Accuray Receives 510(k) FDA Clearance for ClearRT™ Helical kVCT Imaging for the Radixact® Treatment Delivery System

SUNNYVALE, Calif., Jan. 5, 2021 /PRNewswire/ -- Accuray Incorporated (NASDAQ: ARAY) announced today that the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its ClearRT™ Helical kVCT Imaging* for the Radixact^® System, the next generation TomoTherapy^® platform. ClearRT is a cutting-edge imaging solution integrated with a powerful, precise, and adaptive delivery platform, designed to produce exceptional diagnostic-like quality CT images, quickly and cost-effectively, to improve patient care. Accuray is planning commercial release of the ClearRT Helical kVCT Imaging for the Radixact System in the Spring of 2021.

ClearRT delivers enhanced imaging capabilities compared to conventional linear accelerator systems that rely on cone-beam CT (CBCT) imaging and as an alternative to MR-based radiation therapy systems that can be complex and cost prohibitive to use. ClearRT offers excellent uniformity and low noise across the entire image, improved soft tissue visualization and exceptional spatial resolution, which is intended to enhance the versatility and efficiency of the Radixact System in the radiation therapy department.

The ClearRT imaging solution is seamlessly integrated into the Radixact System. Helical fan-beam imaging available at both kV and MV wavelengths provides medical care teams the flexibility to fulfill the patient imaging requirements necessary for accurate patient setup and registration, including imaging patients with metal implants contraindicated for MR imaging. Enabling a "meter in a minute" image acquisition, ClearRT helical kVCT provides the industry's largest transverse field of view and the longest continuous scan length – facilitating fast and easy set-up of any patient requiring radiation treatment and giving clinicians the versatility needed to treat the widest range of indications with confidence.

ClearRT leverages the same simple 5-step delivery workflow that makes the Radixact System easy to use, and easy to adopt. Clear, high-fidelity images will reduce the time required for patient imaging and registration, a crucial part of the treatment delivery process, thereby enabling clinical staff to serve more patients. Additionally, ClearRT helical kVCT images will be available within the Accuray PreciseART^® automated dose trending tool for clinicians to evaluate if plan adaptation would be beneficial, enabling the most personalized patient care.

"ClearRT is a novel, helical CT imaging solution that we believe addresses an unmet market need. It integrates with other Accuray-only applications, such as Synchrony^® Real-time Motion Synchronization and Adaptive Treatment Delivery Technology, on the Radixact System, making it possible for providers to offer a new level of precision and accuracy in the treatment of the simplest to the most complex pathologies," said Suzanne Winter, chief commercial officer and senior vice president, R&D at Accuray. "Our continuing innovation on the Radixact System is designed to leverage the power of its 360-degree, helical delivery platform to facilitate advanced, hypofractionated and ultra-hypofractionated treatments that support our customers' efforts to maintain the highest standard of care for their community."

*ClearRT Helical kVCT Imaging for the Radixact^® Treatment Delivery System is not available for sale in all markets. ClearRT may 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 is committed to expanding the powerful potential of radiation therapy to improve as many lives as possible. We invent unique, market-changing solutions to deliver radiation treatments for even the most complex cases—while making commonly treatable cases even easier—to meet the full spectrum of patient needs. We are dedicated to continuous innovation in radiation therapy for oncology, neuro-radiosurgery, and beyond, as we partner with clinicians and administrators, empowering them to help patients get back to their lives, faster. Accuray is headquartered in Sunnyvale, California, with facilities worldwide. To learn more, 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 the anticipated timing for the ClearRT™ commercial release and its ability to address unmet market needs, clinical applications, clinical results, patient experiences and patient outcomes. 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 improve 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 quarterly report on Form 10-Q, filed with the Securities and Exchange Commission (the "SEC") on November 4, 2020, 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 Contact
Beth Kaplan
Accuray
+1 (408) 789-4426
[email protected]

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Investor Relations, Lytham Partners
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SOURCE Accuray Incorporated

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