience Ltd. (TASE:EXEN) has obtained US Food and Drug Administration (FDA) Humanitarian Device Exemption for its BreathID non-invasive diagnostic device for acute liver failure, which provides for fast-track approval of it.
Humanitarian use device (HUD) designation means that the device will not have to undergo an efficacy trial, thereby greatly shortening the approval process and its cost, subject to meeting FDA requirements.
Exalenz demonstrated the efficacy of the BreathID device in diagnosing acute liver failure in a trial of several dozen patients at Kings College in London and at Hadassah Medical Organization in Jerusalem. The early diagnosis provided by the device can save lives and eliminate unnecessary liver transplants.
Exalenz said that if it succeeds in meeting the FDA's requirements for the BreathID device for this indication, this would expand use of the device for a wider range of applications.
Last week, the FDA approved a clinical trial of the BreathID device for the early diagnosis of Hepatocellular Carcinoma, a liver cancer.
Exalenz's share price fell 1.4% by early afternoon to NIS 0.71, giving a market cap of NIS 96 million.
Published by Globes [online], Israel business news - www.globes-online.com - on September 11, 2011
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