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September 7, 2022
2 Min Read
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Chinese regulatory authority National Medical Products Administration (NMPA) has approved ViewRay's MRI-guided radiation therapy system, the MRIdian. The approval brings cancer patients in China a new radiation therapy option with the MRIdian Stereotactic MRI-Guided Adaptive Radiotherapy (SMART).
Oakwood Village, OH-based ViewRay said the treatment integrates diagnostic-quality MRI, on-table adaptive replanning, and continuous, real-time, soft tissue tracking and automated beam gating.
Marie Thibault, a medtech analyst at BTIG noted in a report Wednesday that the approval comes slightly ahead of expectations. BTIG also reiterated its "buy" rating on ViewRay's stock.
"China is one of the fastest-growing markets for radiation oncology given the high cancer incidence rate and Healthy China 2030 initiative to increase five-year survival rates by 15%," Thibault wrote.
Healthy China 2030 lays out China's long-term approach to healthcare. There are about 4.6 million new cases of cancer diagnosed annually in China.
"With the increasing burden of cancer prevalence in China, we are excited to bring the benefits of MRIdian SMART to these patients," said Paul Ziegler, ViewRay's chief commercial officer. "The availability of more treatment options, excellent treatment outcomes, reduced toxicity, and improved quality of life is an important advance for this market. The China NMPA approval not only supports our global expansion but also our goal of changing the paradigm of care in radiation oncology."
According to ViewRay, the MRIdian system provides oncologists "outstanding" anatomical visualization through diagnostic-quality MR images and the ability to adapt a radiation therapy plan to the targeted cancer with the patient on the table. This combination allows physicians to define tight treatment margins to avoid unnecessary radiation exposure of vulnerable organs-at-risk and healthy tissue and allows the delivery of ablative radiation doses in five or fewer treatment sessions, without relying on implanted markers. By providing real-time continuous tracking of the target and organs-at-risk, MRIdian enables automatic gating of the radiation beam if the target moves outside the user-defined margins, ViewRay said. This allows for delivery of the prescribed dose to the target, while sparing surrounding healthy tissue and critical structures, which results in minimizing toxicities typically associated with conventional radiation therapy, the company noted.
ViewRay said there are currently 53 MRIdian systems installed around the world and that nearly 25,000 patients have been treated with the system to date.
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