Altered Production Process for Japan.Business Editors, Health/Medical Writers MALMO, Sweden--(BUSINESS WIRE)--Nov. 16, 2000 Biora AB (Nasdaq:BIORY) (SSE (1) An earlier full-screen editor in OS/2. (2) (Streaming SIMD Extensions) A series of additional instructions built into Pentium CPU chips for improved multimedia performance by performing mathematical operations on multiple sets of data at the :BIOR) announced today that Biora's partner in Japan, Seikagaku Corp, has unintentionally omitted to report to the Japanese health authority, MHW MHW abbr. mean high water , changes in the production process of Emdogain that were introduced for markets outside Japan. As a result Seikagaku decided on Wednesday, Nov.15 to make a voluntary withdrawal of all deliveries of Emdogain in Japan. It is Seikagaku's intention to apply to MHW for approval of the process changes, including heat treatment, which are already in place in Europe. It should be possible to obtain MHW approval of the European standard for the production process within some months. In a commentary Biora's President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. Rickard Soderberg stated: "Seikagaku is merely complying with the rules of the national authorities, but at the same time points out in their notice to customers that no health problems whatsoever have been reported as a result of using Emdogain. The product has been used successfully on more than 200,000 patients. We are now awaiting their requirements following their evaluation, and will be able to deliver Emdogain immediately after such approval. In the short term we do not foresee any negative impact on Biora's sales of Emdogain to Japan. The direct financial consequences of the withdrawal will be taken by Seikagaku." Biora develops, manufactures, and sells products for the treatment of periodontal disease Periodontal Disease Definition Periodontal diseases are a group of diseases that affect the tissues that support and anchor the teeth. Left untreated, periodontal disease results in the destruction of the gums, alveolar bone (the part of the jaws where 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 The place where a deposit is placed and kept, e.g., a bank, savings and loan institution, credit union, or trust company. A place where something is deposited or stored as for safekeeping or convenience, e.g., a safety deposit box. 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 The Stockholm Stock Exchange (Swedish: Stockholmsbörsen) is a stock exchange located in Stockholm, Sweden. Founded in 1863 [1] it is the primary securities exchange of the Nordic Countries. in Sweden. This press release may contain certain forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. 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. |
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