• Data Highlight Expanding Use of (Ultra) Hypofractionated Treatments, Benefits in Patient Care Made Possible by the Precision and Accuracy of Accuray Technologies

SUNNYVALE, Calif., May 17, 2023 /PRNewswire/ -- Accuray Incorporated (NASDAQ: ARAY) announced today that new data presented at the European Society for Radiotherapy and Oncology (ESTRO) meeting reinforces the benefits of the company's CyberKnife^® and TomoTherapy^® platforms, including the latest generation Radixact^® System. More than 55 abstracts highlighting Accuray technologies were presented at the 2023 ESTRO annual congress held in Vienna, Austria, from May 12 to May 16, 2023, building on existing clinical evidence and supporting the systems' use to deliver (ultra) hypofractionated radiation treatments for the precise and personalized treatment of a wide range of cancers.

"Accuray is committed to advancing radiotherapy and providing innovative, clinically relevant solutions that enable medical care teams to easily deliver the most precise and accurate hypofractionated treatments with confidence – and certainty – each and every treatment session. The ESTRO data show our customers are delivering shorter, more personalized, and more effective treatments, helping to maximize the results patients want and minimize the side effects they don't. We look forward to continuing to partner with those involved in patient care, empowering them to treat more patients, better and faster, than ever before," said Suzanne Winter, president and CEO of Accuray.

During the meeting, Accuray hosted a symposium titled "Advances in Hypofractionation for Breast and Prostate Cancer" featuring clinical experts who discussed the most recent – and promising – clinical studies. Hypofractionated radiotherapy – the delivery of higher doses of radiation over a small number of treatment sessions – provides an efficient and effective treatment option for an increasing number of indications and may improve patients' clinical and financial experiences. The company also unveiled the VitalHold™* breast package for the Radixact System. This new functionality is designed to enable medical care teams to provide an integrated and automated Deep Inspiration Breath Hold (DIBH) solution using Surface Guided Radiation Therapy (SGRT) that simplifies the delivery of ultra-precise treatments, enhancing the safety and speed of care.

"The information sharing that takes place at meetings such as ESTRO is focused on the same critical goal – improving patient care. The breadth of data presented at this year's meeting continues to provide compelling evidence supporting the unique benefits of Accuray CyberKnife and TomoTherapy platforms and their potential to optimize the way cancer is managed throughout the continuum of the care journey," said Seth Blacksburg, M.D., MBA, Chief Medical Officer at Accuray. "The precision and accuracy of the systems, along with Synchrony^® real-time tracking and adaptation technology, enable effective treatments to be completed in the shortest possible schedule, freeing up precious time for those diagnosed with cancer to live their lives."

ESTRO Study Highlights: Advances in Patient Care

CyberKnife Platform for Prostate Cancer: The CyberKnife platform offers an effective treatment option for prostate tumors, of which move unpredictably during treatment, with just five sessions required. Studies on CyberKnife stereotactic body radiation therapy (SBRT) have shown its ability to:

• Effectively treat low-risk disease, preserving quality of life and challenging other treatment alternatives. Study authors concluded, "SBRT is a focused therapy that is feasible, well-tolerated, and preserves quality of life. This innovative robotized approach challenges other focused treatment alternatives as well as active surveillance¹."
• Provide a "safe and viable treatment option" for locally recurrent prostate cancer after definitive radiotherapy, supported by five years of median follow-up².
• Offer a viable treatment option with mild toxicity for patients experiencing prostate bed recurrence following prostatectomy³.

CyberKnife^® Platform for Metastatic Diseases: The CyberKnife platform offers targeted treatment that effectively manages challenging metastatic diseases, often requiring fewer treatment sessions. In some cases, just one treatment session is sufficient. Studies on CyberKnife stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT) highlight the system's capabilities, including:

• Providing a feasible treatment option with excellent local tumor control and minimal side effects for select patients with more than 10 brain metastases⁴.
• Delivering ablative doses to target spinal metastases, ensuring good local control and low rates of toxicity while protecting critical organs⁵.
• Offering a viable treatment option for bone metastases, characterized by low acute and late toxicities. A complete pain response was achieved by patients experiencing symptoms⁶.

Synchrony^® Technology: The Accuray proprietary Synchrony technology is unique in using image guidance during radiation treatment delivery to detect motion and automatically adapt and synchronize the radiation beam in real-time with the movement of the target. Studies presented at ESTRO show:

• Synchrony with the Radixact^® System allows a reduction of the target area to be treated in lung cancer patients, compared to a LINAC based technique without tumor tracking, with a median beam-on time of less than 10 minutes⁷.
• Synchrony with the CyberKnife^® platform is an option for the treatment of inoperable pancreatic cancer, offering promising overall survival (OS at 12 months was 35%) and an excellent post radiotherapy toxicity profile⁸.
• The combination of the CyberKnife System and Synchrony provides an effective and well-tolerated option for the treatment of early-stage breast cancer in five sessions. Cosmesis was rated as excellent by 84% and good by15% of patients⁹.

TomoTherapy^® Platform for Total Marrow Irradiation: The TomoTherapy platform, including the next-generation Radixact System are the only devices to feature helical radiation delivery and integrated CT imaging, providing greater control of the radiation dose so it conforms precisely to the tumor and helps minimize dose to healthy tissue. For example, total marrow irradiation may be used before a bone marrow transplant as part of the treatment regimen for certain types of cancer, but it requires a high degree of precision and accuracy. A study presented at ESTRO provides just one example of the benefits of TomoTherapy delivered total marrow irradiation:

• Total marrow irradiation with TomoHelical^™ in combination with melphalan and autologous transplant provides good results with minimal side effects in patients with relapsed multiple myeloma¹⁰.

*VitalHold™ is 510(k) pending. VitalHold is not available for sale in the USA. It is not CE marked and availability is subject to regulatory clearance or approval in some markets.

About Accuray

Accuray is committed to expanding the powerful potential of radiation therapy to improve as many lives as possible. We invent unique, market-changing solutions to deliver radiation treatments for even the most complex cases—while making commonly treatable cases even easier—to meet the full spectrum of patient needs. We are dedicated to continuous innovation in radiation therapy for oncology, neuro-radiosurgery, and beyond, as we partner with clinicians and administrators, empowering them to help patients get back to their lives, faster. Accuray is headquartered in Sunnyvale, California, with facilities worldwide. To learn more, visit www.accuray.com or follow us on Facebook, LinkedIn, Twitter, and YouTube.

Important Safety Information

For Important Safety Information please refer to https://www.accuray.com/safety-statement.

Safe Harbor Statement

Statements made in this press release that are not statements of historical fact are forward-looking statements and are subject to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release relate, but are not limited, clinical applications, clinical results, patient experiences and patient outcomes. These forward-looking statements involve risks and uncertainties. If any of these risks or uncertainties materialize, or if any of the company's assumptions prove incorrect, actual results could differ materially from the results expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, the company's ability to achieve widespread market acceptance of its products; the company's ability to develop new products or improve existing products to meet customers' needs; the company's ability to anticipate or keep pace with changes in the marketplace and the direction of technological innovation and customer demands and such other risks identified under the heading "Risk Factors" in the company's Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission (the "SEC") on May 8, 2023, and as updated periodically with the company's other filings with the SEC.

Forward-looking statements speak only as of the date the statements are made and are based on information available to the company at the time those statements are made and/or management's good faith belief as of that time with respect to future events. The company assumes no obligation to update forward-looking statements to reflect actual performance or results, changes in assumptions or changes in other factors affecting forward-looking information, except to the extent required by applicable securities laws. Accordingly, investors should not put undue reliance on any forward-looking statements.

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¹ https://www.estro.org/Congresses/ESTRO-2023/1356/urology/15917/stereotacticfocusedradiotherapyforlow-riskprostate.
² https://www.estro.org/Congresses/ESTRO-2023/1397/urology/12946/stereotacticreirradiationforlocallyrecurrentprosta.
³ https://www.estro.org/Congresses/ESTRO-2023/1356/urology/15916/stereotacticsalvageradiotherapyfor-prostate-redrel.
⁴ https://www.estro.org/Congresses/ESTRO-2023/1374/cns/15682/roboticstereotacticradiotherapyfor-10brainmetastas.
⁵ https://www.estro.org/Congresses/ESTRO-2023/1359/mixedsites-palliation/15825/stereotacticbodyradiotherapy-sbrt-forspinalmetasta.
⁶ https://www.estro.org/Congresses/ESTRO-2023/1359/mixedsites-palliation/15826/stereotacticbodyre-irradiationforbonemetastases.
⁷ https://www.estro.org/Congresses/ESTRO-2023/1361/optimisation-algorithmsandapplicationsforphotonand/15391/initialclinicalexperiencewithitv-freelungsabrusing.
⁸ https://www.estro.org/Congresses/ESTRO-2023/1386/rttserviceevaluation-qualityassuranceandriskmanage/14467/clinicaloutcomesfollowingstereotacticablativebodyr.
⁹ https://www.estro.org/Congresses/ESTRO-2023/1352/breast/15626/stereotacticapbiforearly-stagebreastcancer-3-yearo.
¹⁰ https://www.estro.org/Congresses/ESTRO-2023/1619/sarcoma-haematology/14387/phase1studyofescalatedtotalmarrowirradiationandmel.