New Data Indicates the CyberKnife® System Can Provide a Safe and Effective Treatment Option to Control Brainstem Metastases, an Extremely Challenging Location to Treat

Rhea-AI Summary

Accuray (NASDAQ: ARAY) announced positive results from a nine-institution international study on treating brainstem metastases (BSM) using their CyberKnife® System. The study, published in the International Journal of Cancer, analyzed 136 patients with 144 BSM treated between 2005-2022 using radiosurgery (SRS) and fractionated stereotactic radiotherapy (FSRT).

The results demonstrated impressive outcomes with one-year, two-year, and three-year local BSM control rates of 82.9%, 71.4%, and 61.2% respectively. Nearly 70% of patients received treatment in just one session. The treatment showed a robust safety profile with low incidence of side effects, despite targeting the delicate brainstem area.

Positive

• Strong efficacy data with 82.9% one-year local control rate for brainstem metastases
• 69.4% of patients required only single-session treatment, indicating efficiency
• Treatment demonstrated robust safety profile in delicate brain areas
• System offers non-invasive alternative to surgical procedures

Negative

• None.

Insights

Medical Research Analyst

The multicenter study results demonstrate significant clinical validation for CyberKnife's effectiveness in treating brainstem metastases, with impressive 82.9%, 71.4% and 61.2% local control rates at 1, 2 and 3 years respectively. The system's ability to deliver precise radiation without requiring invasive head frames represents a meaningful competitive advantage in the neuro-oncology space. Particularly notable is that 69.4% of patients required only a single treatment session, suggesting improved treatment efficiency and potential cost benefits.

The robust safety profile and low incidence of side effects, despite targeting such a critical brain region, strengthens CyberKnife's position in the stereotactic radiosurgery market. This data could drive increased adoption among radiation oncologists, especially for complex cases where surgical options are The study's large sample size (136 patients across 9 institutions) and long-term follow-up provide compelling evidence that could influence treatment protocols and reimbursement decisions.

Financial Analyst

This clinical validation could positively impact Accuray's market position in the competitive radiation therapy space. With brainstem metastases being particularly challenging to treat, successful outcomes in this indication demonstrate CyberKnife's technical superiority and could drive market share gains. The system's ability to treat patients without invasive head frames expands the addressable patient population, potentially increasing procedure volumes and equipment sales.

The single-session treatment capability in 69.4% of cases suggests improved operational efficiency for healthcare providers, making the CyberKnife system more economically attractive. This could strengthen Accuray's value proposition in capital equipment purchasing decisions. While specific revenue implications aren't quantified, positive clinical data in complex indications typically supports premium pricing and can accelerate adoption in both new and replacement markets.

Study Builds on Extensive Published Literature Highlighting the Benefits of the CyberKnife System in the Treatment of a Wide Range of Neurological Indications

MADISON, Wis., Dec. 18, 2024 /PRNewswire/ -- Accuray Incorporated (NASDAQ: ARAY) announced today an international retrospective multicenter analysis found that radiosurgery (SRS) and fractionated stereotactic radiotherapy (FSRT), delivered with the CyberKnife^® System, can provide an effective and time-saving treatment option for brainstem metastases (BSM). The nine institution study results, published in the International Journal of Cancer, "underscore the long-term benefits in local control and the robust safety profile despite the delicate location of the treated metastases¹."

"The brainstem is an integral part of the central nervous system, and metastatic spread to this part of the brain is a potentially life-threatening situation. Since surgical resection is rarely an option, stereotactic radiosurgery and fractionated stereotactic radiotherapy are both effective and safe treatment options when thoroughly planned and executed. The available literature, along with our multicenter study, clearly underscores the central role of radiosurgery for affected patients," said Felix Ehret, M.D., Department of Radiation Oncology, Charité - Universitätsmedizin Berlin and European Radiosurgery Center Munich, Munich, Germany.

SRS and FSRT – also referred to as fractionated radiosurgery – are advanced forms of radiation therapy. SRS delivers a high dose of radiation in one session, while FSRT divides the total treatment dose into multiple, smaller doses given over several days. Both techniques provide medical care teams with the ability to deliver extremely precise, very targeted doses of radiotherapy, typically to small, specific areas within the body, usually in the brain. In the reported analysis, 136 patients who received treatment in one to five sessions were analyzed; 69.4 percent received radiotherapy in just one treatment dose¹.

"The brain's tissues and structures are incredibly delicate and are essential to everything from basic functions to the very essence of who we are as individuals. That's why we developed the CyberKnife System to deliver radiation with the utmost accuracy and precision, and why we remain committed to innovating for better clinical outcomes for people with brain tumors, lesions, and benign neurological conditions," said Seth Blacksburg, M.D., MBA, Chief Medical Officer at Accuray.

CyberKnife System Expands Treatment Options for People with Brain Tumors and Neurological Conditions
The CyberKnife System can be used to treat brain tumors and neurological conditions with sub-millimeter accuracy and precision in just one to five sessions over one to two weeks. With the CyberKnife System, patients aren't required to have a metal frame attached to their head to undergo treatment, enabling a wide range of people, including those with recurrent tumors and young patients who can't be treated with a fixed head frame, to benefit from a shorter overall course of care that may positively impact their quality of life. The CyberKnife System can also be used at various stages in the treatment journey – from first line to adjuvant therapy and palliation – reinforcing its benefits in daily practice.

About the Study
The objective of this analysis was to provide further evidence for the use of radiosurgery in the treatment of patients with BSM. The retrospective evaluation compared the safety and efficacy results achieved by nine institutions delivering radiotherapy in single (SRS) and up to five sessions (FSRT) with the CyberKnife^® System to available published literature on these techniques. The multicenter study assessed 136 patients with 144 BSM who received treatment from 2005 to 2022. One hundred BSM were treated with SRS, and the remaining 44 received FSRT. The results showed one-year, two-year, and three-year local BSM control rates were 82.9 percent, 71.4 percent, and 61.2 percent. This study helps to underscore the long-term benefits in local control despite the delicate position of the treated metastases. SRS and FSRT treatments were well tolerated and the incidence of treatment-related side effects was low.

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 Madison, Wisconsin, with facilities worldwide. To learn more, visit www.accuray.com or follow us on Facebook, LinkedIn, X, 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, to expectations related to the use of the Company's products in the treatment of neurological indications, clinical applications, clinical results and outcomes, patient experiences and patient outcomes. 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 innovations and releases; the company's ability to develop new products or improve existing products to meet customers' needs; the company's ability to anticipate or keep pace with changes in the marketplace and the direction of technological innovation and customer demands 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 6, 2024, 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 Ehret F, Rueß D, Blanck O, et al. Stereotactic radiosurgery and radiotherapy for brainstem
metastases: An international multicenter analysis. Int J Cancer. 2024;155(5):916‐924. doi:10.1002/ijc.34980

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SOURCE Accuray Incorporated

FAQ

What were the success rates of CyberKnife treatment for brainstem metastases in ARAY's latest study?

The study showed local control rates of 82.9% at one year, 71.4% at two years, and 61.2% at three years for brainstem metastases treatments.

How many patients were included in ARAY's 2005-2022 CyberKnife brainstem metastases study?

The study analyzed 136 patients with 144 brainstem metastases across nine institutions.

What percentage of patients received single-session treatment with ARAY's CyberKnife System?

69.4% of patients received radiotherapy in just one treatment dose.

What are the advantages of ARAY's CyberKnife System for brain tumor treatment?

The CyberKnife System offers sub-millimeter accuracy, doesn't require a metal head frame, can be completed in 1-5 sessions over 1-2 weeks, and is suitable for recurrent tumors and young patients.