Healthcare Industry News:  breast brachytherapy 

Devices Oncology Regulatory

 News Release - October 8, 2013

Cianna Medical Receives Approval In Japan For SAVI Breast Brachytherapy

SAVI is the first commercially available intracavitary APBI catheter in Japan

ALISO VIEJO, Calif., Oct. 8, 2013 -- (Healthcare Sales & Marketing Network) -- Cianna Medical, Inc., a women's health company, today announced approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to market its SAVIŽ applicator in Japan. SAVI delivers accelerated partial breast irradiation (APBI), a 5-day course of targeted radiation for early-stage breast cancer patients. The Company has partnered with MC Medical, Inc., a subsidiary of Mitsubishi Corporation, to bring SAVI to the Japanese healthcare market.

"Entry into Japan is core to our initiative to make SAVI available wherever there is an emergent call to action regarding the treatment of early-stage breast cancer," said Jill Anderson, president and CEO of Cianna Medical. "We believe women across the globe deserve access to therapies that are suitable and specific to their healthcare and lifestyle needs. SAVI uniquely allows women with early-stage breast cancer to be treated in a shorter time frame with less complications, empowering them to reclaim control of their lives more quickly. MC Medical is the ideal partner to convey SAVI?'s benefits to the Japanese medical community."

According to research, breast cancer rates in Japan will rise by an estimated 24% by 2019 to reach 57,000 women compared to 46,000 cases in 2010. SAVI?'s strut-based design allows physicians to deliver customized radiation based on patient-specific anatomy. In Japan, where women have relatively smaller breasts, SAVI could make APBI available to a broader swath of patients.

"Our mission is to protect the lives of every individual and to ensure their good health by bringing the most advanced technology from around the world," said Hideo Nomura, president and CEO of MC Medical. "We are proud to partner with Cianna Medical in order to provide this innovative treatment option to women diagnosed with early-stage breast cancer."

SAVI has been in clinical use in the United States since 2006. The applicator received its CE marking in 2009 and has been in clinical use in Turkey and Poland since 2011. Today, more than 14,000 women have been treated with SAVI.

About Cianna Medical, Inc.

Cianna Medical, Inc. is a medical device company focused on women's health and dedicated to the innovative treatment of early-stage breast cancer. The company manufactures and markets the SAVI breast brachytherapy applicator, for the delivery of radiation after lumpectomy surgery. The applicator allows precise sculpting of the radiation dose, and is designed to make the benefits of accelerated partial breast irradiation available to a greater number of women.

For more information, call (toll-free) 866-920-9444 or visit

Source: Cianna Medical

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