BSD Medical Corporation (NASDAQ:BSDM) (Company or BSD) (www.BSDMedical.com), a leading provider of medical systems utilizing heat therapy to treat cancer, announced today that published study results demonstrate improved rates of complete pathological tumor response (no evidence of viable tumor in primary tumor and lymph nodes) in advanced rectal cancer patients from the addition of hyperthermia, delivered using the BSD-2000 Hyperthermia System. The researchers also reported that hyperthermia may provide enough reduction in tumor size (downstaging) to allow an increased rate of sphincter preservation surgery (which can allow patients to maintain normal rectal function) in a subgroup of patients with rectal tumors located lower in the gastrointestinal tract. Hyperthermia was added to standard preoperative radiochemotherapy (combined radiotherapy and chemotherapy) for 61 patients, and results were retrospectively compared to 45 patients with locally advanced rectal cancer who were treated with standard preoperative radiochemotherapy alone.
The rate of complete pathological tumor response (pCR) was significantly higher in the patients receiving at least four hyperthermia treatments (22.5%), as compared to a rate of only 6.7% for patients receiving radiochemotherapy alone, and a rate of 4.7% for patients treated with radiochemotherapy and only one to three hyperthermia treatments (p=0.043). The researchers also noted that the pCR rate of 22.5% achieved from the addition of hyperthermia is higher than the pCR rate reported in most published presurgical radiochemotherapy studies, including studies utilizing multiple chemotherapy agents. Hyperthermia significantly increased the number of patients with tumors located within 8 cm of the anal verge who were able to have sphincter-sparing surgery: 57% in the hyperthermia group compared to only 35% in the group that did not receive hyperthermia (p=0.077). Sphincter-sparing surgery is expected to provide a dramatic improvement in quality of life for rectal cancer patients.
The study, “Pathological Complete Response and Sphincter-Sparing Surgery after Neoadjuvant Radiochemotherapy with Regional Hyperthermia for Locally Advanced Rectal Cancer Compared with Radiochemotherapy Alone,” was published in The International Journal of Hyperthermia by C. Schroeder, et al., from the Department of Radiation Oncology of the University of Tübingen (Tübingen), in Germany. Tübingen is one of Europe’s oldest and most prestigious universities and an international leader in medical research.
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 shape, size and location of the tumor, thus providing dynamic control of the heating delivered to the tumor region. The BSD-2000 has Humanitarian Device Exemption (HDE) marketing approval from the U.S. Food and Drug Administration (FDA) for use in conjunction with radiation therapy for the treatment of cervical cancer patients who are ineligible for chemotherapy. The BSD-2000 also has CE (Conformité Européenne) Marking approval for the commercial sale in Europe. CE Marking approval is also recognized in many countries outside of the EU.
About BSD Medical Corporation
BSD Medical Corporation develops, manufactures, markets and services systems to treat cancer and benign diseases using heat therapy, which is 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 employ precision-guided microwave energy to ablate (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 and clearances 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.