Accuray: New Data Presented at ESTRO 36 Reinforce Unmatched Versatility and Precision of the CyberKnife® System

Accuray Incorporated (NASDAQ: ARAY) announced today that studies on the clinical use of the leading-edge CyberKnife® System continue to demonstrate its benefits across a wide range of cancer indications and stages in the cancer treatment journey. More than 50 studies were presented during poster and oral sessions at the 36^th Annual European Society for Radiotherapy & Oncology (ESTRO) Meeting in Vienna, Austria, May 5 - 9, 2017. Some of the studies presented show long-term efficacy and safety with median follow-up exceeding five years.

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CyberKnife stereotactic body radiation therapy (SBRT) is used worldwide for effective management of prostate cancer  

• Safety, efficacy, and quality of life (QOL) outcomes were reported for 309 patients with low- or intermediate-risk prostate cancer receiving SBRT administered with the CyberKnife System. The study showed cancer control was excellent in both risk groups with 97% of patients free from recurrence at five years. Transient decreases in bowel and urinary QOL were observed, but returned to baseline. Twenty-one U.S. hospitals participated in this prospective study including Swedish Cancer Institute in Seattle, Washington and Beth Israel Deaconess Medical Center in Boston, Massachusetts.
• A study evaluated the long-term results of CyberKnife prostate SBRT delivered either on consecutive days or every other day. The treatment was well-tolerated with high rates of five-year biochemical relapse free survival (BRFS). Low rates of toxicity were unaffected by the treatment schedule. The research was conducted at the Hacettepe University in Ankara, Turkey.
• Long-term results of another study conducted on 329 patients with low- and intermediate-risk prostate cancer revealed that extreme hypofractionated radiotherapy delivered with the CyberKnife System is well tolerated and safe with comparable late toxicity as other treatment modalities. Clinicians of the Erasmus MC Cancer Institute, in Rotterdam (The Netherlands) conducted the study.

The CyberKnife System provides benefits for primary cases, recurrent and metastatic diseases 

Recurrent Disease 

• Although re-irradiation of recurrent diseases can be challenging in clinical practice, four European studies confirmed its feasibility in prostate and rectal cancer, as well as in recurrent high grade gliomas. These studies concluded that re-irradiation with the CyberKnife System is well-tolerated and effective in controlling local recurring disease.
• A study of CyberKnife SBRT for oligorecurrent liver disease showed treatment was well-tolerated and resulted in favorable survival data. Clinicians at three European hospitals conducted the research.
• A study evaluated the efficacy and toxicity of single fraction SBRT for isolated nodal failure in prostate cancer patients, after primary surgical or radiation treatment. Treatment with the CyberKnife System provided excellent tolerability and promising biochemical control at 13 months' follow-up. Research was conducted at three Italian hospitals.

Metastatic Disease 

• A study of patients with solitary extracranial metastases from gynecologic malignancies demonstrated that SBRT delivered with the CyberKnife® System is well-tolerated and highly effective. An excellent 5-year local control of 93.7% was achieved in patients with classical ovarian and uterine primary tumors. Research was conducted at Georgetown University Hospital in Washington, DC.
• Another study evaluated 206 patients with 326 inoperable pulmonary oligometastases, from colorectal tumors, lung cancers, melanoma, sarcoma, breast carcinoma, and from other sites, treated with SBRT. This long-term follow-up study showed good local control (83% at 2-years and 73% at 5-years) and overall survival (2, 3, and 5-year OS rates were 63%, 47% and 30%, respectively), as well as low rates of serious toxicity. Research was conducted at Erasmus MC-Daniel den Hoed Cancer Center in Rotterdam (The Netherlands).

Technical innovations improve the delivery of radiation therapy  

• New studies reinforce previous data demonstrating intracranial and extracranial treatments delivered using the CyberKnife System InCise™ Multileaf Collimator result in comparable target coverage and organ-at-risk sparing to the Iris™ Collimator, while significantly reducing treatment times (15% to 47% reduction compared to Iris plans depending on tumor type). Research was conducted at six European hospitals.
• The first study to use three-dimensional performance analysis of the Synchrony® Respiratory Tracking System found it successfully tracks lung tumors regardless of the amplitude of movement. Research was conducted at Hacettepe University in Ankara, Turkey.

The CyberKnife System was designed to deliver treatment beams of different size and shape from hundreds of non-coplanar, isocentric or non-isocentric angles around the patient, enabling the clinician to deliver high-quality treatment plans with extreme precision, sparing surrounding healthy tissue and structures. The system's tracking capabilities eliminate the need for gating techniques and restrictive head frames, providing greater comfort for the patient.

"I am proud to see that the unique capabilities of our radiation therapy delivery systems are enabling clinicians to develop innovative approaches for delivering radiation treatments which make a real difference in their patients' lives," said Fabienne Hirigoyenberry, VP Global Medical and Scientific Affairs of Accuray. "Since 1994 when the first patient was treated with the CyberKnife System, it has set the bar for delivering precise radiation treatments while avoiding healthy tissue. The data presented at ESTRO 36 reinforce the system's benefits and show it is increasingly being used to treat a wide range of cancer cases."

About Accuray 

Accuray Incorporated (NASDAQ: ARAY) is a radiation oncology company that develops, manufactures, and sells precise, innovative tumor treatment solutions that set the standard of care with the aim of helping patients live longer, better lives. The company's leading-edge technologies deliver the full range of radiation therapy and radiosurgery treatments. For more information, please visit http://www.accuray.com .

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, to clinical applications, clinical results, patient outcomes and Accuray's leadership position in radiation oncology innovation and technologies. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from expectations, including but not limited to the risks detailed from time to time under the heading "Risk Factors" in the company's report on Form 10-K, filed on August 24, 2016, the company's reports on Form 10-Q, filed on November 1, 2016, February 3, 2017, and May 5, 2017, 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 Accuray 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.