Accuray's CyberKnife® G4 System Receives Shonin Approval

Latest Advances in CyberKnife Radiosurgery Now Available in Japan

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Aug 03, 2010, 08:30 ET

SUNNYVALE, Calif., Aug. 3 /PRNewswire-FirstCall/ -- Accuray Incorporated (Nasdaq: ARAY), a global leader in the field of radiosurgery, announced today it received Shonin approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to market the CyberKnife® G4 Robotic Radiosurgery System to treat tumors non-invasively anywhere in the body, inclusive of head and neck. The System will be marketed in Japan as the "CyberKnife® Radiosurgery System."

The CyberKnife G4 System will provide Japanese patients with some of the latest advances in CyberKnife technology including:

Motion management technology to correct for tumor motion including the Xsight® Lung Tracking System, which eliminates the need for fiducials in many lung cases;
Hardware and software enhancements that enable up to 50 percent reduction in treatment time;
Customized treatment plans dictated by clinical requirements and objectives;
Flexibility to adapt the fractionation scheme to meet the unique needs of each patient simply and conveniently in routine clinical practice.

In June 2008 Accuray was granted Shonin approval of the CyberKnife System for use in Japan in the treatment of extracranial tumors, including tumors that move with respiration. This regulatory approval dramatically expanded the types of Japanese patients that could be treated with radiosurgery to include those with cancers of the spine, lung, liver, pancreas and prostate.

Since the 2008 regulatory approval, there has been significant interest in the treatment of tumors throughout the body using CyberKnife radiosurgery and the availability of the CyberKnife G4 System in Japan further expands the planning, application and throughput capabilities of the system. The CyberKnife G4 System addresses the unique challenges of random and excessive target motion by using intelligent and adaptive image guidance, which minimizes dose to surrounding healthy tissue and critical structures, ultimately minimizing treatment complications and side effects.

"This is an important milestone for Accuray as we continue our journey to expand the global footprint of our best-in-class radiosurgery treatment, the CyberKnife System," said Euan S. Thomson, Ph.D., president and CEO of Accuray. "With the availability of these capabilities, we anticipate enhanced interest in the acquisition of CyberKnife technology and we will work closely with our Japanese regional office in Tokyo to enable quick adoption of the CyberKnife G4 System throughout Japan."

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. With 21 CyberKnife Systems installed throughout Japan, it is the second largest installed base of CyberKnife Systems 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 90,000 patients worldwide and currently more than 200 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 approvals, market need and clinical acceptance 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 2009 fiscal year, our quarterly report on Form 10-Q filed on May 6, 2010, 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