Biora Responding to 'Warning Letter' From U.S. Food and Drug Administration


BASEL, Switzerland, Jan. 19, 2007 (PRIME NEWSWIRE) -- In the course of a routine inspection of Biora AB, Straumann's oral regenerative product company in Sweden, in October 2006, a U.S. Food and Drug Administration (FDA) investigator made a number of observations predominantly concerning maintenance of quality system documentation and procedures associated with the company's products. Biora has received a "warning letter" from the FDA, which indicated that its "dental bone grafting materials" are on import detention in the U.S., until the inspectional observations are resolved. No other countries apart from the U.S. are affected.

The company is fully confident that its products continue to meet specifications and can be used safely. FDA has not requested that Biora recall product in the U.S. The company also believes that current supplies will meet customer and patient needs for the immediate future.

Straumann and Biora take the concerns of regulatory authorities very seriously and are committed to operating in full compliance with the FDA's regulations. Biora has already responded in detail to the observations raised by the inspection and will work with the FDA to resolve the issues in the warning letter as quickly as possible.

The products concerned are: Straumann BoneCeramic, Emdogain, and PrefGel.

BoneCeramic was introduced in North America in 2005. It is a fully synthetic alternative to human or animal derived bone substitutes and is used for bone augmentation in implant dentistry.

Emdogain is used as an adjunct to periodontal surgery as a topical application onto exposed root surfaces, and is indicated for the treatment of intra-bony defects due to moderate or severe periodontitis. Since its introduction in 1996, Emdogain has been used to treat more than one million patients and has been the subject of more than 300 scientific publications.

PrefGel is a convenient gel used to remove the smear layer on the tooth surface prior to application of Emdogain.

About Straumann

Headquartered in Basel, Switzerland, the Straumann Group (SWX:STMN) is a global leader in implant dentistry and oral tissue regeneration. In collaboration with the International Team for Implantology (ITI), leading clinics, research institutes and universities, the Group researches and develops implants, instruments and tissue regeneration products for use in tooth replacement solutions or to prevent tooth loss. The Group manufactures implant system components and instruments in Switzerland and the U.S. and oral tissue regeneration products in Sweden. Straumann also offers comprehensive training and services to the dental profession worldwide. Altogether, Straumann employs approximately 1544 people worldwide and its products and services are available in more than 60 countries through the Group's 18 distribution subsidiaries and broad network of distribution partners.


 Straumann Holding AG, Peter Merian-Weg 12, 4002 Basel, Switzerland
 Phone: +41 (0)61 965 11 11 / Fax: +41 (0)61 965 11 01
 E-mail: corporate.communication@straumann.com
 Homepage: www.straumann.com

Disclaimer

This release contains certain "forward-looking statements," which can be identified by the use of terminology such as "until," "are resolved," "will," "to resolve," 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.


            

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