SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 6-K
REPORT OF FOREIGN ISSUER
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
Date of Report: August 11, 1999
BIORA AB
SE-205 12 Malmo, Sweden
Telephone: (011) 46-40-32-13-33
Indicate by a check mark whether the registrant files or will
file annual reports under cover of Form 20-F or Form 40-F.
(X) Form 20-F ( ) Form 40-F
Indicate by check mark whether the registrant by furnishing the
information contained in this Form is also thereby furnishing the
information to the Commission pursuant to Rule 12g3-2(b) under the
Securities Exchange Act of 1934.
( ) Yes (X) No
If "Yes" is marked, indicate below the file number assigned to
the registrant in connection with Rule 12g3-2(b):
Not applicable.
This Form 6-K consists of a press release issued by Biora AB on
August 11, 1999 relating to Biora's principal product, Emdogain, being
approved by the United States Food and Drug Administration for minimally
invasive surgical treatment of periodontitis.
Press Release from Biora AB (publ), dated August 11, 1999
BIORA'S PRINCIPAL PRODUCT EMDOGAIN APPROVED BY FDA
FOR MINIMALLY INVASIVE SURGICAL TREATMENT OF PERIODONTITIS
Malmo, Sweden, April 23 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 planing 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 planing 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 clinical
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 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
Securities and Exchange Commission.
PRESIDENT AND CEO INVESTOR RELATIONS U.S INVESTOR RELATIONS
TOMAS HAMMARGREN MIKAEL SJOBLOM ELISABETH LAVERS
+ 46 40 32 13 36 + 46 40 32 13 65 + 1 203 977 7797
Pursuant to the requirements of the Securities Exchange Act of 1934,
the Registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
BIORA AB
Dated: August 11, 1999 By: /s/ Anders Agering
-------------------------
Anders Agering
Chief Financial Officer
