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FOR IMMEDIATE RELEASE

FDA approves gumEase® Cryo-Anesthetic dental mouthpiece for relief of dental pain without drugs

Laguna Hills, California USA (November 5, 2007) BioMeDevice Ltd. today announced that it has received FDA approval to market the new and innovative gumEase® Cryo-Anesthetic dental mouthpiece to US dental practitioners, and over the counter across the United States.

In 2006, gumEase® dental mouthpiece received its CE marking from the European Union, permitting the device to be sold throughout the European Economic Area.

gumEase® provides direct oral pain relief without the side effects or complications of drugs. It's a real time solution for practitioners plagued with patient needle phobia, sharps and the costs and complex issues of hypodermic delivery.

The easy-to-use, disposable device is a breakthrough in pain management - as effective as it is inexpensive. Inserted into the sulci above and below the upper and lower gums, the latex-free device delivers anesthetic pain relief to the maxillofacial nerves, quickly diminishing pain. In tests, 90% of patients had complete pain relief in just 2 to 3 minutes, regardless of severity.

"It gives practitioners and patients an option they didn't have before", says Tay McClellan, BioMeDevice CSO, "they can manage patient pain more effectively in a wider range of situations. Now it's not a problem to have a patient who cannot tolerate or will not use drug-based anesthesia." The device also holds promise for situations where needle use is limited such as the developing world, whose interest in the gumEase® is spurred by it's unique ease of use and cost efficiency.