Healthcare Industry News:  Balloon catheter 

Devices Neurosurgery Oncology

 News Release - June 5, 2012

IsoRay Announces World's First Cesium-131 Mesh Treatment for Meningioma Brain Tumors

Seed Sutured Mesh Delivers Impressive Early Results at St. Joseph's Hospital & Medical Center, Barrow Neurological Institute

RICHLAND, WA--(Healthcare Sales & Marketing Network)- IsoRay Inc. (ISR), a medical technology company and innovator in seed brachytherapy and medical radioisotope applications, today announced another milestone in the treatment of brain tumors using its groundbreaking Cesium-131 (Cs-131) seed sutured mesh for internal radiation therapy. Dr. Kris Alan Smith, surgeon and Medical Director, Gamma Knife Center, supported by Dr. David G. Brachman, Medical Director of Radiation Oncology at St. Joseph's Hospital & Medical Center, Barrow Neurological Institute in Phoenix, Arizona, performed the world's first Cesium-131 brachytherapy seed sutured mesh implant on a female patient suffering from a recurring meningioma tumor.

Meningiomas are an assorted set of tumors that develop in membranous layers surrounding the central nervous system. According to the American Brain Tumor Association, meningiomas are the most common primary brain tumor and represent one-third of all brain tumors. These fast growing tumors often reoccur. They cause pressure on the brain, destroying brain cells and causing a variety of health and quality of life problems for the stricken patient. There are both benign and malignant meningioma tumors.

The Cesium-131 brachytherapy sutured mesh implant was performed on a female patient suffering from her fourth reoccurrence of a meningioma. The sutured mesh was placed over the resected tumor at the time of surgery to provide immediate radiation therapy to the entire tumor bed and margins, which is aimed at preventing tumor reoccurrence. While the patient's tumor had previously reoccurred as early as 6 weeks following her prior treatments with external beam radiation, now, at 90 days after treatment with Cesium-131 seed sutured mesh, there is no sign of tumor reoccurrence.

Typically, meningiomas require multiple treatments with external beam radiation following surgery. Treatment in this manner represents great complexity and difficulty. Because tumors are often large and irregular in shape, delivering a precise dose of radiation is problematic.

Board certified in both Internal Medicine by the American Board of Internal Medicine as well as Radiation Oncology by the American Board of Radiology, Dr. Brachman said, "Patient acceptance has been very high, and no adverse outcomes have been noted to date." Dr. Brachman also pointed to Cesium-131's distinctive abilities. "Cesium-131 provides a unique biological advantage regarding the timing of radiation, being utilized at the time of the surgery before tumor cells can repopulate, which helps to maximize the therapeutic benefit of radiation treatment," he explained.

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).

IsoRay CEO Dwight Babcock says this is just the latest application in brain tumor treatment representing the continued expansion of use of the Company's pioneering Cesium-131 brachytherapy seeds and liquid isotopes. "We are advancing our domestic and international goal of creating widespread awareness and adoption of Cesium-131. The exceptional results that have been realized in treating such a wide array of cancers is drawing an increasing number of inquiries from the medical community. 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."

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, 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 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 Cesium-131 seed, the advantages of Cesium-131 in mesh form, whether adoption of Cesium -131 will continue to increase, whether IsoRay will be able to continue to expand its base beyond prostate cancer, whether treatment of brain cancer using Cesium-131 will be successful in future cases, 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 Cesium-131 are favorable and in line with the conclusions of clinical studies and initial patient results, patient results achieved when Cesium-131 is used for the treatment of cancers and malignant diseases beyond prostate, whether we, our distributors and our customers will successfully obtain and maintain all required regulatory approvals and licenses to market, sell and use Cesium-131 in its various forms, successful completion of future research and development activities, and other risks detailed from time to time in IsoRay's reports filed with the SEC.

Source: IsoRay

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