Clearance Expected to Accelerate Market Adoption of Next-Generation Cancer Care
CLEVELAND, March 15, 2018 /PRNewswire/ — ViewRay, Inc. (Nasdaq: VRAY) announced today that the company received Shonin approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to market the MRIdian Linac System, the company’s next-generation MRIdian System, featuring linear accelerator (Linac) delivery. The MRIdian cobalt system received Shonin approval in August 2016.
MRIdian is the first and only MRI-guided radiation therapy system to receive Shonin approval in Japan, the world’s third largest market for radiation oncology. One MRIdian cobalt system is currently treating in Tokyo at the National Cancer Center (NCC) and one is under installation at the private Edogawa Hospital.
The MRIdian Linac System combines MR imaging with linear accelerator radiation delivery so clinicians can visualize the tumor and nearby soft tissue and organs in real-time. Like the MRIdian cobalt system, MRIdian Linac enables daily on-table adaptive radiotherapy and real-time tracking to adjust radiation beam delivery dynamically for subtle anatomical changes that may occur, both during treatment delivery and throughout the course of treatment. Combined, these capabilities provide the potential for clinicians to improve targeting precision and thus deliver higher radiation doses.
ViewRay is represented in Japan by ITOCHU Corporation, one of the three largest general trading companies in Japan. ITOCHU has been focusing on the healthcare business to promote important medical innovations in Japan for approximately 40 years.
“In collaboration with our partner ITOCHU Corporation, we’re excited to expand the MR image-guided radiation therapy solutions available to clinicians in Japan to now include MRIdian Linac,” said Chris A. Raanes, president and chief executive officer of ViewRay. “The regulatory approval of MRIdian Linac in Japan, a market that highly values advanced medical technologies, is an important milestone in the System’s global adoption.”
ViewRay®, Inc. (Nasdaq: VRAY), designs, manufactures and markets the MRIdian® radiation therapy system. MRIdian is built upon a proprietary high-definition MR imaging system designed from the ground up to address the unique challenges and clinical workflow for advanced radiation oncology. Unlike MR systems used in diagnostic radiology, MRIdian’s high-definition MR was purpose-built to address specific challenges including beam distortion, skin toxicity, and other safety concerns, which may potentially occur when high magnetic fields interact with radiation beams. 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. These statements are subject to risks and uncertainties that could cause future results to differ materially from those referenced. Forward looking statements include the ability to potential for clinicians to improve targeting precision and thus deliver higher radiation doses. Given these uncertainties, the reader is advised not to place any undue reliance on any forward-looking statements. Additional risk 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 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.