RICHLAND, Wash.--(BUSINESS WIRE)--IsoRay, Inc. (Amex:ISR - News) announced today that it has received clearance from the FDA for its Premarket Notification, [510(k)] for Proxcelan™ Cesium-131 Brachytherapy Seeds enabling the company to preload Cesium-131 into flexible braided strands and surgical mesh. This FDA clearance allows IsoRay to market Cesium-131 seeds for use in the treatment of cancers well beyond the current prostate market.
This order clears the product for commercial distribution for treatment of lung and head and neck tumors as well as tumors in other organs. While Cesium-131 seeds themselves have been cleared for this indication since 2003, this current 510(k) allows Cesium-131 to be delivered in a new, convenient and sterile format that can be implanted without additional seed loading by the facility. The 510(k) also clears the application of the braided strands onto a bioabsorbable mesh matrix to further facilitate implant procedures.
Dwight Babcock, IsoRay CEO, stated. “The FDA’s decision will accelerate our strategy to significantly broaden the scope of Cesium-131 cancer treatments well beyond the current major prostate market. A growing number of physicians have indicated that they believe Cs-131’s unique characteristics of shorter half life and high energy are particularly suitable for many applications beyond prostate.”
In 2008 it was estimated that there were a total of 47,560 head and neck cases and 220,000 cases of lung cancer diagnosed in the United States. (Cancer Management: A Multidisciplinary Approach, 11th Edition (2008). Richard Pazdur, Lawrence R. Coia, William J. Hoskins, Lawrence D. Wagman; American Cancer Society, 2009.)
IsoRay, Inc., through its subsidiary, IsoRay Medical, Inc., is the sole producer of the Cesium-131 brachytherapy seed.
The Cesium-131 seed offers a significantly shorter radiation half-life than the two other isotopes commonly used for brachytherapy, which results in a substantially faster delivery of therapeutic radiation, a theoretically improved radiation delivery against aggressively replicating cancer(a), and the potential for a reduced longevity of common brachytherapy side effects(b).
Cesium-131 is currently used in the treatment or prostate cancer(c) and ocular melanoma(d), among other cancerous conditions.
IsoRay is based in Richland, Washington. More information is available about IsoRay at www.isoray.com.
(a) Armpilia CI, Dale RG, Coles IP, et al. The Determination of Radiobiologically Optimized Half-lives for Radionuclides Used in Permanent Brachytherapy Implants. International Journal of Radiation Oncology, Biology, and Physics 2003;55(2):378-385.
(b) DeFoe SG, Beriwal S, Smith R, Benoit R. Is there decreased duration of acute urinary and bowel symptoms after prostate brachytherapy with cesium 131 isotope? International Journal of Radiation Oncology, Biology, and Physics 2008;72(S1):S317.
(c) Bice WS, Prestidge BR, Kurtzman SM, Beriwal S, Moran BJ, Patel RR, Rivard, MJ. Recommendations for permanent prostate brachytherapy with (131)Cs: a consensus report from the cesium advisory group. Brachytherapy 2008;7(4):290-6.
(d) Melhus CS, Rivard MJ. COMS eye plaque brachytherapy dosimetry simulations for 103Pd, 125I, and 131Cs. Medical Physics 2008;35(7):3364-71.
Safe Harbor Statement
Statements in this news release about IsoRay's future expectations, including: the advantages of our Proxcelan Cesium-131 seed, whether IsoRay will continue to meet FDA requirements, whether IsoRay will be able to expand its base beyond prostate cancer into the lung and head and neck tumor markets, whether physicians will expand use of brachytherapy to treat lung and head and neck tumors and tumors in other organs, whether IsoRay's Cesium-131 seed will be used to treat additional cancers and malignant disease, whether the use of Cesium-131 to treat lung and head and neck cancers will be successful in clinical implants, 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 early clinical studies, whether initial implants of Cesium-131 to treat lung and head and neck cancers result in favorable patient outcomes, patient results achieved when Cesium-131 is used for the treatment of cancers and malignant diseases beyond prostate cancer, successful completion of future research and development activities, and other risks detailed from time to time in IsoRay's reports filed with the SEC.
Dwight Babcock, CEO, 520-240-4840