Accuray Receives FDA 510(k) Clearance for New CyberKnife® M6™ Series, Merging Multileaf Collimation with Non-Isocentric Robotic Delivery

SUNNYVALE, Calif., Nov. 1, 2012 /PRNewswire/ -- Accuray Incorporated (Nasdaq: ARAY), the premier radiation oncology company, today announced that the company received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new CyberKnife^® M6^™ Series. The CyberKnife M6 Series features expanded clinical capabilities, reduced treatment times and an enhanced patient experience. The new CyberKnife M6 FIM and FM Systems, featuring the InCise™ Multileaf Collimator combines the benefits of beam shaping with the flexibility of non-isocentric, non-coplanar delivery offering unmatched clinical capabilities and expanding the number of patients eligible for treatment.

The new InCise Multileaf Collimator was designed specifically for stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT) treatments, giving the system the capability to extend its radiosurgical accuracy into a broader field of applications, meeting radiosurgery and radiotherapy needs. With the InCise Multileaf Collimator, the CyberKnife M6 Series can be used to treat large and irregular tumors more efficiently with excellent dose gradients. This added flexibility expands the number of patients eligible for treatment with the CyberKnife M6 Series.

"The CyberKnife M6 Series offers a collimation option to address a variety of clinical applications, including large, complex tumors. The InCise Multileaf Collimator is designed to sculpt a single radiation beam to match the exact contour of a tumor, which would significantly minimize the amount of radiation to the surrounding tissues and reduce the treatment time," said Dwight Heron, M.D., Professor and Vice-Chairman, Radiation Oncology, Otolaryngology, Head & Neck Surgery at the University of Pittsburgh School of Medicine. "Now many targets previously unsuited for SRS/SBRT can be treated more quickly and effectively than before."

Unlike any other MLC on the market, the InCise Multileaf Collimator can not only move its leaves to create complex shapes, it can also be moved around the patient by a robot in 3D to deliver precisely shaped beams to the target from hundreds of unique angles. This non-isocentric, non-coplanar delivery enables the highest level of accuracy and healthy tissue sparing. The added flexibility is further enhanced when combined with the CyberKnife's Synchrony® System, which enables the CyberKnife M6 System to track tumors as they move and automatically correct for their movement throughout treatment.

"The field of radiation oncology is moving to treating in fewer fractions with higher doses," said Charlie Ma, Ph.D., Vice Chairman, Department of Radiation Oncology, Director, Radiation Physics at the Fox Chase Cancer Center in Philadelphia.  "The addition of the MLC, combined with the CyberKnife's ability to deliver treatment from hundreds of angles while tracking and correcting for motion, will give us the flexibility to deliver the most accurate patient-specific and tailored dose distributions and allows a broader range of patients to benefit from highly efficient and effective treatments."

The CyberKnife M6 Series reduces treatment times with fewer Monitor Units (MUs) while delivering unrivaled dose distributions and further improving plan quality. This heightened efficiency allows users to schedule more patients per day, to not only ensure timely care to more cancer patients, but to also improve the return on their investment.

"Accuray developed the CyberKnife M6 Series to provide the radiation oncology community with a personalized, patient-focused treatment that delivers unmatched clinical capabilities and the ability to treat more patients with unprecedented levels of precision and efficiency," said Joshua H. Levine, president and chief executive officer of Accuray. "The development of the CyberKnife M6 Series addresses the needs of both physicians and patients, and reinforces Accuray's position as the leading technical innovator driving new clinical solutions in radiation oncology." 

About Accuray
Accuray Incorporated (Nasdaq: ARAY), based in Sunnyvale, Calif., is the premier radiation oncology company that develops, manufactures and sells personalized innovative treatment solutions that set the standard of care, with the aim of helping patients live longer, better lives. The Company's leading edge technologies – the CyberKnife and TomoTherapy Systems – are designed to deliver radiosurgery, stereotactic body radiation therapy, intensity modulated radiation therapy, image guided radiation therapy, and adaptive radiation therapy. To date 642 systems have been installed in leading hospitals around the world. For more information, please visit www.accuray.com.

Safe Harbor Statement
Statements made in this press release that are not statements of historical fact are forward-looking statements and are subject to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release relate, but are not limited, to expansion of the Company's global presence, clinical capabilities, treatment times, clinical efficiency, dose delivery, and the Company's leadership position in radiation oncology innovation. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from expectations, including risks detailed from time to time under the heading "Risk Factors" in the company's report on Form 10-K filed on September 10, 2012. Forward-looking statements speak only as of the date the statements are made and are based on information available to the Company at the time those statements are made and/or management's good faith belief as of that time with respect to future events. The Company assumes 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.  Accordingly, investors should not place undue reliance on any forward-looking statements.

SOURCE Accuray Incorporated