SUNNYVALE, CA -- Accuray Incorporated, a global leader in the field of radiosurgery, has announced 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 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 www.accuray.com.

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