Biora's Principal Product Emdogain Approved By FDA For Minimally Invasive Surgical Treatment of Periodontitis.

MALMO, Sweden--(BUSINESS WIRE)--August 11, 1999--

BIORA AB (Nasdaq: BIORY, SSE: BIOR) The United States Food and Drug Administration (FDA) has approved Biora's principal product, Emdogain, for use as an adjunct to a minimally invasive surgical technique.

This indicates that Emdogain can be utilized in conjunction with scaling and root planning procedures for the treatment of periodontal intrabony defects in aesthetic zones to optimize tissue height. Aesthetic zones include the teeth and gums which appear when a person smiles. The aesthetic zone poses particular challenges to the dental practitioner in that soft tissue aesthetics is compromised in traditional periodontal surgical procedures.

"This is an important step for Biora and gives us the possibility to offer Emdogain to a greater number of customers than we do today," said Biora's CEO Tomas Hammargren. "This new indication places greater demands upon our marketing organization and we are evaluating additional sales channels."

According to data from ADA (American Dental Association) there are appr. 140,000 dentists in the United States and Biora estimates that the target group for this new indication is 60,000. Biora expects that Emdogain used in a minimally invasive surgical technique will have a potential application in conjunction with the approximately 17 million scaling and root planning procedures performed annually in the United States. Biora estimates that half of those are performed in the aesthetic zone.

Although this presents a marketing opportunity, additional clinincal documentation and market information will be required prior to introduction in the United States, which Biora expects within the next twelve months.

Emdogain was launched in Europe during 1996 for surgical treatment of severe periodontitis, in the USA during 1997 and in Japan during 1998. Sales during 1998 were approximately SEK 50 million and approximately SEK 17.2 million during the first quarter of 1999. The Interim Report for the first half of 1999 will be released on August 18.

Biora develops, manufactures and sells products for the treatment of periodontal disease and for use in oral surgery. Using its proprietary technology and expertise, Biora aims to become a world leader in biology-based products for specialized dental therapy. Biora's American Depository Shares are listed on the Nasdaq National Market in the US and Biora's ordinary shares are listed on the "O-list" of the Stockholm Stock Exchange in Sweden.

This press release may contain certain forward-looking statements that relate to the 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 discusses in periodic reports filed with the Securities and Exchange Commission.