FDA continues review of BSD Medical's HDE for the BSD-2000 Hyperthermia System

Sep 19 2009

BSD Medical Corporation (NASDAQ: BSDM) (www.bsdmedical.com) reported today that the U.S. Food and Drug Administration (FDA) continues its review of the Company's Humanitarian Device Exemption (HDE) marketing submission for the Company’s BSD-2000 Hyperthermia System.

On May 15, 2009, the FDA granted Humanitarian Use Device (HUD) designation for the Company’s BSD-2000 Hyperthermia System for use in conjunction with radiation therapy for the treatment of cervical carcinoma patients who are ineligible for chemotherapy. The HUD for the BSD-2000 confirmed that the intended use population is fewer than 4,000 patients per year. Following receipt of the HUD designation, the Company filed a Humanitarian Device Exemption (HDE) marketing submission with the FDA, and the FDA review process of this submission is ongoing.

If received, the HDE approval of the BSD-2000 Hyperthermia System would authorize the commercial sale of the BSD-2000 in the United States. Although the Company remains optimistic, it is unable to predict when the review process will be completed and its ultimate outcome.

www.bsdmedical.com