Linden Bioscience Co., BSD Medical Corp.'s exclusive Taiwan distributor, has informed 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 is a leading distributor of sophisticated medical devices in Taiwan and has committed to an initial purchase of four 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 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.
The BSD-2000 – developed and patented exclusively by BSD – delivers localized therapeutic heating (hyperthermia) by applying radiofrequency (RF) energy. The BSD-2000 creates a central focusing of energy that can be electronically focused to target the shape, size and location of the tumour, thus providing dynamic control of the heating delivered to the tumour region. The BSD-2000 has Humanitarian Device Exemption (HDE) marketing approval from the US Food and Drug Administration (FDA) for use in conjunction with radiation therapy for the treatment of cervical cancer patients who are ineligible for chemotherapy. The BSD-2000 also has CE (Conformité Européenne) Marking approval for the commercial sale in Europe. CE Marking approval is also recognized in many countries outside of the EU.
BSD Medical Corporation is a leading provider of medical systems that utilize heat therapy to treat cancer.