Accuray CyberKnife Gets Shonin OK - Analyst Blog - Accuray (NASDAQ:ARAY)

Accuray Incorporated (ARAY) reported that its CyberKnife G4 Robotic Radiosurgery System has received the Japanese “Shonin” clearance (pre-market approval) to market the therapy system for non-invasive treatment of all tumor types. The company will sell the product in Japan as CyberKnife Radiosurgery System.

CyberKnife G4 System offers the latest advancements in Accuray’s proprietary CyberKnife technology. CyberKnife was first approved in Japan in 1999 for treating head and neck tumors. Accuray received Shonin approval for the system in June 2008 for treating extracranial tumors (tumors in the lung, prostate, spine, liver and pancreas).

Japan represents the second largest installed base for the CyberKnife Systems after the U.S. The latest Shonin approval of CyberKnife G4 System has broadened the application, capabilities and adoption of this novel therapy system for treating multiple tumors, thereby expanding its addressable market.

California-based Accuray is a global leader in the field of radiosurgery and provides a non-surgical treatment option for patients diagnosed with cancer. The company secured the U.S. regulatory clearance in July 1999 to market the CyberKnife System for treating tumors and certain other conditions in the head, neck and upper spine. The product was approved for sale in Europe in September 2002. The global CyberKnife installed base is 200 currently.

The CyberKnife System is the first and only commercially available intelligent robotic radiosurgery system designed to treat solid tumors anywhere in the body. It is a non-invasive alternative to traditional surgery. CyberKnife combines continuous image-guidance technology with a compact linear accelerator that has the ability to move in three dimensions according to the treatment plan. Its unique technology differentiates it from traditional treatments.

Patients can be treated with the CyberKnife System on an outpatient basis without anesthesia and without the risks and complications inherent in traditional surgery. The CyberKnife procedure is well tolerated. Patients do not require substantial pre-treatment preparation, and typically there is little to no recovery time or hospital stay required for the CyberKnife procedure. All these features make CyberKnife a preferred choice for physicians. Currently, we have a Neutral recommendation on Accuray.

ACCURAY INC (ARAY

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