Accuray Nets Regulatory Approval in China for Radixact SynC and CyberKnife S7 Systems

Accuray Incorporated announced 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 needng 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 years. 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.

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 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.