FDA grants HDE marketing approval for BSD-2000 Hyperthermia System to treat cervical cancer

BSD Medical Corporation (NASDAQ:BSDM) (Company or BSD) (www.BSDMedical.com), a leading provider of medical systems that utilize heat therapy to treat cancer, announced today that the Company has obtained Humanitarian Device Exemption (HDE) marketing approval for the BSD-2000 Hyperthermia System (BSD-2000) from the U.S. Food and Drug Administration (FDA). The BSD-2000 is approved for use in conjunction with radiation therapy for the treatment of cervical cancer patients who normally would be treated with combined chemotherapy and radiation but are ineligible for chemotherapy due to patient related factors. The HDE approval authorizes the commercial sale of the BSD-2000. An HDE approval is obtained after a company has demonstrated the product's safety and probable benefit for the treatment of a disease affecting fewer than 4,000 people in the United States every year.

Harold Wolcott, CEO of BSD Medical, stated, "We are excited to reach this significant milestone in BSD's history and obtain marketing approval for the BSD-2000 Hyperthermia System. This HDE approval provides physicians a new clinical tool for cervical cancer patients who are candidates for radiation therapy but ineligible for chemotherapy, a patient group that has few, if any, therapeutic options. The HDE approval provides a new marketing opportunity for BSD."

In 2010, an estimated 12,200 women in the United States were diagnosed with cervical cancer, and an estimated 4,210 died of the disease. It is estimated that approximately $1.4 billion is spent in the U.S. each year on cervical cancer treatment. Cervical cancer is the fifth most common cancer in women worldwide and the leading cause of death from cancer among women in developing countries. Researchers have predicted that developing countries could face a 75% increase in the number of cervical cancer cases in the next two decades due to growth and aging of the population.

The BSD-2000 Hyperthermia System - developed and patented exclusively by BSD - delivers localized therapeutic heating (hyperthermia) to solid tumors 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. This method of therapeutic heating utilizes the adjustment of frequency, phase, and amplitude from multiple power sources, along with applicator selection and patient positioning, to optimize the deposition of heating energy into the targeted body tissues.