Accuray receives Shonin approval to market CyberKnife G4 Robotic Radiosurgery System

Accuray IncorporatedAug 3 2010

Accuray Incorporated (Nasdaq: ARAY), a global leader in the field of radiosurgery, announced today it received Shonin approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to market the CyberKnife® G4 Robotic Radiosurgery System to treat tumors non-invasively anywhere in the body, inclusive of head and neck. The System will be marketed in Japan as the "CyberKnife® Radiosurgery System."

The CyberKnife G4 System will provide Japanese patients with some of the latest advances in CyberKnife technology including:

• Motion management technology to correct for tumor motion including the Xsight® Lung Tracking System, which eliminates the need for fiducials in many lung cases;
• Hardware and software enhancements that enable up to 50 percent reduction in treatment time;
• Customized treatment plans dictated by clinical requirements and objectives;
• Flexibility to adapt the fractionation scheme to meet the unique needs of each patient simply and conveniently in routine clinical practice.

In June 2008 Accuray was granted Shonin approval of the CyberKnife System for use in Japan in the treatment of extracranial tumors, including tumors that move with respiration. This regulatory approval dramatically expanded the types of Japanese patients that could be treated with radiosurgery to include those with cancers of the spine, lung, liver, pancreas and prostate.

Since the 2008 regulatory approval, there has been significant interest in the treatment of tumors throughout the body using CyberKnife radiosurgery and the availability of the CyberKnife G4 System in Japan further expands the planning, application and throughput capabilities of the system. The CyberKnife G4 System addresses the unique challenges of random and excessive target motion by using intelligent and adaptive image guidance, which minimizes dose to surrounding healthy tissue and critical structures, ultimately minimizing treatment complications and side effects.

"This is an important milestone for Accuray as we continue our journey to expand the global footprint of our best-in-class radiosurgery treatment, the CyberKnife System," said Euan S. Thomson, Ph.D., president and CEO of Accuray. "With the availability of these capabilities, we anticipate enhanced interest in the acquisition of CyberKnife technology and we will work closely with our Japanese regional office in Tokyo to enable quick adoption of the CyberKnife G4 System throughout Japan."

The CyberKnife System offers cancer patients worldwide a pain-free, non-invasive alternative to surgery. In 1996 the CyberKnife System was first approved in Japan to treat tumors in the head and neck. With 21 CyberKnife Systems installed throughout Japan, it is the second largest installed base of CyberKnife Systems after the United States.