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NEWS RELEASE for January 25, 2010

Contact Dwight Babcock, CEO
520 240 4840
dbabcock@isoray.com
 


ISORAY ANNOUNCES IT HAS PROVIDED SEEDS TO CANADA FOR RESEARCH INITIATIVES TO EXPAND THE USE OF CESIUM-131 FOR NEW CANCER APPLICATIONS

Richland, WA (January 25, 2010) … IsoRay, Inc. (Amex: ISR) announced today that it has successfully shipped the first set of Cesium-131 brachytherapy seeds to a Canadian customer for the purpose of furthering research and development of Cesium-131 in Canada.  Cesium-131 is currently approved by Health Canada for the treatment of low-risk prostate cancers and has been cleared by the US FDA for treatment of a wide variety of malignant disease (e.g. prostate, head and neck, brain, breast, lung, eye, etc.).

IsoRay Medical in conjunction with its Canadian distribution partner, Inter V Medical, looks forward to expanding the application of Cesium-131 for other cancer treatment areas of the body.  IsoRay is seeking additional clinical evidence to allow Health Canada to approve expanded indications for use of Cesium-131 for other malignant disease locations. The goal is to obtain approvals for a wide variety of malignant disease sites (as has already been obtained in the United States).

Dwight Babcock, Chairman and CEO, stated.  “We are very excited to take this first step in gathering clinical data to support the expanded use of Cesium-131 in Canada.  We have experienced successful treatments of numerous cancers here in the US, such as lung, head and neck, and colon cancers, and look forward to bringing this technology to physicians in Canada to use in treating their patients.  We are working closely with our distribution partner Inter V Medical to expedite the penetration of the Canadian market.”

Babcock continued, “Inter V Medical, our distributor, brings to IsoRay Medical a team of nine dedicated sales professionals strategically placed across Canada with exclusive rights to sell Cesium-131 brachytherapy seeds.  Inter V Medical has been bringing new medical technologies, including brachytherapy and related products, to the Canadian market for nearly twenty years.” 

 

 

About IsoRay
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 of 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 and Inter V will continue to meet Health Canada's requirements and expectations to sell Proxcelan in Canada, whether additional approvals will be obtained from Health Canada to use Proxcelan for malignant disease other than prostate cancer, whether the contemplated clinical trials will be completed and will result in favorable findings with respect to Proxcelan, whether IsoRay’s relationships with Inter V and Canadian physicians will result in continued and expanded sales in Canada, whether IsoRay's Cesium-131 seed will be used to treat additional cancers and malignant disease, whether physicians and facilities will adopt Cs-131 for use for non-prostate cancers, future demand for IsoRay's existing and planned products, 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, patient results achieved when Cesium-131 is used for the treatment of cancers and malignant diseases beyond prostate cancer, changing levels of demand for IsoRay's current and proposed future products, changes in laws and regulations applicable to our product both in the United States and internationally, Health Canada’s perception of the clinical results obtained for IsoRay’s Cesium-131 brachytherapy seed, and other risks detailed from time to time in IsoRay's reports filed with the SEC.

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