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Accuray Incorporated (NASDAQ: ARAY) is a pioneering radiation oncology company dedicated to advancing precise, innovative tumor treatment solutions. Headquartered in Madison, Wisconsin, Accuray develops, manufactures, and markets cutting-edge technology designed to deliver a full spectrum of radiation therapy and radiosurgery treatments. Their flagship products, such as the CyberKnife® and Radixact® Systems, set new standards in cancer treatment by offering unparalleled precision and real-time tumor tracking capabilities.
The CyberKnife® System utilizes a non-invasive robotic platform to treat various types of cancer and tumors throughout the body. This system excels through its ability to track, detect, and correct for tumor and patient movement in real-time during procedures, enhancing the accuracy of radiation delivery. This unique approach ensures high-dose radiation is administered with sub-millimeter precision, allowing patients to breathe normally without manual intervention.
Accuray's recent achievements include significant milestones in product development and market expansion. In October 2023, the company announced the Chinese National Medical Products Administration's approval of the CNNC-Accuray joint venture Tomo® C radiation therapy system. This system, tailored for the Chinese Type B market, aims to expand access to radiotherapy treatments, addressing the country's growing demand for cancer care solutions.
Financially, Accuray has demonstrated robust performance. According to their first-quarter fiscal 2024 report, the company achieved a total net revenue of $103.9 million, reflecting a year-over-year increase. Despite a net loss of $3.0 million, the company reported a significant improvement in gross profit margins, emphasizing its strategic focus on revenue growth and operational efficiency.
Accuray remains committed to continuous innovation. The launch of the VitalHold™ package supporting surface-guided radiation therapy (SGRT) on the Radixact® System in Japan highlights their ongoing efforts to enhance treatment options. This feature enables deep inspiration breath hold (DIBH) treatments, particularly for breast cancer, thereby improving patient outcomes and reducing treatment-associated stress.
The company's dedication to excellence is further exemplified by its recent partnerships and educational initiatives. In April 2024, Accuray opened a new training center in Genolier, Switzerland, which serves as a European hub for advanced radiosurgery and radiotherapy training. This facility aims to elevate the skills and knowledge of medical professionals, ensuring the delivery of high-quality, precise treatments.
Accuray's vision of transforming patient care is evident in their continuous pursuit of technological advancements and strategic collaborations. Their products not only enhance the precision and effectiveness of cancer treatments but also contribute to improved patient quality of life post-treatment. With a strong commitment to innovation, Accuray is well-positioned to lead the radiation therapy industry into the future.
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.
Accuray (NASDAQ: ARAY) has granted equity inducement awards to Mike Murphy, their new Vice President, Corporate Controller. The awards consist of 150,000 restricted stock units of company common stock, effective November 29, 2024. The Inducement Awards were granted outside the company's current equity plan but follow similar terms to their 2016 Equity Incentive Plan. The restricted stock units will vest at 25% annually over four years, starting from October 31, 2024, contingent on Murphy's continued employment.
Accuray reported its fiscal 2025 Q1 financial results, showing a mixed performance. Total net revenue was $101.5 million, slightly down from $103.9 million in the prior year. Product revenue decreased to $48.4 million from $53.4 million, while service revenue rose to $53.2 million from $50.5 million. Total gross profit was $34.5 million, or 33.9% of total net revenue, compared to $39.5 million or 38.0% last year. Operating expenses were $36.6 million, a slight decrease from $37.3 million the previous year. The company reported a net loss of $4.0 million or $0.04 per share, compared to a net loss of $3.0 million or $0.03 per share last year. Adjusted EBITDA was $3.1 million, down from $6.5 million. Gross product orders totaled $55.4 million, down from $63.7 million. Cash reserves stood at $59.7 million, a decrease of $9.4 million from June 30, 2024.
Accuray (NASDAQ: ARAY) has announced it will release its first quarter fiscal 2025 financial results on November 6, 2024. The company will host a conference call at 1:30 p.m. PT/4:30 p.m. ET on the same day. Investors can access the call via USA dial-in (833) 316-0563 or international dial-in (412) 317-5747. A replay will be available for one week. Additionally, a live webcast will be accessible through the company's Investor Relations website, with the replay available until Q2 FY2025 results announcement.
Accuray Incorporated (NASDAQ: ARAY) has announced the appointment of Michael Murphy, CPA as Vice President, Corporate Controller. Murphy will lead the global accounting function, including corporate tax, regulatory reporting, accounting policies, and risk management. He brings over 15 years of finance and accounting expertise to Accuray, most recently serving as VP, Chief Accounting Officer and Treasury at Duluth Holdings Inc.
Murphy is expected to be appointed as principal accounting officer following the filing of the company's quarterly report for the period ended September 30, 2024. He will report to Accuray's Senior VP & CFO Ali Pervaiz. Accuray's leadership expressed confidence in Murphy's ability to support the company's revenue and profitability goals, citing his experience and business acumen.
Accuray Incorporated (NASDAQ: ARAY) announced results of the PACE-B trial published in the New England Journal of Medicine. The study shows that at five years, stereotactic body radiation therapy (SBRT) provides comparable rates of cancer control, tolerability, and sexual functioning to conventional radiotherapy (CRT) for men with localized prostate cancer. SBRT, delivered using Accuray's CyberKnife System, reduces treatment time from up to 39 days to just five days.
Key findings include:
- High cancer control rates: 95.8% for SBRT vs 94.6% for CRT
- Similar rates of erectile dysfunction: 26.4% for SBRT vs 29.1% for CRT
- Stable urinary and bowel symptoms at five years for both groups
The study provides strong evidence supporting SBRT as an effective, time-efficient treatment option for men with low- or intermediate-risk prostate cancer.
Accuray Incorporated (NASDAQ: ARAY) announced that Suzanne Winter has returned from her temporary medical leave and resumed her full duties as President and Chief Executive Officer, effective October 15, 2024. Sandeep Chalke, who served as interim CEO during Winter's absence, will continue in his role as Senior Vice President and Chief Commercial Officer.
Joseph Whitters, Chairman of the Board at Accuray, expressed delight at Winter's return and appreciation for Chalke's leadership during her absence. Accuray, headquartered in Madison, Wisconsin, is committed to expanding the potential of radiation therapy in oncology and neuro-radiosurgery, focusing on innovative solutions for complex and common cases alike.
Accuray has opened an education center at the new Genolier Innovation Hub in Switzerland, marking the initiation of CyberKnife® S7™ System medical professional training. As the first industry partner at the hub, Accuray offers training on both CyberKnife and Radixact® Radiation Treatment Delivery Systems.
The center provides comprehensive learning experiences with expert instructors and hands-on simulation facilities. Accuray's presence at the hub aims to expand access to advanced training for system users, supporting the company's commitment to improving cancer patient care.
The CyberKnife and Radixact Systems offer complementary clinical applications, designed to deliver precise and accurate treatments while minimizing dose to healthy tissue. These systems include advanced functionality for efficient administration of radiation treatments, even for moving targets, providing options for managing various cancer cases and neurologic disorders.
Accuray Incorporated (NASDAQ: ARAY) announced that Gifu Prefectural General Medical Center in Japan has become the first hospital in the country to treat cancer patients using the Radixact® Radiation Delivery System and VitalHold™ solution for surface-guided radiation therapy (SGRT). This technology enables precise patient positioning and monitoring during treatment, including the deep inspiration breath hold (DIBH) technique for left breast cancer.
The hospital's adoption of this technology is part of its plan to expand patient access to high-precision radiation therapy. Dr. Yuichi Kajiura, from the department of radiation oncology, highlighted the benefits of the Radixact System with VitalHold, including faster patient setup and improved monitoring throughout treatment. The hospital is also using ClearRT™ to produce diagnostic-like quality images for more informed treatment decisions.
Accuray Incorporated (NASDAQ: ARAY) announced that President and CEO Suzanne Winter is taking a temporary medical leave for cancer treatment. Sandeep Chalke, SVP and Chief Commercial Officer, will serve as interim CEO. An Executive Committee of the Board, including Chairman Joseph Whitters and Anne Le Grand, will advise Chalke.
Winter expressed gratitude for advancements in cancer detection and treatment. Whitters affirmed confidence in Chalke and the leadership team's ability to maintain the company's vision and operations. Chalke, who joined Accuray in May 2022, brings over 30 years of medical device expertise to his role overseeing global commercial functions.
Accuray, headquartered in Madison, Wisconsin, is committed to advancing radiation therapy for oncology and neuro-radiosurgery, partnering with clinicians to improve patient outcomes.
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