Accuray Announces Tomo® C Registration Submission to China's National Medical Products Administration

Accuray Announces Tomo® C Registration Submission to China's National Medical Products Administration

SUNNYVALE, Calif., Nov. 1, 2022 /PRNewswire/ -- Accuray Incorporated (NASDAQ: ARAY) announced today that the registration dossier for the CNNC-Accuray joint venture Tomo® C radiation therapy system for the Type B market has been submitted to the Chinese National Medical Products Administration (NMPA). This milestone aligns with the timeline communicated by Accuray during the company's Q4 FY2022 earnings call. The availability of Tomo C is subject to review and approval by the NMPA. The new made in China system, designed specifically to expand access to precise radiation treatments to more cancer patients in China, is the first joint venture product.

The number of new cancer cases diagnosed in China is anticipated to increase by approximately 50 percent from 2020 to 20401, with increases in the incidence of not just lung cancer, but also colorectum, breast and prostate cancers2. Radiation therapy is one of the primary treatment options for lung, breast and prostate cancers, reinforcing the need for innovative new approaches that effectively manage the disease while minimizing the risk of side effects and their impact on quality of life.

"The submission of the Tomo C dossier is an important step for the CNNC-Accuray joint venture and represents an important growth catalyst for Accuray. I'm confident that the system will significantly enhance the joint venture's product portfolio and ability to compete in the large and rapidly growing Type B segment in the future. The team's focus on ensuring we have the right products to address the needs of the Chinese radiation therapy market – the fastest growing in the world – will enable more people in China to get the care that is essential to their long-term health," said Suzanne Winter, president and chief executive officer of Accuray. 

The TomoTherapy® platform is the first in the world capable of integrated helical fan beam imaging and radiation delivery, providing greater control of the radiation dose so it conforms precisely to the tumor and provides superior normal tissue preservation, enabling delivery of conventionally fractionated to ultra-hypofractionated treatments. The system is capable of treating all standard radiation therapy indications including breast, prostate, lung, abdominal, and head and neck cancers, in addition to complex treatments such as total marrow irradiation.

"This submission and the manufacture of a locally made TomoTherapy platform device underscores Accuray's commitment to the joint venture. I believe Tomo C will meet the requirements of the majority of Chinese customers who need a radiation delivery system that is effective and fast. This first China-made system will enable Chinese customers to offer highly precise radiation therapy to more patients each day," said Dr. Roger Cao, president & general manager APAC at Accuray.

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 https://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 anticipated growth catalysts for the company, the enhancement of the joint venture's product portfolio, the joint venture's ability to compete in the growing Type B segment, the ability of the Tomo C system to meet Chinese customer needs, clinical applications, clinical results, patient outcomes and Accuray's leadership position in radiation oncology innovation and technologies. 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, risks related to the global macroeconomic environment; the effect of Covid-19; the company's ability to achieve widespread market acceptance of its products, including new product offerings and improvements; the company's ability to develop new products or improve existing products to meet customers' needs; 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 17, 2022, 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                                                    

1 https://gco.iarc.fr/tomorrow/en/dataviz/bars?mode=population&populations=935_160
2 Xia C, Dong X, Li H, Cao M, Sun D, He S, Yang F, Yan X, Zhang S, Li N, Chen W. Cancer statistics in China and United States, 2022: profiles, trends, and determinants. Chin Med J (Engl). 2022 Feb 9;135(5):584-590. doi: 10.1097/CM9.0000000000002108. PMID: 35143424; PMCID: PMC8920425


Source: Accuray Incorporated Related Stocks: NASDAQ:ARAY
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