SALT LAKE CITY
BSD Medical Corporation (NASDAQ:BSDM) (the “Company” or “BSD”) announced today the sale and shipment of a BSD-2000 hyperthermia system (BSD-2000) to Dalian Orientech Co. LTD (“Orientech”), the Company’s exclusive distributor in the People’s Republic of China. Orientech has placed a significant number of BSD-2000 Hyperthermia Systems in leading hospitals throughout China. The BSD-2000 non-invasively delivers localized therapeutic heating (hyperthermia) by applying radiofrequency (RF) energy to certain cancerous tumors, including those located deep within the body. Clinical studies have shown that hyperthermia treatment can kill cancer cells directly, as well as increase the effectiveness of other cancer therapies, including radiation therapy, for the treatment of certain tumors.
BSD signed a long-term exclusive distributor agreement with Orientech in 2005. During the period of the original agreement BSD sold 17 BSD-2000s to Orientech. In 2012 BSD renewed its exclusive distributorship agreement with Orientech. The 2012 agreement requires Orientech to purchase a minimum of 32 BSD-2000s over a four-year period, commencing when Orientech receives renewal of their original approval to sell the BSD-2000 from China’s Food and Drug Administration (the “CFDA”). CFDA approval has to be renewed every four years for all medical devices. While renewal from the CFDA is pending, Orientech has obtained approval to import BSD-2000s on a limited basis.
About the BSD-2000 Hyperthermia System
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 is a leading developer of systems used to provide cancer therapies requiring precision-focused heat through RF/microwave technologies. The Company’s systems have been designed to kill cancer through heat alone, and as companion therapies to improve the combined results when used along with radiation and chemotherapy treatments. 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.
CONTACT
BSD Medical Corporation
William Barth, 801-972-5555
fax:
801-972-5930
investor@bsdmc.com
