Healthcare Industry News:  Accuray 

Devices Oncology Regulatory

 News Release - June 19, 2008

Japan Approves CyberKnife System for Extracranial Use

Robotic Radiosurgery System Offers Non-Invasive Treatment Alternative for Tumors Anywhere in the Body

SUNNYVALE, Calif., June 19 (HSMN NewsFeed) -- Accuray Incorporated (Nasdaq: ARAY ), a global leader in the field of radiosurgery, announced today that Japan's Ministry of Health, Labor and Welfare (MHLW) has granted Shonin approval of the CyberKnife® Robotic Radiosurgery System for use in treatment of extracranial tumors, including tumors that move with respiration. This regulatory approval dramatically expands the types of patients that can be treated with radiosurgery. As a result of this approval, the CyberKnife System may be used in Japan to treat tumors anywhere in the body, including those in the spine, lung, liver, pancreas and prostate.

"Japanese regulatory approval for these expanded indications is a noteworthy milestone for Accuray and significantly expands the potential for the CyberKnife System in Japan," said Eric P. Lindquist, senior vice president and chief marketing officer of Accuray Incorporated. "Because customers in Japan have a long history of using the CyberKnife System for tumors in the head and neck, we are pleased that the benefits of extracranial radiosurgery will finally be realized by this important market."

The CyberKnife System offers cancer patients worldwide a pain-free, non- invasive alternative to surgery. In 1996 the CyberKnife System was first approved in Japan to treat tumors in the head and neck. Currently, there are 20 CyberKnife Systems installed throughout Japan, making it the second largest installed base of CyberKnife Systems after the United States.

Recently Accuray established an office in Tokyo, Japan to better address this strategic market. Accuray will work with its existing distributor to sell the CyberKnife System and increase patient access to its benefits.

Japan is currently facing a rapidly aging population and the incidence of lung cancer is on the rise. Lung cancer is the leading cause of cancer death among men and women in Japan. In 2003, the number of lung cancer deaths reached 41,615 (22 percent of all cancer-related deaths) in men and 15,086 deaths (12 percent of all cancer-related deaths) in women. Additionally, according to a 2006 report from global research firm, Research and Markets, Japan remains the world's second largest medical device market after the United States.

About the CyberKnife® Robotic Radiosurgery System

The CyberKnife Robotic Radiosurgery System is the world's only robotic radiosurgery system designed to treat tumors anywhere in the body non- invasively. Using continual image guidance technology and computer controlled robotic mobility, the CyberKnife System automatically tracks, detects and corrects for tumor and patient movement in real-time throughout the treatment. This enables the CyberKnife System to deliver high-dose radiation with pinpoint precision, which minimizes damage to surrounding healthy tissue and eliminates the need for invasive head or body stabilization frames.

About Accuray

Accuray Incorporated (Nasdaq: ARAY ), based in Sunnyvale, Calif., is a global leader in the field of radiosurgery dedicated to providing an improved quality of life and a non-surgical treatment option for those diagnosed with cancer. Accuray develops and markets the CyberKnife Robotic Radiosurgery System, which extends the benefits of radiosurgery to include extracranial tumors, including those in the spine, lung, prostate, liver and pancreas. To date, the CyberKnife System has been used to treat more than 40,000 patients worldwide and currently more than 130 systems have been installed in leading hospitals in the Americas, Europe and Asia. For more information, please visit http://www.Accuray.com.

Safe Harbor Statement

The foregoing may contain certain forward-looking statements that involve risks and uncertainties, including uncertainties associated with the medical device industry. Except for the historical information contained herein, the matters set forth in this press release regarding procedure growth and market acceptance, clinical studies, regulatory review and approval, and commercialization of products are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements speak only as of the date the statements are made and are based on information available at the time those statements are made and/or management's good faith belief as of that time with respect to future events. You should not put undue reliance on any forward- looking statements. Important factors that could cause actual performance and results to differ materially from the forward-looking statements we make include: market acceptance of products; risks associated with international sales and reimbursement, risks associated with regulatory clearances and approvals; competing products, the combination of our products with complementary technology; and other risks detailed from time to time under the heading "Risk Factors" in our report on Form 10-K for the 2007 fiscal year, as updated from time to time by our quarterly reports on Form 10-Q and our other filings with the Securities and Exchange Commission. The Company's actual results of operations may differ significantly from those contemplated by such forward-looking statements as a result of these and other factors. We assume no obligation to update forward-looking statements to reflect actual performance or results, changes in assumptions or changes in other factors affecting forward-looking information, except to the extent required by applicable securities laws.


Source: Accuray

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