Category: Medical Devices

IsoRay Announces Five Presentations at the American Brachytherapy Society (ABS) Convention Reporting on the Ongoing Success of Cesium-131 in Fighting Cancer

Oral Presentations and Posters on Various Studies Utilizing Cesium-131 Will Be at Center Stage

IsoRay Inc. (NYSE MKT: ISR), a medical technology company and innovator in seed brachytherapy and medical radioisotope applications, today announced it will host a booth (#301) at the Annual Meeting of the American Brachytherapy Society (ABS). The annual ABS meeting will take place April 3-5, 2014 in San Diego, California at the Manchester Grand Hyatt.


IsoRay CEO Dwight Babcock commented, "IsoRay is pleased to once again participate at the ABS annual meeting. At this venue, thought leaders including Drs. Ron Benoit, Sushil Beriwal and Ryan P. Smith of the University of Pittsburg Medical Center (UPMC), Drs. Bhupesh Parashar and Gabriella Wernicke of Weill Cornell Medical College, and Dr. Brian Moran of the Chicago Prostate Center will be panelists or present their papers documenting their experiences and success in using our products. Five papers will be presented during the convention. Management believes that all studies will show exceptional results realized in all areas of the body where Cesium-131, or the physics associated with Cesium-131, was used. With the ongoing publication of positive study results like these, the medical community is becoming increasingly aware of the innovative alternative our Cesium-131 products offer to cancer patients."

There are five presentations on Cesium-131 listed in the ABS program, with a summary as follows:

(1.) OR40 (Oral) Presentation Time: 9:03 AM Friday April 4th
Six-Year Biochemical Outcome in Patients Treated with Cs-131 Brachytherapy as Monotherapy for Prostate Cancer
Malolan S. Rajagopalan, MD1, Sushil Beriwal, MD1, Ryan P. Smith, MD1, Christopher J. Houser, MS1, Ronald M. Benoit, MD2.
1Radiation Oncology, University of Pittsburgh Cancer Institute, Pittsburgh, PA;
2Urology, University of Pittsburgh Cancer Institute, Pittsburgh, PA
Results: 243 prostate cancer patients; 57% low and 43% intermediate risk. Six year freedom from disease is 95%. "Results indicate that [prostate brachytherapy] monotherapy with Cs-131 is able to achieve excellent outcomes..."

(2.) OR33 (Oral) Presentation Time: 8:00 AM Friday April 4th
PSA Outcomes in a Single Institution, Prospective Randomized 131Cs/125I Permanent Prostate Brachytherapy Trial
Brian J. Moran, MD, Michelle H. Braccioforte, MPH.
Prostate Cancer Foundation of Chicago, Westmont, IL.
Results: 69 Cesium-131 and 71 Iodine-125 patients were randomized to study. 81% low and 19% intermediate risk prostate cancer. Five year freedom from disease is 93% for Cesium-131 patients and 90% for Iodine-125 patients.

(3.) PD19 (Poster Discussion) TBD
Investigation of the GliaSite Balloon Brachytherapy System Using I-125 and Cs-131 Solutions
Mark J. Rivard, PhD, Yun Yang, PhD.
Radiation Oncology, Tufts University School of Medicine, Boston, MA
Results: Earlier Data related to I-125 Iotrex have been confirmed. Evaluation of Cesium-131-based GliaSite® therapy revealed superior dosimetry.

(4.) PO53 (Poster TBD)
Radiation Exposure after Neurosurgical Resection and Permanent Intraoperative Cesium-131 Radio-isotope Brachytherapy in Patients with Brain Tumors
Menachem Z. Yondorf, BS1, Bhupesh Parashar, MD1, Albert Sabbas, PhD1, Samuel Trichter, MSc1, Lucy Nedialkova, PhD1, Theodore H. Schwartz, MD2, John A. Boockvar, MD2, Phillip Stieg, MD1, Susan Pannullo, MD2, Dattatreyudu Nori, MD1, KS Clifford Chao, MD1, A. Gabriella Wernicke, MD, MSc1.
1Radiation Oncology, Weill Cornell Medical College, New York, NY; 2Neurosurgery, Weill Cornell Medical College, New York, NY
Results: Exposure to uninvolved parties outside of the patient is minimal following Cesium-131 implants for the treatment of brain cancer.

(5.) PO59 (Poster TBD)
Rectal Dose Vs. Rectal Separation: A Dosimetric Study from a Single I-125, Cs-131 and Pd-103 Seed
Ravindra Yaparpalvi, MS, Hsiang-Chi Kuo, PhD, William Bodner, MD, Wolfgang A. Tome', PhD, Chandan Guha, MD, PhD.
Radiation Oncology, Montefiore Medical Center, Bronx, NY.
Results: Concludes that Palladium-103 is more of a concern around the rectum than Cesium-131 and Iodine-125 seeds.

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 says, "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 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 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 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, and other risks detailed from time to time in IsoRay's reports filed with the SEC.


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