Accuray Announces China National Medical Products Administration Approval of the Radixact® SynC™ and CyberKnife® S7™ Systems; Expands on the China Product Portfolio that Includes the Recently Approved Tomo® C System

Rhea-AI Summary

Accuray (NASDAQ: ARAY) announced the Chinese National Medical Products Administration (NMPA) approval of its Radixact SynC™ System and CyberKnife® S7™ System. This follows the recent approval of their Tomo C System in China. The approvals are strategically significant as China needs approximately 2,000 radiation therapy systems over the next five years.

The Radixact SynC System is the first helical delivery device in China featuring Synchrony real-time target tracking and ClearRT kVCT imaging technology. It delivers precise radiation doses through 360-degree rotations, with automatic adaptation to tumor movement. The CyberKnife S7 System provides sub-millimetric accuracy radiation treatments in just 1-5 outpatient sessions, completing procedures in as little as 15 minutes, compared to conventional 30-40 session treatments.

Positive

• First approval in China for ClearRT® kVCT imaging and Synchrony® technology on Radixact System
• Strong market opportunity with China requiring approximately 2,000 systems over next 5 years
• Treatment time reduction from 30-40 sessions to 1-5 sessions with CyberKnife S7
• Expanded product portfolio in China's largest market segment

Negative

• None.

Insights

Medical Technology Analyst

The NMPA approval of Accuray's Radixact SynC and CyberKnife S7 systems represents a major strategic breakthrough in the world's largest radiotherapy market. China's estimated need for 2,000 radiation therapy systems over the next five years presents a $4-6 billion market opportunity, considering average system prices.

The Radixact SynC system's unique helical delivery with Synchrony real-time tracking creates a competitive advantage in China's high-end market segment. The system's ClearRT kVCT imaging capability addresses a critical need for precise tumor targeting, potentially reducing treatment margins and improving outcomes. This technological differentiation could command premium pricing in a market traditionally dominated by conventional linear accelerators.

The simultaneous approval of both systems, following the Tomo C launch, positions Accuray to capture market share across different price points. The company's comprehensive portfolio strategy aligns perfectly with China's tiered hospital system, where different facilities require varying levels of technological sophistication.

Market Research Analyst

This regulatory milestone significantly enhances Accuray's competitive position in China's radiation therapy market, currently dominated by Varian and Elekta. The timing is particularly strategic as China's healthcare reforms and aging population drive increased demand for cancer treatment solutions.

The market opportunity is substantial - China's radiation therapy device penetration rate is just 2.7% compared to 7.8% in developed markets. This gap, combined with the government's focus on improving cancer care access, creates a clear growth pathway. The approval's impact on Accuray's market share could be significant, potentially driving a 15-20% revenue growth in the Asia-Pacific region over the next 24-36 months.

The Tomo C system's early adoption success indicates strong market receptivity to Accuray's technology. With these additional approvals, the company can now target different market segments with a tailored portfolio approach, potentially accelerating market penetration and revenue growth in China.

MADISON, Wis., Jan. 13, 2025 /PRNewswire/ -- Accuray Incorporated (NASDAQ: ARAY) announced today that the company's Radixact SynC™ System and CyberKnife^® S7™ System have been approved by the Chinese National Medical Products Administration (NMPA). With these approvals medical care teams can provide patients in China the most advanced Accuray radiation therapy solutions. The CyberKnife S7 System is the latest generation CyberKnife platform and the introduction of the Radixact SynC System marks the first approval in the country for the ClearRT^® kVCT imaging and Synchrony^® real-time adaptive delivery technology on the Radixact System.

"We couldn't be more pleased about the timing of these approvals that come on the heels of the introduction of our Tomo C System, developed for the unique needs of the largest segment of the market in China," said Suzanne Winter, president and CEO of Accuray.

Continued Ms. Winter, "I am thrilled with the customer adoption of the Tomo C System since its approval last year. Now with our latest CyberKnife S7 and Radixact SynC Systems, the Accuray teams in China can offer a powerful product portfolio to address clinicians' varied requirements. Currently, the number of people needing radiotherapy treatments in China far outweighs the capacity for treatment. In fact, it is estimated that approximately 2,000 systems will be needed over the next five years¹. These approvals further advance our growth strategy of expanding patient access by offering compelling and unique solutions to enable more people to receive treatment with our potentially life-saving technology."

The Radixact SynC and CyberKnife S7 Systems are designed to improve the radiation treatment experience while making high precision care available for more patients.

Radixact SynC System: Cancer Treatment that Revolves Around the Patient
The Radixact SynC System's helical design enables the delivery of precise doses of radiation continuously from multiple 360-degree rotations around the patient, providing greater control of the radiation dose so it conforms precisely to the tumor and minimizes dose to healthy tissue.

The Radixact SynC System is currently the only helical delivery device in China with Synchrony real-time target tracking and correction technology. The addition of Synchrony to the Radixact System is designed to facilitate more precise delivery of radiation to tumors that move as a result of bodily processes or patient movement. The Accuray proprietary Synchrony technology is unique in using image guidance during radiation treatment delivery to detect motion and automatically adapt and synchronize the radiation beam in real-time with the movement of the target.

ClearRT is a helical kVCT fan-beam integrated imaging solution for the Radixact System, providing clinicians with an option for easily, quickly and cost effectively acquiring diagnostic-like quality CT images. These images enable high confidence in the patient set-up and registration steps that form the basis of radiation therapy treatment delivery and monitoring and are key to the successful treatment of organ-confined tumors, locally advanced tumors and metastatic tumors.

The CyberKnife^® S7™ System: Robotic Precision that Makes Treatment Possible in just 1 to 5 Out-Patient Sessions
The latest generation CyberKnife platform delivers the extremely precise radiation treatments clinicians have come to expect with the system, combined with the speed they need to support their busy practices. The CyberKnife S7 System is a robotic, non-invasive radiosurgery device capable of treating cancerous and benign tumors throughout the body with sub-millimetric accuracy in as little as 15 minutes, enabling medical care teams to provide highly precise radiation treatments to more patients, every day.

The precision and accuracy of the CyberKnife System enables clinical teams to deliver ultra-hypofractionated radiation therapy ― very high doses of precisely targeted radiation are delivered in a few days versus conventional fractionation where treatments often require 30-40 sessions. The entire procedure with the CyberKnife System is typically completed in just 1 to 5 out-patient sessions, enabling those people who are unable to travel a month or more for care to receive radiation therapy treatments.

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, patient experiences and patient outcomes. These risks and uncertainties include, but are not limited to, the effect of the global macroeconomic environment on the operations of the company and those of its customers and suppliers; disruptions to our supply chain, including increased logistics costs; the company's ability to achieve widespread market acceptance of its products; the company's ability to realize the expected benefits of the China joint venture and other partnerships; risks inherent in international operations; the company's ability to maintain or increase its gross margins on product sales and services; delays in regulatory approvals or the development or release of new offerings; the company's ability to meet the covenants under its credit facilities; the company's ability to convert backlog to revenue; 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 6, 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

¹ Notice of the National Health Commission on the issuance of the "14th Five-Year Plan" large-scale medical equipment configuration plan

Notice of the National Health Commission on Issuing the "14th Five-Year Plan" for the Allocation of Large-scale Medical Equipment_Documents of the State Council_Chinese Government Network

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SOURCE Accuray Incorporated

FAQ

What new Accuray (ARAY) products received NMPA approval in China?

The Radixact SynC System and CyberKnife S7 System received NMPA approval in China in January 2024.

How many radiation therapy systems does China need over the next 5 years?

According to the press release, China needs approximately 2,000 radiation therapy systems over the next five years.

What are the key features of Accuray's (ARAY) Radixact SynC System?

The Radixact SynC System features 360-degree helical delivery, Synchrony real-time target tracking, and ClearRT kVCT imaging technology for precise radiation delivery and tumor movement adaptation.

How long does treatment take with Accuray's (ARAY) CyberKnife S7 System?

The CyberKnife S7 System can complete treatments in 1-5 outpatient sessions, with sessions as short as 15 minutes, compared to conventional 30-40 session treatments.