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IsoRay's GliaSite radiation therapy for brain cancer receives FDA clearance

Published: 10:56 12 Sep 2011 EDT

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IsoRay (AMEX:ISR) said Monday that the US Food and Drug Agency has cleared the company's GliaSite radiation therapy system, a balloon catheter device used in the treatment of brain cancer.

Shares in the radioation therapy company were up 22% at $1.35 on Monday.

With the FDA clearance, the company said it will now be able to move forward in seeking additional regulatory approval for its new liquid form of Cesium-131 internal radiation therapy for the treatment of brain cancer that would be delivered using the GliaSite system replacing Iotrex.

IsoRay's CEO Dwight Babcock said: "FDA clearance of the GliaSite system represents a key development in opening the door to further advances that can expand treatment efficacy as we seek clearance for the use of liquid Cesium-131."

"With our sales launch expected in the fourth quarter, we know there is great interest and a growing number of inquiries from the marketplace."

The GliaSite radiation system offers a number of advantages in brain cancer treatment, IsoRay said. A specified high dose of a liquid radiation source is placed in the areas most likely to contain cancer after brain tumor removal. This form of radiation is less likely to damage healthy brain tissue than other alternatives. The ability for the tumor to recur is greatly diminished, impacting patient longevity and quality of life.

IsoRay has exclusive worldwide distribution rights for the GliaSite radiation therapy system as well as exclusive worldwide licensing rights to Iotrex, a liquid iodine radiation for use in brain cancer treatment.

Brain cancer is one of the fastest growing cancers and recurrence often proves fatal. Over 575 people a day are diagnosed with brain cancer in the United States alone. No two brain tumors are alike and brain cancers can range from Glioblastomas to metastasized brain cancer.

Cesium-131 is FDA-cleared in seed form for the treatment of prostate, lung, ocular melanoma, brain, colorectal, gynecologic, and head and neck cancer and other cancers throughout the body.

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