GOTEBORG, Sweden, Dec. 16, 2005 (PRIMEZONE) -- Allegations from university professors in Gothenburg that the NobelDirect implant is causing bone loss are today met with firm denials by Nobel Biocare (Other OTC:NBCHF) (Stockholm:NOBE). "We have until today not seen one trace of evidence to support these allegations," stated Heliane Canepa, President and CEO of Nobel Biocare. "However, we are taking these allegations very seriously and consequently made a thorough analysis of our clinical studies. We have also contacted many clients to verify whether they have made any unusual observations. None of the available information supports the critical remarks of the professors."
One year after the launch of NobelDirect, two professors at the Sahlgrens Academy pronounced criticism and urged Nobel Biocare to withdraw the implant due to findings of what they call bone loss.
Already at first notice in May 2005, Nobel Biocare immediately and also later repeatedly asked the professors to provide their research leading to these allegations, but they have refused to present their material to Nobel Biocare. Until these data are presented, their data has to be considered as anecdotal information. The university's alleged findings were also not presented to the Swedish Medical Products agency (Lakemedelsverket), which Nobel Biocare approached immediately after the allegations were presented on Swedish TV in October. Based upon Nobel Biocare's suggestion, however, the agency plans to review the information, a process that Nobel Biocare is fully supporting.
"Lacking the two professors alleged research findings, we must lean upon our own very thorough analysis," said Heliane Canepa. "Nobel Biocare continuously conducts evidence-based research with clinical studies and investigations. Available data for the implant, now in the market more than one and a half years, show the same good results as for the company's other implant lines. These analyses in fact show that NobelDirect behaves very similarly to the company's Branemark System, which is the most documented implant on the market with over 1,500 scientific publications."
"The changes around the NobelDirect implant criticized by the professors could be explained by the fact that this implant can be placed deeper in the bone as compared to other implants," stated Jeppe Magnusson, Vice President Research and Development. "They are looking at a bone remodelling figure that depends on how deeply the implant is placed. What is relevant though, is how much of the threaded part of the implant remains covered by bone."
Nobel Biocare has contacted high volume NobelDirect clients to verify whether they have made observations similar to those of the Gothenburg professors. These clients have in their turn examined their patients to make further investigations. None of these contacts have given support to the critical remarks of the professors.
"During 40 years, millions of patients from all over the world have been treated with Nobel Biocare implants. This bank of knowledge, made up from the practicing dentists' experience with implants, is of greatest importance for a professional evaluation of the quality of NobelDirect," Heliane Canepa states.
"We hope to bring this dispute to an end," Heliane Canepa continued. "We are committed to the safety of the patients and we fear that some patients will be unnecessarily worried over these unsubstantiated claims."
As the relatively new NobelDirect represents a very small portion, just around 2%, of the total revenue for Nobel Biocare, the company is confident to reach this year's guidance.
NOBEL BIOCARE HOLDING AG
Facts and figures about NobelDirect(r)
Nobel Biocare introduced the NobelDirect implant in March 2004, a derivative of the successful NobelReplace implant. To date, approximately 60,000 NobelDirect implants have been installed showing the same good results as for the company's other implant lines.
NobelDirect is a one-piece implant, which means that the portion of the implant anchored in bone and the portion penetrating the soft tissue are combined in one piece, as opposed to a two-piece implant where one part is anchored in bone and a separate part penetrates the soft tissue.
The bone-anchored portion of NobelDirect is identical to the NobelReplace implant, which was introduced on the market in 1997. The surface on the NobelDirect implant is the TiUnite surface, which is the same surface used on the Branemark System and NobelReplace implants. NobelReplace and TiUnite are successfully documented in 71 scientific publications.
Nobel Biocare is conducting a prospective study, including 111 implants in 65 patients, on the NobelDirect implant, in 5 different clinics in Europe and the U.S. The implant survival rate in this clinical study is 98.1% after 1 year of loading. The average bone level is located -0.82 plus or minus 1.40 mm below the reference point, i.e. the lower corner of the vertical part of the implant. This means that the bone level is slightly above the first thread of the implant. The reported survival rate is at or above what is typical.
In addition, Nobel Biocare is conducting prospective clinical studies on the NobelPerfect One-Piece and the NobelDirect 3mm implants, respectively. These multi-center studies include another 125 implants in 81 patients.
The current outcome of these ongoing studies demonstrate a mean marginal bone level and frequency distribution at 1 year similar to that reported by Glauser(a) et al in which Branemark System implants were followed in an prospective clinical study. This means that the amount of implants showing bone-remodelling below the first thread is similar in the NobelDirect Study and the Branemark System study respectively.
The studies are 3-year follow-up projects and Nobel Biocare will continue to monitor the outcome carefully. Results will be presented periodically and upon completion.
Disclaimer:
This release 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 and bridge and 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.
(a) Glauser R, Ruhstaller P, Windisch S, Zembic A, Lundgren AK, Gottlow J, Hammerle CHF. Immediate occlusal loading of Branemark System TiUnite implants placed in predominantly soft bone: 4-year results of a prospective clinical study. Clin Implant Dent Relat Res 2005;7 (Suppl 1):52-59.