RICHLAND, Wash.--(BUSINESS WIRE)--IsoRay, Inc. (Amex: ISR - News) announced today that Health Canada’s Therapeutic Products Directorate has approved Proxcelan Cs-131 brachytherapy seeds for sale throughout Canada.
IsoRay submitted all the required documentation to Health Canada earlier this year and received notification on April 24, 2009 that approval of IsoRay’s Class 3 Medical Device License Applications for Model CS-1 Proxcelan ™ (Cesium-131) Brachytherapy Seeds and the Proxcelan™ Sterile Implant Devices containing Model CS-1 Seeds had been granted.
“This completes another step in being able to expand the potential distribution of cesium-131 brachytherapy seeds,” stated Dwight Babcock, CEO. “We initially plan to leverage the relationships of our exclusive U.S. distributor, BrachySciences, and contacts we have made with Canadian physicians who are interested in using cesium-131 to treat their patients. Through these channels we hope to begin to penetrate the Canadian brachytherapy market.”
About IsoRay
IsoRay, Inc., through its subsidiary, IsoRay Medical, Inc., is the sole producer of the Proxcelan Cesium-131 brachytherapy seeds, used to treat prostate and other cancers. Proxcelan seeds offer a significantly shorter half-life than the two other isotopes commonly used for brachytherapy, which results in a substantially faster delivery of therapeutic radiation, lower probability of cancer cell survival and reduction of the longevity of common brachytherapy side effects.(a)(b) 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. Int. J. Radiation Oncology Biol. Phys. 2003; 55 (2): 378-385. (b) Prestidge B.R., Bice W.S., Jurkovic I., et al. Cesium-131 Permanent Prostate Brachytherapy: An Initial Report. Int. J. Radiation Oncology Biol. Phys. 2005; 63 (1): 5336-5337.
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 Health Canada’s requirements and expectations to sell Proxcelan in Canada, whether IsoRay’s relationships with BrachySciences and Canadian physicians will result in sales in Canada, 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, and other risks detailed from time to time in IsoRay’s reports filed with the SEC.
Contact:
IsoRay, Inc. Dwight Babcock, CEO, 520-240-4840 dbabcock@isoray.com
