IsoRay’s Liquid Cesium-131 (Cesitrex®) Receives Final Regulatory Approval for Use in GliaSite® Brain Cancer Treatment System
Revolutionary Therapy Now Available For Brain Cancers.
Richland, WA (May 12, 2014) – IsoRay Inc. (NYSE MKT: ISR), a medical technology company and innovator in seed brachytherapy and medical radioisotope applications, today announced Isoray has now received final approval from state of Washington Department of Health to manufacture its recently FDA cleared Liquid Cesium- 131 (Cesitrex®) for use with GliaSite® balloon catheter for the treatment of metastatic and glioblastoma brain cancers.
The GliaSite® balloon catheter can now incorporate the use of Liquid Cesium-131 for the treatment of metastatic and glioblastoma brain cancers and management believes this combination will offer a number of advantages in treating these debilitating brain cancers. Liquid Cesium-131 eliminates the need for a thyroid block as required with Iodine-125, is safer for the patient and staff, and if a spill were to occur, it is an easier cleanup than with other isotopes. With a specified dose of liquid Cesium-131 within the balloon is placed in the tumor cavity most likely to contain cancer cells following surgery. This form of radiation is less likely to damage healthy brain tissue than other available alternatives. The ability for the tumor to recur is greatly diminished by treating the tumor bed immediately at the time of surgery with a single treatment, impacting patient longevity and quality of life.
IsoRay CEO Dwight Babcock commented, “We are very excited to have our Liquid Cesium-131 isotope now available for use with our GliaSite® balloon catheter system. With reimbursement codes already available, we will immediately begin offering our newest innovation to major medical centers to establish patient studies, ultimately resulting in these thought leaders reporting their study findings for peer review and publication. As a company, we are witnessing a growing adoption of our products in hospitals and medical practices nationwide. Equally important, we are proud to have reached this new milestone for patients who are searching for treatment options and hope in their fight against brain cancer.”
IsoRay’s additional products include Cesium-131 seeds (loose and stranded), sutured seeds and seeds in a stranded mesh. These products together with the GliaSite® balloon catheter system provide physicians with a new powerful weapon in the battle against cancer
IsoRay is the exclusive manufacturer of Cesium-131. The pioneering brachytherapy therapy is one of the most significant advances in internal radiation therapy in 20 years. Cesium-131 allows for the precise treatment of many different cancers because of its unrivaled blend of high energy and its 9.7 day half-life (its unequaled speed in giving off therapeutic radiation).
In addition to its CMS codes, Cesium-131 is FDA-cleared and holds a CE mark for international sales in seed form for the treatment of brain cancer, prostate cancer, lung cancer, ocular melanoma cancer, colorectal cancer, gynecologic cancer, head and neck cancer and other cancers throughout the body. The treatment can be deployed using several delivery methods including single seed applicators, implantable strands and seed sutured mesh. IsoRay also sells several new implantable devices, including the GliaSite® radiation therapy system.