BSD Medical Corporation Reports FDA Review Of BSD-2000 Hyperthermia System Continues

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Regulatory Affairs / Drug Approvals;  Radiology / Nuclear Medicine
Article Date: 22 Sep 2009 - 0:00 PDT

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BSD Medical Corporation (NASDAQ: BSDM) reported 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.

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BSD Medical Corporation