IsoRay's GliaSite Gets Final Nod

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IsoRay Inc (AMEX:ISR - News), which makes the Cesium-131 internal radiation therapy (brachytherapy) isotope, has crossed the last regulatory hurdle for its GliaSite radiation therapy system, a balloon catheter used in treating brain cancer.

The product has been cleared by the Washington State Department of Health, representing the final step required to commence its commercialization in the U.S. GliaSite was approved by the U.S. Food and Drug Administration (“FDA”) in September 2011.

IsoRay had acquired the exclusive global distribution rights to GliaSite from Hologic Inc (NasdaqGS:HOLX - News) in June 2010. The company, in June 2011, secured the exclusive global licensing rights to Iotrex, a key component in the GliaSite system, from Dr. Reddy’s Laboratories (NYSE:RDY - News).

Brain cancer is among the fastest growing cancers with more than 575 people being diagnosed with this condition in the U.S. each day. Treatment of brain tumors is challenging as they are very 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 shortly following the surgery.   

The GliaSite balloon catheter is used to perform brachytherapy 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 (such as Iotrex) 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 extending patient survival. IsoRay expects GliaSite to be a major contributor to its top-line over the next 2-3 years.

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