SALT LAKE CITY--(BUSINESS WIRE)--
BSD Medical Corporation (BSDM) (Company or BSD) (www.BSDMedical.com), a leading provider of medical systems that utilize heat therapy to treat cancer, announced today that its exclusive Taiwan distributor Linden Bioscience Co., Ltd. (Linden), has submitted its BSD-2000 marketing approval application for the BSD-2000 Hyperthermia System (BSD-2000) to the Taiwan Food and Drug Administration (TFDA). The TFDA approval of the BSD-2000 could occur as early as November 2013.
“Since signing our exclusive distributor agreement with BSD, Linden has had ongoing and very productive meetings with the TFDA,” stated Mr. Tainang Huang, President of Linden. “We have filed the BSD-2000 marketing application with the TFDA, and we are working closely with the TFDA to obtain an expedited approval for marketing the BSD-2000 in Taiwan. We have also met with many prominent Taiwan physicians from several hospitals, including the very influential and largest hospital system in Taiwan, Chang Gung Memorial. As a result of our extensive efforts to introduce the BSD-2000 in Taiwan, we have been invited to present on the BSD-2000 at an international symposium on hyperthermia in Taipei, which will be held in November 2013 at Wan Fan Hospital, Taipei Medical University. We are excited about the interest expressed in the BSD-2000 in Taiwan.”
About the BSD Hyperthermia Systems
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 tumor, thus providing dynamic control of the heating delivered to the tumor region. The BSD-2000 has Humanitarian Device Exemption (HDE) marketing approval from the U.S. 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.
About BSD Medical Corporation
BSD Medical Corporation develops, manufactures, markets and services systems to treat cancer and benign diseases using heat therapy, which is delivered using focused radiofrequency (RF) and microwave energy. BSD’s product lines include both hyperthermia and ablation treatment systems. BSD’s hyperthermia cancer treatment systems, which have been in use for several years in the United States, Europe and Asia, are used to treat certain tumors with heat (hyperthermia) while increasing the effectiveness of other therapies such as radiation therapy. BSD’s microwave ablation system has been developed as a stand-alone therapy to employ precision-guided microwave energy to ablate (destroy) soft tissue. The Company has developed extensive intellectual property, multiple products in the market and established distribution in the United States, Europe and Asia. Certain of the Company’s products have received regulatory approvals and clearances in the United States, Europe and China. For further information visit BSD Medical's website at www.BSDMedical.com.
This press release may be deemed to contain forward-looking statements, which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including the expected use of proceeds relating to the recently completed offering. Readers are cautioned that these forward-looking statements are only predictions and may differ materially from actual future events or results due to a variety of factors, including, among other things, the demand for the Company’s products, the ability of the Company to produce the products to meet the demand, global economic conditions and uncertainties in the geopolitical environment and other risk factors set forth in the Company’s most recent reports on Form 10-K and Form 10-Q. Any forward-looking statements in this release are based on limited information currently available to the Company, which is subject to change, and the Company will not necessarily update the information.
William Barth, 801-972-5555