First Patient Outside of the United States Treated at Seoul National University Hospital
Cleveland, October 18, 2015 — ViewRay, Inc. (OTCQB:VRAY) announced today that the company has received regulatory approval from the Ministry of Food and Drug Safety (MFDS) – formerly known as the Korean Food and Drug Administration (KFDA) – to sell its ViewRay system in Korea. On October 13, 2015, the first patient treatments commenced less than four weeks after the system completed installation at Seoul National University Hospital (SNUH), a leading healthcare facility in Korea.
The first treatment at SNUH was for a patient with a single liver metastasis. Hong-Gyun Wu, M.D., Ph.D., Professor and Department Chairman of SNUH chose the ViewRay system to treat the patient with stereotactic body radiation therapy (SBRT), because the system offers the accuracy needed, through real-time MRI imaging during treatment, to deliver the required high doses to the target and minimize damage to the surrounding healthy tissue.
“We are extremely pleased that our clinical MRI-guided radiotherapy program is underway, with the completion of our first patient treatment,” said Dr. Wu. “The ability to visualize the tumor and surrounding soft tissues throughout treatment was unlike anything we’ve experienced before and will significantly enhance our ability to deliver the best care to the patients we serve.”
“Receipt of Korean regulatory approval and the completion of the first international patient treatment are exciting milestones for us as we work to bring the benefits of MRI-guided radiation therapy to patients around the world,” said Chris A. Raanes, President and Chief Executive Officer of ViewRay. “We are particularly pleased with how quickly and easily the system went from installation to first patient treatment.”
The Cancer Hospital at SNUH opened in March 2011 and is dedicated to providing the best medical service to cancer patients. It is made up of 15 cancer specialty centers and nine multidisciplinary cancer treatment centers. The center offers state-of-the-art medical systems, world-class R&D capabilities and doctors skilled in the treatment of cancer.
ViewRay, Inc. of Cleveland, Ohio, is a medical device company that develops advanced radiation therapy technology for the treatment of cancer. The MRIdian® system provides continuous soft-tissue imaging during treatment, using MRI-guided radiation therapy, so that clinicians are able to see where the actual radiation dose is being delivered and adapt to changes in the patient’s anatomy.
ViewRay and MRIdian are registered trademarks of ViewRay, Inc.
ViewRay acknowledges the contribution of the State of Ohio, Department of Development and Third Frontier Commission, which provided funding in support of the MRI Technology Enabling Expansion of MRI into Radiotherapy Guidance Project.
Forward Looking Statements:
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 treatment of patients and research plans at SNUH, future international sales of MRIdian and the use of MRI-guided radiation therapy in the treatment of cancer. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such 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, the ability to commercialize MRIdian, 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 atwww.sec.gov.
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