BSD Medical Corporation (NASDAQ:BSDM) 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 Medical is also making major progress in the application of its technology for other therapies.

Microwave and RF hyperthermia therapy has been shown to substantially improve local control of cancer, tumor response and survival rates when added to radiation treatments. In phase III clinical trials where hyperthermia was combined with radiation therapy, hyperthermia improved 2-year local control of melanoma from 28% to 46%, complete response for recurrent breast cancer from 38% to 60%, 2-year survival for glioblastoma (brain cancer) from 15% to 31% and complete response for advanced cervical cancer from 57% to 83%, as compared to the use of radiation therapy alone.

BSD Medical Corporation was the first company to obtain PreMarket Approval (PMA) from the Food and Drug Administration (FDA) for a hyperthermia cancer therapy system and the first company to obtain Investigational Device Exemption (IDE) approval from the FDA for thermotherapy systems for the treatment of Benign Prostatic Hyperplasia (BPH). BSD has sold and manufactured over 200 hyperthermia systems installed throughout the world. Since its founding, BSD Medical has invested over $20 million in development of technology for hyperthermia treatment, and substantially greater funding has been provided for the clinical trials by the U.S. National Institutes of Health (NIH) and European governments.

BSD is also the developer of the microwave thermal therapy systems used by TherMatrx, Inc., a company dedicated to the treatment of symptoms associated with enlarged prostate, a health condition affecting half of men over age 50. BSD Medical is currently engaged in an earn-out that is projected to provide a cash return of approximately $30-40 million for the sales of its shares in TherMatrx, Inc.

BSD Medical has numerous domestic and foreign patents and patent licenses covering it's current applications and products. New technologies are also under development that may qualify for patent protection.

Four additional BSD patents that apply to the treatment of enlarged prostate (BPH), a urological disease, have been assigned to TherMatrx, Inc. BSD Medical’s prior licensee, Urologix, Inc. (NAS :ULGX), which has marketed under license to these patents, subsequently became a licensee to TherMatrx.

Over 1,000 researchers, consisting substantially of physicians and physicists, are members of world organizations dedicated exclusively to research in hyperthermic oncology. Three hyperthermia research organizations service North America, Europe and Asia.

In the opening address of the 2001 annual conference of the North American Hyperthermic Society (sponsored by the Radiological Society of North America), P. K. Sneed, M. D. (Univ. of California San Francisco) offered the following summary of completed Phase III randomized clinical trials involving combination ionizing radiation (RT) plus hyperthermia therapy (HT) vs. ionizing radiation treatments alone: “for melanoma (2-year local control 28% for RT vs. 46% for RT + HT), recurrent breast cancer (complete response rate 38% for RT vs. 60% for RT + HT), glioblastoma (2-year survival 15% for RT vs. 31% for RT + HT), and advanced cervical cancer (complete response rate 57% for RT vs. 83% for RT + HT).”

BSD Medical Corporation has developed the technology required to approach hyperthermia therapy through three techniques: superficial, interstitial and deep hyperthermia. These methods allow cancer to be treated virtually anywhere in the body.

Superficial hyperthermia systems are used to non-invasively treat tumors within a few centimeters of the surface of the body, typical in conditions of melanoma and recurrent breast cancer. Interstitial hyperthermia is primarily used to treat tumors in combination with popular interstitial and endocavitary ionizing radiation therapy (brachytherapy), using tiny microwave antennae inserted through the same catheters required to deliver radioactive seeds. This technique can be employed in treating prostate cancer, breast cancer, head and neck cancer and a variety of other cancer sites. Deep hyperthermia is used to non-invasively treat tumors deep within the body, including many problematic cancer sites located in the pelvis, abdomen and chest areas.

Development of the BSD-2000 Regional Hyperthermia System has been a substantial effort involving the cooperative work of such American research institutions as Duke University, Northwestern University, University of Southern California, Stanford University, University of Utah and University of Washington St. Louis. Contributing European research institutions included Daniel den Hoed Cancer Center of the Academisch Ziekenhuis (Rotterdam, Netherlands), Haukeland University Hospital (Bergen, Norway), Düsseldorf University Medical School, Tübingen University Medical School, Essen University Hospital, Charité Medical School of Humboldt University (Berlin), Luebeck University Medical School, Munich University Medical School Grosshadern, Interne Klinik Argirov of the Munich Comprehensive Cancer Center (all of Germany), University of Verona Medical Center (Italy), Graz University Medical School (Austria) and Kantonsspital Aarau (Switzerland).

Through research funded by the National Cancer Institute and supportive efforts by other research institutions, BSD Medical has been able to further enhance the BSD-2000. The BSD-2000/3D adds three-dimensional steering of deep focused energy, delivering even more precise heating to the tumor. As part of the international collaborative research efforts, sophisticated treatment planning software for the BSD-2000/3D has also been developed.

Both the BSD-2000 and BSD-2000/3D administer non-invasive treatment to deep tumors. As a further objective, MRI treatment monitoring has also been added. The BSD-2000/3D/MR provides magnetic resonance imaging (MRI) as an interface with the BSD-2000/3D. The development of MRI treatment monitoring has been a long-awaited breakthrough in hyperthermic oncology. Among many benefits, MRI treatment monitoring opens the way for the application of MRI monitored hyperthermia for better treatment of new cancer sites, using non-invasive imaging (including temperature monitoring) of tumors during therapy.