Category: Medical Devices

Weill Cornell Clinical Study Notes Cesium-131 Brachytherapy Can Provide a Viable Alternative to Whole Brain Radiotherapy With Excellent Response Rates and Minimal Toxicity

RICHLAND, WA--December 14, 2015) - IsoRay Inc. (ISR), a medical technology company and innovator in seed brachytherapy and medical radioisotope applications for the treatment of prostate, brain, lung, head and neck and gynecological cancers, today announced the recent publication of the peer-reviewed results of a study entitled: "Neurocognitive function and quality of life in patients with newly diagnosed metastasis after treatment with intra-operative cesium-131 brachytherapy: a prospective trial."

Twenty-four patients with newly diagnosed metastasis to the brain were treated with Cs-131 brachytherapy seeds after surgical resection between 2010 and 2012. Study protocols required physician administered mini-mental status examinations (MMSE) and functional assessment of cancer brain therapy (FACT-Br) questionnaires to all patients before treatment, and again every 2 months for a 6 month period, with a final follow-up at 12 months. Results of the study suggest that surgical resection with intraoperative Cs-131 brachytherapy is able to "stabilize or improve NCF [neurocognitive function] for patients with metastatic brain tumors by improving control of brain tumors and avoiding the toxicity of WBRT [whole brain radiotherapy]."

The study was presented at ASTRO's 56th Annual Meeting in San Francisco, CA, on September 16, 2014. The research paper was published online on December 9, 2015 in the Journal of Neuro-Oncology (Pham, Anthony, et. al., "Neurocognitive function and quality of life in patients with newly diagnosed brain metastasis after treatment with intra-operative cesium-131 brachytherapy: a prospective trial," p.1-9.) and is available at - http://link.springer.com/article/10.1007/s11060-015-2009-5.

Dwight Babcock, IsoRay's Chairman and CEO, stated: "This study suggests that surgical resection with intraoperative Cs-131 has the capacity to preserve or even improve quality of life after treatment in the short-term. This is encouraging and we look forward to the results of a comprehensive, longitudinal multi-center study, which is currently underway. We thank Weill Cornell Medical College and the authors of this study for their ongoing work in cancer research and Cs-131's potential applications."

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, whether interest in and use of our products will increase or continue, whether awareness and adoption of our products in the medical community will continue or increase, whether ongoing studies will continue and any future studies using our products will commence or continue, whether future peer-reviewed publications of treatment results using our products will report favorable results, 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, whether ongoing patient results with our products are favorable and in line with the conclusions of clinical studies and initial patient results, patient results achieved when our products are used for the treatment of cancers and malignant diseases beyond prostate, 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 our products in its various forms, 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. Unless required to do so by law, the Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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