Japan's regulators OK Accuray's latest robotic radiosurgery system

The Cyberknife surgical suite--Courtesy Accuray
The Cyberknife surgical suite--Courtesy of Accuray

California's Accuray ($ARAY) snagged Japanese regulatory approval for a new iteration of its CyberKnife robotic full-body radiosurgery system--a market known for its robust demand for med tech products and services.

Accuray said it won Shonin approval from the Japanese Ministry of Health, Labor and Welfare to market its CyberKnife M6 System to treat radiation therapy patients. The product, to be known there as the CyberKnife M6 Series, is billed as allowing for high dose radiation therapy in a relatively short number of treatments, a potential market edge that can help reduce side effects and preserve a better patient quality of life as a result.

The CyberKnife M6 win follows Japanese approval of the CyberKnife G4 system in 2010 to treat head, neck and other tumors in the body. Japanese regulators approved Accuray's CyberKnife VSI System in 2012 for robotic radiosurgery.

Joshua Levine, Accuray's president and CEO, said in a statement that the Japanese regulatory win "marks a key milestone in our strategic growth plan for the market in Japan."

Japan is arguably the largest developed market for med tech products and services outside of the U.S., so the more CyberKnife products and services Accuray can offer there, the better.

The revenue boost can't hurt. Accuray reported $93.6 million in sales during its fiscal 2014 second quarter, a 20% jump over the previous year. Its net losses during the period hit $5.4 million, but that's a big improvement over $29.2 million in net losses during the fiscal 2013 second quarter. Accuray hit a slump and has spent the last year focusing on job cuts and a revamp of its marketing efforts. For the company, Q2 represents progress, and the latest Japanese regulatory win is another step toward renewed growth.

Accuray traded at $9.07 late morning on March 27, down 6 cents.

- read the release

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