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.
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.
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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|
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