Advertisement
Advertisement
U.S. markets open in 7 hours 8 minutes
Advertisement
Advertisement
Advertisement
Advertisement

Accuray Incorporated (ARAY)

NasdaqGS - NasdaqGS Real Time Price. Currency in USD
Add to watchlist
2.2400+0.0600 (+2.75%)
At close: 04:00PM EDT
2.1600 -0.08 (-3.57%)
After hours: 04:03PM EDT
Advertisement

Yahoo Finance will soon be upgrading our Conversations message board platform to provide a better experience for our users. Only comments published since April 21, 2021 will be visible on Yahoo Finance after the upgrade. If you wish to download and save any of your older comments, please submit a request via the Privacy Dashboard by no later than Sept. 30.

Sign in to post a message.
  • R
    Rogk
    GE is going to spin off it's medical division early next year. Don't know why they wouldn't want to own this technology for under half a billion dollars. Maybe after the split? I know people have given up on the buyout theory, but maybe......
  • K
    Kupalo
    Benny! come out! come out! wherever you are you dumbo! Lol!
  • G
    Gregg
    Thu, June 10, 2021, 4:30 AM

    ARAY
    +1.0321%
    Expands Global Access to Exceptional Quality Diagnostic-like CT Images for Medical Care Teams Using the Radixact System

    SUNNYVALE, Calif., June 10, 2021 /PRNewswire/ -- Accuray Incorporated (NASDAQ: ARAY) announced today the company has received CE Mark certification for its ClearRT™ helical fan-beam kVCT imaging capability. The Accuray-only ClearRT technology is now available to customers in the European Union, United States and Japan, as well as other areas in the world where either the CE Mark or FDA 510(k) clearance are required for commercial distribution.

    Accuray Incorporated (PRNewsFoto/Accuray Incorporated) (PRNewsFoto/Accuray Incorporated)
    Accuray Incorporated (PRNewsFoto/Accuray Incorporated) (PRNewsFoto/Accuray Incorporated)
    The Radixact® System, based on the TomoTherapy® platform, with ClearRT imaging provides an integrated 360-degree, helical radiation delivery and imaging system that expands the versatility and performance of image-guided stereotactic body radiation therapy (SBRT) and intensity-modulated radiation treatments (IG-IMRT). The high-fidelity ClearRT imaging solution offers the widest and longest field of view enabling clinicians to see more, know more and do more, offering a new level of precision and accuracy in the treatment of almost any indication that would benefit from radiation therapy.

    "The use of SBRT is growing rapidly, offering patients an important option for treating tumors in fewer visits than with conventionally fractionated radiotherapy. This is a major benefit for the patient, but requires technology that can deliver the radiation dose with extreme accuracy and precision. ClearRT was designed to provide a major leap forward in delivering on this prerequisite," said Suzanne Winter, chief commercial officer and senior vice president, R&D at Accuray. "The combination of ClearRT diagnostic-like CT fan-beam imaging with Synchrony®, advanced technology that adapts treatment delivery to tumor motion in real time, provides an unprecedented set of tools for delivering SBRT and
    Bullish
  • G
    Gregg
    SUNNYVALE, Calif., Jan. 13, 2020 /PRNewswire/ -- Accuray Incorporated (Nasdaq: ARAY) will be discussing its business and revenue growth expectations for the next three fiscal years at the JP Morgan Healthcare Conference on Wednesday, January 15, 2020 at 10:00 am PACIFIC / 1:00 pm EASTERN.

    Accuray Incorporated (PRNewsFoto/Accuray Incorporated) (PRNewsFoto/Accuray Incorporated)
    More
    Josh Levine, president and chief executive officer, said, "We are excited to be presenting at the JP Morgan Healthcare Conference this week to discuss our line of sight to sustainable revenue growth in the coming years. We expect our growth catalysts in China, including the recent grants of 50 out of 58 Type A radiotherapy licenses to Accuray systems by the China Ministry of Health this past October, along with our highly differentiated joint venture strategy, will enable us to achieve compounded annual revenue growth rate in the range of 8% to 12% from Fiscal 2021 through Fiscal 2023. In addition, we expect these revenue growth rates will drive faster expansion in our operating income and adjusted EBITDA for the same periods."
    The presentation to be delivered at the JP Morgan Healthcare Conference can be accessed on the Accuray website
    Bullish
  • G
    Gregg
    Accuray Receives 510(k) FDA Clearance for ClearRT™ Helical kVCT Imaging for the Radixact® Treatment Delivery System
    Tue, January 5, 2021, 5:30 AM MST
    New Option will Provide an Efficient, Versatile and Cost-Effective Approach for Obtaining Exceptional Quality Images

    SUNNYVALE, Calif., Jan. 5, 2021 /PRNewswire/ -- Accuray Incorporated (NASDAQ: ARAY) announced today that the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its ClearRT™ Helical kVCT Imaging* for the Radixact® System, the next generation TomoTherapy® platform. ClearRT is a cutting-edge imaging solution integrated with a powerful, precise, and adaptive delivery platform, designed to produce exceptional diagnostic-like quality CT images, quickly and cost-effectively, to improve patient care. Accuray is planning commercial release of the ClearRT Helical kVCT Imaging for the Radixact System in the Spring of 2021.

    Accuray Incorporated (PRNewsFoto/Accuray Incorporated) (PRNewsFoto/Accuray Incorporated)
    Accuray Incorporated (PRNewsFoto/Accuray Incorporated) (PRNewsFoto/Accuray Incorporated)
    ClearRT delivers enhanced imaging capabilities compared to conventional linear accelerator systems that rely on cone-beam CT (CBCT) imaging and as an alternative to MR-based radiation therapy systems that can be complex and cost prohibitive to use. ClearRT offers excellent uniformity and low noise across the entire image, improved soft tissue visualization and exceptional spatial resolution, which is intended to enhance the versatility and efficiency of the Radixact System in the radiation therapy department.

    The ClearRT imaging solution is seamlessly integrated into the Radixact System. Helical fan-beam imaging available at both kV and MV wavelengths provides medical care teams the flexibility to fulfill the patient imaging requirements necessary for accurate patient setup and registration, including imaging patients with metal implants contraindicated for MR imaging. Enabling a "meter in a minute" image acquisition, ClearRT helical kVCT provides the industry's largest transverse field of view and the longest continuous scan length – facilitating fast and easy set-up of any patient requiring radiation treatment and giving clinicians the versatility needed to treat the widest range of indications with confidence.
    Bullish
  • G
    Gregg
    Seven-year Data Shows Accuray TomoTherapy® System Provides Excellent Long-Term Control of Low-Risk Breast Cancer
    Tue, January 19, 2021, 5:30 AM
    Advanced, 10-Day Radiation Treatment Regimen Enables Patients to Get Back to Their Life, Faster

    SUNNYVALE, Calif., Jan. 19, 2021 /PRNewswire/ -- Accuray Incorporated (NASDAQ: ARAY) announced today that data from a prospective, phase II trial of 338 women with low-risk breast cancer showed 98.8 percent had local disease control seven years after receiving once-daily accelerated partial breast irradiation (APBI) delivered with the TomoTherapy® System. The study, published online in the International Journal of Radiation Oncology*Biology*Physics, also reported that the once-daily schedule was associated with a very low incidence of acute and late toxicities.

    Accuray Incorporated (PRNewsFoto/Accuray Incorporated) (PRNewsFoto/Accuray Incorporated)
    Accuray Incorporated (PRNewsFoto/Accuray Incorporated) (PRNewsFoto/Accuray Incorporated)
    The TomoTherapy platform, including the next-generation Radixact® System, is the first in the world capable of helical radiation delivery. Image-guided, intensity-modulated radiation therapy (IG-IMRT) is continuously delivering from a full 360 degrees around the patient as the treatment table also moves at a deliberate pace, providing greater control of the radiation dose so it conforms precisely to the tumor and helps minimize dose to healthy tissue. This precision enables medical care teams to deliver hypofractionated treatment regimens - a higher dose per fraction in fewer fractions than conventional schedules - such as APBI, with increased confidence.

    "Over the last 10 years, breast-conserving surgery and APBI have been widely used in clinical practice for the treatment of low-risk breast cancer. Our large phase 2 trial demonstrated that IG-IMRT delivered using the TomoTherapy System offers improvements over existing techniques and can provide better APBI outcomes in carefully selected patient populations. The system enabled our team to increase the conformality and homogeneity of the dose to the tumor bed and reduce the dose to surrounding healthy tissue, making APBI an effective and convenient option for our patients," said Prof. Ugo de Paula, Department of Radiation Oncology, San Giovanni-Addolorata Hospital, Rome, Italy.

    Enhanced precision enables excellent long-term results: study highlights

    Once-daily breast APBI delivered with the TomoTherapy System demonstrated the following:

    Ipsilateral breast tumor recurrence (IBTR) free control was 99.4% at a median follow-up of 76 months. This is important because patients with IBTR may be at high risk for subsequent distant metastasis;

    Locoregional control (no recurrence in ipsilateral breast as well as in regional nodes) was 98.8% at a median follow-up of 76 months;

    Progression-free survival was 98.4% and 92% at 5 and 10 years;

    Treatments were very well tolerated with minimal acute or late side effects. Importantly, there were no cases observed of late toxicity such as pneumonitis or rib fractures;

    More than 95 percent of patients and their physicians rated cosmesis -- preservation of the normal appearance of the breast -- as good/excellent at two years, the relevant timepoint for evaluation of cosmesis.

    "This study builds on existing clinical evidence demonstrating the benefits of the TomoTherapy System in the treatment of breast cancer. Integrated image guidance and helical radiation delivery enables exceptional homogeneity in radiation dose delivery and superior treatments for patients. Dr. de Paula and his colleagues found that even those patients deemed cautionary or unsuitable for APBI by American Society of Radiation Oncology (ASTRO) criteria experienced a low rate of IBTR," said Fabienne Hirigoyenberry-Lanson, Ph.D., vice president global medical and scientific affairs, at Accuray.

    About the Phase II Trial
    In this trial, 338 women with low-risk breast cancer received a treatment dose of 3.85 Gray (Gy) delivered by the TomoTherapy® System in 10 consecutive daily fractions, five days per week. Patients who had previously undergone breast-conserving surgery were enrolled in the study. The primary endpoints of this trial were breast tumor recurrence, and acute and late toxicity. Secondary outcomes were progression-free survival (PFS) and rates of adverse cosmesis.
    Bullish
  • G
    Gregg
    Accuray (ARAY) Expands Commercialization of CE-Marked ClearRT

    ARAY
    +4.26%
    Zacks Equity Research
    Mon, June 14, 2021, 7:10 AM

    ARAY
    +4.26%
    Accuray Incorporated ARAY recently received the CE Mark certification for its ClearRT helical fan-beam kVCT imaging capability. Following this, the proprietary ClearRT technology is now available in the European Union, United States and Japan. It is also available in countries across the world where either the CE Mark or FDA’s 510(k) clearance are necessary for commercial distribution.

    Following the regulatory clearance, a larger number of patients will get expanded access to ClearRT, thereby benefiting from precise and accurate radiation treatments.

    For investors’ note, the ClearRT imaging is available for the company’s Radixact System – Accuray’s next-generation TomoTherapy platform.

    With the recent regulatory clearance and subsequent commercialization, the company is expected to strengthen its TomoTherapy Systems technology worldwide.

    Significance of the Approval
    Accuray’s Radixact System, based on its TomoTherapy platform, with ClearRT imaging, offers an integrated 360-degree helical radiation delivery and imaging system. This expands the flexibility and performance of image-guided stereotactic body radiation therapy (“SBRT”) and intensity-modulated radiation treatments (IG-IMRT).

    The ClearRT imaging solution provides the widest and longest field of view, thus offering better precision and accuracy in the treatment of almost any indication that would benefit from radiation therapy.

    Per management, with the use of SBRT growing rapidly, patients can now be offered the option of treating tumors in fewer visits unlike conventionally fractionated radiotherapy. Further, ClearRT is capable of delivering radiation doses with extreme accuracy and precision.

    Moreover, the ClearRT diagnostic-like CT fan-beam imaging, along with Accuray’s Synchrony (technology that adapts treatment delivery to tumor motion in real time), provides a unique set of tools for delivering customized SBRT and IG-IMRT treatments.

    Industry Prospects
    Per a report by MarketsandMarkets, the global radiotherapy market is valued at $5.9 billion in 2021 and is expected to reach $7.3 billion by 2026 at a CAGR of 4.2%. Factors like technological advancements in radiotherapy and the rising incidence of cancer are likely to drive the market.
    Bullish
  • G
    Gregg
    Here's Why You Should Add Accuray to Your Portfolio Now

    Zacks Equity Research
    ,Zacks•June 1, 2020

    Accuray Incorporated ARAY is gaining on progress in its suite of software upgrades and acquisitions. The launch of the precision system and IBMS Data Management system for TomoTherapy has been a key growth driver.
    The company, with a market capitalization of $190.1 million, is the leading designer, developer and seller of radiosurgery and radiation therapy systems for the treatment of tumors. The company's earnings are anticipated to improve 200% in the fourth quarter of fiscal 2020. This Zacks Rank #2 (Buy) company has a trailing four-quarter positive earnings surprise of 34.4%, on average.
    Since the start of the fiscal fourth quarter, the stock has gained 10.6% compared with 24.3% rise of its industry.
    Let’s delve deeper into the factors working in favor of the company.
    Suite of Software Upgrades: A series of software upgrades have been propelling growth for Accuray.
    Recently, the company received FDA approval for its 510(k)-application motion synchronization on the Radixact treatment system.
    In February 2020, the company installed the first CyberKnife M6 System in Mercy Hospital, St. Louis Missouri. This next-generation CyberKnife System can deliver accurate stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT) treatments with ease, thereby enabling the clinical team to expand access to one of the most advanced methods for administering radiation to more cancer patients.
    In the fiscal third quarter, CyberKnife accounted for approximately 20% of the company’s revenues.

    Acquisitions: The acquisitions of TomoTherapy and Morphormics have helped Accuray expand product offerings and capabilities. The collaboration with Christie InnoMed will help the company’s products gain better visibility in Canada.
    The partnerships with Premier and Amerinet are expected to help the company gain significant penetration in hospitals and oncology centers. Further, these will aid in expanding the company’s GPO (Group Purchasing Organization) strategic accounts contract portfolio. Accuray’s strategy of pursuing partnerships with GPOs will drive customer base, thereby improving top-line growth in the long run.
    Precision System & IBMS Data Management System for TomoTherapy:
    Accuray announced the launch of its precision treatment planning system. The system leverages on the company’s flagship Radixact and CyberKnife system platforms. This will significantly improve treatment speed and overall throughput of the existing CyberKnife system.

    Accuray also announced 510(k) clearance for the new IBMS data management system for TomoTherapy. It is a centralized database that shares and makes data accessible between multiple accurate systems, adding flexibility and improving workflow efficiency in the radiation therapy department. Further, studies have proven that CyberKnife provides long-lasting pain relief procedures for Trigeminal Neuralgia patients.
    Estimates Trend
    Over the past 60 days, the Zacks Consensus Estimate for the company’s fiscal 2020 earnings has risen to 2 cents.
    The Zacks Consensus Estimate for its fourth-quarter fiscal 2020 revenues is pegged at $99.4 million, suggesting a 15.4% fall from the year-ago reported number.
    Bullish
  • G
    Gregg
    Recent Company Highlights
    Gross orders increased 27% year-over-year to $106.0 million, including 11 orders from China
    Net orders of $76.7 million, an increase of 28% year-over-year
    Total backlog increased 15% year-over-year to $569.9 million
    Net revenue of $99.5 million, net income of $2.6 million, Adjusted EBITDA of $11.3 million
    "Despite the economic upheaval around the world, Accuray, from an operational standpoint, had a solid third fiscal quarter," commented Joshua H. Levine, president and chief executive officer of Accuray. "Gross orders increased 27% year-over-year to $106 million compared to $84 million in the comparable quarter last year. Order momentum was evident in all but one of our regions. The Americas delivered its third consecutive quarter of double-digit or higher, year-over-year revenue growth. Gross orders in Europe, the Middle East and Asia increased 15% on a year-over-year basis. Our sales team did a great job in generating new orders during the third quarter."
    "Revenue in the third quarter totaled $99.5 million, despite seeing our revenue conversion timing impacted by the COVID-19 pandemic in the month of March, when travel restrictions and lockdowns in certain markets went into effect. As a result, we view the impact to revenue conversion of certain orders during the quarter as 'timing related'."
    Mr. Levine continued, "In China, we booked 11 new orders across both Type A and B products, 7 of which were through our China joint venture. We are pleased with the progress that the joint venture has made both commercially and operationally."
    "We ended the quarter with cash, cash equivalents, and short-term restricted cash totaling $92 million. We remain very focused on cash flow management in this current environment and have taken actions to reduce cash operating expenses without impacting the future commercial trajectory of the business or our ability to service our customers."
    Bullish
  • G
    Gregg
    First Quarter Fiscal 2021 Summary

    Net revenue of $85.3 million, operating income of $5.5 million
    Adjusted EBITDA grew to $9 million from a loss of $1 million in the prior year first quarter
    Gross orders of $50.5 million, ending backlog of $597.3 million, an increase of 21 percent from September 30, 2019
    Other Recent Operational Highlights

    Expect revenue recognition for China Type A systems previously awarded in October 2019 to start in the second quarter of fiscal 2021
    Introduced ClearRT™ Helical kVCT Imaging for the Radixact System at ASTRO 2020
    44 clinical abstracts related to customer clinical experience on CyberKnife and TomoTherapy (TOMO)/Radixact exhibited at ASTRO 2020 Scientific Sessions
    "We are off to a solid start in fiscal 2021 despite the headwinds created by the COVID-19 environment. Our global team continues to adapt and make the necessary adjustments to compete and operate effectively given the current market conditions and delivered the fourth consecutive quarter of operating profit, said Joshua H. Levine, President and CEO of Accuray. "Looking ahead, we will be focused on driving the revenue conversion process related to the China Type A systems beginning in the second quarter. Concurrent with this year's recent ASTRO meeting, we have received very positive customer feedback related to the introduction of our ClearRT™ Helical kVCT imaging upgrade for the Radixact System as we drive our long-term strategic commitment to continued innovation."
    Bullish
  • G
    Gregg
    Accuray Synchrony® Real-time Adaptive Technology for the Radixact® System Wins 2020 MedTech Breakthrough Award

    PR Newswire•May 19, 2020

    Annual Awards Program Recognizes Outstanding Health & Medical Technology Products and Companies
    SUNNYVALE, Calif., May 19, 2020 /PRNewswire/ -- Accuray Incorporated (NASDAQ: ARAY) today announced that MedTech Breakthrough, an independent market intelligence organization that recognizes the top companies, technologies and products in the global health and medical technology market, has selected the Accuray Synchrony® Real-time Adaptive Technology for the Radixact® System as the winner of its "Best Overall Medical Device Solution" award in the fourth annual MedTech Breakthrough Awards program.

    MedTech Breakthrough Best Overall Medical Device Solution Award: Accuray Synchrony® Real-time Adaptive Technology for the Radixact® System
    More
    The Radixact® System, the next-generation TomoTherapy® platform, is a radiotherapy system designed to provide oncology clinical teams with the imaging capabilities, treatment flexibility and precise dose delivery they had come to expect with its predecessor device, with the addition of components that can significantly enhance interoperability and increase patient throughput.
    Originally developed to expand on the Accuray CyberKnife® System's unique automatic motion tracking and synchronization capabilities, Synchrony for the Radixact System is designed to adapt for tumors that move as a result of bodily processes, including respiration and digestion, as well as patient movement. Some tumors may be located in areas of the body that move regularly, such as the lungs. Also, filling of the bladder, gas in the bowel or even slight patient movements can shift the tumor target by a millimeter or more.
    Tracking tumor movement — and synchronizing precise treatment delivery with that movement using the Accuray Synchrony Real-time Adaptive Technology — helps to maximize treatment effectiveness and minimize dose to surrounding tissues. The beams of radiation are delivered continuously throughout the treatment session as the patient breathes naturally. In comparison, gating methods deliver radiation only when the tumor is close to the expected location and pause treatment delivery when the moving tumor is outside of the "treatment window." This lengthens the time the patient needs to be on the treatment table.
    "Cancer is increasingly being managed as a chronic condition. With this will be a corresponding rise in the use of radiation therapy, and a need for technology that can precisely and accurately treat each patient's unique tumor," said Joshua H. Levine, president and CEO at Accuray. "Our one-of-a-kind, artificial-intelligence driven Synchrony software combined with the Radixact System delivers a breakthrough in precision radiation therapy treatments. Synchrony is the only technology that uses image guidance to automatically adapt and synchronize the radiation beam to the position of the tumor if and when it moves during treatment. When used with the Radixact System, it facilitates the efficient and effective delivery of both hypofractionated and standard radiation therapy, making it easier for clinical teams to provide treatments tailored to meet each individual patient's needs."
    The mission of the MedTech Breakthrough Awards is to honor excellence and recognize the innovation, hard work and success in a range of health and medical technology categories, including Robotics, Clinical Administration, Telehealth, Patient Engagement, Electronic Health Records (EHR).
    Bullish
  • G
    Gregg
    Second Quarter Fiscal 2021 Summary

    Net revenue of $97.5 million including $21.3 million of system revenue in China

    Gross orders of $75.4 million, ending backlog of $596.2 million, an increase of 11 percent from December 31, 2019

    GAAP operating income of $8.2 million and GAAP net income of $4.8 million compared to GAAP operating income of $3.6 million and GAAP net income of $10.7 million in the prior year second quarter

    Adjusted EBITDA grew to $13.5 million from $7.1 million in the prior year second quarter

    Received 510(k) FDA clearance for ClearRT™ Helical kVCT Imaging for the Radixact® System

    "Our second quarter performance continues to reflect the positive momentum our business is making despite the headwinds created by the COVID-19 environment, said Josh Levine, President and CEO of Accuray. "Highlights from our second quarter performance include the beginning of system revenue conversion related to the Type A radiotherapy licenses in China as well as receiving 510(k) FDA clearance of our ClearRT Helical kVCT Imaging platform for the Radixact System. We are pleased with the continued resilience and commercial cadence that our business is exhibiting as well as the recent product innovation/upgrades coming through our development pipeline. We believe the additions of the Cyberknife S7 System, Synchrony on Radixact, and ClearRT Helical kVCT Imaging to our portfolio will have meaningful clinical impact for our customers and we look forward to the adoption of these important features and the functional improvement they represent in clinical practice."
    Bullish
  • G
    Gregg
    I am concerned that there hasn't been any news of China except hat was written in the 3 quarter transcript:
    Turning now to China. When we look at the overall level of linac market penetration compared to mature markets around the world, it is clear that China is currently operating at a significant deficit in terms of clinical treatment capacity. To put this in comparative perspective, in the U.S., we have roughly 12.4 linacs installed per 1 million people. Western Europe has roughly 6 to 7 linacs per 1 million and China is estimated currently to be at 1.4 linacs per 1 million. When China's disease incidents forecasts are taken into account, the current level of radiotherapy treatment capacity represents both a significant concern as well as an opportunity. While the near-term addressable market today is defined by the roughly 1,400 radiotherapy license quota outlined by China's Ministry of Health last October, to keep pace with future patient treatment needs, China will likely need a total of 5,000-plus linacs over the next decade. Given Accuray's current installed base of 900 devices, you can see why we are so excited about China as an overall growth catalyst for our business
  • G
    Gregg
    Accuray Incorporated ARAY: This Zacks Rank #2 company introduced the CyberKnife S7 System — the next generation CyberKnife platform — in June 2020. It is the only robotic radiosurgery system, which can deliver non-surgical stereotactic treatments with sub-millimeter accuracy anywhere in the body. This new CyberKnife technology is the most recent instance of the company’s innovation in radiation therapy that enables healthcare providers in offering best care to patients on new capabilities.

    For the first quarter of fiscal 2021, the company has an earnings growth rate of 18.2%, which is favorable compared to the S&P 500 Index’s (24.6)%. It has a Value Score of B.

    Accuray Incorporated
    Bullish
Advertisement
Advertisement