PatIntNews

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

In August 2007, SomnoMed acquired 50 percent of SMH Biomaterial AG, now a joint venture company with Mr 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 is assessing the global application and potential for SMH BFlex, especially outside the dental industry. "The global applications for SMH BFlex could be substantial and we will only make final decisions on how to distribute the material once thorough investigations are completed," said Barschow.

SomnoMed will use SMH BFlex as a new superior lining for its own SomnoMed MAS™, the dental device used to treat sleep apnoea and snoring. "The use of SMH BFlex in our SomnoMed and SomnoDent oral sleep devices will give us a competitive advantage. 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 odours over time. We believe the use of SMH BFlex in our devices will strengthen SomnoMed's claim for leadership in the dental sleep markets around the world," said Barschow.