Accuray Announces Approval of the Accuray Precision® Treatment Planning System by China's National Medical Products Administration

Rhea-AI Summary

Accuray announced the approval of its Accuray Precision Treatment Planning System (TPS) by China's National Medical Products Administration (NMPA). This approval allows the system to be used with the CNNC-Accuray joint venture Tomo C radiation therapy system. This combination aims to provide precise radiotherapy treatments, expanding access for cancer patients in China. Suzanne Winter, CEO of Accuray, highlighted the system's benefits in addressing the high incidence of cancer in China. The Accuray Precision TPS facilitates rapid adaptation of treatment plans to changes in tumor characteristics and healthy tissue, enhancing treatment accuracy. The Tomo C platform includes helical imaging and radiation delivery with patented beam-shaping technology, optimizing radiation dose control.

Positive

• Approval of Accuray Precision TPS by China's NMPA.
• Availability of the TPS with Tomo C system expands treatment options in China.
• Potential to address the high incidence of cancer in China, which accounted for 25% of new cases globally in 2020.
• Enhances Accuray's portfolio and market access in China's Type B market.
• Provides medical teams with tools for precise and adaptable treatment plans, improving patient outcomes.
• The Tomo C system's advanced imaging and radiation delivery capabilities enable optimized radiation dose control, minimizing impact on healthy tissues.

Negative

• No immediate financial data provided to assess direct financial impact.
• Potential competition in the regional Type B market might affect market penetration.
• Dependence on regulatory approvals and compliance could pose risks for future product offerings.

MADISON, Wis., June 12, 2024 /PRNewswire/ -- Accuray Incorporated (NASDAQ: ARAY) announced today that the registration dossier for the Accuray Precision^® Treatment Planning System (TPS) has been approved by the Chinese National Medical Products Administration (NMPA). The Accuray Precision TPS is now available for use with the CNNC-Accuray joint venture Tomo^® C radiation therapy system and in combination, will provide medical care teams with a new option for delivering extremely precise and accurate radiotherapy treatments, ultimately expanding access to care for more cancer patients in China.

"We couldn't be more pleased about the approval of the Accuray Precision Treatment Planning System and the potential it represents, in combination with the Tomo C System, for cancer patients in China, a country which accounted for approximately 25 percent of new cancer cases diagnosed worldwide in 2020¹. With this approval our China joint venture can begin shipping the Tomo C System to their end customers, an important step forward in helping to address an unmet need for precision radiation therapy," said Suzanne Winter, president and CEO of Accuray.

Continued Ms. Winter, "Customers in China who use our organization's CyberKnife^®, Radixact^® and TomoTherapy^® Systems are familiar with the Accuray Precision Treatment Planning System, a powerful, full-featured system that enables clinicians to efficiently generate high quality radiation therapy treatment plans. The availability of the treatment planning solution for the Tomo C System, a domestic made radiation therapy delivery device, will expand our portfolio in China and enhance our access in the regional Type B market."

The Accuray Precision TPS was developed to facilitate the creation and adaptation of precise treatment plans in less time. The planning solution enables clinicians to routinely incorporate modifications to treatment planning into the course of treatment to account for changes in tumor size, shape and location – as well as subtle changes in the location of organs and other healthy tissue – thereby increasing treatment precision.

The Tomo C platform features helical imaging and radiation delivery. With fully-integrated treatment planning, centralized data management and ultra-precise treatment delivery using patented beam-shaping technology, the system enables greater control of the radiation dose so it conforms precisely to the tumor and helps minimize dose to healthy tissue. The system is designed to enable medical care teams to optimize outcomes for standard radiation therapy indications including breast, prostate, lung, and head and neck cancers, in addition to complex treatments such as total marrow irradiation.

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 Madison, Wisconsin, 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 expectations and goals regarding new products, services and innovations, expectations regarding our joint venture, and patient experiences and patient outcomes. These risks and uncertainties include, but are not limited to, the effect of the current global economic environment, including in connection to the COVID-19 pandemic, on the operations of the company and those of its customers and suppliers; 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; reliance on third party collaborators, partnerships, strategic alliances and joint ventures; and such other risks identified under the heading "Risk Factors" in 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       
Public Relations Director, Accuray                                       
+1 (408) 789-4426                                                                   
bkaplan@accuray.com                                                    

¹https://pubmed.ncbi.nlm.nih.gov/37755589/#:~:text=A%20total%20of%204%2C546%2C400%20new,leading%20cancer%20types%20in%20China.

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SOURCE Accuray Incorporated

FAQ

What is the Accuray Precision Treatment Planning System (TPS)?

The Accuray Precision TPS is a treatment planning system designed to generate high-quality radiation therapy plans efficiently.

What approval did Accuray receive from the Chinese NMPA?

Accuray received approval from the Chinese NMPA for its Precision Treatment Planning System, enabling its use with the Tomo C radiation therapy system.

What benefits does the Tomo C system provide?

The Tomo C system offers helical imaging, radiation delivery, centralized data management, and precise dose control, optimizing radiation therapy outcomes.

How does the Accuray Precision TPS enhance treatment plans?

The Accuray Precision TPS allows for rapid adaptation of treatment plans to changes in tumor size, shape, and location, improving treatment precision.

What is the significance of the Accuray TPS approval in China?

The approval allows Accuray to expand its market presence in China, addressing the high cancer incidence and offering advanced treatment options.