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About Accuray Incorporated
Accuray Incorporated (NASDAQ: ARAY) is a global leader in radiation oncology, dedicated to advancing cancer care through cutting-edge radiation therapy and radiosurgery solutions. Headquartered in Madison, Wisconsin, the company develops, manufactures, and markets innovative technologies that enable healthcare providers to deliver precise, non-invasive treatments for a wide range of cancers and neurological conditions. With a focus on improving patient outcomes and expanding access to care, Accuray’s systems are designed to meet the diverse needs of clinicians and patients worldwide.
Core Technologies and Solutions
Accuray’s flagship products include the CyberKnife® System, a robotic radiosurgery platform, and the Radixact® System, an advanced helical radiation therapy device. These systems are equipped with proprietary features such as Synchrony® real-time motion tracking and ClearRT® imaging, enabling sub-millimeter accuracy in radiation delivery. The CyberKnife System is renowned for its ability to treat tumors in just 1 to 5 outpatient sessions, making it a preferred choice for patients requiring ultra-hypofractionated therapy. Similarly, the Radixact System’s continuous 360-degree helical delivery allows for precise dose conformity, minimizing radiation exposure to healthy tissues.
Market Position and Global Reach
Operating in the highly competitive radiation therapy market, Accuray distinguishes itself through its focus on robotic precision and adaptive technologies. The company has a strong presence in emerging markets, particularly in China, where its joint venture has facilitated the introduction of systems like the Tomo® C and Radixact SynC. Recent regulatory approvals for the CyberKnife S7™ and Radixact SynC Systems underscore Accuray’s commitment to addressing the growing demand for advanced cancer treatments in underserved regions.
Commitment to Innovation
Accuray’s 30-year legacy of innovation is exemplified by its continuous development of groundbreaking solutions, such as the recently launched Helix™ System, designed to improve access to radiotherapy in non-urban areas. The company also invests in clinical research, with studies like the PACE-B trial demonstrating the efficacy of its technologies in reducing treatment times while maintaining high rates of cancer control. These efforts align with Accuray’s mission to set new standards of care in radiation therapy.
Challenges and Opportunities
While Accuray faces challenges such as supply chain disruptions and competitive pressures, its strategic initiatives—such as expanding its service business and entering high-growth markets—position it for long-term success. The company’s focus on partnerships, like its collaboration with TrueNorth Medical Physics, further enhances its ability to support healthcare providers in delivering personalized, high-quality care.
Impact on Patients and Clinicians
Accuray’s technologies empower clinicians to treat complex cases with confidence, offering patients shorter treatment durations, reduced side effects, and improved quality of life. By combining precision, adaptability, and accessibility, Accuray is transforming the way cancer is managed, enabling more patients to benefit from life-saving radiation therapy.
Accuray Incorporated (NASDAQ: ARAY) announced promising results from a phase II trial involving 338 women with low-risk breast cancer. Seven years after receiving once-daily accelerated partial breast irradiation (APBI) with the TomoTherapy System, 98.8% achieved local disease control. The study, published in the International Journal of Radiation Oncology*Biology*Physics, found minimal acute and late toxicities. Key findings include 99.4% ipsilateral breast tumor recurrence-free control at 76 months and excellent patient-reported outcomes regarding breast appearance.
Accuray Incorporated (NASDAQ: ARAY) will announce its financial results for the second quarter of fiscal year 2021, ending December 31, 2020, on January 27, 2021, after market close. A conference call is scheduled for the same day at 1:30 p.m. PT / 4:30 p.m. ET to discuss these results. Investors can participate via dial-in or listen to a live webcast available on the Company's Investor Relations website. A replay of the call will also be accessible for one week following the event.
Accuray Incorporated (Nasdaq: ARAY) will participate in the 39th J.P. Morgan Annual Healthcare Conference on January 14, 2021, at 11:00 am Pacific / 2:00 pm Eastern. Josh Levine, President and CEO, is set to present. The presentation can be accessed on Accuray's official website post-event. Institutional investors are invited to arrange one-on-one virtual meetings with senior management during the conference. Accuray is dedicated to advancing radiation therapy solutions for complex medical cases.
Accuray Incorporated (NASDAQ: ARAY) has received 510(k) clearance from the FDA for its ClearRT™ Helical kVCT Imaging. Integrated with the Radixact® System, this advanced imaging solution enhances diagnostic quality, enabling faster patient setup and improved treatment accuracy. Scheduled for commercial release in Spring 2021, ClearRT offers superior image quality and versatility, providing essential support for radiation therapy. Accuray aims to meet the diverse needs of patients while maintaining a high standard of care with this innovative technology.
Accuray Incorporated (NASDAQ: ARAY) announced inducement awards for new Senior Vice President, Quality & Regulatory Affairs, Jim Dennison. Effective November 30, Dennison will receive 56,053 restricted stock units and a stock option for 105,485 shares at an exercise price of $4.46. The awards are not part of the current equity plan but follow guidelines similar to those in the 2016 Equity Incentive Plan. Restricted stock units will vest annually, while the stock option will vest 25% after one year and monthly thereafter, contingent on Dennison's ongoing service.
Accuray Incorporated (NASDAQ: ARAY) and DHL Supply Chain have formed a global service parts logistics partnership aimed at enhancing Accuray's supply chain and customer service capabilities. This collaboration, effective February 2021, will create a dedicated logistics network across 34 warehousing sites in 16 countries, ensuring medical teams have reliable access to critical radiotherapy technologies. DHL's Control Centers in Columbus, Budapest, and Singapore will provide 24/7 operational support, while advanced software tools will enhance inventory management.
Accuray has appointed Jim Dennison as senior vice president of global quality and regulatory affairs, effective immediately. Dennison, with nearly 15 years at GE Healthcare, will oversee quality, regulatory, and government affairs, reporting to Joshua H. Levine, CEO. His previous experience includes managing global design and manufacturing sites, standardizing quality systems, and improving FDA submission processes. Accuray expresses confidence in Dennison's ability to advance quality and regulatory functions to support R&D investments and market expansion.
Accuray Incorporated (NASDAQ: ARAY) showcased its latest innovations in radiation therapy at the ASTRO Annual Meeting on Nov 10, 2020. The company emphasized the enhanced capabilities of its CyberKnife and TomoTherapy platforms, particularly the Radixact System, designed for hypofractionated treatments. Notable advancements include the Synchrony Motion Synchronization technology, enabling real-time adaptive therapy, and the CyberKnife S7 System, ensuring precision in delivering treatments. The introduction of ClearRT Helical kVCT Imaging further enhances patient care through improved imaging capabilities.
Accuray Incorporated (NASDAQ: ARAY) reported its Q1 fiscal 2021 results, ending September 30, 2020, with net revenue of $85.3 million and operating income of $5.5 million. Adjusted EBITDA increased to $9 million from a loss of $1 million year-over-year. Gross orders were $50.5 million, and the backlog rose to $597.3 million, marking a 21% increase compared to the previous year. Notably, revenue from products decreased from $37.6 million to $31.3 million, while service revenue grew slightly to $54.1 million. The company refrained from providing fiscal 2021 guidance due to COVID-19 uncertainty.
Accuray Incorporated (NASDAQ: ARAY) announced a collaboration with Brainlab to enhance the CyberKnife treatment platform for neuro-radiosurgery. This partnership will integrate Brainlab's Elements planning software, improving contouring capabilities for neurosurgeons. Additionally, interoperability with Brainlab's Snke OS will streamline patient data management and optimize treatment workflows. The CyberKnife S7 System utilizes advanced robotic technology for precise radiation therapy targeting tumors while preserving healthy tissue. The collaboration aims to elevate the standard of care in neurosurgery.
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