Accuray Receives AERB Approval for Sale and Supply of its Radixact® X9 System in India

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Jun 21, 2018, 07:30 ET

SUNNYVALE, Calif., June 21, 2018 /PRNewswire/ -- Accuray Incorporated (NASDAQ: ARAY) announced today that the Company has received an Atomic Energy Regulatory Board (AERB) Type Approval for its Radixact^® X9 System in India. The AERB Type Approval indicates the device conforms to established safety standards and will enable Accuray to sell, and Indian hospitals throughout the country to import, this next-generation TomoTherapy^® platform. The Radixact and TomoTherapy Systems are the only radiation therapy devices capable of delivering treatment both from clinician-specified beam angles and by continuous delivery of radiation from 360 degrees around the patient, expanding the type of cancer cases that can be precisely and efficiently treated on a daily basis.

"This milestone demonstrates continued momentum in the global commercialization of the Radixact System, further enhancing our ability to make advanced radiation therapy more accessible to clinicians and their patients," said Lionel Hadjadjeba, M.D., Senior Vice President, and Chief Commercial Officer at Accuray. "We are currently partnering with clinicians throughout India who are using our TomoTherapy and CyberKnife^® Systems. With the introduction of the Radixact System, we are delivering on our commitment to them to provide innovative technology that has the potential to truly change the radiation treatment experience."

The Radixact System is fully integrated with the Accuray Precision^® Treatment Planning System (TPS) and iDMS™ Data Management System. Together, these radiation therapy solutions are designed to improve treatment outcomes and workflow efficiencies, enabling clinicians to provide optimal treatments for more patients, every day.

Radixact X9 System clinician and patient benefits

The Radixact System delivers the same highly conformal and homogeneous dose distribution faster than the previous TomoTherapy platform, with a higher dose rate (1000 MU/minute) and imaging time that is 66 percent faster. A combination of higher dose output and faster image acquisition can shorten treatment times, while improving the patient experience
The CTrue™ IR (Iterative Reconstruction) image guidance software improves soft-tissue contrast and reduces noise, enhancing image quality, while maintaining the same low imaging dose and fast reconstruction time as earlier versions of the software. Patient workflows are also more efficient, facilitating the delivery of precise treatments more quickly, for more patients
PreciseART™ Adaptive Radiation Therapy Software makes adaptive radiotherapy simple and practical for every practice. This software enables clinicians to monitor every patient and efficiently adapt plans, helping clinics of all sizes deliver more precise treatments to more patients
The PreciseRTX™ Retreatment Option accelerates and automates the re-planning process to make re-treatment more efficient for practices and more effective for patients in those cases where, unfortunately, cancer has recurred and additional radiation treatments are necessary
The system is pre-commissioned and only needs to be verified by the customer. This speeds the overall process, with time to first treatment proven to typically take only two weeks from the start of installation

A wide range of cancer indications can be treated

The Radixact^® System can be used for virtually any case for which radiation therapy is prescribed, including:

Large tumors or multiple tumors throughout the body
Standard radiation therapy indications such as breast, lung, prostate, and head and neck cancers
Complex treatments such as total marrow irradiation and whole-brain with simultaneous boosts to multiple metastases

The system precisely targets cancer cells, enabling doctors to effectively treat:

Hard-to-reach tumors
Tumors that have recurred, including those in patients who may not be candidates for retreatment with traditional delivery systems

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

About Accuray
Accuray Incorporated (Nasdaq: ARAY) is a radiation oncology company that develops, manufactures and sells precise, 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 deliver the full range of radiation therapy and radiosurgery treatments. For more information, please visit www.accuray.com or follow us on Facebook, LinkedIn, Twitter and YouTube.

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, patient experiences and outcomes, and Accuray's ability to continue to penetrate the global radiation therapy market. These forward-looking statements involve risks and uncertainties. If any of these risks or uncertainties materialize, or if any of the company's assumptions prove incorrect, actual results could differ materially from the results expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, the company's ability to achieve widespread market acceptance of its products, the company's ability to develop new products or enhance existing products to meet customers' needs, the company's ability to anticipate or keep pace with changes in the marketplace and the direction of technological innovation and customer demands and such other risks identified under the heading "Risk Factors" in the company's annual report on Form 10-K, filed with the Securities and Exchange Commission (the "SEC") on August 25, 2017, the company's quarterly report on Form 10-Q, filed with the SEC on May 2, 2018 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.

Media Contacts
Beth Kaplan
Public Relations Director, Accuray
+1 (408) 789-4426
[email protected]

Jayme Maniatis
MSLGROUP
+1 (781) 684-6662
[email protected]

SOURCE Accuray Incorporated