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Accuray Receives CE Mark for a New Helical Radiation Delivery System, Accuray Helix™

August 27, 2024 | Last Trade: US$1.91 0.14 7.91

TOPLINE SUMMARY

• Accuray Incorporated has received the CE Mark for its Accuray HelixTM, a CT-guided helical radiotherapy system designed to provide high-performance and high-throughput.
• The new system is intended for emerging markets where access to advanced cancer care, including radiotherapy treatments, is typically obtainable only within urban areas and where the availability of linear accelerators per million population is well below the World Health Organization recommended guidelines.
• Accuray Helix aims to close some of these gaps in patient access with its comprehensive solutions.
• India is a priority due to this disparity as there is a significant deficit in availability of radiation therapy systems compared to the size of its population and incidence of cancer.
• Suzanne Winter, president and CEO of Accuray, stated that the Ac.

  • Developed for India and other countries where patient access to care with radiotherapy is challenged and where versatility and ease of use are a high priority
  • Drives the next phase of company's strategic plan to expand its portfolio of helical radiation therapy delivery systems

MADISON, Wis., Aug. 27, 2024 /PRNewswire/ -- Accuray Incorporated (NASDAQ: ARAY) announced today the company has received CE Mark for Accuray Helix™, a CT-guided helical radiotherapy system designed to provide high-performance and high-throughput. The new system is intended for emerging markets where access to advanced cancer care, including radiotherapy treatments, is typically obtainable only within urban areas and where the availability of linear accelerators per million population is well below the World Health Organization recommended guidelines. Accuray Helix offers a solution for clinical teams that require short treatment times and cost effectiveness to establish a care path for patients in non-urban communities who previously had limited options.

Radiotherapy is a fundamental component of cancer care1 and can be used in the treatment of localized disease, recurrent or metastatic cancer. An estimated 50 percent of people with cancer would benefit from radiation therapy2 either as their sole care option or along with other modalities such as surgery, chemotherapy or immunotherapy.

"While the demand for cancer services is increasing globally, there are certain areas of the world where there continues to be greater gaps in access to radiation medicine. India is a priority due to this disparity as there is a significant deficit in availability of radiation therapy systems compared to the size if its population and incidence of cancer. Our goal with the introduction of Accuray Helix is to close some of these gaps to patient access with our comprehensive solutions," said Suzanne Winter, president and CEO of Accuray. "The Accuray Helix system combines affordability with automation and tools for enhancing the speed of planning and delivery of radiation. We believe it will enable a broader range of capabilities for facilities that may have resources and staffing for only one system, enabling them to offer state-of-the-art cancer care in their communities."

Accuray Helix delivers precise, targeted radiation treatments, an important option for the routine cases clinical teams see daily in their practice including breast, cervix, head and neck, gastrointestinal, lung and prostate. The system's flexibility and versatility are intended to drive improvements in personalization and patient care, while simultaneously facilitating treatment of more patients each day, boosting productivity for clinics and enabling them to efficiently manage the growing demand for cancer care.

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 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 Madison, Wisconsin, with facilities worldwide. To learn more, visit www.accuray.com or follow us on Facebook, LinkedIn, X, 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 expectations related to Accuray Helix and its effect on the field of radiation oncology and clinical practice, expectations with respect to the markets in the company plans to offer Accuray Helix, 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 May 8, 2024, 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
This email address is being protected from spambots. You need JavaScript enabled to view it.

1INTERNATIONAL ATOMIC ENERGY AGENCY, Radiotherapy in Cancer Care: Facing the Global Challenge, Non-serial Publications , IAEA, Vienna (2017).
2Atun et al. Expanding global access to radiotherapy. Lancet Oncol 2015; 16:1153-86.

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