Healthcare Industry News: hyperthermia
News Release - November 18, 2009
BSD Medical Corporation Reports Continuation of FDA Review of BSD-2000 Hyperthermia System
SALT LAKE CITY--(HSMN NewsFeed)--BSD Medical Corporation (NASDAQ: BSDM ) (www.bsdmedical.com) today provided an update on the U.S. Food and Drug Administration’s (FDA) review of the Company's Humanitarian Device Exemption (HDE) marketing submission for the Company’s BSD-2000 hyperthermia System.The FDA’s review process continues, and the FDA has submitted additional questions to the Company for which the Company is preparing responses. Although the Company remains optimistic, it is unable to predict when the review process will be completed and its ultimate outcome.
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.
About BSD Medical Corporation
BSD Medical is a leading developer of systems used to provide cancer therapies requiring precision-focused heat through RF/microwave technologies. The Company’s systems have been designed to kill cancer through heat alone, and as companion therapies to improve the combined results when used along with radiation treatments. 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.
Source: BSD Medical
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