IsoRay Inc. (AMEX: ISR), a medical technology company and innovator in seed brachytherapy and medical radioisotope applications, today announced that the GliaSite® radiation therapy system, the world's only balloon catheter device used in the treatment of brain cancer , has earned the European CE Mark, allowing immediate sale in 31 European countries. The system’s balloon catheter is a landmark technology that allows physicians to treat more patients than ever before with brachytherapy or internal radiation and provides important benefits over other radiation treatment options.
The CE mark designates that the manufacturer conforms with the essential product requirements of the applicable European Commission directives. Granted after a rigorous evaluation process, the CE mark allows a product to be legally marketed in the European Free Trade Association (EFTA) member states as well as the European Union.
IsoRay Chairman and CEO Dwight Babcock commented, "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. 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".
The GliaSite ® radiation therapy is being reintroduced to the market by IsoRay, which has exclusive worldwide rights to the system. IsoRay is also the exclusive manufacturer of Cesium-131, which represents one of the most important advancements in internal radiation therapy in 20 years. Cesium-131 allows for the internal radiation treatment of many different cancers because of its unequaled combination of high energy and its unrivaled speed in giving off therapeutic radiation (9.7 day half-life).IsoRay has already received a CE mark for its Cesium-131 lung cancer sutures and mesh. Cesium-131 mesh brachytherapy gives physicians and their patients a viable treatment option for those early stage lung cancer patients who otherwise would be inoperable because of limited pulmonary function or other health issues. With mesh brachytherapy, patients benefit from getting the most targeted radiation possible, which decreases the chance of the cancer recurring and decreases the amount of potential lung damage as compared to other available treatments. Some doctors report that they have found placing Cesium-131 lung mesh over the surgical suture line reduces the risk of cancer recurrence in patients to 2 percent or less. Patients accrue additional quality of life benefits because targeted radiation does not involve the many weeks of treatment required in traditional external radiation since it can be done at the time of surgery, with or without robotics, and does not involve return trips to the hospital, except for routine follow-up visits. Babcock says this latest achievement comes on the heels of the Company's reintroduction of the GliaSite ® radiation therapy system and introduction of Cesium-131 sutures and mesh to the international medical community at the World Congress of Brachytherapy where they all drew strong interest. According to Babcock, these developments are in keeping with the Company's strategic objectives. "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. This product portfolio is central to our goal of growing revenues and creating value for our stockholders." 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, head and neck cancer and other cancers throughout the body. About IsoRay, Inc. IsoRay, Inc., through its subsidiary, IsoRay Medical, Inc., is the exclusive producer of Cesium-131 internal radiation therapy, which is expanding brachytherapy options throughout the body and the GliaSite® radiation therapy system, the world's only balloon catheter device used in the treatment of brain cancer. Learn more about this innovative Richland, Washington company and explore the many benefits and uses of Cesium-131 and the GliaSite® radiation therapy system by visiting www.isoray.com . Join us on Facebook/Isoray. Follow us on Twitter @Isoray . Safe Harbor Statement Statements in this news release about IsoRay's future expectations, including: the advantages of our Cesium-131 seed, future demand for IsoRay's existing and planned products, whether revenue and other financial metrics will improve in the future, whether IsoRay will be able to continue to expand its base beyond prostate cancer to use Cesium-131 to treat additional cancers and malignant disease, whether IsoRay will be able to generate sales internationally and enter into new international distribution agreements, the advantages of the GliaSite® delivery system, whether sales will increase as we can sell our products in additional countries, whether additional studies will be published with favorable outcomes from treatment with Cesium-131, 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 IsoRay's products, changing levels of demand for IsoRay's current and proposed future products, IsoRay's ability to reduce or maintain expenses while increasing sales, whether later studies and protocols support the findings of the initial studies, success of future research and development activities, IsoRay's ability to successfully manufacture, market and sell its products, success of any negotiations undertaken with potential distributors, patient results achieved when Cesium-131 is used for the treatment of cancers and malignant diseases beyond prostate cancer, patient results achieved with the GliaSite® radiation therapy system, IsoRay's ability to manufacture its products in sufficient quantities to meet demand within required delivery time periods while meeting its quality control standards, IsoRay's ability to enforce its intellectual property rights, changes in reimbursement rates, changes in laws and regulations applicable to our product, and other risks detailed from time to time in IsoRay's reports filed with the SEC.