6 unchanged sentences
Our solutions include:
−Removed: • Novel artificial intelligence driven radiation therapy systems that automatically adapt treatment delivery for targets that move, synchronizing the radiation beam with the target’s motion in real-time throughout treatment delivery.
+Added: • Novel artificial intelligence (“AI”) driven radiation therapy systems that automatically adapt treatment delivery for targets that move, synchronizing the radiation beam with the target’s motion in real-time throughout treatment delivery.
• Powerful treatment planning software that reduces the time to create high quality treatment plans and the time it takes to deliver patient treatments as compared to the prior planning software, so clinicians can treat more patients each day.
2 unchanged sentences
• Distinctive software that accelerates and automates the re-planning process to make re-treatment of a previously irradiated area more efficient for practices and more effective for patients.
−Removed: • Advanced architecture that accommodates third party surface guidance interfaces that can enable deep inspiration breath hold (“DIBH”) for highly accurate and precise breast treatments.
+Added: • Advanced architecture that accommodates third party surface guidance interfaces to support effective positioning of the patient and monitoring of the accuracy of that positioning throughout treatment, and enable deep inspiration breath hold (“DIBH”) for highly accurate and precise breast cancer treatments.
Our innovative technologies, the CyberKnife and TomoTherapy platforms, including the Radixact System, our next generation TomoTherapy platform, are designed to deliver advanced treatments, including stereotactic radiosurgery (“SRS”), stereotactic body radiation therapy (“SBRT”), intensity modulated radiation therapy (“IMRT”), image-guided radiation therapy (“IGRT”), and adaptive radiation therapy (“ART”).
8 unchanged sentences
Our goal is to develop equipment and technology that enable physicians to deliver precise and accurate, customized, leading‑edge treatments that help patients with cancerous or benign tumors, or neurologic or endocrine disorders, get back to living their lives, faster.
−Removed: We endeavor to achieve this goal by expanding the clinical options for healthcare providers, helping them offer the best radiation treatment for each patient and by providing patients with treatment tailored to their specific needs.
+Added: We endeavor to achieve this goal by expanding the clinical options for healthcare providers, helping
+Added: them offer the best radiation treatment for each patient tailored to their specific needs.
Our vision is to expand the curative power of radiation therapy to improve as many lives as possible.
−Removed: We believe our
−Removed: current technologies and our future innovations can help to achieve this.
+Added: We believe our current technologies and our future innovations can help to achieve this.
Some of the key elements of our strategy include the following:
19 unchanged sentences
Outside of the United States, we currently have regional offices in Morges, Switzerland, Hong Kong, China, Shanghai, China and Tokyo, Japan and direct sales staff in most countries in Western Europe, Japan, India and Canada, combined with distributors in Europe, Russia, the Middle East, Africa, the Asia Pacific region, and Latin America.
−Removed: Many of these countries however, are not highly developed at this time and therefore, sales opportunities may be limited.
+Added: Many of the countries in these regions are not highly developed at this time and therefore sales opportunities may be limited.
We intend to increase our international revenue by focused additions of direct sales personnel in targeted areas to further penetrate our most promising international markets, and additional distributors, strategic partnerships, or joint ventures where opportune.
+Added: In addition, we recently introduced Accuray Helix, a CT-guided helical radiotherapy system, to help address gaps in patient access to radiation medicine.
+Added: The Helix system combines affordability with automation and tools for enhancing the speed of planning and delivery of radiation.
Strategic partnerships and joint ventures.
6 unchanged sentences
• In fiscal 2021, we announced a collaboration with Brainlab to enhance and expand the CyberKnife platform’s capabilities for the neuro-radiosurgery market.
−Removed: In fiscal 2022, we signed an agreement with C-RAD to provide customers with a solution for deep inspiration breath hold (“DIBH”) using the C-RAD Catalyst+ HD and
−Removed: Radixact System and with Limbus AI (now Radformation) to augment our adaptive radiotherapy capabilities by leveraging Limbus’ artificial intelligence (“AI”)-driven autocontouring algorithms.
+Added: • In fiscal 2022, we entered into an agreement with C-RAD to provide customers with a solution to enable surface guided radiation therapy (“SGRT”) and DIBH using the C-RAD Catalyst+ HD and Radixact System.
+Added: Additionally, we entered into an agreement with Limbus AI (now Radformation) to augment our adaptive radiotherapy capabilities by leveraging Limbus’ AI-driven autocontouring algorithms.
• In fiscal 2023, we announced a global, commercial partnership with GE Healthcare, intended to enable both companies to advance personalized cancer care and offer solutions throughout the care pathway from precision diagnostics, precision treatment planning and delivery to precision monitoring post-treatment.
−Removed: • In fiscal 2024, we announced a collaboration agreement with Oncopole Claudius Regaud (IUCT-Oncopole) in France, and Airbus SAS, a leader in the aerospace industry, to develop an artificial intelligence driven solution for predicting radiotherapy system performance.
−Removed: We also announced an agreement with TrueNorth Medical Physics LLC to provide radiation oncology departments with third-party support services that are complementary and supplementary to those already supplied by Accuray.
+Added: • In fiscal 2024, we announced a collaboration agreement with Oncopole Claudius Regaud (IUCT-Oncopole) in France, and Airbus SAS, a leader in the aerospace industry, to develop an AI-driven solution for predicting radiotherapy system performance.
+Added: We also announced an agreement with TrueNorth Medical Physics LLC to provide radiation oncology departments with third-party support services that are complementary and supplementary to those already supplied by us.
From oncology to radiosurgery and beyond, our solutions enable clinicians to deliver shorter, more personalized, and more effective treatments.
−Removed: Our suite of radiation delivery devices includes the CyberKnife System and our next generation TomoTherapy platform, the Radixact System.
+Added: Our suite of radiation delivery devices includes the CyberKnife System and our next generation TomoTherapy platform-based solutions, including the Radixact System.
In addition, our portfolio includes comprehensive software solutions to enable and enhance the precise and efficient radiotherapy treatments with our advanced delivery systems.
−Removed: The CyberKnife Platform
+Added: Robotic Radiation Delivery Solutions
The CyberKnife platform is the only robotic, full-body SRS and SBRT delivery device on the market.
6 unchanged sentences
The system includes disease-specific tracking and treatment delivery solutions for brain, spine, lung and prostate tumors, improvements in treatment speed as compared to earlier systems, more options to configure the treatment room, and expanded number of nodes leading to more coverage and minimizing the dose to healthy tissue.
−Removed: The CyberKnife S7 System has the option of fixed collimators plus the Iris Variable Aperture Collimator and/or InCise multi-leaf collimators (“MLC”).
+Added: The CyberKnife S7 System comes in a variety of radiation oncology suited configurations, with the option of fixed collimators plus the Iris Variable Aperture Collimator and/or InCise multi-leaf collimators (“MLC”).
With the addition of the InCise MLC, the CyberKnife S7 System is designed to enable the treatment of larger tumors that were previously thought untreatable with radiosurgery and SBRT.
The InCise MLC and IMRT planning tools are designed to enable expansion of indications that can be treated with a CyberKnife platform to include many IMRT indications.
−Removed: Using our Synchrony® real-time target tracking with dynamic delivery technology and computer controlled robotic mobility, the CyberKnife platform is designed to deliver radiation from a wide array of beam angles and autonomously track, detect and correct for even the slightest tumor and patient movement in real‑time throughout the entire treatment.
+Added: In addition, we also offer a specific configuration for the neuro-radiosurgery space.
+Added: The CyberKnife S7 F System is designed to deliver radiosurgery treatments to central nervous system tumors and lesions with sub-millimeter accuracy.
+Added: It offers precise, frameless, and non-invasive radiosurgery, with features for real-time correction of positional and anatomical changes, and fixed collimators to shape and direct the radiation beam when treating small targets.
+Added: The system can deliver plans using the Brainlab Elements software to enhance the target definition for radiosurgery treatments for functional neurological indications such as essential tremor, Parkinson’s, and epilepsy.
+Added: Brainlab Elements software augments the capabilities of the Accuray Precision ® Treatment Planning System for contouring, fusion and correction.
+Added: Using our Synchrony real-time target tracking with dynamic delivery technology and computer controlled robotic mobility, the CyberKnife platform is designed to deliver radiation from a wide array of beam angles and autonomously track,
+Added: detect and correct for even the slightest tumor and patient movement in real‑time throughout the entire treatment.
This design is intended to enable the CyberKnife platform to deliver high‑dose radiation with sub-millimeter precision and accuracy, which minimizes damage to surrounding healthy tissue and eliminates the need for invasive head or body immobilization frames.
1 unchanged sentence
The next-generation TPS with the VOLO Optimizer facilitates the development of clinically optimal treatment plans up to an estimated 90 percent faster than before and the delivery of the treatment up to an estimated 50 percent faster than before the availability of this software.
−Removed: We believe the CyberKnife platform offers clinicians and patients the following benefits over other vendors’ radiation therapy systems in the market:
+Added: We believe that our robotic delivery systems offer clinicians and patients the following benefits:
The only truly robotic system in the market.
5 unchanged sentences
Treatment of tumors throughout the body.
−Removed: The CyberKnife platform has been cleared by the Food and Drug Administration (“FDA”) to provide treatment planning and image‑guided radiation treatment for tumors anywhere in the body where radiation treatment is indicated.
+Added: The CyberKnife platform has been cleared by the Food and Drug Administration (“FDA”) to provide treatment planning and image-guided radiation therapy treatment for tumors anywhere in the body where radiation treatment is indicated.
By comparison, traditional frame‑based radiosurgery systems are generally limited to treating brain tumors with some using cobalt 60 radioactive material, which decays over time and is difficult and expensive to replace.
13 unchanged sentences
We continue to work to develop and offer new clinical capabilities enhancing ease of use, reducing treatment times, improving accuracy and improving patient access.
−Removed: The main components and options of the CyberKnife platform include:
−Removed: compact X‑band linear accelerator;
+Added: The main components and options of the CyberKnife platform include compact
+Added: X‑band linear accelerator;
robotic manipulator arm, real‑time image‑guidance system with continuous target tracking and correction.
6 unchanged sentences
The manipulator arm provides what we believe to be a unique method of positioning the linac to deliver doses of radiation from nearly any direction and position, without the limitations inherent in gantry-based systems, creating a non‑isocentric composite dose pattern with a high level of conformance to the shape of each treated tumor.
−Removed: This flexibility
−Removed: enhances the ability to diversify beam trajectories and beam entrance and exit points, helping to minimize risks of radiation damage to healthy cells near the tumor.
+Added: This flexibility enhances the ability to diversify beam trajectories and beam entrance and exit points, helping to minimize risks of radiation damage to healthy cells near the tumor.
Furthermore, the rapid response time of the manipulator arm allows tracking of tumors that are prone to movement.
−Removed: Real‑time image‑guidance system with continuous target tracking and correction.
+Added: Realtime image guidance system with continuous target tracking and correction.
Without the need for clinician intervention or treatment interruption, Synchrony is designed to enable continuous monitoring and correction for patient and tumor movements throughout each treatment as it is being delivered.
1 unchanged sentence
This, in turn, enables delivery of a highly conformal, non-isocentric dose of radiation to the tumor, minimizing radiation delivered to surrounding healthy tissue.
−Removed: Synchrony is the only technology that uses artificial intelligence, through image guidance, to automatically adapt and synchronize the treatment delivery beam position to the target location precisely and accurately during the delivery of a treatment fraction.
+Added: Synchrony is the only technology that uses AI, through image guidance, to automatically adapt and synchronize the treatment delivery beam position to the target location precisely and accurately during the delivery of a treatment fraction.
The beams of radiation are delivered continuously throughout the treatment session as the patient behaves naturally.
18 unchanged sentences
Lung Optimized Treatment.
−Removed: An integrated suite of tools that provides a complete fiducial‑free clinical solution for lung cancer patients and optimizes non‑invasive lung SBRT treatments.
+Added: An integrated suite of tools that provides a complete fiducial free clinical solution for lung cancer patients and optimizes noninvasive lung SBRT treatments.
InTempo Imaging System.
16 unchanged sentences
• Our ability to expand sales of CyberKnife M6 and S7 Systems in countries throughout the world where we do not currently sell or have not historically sold a significant number of any CyberKnife platform configurations.
−Removed: The Radixact System, the Next-Generation TomoTherapy Platform
−Removed: The Radixact System, the next generation TomoTherapy platform, allows for fully integrated radiation treatment planning, delivery and data management, enabling clinicians to deliver ultra-precise treatments to more than 50 patients per day.
−Removed: Additionally, the Radixact System offers two treatment delivery modes - TomoHelical and TomoDirect - providing flexibility in the types of indications that can be treated with radiation - from the simplest to the most complex cases, multiple tumors and recurrent tumors.
−Removed: The system seamlessly integrates with ClearRT helical kilovoltage computerized tomography (“kVCT”) high-fidelity imaging, providing clinicians with an option to produce exceptional diagnostic-like quality CT images, quickly and cost-effectively, to improve patient care.
−Removed: Synchrony on the Radixact System tracks and automatically adapts radiation delivery for targets that move, offering the possibility to decrease margins and hypofractionate treatments while efficiently delivering truly personalized care.
−Removed: We believe the TomoTherapy platform offers clinicians and patients the following benefits:
+Added: Helical Radiation Delivery Solutions
+Added: Through the TomoTherapy platform, we were the first to introduce helical radiation therapy, revolutionizing the way radiation is delivered.
+Added: Helical radiation therapy is a type of treatment that integrates the linear accelerator and CT imaging technology to deliver radiation from multiple 360-degree rotations around the patient while the patient table moves through center of the system.
+Added: Helical radiation therapy helps to provide greater control of the radiation dose so it conforms precisely to the tumor and helps minimize dose to healthy tissue.
+Added: Since the introduction of the TomoTherapy platform, Accuray has built on its legacy with the introduction of innovative solutions including the Radixact, Accuray Helix and Tomo C Systems, each tailored to meet the evolving needs of global markets.
+Added: The Radixact System is the next generation TomoTherapy platform.
+Added: The system allows for fully integrated radiation treatment planning, delivery and data management, enabling clinicians to deliver ultra-precise treatments to more than 50 patients per day.
+Added: Additionally, the system offers two treatment delivery modes - TomoHelical and TomoDirect - providing flexibility in the types of indications that can be treated with radiation - from the simplest to the most complex cases, multiple tumors and recurrent tumors.
+Added: Accuray Helix combines affordability with automation and tools for enhancing the speed of planning and delivery of radiation.
+Added: The system is designed to provide a broad range of capabilities to increase flexibility and versatility 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.
+Added: The new, made in China Tomo ® C System, is the first CNNC-Accuray joint venture product.
+Added: A fast and effective radiation delivery device, the system will enable more medical care teams within China to provide personalized and highly precise treatments to more people each day.
+Added: We believe that our helical delivery systems offer clinicians and patients the following benefits:
Versatile treatment capabilities.
−Removed: The TomoTherapy platform’s ring gantry architecture enables precise and efficient treatments with a high degree of dose conformity.
+Added: The ring gantry architecture enables precise and efficient treatments with a high degree of dose conformity.
The high‑speed binary MLC is integrated with the linac and consists of 64 individual low leakage tungsten leaves that move across the beam to either block or allow the passage of radiation, effectively modulating and shaping the beam as it is emitted.
4 unchanged sentences
The TomoTherapy platform’s versatility, efficiency and precision offer clinicians an extensive range of effective treatment possibilities.
−Removed: Real-time tracking of tumor movement.
−Removed: The Accuray proprietary Synchrony® AI-driven real-time target tracking with dynamic delivery technology is a collection of unique hardware and software technologies that enables personalized real-time adaptive delivery of radiation treatment to targets while they are in motion by synchronizing the treatment delivery beam position to the target location precisely and accurately during the delivery of a treatment fraction.
−Removed: Synchrony is the only technology that uses artificial intelligence, through image guidance, to automatically adapt and synchronize the radiation beam to the position of the tumor if and when it moves during treatment.
−Removed: The beams of radiation are delivered continuously throughout the treatment session as the patient behaves naturally.
−Removed: Synchrony can be used on the Radixact System to adapt treatment delivery for tumors that move as a result of bodily processes, including respiration and digestion, as well as patient movement.
−Removed: Synchrony treatments are truly personalized, as delivery is adapted to the individual’s unique movements throughout treatment delivery.
−Removed: If movement changes during treatment, delivery is adapted for that unique change.
−Removed: The Synchrony technology makes it possible and practical for clinicians to deliver radiation dose with accuracy and precision,
−Removed: even for tumors that move.
−Removed: Synchrony helps to maximize treatment effectiveness and minimize dose to surrounding healthy tissue because it accounts for the current and changing conditions of the patient during treatment delivery.
Diagnostic-like quality kVCT images enable better visualization of tumors, dose verification and re-planning.
−Removed: We launched ClearRT helical kVCT imaging technology for the Radixact System.
−Removed: The Radixact System seamlessly integrates with ClearRT helical kVCT high-fidelity imaging, providing clinicians with an option to produce exceptional diagnostic-like quality CT images, quickly and cost-effectively, to improve patient care.
+Added: We launched ClearRT helical kVCT imaging technology for the Radixact System, and have also made this advanced imaging available on the Accuray Helix and Tomo C systems.
+Added: ClearRT helical kVCT enables high-fidelity imaging, providing clinicians with an option to produce exceptional diagnostic-like quality CT images, quickly and cost-effectively, to improve patient care.
ClearRT imaging brings low dose diagnostic-like kVCT imaging quality, the largest imaging field of view available on a radiation delivery system at 50 cm (diameter) by 135 cm (long), and speed, as evidenced by its ability to capture a 1-meter image in only 1 minute.
1 unchanged sentence
ClearRT offers excellent uniformity and low noise across the entire image, improved soft tissue visualization while maintaining exceptional spatial resolution, which is intended to enhance the versatility and efficiency of the Radixact System in the radiation therapy department.
+Added: ClearRT helical kVCT images are also available within the Accuray PreciseART ® automated dose trending tool for clinicians to evaluate if plan adaptation would be beneficial, enabling the most personalized patient care.
Integrated treatment system for precise radiation delivery.
3 unchanged sentences
These features significantly benefit patients by increasing the radiation delivered to cancerous tissues, while minimizing damage to nearby healthy tissues, thus also minimizing side effects.
+Added: Enhancing efficiency and quality of treatment planning and delivery.
+Added: We are committed to providing clinical teams with technologies that improve both the efficiency and quality of radiation therapy planning.
+Added: Our goal is to streamline workflows while maintaining the precision and consistency essential to modern oncology.
+Added: VOLO Ultra, our next-generation optimization engine, supports this by dramatically accelerating treatment planning without compromising accuracy—enabling faster plan generation, improved throughput, and greater support for adaptive and personalized radiotherapy.
Efficient clinical workflow for Image-Guided Radiation Therapy and adaptive radiation therapy.
1 unchanged sentence
The imaging and treatment planning capabilities of many traditional systems are more modular or require cumbersome add‑ons or separate treatment planning systems that result in clinicians taking more steps between scanning, planning and treatment of patients.
−Removed: Conversely, the integrated imaging and treatment features of the Radixact System allows clinicians to scan, plan and treat cancer patients efficiently.
+Added: Conversely, the integrated imaging and treatment features allow clinicians to scan, plan and treat cancer patients efficiently.
Treatment plans as well as daily images can be easily accessed remotely, enabling clinical teams to collaboratively work together, regardless of location, ensuring higher quality plan development and delivery.
−Removed: Additionally, ClearRT provides clear, high-fidelity images that are designed to reduce the time required for patient imaging and registration, a crucial part of the treatment delivery process, thereby enabling clinical staff to serve more patients.
−Removed: ClearRT helical kVCT images are also available within the Accuray PreciseART ® automated dose trending tool for clinicians to evaluate if plan adaptation would be beneficial, enabling the most personalized patient care.
Low barriers to installation and implementation.
All external beam radiation systems must be housed in rooms that have special radiation shielding to capture any radiation not absorbed by the patient.
−Removed: The TomoTherapy platform’s size and self‑contained design allow customers to retrofit them into existing treatment rooms previously used for legacy radiation therapy systems and avoid, or reduce, the significant construction costs that can be associated with building new, larger treatment rooms, which are often required of other radiation therapy systems.
−Removed: With both imaging and radiation delivery capabilities integrated on a ring gantry, the Radixact System requires less space than other linac systems, which use large moving arms to position the linac or incorporate adjacent imaging equipment used for treatment planning.
+Added: The TomoTherapy platform’s size and self‑contained design allow customers to retrofit them into existing treatment rooms previously used for legacy radiation therapy systems and avoid, or reduce, the significant construction costs that can be associated with building new, larger
+Added: treatment rooms, which are often required of other radiation therapy systems.
+Added: With both imaging and radiation delivery capabilities integrated on a ring gantry, the systems require less space than other linac systems, which use large moving arms to position the linac or incorporate adjacent imaging equipment used for treatment planning.
In addition, because the Radixact System has an integrated radiation beam stop, which shields radiation that passes through the patient, they require less radiation shielding in treatment room walls as compared to traditional systems.
−Removed: We also preassemble, test and commission each Radixact System at our manufacturing facility, and ship the system almost fully assembled.
+Added: We also preassemble, test and commission each system at our manufacturing facility, and ship the system almost fully assembled.
This process typically allows radiation “beam on” within four days after delivery and first patient treatments to begin within 14 to 28 days after delivery.
−Removed: Platform for further technological advancements in adaptive radiation therapy.
−Removed: We believe the Radixact System is uniquely positioned to enable truly adaptive radiation therapy because of its ability to provide daily, quantitative images, high speed delivery of radiation from fixed beam angles or helically from 360 degrees around the body and real time verification of the dose received by the patient.
−Removed: We believe the combination of these design features and our integrated treatment planning and optimization software will allow us to continue to enhance the Radixact System’s adaptive capabilities to enable clinicians to routinely and easily adjust a patient’s treatment as needed, thereby remaining true to the intent of the original treatment plan.
−Removed: In addition to the functionality listed above, the Radixact System may be enhanced with the following product options:
−Removed: TomoDirect Mode and TomoEDGE Delivery.
−Removed: Key capabilities of these options are as follows:
+Added: Enhance precision and reduce treatment time.
TomoEDGE Delivery.
−Removed: TomoEDGE is standard on the Radixact X7 and X9 models.
−Removed: By dynamically varying the width of the collimator jaws during treatment delivery, dose to normal healthy tissues immediately adjacent to the tumor is reduced, helping to minimize the risk of radiation side effects.
+Added: TomoEDGE dynamically varies the width of the collimator jaws during treatment delivery, dose to normal healthy tissues immediately adjacent to the tumor is reduced, helping to minimize the risk of radiation side effects.
Additionally, overall treatment time is shortened because the jaws opening can be effectively tailored to the size of the tumor, enabling more efficient dose coverage.
The resulting gains in treatment quality and speed expand the Radixact Systems’ clinical and market reach within the conventional and stereotactic radiotherapy spaces.
+Added: Platform for further technological advancements in adaptive radiation therapy.
+Added: We believe the helical delivery systems are uniquely positioned to enable truly adaptive radiation therapy because of their ability to provide daily, quantitative images, high speed delivery of radiation from fixed beam angles or helically from 360 degrees around the body and real time verification of the dose received by the patient.
+Added: We believe the combination of these design features and our integrated treatment planning and optimization software will allow us to continue to enhance our systems adaptive capabilities to enable clinicians to routinely and easily adjust a patient’s treatment as needed, thereby remaining true to the intent of the original treatment plan.
+Added: In addition to the functionality listed above, the Radixact System may be enhanced with the following product options:
+Added: Real-time tracking of tumor movement.
+Added: The Accuray proprietary Synchrony® AI-driven real-time target tracking with dynamic delivery technology is a collection of unique hardware and software technologies that enables personalized real-time adaptive delivery of radiation treatment to targets while they are in motion by synchronizing the treatment delivery beam position to the target location precisely and accurately during the delivery of a treatment fraction.
+Added: Synchrony is the only technology that uses AI, through image guidance, to automatically adapt and synchronize the radiation beam to the position of the tumor if and when it moves during treatment.
+Added: The beams of radiation are delivered continuously throughout the treatment session as the patient behaves naturally.
+Added: Synchrony can be used on the Radixact System to adapt treatment delivery for tumors that move as a result of bodily processes, including respiration and digestion, as well as patient movement.
+Added: Synchrony treatments are truly personalized, as delivery is adapted to the individual’s unique movements throughout treatment delivery.
+Added: If movement changes during treatment, delivery is adapted for that unique change.
+Added: The Synchrony technology makes it possible and practical for clinicians to deliver radiation dose with accuracy and precision, even for tumors that move.
+Added: Synchrony helps to maximize treatment effectiveness and minimize dose to surrounding healthy tissue because it accounts for the current and changing conditions of the patient during treatment delivery.
+Added: The VitalHold Solution enables medical care teams to treat patients with SGRT using the Radixact System.
+Added: SGRT helps to effectively position the patient and monitor the accuracy of that positioning throughout their treatment, enhancing precision in radiation delivery.
+Added: VitalHold also enables DIBH treatments on the Radixact System.
+Added: During DIBH treatments, a patient takes a deep breath which moves the heart away from the chest wall and the targeted tumor to help minimize radiation dose to organs at risk (“OARs”) and reduce associated complications later in life.
We believe the TomoTherapy platform offers clinicians and patients significant benefits over other vendors’ radiation therapy systems in the market.
The long-term success of the TomoTherapy platform is dependent on a number of factors, including the following:
−Removed: • Continued adoption of our TomoTherapy platform, including the Radixact System, in markets where it is available;
+Added: • Continued adoption of our TomoTherapy platform, including the Radixact System, Accuray Helix, and Tomo C System, in markets where they are available;
• Greater awareness among doctors and patients of the unique benefits of radiation therapy using the TomoTherapy platform, including its ring gantry architecture that enables treatment delivery from multiple 360 degree rotations around the patient, and ClearRT helical kVCT imaging for the Radixact System, which are designed to produce exceptional diagnostic-like quality CT images, quickly and cost-effectively;
6 unchanged sentences
With a streamlined and intuitive interface, Accuray Precision TPS enables clinicians to efficiently generate high quality radiation therapy treatment plans for all case types.
−Removed: It is a complete planning solution, including multi‑modality image fusion with proprietary deformable image registration algorithm, comprehensive suite of contouring tools, AutoSegmentation auto‑contouring options for head and neck, brain, and prostate, side‑by‑side treatment plan comparison, plan summation and evaluation.
+Added: It is a complete planning solution, including multi‑modality image fusion with proprietary deformable image registration algorithm, comprehensive suite of contouring tools, AutoSegmentation and auto contouring options for head and neck, brain, and prostate, side-by-side treatment plan comparison, plan summation and evaluation.
It supports treatment plan creation for all case types with TomoHelical, TomoDirect IMRT and 3D CRT planning mode on both Radixact and TomoTherapy Systems enabled with iDMS Data Management Systems.
1 unchanged sentence
It provides fast and accurate dose computation engines for both Accuray platforms, including Monte Carlo dose calculation for the CyberKnife InCise Multileaf Collimator and VOLO Technology for the CyberKnife, Radixact and TomoTherapy Systems.
−Removed: The VOLO solution features high‑speed processing for both dose calculation and optimization that empowers clinicians to create highly customized treatment plans in less time, with greater flexibility to work interactively and in real time to efficiently develop the best IMRT treatment plans for even the most complex cases.
+Added: The VOLO and VOLO Ultra solutions feature high-speed processing for both dose calculation and optimization that empowers clinicians to create highly customized treatment plans in less time, with greater flexibility to work interactively and in real time to efficiently develop the best IMRT treatment plans for even the most complex cases.
The Accuray Precision TPS can be further enhanced with optional advanced capabilities described below:
3 unchanged sentences
It offers automated processing of daily imaging to enable clinicians to monitor all patients and set protocol specific action levels to flag cases for review and possible plan adaptation.
−Removed: The PreciseART software's streamlined re‑planning capabilities leverage full integration of treatment delivery, planning and database systems to allow clinicians to efficiently generate new treatment plans based on
−Removed: previous plan data.
−Removed: It is also designed to maintain the integrity of original treatment plans to ensure tumor coverage, preserve Organ‑At‑Risk (“OAR”) doses and reduce toxicity.
+Added: The PreciseART software's streamlined re‑planning capabilities leverage full integration of treatment delivery, planning and database systems to allow clinicians to efficiently generate new treatment plans based on previous plan data.
+Added: It is also designed to maintain the integrity of original treatment plans to ensure tumor coverage, preserve OAR doses and reduce toxicity.
PreciseRTX Retreatment Option.
33 unchanged sentences
We intend to continue to increase our focus on marketing and education efforts to surgical specialists and oncologists responsible for treating tumors throughout the body and are also working closely with hospital administrators to demonstrate the economic benefits of our offering.
−Removed: Our marketing activities also include efforts to inform and educate patients with cancerous or benign tumors, or neurologic and/or endocrine disorders, about the benefits of the CyberKnife and TomoTherapy platforms.
+Added: Our marketing activities also include efforts to inform and educate patients with cancerous or benign tumors, or neurologic and/or endocrine disorders, about the benefits of the CyberKnife and TomoTherapy robotic and helical platforms.
Under our standard distribution agreement, we generally appoint a distributor for a specific country.
−Removed: We typically also retain the right to distribute the CyberKnife and TomoTherapy platforms in such territories.
+Added: We typically also retain the right to distribute our full portfolio of solutions in such territories.
In most territories, our distributors generally provide the full range of service and sales capabilities, although we may provide installation and service support for certain distributors.
6 unchanged sentences
In September 2023, we received approval for our Class B device from the National Medical Products Administration (“NMPA”) and our Accuray Precision Treatment Planning System for the Class B device was approved by the NMPA in June 2024.
−Removed: The JV also distributes other Accuray treatment delivery systems like the Radixact and CyberKnife treatment delivery systems.
+Added: The JV also distributes other Accuray treatment delivery systems like the Radixact and CyberKnife treatment delivery systems, including the Radixact SynC and CyberKnife S7 Systems, which received NMPA approval in January 2025.
For more information on the JV, see Note 11, “Joint Venture,” of the Notes to the consolidated financial statements.
11 unchanged sentences
Our facilities employ state‑of‑the‑art manufacturing techniques and equipment.
−Removed: The components manufactured at our Chengdu facility are produced under the International Standard Organization (“ISO”), 13485:2016 certified quality management systems.
−Removed: The completed medical devices are designed, manufactured, installed, serviced and distributed at our Sunnyvale, Madison and Morges facilities under quality management systems which are compliant to the internationally recognized quality system standard for medical devices ISO, 13485:2016, and the Quality System regulations enforced by the FDA.
+Added: Our Madison headquarters manages and oversees the complete design, manufacturing, installation, service and distribution for our medical devices under one global quality management systems compliant to the internationally recognized quality system standard for medical devices ISO, 13485:2016, and the Quality System regulations enforced by the FDA.
We believe our manufacturing facilities will be adequate for our expected growth and foreseeable future demands for at least the next three years.
40 unchanged sentences
Our other competitors include RefleXion Medical Inc., ZAP® Surgical Systems, Inc., and other companies in the radiosurgical and radiation therapy markets.
−Removed: Furthermore, many government, academic and business entities are investing substantial resources in research and development of cancer treatments, including surgical approaches, radiation treatment, MRI‑guided radiotherapy systems, proton therapy systems, drug treatment, immunotherapy, gene therapy, and other approaches.
+Added: Furthermore, many government, academic and business entities are investing substantial resources in research and development of cancer treatments, including surgical approaches, radiation treatment, MRI-guided radiotherapy systems,
+Added: proton therapy systems, drug treatment, immunotherapy, gene therapy, and other approaches.
Successful developments that result in new approaches for the treatment of cancer could reduce the attractiveness of our products or render them obsolete.
22 unchanged sentences
In addition to competition from technologies performing similar functions as our platforms, competition also exists for the limited capital expenditure budgets of our customers.
−Removed: For example, our platforms may compete with other equipment required by a radiation therapy department for financing under the same capital expenditure budget, which is typically limited.
+Added: For example, our platforms may compete with other equipment required by a radiation therapy department for financing under the same capital expenditure budget, which is typically
A purchaser, such as a hospital or cancer treatment center, may be required to select between the two items of capital equipment.
15 unchanged sentences
3D-CRT treatments delivered using the TomoTherapy and Radixact Systems are considered complex treatments and reported under the complex 3D‑CRT code 77412.
−Removed: In December 2015, the Patient Access and Medicare Protection Act (PAMPA) stopped the
−Removed: IMRT and 3D CRT delivery codes from being implemented and prevented reimbursement reductions in the freestanding center setting through calendar year 2019.
+Added: In December 2015, the Patient Access and Medicare Protection Act (PAMPA) stopped the IMRT and 3D CRT delivery codes from being implemented and prevented reimbursement reductions in the freestanding center setting through calendar year 2019.
Although the payment freeze was set to expire on December 31, 2019, the Centers for Medicare and Medicaid Services (“CMS”) has continued to recognize these temporary HCPCS G codes in this setting.
6 unchanged sentences
In 2025, the primary treatment delivery codes for robotic radiosurgery are priced by the regional Medicare Administrative Contractors.
−Removed: In 2024, the robotic SRS/SBRT delivery codes remain contractor priced for providers paid under the traditional fee-for-service methodology.
+Added: In 2025, the robotic SRS/SBRT delivery codes remain contractor priced for providers paid under the traditional
+Added: fee-for-service methodology.
Payment rates for IMRT and 3DRT procedures are set by CMS with adjustments to account for geographic market variations.
26 unchanged sentences
Some low risk devices are exempted from this requirement.
−Removed: Devices deemed by the FDA to pose the greatest risks, such as life‑sustaining, life‑supporting or implantable devices, or devices deemed not substantially equivalent to a previously cleared 510(k) devices, are placed in class III, requiring pre‑market approval.
+Added: Devices deemed by the FDA to pose the greatest
+Added: risks, such as life‑sustaining, life‑supporting or implantable devices, or devices deemed not substantially equivalent to a previously cleared 510(k) devices, are placed in class III, requiring pre‑market approval.
All of our current products are class II devices requiring 510(k) clearances.
18 unchanged sentences
Regulations provide that the manufacturer initially determines when a specific modification requires notification to FDA.
−Removed: The FDA has issued draft guidance that, if finalized and implemented,
−Removed: will result in manufacturers needing to seek a significant number of new clearances for changes made to legally marketed devices.
+Added: The FDA has issued draft guidance that, if finalized and implemented, will result in manufacturers needing to seek a significant number of new clearances for changes made to legally marketed devices.
The FDA reviews the manufacturer’s decision to file a 510(k) or PMA for modifications during facility audits.
13 unchanged sentences
The August 2017 inspection resulted in no observations.
+Added: We voluntarily participate in the Medical Device Single Audit Program (“MDSAP”).
+Added: The MDSAP program allows recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.
+Added: The MDSAP participating members include FDA, Therapeutic Goods Administration of Australia, Brazil’s Agência Nacional de Vigilância Sanitária, Health Canada, Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency.
+Added: FDA accepts MDSAP audit reports as a substitute for routine Agency inspections.
+Added: We are routinely audited by an MDSAP-recognized Auditing Organization to international medical device requirements.
We believe we are in substantial compliance with the QSR.
13 unchanged sentences
Various warning labels must be affixed.
−Removed: Assemblers of diagnostic X‑ray
−Removed: systems are also required to certify in reports to the FDA, equipment purchasers, and where applicable, to state agencies responsible for radiation protection, that diagnostic and/or therapeutic X‑ray systems they assemble meet applicable requirements.
+Added: Assemblers of diagnostic X‑ray systems are also required to certify in reports to the FDA, equipment purchasers, and where applicable, to state agencies responsible for radiation protection, that diagnostic and/or therapeutic X‑ray systems they assemble meet applicable requirements.
Failure to comply with these requirements could result in enforcement action by the FDA, which can include injunctions, civil penalties, and the issuance of warning letters.
3 unchanged sentences
Because of the far‑reaching nature of these laws, there can be no assurance that we would not be required to alter one or more of our practices to be in compliance with these laws.
−Removed: Evolving interpretations of current laws or the adoption of new federal or state laws or regulations could adversely affect many of the arrangements we have with customers and physicians.
+Added: Evolving interpretations of current
+Added: laws or the adoption of new federal or state laws or regulations could adversely affect many of the arrangements we have with customers and physicians.
In addition, there can be no assurance that the occurrence of one or more violations of these laws or regulations would not result in a material adverse effect on our financial condition and results of operations.
20 unchanged sentences
In the case of our former placement program, certain services and upgrades were provided without additional charge based on procedure volume.
−Removed: In the past, we have also provided loans to our customers.
+Added: In the past, we
+Added: have also provided loans to our customers.
We also provide research or educational grants to customers to support customer studies related to, among other things, our CyberKnife and TomoTherapy platforms.
25 unchanged sentences
The final rule also prohibits percentage‑based compensation in equipment leases.
−Removed: As a result of the finalization of these regulations, some
−Removed: existing CyberKnife platform operators have modified or restructured their corporate or organizational structures.
+Added: As a result of the finalization of these regulations, some existing CyberKnife platform operators have modified or restructured their corporate or organizational structures.
In addition, certain customers that planned to open CyberKnife centers in the United States involving physician ownership have restructured their legal ownership structure.
28 unchanged sentences
The United States and foreign government regulators have increased regulation, enforcement, inspections and governmental investigations of the medical device industry, including increased United States government oversight and enforcement of the Foreign Corrupt Practices Act.
−Removed: Whenever the United States or another foreign governmental authority concludes that we are not in compliance with applicable laws or regulations, such governmental
−Removed: authority can impose fines, delay or suspend regulatory clearances, institute proceedings to detain or seize our products, issue a recall, impose operating restrictions, enjoin future violations and assess civil penalties against us or our officers or employees, and can recommend criminal prosecution to the Department of Justice.
+Added: Whenever the United States or another foreign governmental authority concludes that we are not in compliance with applicable laws or regulations, such governmental authority can impose fines, delay or suspend regulatory clearances, institute proceedings to detain or seize our products, issue a recall, impose operating restrictions, enjoin future violations and assess civil penalties against us or our officers or employees, and can recommend criminal prosecution to the Department of Justice.
Moreover, governmental authorities can ban or request the recall, repair, replacement or refund of the cost of any device or product we manufacture or distribute.
35 unchanged sentences
If these appeals are not resolved in favor of these prospective customers, they may be precluded from purchasing and/or performing services using one of our systems.
−Removed: Certificate of need laws are the subject of continuing legislative activity, and a significant increase in the number of states regulating the acquisition and use of one of our systems through certificate of need or similar programs could adversely affect us.
+Added: Certificate of need laws are the subject of continuing
+Added: legislative activity, and a significant increase in the number of states regulating the acquisition and use of one of our systems through certificate of need or similar programs could adversely affect us.
For a discussion of our fiscal 2025 backlog, please refer to the section entitled “Backlog,” in Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations.
20 unchanged sentences
a 401(k) retirement plan with a company match, an employee stock purchase plan, a company-provided basic life insurance and disability benefits, a corporate wellness program, an employee assistance program, and local employee discounts programs.
−Removed: Diversity, Equity, and Inclusion
−Removed: We strive to foster a diverse and inclusive culture and environment that encourages active dialogue and robust engagement on the issues most salient to employee satisfaction and believe our employees are empowered to play a significant role in shaping the direction and success of the company.
−Removed: We believe that this helps to foster a positive and collaborative work environment that values teamwork, respect, integrity, and customer focus.
−Removed: Furthermore, we are committed
−Removed: to promoting diversity, equity, and inclusion across our organization and in our communities.
−Removed: We believe that having a diverse and inclusive workforce enhances our creativity, innovation, and problem-solving abilities, and enables us to better serve our customers and stakeholders.
−Removed: We have implemented various initiatives to support and advance our diversity and inclusion goals, such as establishing a Diversity, Equity, and Inclusion Committee that oversees and guides our diversity and inclusion strategy, programs, and activities.
−Removed: We provide diversity and inclusion training and education for all employees, including all managers, covering topics such as unconscious bias and allyship.
−Removed: We track and report internally on our diversity metrics and progress, such as the composition and representation of our workforce by gender, race, ethnicity, age, disability, and veteran status.
−Removed: We believe that by focusing on these initiatives, we can create a more sustainable and successful company.
Geographic Information
16 unchanged sentences
• Our ability to achieve profitability depends in part on maintaining or increasing our gross margins on product sales and services, which we may not be able to achieve.
−Removed: • We have outstanding indebtedness and may incur other debt in the future, which may adversely affect our financial condition and future financial results.
−Removed: • Our operating results, including our cash flows, quarterly orders, revenues and margins fluctuate from quarter to quarter and may be unpredictable, which may result in a decline in our stock price.
+Added: • We have substantial indebtedness and may incur other debt in the future, which may adversely affect our financial condition and future financial results.
+Added: In the past, we have not been in compliance with certain financial covenants relating to our indebtedness and have been required to obtain waivers to avoid defaulting under such indebtedness.
+Added: • Enhanced international tariffs, including tariffs imposed by the United States and China that affect our products or components within our products, other trade barriers or a global trade war could decrease the volume of product sales in China and increase our costs and materially and adversely affect our business condition and results of operations.
+Added: • Our operating results, including our cash flows, quarterly orders, revenues and margins fluctuate from quarter to quarter and may be unpredictable.
• Our industry is subject to intense competition and rapid technological change, which may result in products or new tumor treatments that are superior to the CyberKnife and TomoTherapy platforms.
16 unchanged sentences
• It is difficult and costly to protect our intellectual property and our proprietary technologies and we may not be able to ensure their protection.
−Removed: • We have identified material weaknesses in our system of internal controls as of June 30, 2024 and are in the process of remediation.
−Removed: If we fail to remediate such material weakness or otherwise fail to achieve and maintain an effective system of internal control over financial reporting, our ability to produce timely and accurate financial results could be adversely impacted.
+Added: • We previously identified material weaknesses in our system of internal controls as of June 30, 2024.
+Added: Although such material weaknesses were remediated as of March 31, 2025, if we fail to maintain an effective system of internal control over financial reporting, our ability to produce timely and accurate financial results could be adversely impacted.
Risks related to the regulation of our products and business
5 unchanged sentences
• Future issuances of shares of our common stock could dilute the ownership interests of our stockholders.
+Added: • The exercise of outstanding warrants for our common stock would increase the number of shares eligible for future resale in the public market and result in dilution to our stockholders.
• The conditional conversion features of the 2026 Notes, if triggered, may adversely affect our financial condition and operating results.
−Removed: • Provisions in the indenture for the Notes, the credit agreement for our Credit Facilities (as defined below), our certificate of incorporation and our bylaws could discourage or prevent a takeover, even if an acquisition would be beneficial in the opinion of our stockholders.
+Added: • Provisions in the indenture for the 2026 Notes, the financing agreement for our Credit Facilities (as defined below), our certificate of incorporation and our bylaws could discourage or prevent a takeover, even if an acquisition would be beneficial in the opinion of our stockholders.
General Risks
1 unchanged sentence
We operate in a rapidly changing environment that involves significant risks, a number of which are beyond our control.
−Removed: In addition to the other information contained in this Form 10‑K, the following discussion highlights some of these risks and the possible impact of these factors on our business, financial condition and future results of operations.
+Added: In addition to the other information contained in this Form 10‑K, the following discussion highlights some of these risks and
+Added: the possible impact of these factors on our business, financial condition and future results of operations.
If any of the following risks actually occur, our business, financial condition or results of operations may be adversely impacted, causing the trading price of our common stock to decline.
2 unchanged sentences
Risks Related to Our Business and Results of Operations
−Removed: We face risks related to the current global economic environment, including risks arising in connection with inflation, recession or currency fluctuations, any of which could adversely affect our business, financial condition and results of operations by, among other things, delaying or preventing our customers from obtaining financing to purchase our products and services or implementing the required facilities to house our systems.
+Added: We face risks related to the current global economic environment, including risks arising in connection with tariffs, inflation, recession or currency fluctuations, any of which could adversely affect our business, financial condition and results of operations by, among other things, delaying or preventing our customers from obtaining financing to purchase our products and services or implementing the required facilities to house our systems.
Our business and results of operations are materially affected by conditions in the global markets and the economy generally.
+Added: We expect that the business of our customers and our own business will continue to be adversely impacted, directly or indirectly, by macroeconomic and geopolitical issues.
Concerns over economic and political stability;
9 unchanged sentences
the availability and cost of credit;
−Removed: trade relations, including the imposition of various sanctions and tariffs in other countries;
−Removed: the duration and severity of the ongoing recovery from the COVID-19 pandemic;
+Added: trade relations, including the imposition of various sanctions, export controls, and tariffs by the United States and other countries;
energy costs;
−Removed: instability in the banking and financial services sector and geopolitical uncertainty and conflict, including the upcoming U.S.
−Removed: presidential election, have contributed to increased volatility and diminished expectations for the economy and the markets in general.
+Added: instability in the banking and financial services sector;
+Added: geopolitical uncertainty and conflict, including with respect to Russia-Ukraine and the Middle East conflicts, including with respect to Iran;
+Added: changes in government administration policy positions and recent executive orders to impose new tariffs on global imports that could result in additional tariffs on specific industries, and uncertainties regarding impact, retaliations and further escalation, have contributed to increased volatility and diminished expectations for the economy and the markets in general.
In turn, periods of economic slowdown or recession could lead to a reduction in demand for our products and services, which in turn would reduce our revenues and adversely affect our results of operations and our financial position.
6 unchanged sentences
A higher inflationary environment can also negatively impact raw material, component, and logistics costs that, in turn, has increased the costs of producing and distributing our products.
−Removed: For example, inflationary pressures beginning in fiscal year 2023 have resulted in rising costs for certain materials, including increased logistics and duties costs, that have adversely affected our gross margins, which have had a material effect on our business, financial condition or results of operations.
−Removed: Continued pressure from these inflationary factors could further exacerbate these effects.
+Added: For example, inflationary pressures as well as ongoing supply chain challenges beginning in fiscal year 2023 have resulted in rising costs for certain materials, including increased logistics and duties costs, that have materially affected our gross margins and net income (loss), which have had a material effect on our business, financial condition or results of operations.
+Added: We expect that gross margins and net income (loss) will continue to be adversely affected by increased material costs and freight and logistics expenses through at least calendar year 2025, and potentially longer.
+Added: In addition, we expect inflation and the ongoing supply chain challenges and logistics costs to impact our cash from operations through at least calendar year 2025, as we are unable to pass all of these increased costs to our customers.
Further, the U.S.
federal government has called for, or enacted, substantial changes to healthcare, trade, fiscal, and tax policies, which may include changes to existing trade agreements and may have a significant impact on our operations.
−Removed: For example, the United States has imposed tariffs on certain foreign products, including from China, that have resulted in and may result in future retaliatory tariffs on U.S.
−Removed: goods and products.
−Removed: We cannot predict whether these policies will continue, or if new policies will be enacted, or the impact, if any, that any policy changes could have on our business.
+Added: For example, the United States has imposed tariffs on many foreign products, including tariffs on imports from China, that in the past have resulted in and may result in future retaliatory tariffs on U.S.
+Added: goods and products and restrictions on exports to the United States.
+Added: In light of the uncertainty surrounding tariffs imposed by the United States and China and trade relations between the two countries, we expect the volume of product sales in China to decrease and costs associated with tariffs to increase.
+Added: We cannot predict whether these policies will continue, or if new policies will be enacted, or the impact, if any, that
+Added: any policy changes could have on our business.
In addition, failure of the U.S.
Government to pass a budget in a timely manner or any reductions in healthcare spending in the budget may adversely impact us or our customers.
−Removed: If economic conditions worsen, or new legislation is passed related to the healthcare
−Removed: system, trade, fiscal or tax policies, customer demand may not materialize to levels we require to achieve our anticipated financial results, which could have a material adverse effect on our business, financial condition and results of operations.
−Removed: Additionally, inflation and the ongoing supply chain challenges and logistics costs have materially affected our gross margins and net income (loss), and we expect that gross margins and net income (loss) will continue to be adversely affected by increased material costs and freight and logistic expenses through at least the remainder of calendar year 2024, and potentially longer.
−Removed: In addition, we expect inflation and the ongoing supply chain challenges and logistics costs to impact our cash from operations through at least the remainder of calendar year 2024, if not longer.
−Removed: The uncertain macroeconomic environment, including volatile credit markets and concerns regarding the availability and cost of credit, increased interest rates, inflation, reduced economic growth or a recession, instability in the banking and financial services sector and concerns relating to the upcoming U.S.
−Removed: presidential election, in any of the geographic areas where we do business, could impact consumer and customer demand for our products and services, as well as our ability to manage normal commercial relationships with our customers, suppliers and creditors, including financial institutions, and the ability of our customers to meet their obligations to us.
+Added: If economic conditions worsen, or new legislation is passed related to the healthcare system, trade, fiscal or tax policies, customer demand may not materialize to levels we require to achieve our anticipated financial results, which could have a material adverse effect on our business, financial condition and results of operations.
+Added: The uncertain macroeconomic environment, including volatile credit markets and concerns regarding the availability and cost of credit, increased interest rates, inflation, reduced economic growth or a recession, instability in the banking and financial services sector, and changes in government administration policy positions, in any of the geographic areas where we do business, could impact consumer and customer demand for our products and services, as well as our ability to manage normal commercial relationships with our customers, suppliers and creditors, including financial institutions, and the ability of our customers to meet their obligations to us.
For example, in the United States, at least one customer declared bankruptcy in fiscal 2023 causing us to increase our bad debt reserve due to the expectation that they will be unable to pay us.
2 unchanged sentences
These delays have, in some instances, led to our customers postponing the shipment and installation of previously ordered systems or cancelling their system orders and may cause other customers to postpone their system installation or to cancel their agreements with us.
−Removed: Reduced budgets and lower capital deployment priority for radiotherapy equipment, along with longer customer installation timelines, in the United States have also negatively impacted our revenue during fiscal year 2024, and we expect this will continue to have an impact through fiscal year 2026.
+Added: Reduced budgets and lower capital deployment priority for radiotherapy equipment, along with longer customer installation timelines, in the United States have also negatively impacted our net revenue since fiscal year 2024, and we expect this will continue to have an impact through fiscal year 2026.
A continuation or further deterioration of the adverse economic environment would further increase delays and order cancellations, or affect our ability to collect from our customers, any of which would continue to adversely affect revenues, and therefore, harm our business and results of operations.
11 unchanged sentences
We cannot be sure that our products will gain significant market acceptance among physicians, patients and healthcare payors, even if we spend significant time and expense on their education.
−Removed: In addition to achieving market acceptance of our products and the need to educate physicians and others about the benefits of our products, the CyberKnife and TomoTherapy platforms are major capital purchases, and purchase decisions are
−Removed: greatly influenced by hospital administrators who are subject to increasing pressures to reduce costs.
−Removed: In addition, hospitals and other health professionals may reduce staffing and reduce or postpone meetings with potential suppliers in response to the spread of an infectious disease, such as COVID-19, effectively delaying the decision on potential purchases of new products such as ours.
+Added: In addition to achieving market acceptance of our products and the need to educate physicians and others about the benefits of our products, the CyberKnife and TomoTherapy platforms are major capital purchases, and purchase decisions are greatly influenced by hospital administrators who are subject to increasing pressures to reduce costs.
These and other factors, including the following, may affect the rate and level of market acceptance of the CyberKnife and TomoTherapy platforms:
26 unchanged sentences
• changes to U.S.
−Removed: and foreign trade policies, including enactments of tariffs on goods imported into the U.S.
−Removed: and any retaliatory tariffs imposed by other countries on U.S.
−Removed: goods, including our products;
+Added: and foreign trade policies, including imposition of tariffs on goods imported into the U.S.
+Added: including, but not limited to, tariffs on goods imported from China and other countries, and any retaliatory tariffs imposed by other countries on U.S.
+Added: goods, including our products, and retaliatory export controls that could impact our supply chain;
+Added: • fluctuations in foreign currency exchange rates;
• how well we execute on our strategic and operating plans.
If we are unable to maintain or increase our gross margins on product sales and service, our results of operations could be adversely impacted, we may not achieve profitability and our stock price could decline.
−Removed: We have outstanding indebtedness in the form of Convertible Senior Notes and a credit facility and may incur other debt in the future, which may adversely affect our financial condition and future financial results.
−Removed: In May 2021, we issued $100.0 million aggregate principal amount of our 3.75% Convertible Senior Notes due 2026 (the “Notes”).
−Removed: As our debt matures, we anticipate having to expend significant resources to either repay or refinance the Notes.
−Removed: For example, in May 2021, in connection with the issuance of the Notes, we (i) exchanged approximately $82.1 million aggregate principal amount of our previously issued 3.75% Convertible Senior Notes due 2022 for approximately $97.1 million aggregate principal amount of the Notes and (ii) sold approximately $2.9 million aggregate principal amount of the Notes for cash.
−Removed: If we decide to, or are required to, refinance the Notes in the future, we may be required to do so on different or less favorable terms or we may be unable to refinance the Notes at all, both of which may adversely affect our financial condition.
−Removed: In May 2021, we entered into a credit agreement that provided us with a five-year $80.0 million term loan (the “Term Loan Facility”) and $40.0 million revolving credit facility (the “Revolving Credit Facility” and together with the “Term Loan Facility”, the “Credit Facilities”).
−Removed: As of June 30, 2024, we had total consolidated liabilities of $423.5 million;
−Removed: including long-term liabilities of the Notes of $100.0 million, the Revolving Credit Facility of $10.0 million and the Term Loan Facility of $64.0 million, of which $7.8 million is classified as short-term loan.
+Added: We have substantial indebtedness in the form of a credit facility and convertible senior notes and may incur other debt in the future, which may adversely affect our financial condition and future financial results.
+Added: In the past, we have not been in compliance with certain financial covenants relating to our indebtedness and have been required to obtain waivers to avoid defaulting under such indebtedness.
+Added: As of June 30, 2025, we had outstanding borrowings of $150 million under our five-year term loan (the “Term Loan Facility”) with additional borrowings available of $20 million under our revolving credit facility (the “Revolving Credit Facility”) and $20 million under our delayed draw term loan (the “Delayed Draw Facility” and together with the Term Loan Facility and Revolving Credit Facility, the “Credit Facilities”), each of which will mature on June 6, 2030, and $18.0 million in principal amount outstanding of our 3.75% Convertible Senior 2026 Notes due June 1, 2026 (the “2026 Notes”).
Our existing and future levels of indebtedness could have important consequences to stockholders and note holders and may adversely affect our financial conditions and future financial results by, among other things:
4 unchanged sentences
• increasing our vulnerability to downturns in our business, our industry or the economy in general.
−Removed: The credit agreement governing the Credit Facilities (the “Existing Credit Agreement”) also includes certain restrictive covenants that limit, among other things, our ability and our subsidiaries’ ability to (i) incur indebtedness, (ii) incur liens on their property, (iii) pay dividends or make other distributions, (iv) sell their assets, (v) make certain loans or investments, (vi) merge or consolidate, (vii) voluntarily repay or prepay certain indebtedness and (viii) enter into transactions with affiliates, in
−Removed: each case, subject to certain exceptions.
−Removed: In addition, such agreements require us to meet certain financial covenants, including a consolidated fixed charge coverage ratio and consolidated senior net leverage ratio, as defined in the Existing Credit Agreement.
+Added: Concurrently and in connection with our entry into the credit agreement governing the Credit Facilities (the “Financing Agreement”), we issued to our lenders (i) an aggregate of 17,180,710 shares of our common stock issuable upon exercise of outstanding warrants (the “Premium Warrants”), which are exercisable starting on December 7, 2025 and until June 6, 2032 and have an exercise price of $1.68 per share, and (ii) an aggregate of 6,247,531 shares of our common stock issuable upon exercise of warrants (the “Penny Warrants” and, together with the Premium Warrants, the “Warrants”), which are exercisable until June 6, 2032 and have an exercise price of $0.01 per share.
+Added: The Financing Agreement also includes certain restrictive covenants that limit, among other things, our ability and our subsidiaries’ ability to (i) incur indebtedness, (ii) incur liens on their property, (iii) pay dividends or make other distributions, (iv) sell their assets, (v) make certain loans or investments, (vi) merge or consolidate, (vii) voluntarily repay or prepay certain indebtedness and (viii) enter into transactions with affiliates, in each case, subject to certain exceptions.
+Added: In addition, such agreements require us to meet certain financial covenants, including a fixed charge coverage ratio, total leverage ratio and liquidity level, as defined in the Financing Agreement.
These restrictions could adversely affect our ability to finance our future operations or capital needs, withstand a future downturn in our business or the economy in general, engage in business activities, including future opportunities that may be in our interest, and plan for or react to market conditions or otherwise execute our business strategies.
2 unchanged sentences
In addition, because substantially all of our assets are pledged as a security under the Credit Facilities, if we are not able to cure any default or repay outstanding borrowings, such assets are subject to the risk of foreclosure by our lenders.
−Removed: From time to time, we have not been in compliance with such covenants or other terms governing the Credit Facilities and we have been required to obtain waivers or amendments to the Existing Credit Agreement from our lenders in order to maintain compliance.
−Removed: For example, in the fourth quarter of 2024, we amended the Existing Credit Agreement to make certain changes to our financial covenants that enabled us to remain in compliance with such covenants.
−Removed: There can, however, be no certainty that any such waiver or amendment will be available to us in the future, or what the cost of such waiver or amendment, if obtained, would be.
−Removed: If we are unable to obtain necessary waivers or relevant amendments and the debt under such credit facility is accelerated, we would be required to obtain replacement financing at prevailing market rates, which may not be favorable to us.
−Removed: Additionally, a default on indebtedness could result in a default under the terms of the indenture governing the Notes.
−Removed: There is no guarantee that we would be able to satisfy our obligations if any of our indebtedness is accelerated.
−Removed: In addition, our debt obligations consist of a variety of financial instruments that expose us to interest rate risk, including, but not limited to the Credit Facilities and Notes.
−Removed: If the amount outstanding under the Credit Facilities remained at this level for the next 12 months and interest rates increased or decreased by 50 basis point change, our annual interest expense would increase or decrease, respectively, approximately $0.4 million.
−Removed: Our operating results, including our cash flows, quarterly orders, revenues and margins fluctuate from quarter to quarter and may be unpredictable, which may result in a decline in our stock price.
+Added: From time to time, we have not been in compliance with certain similar covenants or other terms governing the prior credit facilities and we have been required to obtain waivers or amendments to the previous credit agreement from our lenders in order to maintain compliance.
+Added: There can, however, be no certainty that any such waiver or amendment will be available to us in the future, which may lead to a default under the terms of the Financing Agreement governing the Credit Facilities, or what the cost of such waiver or amendment, if obtained, would be.
+Added: If we are unable to obtain necessary waivers or relevant amendments as required and the debt under such credit facility is accelerated, we would be required to obtain replacement financing at prevailing market rates, which may not be available to us on favorable terms or at all.
+Added: Failure to obtain replacement financing could result in
+Added: certain of our long-term indebtedness being reclassified current, which could in turn impact our ability to continue as a going concern.
+Added: Additionally, a default on indebtedness would likely result in a default under the terms of the indenture governing the 2026 Notes.
+Added: We may not be able to satisfy our obligations if any of our indebtedness is accelerated.
+Added: In addition, the Credit Facilities expose us to interest rate risk.
+Added: If the amount outstanding under the Credit Facilities remained at the level outstanding as of June 30, 2025 for the next 12 months and interest rates increased or decreased by 50 basis point change, our annual interest expense would increase or decrease, respectively, approximately $0.8 million.
+Added: Enhanced international tariffs, including tariffs imposed by the United States and China that affect our products or components within our products, other trade barriers or a global trade war could decrease the volume of product sales in China and increase our costs and materially and adversely affect our business condition and results of operations.
+Added: Our global business has been and could continue to be negatively affected by trade barriers and other governmental protectionist measures, any of which can be imposed or modified suddenly and unpredictably.
+Added: There is currently significant uncertainty about the future relationship between the U.S.
+Added: and various other countries, most significantly China, with respect to trade policies, treaties, government regulations and tariffs and such uncertainty could continue with the changes in government administration policy positions.
+Added: Recently, the U.S.
+Added: presidential administration has indicated its intent to modify U.S.
+Added: trade policy and in some cases to renegotiate, or potentially terminate, certain existing bilateral or multi-lateral trade agreements.
+Added: It has also imposed or announced tariffs on certain imports, including a baseline tariff of 10% on virtually all imports, higher tariffs on imports from China, as well as certain imports from Mexico and Canada.
+Added: The administration has also announced and subsequently paused higher tariffs on additional countries, including the European Union pending the outcome of trade negotiations.
+Added: These tariffs affect component parts including the linear accelerator for our CyberKnife platforms, which we manufacture in China and import into the U.S., as well as other components that we import into the U.S.
+Added: from other suppliers, which could significantly impact the cost of these parts.
+Added: Any retaliatory tariffs could also impact our ability to export and sell our products into those countries.
+Added: For example, during the last half of calendar year 2018, the U.S.
+Added: federal government imposed a series of tariffs ranging from 10% to 25% on a variety of imports from China, to which China responded with retaliatory tariffs ranging from 5% to 25% on a wide range of products from the U.S., which included certain of our products.
+Added: If these tariffs continue, if additional tariffs are placed on certain of our components or products, or if any related counter-measures are taken by China, the U.S.
+Added: or other countries, our business, financial condition and results of operations may be materially harmed.
+Added: We have experienced increased costs associated with tariffs and in light of continued uncertainty surrounding tariffs imposed by the United States and China, and overall trade relations between the two countries, the volume of our product sales in China may decrease.
+Added: An increase in our costs could require us to raise prices on our products, which may negatively impact the demand for our products in the affected market.
+Added: We may not be able to forecast such impacts accurately.
+Added: Although we continue to work with our vendors and customers to mitigate our exposure to current or potential tariffs, there can be no assurance that we will be able to offset any increased costs.
+Added: The ultimate impact of any tariffs will depend on various factors, including if any tariffs are ultimately implemented, the timing of implementation, and the amount, scope, and nature of the tariffs.
+Added: If we are not successful in offsetting the impact of any such tariffs, our revenue, gross margins and operating results may be adversely affected.
+Added: These tariffs are subject to a number of uncertainties as they are implemented, including future adjustments and changes.
+Added: The ultimate reaction of other countries and the impact of these tariffs or other actions on the U.S., the global economy and our business, financial condition and results of operations, cannot be predicted at this time, nor can we predict the impact of any other developments with respect to global trade.
+Added: Further, the imposition of additional tariffs by the U.S.
+Added: could result in the adoption of additional tariffs by other countries, as well as export controls and further retaliatory actions by any affected country.
+Added: Any resulting trade war could negatively impact the global market for medical devices, including radiation therapy devices, and could have a significant adverse effect on our business.
+Added: These developments may have a material adverse effect on global economic conditions and the stability of global financial markets, and they may significantly reduce global trade.
+Added: Any of these factors could depress economic activity, restrict our access to customers and have a material adverse effect on our business, financial condition and results of operations.
+Added: In addition, economic sanctions imposed by the United States and other countries could negatively affect our global business.
+Added: For example, following Russia’s invasion of Ukraine, the United States and other countries imposed economic sanctions and severe export control restrictions against Russia and Belarus, and the United States and other countries could impose wider sanctions and export restrictions and take other actions should the conflict further escalate.
+Added: Any exports or sales of our products into Russia and Belarus may be impacted by these restrictions.
+Added: For instance, we are not able to ship certain spare or replacement parts into Russia and Belarus, which impacts our distributor's ability to service our installed base in such
+Added: countries as we have distributors in Russia.
+Added: The military conflict in Ukraine has also led to an expansion of sanction programs imposed against Russia by the United States, Canada, the EU, the United Kingdom, Switzerland, and Japan, among others, that in relevant part, impose sanctions against some of the largest state-owned and private Russian financial institutions (and their subsequent removal from the Society for Worldwide Interbank Financial Telecommunication (“SWIFT”) payment system) and certain Russian businesses, some of which have significant financial and trade ties to the EU, making it increasingly difficult to transfer money from Russia to other countries.
+Added: In response to international sanctions, and as part of measures to stabilize and support the volatile Russian financial and currency markets, the Russian authorities imposed significant currency control measures aimed at restricting the outflow of foreign currency and capital from Russia, imposed various restrictions on transacting with non-Russian parties, banned exports of various products and imposed other economic and financial restrictions.
+Added: If we are unable to receive payment from customers in Russia or transfer money outside of Russia, it could affect our ability to convert backlog from that region into revenue.
+Added: The situation continues to evolve, and the United States, the EU, the United Kingdom and other countries may implement additional sanctions, export controls or other measures against Russia and other countries, regions, officials, individuals or industries in the respective territories.
+Added: Such sanctions and measures, as well as existing and potential further responses from Russia or other countries, could adversely affect the global economy and financial markets, as well as our business, financial condition and results of operations, which may also magnify the impact of other risks described in this “Risk Factors” section.
+Added: Our operating results, including our cash flows, quarterly orders, revenues and margins fluctuate from quarter to quarter and may be unpredictable.
We have experienced and expect in the future to experience fluctuations in our operating results, including gross orders, revenues and margins, from period to period.
6 unchanged sentences
For example, multi-system sales or sales involving negotiations with integrated delivery networks involve additional complexities to the transaction and require a longer timeline to finalize the sale, which make it more difficult to predict the quarter in which the sale will occur.
−Removed: In addition, we have experienced delays in orders and installations due to the impact of macroeconomic factors as well as the COVID-19 pandemic at our customer sites.
+Added: In addition, we have experienced delays in orders and installations due to the impact of macroeconomic factors.
Once orders are received and booked into backlog, there is a risk that we may not recognize revenue in the near term or at all.
The pace at which backlog converts to revenue has been adversely impacted in recent years, primarily due to delays in the timing of deliveries and installations in fiscal 2020 through 2022 caused by the COVID-19 pandemic and the resulting effects on the global economic environment.
−Removed: These delays in deliveries and installations have occurred and may continue, to some degree, through the remainder of calendar year 2024, which could have a negative impact on our revenue during such period.
+Added: These delays in deliveries and installations could occur again in the future, which could have a negative impact on our revenue.
Factors that may affect whether these orders become revenue (or are cancelled or deemed aged‑out and reflected as a reduction in net orders) and the timing of revenue include:
5 unchanged sentences
• the proportion of revenue attributable to orders placed by our distributors, which may be more difficult to forecast due to factors outside our control.
−Removed: Our operating results may also be affected by a number of other factors, some of which are outside of our control, including:
+Added: Our operating results have previously and may in the future also be affected by a number of other factors, some of which are outside of our control, including:
• delays in business operations of our customers or vendors, construction at customer sites and installation, including delays caused by supply chain delays;
6 unchanged sentences
• the timing and level of expenditures associated with our financing activities;
+Added: • our ability to satisfy the covenants associated with our indebtedness and our ability to generate sufficient cash flow or obtain additional financing to satisfy our obligations as they come due;
• the effects of foreign currency adjustments;
+Added: • the effects of macroeconomic factors, including the effects of enhanced international tariffs;
• changes in accounting principles, such as those related to revenue recognition, or in the interpretation or the application thereof;
33 unchanged sentences
In addition to competition from technologies performing similar functions as our platforms, competition also exists for the limited capital expenditure budgets of our customers.
−Removed: For example, our platforms may compete with other equipment required by a radiation therapy department for financing under the same capital expenditure budget, which is typically
+Added: For example, our platforms may compete with other equipment required by a radiation therapy department for financing under the same capital expenditure budget, which is typically limited.
A purchaser, such as a hospital or cancer treatment center, may be required to select between the two items of capital equipment.
5 unchanged sentences
operations, we are affected by economic, business, regulatory, social, and political conditions in foreign countries, including the following:
−Removed: • economic or political instability in the world or in particular regions or countries in which we do business, including the market volatility resulting from conflicts or war, such as the Russia-Ukraine and Israel-Hamas conflicts, and the upcoming U.S.
−Removed: presidential election;
+Added: • economic or political instability in the world or in particular regions or countries in which we do business, including the market volatility resulting from conflicts or war, such as the Russia-Ukraine and the Middle East conflicts including with respect to Iran, and changes in government administration policy positions;
• import delays;
2 unchanged sentences
relations with the governments of the foreign countries in which we operate, which may, among other things, affect our access to such markets, including China, where our JV is located;
+Added: • protectionist laws, policies, business practices and nationalistic campaigns that favor local competitors, which could slow our growth, increase our costs, or make our products less competitive in our international markets;
+Added: trade and economic sanctions policies that are in effect from time to time including, but not limited to, tariffs on goods imported from China and other countries, and the possibility that foreign countries may impose additional taxes, tariffs or other restrictions on foreign trade;
• longer payment cycles associated with many customers outside the United States;
3 unchanged sentences
• failure of local laws to provide the same degree of protection against infringement of our intellectual property;
−Removed: • protectionist laws and business practices that favor local competitors;
−Removed: trade and economic sanctions policies that are in effect from time to time and the possibility that foreign countries may impose additional taxes, tariffs or other restrictions on foreign trade;
• trade restrictions that are in effect from time to time, including U.S.
3 unchanged sentences
• the inability to obtain required export or import licenses or approvals;
−Removed: • risks relating to foreign currency, including fluctuations in foreign currency exchange rates possibly causing fewer sales due to the strengthening of the U.S.
+Added: • risks relating to foreign currency, including fluctuations in foreign currency exchange rates possibly causing fewer sales due to any strengthening of the U.S.
• effects of and uncertainties caused by the United Kingdom’s withdrawal from the European Union;
10 unchanged sentences
Dollar relative to foreign currencies could require us to reduce our sales price or make our products less competitive in international markets.
−Removed: Foreign exchange continues to be a significant headwind as the U.S.
−Removed: Dollar has continued to strengthen, which affect our results of operations and could cause potential delays in orders and we may see our sales and margins outside of the U.S.
−Removed: decline as we may not be able to raise local prices to fully offset the strengthening of the U.S.
+Added: Foreign exchange has previously been and could in the future be a significant headwind if the U.S.
+Added: Dollar strengthens, which could affect our results of operations and could cause potential delays in orders and we may see our sales and margins outside of the U.S.
+Added: decline as we may not be able to raise local prices to fully offset any strengthening of the U.S.
Also, if our international sales continue to increase, we may enter into a greater number of transactions denominated in non‑U.S.
1 unchanged sentence
If we are unable to address these risks and challenges effectively, our international operations may not be successful and our business would be materially harmed.
−Removed: Enhanced international tariffs, including tariffs imposed by the United States and China that affect our products or components within our products, other trade barriers or a global trade war could increase our costs and materially and adversely affect our business operations and financial condition.
−Removed: Our global business could be negatively affected by trade barriers and other governmental protectionist measures, any of which can be imposed suddenly and unpredictably.
−Removed: For example, following Russia’s invasion of Ukraine, the United States and other countries imposed economic sanctions and severe export control restrictions against Russia and Belarus, and the United States and other countries could impose wider sanctions and export restrictions and take other actions should the conflict further escalate.
−Removed: Any exports or sales of our products into Russia and Belarus may be impacted by these restrictions.
−Removed: For instance, we are not able to ship certain spare or replacement parts into Russia and Belarus, which impacts our distributor's ability to service our installed base in such countries.
−Removed: The military conflict in Ukraine has also led to an expansion of sanction programs imposed against Russia by the United States, Canada, the EU, the United Kingdom, Switzerland, and Japan, among others, that in relevant part, impose sanctions against some of the largest state-owned and private Russian financial institutions (and their subsequent removal from the Society for Worldwide Interbank Financial Telecommunication (“SWIFT”) payment system) and certain Russian businesses, some of which have significant financial and trade ties to the EU, making it increasingly difficult to transfer money from Russia to other countries.
−Removed: In response to international sanctions, and as part of measures to stabilize and support the volatile Russian financial and currency markets, the Russian authorities imposed significant currency control measures aimed at restricting the outflow of foreign currency and capital from Russia, imposed various restrictions on transacting with non-Russian parties, banned exports of various products and imposed other economic and financial restrictions.
−Removed: If we are unable to receive payment from customers in Russia or transfer money outside of Russia, it could affect our ability to convert backlog from that region into revenue.
−Removed: The situation continues to evolve, and the United States, the EU, the United Kingdom and other countries may implement additional sanctions, export controls or other measures against Russia and other countries, regions, officials, individuals or industries in the respective territories.
−Removed: Such sanctions and measures, as well as existing and potential further responses from
−Removed: Russia or other countries, could adversely affect the global economy and financial markets, as well as our business, financial condition and results of operations, which may also magnify the impact of other risks described in this “Risk Factors” section.
−Removed: There is also currently significant uncertainty about the future relationship between the U.S.
−Removed: and various other countries, most significantly China, with respect to trade policies, treaties, government regulations and tariffs and such uncertainty could continue following the upcoming U.S.
−Removed: presidential election.
−Removed: Since the beginning of 2018, there has been legislative or executive action, from U.S.
−Removed: and foreign leaders regarding instituting tariffs against foreign imports of certain materials.
−Removed: During the last half of calendar year 2018, the federal government imposed a series of tariffs ranging from 10% to 25% on a variety of imports from China.
−Removed: These tariffs affect certain components, including the linear accelerator for our CyberKnife platforms, which we manufacture in China and import into the U.S., as well as other components that we import into the U.S.
−Removed: from our suppliers.
−Removed: China responded to these tariffs with retaliatory tariffs ranging from 5% to 25% on a wide range of products from the U.S., which include certain of our products.
−Removed: Although the U.S.
−Removed: and China signed an initial trade deal in January 2020 and we have thus far been able to obtain tariff exemptions for medical linear accelerators imported into the U.S.
−Removed: from China, there is no assurance that the exemption on medical linear accelerators will continue or that we will continue to qualify for such exemption.
−Removed: If these tariffs continue, if additional tariffs are placed on certain of our components or products, or if any related counter-measures are taken by China, the U.S.
−Removed: or other countries, our business, financial condition and results of operations may be materially harmed.
−Removed: The imposition of tariffs could also increase our costs and require us to raise prices on our products, which may negatively impact the demand for our products in the affected market.
−Removed: If we are not successful in offsetting the impact of any such tariffs, our revenue, gross margins and operating results may be adversely affected.
−Removed: These tariffs are subject to a number of uncertainties as they are implemented, including future adjustments and changes.
−Removed: The ultimate reaction of other countries and the impact of these tariffs or other actions on the U.S., the global economy and our business, financial condition and results of operations, cannot be predicted at this time, nor can we predict the impact of any other developments with respect to global trade.
−Removed: Further, the imposition of additional tariffs by the U.S.
−Removed: could result in the adoption of additional tariffs by other countries, as well as further retaliatory actions by any affected country.
−Removed: Any resulting trade war could negatively impact the global market for medical devices, including radiation therapy devices, and could have a significant adverse effect on our business.
−Removed: These developments may have a material adverse effect on global economic conditions and the stability of global financial markets, and they may significantly reduce global trade.
−Removed: Any of these factors could depress economic activity, restrict our access to customers and have a material adverse effect on our business, financial condition and results of operations.
If we encounter manufacturing problems, or if our manufacturing facilities do not continue to meet federal, state or foreign manufacturing standards, we may be required to temporarily cease all or part of our manufacturing operations, which would result in delays and lost revenue.
3 unchanged sentences
In addition, the macroeconomic environment has and may continue to impact the supply of key components such that we may not receive them in a timely manner, in sufficient quantities, or at a reasonable cost.
−Removed: In addition, as a result of COVID-related restrictions in China, we may also experience limitations in the availability of qualified personnel.
If component supply or our manufacturing capacity does not keep pace with demand, we will not be able to fulfill product orders or service our products in a timely manner, which in turn may have a negative effect on our financial results and overall business.
2 unchanged sentences
The QSR is a complex regulatory scheme that covers the methods and documentation of the design, testing, production process and controls, manufacturing, labeling, quality assurance, packaging, storage and shipping of our products.
−Removed: Furthermore, we are required to
−Removed: verify that our suppliers maintain facilities, procedures and operations that comply with our quality requirements.
+Added: Furthermore, we are required to verify that our suppliers maintain facilities, procedures and operations that comply with our quality requirements.
We are also subject to state licensing and other requirements and licenses applicable to manufacturers of medical devices, and we are required to comply with International Organization for Standardization (“ISO”), quality system standards in order to produce products for sale in Europe and Canada, as well as various other foreign laws and regulations.
6 unchanged sentences
If we or a third‑party supplier receive a Form FDA 483 with material or major observations that are not promptly corrected, fail to pass a QSR inspection, or fail to comply with these, ISO and other applicable regulatory requirements, our operations could be disrupted and our ability to generate sales could be delayed.
−Removed: Our failure to take prompt and satisfactory corrective action in response to an adverse inspection or our failure to comply with applicable standards could result in enforcement actions, including a public warning letter, a shutdown of our manufacturing operations, a recall of our products, civil or criminal penalties, or other sanctions, which would cause our sales and business to suffer.
+Added: failure to take prompt and satisfactory corrective action in response to an adverse inspection or our failure to comply with applicable standards could result in enforcement actions, including a public warning letter, a shutdown of our manufacturing operations, a recall of our products, civil or criminal penalties, or other sanctions, which would cause our sales and business to suffer.
In addition, because some foreign regulatory approvals are based on approvals or clearances from the FDA, any failure to comply with FDA requirements may also disrupt our sales of products in other countries.
16 unchanged sentences
In addition, we depend on one of our customers for a substantial portion of our revenue, and the loss of, or a significant reduction in orders from our major customer could have a material adverse effect on our revenue and operating results.
−Removed: had one customer that represented 10% or more of total net revenue for the years ended June 30, 2024, 2023, and 2022, respectively.
+Added: We had one customer that represented 10% or more of total net revenue for the years ended June 30, 2025 and 2024, respectively.
In the future, our major customer may decide not to purchase our products at all, may purchase fewer products than they did in the past, or may defer or cancel purchases or otherwise alter their purchasing patterns.
18 unchanged sentences
In order to implement our business strategy, we expect continued growth in our infrastructure requirements, particularly as we expand into new and growing markets as well as expand our manufacturing capacities and sales and marketing capabilities.
−Removed: To manage our growth, we must expand our facilities, augment our management, operational and financial systems, hire and train additional qualified personnel, scale‑up our manufacturing capacity and expand our marketing and distribution capabilities, all of which will be more difficult to accomplish the more employees we have that work remotely from home.
+Added: To manage our growth, we must expand our facilities, augment our management, operational and financial systems, hire and train additional qualified personnel, scale‑up our manufacturing capacity and expand our marketing and distribution capabilities.
Our manufacturing, assembly and installation process is complex and occurs over many months and we must effectively scale this entire process to satisfy customer expectations and changes in demand.
Further, to accommodate our growth and compete effectively, we will be required to make improvements to our business operations.
−Removed: We cannot be certain
−Removed: that our personnel, systems, procedures and internal controls will be adequate to support our future operations and any expansion of our systems and infrastructure may require us to commit significant additional financial, operational and management resources.
+Added: We cannot be certain that our personnel, systems, procedures and internal controls will be adequate to support our future operations and any expansion of our systems and infrastructure may require us to commit significant additional financial, operational and management resources.
If we cannot manage our growth effectively, our business will suffer.
16 unchanged sentences
We have voluntarily initiated recalls and other product corrections in the past.
−Removed: For example, in fiscal year 2024, we voluntarily initiated one recall related to the Radixact platform, which was reported to the FDA.
+Added: For example, in fiscal year 2025, we voluntarily initiated one recall related to the couch for the CyberKnife System, which was reported to the FDA.
We are committed to the safety and precision of our products and while no serious adverse health consequences have been reported in connection with these recalls and the costs associated with each such recall were not material, we cannot ensure that the FDA will not require that we take additional actions to address problems that resulted in previous recalls or that similar or more significant product recalls will not occur in the future.
4 unchanged sentences
We currently depend on single source suppliers for some of the critical components necessary to assemble the CyberKnife and TomoTherapy platforms, including, with respect to the CyberKnife platform, the robot, couch and magnetron and, with respect to the TomoTherapy platforms, the couch, solid state modulator and magnetron.
−Removed: In addition, as a result of global supply chain disruptions, we have experienced and continue to experience disruptions in parts of our supply chain, which has caused delays in the receipt of certain component parts for our products and increased pricing pressure for such parts, including with respect to parts purchased from our single-source suppliers, adversely affecting our gross margins in the near term, and increasing the risk that these supply chain disruptions could materially affect our ability to meet customer demand.
+Added: Global supply chain disruptions in parts of our supply chain, have occurred and could occur again in the future, causing delays in the receipt of certain component parts for our products and increased pricing pressure for such parts, including with respect to parts purchased from our single-source suppliers, adversely affecting our gross margins and increasing the risk that these supply chain disruptions could materially affect our ability to meet customer demand.
Furthermore, as a result of the effects of the macroeconomic conditions, including inflation, and supply chain challenges, some of our suppliers have limited or reduced the sale of such components to us or increased the cost of such components to us.
4 unchanged sentences
The disruption or termination of the supply of components, including as a result of global shortages in important components, have resulted in, and will continue to cause, inflationary pressure on our supply chain and a significant increase in the costs of these components, which have materially affected and could continue to adversely affect our results of operations.
−Removed: In addition, we expect inflation and the ongoing supply chain challenges and logistics costs to impact our cash from operations through at least the remainder of calendar year 2024, if not longer.
+Added: In addition, we expect inflation and the ongoing supply chain challenges and logistics costs to impact our cash from operations through at least calendar year 2025.
In some cases, alternative suppliers may be located in the same geographic area as existing suppliers, and are thus subject to the same economic, political and geographic factors that may affect existing suppliers to meet our demand.
We may have difficulty or be unable to find alternative sources for these components.
−Removed: Difficulties in obtaining a sufficient supply of component materials could increase as well as the costs associated with such components, and we expect such difficulties to persist through at least the remainder of fiscal year 2024, if not longer.
+Added: Difficulties in obtaining a sufficient supply of component materials could increase as well as the costs associated with such components, and we expect such difficulties to persist through at least calendar year 2025.
As a result, we may be unable to meet the demand for the CyberKnife or TomoTherapy platforms, which could harm our ability to generate revenue and damage our reputation.
1 unchanged sentence
We cannot assure you that our single‑source suppliers will be able or willing to meet our future demands.
−Removed: We generally do not maintain large volumes of inventory, which makes us even more susceptible to harm if a single source supplier fails to deliver components on a timely basis or we experience quality issues with the components we do have in inventory, and maintaining our historical levels of inventory has been adversely impacted by the macroeconomic environment.
+Added: We generally do not maintain large volumes of inventory, which makes us even more susceptible to harm if a single source supplier fails to deliver components on a timely basis or we experience quality issues with the components we do have in inventory, and maintaining our historical levels of inventory has been adversely impacted by the macroeconomic
For example, a supplier quality issue resulted in higher than anticipated failure rates for a component in our platforms, which resulted in higher parts consumption costs that adversely affected our financial results in fiscal year 2024.
12 unchanged sentences
Fluctuations in labor availability globally, including labor shortages and staff burnout and attrition, may also impact our ability to hire and retain personnel critical to our manufacturing, logistics, and commercial operations.
−Removed: As a result, we may not be able to retain our existing employees or hire new employees quickly enough to meet
+Added: In addition, no payments were made under the company bonus plan in fiscal year 2025.
+Added: As a result, we may not be able to retain our existing employees or hire new employees quickly enough to meet our needs.
Moreover, we have from time to time conducted reductions in force in order to optimize our organizational structure and reduce costs, some of which were substantial, and certain senior personnel have also departed for various reasons.
−Removed: For example, in October 2023, we informed affected employees of a cost savings initiative to reduce operating expenses resulting in the elimination of approximately 5.9 percent of our global workforce.
At the same time, we may face high turnover among employees that are critical to our ongoing operations, requiring us to expend time and resources, including financial resources, to source, train and integrate new employees.
6 unchanged sentences
Information technology helps us operate more efficiently, interface with customers, maintain financial accuracy and efficiency and accurately produce our financial statements.
−Removed: If we do not allocate and effectively manage the resources necessary to build, sustain and secure the proper technology infrastructure, we could be subject to transaction errors, processing inefficiencies, the loss of customers, business disruptions or the loss, unavailability of or damage to data and intellectual property through a cyberattack (including ransomware and other attacks) or other security breach or incident.
−Removed: While management is committed to identifying and improving data security risks through oversight of data security by our Chief Information Security Officer and implementation of various technical safeguards, procedural requirements and policies, regardless of the resources we allocate and the effectiveness with which we manage them, we face a risk of cyberattacks and other security breaches and incidents.
−Removed: Any cyberattacks or other security breaches or incidents we suffer could expose us to a risk of lost, unavailable, or corrupted information, unauthorized disclosure or other processing of information, claims, litigation and possible liability to employees, customers and others, and investigations and proceedings by regulatory authorities.
−Removed: Artificial intelligence ("AI") technologies may be used for certain cyberattacks or to increase the frequency or intensity of certain cyberattacks, which may increase our risks presented by cyberattack activity.
−Removed: Additionally, cyberattack activity may be heightened in connection with geopolitical events and conflicts such as the Russia-Ukraine and Israel-Hamas conflicts.
+Added: If we do not allocate and effectively manage the resources necessary to build, sustain and secure the proper technology infrastructure, we could be subject to transaction errors, processing inefficiencies, the loss of customers, business disruptions or the loss, unavailability of or damage to data and intellectual property through a cyberattack (including ransomware and other attacks) or other security breaches or incidents.
+Added: While management is committed to identifying cybersecurity risks and working to address them through oversight of data security by our Chief Information Security Officer and implementation of various technical safeguards, procedural requirements and policies, regardless of the resources we allocate and the effectiveness with which we manage them, we face a risk of cyberattacks and other security breaches and incidents.
+Added: Any cyberattacks or other security breaches or incidents we suffer could expose us to a risk of lost, unavailable, or corrupted information, unauthorized disclosure or other processing of information, claims, litigation and possible liability to employees, customers and others, and investigations and proceedings
+Added: by regulatory authorities.
+Added: Cyberattacks and other means of creating security breaches and incidents or disruptions continue to increase in frequency, sophistication, and intensity and are becoming increasingly difficult to detect on a timely basis or otherwise, especially as they relate to attacks on third-party providers or their vendors.
+Added: Such attacks are often carried out by motivated and highly skilled actors, who are increasingly well-resourced.
+Added: Techniques used to compromise or sabotage systems, including the use of advanced technologies, such as machine learning or artificial intelligence ("AI") change frequently, may originate from less regulated and remote areas of the world, may be difficult to detect, and generally are not recognized until after they are launched against a target.
+Added: As a result, we may be unable to anticipate these techniques or implement adequate preventative measures.
+Added: Additionally, cyberattack activity may be heightened in connection with geopolitical events such as the Russia-Ukraine and Middle East conflicts.
In addition to potential exposure to cyberattacks, security incidents, or other actions that may compromise the security of or interfere with the function of our products, defects or vulnerabilities in the software or systems of our third-party vendors may expose failures in our internal controls and risk management processes, which may adversely impact our business, financial condition, results of operations, or cash flows and may also harm our reputation, brand, and customer relationships.
4 unchanged sentences
In addition, privacy and security breaches and incidents arising from errors, malfeasance or misconduct by employees, contractors or others with permitted access to our systems may pose a risk that sensitive data, including individually identifiable data, may be exposed to unauthorized persons or to the public and may compromise our security systems.
−Removed: There can be no assurance that any efforts we make to prevent against such privacy or security breaches or incidents have been or
−Removed: will be able to prevent breakdowns or breaches or incidents in our systems or those of our third-party service providers that could adversely affect our business.
+Added: There can be no assurance that any efforts we make to prevent against such privacy or security breaches or incidents have been or will be able to prevent breakdowns or breaches or incidents in our systems or those of our third-party service providers that could adversely affect our business.
Third parties may also attempt to fraudulently induce employees or customers into disclosing usernames, passwords or other sensitive information, which may in turn be used to access our information technology systems.
1 unchanged sentence
We may also face increased cybersecurity risks due to our reliance on internet technology and many of our employees working remotely at least part of the time, which may create additional opportunities for cybercriminals to exploit vulnerabilities.
−Removed: In addition, unauthorized persons may attempt to hack into our products or systems to obtain personal data relating to patients or employees, our confidential or proprietary information or confidential information we hold on behalf of third parties, which, if successful, could pose a risk of loss, unavailability, or corruption of, or unauthorized access to or acquisition of, data, risk to patient safety and risk of product recall.
+Added: In addition, adversaries might attempt to gain unauthorized access to our products or systems to obtain personal data relating to patients or employees, our confidential or proprietary information or confidential information we hold on behalf of third parties, which, if successful, could pose a risk of loss, unavailability, or corruption of, or unauthorized access to or acquisition of, data, risk to patient safety and risk of product recall.
The techniques used to obtain unauthorized access to our systems change frequently and may be difficult to detect, and we may not be able to anticipate and prevent these intrusions or mitigate them when they occur.
Third-party service providers store and otherwise process certain personal data and other confidential or proprietary information of ourselves and third parties on our behalf, and these service providers face similar risks.
−Removed: In addition, our employees, third-party service providers, strategic partners, or other contractors or consultants may input personal or confidential information, or other business data of ours, into an artificial intelligence system (in particular, a system that is managed, owned, or controlled by a third party), which may disrupt and otherwise compromise our business operations, divert the attention of management and key information technology resources, potentially lead to security breaches or incidents or other unauthorized access to, or other use or processing of, personal information, our confidential information or other business data.
+Added: In addition, our employees, third-party service providers, strategic partners, or other contractors or consultants may input personal or confidential information, or other business data of ours, into an AI system (in particular, a system that is managed, owned, or controlled by a third party), which may disrupt and otherwise compromise our business operations, divert the attention of management and key information technology resources, potentially lead to security breaches or incidents or other unauthorized access to, or other use or processing of, personal information, our confidential information or other business data.
Moreover, we manufacture and sell hardware and software products that allow our customers to store confidential information about their patients.
Both types of products are often connected to and reside within our customers’ information technology infrastructures.
−Removed: We do not have measures to configure or secure our customers’ equipment or any information stored in our customers’ systems or at their locations, which is the responsibility of our customers.
+Added: We do not have measures to configure or secure our customers’ equipment or any information stored in our customers’ systems or at
+Added: their locations, which is the responsibility of our customers.
Our customers are also continually updating their cybersecurity standards for the products that they purchase.
1 unchanged sentence
A network security or systems security breach of incident suffered by ourselves or our third-party service providers or other events that cause the loss or unauthorized use or disclosure of, or access by third parties to, sensitive information stored by us or our customers could result in loss, unavailability, or unauthorized acquisition, modification, or other processing of data, and any such events, or the perception that these events have occurred or that our security measures for our products are lacking, could have serious negative consequences for our business, including indemnity obligations, possible fines, penalties and damages, reduced demand for our products and services, an unwillingness of our customers to use our products or services, harm to our reputation and brand, and time consuming and expensive litigation, any of which could have an adverse effect on our business, financial condition, and operating results.
−Removed: Due to frequently changing attack techniques, along with the increased volume and sophistication of the attacks, including the increasing use of tools and techniques that are designed to circumvent controls, avoid detection, and remove or obfuscate forensic evidence, all of which hinders our ability to identify, investigate, and recover from incidents, we could be adversely impacted by cybersecurity attacks or other security breaches.
+Added: Due to frequently changing attack techniques, along with the increased volume and sophistication of the attacks, including the increasing use of tools and techniques that are designed to circumvent controls, avoid detection, and remove or obfuscate forensic evidence, all of which hinders our ability to identify, investigate, and recover from incidents, we could be adversely impacted by cybersecurity attacks or other security breaches or incidents.
This impact could result in reputational, competitive, operational, or other business harm as well as financial costs and claims, demands, litigation and regulatory action.
4 unchanged sentences
For example, in the U.S., privacy and security rules implementing the Health Insurance Portability and Accountability Act (“HIPAA”) require us as a business associate, in certain instances, to protect the confidentiality of patient health information, and the Federal Trade Commission has consumer protection authority, including with regard to privacy and cybersecurity.
−Removed: In Europe, the GDPR imposes several
−Removed: stringent requirements for controllers and processors of personal data that impose substantial obligations and, in the event of violations, may impose significant fines of up to the greater of 4% of worldwide annual revenue or €20 million.
+Added: In Europe, the GDPR imposes several stringent requirements for controllers and processors of personal data that impose substantial obligations and, in the event of violations, may impose significant fines of up to the greater of 4% of worldwide annual revenue or €20 million.
In the UK, the Data Protection Act of 2018 and the UK GDPR collectively implement material provisions of the GDPR and provide for penalties for noncompliance of up to the greater of £17.5 million or four percent of worldwide revenues.
13 unchanged sentences
issued an executive order in furtherance of the DPF, on which basis the European Commission adopted an adequacy decision with respect to the DPF in July 2023, allowing its implementation and availability for companies to use to legitimize transfers of personal data from the E.U.
−Removed: It remains unclear, however, whether this new framework will be appropriate for us to rely upon.
−Removed: The DPF has already faced a legal challenge and it may be subject to additional challenges.
−Removed: Additionally, the European Commission’s adequacy decision regarding the DPF provides that the DPF will be subject to future reviews and may be subject to suspension, amendment, repeal, or limitations to its scope by the European Commission.
−Removed: The CJEU Decision, the revised EU SCCs and UK SCCs, regulatory guidance and opinions, and other developments relating to cross-border data transfer may require us to implement additional contractual and technical safeguards for any personal data transferred out of the EEA, Switzerland, and the United Kingdom, which may increase compliance costs, lead to increased regulatory scrutiny or liability, may require additional contractual negotiations, and may adversely impact our business, financial condition and operating results.
+Added: It remains unclear, however, whether this framework will be appropriate for us to rely upon.
+Added: The DPF has faced a legal challenge and it may be subject to additional challenges.
+Added: Additionally, the European Commission’s adequacy decision regarding the DPF provides
+Added: that the DPF will be subject to future reviews and may be subject to suspension, amendment, repeal, or limitations to its scope by the European Commission.
+Added: Additionally, the U.S.
+Added: Department of Justice issued a final rule that took effect in April 2025 and places limitations, and in some cases prohibitions, on certain transfers of sensitive personal data to data to business partners located in China or with other specified links to China and other designated countries (the “DOJ Sensitive Personal Data Transfer Limitations Rule”).
+Added: These and other developments relating to cross-border data transfer may require us to implement additional contractual and technical safeguards for any personal data transferred out of various jurisdictions, which may increase compliance costs, lead to increased regulatory scrutiny or liability, may require additional contractual negotiations, and may adversely impact our business, financial condition and operating results.
Other jurisdictions have adopted laws and regulations addressing privacy, data protection, data security, or other aspects of data processing, such as data localization.
4 unchanged sentences
We may be required to modify our policies, procedures, and data processing measures in order to address requirements under these or other privacy, data protection, or cybersecurity regimes, and may face claims, litigation, investigations, or other proceedings regarding them and may incur related liabilities, expenses, costs, and operational losses.
−Removed: Further, the current U.S.
−Removed: administration is engaged in a comprehensive evaluation of national security concerns and other risks relating to the transfer of personally identifiable information from the United States to China, and on June 9, 2021, U.S.
+Added: Further, the U.S.
+Added: government has undertaken an evaluation of national security concerns and other risks relating to the transfer of personally identifiable information from the United States to China, and on June 9, 2021, U.S.
President Biden signed an executive order instituting a framework for determining national security risks of transactions that involve applications connected to governments or militaries of certain foreign adversaries or that collect sensitive personal data from U.S.
+Added: consumers, with the DOJ Sensitive Personal Data Transfer Limitations Rule issued in April 2025.
In 2019, an executive order citing national security risks in the telecommunications sector served to block U.S.
2 unchanged sentences
national security risk, those operations may become subject to executive orders, sanctions, or other measures.
−Removed: Any ban or other restriction on our transfer of data to the JV in China may increase costs as we seek operational and data processing alternatives.
+Added: The DOJ Sensitive Personal Data Transfer Limitations Rule, and any other ban or other restriction on our transfer of data to the JV in China, may increase costs as we seek operational and data processing alternatives.
New and proposed privacy, cybersecurity, and data protection laws are also providing new rights to individuals and increasing the penalties associated with non-compliance.
5 unchanged sentences
For example, Virginia, Colorado, Utah, and Connecticut all have enacted state laws that became effective in 2023;
−Removed: Texas, Montana, Oregon, and Florida have adopted laws that have become or will become effective in 2024, Delaware, Iowa, Maryland, Minnesota, Nebraska, New Hampshire, New Jersey and Tennessee have adopted laws that will become effective in 2025;
+Added: Texas, Montana, Oregon, and Florida have adopted laws that became effective in 2024, Delaware, Iowa, Maryland, Minnesota, Nebraska, New Hampshire, New Jersey and Tennessee have adopted laws that have become or will become effective in 2025;
and Indiana, Kentucky, and Rhode Island have adopted laws that will become effective in 2026.
6 unchanged sentences
and international laws that have been applied to protect consumer privacy (including laws regarding unfair and deceptive practices in the U.S.
−Removed: and GDPR in the EU) may be subject to evolving interpretations or applications in light of privacy developments.
+Added: and GDPR in the EU) may be subject to evolving interpretations or applications in light of privacy
+Added: developments.
As a result, we may be subject to significant consequences, including penalties and fines, for any failure to comply with such laws, regulations and directives.
10 unchanged sentences
We have integrated AI, including machine learning, in certain of our products, services and internal operations.
+Added: Some of the uses in our internal operations include using AI to help detect and respond to abnormalities that could indicate a part is about to break, provide our service engineers support on information about parts, analyzing datasets, creating documents for internal purposes, and develop processes for internal departments to manage internal workflows.
Further, certain of our third-party vendors utilize AI and machine learning technologies in furnishing services to us.
2 unchanged sentences
If these AI or machine learning models are incorrectly designed, the performance of our products, services, and business, as well as our reputation, could suffer or we could incur liability through the violation of laws or contracts to which we are a party.
−Removed: Additionally, many countries and regions, including the United States, have proposed new and evolving regulations related to the use of AI and machine learning technologies, and the EU has adopted an AI Act that adopts an overall regulatory framework for AI.
−Removed: The regulations may impose onerous obligations and may require us to unexpectedly rework or reevaluate improvements to be compliant.
+Added: Additionally, new and evolving laws and regulations related to the development and use of AI and machine learning technologies have been proposed, and in certain cases enacted, in various jurisdictions, including the United States, and the EU has adopted an AI Act that adopts an overall regulatory framework for AI.
+Added: These laws and regulations may impose onerous obligations and may require us to unexpectedly rework or reevaluate improvements to be compliant.
Use of AI technologies may expose us to an increased risk of regulatory enforcement and litigation.
−Removed: some of the AI features involve the processing of personal data and may be subject to laws, policies, legal obligations, and codes of conduct related to privacy and data protection.
+Added: Moreover, some of the AI features involve the processing of personal data and may be subject to laws, policies, legal obligations, and codes of conduct related to privacy and data protection.
Though we have taken steps to be thoughtful in our development, training, and implementation of AI, it could pose certain risks to our customers, including patients, clinicians, and healthcare institutions, and it is not guaranteed that regulators will agree with our approach to limiting these risks or to our compliance more generally.
Risks can include, but are not limited to, the potential for errors or inaccuracies in the algorithms or models used by AI, the potential for bias or inaccuracies in the data used to train the AI, the potential for improper processing of personal information, and the potential for cybersecurity breaches that could compromise patient data or product functionality.
−Removed: Such risks could negatively affect the performance of our products, services, and business, as well as our reputation and the reputations of our customers, and we could incur liability through the violation of laws or contracts to which we are a party or civil claims.
+Added: Such risks could negatively affect the performance of
+Added: our products, services, and business, as well as our reputation and the reputations of our customers, and we could incur liability through the violation of laws or contracts to which we are a party or civil claims.
Continued consolidation in the healthcare industry could have an adverse effect on our business, financial condition, or results of operations.
16 unchanged sentences
In addition, we have only limited five‑year patient survival rate data, which is a common long‑term measure of clinical effectiveness in cancer treatment.
−Removed: We also have limited clinical data directly comparing the effectiveness of the CyberKnife platform to other
−Removed: competing platforms.
+Added: We also have limited clinical data directly comparing the effectiveness of the CyberKnife platform to other competing platforms.
Future patient studies or clinical experience may indicate that treatment with the CyberKnife platform does not improve patient survival or outcomes relative to other platforms.
9 unchanged sentences
For example, in recent years, we have experienced delays in shipment of parts to customers as well as increased freight and logistics expenses due to macroeconomic factors and these impacts could intensify.
−Removed: These delays and increased costs have adversely affected our gross margins and net income (loss) and we currently expect such delays and increased costs to continue through the remainder of calendar year 2024, if not longer.
+Added: These delays and increased costs have adversely affected our gross margins and net income (loss) and we currently expect such delays and increased costs to continue through at least calendar year 2025, and potentially longer.
If this continues for longer than we expect or if any of the above occurs our customers may experience further delays and higher costs and our reputation, business, financial condition and results of operations, including our ability to recognize revenue, may be adversely affected.
15 unchanged sentences
In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on our ability to raise funds, if necessary, to continue our operations.
−Removed: Also, because we purchase major components and software for each of our products from third party suppliers and manufacturers, we face the additional risk that infringement claims may be brought against us based on patents and other intellectual property rights that are embodied or contained in, or practiced by, those components (including software components) that we obtain from third parties, and any such claims against us, such as by our direct and indirect suppliers, may additionally allege that we are operating outside the scope of or violating a license or other agreement relating to their intellectual property.
+Added: Also, because we purchase major components and software for each of our products from third party suppliers and manufacturers, we face the additional risk that infringement claims may be brought against us based on patents and other
+Added: intellectual property rights that are embodied or contained in, or practiced by, those components (including software components) that we obtain from third parties, and any such claims against us, such as by our direct and indirect suppliers, may additionally allege that we are operating outside the scope of or violating a license or other agreement relating to their intellectual property.
These third party suppliers or manufacturers may terminate their licenses with us for a variety of reasons, including actual or perceived failures or breaches of contractual commitments, or they may choose not to renew their licenses with us.
20 unchanged sentences
If these measures do not protect our rights adequately, third parties could use our technology, and our ability to compete in the market would be reduced.
−Removed: Although we have attempted to obtain patent coverage for our
−Removed: technology where available and appropriate, there are aspects of the technology for which patent coverage was never sought or never received.
+Added: Although we have attempted to obtain patent coverage for our technology where available and appropriate, there are aspects of the technology for which patent coverage was never sought or never received.
There also may be countries in which we sell or intend to sell the CyberKnife or TomoTherapy platforms but have no patents or pending patent applications.
4 unchanged sentences
In addition, many countries limit the enforceability of patents against certain third parties, including government agencies or government contractors.
−Removed: In these countries, patents may provide limited or no benefit.
+Added: In these countries, patents
+Added: may provide limited or no benefit.
Patent protection must ultimately be sought on a country-by-country basis, which is an expensive and time consuming process with uncertain outcomes.
31 unchanged sentences
The outcomes of such matters are uncertain and difficult to predict.
−Removed: If any such matters are adjudicated against us, in whole or in part, we may be subject to substantial monetary damages, disgorgement of profits and injunctions that prevent us from operating our business, any of which could materially and adversely affect our business and financial condition.
+Added: If any such matters
+Added: are adjudicated against us, in whole or in part, we may be subject to substantial monetary damages, disgorgement of profits and injunctions that prevent us from operating our business, any of which could materially and adversely affect our business and financial condition.
We cannot guarantee that our insurance coverage will be sufficient to cover any damages awarded against us.
10 unchanged sentences
After the customer has expressed an intention to purchase a CyberKnife or TomoTherapy platform, we negotiate and enter into a definitive purchase contract with the customer.
−Removed: The negotiation of terms that are not standard for Accuray may require additional time and approvals.
+Added: The negotiation of terms that are not standard for Accuray typically requires additional time and approvals.
Typically, following the execution of the contract, the customer begins the building or renovation of a radiation‑shielded facility to house the CyberKnife or TomoTherapy platform, which together with the subsequent installation of the CyberKnife or TomoTherapy platform, can take up to 24 months to complete.
6 unchanged sentences
Such events may include a delay in the construction at the customer site or customer delay in obtaining receipt of regulatory approvals such as certificates of need.
−Removed: In addition, disruption in operations of certain customers caused by the COVID-19 pandemic or other macroeconomic factors have resulted in delays in construction, shipment or installation and some have failed to timely pay their obligations when due.
−Removed: For example, reduced budgets and lower capital deployment priority for radiotherapy equipment, along with longer customer installation timelines, in the United States have negatively impacted our revenue during fiscal year 2024, and we expect this will continue to have an impact through fiscal year 2026.
+Added: In addition, disruption in operations of certain customers macroeconomic factors have resulted in delays in construction, shipment or installation and some have failed to timely pay their obligations when due.
+Added: For example, reduced budgets and lower capital deployment priority for radiotherapy equipment, along with longer customer installation timelines, in the United States have negatively impacted our net revenue since fiscal year 2024, and we expect this will continue to have an impact through fiscal year 2026.
If the events which are beyond our control delay the customer from obtaining funding or financing of the entire transaction, we may not be able to recognize revenue for the sale of the entire system because the collectability of contract consideration is not reasonably assured.
1 unchanged sentence
Our historical experience indicates that some of our customers will cancel or renegotiate contracts as economic conditions change or when product offerings change during the long sales cycle.
−Removed: We anticipate a portion of our open contracts may never result
−Removed: in revenue recognition primarily due to the long sales cycle and factors outside of our control including changes in customers' needs or financial condition, changes in government or health insurance reimbursement policies or changes to regulatory requirements.
+Added: We anticipate a portion of our open contracts may never result in revenue recognition primarily due to the long sales cycle and factors outside of our control including changes in customers' needs or financial condition, changes in government or health insurance reimbursement policies or changes to regulatory requirements.
As a result of these fluctuations, it is likely that in some future quarters, our operating results will fall below the expectations of securities analysts or investors.
3 unchanged sentences
If our distributors fail to successfully market and distribute our products, our business will be materially harmed.
−Removed: We have strategic relationships with a number of key distributors for sales and service of our products in certain foreign countries, including the JV in China and other third-party distributors in other regions.
+Added: We have strategic relationships with a number of key distributors for sales and service of our products in certain foreign countries, including the JV in China and other third-party distributors in other regions, including Europe, Russia, the Middle East, Africa, the Asia Pacific region, and Latin America.
+Added: Many of the countries in these regions are not highly developed at this time and therefore, sales opportunities may be limited.
We cannot control the efforts and resources our third party distributors will devote to marketing the CyberKnife or TomoTherapy platforms.
31 unchanged sentences
• we may not be in a position to exercise sole decision making authority regarding any collaboration, partnership, alliance or joint venture, which could result in impasses on decisions or decisions made by our partners, and our partners in such collaborations, partnerships, alliances or joint ventures may have economic or business interests that are, or may become, inconsistent with our interests.
+Added: For example, our JV partner, CNNC High Energy Equipment (Tianjin) Co., Ltd., is a subsidiary of China Isotope and Radiation Corporation, which is a holding subsidiary of China National Nuclear Corporation (“CNNC”), which is a Chinese state-owned entity.
+Added: We may be exposed to certain commercial, operational, and reputational risks as a result of CNNC being a state-owned entity and thus controlled by the Chinese government where CNNC may make politically motivated business decisions that do not align with our commercial interests.
+Added: In addition, CNNC could conduct business with other companies, organizations or institutions that attract unfavorable political attention in the United States, which could harm our reputation.
+Added: CNNC is also on the United States Department of Defense’s list of Chinese Military Companies operating directly or indirectly in the United States under section 1260H of the National Defense Authorization Act for Fiscal Year 2021.
+Added: This designation may result in negative publicity for us and the JV.
+Added: Further regulatory changes adding CNNC or our JV partner to additional lists or export and sanctions related restricted or prohibited parties or further controls on entities viewed as connected to the Chinese military could impact the JV.
+Added: Any such actions could negatively impact our relationship with CNNC, which could materially and adversely affect our business, financial condition, results of operations and profitability;
• collaborations, partnerships, alliances and joint ventures can be difficult to manage and may involve significant expense and divert the focus and attention of our management and other key personnel away from our existing businesses;
20 unchanged sentences
The failure to successfully consummate such strategic transactions and effectively integrate and execute following such consummation may have an adverse impact on our growth, profitability, financial position and results of operations.
−Removed: We have identified material weaknesses in our system of internal controls as of June 30, 2024 and are in the process of remediation.
−Removed: If we fail to remediate such material weakness or otherwise fail to achieve and maintain an effective system of internal control over financial reporting, our ability to produce timely and accurate financial results could be adversely impacted.
+Added: We previously identified material weaknesses in our system of internal controls as of June 30, 2024.
+Added: Although such material weaknesses have been remediated, if we fail to maintain an effective system of internal control over financial reporting, our ability to produce timely and accurate financial results could be adversely impacted.
As a result, current and potential stockholders could lose confidence in our financial reporting, which could have an adverse effect on our business and our stock price.
1 unchanged sentence
If we cannot maintain effective controls and provide timely and reliable financial reports, our business and operating results could be harmed.
−Removed: As more fully disclosed in Part II, Item 9A “Controls and Procedures,” in the course of preparing the audited consolidated financial statements for this Annual Report on Form 10-K, the Company concluded that as of June 30, 2024, its internal control over financial reporting was not effective as a result of two material weaknesses at the control activity level related to ensuring all manual journal entries consistently enforced segregation of duties in the approval process and ensuring that the existence of inventory at manufacturing warehouse locations was accurate.
+Added: In the course of preparing the audited consolidated financial statements for the Company’s Annual Report on Form 10-K for the year ended June 30, 2024, the Company concluded that as of June 30, 2024, its internal control over financial reporting was not effective as a result of two material weaknesses at the control activity level related to ensuring all manual journal entries consistently enforced segregation of duties in the approval process and ensuring that the existence of inventory at manufacturing warehouse locations was accurate.
These material weaknesses were specifically related to the implementation of the Company’s new ERP system in August 2023 and did not result in any material identified misstatements to the consolidated financial statements, and there were no changes to previously issued financial results.
−Removed: Management is actively engaged in the planning for, and implementation of, remediation efforts to address these material weaknesses.
−Removed: However, we may not be successful in promptly remediating the material weaknesses identified by management or be able to identify and remediate additional control deficiencies, including material weaknesses, in the future.
+Added: Management also concluded that the Company's disclosure controls and procedures were not effective as of June 30, 2024, September 30, 2024, and December 31, 2024 due to the material weaknesses.
+Added: For a discussion of
+Added: management’s considerations of the Company’s disclosure controls and procedures, internal control over financial reporting, and the material weaknesses identified, refer to Controls and Procedures in Part I, Item 4.
+Added: Although the material weaknesses have both been remediated as of March 31, 2025, these remediation efforts have been time consuming and costly and may continue to incur additional time and expense.
+Added: We may not be able to identify and remediate additional control deficiencies, including material weaknesses, in the future.
+Added: We cannot assure you that the measures we have taken to date, or any measures we may take in the future, will be sufficient to prevent or avoid potential future material weaknesses.
Our management may also be unable to conclude in future periods that our disclosure controls and procedures are effective due to the effects of various factors, which may, in part, include unremediated material weaknesses in internal control over financial reporting.
−Removed: Any further disruptions or difficulties that may occur in connection with our ERP system or other systems (whether in connection with the regular operation, periodic enhancements, modifications or upgrades of such systems or the integration of any acquired businesses into such systems, or due to cybersecurity events such as ransomware attacks) could adversely impact the effectiveness of our internal control over financial reporting as well as affect our ability to manufacture products, process orders, deliver products, provide customer support, fulfill contractual obligations, track inventories, or otherwise operate our business, in particular as a result of our limited experience implementing such systems and the
−Removed: complex nature of the system itself.
+Added: Any further disruptions or difficulties that may occur in connection with our ERP system or other systems (whether in connection with the regular operation, periodic enhancements, modifications or upgrades of such systems or the integration of any acquired businesses into such systems, or due to cybersecurity events such as ransomware attacks) could adversely impact the effectiveness of our internal control over financial reporting as well as affect our ability to manufacture products, process orders, deliver products, provide customer support, fulfill contractual obligations, track inventories, or otherwise operate our business, in particular as a result of our limited experience implementing such systems and the complex nature of the system itself.
Any failure to establish and maintain effective disclosure controls and procedures and internal control over financial reporting, including due to a failure to remediate the material weaknesses mentioned above or the discovery or occurrence of any additional material weaknesses in our internal control over financial reporting in the future, could adversely affect our ability to prepare financial statements within required time periods and record, process and report financial information accurately, which could result in material misstatements in our financial statements and cause us to fail to meet our reporting and financial obligations, negatively impact the price of our common stock, limit our liquidity and access to capital markets, adversely affect our business, harm our reputation or subject us to litigation or investigations requiring management resources and payment of legal and other expenses.
14 unchanged sentences
Failures at banks and other financial institutions, or issues in the broader U.S.
−Removed: financial system, including uncertainty related to the debt ceiling, increased interest rates, and lack of availability of credit, which may have an impact on the broader capital markets and, in turn, our ability to access those markets.
+Added: financial system, including uncertainty related to the debt ceiling,
+Added: increased interest rates, and lack of availability of credit, which may have an impact on the broader capital markets and, in turn, our ability to access those markets.
In addition, the tightening of the credit markets and lending standards could it make more difficult to raise capital through either debt or equity offerings on commercially reasonable terms or at all.
1 unchanged sentence
The sale of additional equity securities or convertible debt securities would result in additional dilution to our stockholders.
+Added: In particular, the Warrants that we issued to the lenders in connection with the Credit Facilities contain anti-dilution provisions, among other things, including price protection anti-dilution protection in the event that the Company sells stock at a price below $1.00 per share in the case of the Penny Warrants and $1.25 per share in the case of the Premium Warrants.
We cannot assure that additional financing, if required or desired, will be available in amounts or on terms acceptable to us, if at all.
−Removed: If we are unable to obtain adequate financing or financing on terms satisfactory to us when we require it, our ability to continue to support our business growth and to respond to business challenges could be significantly impaired, and our business may be adversely affected.
+Added: If we are unable to obtain adequate financing or financing on terms satisfactory to us when we require it, our ability to continue to support our business growth and to respond to business challenges, and our business and ability to continue as a going concern may be adversely affected.
If we need to accept less favorable terms, it could increase our cost of capital, reduce our cash balances or otherwise restrict our ability to grow.
2 unchanged sentences
The federal and state carryforwards expire in varying amounts beginning in 2029 for federal and 2026 for state purposes.
−Removed: In addition, as of June 30, 2024, we had federal and state research and development tax credit
−Removed: carryforwards of approximately $28.4 million and $22.8 million, respectively.
+Added: In addition, as of June 30, 2025, we had federal and state research and development tax credit carryforwards of approximately $28.5 million and $22.8 million, respectively.
The California research credits have no expiration date, but if not utilized, the federal research credits and other non-California state research credits will begin to expire in 2026.
Federal net operating losses arising in tax years beginning after December 31, 2017 are subject to an 80% of taxable income limitation (as calculated before taking the net operating losses into account).
−Removed: It is uncertain if and to what extent various states will conform to the Tax Act Coronavirus Aid, Relief and Economic Security Act (the “CARES Act”).
−Removed: In addition, utilization of our net operating loss and credit carryforwards is subject to annual limitation due to the application of the ownership change limitations provided by Section 382 of the Internal Revenue Code and similar state provisions to us.
−Removed: Future changes in our stock ownership, including future offerings, as well as changes that may be outside of our control, could result in an ownership change under Section 382 of the Internal Revenue Code.
+Added: It is uncertain if and to what extent various states will conform to these limitations.
+Added: In addition, utilization of our net operating loss and credit carryforwards is subject to annual limitation due to the application of the ownership change limitations provided by Section 382 of the Internal Revenue Code (“IRC”) and similar state provisions to us.
+Added: Future changes in our stock ownership, including future offerings, as well as changes that may be outside of our control, could result in an ownership change under Section 382 of the IRC.
In addition, the use of our net operating losses and other tax attributes may be subject to other limitations under applicable law.
−Removed: On June 27, 2024, California enacted Senate Bill 167 and 175 which included suspension on the use of state net operating losses beginning with our fiscal years 2025, 2026, and 2027.
−Removed: This new California law should not have a material impact on our financials due to our low sales apportionment in the state.
−Removed: Additionally, one of the provisions under the Tax Cuts and Jobs Act that became effective in tax years beginning after December 31, 2021 required the capitalization and amortization of research and experimental expenditures, and although this change did not have an impact on our current consolidated financial statements, it may have an impact on future periods as our research and experimental expenditures have been a material amount on our financial statements.
+Added: Additionally, one of the provisions under the Tax Cuts and Jobs Act that became effective in tax years beginning after December 31, 2021 required the capitalization and amortization of domestic and foreign research and experimental expenditures.
+Added: On July 4, 2025, the One Big Beautiful Bill Act (the “OBBB Act”) was enacted, which makes a number of changes to U.S.
+Added: federal income tax law, including permanently suspending the requirement to capitalize and amortize domestic research and development expenditures and permitting such deductions on a current basis.
+Added: We are currently evaluating the full impact of the OBBB Act on us.
We are subject to the tax laws of various foreign jurisdictions, as well as within the United States, which are subject to unanticipated changes and interpretation and could harm our future results.
4 unchanged sentences
Further, tax laws are subject to change, which could adversely impact our tax rate.
−Removed: A number of countries, as well as organizations such as the Organization for Economic Cooperation and Development, support the 15% global minimum tax initiative, and have adopted or intend to adopt laws to implement this initiative.
−Removed: Such countries and organizations are also actively considering changes to existing tax laws or have proposed or enacted new laws that could increase our tax obligations in countries where we do business or cause us to change the way we operate our business, which could materially impact our results of operation.
+Added: A number of countries, as well as organizations such as the Organization for Economic Cooperation and Development, support the 15% global minimum tax initiative ("Pillar Two"), and have adopted or intend to adopt laws to implement this initiative.
+Added: However, on June 28, 2025, the G7 released a joint statement that it had reached an understanding with the United States for a side-by-side system based on certain accepted principles, including that U.S.-parented groups, such as ours, would be exempt from certain provisions of Pillar Two.
+Added: Many countries and organizations are also actively considering changes to existing tax laws or have proposed or enacted new laws, such as the OBBB Act, that could increase our tax obligations in countries where we do business or cause us to change the way we operate our business, which could materially impact our results of operation.
Risks Related to the Regulation of our Products and Business
1 unchanged sentence
Such modifications, or any defects in design, manufacture or labeling may require us to recall or cease marketing the affected systems or software until approvals or clearances are obtained.
−Removed: The CyberKnife and TomoTherapy platforms as well as the Precision Treatment Planning with iDMS Data Management System software are medical devices that are subject to extensive regulation in the United States by local, state and the federal government, including the FDA.
−Removed: The FDA cleared the latest imaging feature for the Radixact System, ClearRT TM , under K202412 on December 18, 2020.
+Added: The CyberKnife and TomoTherapy platforms as well as the Precision Treatment Planning software are medical devices that are subject to extensive regulation in the United States by local, state and the federal government, including the FDA.
+Added: The iDMS Data Management System may be regulated as a medical device in some markets.
+Added: The FDA most recently cleared Surface Guided Radiation Therapy (SGRT) on Radixact System under K223159 on June 23, 2023.
+Added: ClearRT TM for onboard kVCT imaging was previously cleared on the Radixact System under K202412 on December 18, 2020.
The FDA regulates virtually all aspects of a medical device design, development, testing manufacturing, labeling, storage, record keeping, adverse event reporting, sale, promotion, distribution and shipping.
3 unchanged sentences
The process of obtaining premarket approval is much more costly and uncertain than the 510(k) clearance process and it generally takes from one to three years, or even longer, from the time the application is filed with the FDA.
−Removed: Additionally, outside of the United States, our products are subject to clearances and approvals by
−Removed: foreign governmental agencies similar to the FDA.
+Added: Additionally, outside of the United States, our products are subject to clearances and approvals by foreign governmental agencies similar to the FDA.
In order to market our products internationally, we must obtain licenses or approvals from these governmental agencies, which could include local requirements, safety standards, testing or certifications, and can be time consuming, burdensome and uncertain.
16 unchanged sentences
Any modification to an FDA approved or cleared device that would significantly affect its safety or efficacy or that would constitute a major change in its intended use would require a new premarket approval or 510(k) clearance.
−Removed: We cannot assure you that the FDA will agree with our decisions not to seek approvals or clearances for particular device modifications or that we will be successful in obtaining premarket approvals or 510(k) clearances for modifications in a timely fashion, if at all.
+Added: We cannot assure you that the FDA will agree with our decisions not to seek approvals or clearances for particular device
+Added: modifications or that we will be successful in obtaining premarket approvals or 510(k) clearances for modifications in a timely fashion, if at all.
We have obtained 510(k) clearance for the CyberKnife platform for the treatment of conditions anywhere in the body when radiation treatment is indicated, and we have obtained 510(k) clearance for the TomoTherapy platform to be used as integrated systems for the planning and delivery of IMRT for the treatment of cancer.
5 unchanged sentences
In these circumstances, we may also be subject to significant enforcement action.
−Removed: If any of these events were to occur,
−Removed: our ability to introduce new or enhanced products in a timely manner would be adversely affected, which in turn would harm our future growth.
+Added: If any of these events were to occur, our ability to introduce new or enhanced products in a timely manner would be adversely affected, which in turn would harm our future growth.
We are subject to federal, state and foreign laws and regulations applicable to our operations, the violation of which could result in substantial penalties and harm our business.
13 unchanged sentences
Although we do not submit claims directly to payors, manufacturers can be held liable under these laws if they are deemed to “cause” the submission of false or fraudulent claims by providing inaccurate billing or coding information to customers, or through certain other activities, including promoting products for uses or indications that are not approved by the FDA.
−Removed: In addition to actions initiated by the government itself, the federal False Claims Act authorizes actions to be brought on behalf of the federal government by a private party having knowledge of the alleged fraud called a “relator”.
−Removed: Because the complaint is initially filed under seal, the action may be pending for some time before the defendant is even aware of the action.
+Added: In addition to actions initiated by the
+Added: government itself, the federal False Claims Act authorizes actions to be brought on behalf of the federal government by a private party having knowledge of the alleged fraud called a “relator.” Because the complaint is initially filed under seal, the action may be pending for some time before the defendant is even aware of the action.
If the government is ultimately successful in obtaining redress in the matter or if the relator succeeds in obtaining redress without the government’s involvement, then the relator is typically entitled to receive a percentage of the recovery.
6 unchanged sentences
Both the scope and exceptions for such laws vary from state to state.
−Removed: If our past or present operations are found to be in violation of any of these “anti‑kickback,” “false claims,” “self‑referral” or other similar laws in foreign jurisdictions, we may be subject to the applicable penalty associated with the violation, which
−Removed: may include significant civil and criminal penalties, damages, fines, imprisonment and exclusion from healthcare programs.
+Added: If our past or present operations are found to be in violation of any of these “anti‑kickback,” “false claims,” “self‑referral” or other similar laws in foreign jurisdictions, we may be subject to the applicable penalty associated with the violation, which may include significant civil and criminal penalties, damages, fines, imprisonment and exclusion from healthcare programs.
The impact of any such violations may lead to curtailment or restructuring of our operations, which could adversely affect our ability to operate our business and our financial results.
16 unchanged sentences
licensed physicians and teaching hospitals as well as physician ownership of such applicable manufacturer’s equity, in each case subject to certain statutory exceptions.
−Removed: Furthermore, on October 25, 2018, President Trump signed into law the “Substance Use-Disorder Prevention that Promoted Opioid Recovery and Treatment for Patients and Communities Act” which in part (under a provision entitled “Fighting the Opioid Epidemic with Sunshine”) extends the reporting and transparency requirements for physicians in the Physician Payments Sunshine Act to physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives.
+Added: Furthermore, on October 25, 2018, President
+Added: Trump signed into law the “Substance Use-Disorder Prevention that Promoted Opioid Recovery and Treatment for Patients and Communities Act” which in part (under a provision entitled “Fighting the Opioid Epidemic with Sunshine”) extends the reporting and transparency requirements for physicians in the Physician Payments Sunshine Act to physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives.
Such data is available by the government on a publicly searchable website.
26 unchanged sentences
There may be variability in review timeframes and requirements as both manufacturers and authorities navigate these new requirements.
−Removed: In addition, the EU and Switzerland failed to establish a Mutual Recognition Agreement (“MRA”) for medical devices to include Switzerland within the MDR and as a result, Switzerland has initiated its own medical device regulation similar to the EU MDR, which will require additional registrations for economic operators and products within Switzerland for our devices.
+Added: In addition, the EU and Switzerland failed to establish a Mutual Recognition Agreement (“MRA”) for medical devices to include Switzerland within the MDR and as a result, Switzerland has initiated its own
+Added: medical device regulation similar to the EU MDR, which will require additional registrations for economic operators and products within Switzerland for our devices.
Under the Pharmaceutical Affairs Law in Japan, a pre‑market approval necessary to sell, market and import a product, or Shonin, must be obtained from the Ministry of Health, Labor and Welfare (“MHLW”), for our products.
9 unchanged sentences
Failure to meet these standards could limit our ability to market our products in those regions that require compliance to such standards.
−Removed: For example, the European Union has adopted directives that may lead to restrictions on the use of certain hazardous substances or other regulated substances in some of our products sold there, unless such products are
−Removed: eligible for an exemption.
+Added: For example, the European Union has adopted directives that may lead to restrictions on the use of certain hazardous substances or other regulated substances in some of our products sold there, unless such products are eligible for an exemption.
While we believe that certain of our products are exempt, there can be no guarantee that such determination would not be challenged or that the regulations would not change in a way that would subject our products to such regulation.
4 unchanged sentences
In particular, on December 14, 2018, a Texas U.S.
−Removed: District Court Judge ruled that the ACA is unconstitutional in its entirety because the “individual mandate” was repealed by Congress as part of the Tax Act.
+Added: District Court Judge ruled that the ACA is unconstitutional in its entirety because the “individual mandate” was repealed by Congress as part of the Tax Cuts and Jobs Act.
Additionally, on December 18, 2019, the U.S.
10 unchanged sentences
Future legislative or policy initiatives directed at reducing costs or limiting coverage or amounts of reimbursement available for our products could be introduced at either the federal or state level, which could have a negative impact on the demand for our products and services, and therefore on our financial position and results of operations.
−Removed: We cannot predict what healthcare reform legislation or regulations, if any, including any potential repeal or amendment of the ACA, will be enacted in the United States or elsewhere, what impact any legislation or regulations related to the healthcare system that may be enacted or adopted in the future might have on our business, or the effect of ongoing uncertainty or public perception about these matters will have on the purchasing decisions of our customers.
+Added: We cannot predict what healthcare reform legislation or regulations, if any, including any potential repeal or amendment of the ACA, will be
+Added: enacted in the United States or elsewhere, what impact any legislation or regulations related to the healthcare system that may be enacted or adopted in the future might have on our business, or the effect of ongoing uncertainty or public perception about these matters will have on the purchasing decisions of our customers.
However, the implementation of new legislation and regulation may materially lower reimbursements for our products, materially reduce medical procedure volumes and significantly and adversely affect our business.
10 unchanged sentences
• variations in our operating results, as well as costs and expenditures;
−Removed: • impacts to our business, operations or financial condition caused by concerns in connection with the global economic environment, supply chain disruptions or as a result of the upcoming U.S.
−Removed: presidential election;
+Added: • impacts to our business, operations or financial condition caused by concerns in connection with the global economic environment, supply chain disruptions or as a result of changes in government administration policy positions;
• regulatory developments related to manufacturing, marketing or sale of the CyberKnife or TomoTherapy platform;
−Removed: • political or social uncertainties, including as a result of the Russia-Ukraine and Israel-Hamas conflicts;
+Added: • political or social uncertainties, including as a result of the Russia-Ukraine and the Middle East conflicts including with respect to Iran;
• changes in product pricing policies;
8 unchanged sentences
We may issue equity securities in the future for a number of reasons, including to finance our operations and business strategy (including in connection with acquisitions, strategic collaborations or other transactions), to adjust our ratio of debt to equity, to satisfy our obligations upon the exercise of outstanding options or for other reasons.
−Removed: In May 2021, we issued $100.0 million aggregate principal amount of the Notes.
−Removed: We exchanged approximately $82.1 million aggregate principal amount of then-outstanding 3.75% Convertible Senior Notes due 2022 for approximately $97.1 million aggregate principal amount of the Notes and issued approximately $2.9 million aggregate principal amount of the Notes to certain other qualified new investors for cash.
−Removed: To the extent we issue common stock upon conversion of any outstanding convertible notes, that conversion would dilute the ownership interests of our stockholders.
+Added: In addition, to the extent we issue common stock upon conversion of any outstanding convertible notes such as the 2026 Notes, that conversion would dilute the ownership interests of our stockholders.
+Added: The exercise of outstanding warrants for our common stock would increase the number of shares eligible for future resale in the public market and result in dilution to our stockholders.
+Added: The exercise of outstanding warrants to acquire our common stock will increase the number of shares eligible for future resale in the public market and result in dilution to our stockholders.
+Added: As of June 30, 2025, there are (i) an aggregate of 17,180,710 shares of our common stock issuable upon exercise of the Premium Warrants, and (ii) an aggregate of 6,247,531 shares of our common stock issuable upon exercise of the Penny Warrants (together, the “Warrants”).
+Added: If we use the Delayed Draw Down Facility, we will be subject to issuing additional detachable warrants to our lender and its investors.
+Added: Sales of substantial numbers of such shares in the public market could adversely affect the market price of our shares.
+Added: In addition, the perceived risk of dilution as a result of the number of outstanding Warrants may cause our stockholders to be more inclined to sell their shares, which would contribute to a downward movement in the price of our common stock.
+Added: Moreover, the perceived risk of dilution and the resulting downward pressure on our common stock price could encourage investors to engage in short sales of our common stock, which could further contribute to price declines in our common stock.
+Added: The fact that our warrant holders can sell substantial amounts of our common stock in the public market could make it more difficult for us to raise additional funds through the sale of equity or equity-related securities in the future at a time and price that we deem reasonable or appropriate, or at all.
+Added: In addition, the Warrants have certain anti-dilution protection provisions, including price protection anti-dilution protection in the event that the Company sells stock at a price below $1.00 per share in the case of the Penny Warrants and $1.25 per share in the case of the Premium Warrants.
+Added: Depending on the nature and price of any equity issuances by us, the number of shares of common stock issuable upon the exercise of such Warrants could be increased and that would likely make an equity financing more difficult.
The conditional conversion features of the 2026 Notes, if triggered, may adversely affect our financial condition and operating results.
1 unchanged sentence
If one or more holders elect to convert such notes, unless we elect to satisfy our conversion obligation by delivering solely shares of our common stock (other than paying solely cash in lieu of any fractional share), including if we have irrevocably elected full physical settlement upon conversion, we would be required to make cash payments to satisfy all or a portion of our conversion obligation based on the applicable conversion rate, which could adversely affect our liquidity.
−Removed: In addition, even if holders do not elect to convert such notes, if we have irrevocably elected net share settlement upon conversion we could be required under applicable accounting rules to reclassify all or a portion of the outstanding principal of such notes as a current rather than long‑term liability, which could result in a material reduction of our net working capital.
−Removed: Provisions in the indenture for the Notes, the credit agreement for our Credit Facilities, our certificate of incorporation and our bylaws could discourage or prevent a takeover, even if an acquisition would be beneficial in the opinion of our stockholders.
+Added: Provisions in the indenture for the 2026 Notes, the Financing Agreement for our Credit Facilities, our certificate of incorporation and our bylaws could discourage or prevent a takeover, even if an acquisition would be beneficial in the opinion of our stockholders.
Provisions of our certificate of incorporation and bylaws could make it more difficult for a third‑party to acquire us, even if doing so would be beneficial in the opinion of our stockholders.
7 unchanged sentences
In addition, Section 203 of the Delaware General Corporation Law may discourage, delay or prevent a change of control of our company.
−Removed: Generally, Section 203 prohibits stockholders who, alone or together with their affiliates and associates, own more than 15% of the subject company from engaging in certain business combinations for a period of three years following the date that the stockholder became an interested stockholder of such subject company without approval of the board or 66 2 / 3 % of the independent stockholders.
+Added: Generally, Section 203 prohibits stockholders who, alone or together with their affiliates and associates,
+Added: own more than 15% of the subject company from engaging in certain business combinations for a period of three years following the date that the stockholder became an interested stockholder of such subject company without approval of the board or 66 2 / 3 % of the independent stockholders.
The existence of these provisions could adversely affect the voting power of holders of common stock and limit the price that investors might be willing to pay in the future for shares of our common stock.
21 unchanged sentences
natural disasters, such as hurricanes, floods, tornadoes and earthquakes;
−Removed: war or terrorist activities (including the conflicts between Russia and Ukraine and Israel and Hamas);
+Added: war or terrorist activities (including the conflicts in Russia-Ukraine and the Middle East including with respect to Iran);
unplanned outages;
10 unchanged sentences
Further, concerns about terrorism, the effects of a terrorist attack, political turmoil or an epidemic outbreak could have a negative effect on our operations and the operations of our suppliers and customers and the ability to travel, which could harm our business, financial condition and results of operations.
−Removed: For example, the COVID-19 pandemic and its effects on the global economic environment adversely impacted the pace at which our backlog converted to revenue due to delays in deliveries and installations.
−Removed: Additionally, China has suffered health epidemics including COVID-19, which could adversely affect our operations in China, including our manufacturing operations in Chengdu, as well as the operations of the JV and those of our customers.
−Removed: For example, as a result of COVID-19 related restrictions in China, sales in China decreased and we experienced delays in the JV obtaining certain necessarily regulatory approvals.
In addition, risks associated with climate change are subject to increasing societal, regulatory and political focus in the U.S.
2 unchanged sentences
In addition, increased public concern over climate change has and could result in new legal or regulatory requirements designed to mitigate the effects of climate change, including regulating greenhouse gas emissions, alternative energy policies, and sustainability initiatives.
−Removed: Although the SEC issued an order implementing a stay of its final climate-related disclosure rules, there have also been substantial legislative and regulatory developments on climate-related issues, including proposed, issued and implemented legislation and rulemakings that would require companies to
−Removed: assess and/or disclose climate metrics, risks, opportunities, policies and practices by both the Securities and Exchange Commission and California.
+Added: Although the SEC issued an order implementing a stay of its final climate-related disclosure rules, there have also been substantial legislative and regulatory developments on climate-related issues, including proposed, issued and implemented legislation and rulemakings that would require companies to assess and/or disclose climate metrics, risks, opportunities, policies and practices by both the Securities and Exchange Commission and California.
These initiatives could result in the adoption of more stringent environmental laws and regulations or stricter enforcement of existing laws and regulations, which could result in increased compliance burden and costs to meet such regulatory obligations and could also impact how we source raw materials from suppliers, our manufacturing operations, and how we distribute our products.
−Removed: There also may be increasing scrutiny and changing expectations from the market and other stakeholders with respect to Environmental, Social, and Governance practices.
+Added: There has also been increasing scrutiny and changing expectations from the market and other stakeholders with respect to Environmental, Social, and Governance ("ESG") practices.
+Added: Opinions, perspectives and expectations on ESG matters may differ among our stakeholders and may evolve over time.
+Added: We have been and may continue to be subject to conflicting expectations and views on various matters, and legal requirements and interpretations may change.
Any such developments could have a significant effect on our operating and financial decisions, including those involving capital expenditures to comply with new regulatory requirements or stakeholder expectations, which could harm our business, financial condition and results of operations.
+Added: If we fail to comply with certain ESG-related laws, our products become non-compliant with such laws, or we fail to meet the expectations of our stakeholders on ESG-related matters, it could result in a loss of market access or a decline in our success in competitive bidding or public tender processes, and we could incur costs or face other sanctions, such as restrictions on our products entering certain jurisdictions, fines, and/or civil or criminal sanctions.
Changes in interpretation or application of generally accepted accounting principles may adversely affect our operating results.
15 unchanged sentences
We evaluate and monitor cybersecurity risk as part of our overall enterprise risk management program, which considers cybersecurity risks alongside other company risks as part of our overall risk assessment process.
−Removed: In addition, the risk oversight responsibility of our Board of Directors and its committees is supported by our cybersecurity risk assessment program, which include policies and processes that are designed to provide visibility and information about the identification, assessment, and management of critical risks and management’s risk mitigation strategies, to our Board of Directors and personnel that are responsible for risk assessment.
−Removed: These policies also govern the security of our products and the protection of customer and patient data, provide for vulnerability remediation, regular system updates and patches, employee training on cybersecurity and HIPAA best practices, incident reporting, and the use of encryption to secure sensitive information.
+Added: In addition, the risk oversight responsibility of our Board of Directors and its committees is supported by our cybersecurity risk assessment program, which includes policies and processes that are designed to provide visibility and information about the identification, assessment, and management of critical risks and management’s risk mitigation strategies to our Board of Directors and personnel that are responsible for risk assessment.
+Added: These policies also govern the security of our products and the protection of customer and patient data and provide for vulnerability remediation, regular system updates and patches, employee training on cybersecurity and HIPAA best practices, incident reporting, and the use of encryption to secure sensitive information.
To identify, assess, and manage material cybersecurity risks, our team uses a cybersecurity risk assessment process aligned with leading frameworks such as the National Institute of Standards and Technology’s Cyber Security Framework and HIPAA.
−Removed: Our cybersecurity risk assessment
−Removed: program provides the underlying basis for the activities of our team to identify and mitigate risks from, as well as develop risk management and response strategies for, evolving and emerging cybersecurity threats.
+Added: Our cybersecurity risk assessment program provides the underlying basis for the activities of our team to identify and mitigate risks from, as well as develop risk management and response strategies for, evolving and emerging cybersecurity threats.
Our cybersecurity program includes a variety of processes to assess, identify and manage risks from cybersecurity threats arising from our own and third-party provided systems, including annual training requirements, simulation exercises, threat monitoring and detection tools (including those using artificial intelligence and machine learning), threat containment methods, risk assessments, third-party penetration testing and security requirements for our suppliers and other third parties.
5 unchanged sentences
To this end, we engage in the periodic assessment of our policies, standards, processes, and practices that are designed to address cybersecurity threats and incidents, internally and through assessments by external providers.
−Removed: The results of such assessments, audits, and reviews are reported to the Audit Committee and the Board of Directors, and we adjust our cybersecurity policies, standards, processes, and practices as necessary based on the information provided by these assessments, audits, and reviews.
+Added: The results of such assessments, audits, and reviews are reported to the Audit Committee and the
+Added: Board of Directors, and we adjust our cybersecurity policies, standards, processes, and practices as necessary based on the information provided by these assessments, audits, and reviews.
We also monitor and test our safeguards and train all our employees on cybersecurity safeguards related to our information technology systems.
6 unchanged sentences
and confirmation by each service provider that its SOC-2 reports, or equivalent reports, are current and available, where applicable.
−Removed: In the event a service provider does not have a current and available SOC-2 or equivalent report, we review of the service provider’s cybersecurity risk management and advise relevant business stakeholders of any significant identified risks.
+Added: In the event a service provider does not have a current and available SOC-2 or equivalent report, we review the service provider’s cybersecurity risk management and advise relevant business stakeholders of any significant identified risks.
While we regularly experience cybersecurity incidents, and we expect to continue to be subject to such incidents, as of the date of this report, we are not aware of any cybersecurity incidents that have had or are reasonably likely to have a material impact on our business or operations.
1 unchanged sentence
Risk Factors in the risk factor entitled “Disruption of critical information technology systems, infrastructure and data or cyberattacks or other security breaches or incidents could harm our business and financial condition.”
−Removed: Our Board of Directors, both directly and through the delegation of responsibilities to the Audit Committee, oversees the proper functioning of our cybersecurity risk management program and ensures strategic alignment and governance of our cybersecurity efforts at the highest level.
+Added: Our Board of Directors, both directly and through the delegation of responsibilities to the Audit Committee, oversees the functioning of our cybersecurity risk management program and ensures strategic alignment and governance of our cybersecurity efforts at the highest level.
Our Board of Directors receives periodic briefings on the outcome of our cybersecurity risk management program, including steps that we are taking to mitigate risks that the program identifies, and each quarter, the Audit Committee reviews cybersecurity incidents, metrics, and the state of the program.
2 unchanged sentences
Our Chief Information and Security Officer also serves as the officer who reports directly to senior management and makes regular reports to the Audit Committee and Board of Directors as described in this Item 1C .
−Removed: Under the direction of our Chief Information and Security Officer and deputy CISO, we monitor developments that could affect our long-term organizational cybersecurity strategy based on threats globally and to enhance our cybersecurity program as needed in response to such developments.
+Added: Under the direction of our Chief Information and Security Officer and Deputy CISO, we monitor developments that could affect our long-term organizational cybersecurity strategy based on threats globally and work to enhance our cybersecurity program as needed in response to such developments.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.