Accuray CyberKnife® Robotic Radiosurgery System Receives Shonin Approval to Treat Trigeminal Neuralgia, a Chronic Pain Condition Affecting a Facial Nerve

Rhea-AI Summary

Accuray Incorporated (NASDAQ: ARAY) received approval from Japan's Ministry of Health to market its CyberKnife^® Robotic Radiosurgery System for treating trigeminal neuralgia (TN). This expands access to a high-precision treatment already in use in the U.S. and EIMEA. TN, characterized by severe facial pain, often necessitates ongoing medical care. Notably, 93.5% of patients experience relief from TN after three weeks using CyberKnife. This approval paves the way for potential reimbursement under Japan's health insurance system, enhancing treatment options for TN patients.

Positive

• Approval for CyberKnife System to treat trigeminal neuralgia increases market potential in Japan.
• Clinical data shows 93.5% of TN patients experienced pain relief after three weeks.
• The CyberKnife offers a non-surgical, outpatient treatment option for patients.

Negative

• None.

SUNNYVALE, Calif., Dec. 15, 2021 /PRNewswire/ -- 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.

Important Safety Information
For Important Safety Information, please refer to https://www.accuray.com/safety-statement.

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 Sunnyvale, California, 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, the CyberKnife platform's potential for the treatment of trigeminal neuralgia, clinical applications, clinical results, patient experiences and outcomes, and Accuray Incorporated's leadership position in radiation oncology innovation and technologies. These forward-looking statements involve risks and uncertainties. If any of these risks or uncertainties materialize, or if any of the company's assumptions prove incorrect, actual results could differ materially from the results expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, the company's ability to achieve widespread market acceptance of its products, including new product offerings and improvements; the company's ability to develop new products or improve existing products to meet customers' needs; the company's limited long-term clinical data supporting the safety and efficacy of its products, including product improvements, for certain users 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 4, 2021, 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 Contacts:
Beth Kaplan	Christy Maginn
Public Relations Director, Accuray	Havas
+1 (408) 789-4426	+1 (703) 297-7194
bkaplan@accuray.com	christina.maginn@havas.com

¹ https://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Trigeminal-Neuralgia
² https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Trigeminal-Neuralgia-Fact-Sheet
³ Romanelli P, Conti A, Bianchi L, Bergantin A, Martinotti A, Beltramo G. Image-Guided Robotic Radiosurgery for Trigeminal Neuralgia. Neurosurgery. 2018 Nov 1;83(5):1023-1030

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SOURCE Accuray Incorporated

FAQ

What is the significance of the approval for Accuray's CyberKnife system in Japan?

The approval enables Accuray to market the CyberKnife system for treating trigeminal neuralgia in Japan, increasing access to advanced treatment for patients.

What percentage of patients experience pain relief using the CyberKnife for trigeminal neuralgia?

Clinical data indicates that 93.5% of patients experience pain relief after three weeks of treatment with the CyberKnife system.

How does the CyberKnife System provide treatment for trigeminal neuralgia?

The CyberKnife System delivers high-precision stereotactic radiosurgery, allowing for effective treatment of trigeminal neuralgia in a single outpatient procedure.

What market potential does the approval create for Accuray's CyberKnife system?

The approval opens up a new market in Japan for the CyberKnife system, potentially leading to increased sales and revenue opportunities.

Is reimbursement expected for the CyberKnife treatment in Japan?

Following approval, the CyberKnife system is expected to receive reimbursement under Japan’s health insurance system, making it more accessible for patients.