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Accuray Receives CE Mark for a New Helical Radiation Delivery System, Accuray Helix™

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Accuray Incorporated (NASDAQ: ARAY) has received CE Mark for Accuray Helix™, a new CT-guided helical radiotherapy system designed for emerging markets with access to advanced cancer care. The system aims to provide high-performance, high-throughput radiotherapy in non-urban communities, offering short treatment times and cost-effectiveness.

Accuray Helix is part of the company's strategic plan to expand its portfolio of helical radiation therapy delivery systems. It's designed to treat routine cancer cases including breast, cervix, head and neck, gastrointestinal, lung, and prostate. The system's flexibility and versatility aim to improve personalized patient care while boosting clinic productivity to meet growing cancer care demands.

Accuray Incorporated (NASDAQ: ARAY) ha ricevuto il marchio CE per Accuray Helix™, un nuovo sistema di radioterapia elicoidale guidata da TC progettato per i mercati emergenti con accesso a cure avanzate per il cancro. Il sistema si propone di fornire radioterapia ad alte prestazioni e ad alto rendimento nelle comunità non urbane, offrendo tempi di trattamento brevi e un buon rapporto costo-efficacia.

Accuray Helix fa parte del piano strategico dell'azienda per espandere il proprio portafoglio di sistemi di erogazione della terapia radiante elicoidale. È progettato per trattare casi di cancro di routine, inclusi quelli al seno, alla cervice, della testa e del collo, gastrointestinali, polmonari e prostatici. La flessibilità e la versatilità del sistema mirano a migliorare la cura personalizzata dei pazienti, aumentando al contempo la produttività della clinica per soddisfare la crescente domanda di cure oncologiche.

Accuray Incorporated (NASDAQ: ARAY) ha recibido la Marca CE para Accuray Helix™, un nuevo sistema de radioterapia helical guiado por TC diseñado para mercados emergentes con acceso a atención avanzada del cáncer. El sistema tiene como objetivo proporcionar radioterapia de alto rendimiento y alto rendimiento en comunidades no urbanas, ofreciendo tiempos de tratamiento cortos y rentabilidad.

Accuray Helix es parte del plan estratégico de la compañía para expandir su portafolio de sistemas de entrega de terapia de radiación helical. Está diseñado para tratar casos de cáncer de rutina, incluidos cánceres de mama, cuello uterino, cabeza y cuello, gastrointestinal, pulmonar y prostático. La flexibilidad y versatilidad del sistema pretenden mejorar la atención personalizada del paciente, al mismo tiempo que aumentan la productividad de la clínica para satisfacer la creciente demanda de atención oncológica.

Accuray Incorporated (NASDAQ: ARAY)는 Accuray Helix™에 대해 CE 마크를 받았습니다. 이 새로운 CT 유도 헬리컬 방사선 요법 시스템은 고급 암 치료에 접근할 수 있는 신흥 시장을 위해 설계되었습니다. 이 시스템은 비도시 지역 사회에서 고성능 및 고처리량 방사선 요법을 제공하여 짧은 치료 시간과 비용 효율성을 제공합니다.

Accuray Helix는 헬리컬 방사선 요법 전달 시스템 포트폴리오를 확장하기 위한 기업의 전략 계획의 일환입니다. 이는 유방암, 자궁경부암, 두경부암, 위장관암, 폐암 및 전립선암과 같은 일반적인 암 사례를 치료하도록 설계되었습니다. 시스템의 유연성과 다재다능성은 개인화된 환자 치료를 개선하면서도 증가하는 암 치료 수요를 충족하기 위해 클리닉의 생산성을 높이는 것을 목표로 합니다.

Accuray Incorporated (NASDAQ: ARAY) a reçu le marquage CE pour Accuray Helix™, un nouveau système de radiothérapie hélicoïdale guidée par scanner TC, conçu pour les marchés émergents ayant accès aux soins avancés contre le cancer. Le système vise à fournir une radiothérapie de haute performance et haute capacité dans les communautés non urbaines, offrant des temps de traitement courts et une rentabilité.

Accuray Helix fait partie du plan stratégique de l'entreprise pour élargir son portefeuille de systèmes de délivrance de thérapie par radiation hélicoïdale. Il est conçu pour traiter des cas de cancer courants, y compris ceux du sein, du col de l'utérus, de la tête et du cou, gastro-intestinaux, pulmonaires et prostatiques. La flexibilité et la polyvalence du système visent à améliorer les soins personnalisés aux patients tout en augmentant la productivité des cliniques pour répondre à la demande croissante en matière de soins contre le cancer.

Accuray Incorporated (NASDAQ: ARAY) hat die CE-Kennzeichnung für Accuray Helix™ erhalten, ein neues CT-geführtes helikales Strahlentherapiesystem, das für aufstrebende Märkte mit Zugang zu fortschrittlicher Krebsbehandlung entwickelt wurde. Das System zielt darauf ab, leistungsstarke, hochproduktive Strahlentherapie in nicht städtischen Gemeinschaften anzubieten, und ermöglicht kurze Behandlungszeiten bei gleichzeitig kosteneffizienten Lösungen.

Accuray Helix ist Teil des strategischen Plans des Unternehmens, um das Portfolio an helikalen Strahlentherapiesystemen zu erweitern. Es ist darauf ausgelegt, routinemäßige Krebsfälle wie Brust-, Zervix-, Kopf- und Hals-, Magen-Darm-, Lungen- und Prostatakrebs zu behandeln. Die Flexibilität und Vielseitigkeit des Systems sollen die personalisierte Patientenversorgung verbessern und gleichzeitig die Produktivität der Klinik steigern, um der wachsenden Nachfrage nach Krebsbehandlungen gerecht zu werden.

Positive
  • Received CE Mark for new Accuray Helix™ radiotherapy system
  • Expands portfolio of helical radiation therapy delivery systems
  • Targets emerging markets with access to advanced cancer care
  • Offers high-performance and high-throughput radiotherapy
  • Designed for cost-effectiveness and short treatment times
Negative
  • None.

Insights

The CE Mark approval for Accuray Helix™ is a significant development in the radiation therapy market, particularly for emerging economies. This system addresses a important gap in cancer care accessibility, especially in non-urban areas where advanced treatment options are

The Helix system's focus on high-performance and high-throughput could potentially increase the number of patients treated per day, improving both clinical efficiency and patient access. Its design for affordability and ease of use is tailored to markets with resource constraints, which could drive adoption in underserved regions.

For investors, this expansion into emerging markets represents a strategic growth opportunity for Accuray. However, success will depend on factors such as pricing strategy, local healthcare infrastructure and competition from established players. The long-term impact on Accuray's financials will need careful monitoring as market penetration unfolds.

The Accuray Helix™ system represents a significant advancement in making advanced radiotherapy more accessible in underserved markets. Its ability to deliver precise, targeted radiation for common cancer types (breast, cervix, head and neck, GI, lung and prostate) addresses a critical need in emerging economies.

The system's versatility is particularly noteworthy, potentially allowing facilities with resources to offer state-of-the-art care across multiple cancer types. This could lead to improved treatment outcomes and quality of life for patients who previously had options.

However, the effectiveness of this technology will also depend on the availability of trained personnel and supporting infrastructure. The success of Accuray Helix™ in improving cancer care in these markets will require a holistic approach, including education and training initiatives.

  • Developed for India and other countries where patient access to care with radiotherapy is challenged and where versatility and ease of use are a high priority
  • Drives the next phase of company's strategic plan to expand its portfolio of helical radiation therapy delivery systems

MADISON, Wis., Aug. 27, 2024 /PRNewswire/ -- Accuray Incorporated (NASDAQ: ARAY) announced today the company has received CE Mark for Accuray Helix™, a CT-guided helical radiotherapy system designed to provide high-performance and high-throughput. The new system is intended for emerging markets where access to advanced cancer care, including radiotherapy treatments, is typically obtainable only within urban areas and where the availability of linear accelerators per million population is well below the World Health Organization recommended guidelines. Accuray Helix offers a solution for clinical teams that require short treatment times and cost effectiveness to establish a care path for patients in non-urban communities who previously had limited options.

Radiotherapy is a fundamental component of cancer care1 and can be used in the treatment of localized disease, recurrent or metastatic cancer. An estimated 50 percent of people with cancer would benefit from radiation therapy2 either as their sole care option or along with other modalities such as surgery, chemotherapy or immunotherapy.

"While the demand for cancer services is increasing globally, there are certain areas of the world where there continues to be greater gaps in access to radiation medicine. India is a priority due to this disparity as there is a significant deficit in availability of radiation therapy systems compared to the size if its population and incidence of cancer. Our goal with the introduction of Accuray Helix is to close some of these gaps to patient access with our comprehensive solutions," said Suzanne Winter, president and CEO of Accuray. "The Accuray Helix system combines affordability with automation and tools for enhancing the speed of planning and delivery of radiation. We believe it will enable a broader range of capabilities for facilities that may have resources and staffing for only one system, enabling them to offer state-of-the-art cancer care in their communities."

Accuray Helix delivers precise, targeted radiation treatments, an important option for the routine cases clinical teams see daily in their practice including breast, cervix, head and neck, gastrointestinal, lung and prostate. The system's flexibility and versatility are intended to drive improvements in personalization and patient care, while simultaneously facilitating treatment of more patients each day, boosting productivity for clinics and enabling them to efficiently manage the growing demand for cancer care.

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 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 Accuray Helix and its effect on the field of radiation oncology and clinical practice, expectations with respect to the markets in the company plans to offer Accuray Helix, clinical applications, 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, 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 May 8, 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
Accuray
+1 (408) 789-4426
bkaplan@accuray.com

1INTERNATIONAL ATOMIC ENERGY AGENCY, Radiotherapy in Cancer Care: Facing the Global Challenge, Non-serial Publications , IAEA, Vienna (2017).
2Atun et al. Expanding global access to radiotherapy. Lancet Oncol 2015; 16:1153-86.

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SOURCE Accuray Incorporated

FAQ

What is Accuray Helix™ and what markets is it designed for?

Accuray Helix™ is a new CT-guided helical radiotherapy system designed for emerging markets, particularly India and other countries where access to advanced radiotherapy is , especially in non-urban areas.

What types of cancer can Accuray Helix™ treat?

Accuray Helix™ is designed to treat routine cancer cases including breast, cervix, head and neck, gastrointestinal, lung, and prostate cancers.

How does Accuray Helix™ benefit clinics and patients?

Accuray Helix™ offers high-performance, high-throughput radiotherapy with short treatment times and cost-effectiveness. It aims to improve personalized patient care while boosting clinic productivity to meet growing cancer care demands.

What certification has Accuray (ARAY) received for Accuray Helix™?

Accuray (ARAY) has received CE Mark certification for Accuray Helix™, allowing it to be marketed in countries that recognize this certification.

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