IsoRay, Inc. Announces First International Orders for GliaSite Radiation Therapy System
Published: Jul 11, 2012
RICHLAND, WA--(Marketwire - July 11, 2012) - IsoRay Inc. (NYSE MKT: ISR) (NYSE Amex: ISR), a medical technology company and innovator in seed brachytherapy and medical radioisotope applications, today announced another step forward in international adoption of its ground-breaking GliaSite® radiation therapy system, the world's only liquid radiation balloon catheter device used in the treatment of brain cancers. IsoRay shipped its first orders to Germany as mounting inquiries continue to grow Company confidence in the international market. According to IsoRay CEO Dwight Babcock, "The medical community is clearly becoming aware of the innovative alternative that GliaSite® presents as an important advance over previous brain cancer treatments. We are seeing a growth in inquiries from Germany, Italy, Austria, Switzerland, and the United Kingdom."
The GliaSite® radiation therapy system gives physicians the ability to directly place a specified dosage of liquid radiation in areas where cancer is most likely to 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. GliaSite® diminishes the ability of the tumor to recur, which means important benefits for patients in longevity as well as quality of life.
Babcock says that physicians from the international medical community are also inquiring about IsoRay's Cesium-131 (Cs-131) seed sutured mesh for the treatment of a wide array of cancers throughout the body including brain and lung cancers. Babcock says exceptional results are driving interest, "The outstanding results that have been realized in treating such a wide array of cancers throughout the body has doctors expressing an interest in exploring the use of Cesium-131. These medical thought leaders recognize the important need for a powerful new weapon in the battle against cancer."
IsoRay has achieved another international milestone with the completion of the annual ISO 13485:2003 audit from BSI (British Standards Institution) with no nonconformities. The successful outcome of the audit means that IsoRay has met or exceeded international standards of manufacturing and quality systems that allows the Company to continue to develop the marketability of IsoRay products in Canada and Europe.
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, and several new implantable devices including the GliaSite® radiation therapy system.
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 GliaSite® and Cesium-131 by visiting www.isoray.com. Join us on Facebook.com/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, the advantages of the Gliasite delivery system, whether IsoRay will be able to continue to expand its base beyond prostate cancer, whether the use of GliaSite® or Cesium-131 internationally will increase or continue, 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, patient results achieved with Cesium-131 or the Gliasite® delivery system, successful completion of future research and development activities, our ability to receive and maintain all required regulatory approvals in the U.S. and internationally, continued compliance with ISO standards as audited by BSI, and other risks detailed from time to time in IsoRay's reports filed with the SEC.