Accuray Inc. Receives 510(K) FDA Clearance For The Radixact Image-Guided Radiation Therapy Platform And Integrated Software

June 27, 2016 |

4 min read

Accuray Receives 510(k) FDA Clearance for the Radixact™ Image-Guided Radiation Therapy Platform and Integrated Software

SUNNYVALE, Calif., June 27, 2016 /PRNewswire/ -- Accuray Incorporated (NASDAQ: ARAY) announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Radixact Treatment Delivery Platform. Accuray also received 510(k) clearance for its new treatment planning and data management systems, Accuray Precision Treatment Planning System and iDMS Data Management System. These next generation hardware and software solutions which, together, make up the new Radixact system, enable faster, more efficient delivery of extremely precise treatment to a wider range of cancer patients, including those undergoing retreatment. The new Radixact system represents a major step forward in the evolution of the TomoTherapy^® System in treatment speed and ease of use.

The system features a more powerful linear accelerator, MVCT imaging and helical treatment delivery, so clinicians can apply highly conformal and homogenous dose distributions to any target volume, while precisely sparing normal healthy tissue during each treatment fraction. The new Accuray Precision Treatment Planning System with smart, automated workflows and midcourse decision-making tools, enables clinicians to adapt delivery to changes in tumor size, shape and location within the patient.

“The Radixact System gives the radiation therapy team expanded capabilities across the widest range of patient cases, from the routine to the most complex, with precision, speed and efficient workflows,” said Joshua H. Levine, president and chief executive officer of Accuray.

According to Jennifer Smilowitz, PhD, clinical associate professor University of Wisconsin School of Medicine and Public Health, who was involved in the development of the new radiation therapy technology, “The Radixact System builds upon the unique strengths of the TomoTherapy platform. Expanded delivery capabilities enable treatment with image-guided, intensity-modulated radiation therapy (IG-IMRT, an extremely accurate form of radiation therapy) to an expanded range of patients. New database features make the ring gantry-based system even easier to operate and integrate within a radiation oncology department.”

Accuray will initiate commercial release of the Radixact System late in the first quarter of fiscal year 2017 (July September 2016).

Important Safety Information

For Important Safety Information please refer to http://www.accuray.com/safety-statement-radiation-treatment

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, market acceptance of our new technologies, patient outcomes 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 April 29, 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
bkaplan@accuray.com

Kirsten Fallon
MSLGROUP in Boston
+1 (781) 684-0770
accuray@MSLGROUP.com

Investor Contact:
Doug Sherk
Investor Relations, EVC Group
+1 (415) 652-9100
dsherk@evcgroup.com