Yesterday, the U.S. Food and Drug Administration (FDA) approved a more flexible design of Hologic Inc.’s (HOLX) MammoSite system, which provides radiation seeds to prevent recurrences of breast cancer. The company intends to launch the radiation therapy system, designed to treat early-stage breast cancer, in the first quarter of fiscal 2010.

The MammoSite ML (multi-lumen) radiation therapy system allows physicians to target radiation to areas which are most likely to be affected by cancer and shift the dose away from areas that do not need it. MammoSite devices include balloon catheters that are inserted into the body after the removal of a tumor. A pellet of radioactive material is inside the catheter.

The radiation treatment is completed in just five days. The therapy aims to prevent recurrence without affecting healthy tissues. Side effects like skin discoloration, fatigue, etc. are minimized by this therapy.

Additionally, the new device expands the treatment scope of radiation oncologists. It helps them treat patients who otherwise cannot undergo radiation seeding.

As a reminder, the U.S. FDA approved the MammoSite therapy system, as a single-lumen device in 2002. It has been used to treat more than 50,000 breast cancer patients in the United States. Approximately, 240,000 confirmed breast cases were reported in the U.S. in 2008.

We believe that the new device will not only increase patient comfort but will also provide greater flexibility to radiation oncologists in delivering radiation treatment directly to areas which are most likely to witness breast cancer recurrence.

The news of the FDA approval sent the company’s shares up by 4% in Tuesday’s after market trading before pulling back to the under-$16 range for most of Wednesday.
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