SALT LAKE CITY--(BUSINESS WIRE)--BSD Medical Corporation (NASDAQ: BSDM) (Company or BSD) (www.BSDMedical.com), a leading provider of medical systems that utilize heat therapy to treat cancer, today reported that the recently issued "National Clinical Practice Guidelines in Oncology for Soft Tissue Sarcoma" (V.2.2011), issued by the National Comprehensive Cancer Network (NCCN), expands the recommendations for the use of hyperthermia and chemotherapy as a cancer treatment to include Stage II and III soft tissue sarcomas of the trunk and the extremities. Previous guidelines only recommended hyperthermia treatment for metastatic stage IV disease. According to the NCCN Guidelines the broadening of the NCCN recommendations to earlier stage disease indicates a uniform NCCN consensus (Category 2A) for a general acceptance of hyperthermia for the treatment of soft tissue sarcomas.
The inclusion of hyperthermia and chemotherapy for high risk sarcoma cancer patients was based on data from a Phase III, randomized, multicenter, clinical trial involving the use of regional hyperthermia and chemotherapy with EIA (etoposide, ifosfamide and adriamycin), as compared to EIA alone. The study involved 341 patients with locally advanced soft tissue sarcomas (STS) who were treated at medical centers in Europe and in the United States using the BSD-2000 Hyperthermia System. The NCCN guidelines include a discussion of the results of this study and note that, after a median follow-up of 34 months, the two-year disease free survival and local progression free survival rates were 70% and 92% respectively for patients treated with hyperthermia and EIA, compared to 57% and 80% for those patients treated with EIA alone. The NCCN guidelines state that "A phase III randomized trial (EORTC 62961) showed that regional hyperthermia (RHT) increases the benefit of neoadjuvant chemotherapy in patients with localized high-risk STS."
The Lancet Oncology, the premier worldwide journal for original oncology research, published the results of this Phase III clinical study of hyperthermia, “Neo-adjuvant chemotherapy alone or with regional hyperthermia for localised high-risk soft-tissue sarcoma: a randomised phase 3 multicentre study” (2010 Jun;11[6]:561-70). The study results demonstrated that the addition of hyperthermia, using the BSD-2000 Hyperthermia System, to chemotherapy (EIA) significantly improved tumor response, local progression-free and disease-free survival for high risk STS patients. Overall survival was also improved in patients who completed the entire course of therapy. An updated analysis of the study data, presented by Issels et al., at the ASCO American Society of Clinical Oncology meeting in June 3-7, 2011, demonstrated that grade II STS patients can also benefit from chemotherapy and hyperthermia treatment.
About the National Comprehensive Cancer Network® (NCCN)
The NCCN is a non-profit association of the 20 leading cancer centers of the US. The "NCCN Clinical Practice Guidelines in Oncology" are the recognized standard for clinical treatment policy in the oncology community. The guidelines are based upon evaluation of scientific data by multidisciplinary panels of expert physicians from NCCN member institutions. The primary goal of all NCCN initiatives is to improve the quality, effectiveness and efficiency of oncology practice so that patients can live better lives. NCCN is recognized by the Centers for Medicare and Medicaid Services and private payers as a mandated reference for oncology coverage policies. Managed care, medical directors, and other healthcare professionals also reference NCCN guidelines when making treatment and reimbursement decisions.
About the BSD-2000 Hyperthermia System
The BSD-2000 – developed and patented exclusively by BSD – delivers phased array, focused therapeutic heating (hyperthermia) by applying radiofrequency (RF) energy to tumors. The BSD-2000 creates a central focusing of energy that can be electronically focused to target the shape, size, and location of the tumor, thus providing dynamic control of the heating delivered to the tumor region. The BSD-2000 is restricted to investigational use in the US, and the Company is currently conducting a clinical study to evaluate the safety and efficacy of hyperthermia using the BSD-2000 combined with radiotherapy for the treatment of patients suffering from locally advanced, persistent, or recurrent deep tumors of the pelvis; i.e., cervical, prostate, rectal, and bladder. BSD has also applied for a Humanitarian Device Exemption (HDE) approval for its BSD-2000 Hyperthermia System and this submission is still under review by the FDA.
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 radiofrequency (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 many 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 has been developed as a stand-alone therapy to ablate and destroy soft tissue. The Company has developed extensive intellectual property, multiple products in the market and 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.