BSD Medical announces Taiwanese regulatory clearance for BSD-2000 hyperthermia system

26 February 2014 (Last Updated February 26th, 2014 01:00)

Provider of medical systems that use heat therapy to treat cancer, BSD Medical, has announced that its exclusive Taiwanese distributor, Linden Bioscience (Linden), has obtained Taiwan Food and Drug Administration (TFDA) marketing clearance for the BSD-2000 hyperthermia system (BSD-2000).

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Provider of medical systems that use heat therapy to treat cancer, BSD Medical, has announced that its exclusive Taiwanese distributor, Linden Bioscience (Linden), has obtained Taiwan Food and Drug Administration (TFDA) marketing clearance for the BSD-2000 hyperthermia system (BSD-2000).

Developed and patented exclusively by BSD Medical, the BSD-2000 is intended to deliver focused therapeutic heating to cancerous tumours by applying radiofrequency (RF) energy.

The system uses focused electromagnetic energy to target the shape, size and location of the tumour, providing dynamic control of the heating delivered to the tumour region.

Linden president Tainang Huang said: "There is significant interest in purchasing the BSD-2000 in Taiwan, and we look forward to being able to capitalise on this substantial marketing opportunity."

Distributor of medical devices in Taiwan, Linden has committed to an initial purchase of four BSD-2000 Hyperthermia systems for market introduction.

BSD Medical is planning to ship the systems in the current fiscal year ending 31 August 2014.

BSD Medical vice-president of sales and marketing Sam Maravich said: "We are excited to work with such a prestigious Taiwanese company, and we are confident in Linden's ability to effectively market the BSD-2000 in Taiwan.

"Taiwan has one of the most advanced medical device markets in Asia and is worth approximately $1.6bn."

"Obtaining TFDA approval in Taiwan validates our efforts to expand our business in Asia."

Taiwan has one of the most advanced medical device markets in Asia and is worth approximately $1.6bn, with a strong healthcare system that provides universal health insurance.

In 2011, the company obtained humanitarian device exemption (HDE) marketing approval for the BSD-2000 from the US Food and Drug Administration (FDA).

The BSD-2000 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.


Image: BSD-2000 system receives Taiwan Food and Drug Administration (TFDA) marketing approval. Photo: courtesy of US Food and Drug Administration.