Healthcare Industry News:  National Comprehensive Cancer Network 

Devices Oncology

 News Release - February 24, 2011

BSD Medical Announces the Inclusion of Hyperthermia and Chemotherapy as a Recommended Cancer Treatment for High Risk Sarcoma in the NCCN Practice Guidelines

SALT LAKE CITY--(Healthcare Sales & Marketing Network)-- BSD Medical Corporation (NASDAQ:BSDM ) (Company or BSD) today announced the inclusion of hyperthermia and chemotherapy as a recommended cancer treatment for Stage IV (metastatic) sarcomas in the "Practice Guidelines in Oncology" (V.2.2010), which is issued by the National Comprehensive Cancer Network (NCCN). NCCN is a not-for-profit alliance of 21 of the world’s leading cancer centers, and its practice guidelines are a benchmark for clinical policy in the oncology community.

The inclusion of hyperthermia and chemotherapy for high-risk sarcoma cancer patients was based on data from a Phase III, randomized, multi-center, clinical trial (EORTC-62961) 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 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 interim results of this Phase III study and note that after a median follow-up of 24.9 months, disease-free survival was 31.7 months for the patients treated with hyperthermia and EIA compared to 6.2 months for the patients treated with EIA alone and that local progression-free survival and overall response rate were also significantly superior.

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.” (Lancet Oncol. 2010 Jun;11(6):561-70.) The published study results demonstrated that the addition of regional hyperthermia, using the BSD-2000 Hyperthermia System, to chemotherapy (EIA) resulted in a significant reduction in disease progression or death, with a median disease-free survival of greater than 120 months (i.e., the median is not yet reached) for the HT+ EIA group, as compared to 75 months in the EIA only group.

About the National Comprehensive Cancer Network® (NCCN)

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. The NCCN guidelines are distributed free of charge to clinical professionals in the United States and internationally. User-friendly patient versions of NCCN guidelines are available to patients and their families. Additional information can be obtained by contacting NCCN at (215) 690-0300 or visiting http://www.nccn.org.

About the BSD-2000 Hyperthermia System

The BSD-2000 – developed and patented exclusively by BSD – delivers localized therapeutic heating (hyperthermia) by applying radiofrequency (RF) energy. The BSD-2000 creates a central focusing of energy that can be electronically focused to target the 3-dimensional 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 several 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 well 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.


Source: BSD Medical

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