RICHLAND, Wash.--(BUSINESS WIRE)--IsoRay, Inc. (Amex: ISR) announced today it has shipped its first GliaSite® radiation therapy system. The Company initiated sales after receiving final approval this week from the State of Washington Department of Health to manufacture its GliaSite® radiation therapy system. The GliaSite® radiation therapy system is a balloon catheter device used in the treatment of brain cancer. Having already received FDA clearance, the Washington State regulatory approval opened the door for sales of IsoRay's GliaSite® brain cancer treatment in the United States.
IsoRay CEO Dwight Babcock says inquiries are on the rise, "News of final regulatory approval has generated a great deal of interest throughout the medical community in the U.S. and internationally. We are hearing from physicians as well as brain cancer patients who are seeking treatment options for Glioblastomas and metastasized brain cancers."
The GliaSite® radiation system offers an innovative alternative that presents an important advance over previous brain cancer treatments. Doctors are able to use the system to directly place a specified dosage of liquid radiation in areas where cancer is most likely to still remain after completion of brain tumor removal. The ability to precisely place a specified dosage of this form of radiation means there is less likelihood for damage to occur to healthy brain tissue compared to other alternative treatments. Importantly, the GliaSite® radiation treatment diminishes the ability of the tumor to recur which means important benefits for patients in longevity as well as quality of life.
The news comes as the Company is moving forward to achieve FDA clearance of liquid Cesium-131 for use with the GliaSite® radiation system. IsoRay is the exclusive manufacturer of Cesium-131 for cancer treatment. In its current form, the pioneering brachytherapy treatment represents one of the most important advancements in internal radiation therapy in 20 years. In other developments, CEO Babcock revealed that discussions are already underway regarding the application of Cesium-131 for treating cancers in other body sites including breast and esophageal cancers.
Babcock says he views the latest developments as just the beginning of important benefits from GliaSite® for the company, too. "We expect GliaSite® to be a tremendous revenue generator. It is my sense that it will fuel other important opportunities for IsoRay's growth and expansion."
IsoRay holds 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. Prior to the Company's acquisition of the GliaSite® technology, approximately 500 GliaSite® cases were performed annually at some 40 hospitals worldwide.
The GliaSite® system has established reimbursement for both in-patient and out-patient settings. In addition to its CMS codes, Cesium-131 is FDA-cleared in seed form for the treatment of prostate cancer, lung cancer, ocular melanoma cancer, brain cancer, colorectal cancer, gynecologic cancer, and head and neck cancer and other cancers throughout the body.
About IsoRay
IsoRay, Inc., through its subsidiary, IsoRay Medical, Inc., is the sole producer of Cesium-131 brachytherapy seeds, which are expanding brachytherapy options throughout the body. Learn more about this innovative Richland, Washington company and explore the many benefits and uses of Cesium-131 by visiting www.isoray.com.
Safe Harbor Statement
Statements in this news release about IsoRay's future expectations, including: the advantages of our Cesium-131 seed, the advantages of the Gliasite delivery system, whether the liquid form of Cesium-131 receives regulatory approval and can be used successfully with the Gliasite delivery system, whether IsoRay will be able to continue to expand its base beyond prostate cancer, whether the use of GliaSite® with Iotrex® or Cesium-131 to treat brain or other cancers will be successful in the initial and any future implants, whether there will be demand for GliaSite® at expected or historic levels, and all other statements in this release, other than historical facts, are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 ("PSLRA"). This statement is included for the express purpose of availing IsoRay, Inc. of the protections of the safe harbor provisions of the PSLRA. It is important to note that actual results and ultimate corporate actions could differ materially from those in such forward-looking statements based on such factors as physician acceptance, training and use of our products, our ability to successfully manufacture, market and sell our products, our ability to manufacture our products in sufficient quantities to meet demand within required delivery time periods while meeting our quality control standards, our ability to enforce our intellectual property rights, whether additional studies are released and support the conclusions of early clinical studies, whether the liquid form of Cesium-131 receives and maintains all required regulatory approvals, whether any liquid form of Cesium-131 is able to be used successfully with the Gliasite delivery system, patient results achieved when Cesium-131 is used for the treatment of cancers and malignant diseases beyond prostate cancer whether with the Gliasite delivery system or in another delivery system, successful completion of future research and development activities, and other risks detailed from time to time in IsoRay's reports filed with the SEC.