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10 October 2008

Direx Korea Achieves KFDA Approval for Tempro BPH Treatment System

Following CE approval and successful use of the Tempro system in Europe, Direx Korea recently received approval for the device by Korean Food and Drug Administration.

Tempro, an innovative system treating BPH, uses a Bipolar Radio Frequency technology. A Multielectrode Applicator on a 16 Foley catheter is used during treatment. The Bipolar technology allows localized treatment around the urethra with maximum safety to rectum and external sphincter.

Direx Korea is presently marketing the Tempro device in Korea.

About DirexGroup:
DirexGroup and Initia have created an alliance that specializes in introducing innovative high-technology treatment devices for urologists in all worldwide markets. DirexGroup, established over 20 years ago, has continuously extended its worldwide presence in numerous countries and markets. DirexGroup has put its emphasis on the field of urology and offers urologists and medical centers various equipment and services solutions to their clinical and economic needs. Our products are characterized by reliability, modularity, and transportability combined with cost effectiveness and ease of use. Worldwide network of committed service centers assure adequate support and maintenance

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Following CE approval and successful use of the Tempro system in Europe, Direx Korea recently received approval for the device by Korean Food and Drug Administration.

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