ZURICH, Switzerland, March 27, 2006 (PRIMEZONE) -- Last Friday, a press agency published a report regarding the ongoing discussion in Sweden about NobelDirect. One could get the impression that the press agency published new facts in this case. That impression is wrong.
After a meeting organized by the Swedish Medical Products Agency on 6 February with Nobel Biocare (Other OTC:NBCHF) and the clinicians who had claimed that there was a problem, the Agency concluded that there was no reason to take any action against Nobel Biocare and its product NobelDirect. As far as the safety and the quality of the product are concerned, the case was closed.
Nevertheless, the Swedish authorities acknowledged that there was a significant difference in the data presented by the clinicians and Nobel Biocare. While the data from a prospective multicenter study presented by the Company show results for the NobelDirect implant that are comparable to conventional implants, the two clinicians claimed to have data which show bone resorption of more than 3mm in 20-30% of the cases.
The Swedish Medical Products Agency stated already after the initial meeting with the clinicians on 25 January, "The visiting clinicians and Nobel Biocare seem to interpret the results and their implications differently." And after the meeting on 6 February the Swedish Medical Products Agency urged Nobel Biocare and the clinicians to meet and carefully assess the underlying data in order to explain the differences observed.
Nobel Biocare has still not succeeded in obtaining access to the data used by the clinicians. The Company has reasons to believe that there are measurement differences or differences in the surgical approach as possible explanations for such clustering.
The Company welcomes the decision made by the Swedish Medical Products Agency to call two additional independent experts to review the data. Just ten days ago Nobel Biocare published a synopsis of three forthcoming scientific publications on NobelDirect. One of the studies consists of 1,009 one-piece implants from 25 clinics that confirm stable bone levels from 6 month up to 6 years, showing an overall survival rate of 98.2%.
Nobel Biocare continues to assure its full cooperation with the Swedish Medical Products Agency in this issue.
Nobel Biocare is a medical devices group and the world leader in innovative esthetic dental solutions with its brands Branemark System(r), NobelSpeedy(tm), NobelReplace(tm), NobelPerfect(r), NobelDirect(r), Replace(r) Select, NobelGuide(tm) (dental implants) and Procera(r) (individualized dental prosthetics). Nobel Biocare is a one-stop shop for restorative esthetic dentistry based on science, offering a wide range of innovative Crown & Bridge & Implant products, as well as training and education and clinically documented treatment concepts.
Nobel Biocare has some 1,650 employees and recorded revenue of EUR 485 million in 2005. The company is domiciled in Zurich, Switzerland with headquarters in Zurich and in Gothenburg, Sweden. Production takes place at four production sites located in Sweden and the USA. Nobel Biocare has direct sales organizations in 33 countries. The shares of the parent company Nobel Biocare Holding AG are listed on the SWX Swiss Exchange and on the Stockholm Stock Exchange, Sweden.