Accuray (ARAY) CyberKnife Receives Shonin Approval to Treat Trigeminal Neuralgia

Accuray Incorporated (NASDAQ: ARAY) announced today it has received approval from the Japanese Ministry of Health, Labor and Welfare (Shonin) to market the CyberKnife® Robotic Radiosurgery System for the treatment of trigeminal neuralgia (TN) in Japan. The system is currently used to treat TN in the U.S., EIMEA and other parts of the world. With the Shonin approval, more TN patients will have access to a high-precision radiosurgery treatment typically delivered in just one out-patient procedure.

"It is with great pride that we announce the expansion of the CyberKnife System's approved indications for use in Japan to now include trigeminal neuralgia. This approval reinforces our team's dedication to providing our customers with innovative products that expand the potential to use radiation in a new field of application, enabling them to enhance the quality of patient care and improve the patient experience. The system provides a proven, non-surgical option for treating trigeminal neuralgia without a fixed frame that must be secured to the patient's head to prevent movement, as required with other devices," said Suzanne Winter, president of Accuray.

TN is a chronic pain condition that affects the trigeminal nerve which carries sensation from the face to the brain. Patients can experience excruciating pain in the areas of the face where the branches of the nerve are distributed including the upper and lower jaws, scalp, forehead, eyes, nose and lips. TN occurs most frequently in people over age 50 and is more common in women than in men2.

People diagnosed with TN require long-term medical care that usually begins with medication to block the pain signals sent to the brain. Over time, however, some medications become less effective, or patients experience unpleasant side effects. For these patients, injections, surgery or radiosurgery may be required.

Data indicate stereotactic radiosurgery (SRS) treatments delivered with the CyberKnife System result in rapid and long-lasting pain relief, with 93.5 percent of patients with TN experiencing relief after three weeks and 76 percent of patients maintaining stable pain control for three years after the first treatment[3]. Following Japanese health insurance system reimbursement approval, the CyberKnife System will be available as a new treatment option for patients experiencing this potentially debilitating condition.

"As a neurosurgeon, I have seen many people suffering from trigeminal neuralgia. Some of them were worried about medication that worked initially and gradually became ineffective, and others were disappointed with the recurrence of pain despite choosing surgery as a potentially curative option. For these people, SRS may be an extremely useful treatment method," said Hiroshi Takahashi, M.D., Ph.D., IFAANS, General Director of Kasugai CyberKnife and Rehabilitation Hospital. "I am very pleased about this recent CyberKnife approval. The system delivers SRS treatments with accuracy and precision, and with the potential for long-lasting results. I believe it will be an important option for our patients with trigeminal neuralgia."

The CyberKnife® System was developed to treat intracranial and spinal conditions with SRS. The device's functionality has significantly evolved, and it has become a premier, full-body robotic radiation delivery system that also enables ultra-precise treatment of a wide range of tumors outside the brain, including those in the liver, lung and prostate.

The CyberKnife System features a linear accelerator directly mounted on a robot that moves and bends around the patient to deliver non-isocentric, non-coplanar radiation beams from potentially thousands of unique angles. This distinctive capability combined with the system's Accuray-only Synchrony® artificial intelligence (AI)-driven tumor tracking with dynamic delivery technology facilitates accurate, sub-millimeter, (ultra) hypofractionated treatments to tumors throughout the body in as little as 15 minutes.

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