GEM 21S gains CE Mark for perio, regenerative use

BioMimetic Therapeutics has received CE Mark approval from the European Union (EU) for its GEM (growth factor enhanced matrix) 21S product, with broader periodontal and alveolar bone regeneration indications than in the U.S. and Canada.

The additional indications approved in the EU are for the treatment of osseous defects resulting from tooth extraction and trauma.

Additionally, GEM 21S is approved in the EU for use in compromised patients in whom poor healing may occur. This approval, obtained on behalf of Luitpold Pharmaceuticals, triggers a $10 million final milestone payment from Luitpold to the company.

The milestone payment was a condition of the company's sale of GEM 21S to Luitpold in 2008, the company said.

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