RICHLAND, WA--(Marketwired - Jan 29, 2014) - IsoRay Inc. (NYSE MKT: ISR) (Isoray.com), a medical technology company and innovator in seed brachytherapy and medical radioisotope applications, today announced that it received a five year extension to its CE mark covering IsoRay's entire product offering of Cesium-131 seeds, permitting sale in the European market of these products into 2018. When combined with a previous enhanced CE mark received in August 2013 extending the useful life for our GliaSite® radiation therapy system and the Iotrex isotope used in the system, this five year extension gives us the ability to continue to sell our entire product line in the European market. As reported in our Form 10-K filed with the SEC on September 30, 2013, the GliaSite® radiation therapy system, the world's only balloon catheter device used in the treatment of brain cancer, and the Iotrex isotope used with the system received an enhanced European CE mark providing for longer shelf life, extended isotope usage and an additional second source isotope manufacturer. The system's balloon catheter is a landmark technology that allows physicians to treat more patients with brachytherapy or internal radiation, and provides important benefits over other radiation treatment options for brain cancer.
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, "The five year extension is a clear indication of the quality and care IsoRay places on producing a truly superior product, and when combined with the enhanced CE mark received several months ago, helps to ensure our future internationally. Specifically, the enhanced CE mark for GliaSite® and Iotrex provides several major product improvements: first, an extended shelf life for our catheter from 12 months to now 36 months; second, our Iotrex isotope has had its useful life extended from 19 days to 30 days giving IsoRay the opportunity to utilize more of the product produced within a single batch, and finally, a second source manufacturer for Iotrex was approved giving more production capability and increasing potential batch sizes. These enhancements improve our ability to pursue additional distribution opportunities in numerous European countries due to the extended product life cycle."
The GliaSite® radiation therapy is exclusively marketed worldwide by IsoRay, which is also the exclusive manufacturer of Cesium-131 in seed form. With the recently announced FDA clearance for liquid cesium-131, IsoRay can now offer multiple isotope options for use within the GliaSite® catheter. Cesium-131 allows for the internal radiation treatment of many different cancers because of its unique combination of high energy and unrivaled speed in providing therapeutic radiation (9.7 day half-life).
Babcock says, "These European developments are consistent with the Company's primary strategic objective of creating groundbreaking products proving to be vital weapons in the treatment of numerous cancers throughout the body, and creating value for our stockholders."
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 products and their various delivery formats, the advantages of the GliaSite® delivery system, whether the use of GliaSite® or Cesium-131 will increase or continue, whether future studies of treatment of various cancers using our products will have favorable results, whether IsoRay will be able to continue to expand its base beyond prostate cancer, whether IsoRay will be able to generate sales internationally and enter into new international distribution agreements, 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 past studies, patient results achieved with Cesium-131 and the Gliasite® delivery system, successful completion of future research and development activities, whether we, our distributors and our customers will successfully obtain and maintain all required regulatory approvals and licenses to market, sell and use Cesium-131 in its various forms as well as our other products in the U.S. and internationally, continued compliance with ISO standards as audited by BSI, changing levels of demand for IsoRay's current and proposed future products, success of any negotiations undertaken with potential distributors, changes in reimbursement rates, changes in laws and regulations applicable to our products, and other risks detailed from time to time in IsoRay's reports filed with the SEC.