Accuray Receives Shonin Approval for ClearRT™ Helical kVCT Imaging, CE Mark Expected by End of June; Expands Commercial Launch

Rhea-AI Summary

Accuray Incorporated (NASDAQ: ARAY) has announced that its ClearRT helical fan-beam kVCT imaging system has been in clinical use for over two months, demonstrating significant potential in radiation oncology. The first patient treatments at Willis-Knighton Cancer Center show enhanced imaging quality, allowing for superior tumor visualization and treatment precision. ClearRT has received Shonin approval in Japan and FDA 510(k) clearance, with a CE Mark expected by the end of June 2021, expanding its market accessibility. The first commercial ClearRT systems have been shipped as scheduled.

Positive

• ClearRT has been clinically used for over two months, showing potential in improving radiation oncology.
• First patient treatments at Willis-Knighton Cancer Center demonstrate superior imaging quality, enhancing precision in tumor treatment.
• ClearRT received Shonin approval in March 2021 and FDA 510(k) clearance in December 2020.
• First commercial shipments of ClearRT systems have been on schedule, with full production release expected by June 30, 2021.

Negative

• None.

SUNNYVALE, Calif., April 22, 2021 /PRNewswire/ -- Accuray Incorporated (NASDAQ: ARAY) announced today that the innovative ClearRT™ helical fan-beam kVCT imaging* capability has now been in clinical use for over two months, and is on track to expand into other markets. ClearRT on the Radixact^® System is believed to have the potential to change the field of radiation oncology by enabling clinicians to easily, quickly and cost effectively acquire diagnostic-like quality CT images that enable them to "See More, Know More, and Do More," when treating tumors with radiation.

High-quality images are central to all aspects of the radiation therapy treatment workflow. ClearRT high-fidelity helical kVCT imaging enables high confidence in the patient set-up and registration that form the basis of radiation therapy treatment planning, delivery and monitoring, and are key to the successful treatment of organ-confined tumors, locally advanced tumors and metastatic tumors.

First Patient Treatments Show Imaging Technology's Promise
The medical care team at Willis-Knighton Cancer Center in Shreveport, Louisiana has treated the first cancer patients in the world using the Radixact System and ClearRT imaging, integrated helical radiation delivery and imaging systems. The team has more than 18 years' experience treating patients with the TomoTherapy^® System and recently upgraded to the Radixact System, the next-generation TomoTherapy platform. The ClearRT imaging modality generated clear, high-fidelity images that improved the Willis-Knighton team's ability to see the tumor and surrounding healthy tissues, and deliver the treatment plan with more confidence and precision.

"At Willis-Knighton, we have always tried to introduce next-generation radiotherapy technology.  The Radixact System with ClearRT has the potential to change clinical practice. The ClearRT daily targeting images exceeded our expectations, and provided noticeably superior image quality compared to more traditional cone-beam CT available on conventional linear accelerators. The Radixact System with ClearRT imaging will allow our team to improve the care we provide our cancer patients by better visualization of tumors and adaptive therapy," said Lane R. Rosen, M.D., director of radiation oncology at Willis-Knighton Cancer Center.

Regulatory Approvals Expand Access
ClearRT received Shonin approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) in March 2021, following FDA 510(k) clearance in December 2020; CE Mark in the European Union (EU) is expected in the company's fiscal fourth quarter ending June 30, 2021. The imaging technology will now be available in Japan and the U.S. ClearRT imaging is expected to be accessible to EU customers following receipt of the CE Mark. Customers residing in other areas of the world where either FDA 510(k) or CE Mark are required for commercial distribution will have access to ClearRT once the appropriate regulatory clearance is met.

Commercial Shipments Begin on Schedule
Accuray has shipped the first commercially released ClearRT imaging system in the U.S. and expects full production release by June 30, 2021.

"We are proud to partner with Dr. Rosen and the Willis-Knighton team, who were instrumental in the development of ClearRT imaging for the Radixact System. The reaction to this innovative fan-beam imaging technology has been extremely positive, and we look forward to making it more broadly available to medical care teams around the world," said Suzanne Winter, chief commercial officer and senior vice president, R&D at Accuray. "As the pioneer and continued leader in helical radiation therapy on our TomoTherapy^® platform, Accuray offers unmatched solutions that expand the curative power of radiation therapy, providing additional care options for a wider range of patients − many of whom would not previously have been candidates for treatment."

*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.

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

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 that are designed 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 potential of ClearRT to change the field of radiation oncology and clinical practice, the anticipated timing for CE Mark approval for the ClearRT and accessibility of ClearRT to EU customers, the anticipated timing for full production release of ClearRT, 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, including new product innovations and releases; 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 February 1, 2021, 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
bkaplan@accuray.com

 

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SOURCE Accuray Incorporated

FAQ

What is the significance of Accuray's ClearRT imaging technology?

Accuray's ClearRT imaging technology allows clinicians to obtain high-quality diagnostic-like CT images, enhancing precision in tumor treatment.

When did Accuray receive Shonin approval for ClearRT?

Accuray received Shonin approval for ClearRT in March 2021.

What regulatory approvals has ClearRT received?

ClearRT received FDA 510(k) clearance in December 2020 and Shonin approval in Japan in March 2021, with a CE Mark expected by the end of June 2021.

When are the full production releases for ClearRT expected?

Full production release of ClearRT is expected by June 30, 2021.

What was the impact of ClearRT during its first patient treatments?

The first patient treatments using ClearRT showed improved imaging quality, allowing for better visualization of tumors and surrounding healthy tissues.