Taiwanese Regulators Approve BSD’s Hyperthermia System

BSD Medical Corporation has received clearance from the Taiwan Food and Drug Administration to market the BSD-2000 hyperthermia system.

Developed and patented exclusively by BSD Medical, the BSD-2000 delivers focused therapeutic heating to cancerous tumors by applying radiofrequency (RF) energy. The system uses focused electromagnetic energy to target the shape, size and location of the tumor, controlling the heating delivered to tumors.

“There is significant interest in purchasing the BSD-2000 in Taiwan, and we look forward to being able to capitalize on this opportunity,” said Tainang Huang, president of BSD’s Taiwanese distributor, Linden Bioscience. The distributor has committed to an initial purchase of four BSD-2000 Hyperthermia systems for market introduction.

Salt Lake City, Utah-based BSD Medical is planning to ship the systems in the current fiscal year ending Aug. 31. Taiwan’s medical device market is worth about $1.6 billion, according to industry estimates.

In 2011, BSD Medical obtained humanitarian device exemption marketing approval for the BSD-2000 from the U.S. Food and Drug Administration. The machine is approved for use in conjunction with radiation therapy for the treatment of cervical cancer patients who normally would be treated with combined chemotherapy and radiation but are ineligible for chemotherapy due to patient-related factors.

The company also has CE mark approval for the commercial sale of BSD-2000 in Europe.