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Media release

Media release

Straumann launches new generation Bone Level Implant in Europe and North America

  • Comprehensive portfolio of implants and prosthetics available in key markets in fourth quarter of 2007; global roll-out underway in 2008
  • Fully integrated into Straumann’s existing Dental Implant System offering unparalleled simplicity and flexibility: one system, one instrument kit, same procedures
  • Data from extensive pre-launch clinical program to be presented at EAO in Barcelona and at AAP in Washington D.C.
  • Highly positive feedback from customers in pre-launch trials

Basel, 25 October 2007: Straumann today announced the eagerly awaited launch of its new-generation Bone Level Implant, which complements and adds to the company’s existing range of highly successful tissue level implants. The new implant line extension will be available in most parts of Europe, North America, Australia and New Zealand starting in the fourth quarter, with the roll-out to the rest of the world beginning in 2008.

The new implant comes in three diameters and four lengths and is suitable for all dental implant indications. There is a full matching prosthetic portfolio comprising 125 components, each carefully designed for simplicity, reliability and esthetic performance. There is also a CAD/CAM custom abutment service in titanium and ceramic. In true Straumann tradition, these have all undergone extensive testing prior to market introduction.

“This is undoubtedly one of the most significant milestones in the history of our company. To launch the new implant simultaneously in key markets with a comprehensive prosthetic portfolio and substantial clinical documentation has been a major organizational undertaking. We have focused our innovation skills on making this the most flexible and simple implant line of its kind. 130 clinical teams around the world as well as the ITI have helped us prove its reliability – to give dental professionals the peace of mind that they are offering the best individual standard of care to their patients”, said Gilbert Achermann, President and CEO.“

Impressive scientific backing
Straumann is making use of two major dental congresses – the 16th Annual Scientific Meeting of the European Association for Osseointegration in Barcelona and the 93rd Annual Meeting of the American Association of Periodontology in Washington, D.C. – to present data from the extensive research program supporting the new implant line. During the next four days, no fewer than 11 internationally renowned clinicians and researchers will present the latest findings from preclinical and multicenter clinical studies, including a large-scale non-interventional study. More than 1500 implants have already been clinically documented in over 800 patients by more than 130 centers around the world. At least 500 implants have been followed for more than 6 months.

Expert panel endorses market introduction
The complete set of available data was recently reviewed by a panel of experts including the principal investigators, who are all independent eminent clinicians. Their positive opinion provided the external confirmation for Straumann to go ahead and launch the product.

Two different types of implant dominate the market
Dental implants broadly fall into two categories depending on the level at which they connect to the prosthetic components that carry the tooth crown. In the case of tissue level implants, which were pioneered by Straumann, the connection is at the level of the gum. With bone level designs the prosthetic connection is underneath the gum at, or close to, the crest of the jaw bone. While advantages are claimed for each design, market research shows that the choice of implant type is driven mainly by user preference.

Research also indicates that up to 60% of implants are placed at bone level1. In the world’s largest market, the US, as many as 70% of all implants are bone level, making this a particularly attractive market opportunity for Straumann, who until now has focused exclusively on tissue level implants.

A new generation of implant with the SLActive surface
While the bone level concept is not new, the Straumann® Bone Level Implant introduces a number of innovative features, which – together with its well-thought-out portfolio of surgical and prosthetic components – position it as the new generation bone level implant.

One of its unique attributes is the remarkable SLActive surface, which has been shown to cut healing time by half2 in addition to providing higher security and more bone3. Preclinical histological studies have also shown that large bone defects are filled by virtue of SLActive’s remarkable ability to promote new bone formation around the implant surface (osseoconduction)4. SLActive is also associated with a significant reduction in the risk of implant loss5.

Reliability with Bone Control DesignTM

The Straumann® Bone Level Implant has been developed using a unique scientific concept called Bone Control DesignTM to preserve bone and provide the foundation for long-term esthetic success. This concept, which applies to Straumann’s entire implant system, respects five fundamental biological principles:

  • Implant surface osseoconductivity (especially with SLActive)
  • Biomechanical implant design (high fatigue strength and optimized bone stimulation)
  • Biological distance (the microgap between the implant and the prosthetic parts is horizontally offset from the bone)
  • Optimal position of the transition from the smooth to the rough surface (the transition is at the crestal bone level to provide maximum surface area for osseointegration)
  • Microgap control (the conical implant-abutment connection provides a tight joint and prevents micro-movement).

Handling simplicity with the CrossFitTM Connection
Implant dentistry involves working with tiny, high-precision components in restricted, poorly visible spaces. Straumann’s new CrossFit™ Connection inside the implant is an ingenious solution to this problem because it guides the abutment precisely into the correct position and enables the user literally to ‘feel the fit’. In addition to offering a variety of four positions, the CrossFit™ Connection safeguards against abutment rotation and has been specifically designed for ceramic as well as titanium abutments.

Esthetics through Consistent Emergence ProfilesTM
For all implant diameters there is a comprehensive matching portfolio of prosthetic components, including CAD/CAM custom ceramic abutments. Importantly, the healing, temporary and final abutments have been designed with matching base shapes, or ‘emergence profiles’. This facilitates the entire process of soft-tissue management and optimizes the esthetic result.

Ultimate simplicity: one system, one instrument set, same procedures
The combination of all these features, together with the impressive body of scientific and clinical data, provides dental professionals with a completely new level of confidence at bone level.

Furthermore, Straumann has carefully integrated the new Bone Level Implant into its existing Dental Implant System so that the same instrument kit and procedures can be used. Clinicians taking part in pre-launch trials have praised this unique advantage in addition to providing highly positive feedback on the implant itself.

Straumann is the only company that offers a full range of tissue and bone level implant options combined with state-of-the-art CAD/CAM prosthetics and regenerative solutions.

1 Straumann estimates based on available market data and independent reports
2 Oates TW et al.: Int J Oral Maxillofac Implants (Accepted)
3 Buser D et al.: J Dent Res 2004;83:529-533, Zöllner A: Clinical update; EAO, Zurich, 2005
4 Becker J, Schwarz F (Heinrich-Heine University, Düsseldorf, Germany): Data presented at 15th Annual Scientific Meeting of the EAO, Zurich, 2006
5 Internal data on first 90 000 SLActive implants sold show loss rate of 0.6% vs. SLA benchmark of 1.3%

Disclaimer
This release contains certain “forward-looking statements”, which can be identified by the use of terminology such as “available…from”, “to be”, “will”, “demand”, or similar wording. Such forward-looking statements reflect the current views of management and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements of the Group to differ materially from those expressed or implied. These include risks related to the success of and demand for the Group’s products, the potential for the Group’s products to become obsolete, the Group’s ability to defend its intellectual property, the Group’s ability to develop and commercialize new products in a timely manner, the dynamic and competitive environment in which the Group operates, the regulatory environment, changes in currency exchange rates, the Group’s ability to generate revenues and profitability, and the Group’s ability to realize its expansion projects in a timely manner. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in this report. Straumann is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in it as a result of new information, future events or otherwise.