biomaterial potential

anti-bacterial biomaterial potential yet to be priced into somnomed's current valuation. product fda approved and in use by somnomed.






SomnoMed Receives Approval for Biomaterial - feb 2008

Maker and marketer of dental sleep devices, SomnoMed Limited, announced that its Swiss Joint Venture, SMH Biomaterial AG, has received US Food and Drug Administration (FDA) approval for a new polymer, the SMH BFlex soft material. The material can now be used to make dental sleep devices in the United States. The company now also can market the material broadly in the United States to other dental and medical device companies.

In August 2007, SomnoMed acquired 50% of SMH Biomaterial AG, now a joint venture company with Konrad Hofmann, the inventor of the polymer. The joint venture owns all intellectual property rights to the product, while SomnoMed is responsible for the global marketing and distribution to manufacturers of dental and medical devices around the world.

"This is a milestone development for SomnoMed," said Ralf Barschow, chief executive of SomnoMed Limited. "We are currently assessing various marketing and distribution options to introduce this novel material to the markets around the world. We have already been approached by large, reputable companies seeking a license, private label agreements, or simply supply."

SomnoMed will use SMH BFlex as a new lining for its own SomnoMed MAS™, a dental device used to treat sleep apnea and snoring. "The use of SMH BFlex in our SomnoMed and SomnoDent oral sleep devices will give us a competitive advantage,” said Barschow. “The new material is not only superior in terms of patient comfort but also in terms of longevity and product appearance. SMH BFlex does not react to bacteria the same way as other materials and as a result does not take on unpleasant odors over time.”

The SomnoMed MAS device with the new SMH BFlex lining will be called SomnoDent Flex in Europe and SomnoMed Flex in the rest of the world. The product has been launched in Europe recently and will be launched in Australia/Asia in February and in the United States in March 2008.

The SomnoMed MAS is an oral appliance, which fits over the upper and lower teeth, much like a sports mouthguard. However, unlike a sports mouthguard, it is a custom-made, clinically tested medical device that is effective (in most cases) in stopping snoring and treating obstructive sleep apnea.