Category: Medical Devices

IsoRay Announces World's First Human Prostate Implant Utilizing Cesium-131 Seeds and C4 Imaging's Positive Signal MRI Markers

Dr. Steven Frank of MD Anderson Performed the First Implant

Apr 7, 2014) - IsoRay Inc. (NYSE MKT: ISR), a medical technology company and innovator in seed brachytherapy and medical radioisotope applications, today announced the first prostate cancer implant combining IsoRay's Cesium-131 seeds with C4 Imaging's Sirius® positive signal MRI markers.

IsoRay CEO Dwight Babcock commented, "We are very excited to have our Cesium-131 isotope seeds chosen to partner with C4 Imaging's innovative positive signal MRI markers in the treatment of prostate cancer. By combining two of the newest technologies available in brachytherapy, we hope to demonstrate superior outcomes with the goal of improving patient lives.

As we continue to develop our product offerings both internally and in partnership with other industry leaders, our message is clear and the medical community is becoming increasingly aware of the innovative alternative our Cesium-131 products offer to cancer patients."

Dr. Steven Frank of MD Anderson Cancer Center, who performed the implant, commented "IsoRay's Cesium-131, with its short half-life, offers rapid resolution of the acute side effects that can be associated with prostate treatment with brachytherapy".

Dr. Frank further stated "Strands utilizing IsoRay's Cesium-131 seeds and C4 Imaging's Sirius® MRI Markers bring together two novel technologies that permit MRI-based brachytherapy in order to optimize the treatment quality and outcomes of prostate cancer patients".

IsoRay's various products, including Cesium-131 seeds, sutured seeds, stranded mesh and the GliaSite® radiation therapy system, give physicians the ability to directly place a specified dosage of radiation in areas where cancer is most likely to remain after completion of a tumor removal or by placing seeds within the prostate. The ability to precisely place a specified dose of radiation means there is less likelihood for damage to occur to healthy surrounding tissue compared to other alternative treatments. IsoRay's cancer fighting products diminish the ability of the tumor to recur, resulting in important benefits for patients in longevity as well as quality of life.

Babcock said, "Leaders in the medical arena recognize the important need for a new powerful weapon in the battle against cancer and I believe Cesium-131 is that solution."

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. 

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 GliaSite® and Cesium-131 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 products and their delivery systems, the advantages of Cesium-131 seeds when used in combination with C4 Imaging's MRI markers, whether IsoRay will be able to continue to expand its base beyond prostate cancer, whether sales of our products will continue at historic levels or increase, whether the use of our products will increase or continue, whether we will continue to partner with other companies, whether awareness of our products in the medical community will continue or increase, 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 our products, successful completion of future research and development activities, our ability and the ability of our distributors and customers to receive and maintain all required regulatory approvals in the U.S. and internationally, continued compliance with ISO standards as audited by BSI, the success of our sales and marketing efforts, 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.

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