Press release from the meeting regarding Nobel Direct implant, February 6, 2006

Yesterday, participants from Medical Products Agency, Nobel Biocare and clinicians met for a discussion regarding the amount of bone resorption for the Nobel Direct dental implant.

Nobel Biocare presented data from the multicenter prospective study. The results for the Nobel Direct implant are comparable to conventional implants. The Gothenburg group appreciates the significance of the information presented in the study that encompasses 12 month prospective data. A constructive discussion followed. Based on the data presented at the meeting the Medical Products Agency has found no reason to withdraw the implant from the market. Nobel Biocare will continue to carefully monitor the development of the prospective study and has an obligation to act swiftly if compromising data should emanate. Visiting clinicians presented data from ongoing clinical studies. The data from the Gothenburg group differ significantly from the rest of the multicenter data which they are part of. The Medical Products Agency as well as Nobel Biocare appreciates the significance and importance of the work of the Gothenburg group. The Medical Products Agency therefore urges Nobel Biocare and the Gothenburg group to meet and carefully assess the underlying data in order to explain the differences observed. Lennart Philipson, Ph.D. Director Medical Devices Medical Products Agency Participants: For the Gothenburg group: Dr. Mats Hellman Dr. Lars Jonsson Professor Lars Sennerby Professor Tomas Albrektsson For Nobel Biocare: Dr. Jeppe Magnusson Dr. Robert Gottlander Dr. Lars Enbom Dr. Torsten Siepenkothen Professor Daniel van Steenberghe, external consulting expert For the Medical Products Agency: Professor Björn Klinge, external consulting expert Mr. Mats Ohlson, MPA Mr. Arne Kardell, MPA Dr. Lennart Philipson, MPA