NICE Endorses Radiosurgery Treatments for Trigeminal Neuralgia, Supporting Accuray CyberKnife® System Indications for Use

Rhea-AI Summary

Accuray Incorporated (NASDAQ: ARAY) has received endorsement from the National Institute for Health and Care Excellence (NICE) for its CyberKnife® Treatment Delivery System for treating trigeminal neuralgia (TN) in the UK. This endorsement enhances access to a precision radiosurgery alternative for managing TN, which causes severe facial pain. The CyberKnife system achieves pain control in nearly 95% of TN patients within 2-4 weeks and offers a minimally invasive outpatient procedure. However, availability may vary based on health insurance and licensing processes.

Positive

• NICE endorsement enhances market access for CyberKnife system in the UK.
• CyberKnife radiosurgery achieves pain control in almost 95% of TN patients within 2-4 weeks.
• The treatment has a low reported complication rate and allows for outpatient procedures.

Negative

• Availability of the CyberKnife system may be limited by health insurance reimbursement and licensing processes.

SUNNYVALE, Calif., Feb. 28, 2022 /PRNewswire/ -- Accuray Incorporated (NASDAQ: ARAY) announced today that the National Institute for Health and Care Excellence (NICE)* has endorsed the use of radiosurgery for trigeminal neuralgia (TN), strengthening the evidence for the company to market its CyberKnife^® Treatment Delivery System for this indication in the United Kingdom. The endorsement increases access to a system used worldwide to provide a high-precision radiosurgery treatment alternative to surgery for the management of this chronic and potentially debilitating neurologic condition.

"CyberKnife radiosurgery enables our team to achieve pain control in almost 95% of patients within 2-4 weeks and long-term healing in 75% of trigeminal neuralgia cases, enabling most patients to resume activities of importance to them. In our 15 years long-term experience, we have established precise treatment parameters that allow us to limit the risk of complications to a very low level and to date, no major issues have been reported," said Alfredo Conti, associate professor of neurosurgery at Alma Mater Bologna University in Bologna, Italy.

Associate professor Conti continued, "The treatment is delivered in a 30 minute out-patient procedure and imaging is obtained days before so the treatment can be planned in a way that is comfortable for both the patient and physicians. The absence of rigid head fixation, the out-patient modality and the treatment delivery speed makes CyberKnife radiosurgery particularly well tolerated and, as a matter of fact, the less invasive non-pharmacological option for trigeminal neuralgia at our hospital."

Precise Treatment Options are Needed
TN affects the trigeminal nerve that 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 such as the upper and lower jaws, teeth and cheek. TN occurs most frequently in people over age 50 and is more common in women than in men¹.

Frequently described as electric shock-like facial pain or a sharp shooting pain, trigeminal neuralgia occurs in unpredictable attacks that may last from a few seconds to approximately two minutes. According to the National Health Service (NHS) UK, "people with the condition may experience attacks of pain regularly for days, weeks or months at a time. In severe cases, attacks may happen hundreds of times a day²."

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, surgery or radiosurgery, may be required for these patients.

"Trigeminal neuralgia has the potential to significantly impact a person's quality of life if not appropriately managed, resulting in issues ranging from weight loss to isolation and depression. I'm honored to share this positive CyberKnife System news and to lead an organization whose radiosurgery device can make such a meaningful difference in the lives of these patients," said Suzanne Winter, president of Accuray.

The CyberKnife^® System was designed to treat diseases in the head and base of the skull, and functional disorders, with radiosurgery – and without the use of a fixed frame bolted to the patient's head. Since its introduction it has evolved into a full-body radiosurgery system that enables consistent delivery of accurate, sub-millimeter, (ultra) hypofractionated treatments to tumors throughout the body, including those in the kidney, liver, lung, prostate and spine.

Using advanced imaging and Accuray-exclusive Synchrony^® real-time target tracking with dynamic delivery technology, the CyberKnife System can see 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 both patient and tumor motion, with uninterrupted treatment delivery and maximum patient comfort. 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.

*CyberKnife System for the treatment of TN may be subject to health insurance reimbursement or licensing processes such that its availability may vary according to geographical location.

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 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                                                    

¹https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Trigeminal-Neuralgia-Fact-Sheet
²https://www.nhs.uk/conditions/trigeminal-neuralgia/

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SOURCE Accuray Incorporated

FAQ

What recent endorsement did Accuray receive for its CyberKnife system?

Accuray received endorsement from NICE for its CyberKnife system to treat trigeminal neuralgia.

How effective is the CyberKnife system for trigeminal neuralgia?

The CyberKnife system achieves pain control in nearly 95% of trigeminal neuralgia patients within 2-4 weeks.

What are the implications of NICE's endorsement for Accuray's market access?

NICE's endorsement increases access to the CyberKnife system in the UK, potentially boosting Accuray's market presence.

What are the limitations regarding the CyberKnife system's availability?

The availability of the CyberKnife system may vary due to health insurance reimbursement and licensing processes.

When was the NICE endorsement announced?

The NICE endorsement was announced on February 28, 2022.