News | May 24, 2012

IsoRay’s GliaSite Approved for Sale in 31 European Countries

Significant Growth Expected as CE Mark Designation Clears Way for International Launch

May 24, 2012 — IsoRay Inc., a medical technology company in seed brachytherapy and medical radioisotope applications, announced that the GliaSite radiation therapy system, the world's only balloon catheter device used in the treatment of brain cancer, has earned the European CE Mark, allowing for immediate sale in 31 European countries. The system’s balloon catheter is a technology that allows physicians to treat more patients than before with brachytherapy or internal radiation, and provides important benefits over other radiation treatment options.

"This is a major event for IsoRay as it opens the door to revenue opportunities in international markets where our current distributor previously marketed GliaSite for its prior manufacturer. In addition, it allows us to pursue other distribution opportunities in countries not previously serviced. This completes the last requirement essential to initiate the international launch of our GliaSite radiation therapy system," said Dwight Babcock, chairman and CEO of IsoRay.

The GliaSite radiation therapy is being reintroduced to the market by IsoRay, which has exclusive worldwide rights to the system. IsoRay is also the manufacturer of cesium-131, which allows for the internal radiation treatment of many different cancers because of its combination of high energy and speed in giving off therapeutic radiation (9.7 day half-life).

IsoRay has already received a CE mark for its cesium-131 lung cancer sutures and mesh. Cesium-131 mesh brachytherapy gives physicians a viable treatment option for early-stage lung cancer patients who otherwise would have been inoperable because of limited pulmonary function or other health issues. With mesh brachytherapy, patients benefit from getting the most targeted radiation possible, which decreases the chance of the cancer recurring and decreases the amount of potential lung damage as compared to other available treatments. Some doctors report that they have found placing cesium-131 lung mesh over the surgical suture line reduces the risk of cancer recurrence in patients to 2 percent or less.

Babcock says this latest achievement comes on the heels of the company's reintroduction of the GliaSite radiation therapy system and introduction of cesium-131 sutures and mesh to the international medical community at the World Congress of Brachytherapy in May 2012.

For more information: www.isoray.com

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