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BSD Medical provides update on Taiwan FDA clearance for BSD-2000

BSD Medical announced that BSD's exclusive Taiwan distributor, Linden Bioscience has informed BSD that the Taiwan Food and Drug Administration (TFDA) marketing approval for the BSD-2000 Hyperthermia System (BSD-2000) is in process and the import permit is expected to be issued in the near future.

Linden has committed to an initial purchase of four (4) BSD-2000 Hyperthermia Systems. BSD will commence shipping systems as soon as the import license is issued.

"We are excited to have the opportunity to start distributing the BSD-2000 Hyperthermia Systems in Taiwan," stated Mr. Tainang Huang, President of Linden. "We have worked closely with the TFDA on the marketing approval process so that we could capitalize on the large market for the BSD-2000 in Taiwan. We have already met with many prominent Taiwan physicians from several hospitals, including the very influential and largest hospital system in Taiwan, Chang Gung Memorial."

"We are pleased at the prospect of the TFDA import permit being issued and excited to work with such a prestigious Taiwanese company. We are confident in Linden’s ability to make the BSD-2000 a success in Taiwan," stated Harold R. Wolcott, President and CEO of BSD Medical. "There is a substantial marketing opportunity for BSD’s products in Taiwan, which is one of the most advanced medical device markets in Asia. The progress in Taiwan validates our efforts to expand our business in Asia."

Taiwan has a strong healthcare system that provides universal health insurance. Taiwan’s medical device market is approximately $1.6 billion.