The BSD 2000 uses RF energy to deliver localized therapeutic heating to tumor sites. In the U.S., the device is sold under a humanitarian device exemption from the FDA, “for use in conjunction with radiation therapy for the treatment of cervical cancer patients who are ineligible for chemotherapy,” according to a regulatory filing.
BSD said its Taiwan distributor, Linden Bioscience, is working with the Taiwan Food & Drug Administration on the licensing and importation process for the device, which is expected to issue "in the near future." Linden committed to an initial purchase of 4 systems, according to the filing.
“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. 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,” president and CEO Harold Wolcott said in prepared remarks.