ViewRay Launches Clinical Trial Following Compelling Early Pancreatic Cancer Data with MRIdian System

CLEVELAND, Sept. 25, 2017 /PRNewswire/ -- ViewRay, Inc. (Nasdaq: VRAY) announced today the launch of a multi-center prospective clinical trial for locally advanced unresectable pancreatic cancer using MRIdian, the world's first and only FDA-cleared MRI-guided radiation therapy system. This study is the first initiative of ViewRay's Clinical Cooperative Think Tank (C²T²), a group of MRIdian clinical users focused on evidence gathering to support MR-guided radiation therapy.

At the inaugural meeting of the C²T² on September 23, 2017, participants formalized the group's first key initiative – a multi-center, prospective, single-arm clinical trial focused on locally advanced unresectable pancreatic cancer. Pancreatic cancer presents considerable radiation targeting challenges given the known limitations of conventional CT image guidance. The novel abilities provided by live MR guidance combined with daily online treatment adaptation have potentially enabled a new approach in pancreatic cancer therapy. Through this trial the group looks to explore new opportunities to improve survival and quality of life for this deadly disease.

One particular impetus for the trial was compelling early results presented as part of the scientific sessions at the American Society for Radiation Oncology (ASTRO) annual meeting. The poster, titled "Higher Maximum Biologic Effective Dose Utilizing Adaptive MRI Guided Radiation Therapy Improves Survival of Inoperable Pancreatic Cancer Patients", provided a retrospective review of 42 locally-advanced pancreatic cancer patients treated at four institutions (Washington University, UCLA, University of Wisconsin, and VUmc). The study found that stereotactic dosing regimens guided by MR imaging and daily online adaptation had led to significantly prolonged patient survival and resulted in favorably low toxicity.

"Based on compelling early evidence on the use of MRIdian to treat locally advanced pancreatic cancer, we are eager to further explore the system's capabilities and associated toxicity, local control and patient outcomes," said Parag Parikh, M.D., Associate Professor of Radiation Oncology at Washington University and lead investigator of the trial. "We believe MRIdian's excellent real-time visualization of organs at risk within the abdomen and its daily treatment adaptation will allow us to deliver higher, more effective doses to the target while minimizing impact on the normal surrounding tissue. The findings of this study could truly change the standard of care for many pancreatic cancer patients."

A video of Dr. Parikh discussing the multi-institutional poster in ViewRay's ASTRO booth is available on the company's website at http://www.viewray.com/ASTRO_2017.

As part of ASTRO's Scientific Sessions, an additional presentation of pancreatic cancer outcomes from UCLA will be delivered. The presentation titled, "Outcomes Utilizing MRI-guided and Real-Time Adaptive Pancreas Stereotactic Body Radiotherapy (SBRT)" will be given on Wednesday, September 27 at 2:40 p.m. PT in room 30 D/E.

ViewRay's C²T², the consortium initiating the trial, comprises clinicians from leading institutions around the world including:

• Dana-Farber/Brigham and Women's Cancer Center in Boston
• Henry Ford Cancer Institute, Detroit
• Institut du Cancer de Montpellier, France
• Institut Paoli Calmettes, Marseille, France
• Loyola Center for Cancer Care and Research at Palos Health South Campus in Illinois
• Moffitt Cancer Center in Tampa, Florida
• Miami Cancer Institute, Baptist Health South Florida
• National Cancer Center (NCC) in Tokyo, Japan
• NewYork-Presbyterian Hospital
• Orlando Health UF Health Cancer Center
• Policlinico Agostino Gemelli, Universita Cattolica del Sacro Cuore, Gemelli ART in Rome, Italy
• Seoul National University Hospital (SNUH) in Seoul, South Korea
• Sylvester Comprehensive Cancer Center, UHealth - University of Miami Health System
• University of California, Los Angeles Health System and Jonsson Comprehensive Cancer Center
• University of Wisconsin Carbone Cancer Center in Madison
• VU University Medical Center in Amsterdam, Netherlands
• Washington University and Siteman Cancer Center at Barnes-Jewish Hospital, St. Louis

About ViewRay

ViewRay®, Inc. (Nasdaq: VRAY), designs, manufactures and markets the MRIdian® radiation therapy system. MRIdian integrates MRI technology, radiation delivery and proprietary software to locate, target and track the position and shape of soft-tissue tumors during radiation. ViewRay believes this combination of enhanced visualization and accuracy will significantly improve outcomes for patients.

ViewRay and MRIdian are registered trademarks of ViewRay, Inc.

This press release contains forward-looking statements. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, references to clinical trial plans and presentations featured at ASTRO, and statements made in the video and poster referenced in this release. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such statements are subject to risks and uncertainties that could cause future results to differ materially from those referenced. Additional factors include, among others, the ability to raise the additional funding needed to continue to pursue ViewRay's business and product development plans, the inherent uncertainties associated with developing new products or technologies, competition in the industry in which ViewRay operates and overall market conditions. These forward-looking statements are made as of the date of this press release, and ViewRay assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents ViewRay files with the SEC available at www.sec.gov.

SOURCE ViewRay, Inc.

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