The Accuray Radixact™ System Receives Shonin Approval
Next-Generation "Smart" TomoTherapy® System Represents Major Step Forward in Treatment Speed, Ease of Use and Adaptive Therapy Capabilities
SUNNYVALE, Calif., February 8, 2017 – Accuray Incorporated (NASDAQ: ARAY) announced today that it has received Shonin approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to market its Radixact™ Treatment Delivery System, Accuray Precision™ Treatment Planning System and iDMS™ Data Management System. Together, the treatment delivery system and software solutions enable clinicians to provide highly precise treatment, efficiently, for a wider range of cancer patients, including those undergoing retreatment. This new Radixact™ platform is now available in Japan, in certain markets in the European Union, and in the U.S. market.
"The Accuray team strives to provide our customers with innovative products that enhance the quality of patient care. With the introduction of the Radixact System, we are demonstrating significant progress in fulfilling on this promise," said Juki Hozumi, president and general manager of Japan at Accuray. "This new, mainstream System enables clinicians to deliver the highly sculpted doses for precise, customized treatments the previous TomoTherapy platform was known for, faster, enabling the treatment of more patients every day. It also provides a foundation for future innovation."
The Radixact System was designed to be an easy-to-operate, highly reliable, advanced radiation therapy device. The System features a more powerful linear accelerator, low-dose fan beam MVCT imaging and unique helical treatment mode, so that clinicians can deliver highly accurate, individualized dose distributions to any tumor. The fully-integrated, simplified adaptive treatment planning solution enables clinicians to routinely adjust treatment plans during the course of treatment to account for changes in tumor size, shape and location – thereby increasing treatment precision.
"The approval of the Radixact System represents a key milestone in our strategic growth plans for the Japanese market," said Joshua H. Levine, president and CEO of Accuray. "We are seeing positive momentum in the adoption of the Radixact System as clinicians become aware of its benefits. Feedback from a number of early customers indicates the System enables them to deliver precise radiation therapy, to more patients, in considerably less time than has been possible with the TomoTherapy System."
For more information about the Radixact platform, visit: http://www.accuray.com/radixact.
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, future innovation, 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 24, 2016, the company's reports on Form 10-Q, filed on November 1, 2016 and February 3, 2017, and as updated periodically with 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 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 put undue reliance on any forward-looking statements.