Japan Approves CyberKnife System for Extracranial Use

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Thu Jun 19, 2008 8:30am EDT

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

SUNNYVALE, Calif., June 19 /PRNewswire-FirstCall/ -- 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(R) 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(R) 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
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SOURCE  Accuray Incorporated

Susan Lehman of Rockpoint Public Relations, +1-510-832-6006,
susan@rockpointpr.com, for Accuray Incorporated; or Stephanie Tomei, Public
Relations Manager of Accuray Incorporated, +1-408-789-4234,
stomei@accuray.com
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