MRIdian Clinical Outcomes Data and Adaptive Capabilities: Highlights from ASTRO 2016

CLEVELAND, Oct. 13, 2016 /PRNewswire/ -- ViewRay, Inc. (Nasdaq: VRAY), makers of the world's first and only clinical MRI-guided radiation therapy system, announced today highlights from the recent 2016 Annual Meeting of the American Society for Radiation Oncology (ASTRO), which featured extensive clinical experience with the company's MRIdian System, as well research highlighting the MRIdian linear accelerator (Linac) technology.

As part of ASTRO's Scientific Sessions, 19 MRIdian clinical presentations and posters were featured from MRIdian users at Washington University and Siteman Cancer Center at Barnes-Jewish Hospital (Washington University); University of California, Los Angeles Health System and Jonsson Comprehensive Cancer Center (UCLA); The University of Wisconsin Carbone Cancer Center (University of Wisconsin); and Seoul National University Hospital, Seoul, South Korea.

Clinical presentations featuring MRIdian

Pancreatic Cancer:  Researchers from the University of Wisconsin shared early data from a multi-institutional study examining MRIdian's stereotactic body radiation therapy (SBRT) capabilities, including its role in enabling dose escalation while reducing normal tissue toxicities to areas such as the duodenum and improving tumor control.
-  Bladder Cancer: Another study by University of Wisconsin researchers used MRI-based daily patient setup to monitor anatomy in bladder cancer patients. Pre-treatment imaging revealed a reduction in tumor size and potential for increased dose to the bowel over the course of treatment, thereby demonstrating the value of MRIdian's on-table adaptive capabilities in reducing normal tissue toxicity.
-  Gynecologic Malignancies: UCLA researchers explored MRIdian's role in delivering intensity modulated radiation therapy (IMRT) for post-operative gynecologic malignancies, where monitoring and management of inter- and intra-fraction vaginal apex motion is vital. The study monitored vaginal apex motion in real-time and observed large, transient displacements arising from transit of bowel gas and changes in bladder filling during an average treatment time of 11.1 minutes, illustrating the importance of real-time MRI-guidance.

ASTRO's Physics Award: An abstract from researchers at Washington University won ASTRO's Physics Award in the Resident ePoster Recognitions. The presentation by Lauren Henke, M.D., highlighted MRIdian's ability to deliver an SBRT ablative dose (50 Gray in 5 fractions) for oligometastatic or unresectable primary abdominal malignancies while decreasing acute normal tissue toxicities. Daily MR-based imaging revealed motion of the gastrointestinal tract that frequently required re-planning to avoid constraint violation. Quality of life (QOL) was recorded pre-treatment and at 6 weeks and 6 months post treatment. There was no change in pre-treatment and 6-week QOL scores. Additionally, the researchers reported no grade 3 toxicities at 6 weeks or 3 months.

Presentations featuring MRIdian Linac Technology

Two ASTRO Scientific Session presentations focused on the MRIdian Linac technology, which recently received European CE Mark clearance, and is pending FDA 510(k) clearance and therefore available for non-clinical research use only in the United States. Researchers from Washington University and UCLA highlighted the design and performance of ViewRay's compact Linac-based MRI-guided radiation therapy research system. This next-generation technology from ViewRay utilizes patented magnetic shielding and RF shielding technology that eliminates cross-talk between Linac and MRI components.

"We're pleased with the caliber of clinical data presented at this year's ASTRO meeting by a variety of MRIdian users from around the world, including research on the MRIdian Linac technology," said Chris A. Raanes, president and chief executive officer of ViewRay. "These institutions are demonstrating the real value of MRIdian in terms of performance, capabilities and most importantly patient outcomes."

Industry Expert Theater and In-booth Presentations

ViewRay hosted one of ASTRO's Industry Expert Theater sessions, which featured presentations by Frank Lagerwaard, M.D., from VU University Medical Center (VUmc) in Amsterdam, and Lorraine Portelance, M.D., from the University of Miami, Sylvester Comprehensive Cancer Center (University of Miami).

-  Dr. Lagerwaard shared outcomes from VUmc's MRIdian program, which began patient treatments in May 2016. VUmc has treated patients for indications such as prostate SBRT, pancreas SBRT, liver metastases SBRT and moderately central lung tumors. The vast majority (96%) were treated using MRIdian's on-table adaptive therapy capabilities. A preliminary analysis of the dosimetric benefit of daily adaptive treatment for prostate cancer at VUmc shows clear benefits, avoiding both overdosage to the surrounding organs at risk such as bladder and rectum, while at the same time ensuring adequate planning target volume (PTV) coverage. VUmc has studies exploring MRIdian for inoperable pancreatic cancer and prostate cancer treated with 5 fraction SBRT, partial breast irradiation, early stage rectal cancer and moderately central lung tumors.

-  Dr. Portelance shared outcomes from University of Miami's MRIdian program, which began patient treatments in April 2016. University of Miami has treated a variety of indications, including breast, bladder, cervical, liver, pancreatic, prostate and rectal cancers. MRIdian has become the University of Miami's preferred method for treating complex cancer cases that are difficult to treat on a standard RT system due to the location of the tumor in relation to the surrounding soft tissue, and has allowed them to treat a number of patients who would not previously have been considered RT candidates.

In ViewRay's booth, MRIdian users from Washington University, UCLA, University of Wisconsin and VUmc presented on their first-hand MRIdian clinical experience. To view videos of these presentations, please visit http://www.viewray.com/astro_2016.htm.

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. The MRIdian Linac is a technology under development and is not available for sale or distribution in the United States.

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 the benefits of the MRIdian System and MRIdian Linac technology, and clinical studies by certain MRIdian users. 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, 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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