Oridion Systems Ltd (SWX NM: ORIDN) announced today that it received clearance from the US Food and Drug Administration for its BreathID breath testing device. The company said it was now preparing for the US launch of the device, expected to begin once the FDA cleared the urea tablet that is part of the device’s first application - Oridion’s C urea breath test.
Oridion president and CEO George Yariv said, “FDA clearance for the BreathID device is a major step towards launching a new and promising segment of Oridion’s business - diagnostic breath tests - which the company believes will lead to a growth in future revenues. The company expects to witness strong interest by the medical community in this new device, due to the device’s ability to help physicians treat patients suffering from peptic ulcers and at risk to developing gastric cancer.”
Oridion said that its BreathID device would give physicians the ability to diagnose the H. pylori bacteria - estimated to currently affect approximately half of the world’s population - in a single office visit.
Oridion said that it was currently developing further breath tests with its patented Microstream platform technology, which it used to develop BreathID. Once available, these tests would expand the device’s ability and offer physicians the ability to diagnose additional medical conditions, Oridion added.
In addition to developing additional breath tests, Oridion has also begun the process for regulatory approval of the BreathID in Japan and other markets worldwide.
Published by Israel's Business Arena on 12 July, 2001