BSD Medical files 510(k) submission for premarket clearance of Phase II MTX-180

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.

“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.”

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.