GOTHENBURG, Sweden, Dec. 21, 2005 (PRIMEZONE) -- Based on Swedish law, Heliane Canepa, President and CEO of Nobel Biocare (Other OTC:NBCHF) in Gothenburg, has sent a formal request to the Vice-Chancellor at the Goteborg University asking for assistance in providing documents regarding alleged observations on NobelDirect implants. Nobel Biocare has made repeated requests to share the information, following the unsubstantiated criticism by two professors that NobelDirect is the cause for unexpected bone loss. Neither Nobel Biocare, nor the supervising authority, the Swedish Medical Products Agency, have as of today received any information supporting these allegations.
Two professors from Gothenburg University demanded in May 2005 that Nobel Biocare should withdraw the implant on grounds of unexpected bone loss. Taking these allegations seriously, Nobel Biocare already at first notice asked the professors to provide their relevant research data. The Company has repeated its request several times, but has been refused access to such data. However, the professors' unsubstantiated views were made public on Swedish National TV on 16 October. In order to bring transparency into the situation, Nobel Biocare requested the Swedish Medical Products Agency to look into this issue and provided its own documentation to the Agency, expecting that the professors would do the same. The Company is surprised that this has not happened so far.
Currently, Nobel Biocare has three multicenter clinical studies covering 236 implants. In addition, the company has collected information from dentists all over the world covering over 2,700 implants. There has been no unusual bone loss observed.
Earlier this week the Company formally requested the Academy to give access to documents, which by law should be presented on demand. Not having received anything, the Company is now in the letter formally requesting assistance from the Vice-Chancellor of Goteborg University. Nobel Biocare reserves its rights to take legal action.
Management concludes that NobelDirect is a safe and reliable product and underlines once more its commitment to the safety of the patients.
Disclaimer
This report may contain forward-looking statements including, but not limited to, projections of future performance of materials and products, financial conditions, results of operations and cash flows, containing risks and uncertainties. These statements are subject to change based on unknown risks and other factors that could cause the actual results or performance to differ materially from the statements made herein.
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, (dental implants) and Procera(r) (individualized dental prosthetics). Nobel Biocare is a one-stop shop for restorative esthetic dentistry, 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 1,600 employees and recorded revenue of EUR 388 million in 2004. 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 29 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.
Celebrating 40 years of scientific heritage. In 1965, the first patient was treated with the original scientific dental implant system, the Branemark System(r). This event marked a breakthrough in modern dental implant therapy. Since then, millions of people have been helped with dental implants, enjoying improved function, appearance and quality of life. The original fixtures that were placed in the first patient 40 years ago are still in place, providing the individual with firm bridge support. The Branemark System(r) has been scientifically documented in 1,500 articles.