SOURCE: IsoRay, Inc.

IsoRay, Inc.

June 17, 2015 08:30 ET

IsoRay's Quality Management System Granted Continued Certification to Highest ISO Standard for Medical Device Manufacturers

British Standards Institution (BSI) Performed a Continuing Assessment (Surveillance) Audit

RICHLAND, WA--(Marketwired - Jun 17, 2015) - IsoRay Inc. (NYSE MKT: ISR), a medical technology company and innovator in seed brachytherapy and medical radioisotope applications, today announced the successful evaluation of its quality management system following an audit conducted by British Standards Institution (BSI).

IsoRay Medical undergoes extensive annual audits in order to maintain the ISO 13485 certification that allows IsoRay to market its brachytherapy products in the 28 countries that make up the EU community, in addition to other countries that recognize ISO certification. IsoRay enjoys both FDA clearance and CE markings for its family of cancer treatment products.

IsoRay CEO Dwight Babcock, commented, "Operating in a heavily regulated international environment as we do, it is crucial that IsoRay continues to dedicate a substantial amount of energy and vigilance to our quality systems. It remains a very high priority that IsoRay products and processes pass muster with the most demanding international standards, including ISO 13485."

ISO (International Organization for Standardization) is the world's largest developer and publisher of international standards. The ISO 13485 certification covers the design, development, production and sales of IsoRay products. IsoRay's ISO 13485 certificate was awarded by BSI, which in this most recent surveillance audit reported no observations or findings.

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.

About BSI -- BSI is the business standards company that helps organizations all over the world make excellence a habit. BSI shows businesses how to improve performance, reduce risk and achieve sustainable growth. As a global leader in helping organizations improve, BSI's clients range from high profile brands to small, local companies in 172 countries worldwide.

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 we will maintain adequate quality control systems, whether we will continue to meet ISO standards, 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 IsoRay's products, changing levels of demand for IsoRay's current and proposed future products, IsoRay's ability to reduce or maintain expenses while increasing sales, patient results achieved using our products in both the short and long term, success of future research and development activities, patient results achieved when Cesium-131 is used for the treatment of cancers and malignant diseases beyond prostate cancer, IsoRay's ability to successfully manufacture, market and sell its products, IsoRay's ability to manufacture its products in sufficient quantities to meet demand within required delivery time periods while meeting its quality control standards, the success of our sales and marketing efforts, IsoRay's ability to enforce its intellectual property rights, changes in reimbursement rates, changes in laws and regulations applicable to our products, whether additional studies and protocols are released and support the conclusions of past studies and protocols, whether ongoing patient results with our products are favorable and in line with the conclusions of clinical studies and initial patient results, whether we, our distributors and our customers will successfully obtain and maintain all required regulatory approvals and licenses to market, sell and use our products in their various forms, 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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