This follows the recent approval of the device by the Washington State Department of Health, which paved the way for its launch in the U.S. GliaSite was approved by the U.S. Food and Drug Administration (“FDA”) in September 2011. The Washington-based company noted that GliaSite has already started attracting the attention of physicians and patients.
Brain cancer is among the fastest growing cancers with more than 575 people being diagnosed with this condition in the U.S. every day. Treatment of brain tumors is challenging as these tumors are difficult to remove completely given the risk of damaging the brain. Typically, surgeons remove most of the tumor followed by treatment of the surrounding areas with radiation therapy. However, brain tumors often recur after the surgery.
The GliaSite balloon catheter is used to perform brachytherapy (internal radiation therapy) following the removal of the brain tumor. It is inserted into the brain (within the resection cavity of the removed tumor) and is inflated with a pre-specified amount of radioactive solution followed by the delivery of radiation to the surrounding tissues.
GliaSite offers a number of advantages including a more targeted dose delivery of liquid radiation which lowers the impact on brain tissues surrounding the tumor. Moreover, the targeted therapy also reduces the chance of recurrence of the tumor, thereby increasing the chances of patient survival.
IsoRay, in June 2010, acquired the exclusive global distribution rights to GliaSite from Hologic Inc (NasdaqGS:HOLX - News). The company also holds the global licensing rights to Iotrex, a key component in the GliaSite system.
The launch of GliaSite represents a major milestone as the company moves towards achieving the U.S. approval for a liquid form of Cesium-131 for treating brain cancer that will be delivered using the GliaSite system. IsoRay is the exclusive producer of Cesium-131 brachytherapy isotope. The company expects GliaSite to be a major sales contributor over the next few years.
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