IsoRay Announces World's First Pediatric Cesium-131 Seeded Mesh Treatment for Metastatic Wilms Tumor

Cesium-131 Implants Used to Provide Needed Radiation to Treat This Aggressive Cancer

IsoRay Inc. (NYSE MKT: ISR) (http://www.isoray.com/), a medical technology company and innovator in seed brachytherapy and medical radioisotope applications, today announced another milestone - the treatment of a pediatric patient's tumor utilizing multiple Cesium-131 sutured seed meshes for internal radiation therapy.

Dr. Anthony Crimaldi at Levine Cancer Institute, Charlotte, NC, successfully completed the world's first pediatric implant using IsoRay Medical's Cesium-131 brachytherapy mesh. Dr. Crimaldi said "The patient was a 12 year old male who was diagnosed with recurrent metastatic Wilms tumor (a type of childhood kidney tumor) in the pleural space of the lower aspect of his left chest. Prior to this he had been treated extensively, but nevertheless the cancer returned.

Due to previous irradiation of his chest (specifically whole lung irradiation), the patient was not a candidate for either SBRT (stereotactic radiosurgery) or proton therapy for treatment of this lesion. Although surgical removal of the tumor was possible, radiation therapy was needed in this case to treat the surgical bed.

I worked closely with IsoRay to design a custom mesh containing Cesium-131 sources and we were able to place the mesh at the time of surgery so as not to expose critical organs to high doses of radiation (lung, spinal cord, and aorta). Post-treatment dose calculations were performed confirming the delivery of dose to the resection bed and sparing of the critical structures. The patient recovered normally and has been discharged home.

The process of designing the treatment mesh was done with the assistance of the IsoRay team, and was quick and simple (done with the use of cross-sectional imaging). The mesh was designed, manufactured, and arrived for placement in less than 1 week. This device is an option that can provide treatment in areas of prior irradiation with a dose that is highly conformal and spares normal critical structures when other treatment modalities (such as external irradiation) are not possible." 

Dwight Babcock IsoRay's Chairman and CEO stated: "When cancers become locally advanced, they recur frequently after surgery. Radiation is therefore performed, but the amount of radiation required to successfully treat the disease is often limited with existing technologies and has the potential to increase negative side effects to the patient. With the Cesium-131 seeded mesh we can get the optimal dose to the area of concern at the time of surgery -- which we think is a real benefit for the patient."

Recent innovations in cancer surgery have allowed surgeons to remove less healthy tissue than in years past. In these cases, however, radiation therapy becomes a critical addition to the treatment of the cancer. IsoRay Medical supplies multiple radiation based products that can be used at the time of surgery to deliver this needed radiation, ensuring direct irradiation of the cancer-involved target while minimizing the damaging effects of radiation on healthy tissues.

IsoRay Chairman and CEO Dwight Babcock noted: "We are very pleased to be working with innovative cancer physicians such as Dr. Crimaldi. We believe that collaboration between the radiation oncologist and the surgeon offers patients the best possible treatment." 

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, occular 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 implantable devices including the GillaSite radiation therapy system, the world's only liquid radiation balloon catheter device used in the treatment of brain cancer. 

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 Cesium-131 by visiting www.isoray.com.
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Safe Harbor Statement
Statements in this news release about IsoRay's future expectations, including: the advantages of our products and their various delivery formats, the advantages of Cesium-131 in mesh form, whether adoption of our products will continue to increase, whether IsoRay will be able to continue to expand its base beyond prostate cancer, whether treatment of Wilms tumors using Cesium-131 will be successful in this and future cases, whether future studies of treatment of various cancers using our products will have 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 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, whether additional studies are released and support the conclusions of past studies, 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, successful completion of future research and development activities, 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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