Healthcare Industry News:  Gamma Knife 

Devices Reimbursement

 News Release - October 26, 2022

New Reimbursement Approved by the Japanese Ministry of Health, Labor and Welfare for the Accuray CyberKnife(R) System to Treat Trigeminal Neuralgia, a Condition Often Causing Severe Facial Pain

SUNNYVALE, Calif., Oct. 26, 2022 -- (Healthcare Sales & Marketing Network) -- Accuray Incorporated (NASDAQ: ARAY) announced today that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved reimbursement for the CyberKnife® System for the treatment of trigeminal neuralgia (TN). The system provides an important new option for people living with this chronic pain disorder, described by some patients as the most excruciating pain human beings can experience1.

TN affects the trigeminal or 5th cranial nerve which carries sensation from the face to the brain, triggering pain in the lower face and jaw, in areas above the eyes or around the nose. One of the most common causes of TN is compression of the nerve by a blood vessel, but there are multiple other causes including a tumor constricting the nerve, surgical injury or stroke. The unpredictable, intense pain patients experience can make living with TN challenging and can lead to weight loss, depression and isolation2.

"Trigeminal neuralgia has the potential to significantly disrupt patients' daily lives if left untreated or inadequately treated. That's why the health insurance reimbursement approval for the CyberKnife System is so important," said Suzanne Winter, president of Accuray. "Our high-precision system provides a unique radiosurgery treatment alternative to surgery supported by long-term data. Importantly, the system's precision makes it possible to deliver radiation typically in just one out-patient procedure without a fixed frame secured to the patient's head to prevent movement, as required with other devices."

People diagnosed with TN require long-term medical care that usually starts with medication to lessen or block the pain signals sent to the brain. Over time, the pain control provided by these drugs diminishes for some patients and others experience unpleasant side effects. For these patients, injections, surgery, or radiosurgery may be necessary.

"Although trigeminal neuralgia is a rare disease with an incidence of about 5 out of 100,000 people, or approximately 5,000 people in Japan, the pain these people experience is significant and more options are needed that can improve their care. CyberKnife radiosurgery offers new hope for people living with this difficult to treat medical condition," said Hiroshi Onishi, M.D., , Chairman of the Health Insurance Committee at the Japanese Society for Radiation Oncology (JASTRO), and Professor and Chairman, Department of Radiology and Vice-director of School Medicine, University of Yamanashi. "Until now, Gamma Knife has been the only device approved to deliver radiosurgery for the treatment of trigeminal neuralgia. I believe insurance coverage for the CyberKnife System to treat this condition is great news for patients, as there will be more opportunities for treatment and better accessibility to treatment facilities."

The CyberKnife System was initially designed by a neurosurgeon for neurosurgeons to treat diseases in the head, the skull base and the spine such as benign and malignant primary tumors, brain metastases, meningiomas, trigeminal neuralgia, acoustic neuromas and arteriovenous malformations (AVMs). The platform's unique robotic technology, non-coplanar beam delivery and Synchrony® motion adaptation technology enable the delivery of radiation with sub-millimeter accuracy, meaning minimal radiation is delivered to the surrounding healthy tissue. Since its introduction the CyberKnife® System has evolved into a full-body radiosurgery system that enables consistent delivery of extremely precise treatments to tumors throughout the body, including those in the kidney, liver, lung, pancreas, prostate, bone metastases and oligo metastases.

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 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 Annual Report on Form 10-K, filed with the Securities and Exchange Commission (the "SEC") on August 17, 2022, 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 Contact

Beth Kaplan
Public Relations Director, Accuray
+1 (408) 789-4426
bkaplan@accuray.com

1 https://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Trigeminal-Neuralgia

2 https://www.nhs.uk/conditions/trigeminal-neuralgia/


Source: Accuray

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