The company aims to obtain FDA approval for its device.
Exalenz Bioscience (TASE: EXEN), which develops and sells instruments for diagnosing diseases of the digestive system through breath tests, announced a further clinical trial success today. The trial was conducted with the aim of obtaining US Food and Drug Administration (FDA) approval for use of the company's IRMS device and its examination kit for identifying Helicobacter pylori bacteria.
Exalenz, among whose shareholders are Moshe (Mori) Arkin and Hadasit, the technology transfer company of Hadassah Hospital, carried out the trial among 167 patients, and obtained a 99.2% degree of accuracy in the results.
Exalenz CEO Steven Eitan said, "The trial results and its impressive success represent an important milestone in the company's business strategy. In addition, the results and the use of the new model considerably enlarge the company's potential market of H. pylori examinations. We believe that a market segment has opened up for us of tests in central laboratories that the company intends to set up. We believe that revenue from this sales model will amount to millions of dollars in 2010."
Published by Globes [online], Israel business news - www.globes-online.com - on December 13, 2009
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