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Accuray Showcases New Long-Term Data¹ on Benefits of 5 Session Radiotherapy Treatment for Men with Prostate Cancer at ESTRO 2025

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Accuray (NASDAQ: ARAY) presented new clinical data at ESTRO 2025 highlighting the effectiveness of its CyberKnife System for prostate cancer treatment. The studies showcased two significant findings: First, a retrospective analysis of 262 high-risk prostate cancer patients over 70 showed favorable outcomes with low toxicity rates after receiving 5-session SBRT treatments. Second, an early analysis of 51 patients demonstrated the system's effectiveness in treating recurrent cancer post-prostatectomy with mild toxicity. The company hosted a symposium attended by 350 healthcare professionals focusing on genitourinary radiotherapy advancements. The data reinforces CyberKnife's capability to deliver precise, non-invasive treatment in shorter courses, expanding treatment options for prostate cancer patients.
Accuray (NASDAQ: ARAY) ha presentato nuovi dati clinici all'ESTRO 2025 che evidenziano l'efficacia del suo sistema CyberKnife nel trattamento del cancro alla prostata. Gli studi hanno mostrato due risultati importanti: innanzitutto, un'analisi retrospettiva su 262 pazienti con cancro prostatico ad alto rischio, di età superiore a 70 anni, ha evidenziato esiti favorevoli con bassi tassi di tossicità dopo trattamenti SBRT in 5 sessioni. In secondo luogo, un'analisi preliminare su 51 pazienti ha dimostrato l'efficacia del sistema nel trattamento del cancro recidivante post-prostatectomia con tossicità lieve. L'azienda ha organizzato un simposio a cui hanno partecipato 350 professionisti sanitari, focalizzato sui progressi nella radioterapia genitourinaria. I dati rafforzano la capacità di CyberKnife di offrire un trattamento preciso e non invasivo in tempi più brevi, ampliando le opzioni terapeutiche per i pazienti con cancro alla prostata.
Accuray (NASDAQ: ARAY) presentó nuevos datos clínicos en ESTRO 2025 que destacan la efectividad de su sistema CyberKnife para el tratamiento del cáncer de próstata. Los estudios mostraron dos hallazgos importantes: primero, un análisis retrospectivo de 262 pacientes con cáncer de próstata de alto riesgo mayores de 70 años mostró resultados favorables con bajas tasas de toxicidad tras recibir tratamientos SBRT de 5 sesiones. Segundo, un análisis inicial de 51 pacientes demostró la efectividad del sistema en el tratamiento del cáncer recurrente después de la prostatectomía con toxicidad leve. La compañía organizó un simposio al que asistieron 350 profesionales de la salud, centrado en los avances en radioterapia genitourinaria. Los datos refuerzan la capacidad de CyberKnife para ofrecer un tratamiento preciso y no invasivo en cursos más cortos, ampliando las opciones de tratamiento para pacientes con cáncer de próstata.
Accuray(NASDAQ: ARAY)는 ESTRO 2025에서 전립선암 치료를 위한 CyberKnife 시스템의 효과를 강조하는 새로운 임상 데이터를 발표했습니다. 연구 결과 두 가지 중요한 발견이 있었습니다. 첫째, 70세 이상의 고위험 전립선암 환자 262명을 대상으로 한 후향적 분석에서 5회 세션 SBRT 치료 후 낮은 독성률과 우수한 치료 결과가 나타났습니다. 둘째, 51명의 환자를 대상으로 한 초기 분석에서는 전립선 절제술 후 재발암 치료에서 CyberKnife 시스템의 효과와 경미한 독성이 확인되었습니다. 회사는 비뇨기 방사선 치료의 최신 발전을 주제로 350명의 의료 전문가가 참석한 심포지엄을 개최했습니다. 이 데이터는 CyberKnife가 짧은 치료 기간 내에 정밀하고 비침습적인 치료를 제공할 수 있음을 뒷받침하며, 전립선암 환자에게 치료 옵션을 확장합니다.
Accuray (NASDAQ : ARAY) a présenté de nouvelles données cliniques lors de l'ESTRO 2025, mettant en avant l'efficacité de son système CyberKnife dans le traitement du cancer de la prostate. Les études ont révélé deux résultats majeurs : d'une part, une analyse rétrospective de 262 patients à haut risque, âgés de plus de 70 ans, a montré des résultats favorables avec de faibles taux de toxicité après des traitements SBRT en 5 séances. D'autre part, une analyse préliminaire de 51 patients a démontré l'efficacité du système dans le traitement du cancer récidivant après prostatectomie, avec une toxicité légère. L'entreprise a organisé un symposium auquel ont assisté 350 professionnels de santé, axé sur les avancées en radiothérapie génito-urinaire. Ces données renforcent la capacité de CyberKnife à offrir un traitement précis et non invasif sur des durées plus courtes, élargissant ainsi les options thérapeutiques pour les patients atteints de cancer de la prostate.
Accuray (NASDAQ: ARAY) präsentierte auf der ESTRO 2025 neue klinische Daten, die die Wirksamkeit seines CyberKnife-Systems bei der Behandlung von Prostatakrebs hervorheben. Die Studien zeigten zwei bedeutende Ergebnisse: Erstens eine retrospektive Analyse von 262 Hochrisiko-Prostatakrebspatienten über 70 Jahre mit günstigen Ergebnissen und niedrigen Toxizitätsraten nach 5 Sitzungen SBRT. Zweitens eine frühe Analyse von 51 Patienten, die die Wirksamkeit des Systems bei der Behandlung von rezidivierendem Krebs nach Prostatektomie mit milder Toxizität belegte. Das Unternehmen veranstaltete ein Symposium mit 350 Gesundheitsfachkräften, das sich auf Fortschritte in der genitourinären Strahlentherapie konzentrierte. Die Daten bestätigen die Fähigkeit von CyberKnife, präzise und nicht-invasive Behandlungen in kürzeren Zeiträumen zu ermöglichen und erweitern die Behandlungsoptionen für Prostatakrebspatienten.
Positive
  • Clinical data showed favorable outcomes with low toxicity rates in high-risk prostate cancer patients
  • System demonstrated effectiveness in treating recurrent cancer with mild toxicity
  • Strong attendance of 350 healthcare professionals at company symposium indicates market interest
  • Treatment requires only 5 sessions, offering convenience and shorter treatment duration
Negative
  • None.

Insights

Accuray's CyberKnife data shows promising results for prostate cancer in fewer treatment sessions, potentially expanding their addressable market.

The clinical evidence presented at ESTRO 2025 provides meaningful validation for Accuray's CyberKnife System in treating prostate cancer with stereotactic body radiation therapy (SBRT). Two key studies showcase the system's versatility and effectiveness:

The first study examined 262 high-risk prostate cancer patients over age 70 or with severe comorbidities, demonstrating favorable outcomes and low toxicity rates with a 39-month median follow-up. This expands the potential patient population for CyberKnife by confirming its suitability for complex, high-risk cases.

The second study (STARR trial) evaluated the system for recurrent cancer after prostatectomy, reporting only mild toxicity in 51 patients with 16-month median follow-up. The investigators specifically noted the convenience advantage of the shorter treatment duration compared to standard approaches.

The condensed five-session treatment protocol represents a significant efficiency improvement over conventional radiotherapy, which typically requires 20+ sessions over several weeks. This reduction in treatment time offers substantial quality-of-life benefits for patients while potentially increasing throughput for treatment centers.

The symposium's attendance by 350 healthcare professionals indicates strong clinical interest, and the 40+ studies using Accuray technology presented at ESTRO suggests broad investigation across applications. While this ongoing clinical validation is encouraging, it represents incremental progress rather than a transformative development. The retrospective nature of the first study and relatively short follow-up in the second study also warrant consideration when evaluating long-term clinical impact.

More than 40 Clinical Studies Using Accuray Technology Presented at ESTRO 2025; Company Highlights Innovation and Educational Symposia

MADISON, Wis., May 7, 2025 /PRNewswire/ -- Accuray Incorporated (NASDAQ: ARAY) announced today that new data presented at the European Society for Radiotherapy and Oncology (ESTRO) meeting reinforces the benefits of the company's CyberKnife® System in the treatment of prostate cancer at multiple stages of the cancer journey. The studies, shared at the annual congress held in Vienna, Austria, indicate the system's accuracy and precision enable treatment of high-risk disease, as well as recurrent prostate cancer following prostatectomy, with stereotactic body radiation therapy (SBRT), expanding access to a non-invasive, short course of care to more men.

"At this year's ESTRO meeting important analyses of real-world evidence (RWE) underscored the benefits of our unique robotic and helical platforms, reaffirming their use as patients' primary care option or along with other modalities such as surgery, chemotherapy or immunotherapy. Stand out studies focused on the company's CyberKnife System for the treatment of prostate cancer, building on a robust body of clinical data supporting its use and confirming the durability and quality of life after 10 years post-treatment. We're grateful to the clinicians who continue to evaluate our technologies and advance personalized and precise care of patients through the work that they do," said Suzanne Winter, president and CEO of Accuray.

During the meeting, Accuray hosted a symposium titled, "Integrating Advanced Techniques in Genitourinary Radiotherapy: Harmonizing Precision, Personalization, and Efficacy," attended by 350 healthcare professionals. The event featured global thought leaders who spoke on advancements in the treatment of genitourinary indications - prostate, kidney, and bladder cancers - with radiotherapy. Patient care in these areas is dynamic and evolving rapidly, with SBRT now recognized as a safe and effective alternative to conventional treatments for localized prostate cancer and evidence continuing to build for the use of SBRT in salvage prostate treatments.

CyberKnife Platform: Empowering Advances in Prostate Cancer Patient Care
A retrospective analysis titled, "Long-term outcomes and treatment efficacy in high-risk prostate cancer patients treated with stereotactic extreme hypofractionated radiotherapy," reports on 262 men over the age of 70 or with severe comorbidities who were diagnosed with either non-metastatic high-risk or very high-risk prostate cancer and received SBRT delivered with the CyberKnife System in five sessions. With a median follow-up of 39 months, investigators found that treatment with the system offers a promising option with favorable outcomes and low rates of acute and late urogenital (UG) and gastrointestinal (GI) toxicities.

"Early results from a trial on stereotactic salvage radiotherapy for macroscopic prostate bed recurrence after prostatectomy: STARR (NCT05455736)" is a prospective study evaluating the use of stereotactic salvage radiotherapy (SSRT) delivered with the CyberKnife System in five sessions. Androgen deprivation therapy was prohibited during SSRT. An early analysis of 51 patients with a median follow up of 16 months found that the CyberKnife System provides an effective and convenient option with mild toxicity for the treatment of recurrent cancer in the prostate bed following prostatectomy. The study investigators concluded, "Only mild toxicity was reported, underlining the safety of the treatment. Moreover, SSRT may be considered a convenient approach considering the shorter treatment duration if compared to standard approach."

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 Company's products, including CyberKnife System; clinical results; 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; 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 February 5, 2025, 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
Accuray
+1 (408) 789-4426
bkaplan@accuray.com

1 ESTRO 2025 annual congress. https://user-swndwmf.cld.bz/ESTRO-2025-Abstract-Book/2003/

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SOURCE Accuray Incorporated

FAQ

What were the key findings of Accuray's CyberKnife System studies presented at ESTRO 2025?

Studies showed favorable outcomes with low toxicity rates in 262 high-risk prostate cancer patients over 70, and demonstrated effectiveness in treating recurrent cancer post-prostatectomy with mild toxicity in 51 patients.

How many treatment sessions are required for ARAY's CyberKnife prostate cancer treatment?

The CyberKnife System delivers treatment in just 5 sessions, offering a shorter and more convenient treatment course compared to standard approaches.

What was the size of the patient study group in Accuray's retrospective analysis?

The retrospective analysis included 262 men over the age of 70 or with severe comorbidities who were diagnosed with non-metastatic high-risk or very high-risk prostate cancer.

How many healthcare professionals attended Accuray's ESTRO 2025 symposium?

350 healthcare professionals attended Accuray's symposium on integrating advanced techniques in genitourinary radiotherapy.

What was the median follow-up period for ARAY's CyberKnife prostate cancer study?

The study had a median follow-up period of 39 months for the high-risk prostate cancer patient group.
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