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Devices Oncology

 News Release - March 31, 2022

10-Year Data Shows Accuray CyberKnife(R) System Provides Long-Lasting Relief of the Excruciating Pain Caused by Trigeminal Neuralgia

Study Abstract Recognized as Best Clinical Abstract at 2022 Radiosurgical Society Meeting

SUNNYVALE, Calif., March 31, 2022 -- (Healthcare Sales & Marketing Network) -- Accuray Incorporated (NASDAQ: ARAY) announced today that long-term follow-up data from a study of men and women with trigeminal neuralgia (TN) showed 72 percent continued to experience pain relief 10 years after receiving image-guided robotic radiosurgery treatments delivered with the CyberKnife® System. The study abstract, titled "Robotic Image-Guided Radiosurgery for Trigeminal Neuralgia: Results after 10 Years," was recognized as Best Clinical Abstract at the recent 2022 Radiosurgical Society Meeting in Carlsbad, California.

TN occurs most frequently in people over the age of 50 years old and is more common in women than in men [1]. A chronic pain condition affecting a craniofacial nerve that is primarily responsible for transmitting sensations from the face to the brain, TN is described by some patients as the most excruciating pain human beings can suffer. Pain can be brought on from the lightest of touches to the face, even a gently breeze can start a painful attack.

"Many people don't understand how debilitating the chronic pain associated with trigeminal neuralgia can be. If left untreated, or inadequately treated, it can be difficult to perform daily activities that most of us take for granted – from eating a meal, washing our face or brushing our teeth, to talking. That's why studies like this are so significant. They demonstrate that with treatment options like CyberKnife radiosurgery, we can provide our patients long-term pain control – without a rigid head frame, surgery or medications. We can offer our patients hope and the chance to once again focus on what's possible in their lives," said Alfredo Conti, associate professor of neurosurgery at Alma Mater Bologna University in Bologna, Italy.

TN can affect patients over the course of their lives, making long-term medical care a necessity. Treatment of TN usually begins with medication to block the pain signals sent to the brain. Over time, some medications become less effective, and certain patients experience unpleasant side effects. Alternative treatments, such as injections, radiofrequency, balloon compression, surgery or radiosurgery, may be required for these patients.

"Clinical data continues to confirm the durable benefits that CyberKnife radiosurgery can provide over the long term. The system delivers advanced radiotherapy treatments with sub-millimeter accuracy, which is of critical importance when treating tumors and lesions in the brain, while minimizing risk of potential side effects," said Suzanne Winter, president of Accuray. "This most recent trigeminal neuralgia study reinforces why medical care teams turn to CyberKnife radiosurgery when precision and accuracy are essential and demonstrates the positive impact this non-invasive treatment option may have on the lives of people living with this severe and challenging-to-treat medical condition."

The CyberKnife System was designed to treat diseases in the head and base of the skull, and functional disorders, with radiosurgery – without the use of a fixed frame bolted to the patient's head. The system features a linear accelerator (linac) 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, facilitating highly precise and accurate treatments – typically in just one to five visits.

Using advanced imaging and Accuray-exclusive Synchrony® real-time target tracking with dynamic delivery technology, the CyberKnife® System can track the tumor or lesion and continually verify its position, automatically correcting and adapting the radiation beam position for even the slightest movement. Synchrony uses advanced algorithms and artificial intelligence (AI) to drive dynamic delivery accounting for motion with uninterrupted treatment delivery and maximum patient comfort. For example, if the patient moves their head during treatment, the CyberKnife System detects this movement and synchronizes the treatment delivery beam to the tumor's or lesion's new position in real-time.

About the Study[2]

The primary study objective was to evaluate the safety and effectiveness of CyberKnife radiosurgery in TN patients. A prescription dose of 60 Gy was delivered in a single fraction to a 6-mm segment of the nerve. The same dose was delivered if a second treatment was needed; over time the second dose was reduced to 45 Gy. All patients had taken medications for an average of 4.3 years before treatment with radiation. The Cyberknife Center of CDI (Milan) treated 668 patients with TN during the last 12 years;10-year data is available for 84 patients.

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, the durable benefits of treatment with the CyberKnife platform, 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; 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 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 January 28, 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.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Trigeminal-Neuralgia-Fact-Sheet

[2] Romanelli P, Bianchi L, Beltramo G (February 11, 2022) Robotic Image-Guided Radiosurgery for Trigeminal Neuralgia: Results after 10 Years. Cureus 14(2): a763 and 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.


Source: Accuray

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