SALT LAKE CITY, Sep 01, 2010 (BUSINESS WIRE) -- BSD Medical Corporation /quotes/comstock/15*!bsdm/quotes/nls/bsdm (BSDM 2.30, +0.10, +4.55%) (Company or BSD) today reported that the Company has received certification that the MicroThermX Microwave Ablation System (MTX-180) meets all requirements for safety and performance needed for compliance with the IEC 60601-1, safety standard, "Medical Electrical Equipment Part 1: General Requirements for Safety." IEC 60601-1 is the global benchmark for safety of medical equipment and is a crucial tool for demonstrating compliance with regulatory requirements around the world, including the requirements for CE Marking and FDA clearance. Receipt of this certification will allow BSD to add the TUV safety mark to the MTX-180 system. Nearly all hospitals and clinics in the U.S. require a safety mark on equipment prior to purchase.
"The receipt of this safety certification for the MTX-180 is a significant milestone for the Company and critical for marketing the MTX-180 system in the U.S. and Europe, as well as in most markets throughout the world," stated Harold Wolcott, President of BSD. "We are excited to have completed this important step toward marketability of the MTX-180."
TUVRheinland(R) performed independent testing of all components and operations of the MTX-180 and performed an on-site assessment of BSD's internal control systems for ensuring product quality before it accredited the MTX-180. TUVRheinland is a nationally recognized testing laboratory and is recognized as a U.S. National Certification Body by the International Electrotechnical Commission.
About BSD Medical Corporation
BSD Medical Corporation develops, manufactures, markets and services systems to treat cancer and benign diseases using heat therapy delivered using focused radio frequency (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, which the Company will introduce to the market this year, has been developed as a stand-alone therapy to employ precision-guided microwave energy to ablate (destroy) soft tissue. The Company has extensive intellectual property, multiple products in the market and well established distribution in the United States, Europe and Asia. Certain of the Company's products have received regulatory approvals in the United States, Europe and China. The U.S. Food and Drug Administration (FDA) has granted the Company a 510(k) clearance to market the MTX-180 for ablation of soft tissue. For further information visit BSD Medical's website at www.BSDMedical.com.
Statements contained in this press release that are not historical facts are forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995. All forward-looking statements are subject to risks and uncertainties detailed in the Company's filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date on which such statements are made, and the Company undertakes no obligation to update such statements to reflect events or circumstances arising after such date.
