ZURICH, Switzerland, March 16, 2006 (PRIMEZONE) -- Nobel Biocare (Other OTC:NBCHF) (Stockholm:NOBE) today released a synopsis of four forthcoming scientific publications on NobelDirect and NobelPerfect. All publications demonstrate that the marginal bone average stabilizes at the level of the first implant thread and consequently shows no unusual bone loss. One of the studies consists of 1,009 one-piece implants that confirm stable bone levels from 6 months up to 6 years, showing an overall survival rate of 98.2%. The data was presented at the 21st Annual Scientific Meeting of the Academy of Osseointegration (AO) in Seattle (USA).
Nobel Biocare has already presented a 1-year follow-up of the prospective multicenter study, initiated and ongoing as part of the regular post-marketing surveillance routinely performed as part of the quality-assurance system at the Company. The 1-year follow-up resulted in a survival rate of 98.3 % and showed that the marginal bone stabilizes at the level of the first thread in exactly the same way as seen in the studies of the well-documented Branemark System and NobelReplace.
To address any lingering concerns resulting from unsubstantiated allegations about the performance of NobelDirect, the Company has made a great effort to compile additional scientific information from clinicians all around the world. This has generated so far radiographs of 1,722 one-piece implants, of which it has so far been possible to evaluate 1,475, which are included in three different retrospective studies. All publications demonstrate that the marginal bone average stabilizes at the level of the first implant thread and consequently show no unusual bone loss.
One of these studies retrospectively covers 1,009 consecutively placed implants in 544 patients in 25 clinics in Germany. The implants were followed from 6 months up to 6 years, with an overall survival rate of 98.2%. The marginal bone level remained stable.
The second retrospective study reports on the radiographic evaluation of one-piece implants followed for up to 2 years. The treatment outcome for 22 patients receiving 37 implants demonstrates an implant survival rate of 97.3%, with a mean marginal bone level located well above the first implant thread, corresponding to the results in the prospective multicenter study.
A third publication of the worldwide radiographic evaluation of Nobel Biocare one-piece implants concerns 429 implants from 49 different clinics in the USA, Japan and Europe. The data shows stabilization of the marginal bone level slightly above the first thread after 1 year of loading.
Professor Daniel van Steenberghe, Holder of the Professor P-I Branemark Chair in Osseointegration, stated: "The fact that the company made the effort to gather data so quickly after the launch of a new implant geometry, the NobelDirect, the steeply accumulating clinical evidence should be welcomed by any concerned clinician." The evaluation continues with collection of additional information and radiographs.
As early as 7 February 2006, after a meeting organized by Lakemedelsverket, the Swedish Medical Products Agency, with Nobel Biocare and the clinicians who had claimed there was a problem with NobelDirect, the conclusion was that there was no reason to take any action and the case was closed.
The company has also compiled information on NobelPerfect. The report, covering 106 implants in 80 patients from 5 different clinics, shows stabilization of the marginal bone slightly above the first thread after 1 year of loading.
This extensive compilation of data on the Nobel Biocare implant systems will be published shortly as a supplement in EDI (European Journal for Dental Implantologists) and other scientific journals.
You will find a synopsis of the data published on www.nobelbiocare.com
Nobel Biocare is a medical devices group and the world leader in innovative esthetic dental solutions with its brands Branemark System, NobelSpeedy(tm), NobelReplace(tm), NobelPerfect, NobelDirect, Replace Select, NobelGuide(tm) (dental implants) and Procera (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.