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FDA Gives Greenlight for IsoRay Inc. (ISR) Brain Cancer Treatment

|Includes: IsoRay, Inc. (ISR)
IsoRay Inc. operates through its subsidiary IsoRay Medical to produce brachytherapy seeds, which are cancer-fighting medical radioisotopes implanted in or as close as possible to the cancerous organ. The company today announced that the FDA has cleared its GliaSite® radiation therapy system, which represents a significant step in the company’s trek to return the device to the market place.
GliaSite is a balloon catheter device used in the treatment of brain cancer through brachytherapy. Current brain cancer treatments are complicated by the fact that most cancerous brain tumors recur near the site of the original tumor following its removal. To reduce the risk of recurrence, GliaSite administers a high dose of liquid radiation, post-brain tumor removal, into areas most likely to contain cancer. This process offers an advantage over other treatments in the market by lowering the risk of damage to healthy brain tissue.
The FDA’s decision clears the path for IsoRay to move forward in obtaining additional regulatory approval for its new liquid form of its internal radiation therapy Cesium-131, which would be delivered using the GliaSite system. IsoRay said Cesium-131 boasts the highest cancer-free success rate for patients being treated for prostate cancer.
“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. We have already seen the importance of Cesium-131 internal radiation therapy seeds in effecting survivability and quality of life in the treatment of cancers throughout the body,” IsoRay CEO Dwight Babcock stated in the press release. “As a company, we are excited to see expanding adoption in hospitals and medical practices nationwide and internationally. Just as importantly, however, we are cognizant of this crucial milestone for patients who are searching for treatment options and hope in their fight against brain cancer.”
Prior to IsoRay’s acquisition of the GliaSite technology, roughly 500 GliaSite cases were performed annually at some 40 hospitals worldwide; the company said it has already received a growing number of inquiries regarding the product’s availability in the marketplace.
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