First Patients Treated in Yokohama, Japan Following Expanded Japanese
Regulatory Approval
SUNNYVALE, Calif., March 19 /PRNewswire-FirstCall/ -- Accuray Incorporated
(Nasdaq: ARAY), a global leader in the field of radiosurgery, announced today
that the first extracranial patients were treated in Japan using CyberKnife
radiosurgery, following the System's recently expanded regulatory approval.
The CyberKnife System (marketed in Japan as CyberKnife II) was previously
approved in Japan to treat only intracranial, head and neck tumors. In June
2008 Accuray announced that Japan's Ministry of Health, Labor and Welfare
(MHLW) had granted Shonin approval of the CyberKnife System for extracranial
treatments, including tumors in the spine, lung, liver, pancreas and prostate.
This regulatory approval and the upgraded capabilities dramatically expand the
types of patients that can be treated with radiosurgery in the country.
"Having personally treated thousands of patients using CyberKnife
radiosurgery, I was thrilled when the technology received Shonin approval for
extracranial use," said Kengo Sato, M.D., chief medical officer at Yokohama
CyberKnife Center in Yokohama, Japan. "I have seen firsthand the System's
benefits in treating brain tumors and am very happy to be able to extend those
benefits to our extracranial patients. We're now treating patients who were
previously considered untreatable and are very pleased with the results we're
seeing."
"Japan remains the second largest installed base of CyberKnife Systems
with more than 20 installed to date, so these extracranial treatments are just
the beginning," said Eric P. Lindquist, senior vice president and chief
marketing officer of Accuray. "These patients are the first of many to
experience a convenient, comfortable and precise form of cancer care."
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 60,000 patients
worldwide and currently more than 155 systems have been installed in leading
hospitals in the Americas, Europe and Asia. For more information, please visit
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, including statements relating to
regulatory review and approval, clinical studies 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; 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 2008
fiscal year, as updated in our Form 10-Q filed on February 5, 2009 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 Incorporated
03/19/2009
CONTACT: Stephanie Tomei, Senior Manager, Public Relations, Accuray
Incorporated, +1-408-789-4234, stomei@accuray.com; or Brianne Donahue of
Schwartz Communications, +1-415-817-2545, bdonahue@schwartz-pr.com
Web Site: http://www.accuray.com
