IsoRay, Inc. (NYSE MKT: ISR), a medical technology company and innovator in seed brachytherapy and medical radioisotope applications, today announced another milestone -- the treatment of a brain tumor that had metastasized from esophageal cancer utilizing IsoRay's liquid Cesium-131 (Cesitrex®) which recently was FDA cleared for internal radiation therapy.
Dr. Randy Sorum, radiation oncologist and Dr. Ryan Halpin, neurosurgeon at Capital Medical Center successfully completed the world's first GliaSite® Radiation Therapy System (RTS) implant utilizing liquid Cesium-131 (Cesitrex®). Dr. Sorum said "The patient was a 72 year old male who was diagnosed with recurrent brain cancer that had metastasized from esophageal cancer. Earlier attempts to control this cancer including surgery, external brain radiation and stereotactic radiosurgery had failed and the metastasis returned."
Due to the need for irradiating the newly resected surgical bed, Dr. Sorum decided to utilize GliaSite® RTS, a balloon catheter system that delivers a high dose of radiation to the surgical bed, minimizing radiation to uninvolved healthy brain tissue. Dr. Sorum stated, "The unique benefit of GliaSite® is its capability to deliver radiation directly to the high risk areas for recurrence, unlike additional external beam radiation which likely would have damaging effects to healthy brain tissue. GliaSite® RTS in combination with Cesitrex® offers the additional benefit of improved quality of life for the patient. To date the majority of my patients treated with liquid I-125 (Iotrex®) and GliaSite® RTS have exceeded my personal survival expectations and those reported in published results. Most important, the patient receiving Cesitrex® did great through the entire treatment process with no post-operative side effects to date."
IsoRay CEO Dwight Babcock said, "This marks a milestone in launching IsoRay's newest product into the US marketplace, supporting management's goal to increase revenues and shareholder value while improving the quality of life for the patient. Our hope is to promote awareness that our product line, including both Cesium-131 brachytherapy seeds and GliaSite® RTS utilizing liquid Cesium-131 isotope (Cesitrex®), can take on difficult cancers throughout the body. We are advancing our ultimate domestic and international goal of making Cesium-131 a standard of care for the treatment of multiple cancers and GliaSite® RTS a standard of care for the treatment of brain cancer. We are extremely pleased with the exceptional results a growing number of thought leaders and major medical centers are experiencing throughout the U.S. and internationally using Cesium-131. We believe Cesium-131's ability to fight cancer and improve the quality of life for the men, women, and children who are battling these devastating cancers distinguishes it from other treatment options."
IsoRay is the exclusive manufacturer of Cesium-131. The pioneering brachytherapy 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 implantable devices including the GliaSite® 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 and systems, whether adoption of our products will continue to increase, whether IsoRay will be able to continue to expand its base beyond prostate cancer, whether treated cancers will reoccur, whether future studies of treatment of various cancers using our products will have favorable results, whether sales of our products will continue at historic levels or increase, whether the use of our products will increase or continue, whether future clinical results achieved with treatment using Cesium-131 in the GliaSite® radiation therapy system will be favorable, 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 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 both in the U.S. and internationally, 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, 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.
SOURCE: IsoRay, Inc.