Xoft has been granted a medical device license by the Medical Devices Bureau of Health Canada to sell and market the Axxent electronic brachytherapy (eBx) system, designed to deliver localized, non-radioactive, isotope-free radiation treatment in minimally shielded clinical settings under the supervision of a radiation oncologist.
Commercially available in the United States since 2006 for treatment of early-stage breast cancer, endometrial cancer, as well as skin and surface indications, the Axxent System is also cleared by the FDA for use in the treatment of surface cancers or conditions where radiation therapy is indicated.
Xoft also received certification from the International Organization for Standardization covering the design, development and manufacture of the Axxent eBX 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.