A new indication for EmdogainGel approved in EU

Report this content

A new indication for EmdogainGel approved in EU Biora has received European Union approval for a new indication for EmdogainGel in the treatment of recession defects (exposed root surfaces). Biora plans to launch this new indication in April, 2003. Donna Janson, CEO and President of Biora comments: " The recent approval within the European Union for the use of EmdogainGel in the treatment of recession defects demonstrates the expanding role of biology-based products in dental applications. Aesthetic soft tissue procedures are common in the United States and it is Biora´s belief that the number of these procedures is now increasing in Europe due to improved surgical techniques and increased patient demand for aesthetic procedures. Currently, there are conventional approaches for soft tissue coverage procedures. The use of EmdogainGel as an adjunct to these techniques increases the quality of the newly regenerated attachment and thereby improves the potential for long-term success." During the third quarter 2002, Biora also submitted an application for this indication to the Food and Drug Administration, the regulatory authority in United States, and is currently awaiting a response. Biora develops, manufactures and sells biology-based products for the treatment of dental diseases. The principal product, Emdogain®Gel, which is approved for sale in Europe, North America and Japan naturally regenerates the supporting structure that the tooth has lost due to periodontal disease. Biora's American Depository Shares are quoted in the OTC market in the US and Biora's ordinary shares are listed on the "O-list" of the Stockholm Stock Exchange (Stockholmsbörsen) in Sweden. This press release may contain certain forward- looking statements that relate to future events or future business and financial performance. Such statements can only be predictions and the actual events or results may differ from those discussed. The Company cautions that these statements are subject to important factors that could cause actual results to differ materially from those expressed or implied in such forward- looking statements and are more fully discussed in periodic reports filed with the Securities and Exchange Commission. For further information, please contact: Tommie Johansson, Corporate Communications and Investor Relations, Biora tel:+46 70 32 21 365 Donna Janson, President and CEO of Biora, tel: +46- 40-32 12 28 http://www.biora.com ------------------------------------------------------------ This information was brought to you by Waymaker http://www.waymaker.net The following files are available for download: http://www.waymaker.net/bitonline/2002/11/22/20021122BIT00210/wkr0001.doc http://www.waymaker.net/bitonline/2002/11/22/20021122BIT00210/wkr0002.pdf