BSD Medical Announces FDA HDE Marketing Approval for the BSD-2000 Hyperthermia System

BSD Medical Corporation (NASDAQ: BSDM) announced today that the Company has obtained Humanitarian Device Exemption marketing approval for the BSD-2000 Hyperthermia System (BSD-2000) from the U.S. Food and Drug Administration. 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."