Healthcare Industry News:  MicroThermX 

Devices Surgery Oncology FDA

 News Release - March 22, 2010

BSD Medical Files FDA 510(k) Submission to Market Phase II MicroThermX Ablation System

SALT LAKE CITY--(HSMN NewsFeed)--BSD Medical Corporation (NASDAQ:BSDM ) (Company or BSD) today announced that the Company has filed a 510(k) submission with the U.S. Food and Drug Administration (FDA) for premarket clearance of the Company's Phase II MicroThermX® Microwave Ablation System (MTX-180) for ablation of soft tissue. Clearance from the FDA of the 510(k) Premarket Notification submission will authorize commercial distribution of the MTX-180 in the United States.

The MTX-180 employs precision-guided microwave energy to ablate (destroy or vaporize) soft tissue. The MTX-180 is a compact, mobile system that includes a state-of-the-art computer, a microwave generator, single-patient-use disposable applicators and a proprietary thermistor-based temperature monitoring system. The delivery of microwave energy is controlled by time and power parameters set by the operator utilizing an interactive touch-screen monitor that allows the operator to quickly and easily control the treatment. The MTX-180 was developed to provide treatments as a stand-alone therapy.

“The MTX-180 represents a major part of our business plan moving forward,” said Harold Wolcott, BSD President. “It introduces into our product line a disposable applicator used in each treatment, which can provide a significant recurring revenue stream after the sale of the system.”

In September 2008, the FDA granted BSD a 510(k) clearance to market the Phase I MicroThermX® Microwave Ablation System (MTX-100). At the same time that BSD received the 510(k) clearance for Phase I of the MTX-100 System, BSD had started design of the more advanced, optimized Phase II ablation system. Clearance from the FDA for the MTX-180 will allow the Company to provide an optimized system targeted to the growing therapeutic interventional oncology market. The worldwide interventional oncology market for 2009 was estimated at $210 million, and this market is projected to grow to $480 million by 2015.

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 or vaporize) 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. 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.


Source: BSD Medical

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