ViewRayのMRIdian MR画像ガイド放射線治療機のLinac型が日本の規制当局から承認される

AsiaNet 72689

【クリーブランド2018年3月29日PR Newswire】

＊この承認により、次世代がん治療の市場への導入が加速すると予想される

ViewRay, Inc.（Nasdaq: VRAY）は15日、日本の厚生労働省（MHLW）から線形加速器(Linac)を搭載した同社の次世代MRIdian Systemについて承認を受けたと発表した。MRIdianコバルトシステムは2016年8月に承認を受けている。

MRIdianは放射線治療で世界第3位の規模を持つ日本で承認を受けた最初で唯一のMRIガイド放射線治療システムである。現在、1台目のMRIdianコバルトシステムが東京の国立がん研究センター中央病院（NCC）で治療に使用されており、もう1台は民間の江戸川病院で設置中である。

MRIdian Linac SystemはMRイメージングと線形加速器による放射線照射を一体化し、それによって臨床医は腫瘍、周辺の軟部組織、臓器をリアルタイムで視覚化できる。MRIdianコバルトシステムと同様に、MRIdian Linacは即時適応放射線治療とリアルタイムの追跡を毎日行うことが可能で、治療照射の間と治療の過程を通して発生しうる微妙な解剖学的変化に対応して放射線ビームの照射を動的に調整する。こうした機能の一体化により臨床医に照準精度向上の可能性を提供し、より高い放射線線量の照射が行える。

日本では、同国の3大総合商社の1つである伊藤忠商事㈱がViewRayの代理店である。伊藤忠商事㈱は約40年にわたって日本の重要な医療革新を促進するために、医療事業を重視している。

ViewRayのクリス・A・ラーネス社長兼最高経営責任者（CEO）は「当社のパートナーである伊藤忠商事㈱との協力を通し、日本の臨床医が利用できるMR画像ガイド放射線治療ソリーションが拡大し、今度はMRIdian Linacが加わったことに興奮している。先端医療技術を高く評価する市場である日本でMRIdian Linacが規制当局の承認を受けたことは、このシステムのグローバルな導入の点で重要なマイルストーンである」と述べた。

▽ViewRayについて

ViewRay（R）, Inc（Nasdaq：VRAY）はMRIdian（R）放射線治療システムを設計、製造、販売している。MRIdianは先端放射線治療に固有の課題と臨床のワークフローに対応するため、基礎から設計した特許を持つ高解像度MRイメージングシステム上に構築されている。診断放射線医学で使用されるMRシステムとは異なり、MRIdianの高解像度MRは専用設計であり、それは高磁場が放射線ビームと相互作用する際に発生しうるビーム中心軸の偏り、皮膚毒性その他の安全性への懸念を含む特有の課題に対応するためである。ViewRayとMRIdianはViewRay, Inc.の登録商標である。

▽問い合わせ先

Michael Saracen

Vice President, Marketing, ViewRay, Inc.

Phone: +1-408-242-2994

Email: media@viewray.com

ソース：ViewRay, Inc.

（日本語リリース：クライアント提供）

ViewRay's MRIdian MR Image-Guided Radiotherapy Linac Receives Japanese Regulatory Approval (Shonin)

PR72689

CLEVELAND, March 29, 2018 /PRNewswire=KYODO JBN/ --

-- Clearance Expected to Accelerate Market Adoption of Next-Generation Cancer

Care

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."

About ViewRay

ViewRay(R), Inc. (Nasdaq: VRAY), designs, manufactures and markets the

MRIdian(R) 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.

CONTACT: Michael Saracen, Vice President, Marketing, ViewRay, Inc., Phone: +1

408-242-2994, Email: media@viewray.com

SOURCE ViewRay, Inc.