Accuray Receives FDA Clearance for the CyberKnife® System's Lung Optimized Treatment

SUNNYVALE, Calif., Dec. 15, 2010 /PRNewswire-FirstCall/ -- Accuray Incorporated (Nasdaq: ARAY), a global leader in the field of radiosurgery, announced today that the U.S. Food and Drug Administration (FDA) has granted the company 510(k) clearance to market Lung Optimized Treatment, a new component of the CyberKnife® VSI™ System. The 510(k) clearance enables Accuray to provide physicians with greater flexibility in delivering radiosurgery treatments to patients with lung cancer, the most common and deadly cancer worldwide.

Recent studies have found radiosurgery to be an effective treatment option for medically inoperable lung cancer patients as it provides good local control and survival rates. Treating these tumors is particularly complex due to movement with respiration and nearby critical structures. This is especially the case for central and chest wall tumors, which are located in close proximity to such critical anatomical structures.

Lung Optimized Treatment offers the accuracy and steep dose fall off required to safely treat lung tumors, even those close to such critical structures. Simulation and comparison workflows, combined with unique tracking modes, allow the clinician to select from multiple, non-invasive options, providing lung SBRT patients the optimal non-invasive treatment option, regardless of tumor location. 

"Lung Optimized Treatment is a new tool we developed to meet the clinical demand for more flexibility in treating lung cancer patients with radiosurgery and the desire to move away from reliance on fiducial markers," said Chris A. Raanes, senior vice president and chief operating officer for Accuray. "This new technology enables treatments throughout the lung without a single incision, all while safeguarding healthy tissue and structures around the tumor to ensure they are not damaged by radiation."

Because fiducial implantation is no longer required, CyberKnife radiosurgery with Lung Optimized Treatment offers a completely non-invasive option, which is particularly important for medically or surgically inoperable patients. This means patients who are not candidates for fiducial placement or physicians who choose not to implant fiducials due to the high risk of pneumothorax, now have a non-invasive alternative using the CyberKnife System's unique tracking and correction capabilities.

"With the FDA 510(k) clearance of Lung Optimized Treatment, we've taken the CyberKnife technology to new heights and enabled care for an expanded group of patients," said Euan S. Thomson, Ph.D., president and chief executive officer of Accuray. "This is yet another step in our efforts to ensure physicians have access to the treatment choices necessary for their patient, based on the patient's specific needs. To this end, Accuray continues to investigate ways to improve patient care across various indications."

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 100,000 patients worldwide and currently more than 215 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 market acceptance 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, clinical acceptance and other risks detailed from time to time under the heading "Risk Factors" in our report on Form 10-K for our 2010 fiscal year, our form 10-Q filed on November 8, 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