FDA Clears IsoRay's GliaSite Treatment for Brain Cancer

IsoRay, Inc. ISR announced today that the FDA has cleared its GliaSite® radiation therapy system, a balloon catheter device used in the treatment of brain cancer. The clearance was the major step required to return the GliaSite® radiation therapy system to the marketplace. The system's balloon catheter is a landmark technology that allows physicians to treat more brain cancer patients than ever before with internal radiation or brachytherapy. The GliaSite® radiation system offers a number of advantages in brain cancer treatment. 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. IsoRay undertook a number of steps ranging from improvement in product design, rigorous testing, and new manufacturing techniques including a new balloon manufacturing system before seeking FDA clearance for use. IsoRay's improved GliaSite® delivery system was found to have exceeded all prior product specifications during the reporting and testing phase.