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Xoft Receives Health Canada Regulatory Approval for the Axxent(R) Electronic Brachytherapy System
Date:4/9/2009

Xoft Also Achieves ISO Certification for Quality Manufacture of the Axxent(R) System

SUNNYVALE, Calif., April 9 /PRNewswire/ -- Xoft, Inc., pioneers in the field of micro-miniature X-ray sources for medical treatment, announced today that it has been granted a medical device license by the Medical Devices Bureau of Health Canada to sell and market the Axxent(R) Electronic Brachytherapy System. The proprietary Electronic Brachytherapy (eBx) treatment platform is designed to deliver localized, non-radioactive, isotope-free radiation treatment in minimally-shielded clinical settings under the supervision of a radiation oncologist to help reduce recurrence of cancer and improve survival.

Health Canada, the regulatory agency responsible for helping Canadians maintain and improve their health, reviews medical devices to assess their safety, effectiveness and quality before being authorized for sale in Canada. Commercially available in the United States since 2006 for treatment of early stage breast cancer, endometrial cancer, and skin and surface indications, the Axxent System is also cleared by the U.S. Food & Drug Administration (FDA) for use in the treatment of surface cancers or conditions where radiation therapy is indicated.

Xoft also announced that it has received certification from the International Organization for Standardization (ISO) covering the design, development and manufacture of the Axxent Electronic Brachytherapy System and its components. Xoft has met the requirements of the ISO 13485:2003 standard.

"With this approval from Health Canada, we are proud to make this critical cancer treatment that can be delivered in virtually any standard medical exam room rather than in heavy lead-shielded vaults available to patients outside the United States," said Michael Klein, president and CEO of Xoft. "Combined with recent FDA clearances for new treatment applications, this
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SOURCE Xoft, Inc.
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