BSD Medical Corp has received FDA approval for a new operating system that revolutionizes the treatment of cancer patients using superficial and interstitial hyperthermia therapy. This approval opens the door to the commercial introduction of four new systems to sales in the United States. In addition to treating melanoma, recurring breast cancer and other cancers requiring superficial therapy, these new products are intended to be companion systems to the more than 1,500 installed brachytherapy systems used for interstitial radiotherapy.

The new systems have been six years in planning and development. Their extensive development effort followed a 1996 publication of a Johns Hopkins Hospital study in CANCER (the official journal of the American Cancer Society), which concluded that interstitial hyperthermia was convenient, safe and effective in treating human cancers. Numerous other studies have supported this conclusion.

The new BSD-500i-4, BSD-500c-4, BSD-500i-8 and BSD-500c-8, which are based on the new operating system, bear little resemblance in appearance to anything previously seen in hyperthermia systems. They are compact, portable and ergonomically engineered for use in a demanding hospital environment. A high-resolution graphic touch-screen display drives the new systems, upstaging anything ever before seen in operator control for similar applications. The over 20,000 lines of code in the new systems software are supported by new high-performance hardware, which the FDA also approved as part of the configuration of the new operating system.

Superficial hyperthermia is used to non-invasively treat cancerous tumors located within a few centimeters of the surface of the body, such as melanoma and recurrent breast cancer. Interstitial hyperthermia is used in treating prostate cancer, breast cancer, head and neck cancer and a variety of other cancers. BSD Medical has FDA market approval for superficial hyperthermia treatment, and has both obtained and owns the rights to all FDA market approvals that have been issued to treat cancer using microwave interstitial hyperthermia.