Austin, TX 11/21/11 (StreetBeat) --Medical systems maker BSD Medical Corp (Nasdaq: BSDM) said the U.S. health regulator approved its device to treat cervical cancer, sending its shares up 14 percent in pre-market trade.The device, BSD-2000 Hyperthermia System, was also granted a humanitarian device exemption (HDE) status that typically allows a device maker to get its device approved without proving the effectiveness requirements of a regular application.
The device is for use along with radiation therapy on patients who are normally treated with a combination of chemotherapy and radiation, but are ineligible for chemotherapy due to certain patient-related factors.
HDE approval is given to a company after it demonstrates its product's safety and probable benefit for the treatment of a disease affecting fewer than 4,000 people in the United States every year.
In 2010, an estimated 12,200 women in the United States were diagnosed with cervical cancer, and an estimated 4,210 died of the disease. It is estimated that about $1.4 billion is spent in the United States each year on cervical cancer treatment, according to the company.
Shares of BSD were trading up at $2.99 before the bell on Monday. They closed at $2.62 on Friday on Nasdaq.
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