BSDM says FDA still reviewing it's submission Print E-mail
By Jude Santos   
Friday, 18 September 2009 09:55

BSD Medical Corporation (NASDAQ:BSDM) is reporting that the FDA is continuing its review of the Company's Humanitarian Device Exemption (HDE) marketing submission for the Company's BSD-2000 Hyperthermia System.

Some of you may recall that on May 15, 2009, the FDA granted Humanitarian Use Device, or 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 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.

There is some chatter that GE could be interested in acquiring BSDM after GE Healthcare (a division of the General Electric Company) and BSD Medical have been collaborating on a project at Duke University.

The BSD-2000 system, which was invented by BSD Medical, delivers energy that can be electronically focused to target the 3-dimensional shape, size, and location of the tumor, thus providing dynamic control of the heating delivered to the tumor region. The BSD-2000/3D/MR system integrates a BSD-2000/3D Hyperthermia System with an MR system. The integrated system was designed to deliver targeted hyperthermia therapy while simultaneously providing non-invasive imaging of the diseased tissue as well as the surrounding healthy tissue. Duke University is a world leader in the development of non-invasive imaging techniques for hyperthermia using MR imaging.




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