Healthcare Industry News:  Accuray 

Devices Oncology

 News Release - August 8, 2007

CyberKnife(R) System Extracranial Treatments Grow 75 Percent in Fiscal Year 2007 Demonstrating Radiosurgery Market Shift

U.S. Patients Treated with CyberKnife System for Lung Cancer Doubled and Prostate Cancer Quadrupled

SUNNYVALE, Calif., Aug. 8 (HSMN NewsFeed) -- Accuray Incorporated (Nasdaq: ARAY ), a global leader in the field of radiosurgery, announced today that use of its CyberKnife® Robotic Radiosurgery System to treat extracranial tumors non-invasively has increased by 75 percent worldwide during Accuray's fiscal year ending June 30, 2007. The most dramatic growth was seen in the treatment of lung and prostate cancer in the United States, which doubled and quadrupled respectively since the end of fiscal year 2006.

For more than four decades, radiosurgery has been used exclusively to treat brain tumors. With U.S. Food and Drug Administration clearance in 2001, the CyberKnife System became the first and only robotic radiosurgery system designed to treat tumors anywhere in the body, including those in the spine, lungs, prostate, liver and pancreas. To date, more than 35,000 patients have been treated with the CyberKnife System worldwide.

"The CyberKnife System has revolutionized cancer care. We are now able to treat a wide array of tumors, including many that were untreatable in the past," said Dr. Greg Gagnon, associate professor, interim chairman of the Department of Radiation Medicine and CyberKnife Program Director at Georgetown University Hospital in Washington, DC. "Because it is non-invasive and delivers high-dose radiation with sub-millimeter accuracy, the CyberKnife System is a perfect tool for destroying tumors quickly with minimal side effects."

Based on robotic technology, the CyberKnife System is able to track, detect and correct for movement of the patient and tumor during treatment making it the ideal delivery system for lung tumor treatments. More than 95 percent of CyberKnife facilities in the United States now treat lung cancer. Furthermore, lung cancer patients accounted for 18 percent of all U.S. CyberKnife treatments during fiscal year 2007.

Prostate cancer is the most common cancer in men in the United States and the second most common cancer in men worldwide. Prostate cancer treatments with the CyberKnife System are expanding at an extraordinary rate. The CyberKnife System tracks the prostate during treatment, automatically compensates for any motion and also shapes the radiation dose to match the shape of the prostate, thereby reducing dose to surrounding tissue. In addition, the CyberKnife System offers patients more convenience than traditional treatments because of its short treatment time -- typically one to five days. Prostate cancer treatments with the CyberKnife System showed a staggering 320 percent growth rate in the United States over the last fiscal year.

"There has been increased interest in the CyberKnife System amongst prostate cancer patients with a number of patients self-referring because of the ease, comfort and convenience associated with CyberKnife treatments," said Dr. Jay Friedland, administrative director and radiation oncologist at Naples Community Hospital Regional Cancer Institute in Naples, Fla. "And from a clinical standpoint, we're seeing local control, low complication rates and immediate, significant drops in patients' PSA levels following treatment."

"Each CyberKnife treatment session lasted about an hour, and throughout the treatment I was able to relax and listen to my own music in a pleasant room," said Scott Silver, prostate cancer patient who was treated with the CyberKnife System at Naples Community Hospital. "And after the treatment was finished, I rested for no more than a day and then resumed my normal activities."

"The CyberKnife System offers a unique blend of continual image guidance and robotic mobility to create the most accurate radiosurgery system in the world," said Euan S. Thomson, Ph.D., president and CEO of Accuray. "Accuray's clinical program has successfully expanded the field of radiosurgery and simultaneously established the CyberKnife as the brand leader in radiosurgery treatment delivery. The increase in utilization of the CyberKnife demonstrates a definitive change in clinical practice and a significant market expansion."

While lung and prostate treatments dominated the growth in whole body radiosurgery applications during fiscal year 2007, significant growth in patient numbers were seen in many body sites. The numbers of patients treated by the CyberKnife System in the United States for liver and pancreas tumors increased by 74 percent and 56 percent respectively. The number of patients treated by the CyberKnife System for spinal tumors in the United States increased 37 percent. Much of the growth is a result of clinician adoption of Accuray's Xsight(TM) Spine Tracking System, which eliminates the need for implanted markers or fiducials by using the body's bony anatomy to identify the location of the tumor and track it throughout the treatment. Growth in the number of patients treated for the traditional indication of brain tumors also occurred.

About the CyberKnife® Robotic Radiosurgery System

The CyberKnife Robotic Radiosurgery System is the world's only robotic radiosurgery system cleared by the FDA to treat tumors anywhere in the body non-invasively and with sub-millimeter accuracy. 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 precise, high-dose radiation, minimizing damage to surrounding healthy tissue and eliminating 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 35,000 patients worldwide and currently more than 100 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 regarding 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; competing products; availability of clinical data; availability of reimbursement for CyberKnife procedures; the combination of our products with complementary technology; and other risks detailed from time to time under the heading "Risk Factors" in our most recent form 10-Q filed on May 14, 2007 and may be updated from time to time by 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

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