IsoRay Introduces Radiation Therapy System in Europe

The GliaSite radiation therapy system, manufactured by medical technology company IsoRay Inc., now will be available in 31 European countries following CE Mark approval. According to the company, the system is the only balloon catheter on the market globally that is used to treat brain cancer. IsoRay asserts that the system allows physicians to treat more patients 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,” said IsoRay Chairman and CEO Dwight Babcock. “In addition, it allows us to pursue other distribution opportunities in countries not previously serviced. This historic moment completes the last requirement essential to initiate the international launch of our GliaSite radiation therapy system.”

GliaSite is intended for use in the management of surgically resectable brain tumors where adjuvant radiation therapy of the post-resection tissue bed is indicated. Cases that have made use of GliaSite have been detailed in peer-reviewed journals such as Brachytherapy and the International Journal of Radiation Oncology-Biology-Physics. Brain cancers treated in these reports include primary and recurrent gilomas, as well as resectable metastatic brain tumors—and more than 2000 patients have been treated with GliaSite.

Kevin Murphy, M.D., chief of the Brain Tumor Service at the University of California, San Diego, Moores Cancer Center, has worked with the GliaSite system extensively. The university website offers a helpful explanation of how the system works: A balloon catheter is introduced into the brain and inflated with a radioactive Iodine-125 solution. Radiation is then delivered locally to the surrounding brain treating primary, recurrent or metastatic tumors. Treatment is delivered during three to seven days as an outpatient, and at the end of treatment, the iodine solution is removed and the patient is discharged.

Richland, Wash.-based IsoRay is re-introducing the system to the market, it having been invented and developed by researchers at the Johns Hopkins Comprehensive Brain Tumor Center in Baltimore, Md. Rather than iodine, the company hopes to use GliaSite with its Cesium-131 isotope, which gives off radiation a lot faster than other isotopes with a 9.7-day half-life. The company has received the CE Mark for Cesium-131 as well.

“IsoRay remains focused on meeting a primary goal of being an innovator with the creation of ground-breaking products that are proving to be vital weapons in the treatment of a number of cancers throughout the body,” said Babcock. “This product portfolio is central to our goal of growing revenues and creating value for our stockholders.”