To: Greg S. who wrote (74 ) 1/25/2000 1:34:00 PM From: Micro-Selector Read Replies (1) | Respond to of 7143
Duke research of BSDM technology It's my understanding this data currently being reviewed by FDA for approval of BSD-2000 system in US. CE Mark for sales to Europe (according to 10Q) is already in the bag. ************************* Tuesday January 25, 8:19 am Eastern Time Company Press Release Duke University Reports Progress in Treating Sarcomas with BSD Equipment SALT LAKE CITY, Jan. 25 /PRNewswire/ -- BSD Medical Corp. (OTC Bulletin Board: BSDM - news) today announced encouraging progress at Duke University in treating soft tissue sarcomas using the BSD-2000 Hyperthermia system. Soft tissue sarcomas are cancerous tumors located in muscle, fat or lymphatic tissue mostly situated in the lower pelvis and/or the upper part of the extremities. The Duke study was published in the Nov. 1999 issue of Int. J. Radiation Oncology Biol Phys and involved 97 patients with high-grade soft tissue sarcomas who were non-responding to standard therapy. Soft tissue sarcomas are "a formidable therapeutic challenge," killing "about 50% of patients with high-grade tumors." The primary therapeutic goals are to remove the tumor surgically, achieve "local regional control" of the tumor area and prevent metastasis. The Duke report explains, "Hyperthermia has a long history and well-established rationale as adjuvant therapy for cancer in combination with radiation and/or chemotherapy. The clinical efficacy of hyperthermia has been reported in a number of Phase II trials and more recently in several Phase III studies in breast cancer, head and neck cancer, melanomas, cervical cancer, and central nervous system (CNS) malignancies." Further, "numerous clinical trials of hyperthermia, particularly in accessible superficial tumors have demonstrated an increased response rate and in some instances a survival benefit with the combination of radiation and hyperthermia compared with radiation alone." Regarding the study rationale, the report states that "Hyperthermia was given approximately 1 hour after radiation utilizing radio-frequency (RF) annular phased arrays driven and controlled by the BSD-2000. This system has phase and amplitude control among array antennas allowing the RF power to be regionally focused at depth in the tumor volume." The positive conclusion of the Duke University study is that through combined hyperthermia and radiation treatments (called "thermoradiotherapy"), "excellent local control, particularly for extremity tumors has indeed been accomplished, with a 10-year actuarial local control of 94% for this latter group." For patients "with a variety of nonextremity sites, actuarial local control at 10 years was 63%." The Duke study states: "In general, excellent local control has been achieved. Distant metastases, however, remain a formidable problem." BSD Medical is currently supporting a Phase III clinical trial using the BSD-2000 system for hyperthermia and chemotherapy treatment of soft sarcomas with the objectives of eliminating amputation and increasing long-term survival. This trial, which also involves Duke University, is being sponsored by the EORTC (European Oncology and Radiation Therapy Committee), the Brussels (Belgium) based European equivalent of the RTOG and most authoritative European control organization of oncology related clinical trials. BSD Medical Corporation [BSDM] is the leading developer and manufacturer of hyperthermia systems for cancer therapy, and pioneered the non-surgical treatment of benign diseases of the prostate using microwave energy. For information on the Company, or to find hyperthermic oncology information sources and treatment centers, please visit the BSD Medical Corporation web site (www.bsdmc.com). Statements contained in this press release that are not historical facts are forward looking statements, as that item is defined in the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to risks and uncertainties (detailed in the Company's findings with the Securities and Exchange Commission) that could cause actual results to differ materially from estimated results. SOURCE: BSD Medical Corp.