Accuray wins Japanese regulatory nod for Radixact platform

Accuray (NSDQ:ARAY) said today it won approval from the Japanese Ministry of Health, Labor and Welfare for its Radixact treatment delivery platform designed for image-guided radiotherapy treatments designed for cancer patients.

Clearances include the Radixact treatment delivery system, Accuray Precision treatment planning system and iDMS data management system, the Sunnyvale, Calif.-based company said.

“The approval of the Radixact System represents a key milestone in our strategic growth plans for the Japanese market. We are seeing positive momentum in the adoption of the Radixact System as clinicians become aware of its benefits. Feedback from a number of early customers indicates the System enables them to deliver precise radiation therapy, to more patients, in considerably less time than has been possible with the TomoTherapy System,” prez & CEO Joshua Levine said in a prepared statement.

The newly cleared system features a more powerful linear accelerator, MVCT imaging and helical treatment delivery designed for the application of conformal and homogenous dose distributions. The system also includes smart, automated workflows and midcourse decision making tools to allow for adaptation to changes in tumor size, shape and location within the patient.

“The Accuray team strives to provide our customers with innovative products that enhance the quality of patient care. With the introduction of the Radixact System, we are demonstrating significant progress in fulfilling on this promise. This new, mainstream System enables clinicians to deliver the highly sculpted doses for precise, customized treatments the previous TomoTherapy platform was known for, faster, enabling the treatment of more patients every day. It also provides a foundation for future innovation,” Accuray Japan prez & GM Juki Hozumi said in a press release.

Last month, Accuray posted 2nd quarter earnings that missed expectations on The Street and sent shares down in after-hours trading.

The Sunnyvale, Calif.-based company posted losses of $9.4 million, or 11¢ per share, on sales of $87.5 million for the 3 months ended December 31. That equates to a 55.5% increase in losses while sales shrunk 19.7% compared with the same period in 2015.

Accuracy was behind the consensus on The Street, where analysts were looking for losses per share of 9¢ and sales of $90.4 million.

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