Accuray Submits 510(k) Premarket Notification to FDA for Its Radixact™ Treatment Delivery System

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Apr 26, 2016, 04:05 ET

SUNNYVALE, Calif., April 26, 2016 /PRNewswire/ -- Accuray Incorporated (NASDAQ: ARAY) announced today the submission of its 510(k) premarket notification with the Food and Drug Administration (FDA) for the company's Radixact™ Treatment Delivery System. Accuray also submitted 510(k) premarket notification for its treatment planning and data management systems, Precision™ Treatment Planning System and iDMS™ Data Management System.

The treatment delivery system, Precision Treatment Planning System, and iDMS Data Management System have been designed to seamlessly work together and improve treatment workflow processes. Multiple Radixact Systems may use a single, centralized database for treatment planning and patient data management.

"The Radixact System is the next generation TomoTherapy^® platform and is being designed to leverage its unique architecture, providing a mainstream option for more clinicians. The new platform, comprised of the treatment delivery, treatment planning and data management systems, is expected to expand clinical capabilities while significantly increasing the ease and speed with which clinicians can provide precise radiation treatments," said Joshua H. Levine, president and chief executive officer of Accuray. "The Radixact System will provide the foundation for continued innovation in the months and years ahead. Working with clinicians we will continue the development of clinically relevant, leading-edge technologies with the potential to truly change the radiation therapy treatment experience."

The next generation platform is designed for increased throughput, higher reliability and ease of serviceability. The ring gantry-based delivery system will offer the same proven gold-standard delivery capabilities as today's devices: TomoHelical™ and TomoDirect™ treatment modes. The high output, compact linear accelerator will be capable of producing a dose rate of 1,000 MU per minute, and imaging speed will increase. The integrated treatment planning system is intended to reduce workflow complexities and save time in the treatment planning process.

Clinicians at the University of Wisconsin-Madison played an important role in developing this newest radiation therapy system, collaborating with Accuray to ensure the Radixact System design objectives were met.

"The University of Wisconsin team is excited to be involved in the development of a new radiation therapy technology which builds upon the pioneering work initiated here," said Jennifer Smilowitz, PhD, clinical associate professor University of Wisconsin School of Medicine and Public Health. "We look forward to sharing the initial experiences of our Radixact System work at the ESTRO meeting in Turin, Italy on Sunday, May 1, 2016 at 10:05 am – 10:25 am and
2:00 pm – 2:20 pm, Accuray booth #1300."

*The Radixact Treatment Delivery System, Precision Treatment Planning System and iDMS Data Management System are pending FDA 510(k) clearance and not available for sale within the United States. These products may also be subject to international regulatory approval or licensing processes such that the availability of these products may vary according to geographical location.

About Accuray
Accuray Incorporated (NASDAQ: ARAY) is a radiation oncology company that develops, manufactures and sells precise, innovative tumor treatment solutions that set the standard of care with the aim of helping patients live longer, better lives. The company's leading-edge technologies deliver the full range of radiation therapy and radiosurgery treatments. 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 clinical applications, clinical results, anticipated regulatory approvals and launches of new products, market uptake of recently launched products, market growth and Accuray's leadership position in radiation oncology innovation and technologies. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from expectations, including but not limited to the risks detailed from time to time under the heading "Risk Factors" in the company's report on Form 10-K, filed on August 28, 2015, the company's reports on Form 10-Q, filed on November 5, 2015 and February 1, 2016, and the company's other filings with the SEC.

Forward-looking statements speak only as of the date the statements are made and are based on information available to Accuray 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 put undue reliance on any forward-looking statements.

Media Contacts:
Beth Kaplan
Accuray
+1 (408) 789-4426
[email protected]

Kirsten Fallon
MSLGROUP in Boston
+1 (781) 684-0770
[email protected]

Investor Contact:
Chris Dailey
Investor Relations, EVC Group
+1 (646) 445-4801
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SOURCE Accuray Incorporated