Healthcare Industry News:  Electronic Brachytherapy 

Devices Oncology Regulatory

 News Release - April 9, 2009

Xoft Receives Health Canada Regulatory Approval for the Axxent(R) Electronic Brachytherapy System

Xoft Also Achieves ISO Certification for Quality Manufacture of the Axxent® System

SUNNYVALE, Calif., April 9 -- (Healthcare Sales & Marketing Network) -- 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® 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 approval is another significant milestone supporting Xoft's mission of expanding the number of patients who can access radiation therapy and can dramatically benefit from it."

Used to treat cancer for more than 100 years, radiation therapy is administered after breast-sparing surgery to hopefully kill stray cancer cells that might remain in the breast and is proven to reduce the rate of local recurrences and improve long-term survival. As a cancer treatment platform, the Axxent System addresses a variety of oncological and non-oncological indications. The Axxent System delivers non-radioactive therapy directly to cancer sites with minimal radiation exposure to surrounding healthy tissue. Designed to deliver electronic, X-ray-based radiation treatment, the proprietary system can be used in many clinical settings. Treatment can be performed without the need for a shielded room, allowing the radiation oncologist and other medical personnel to be present during treatment delivery and minimizing patient anxiety.

Use of the Axxent eBx System allows physicians to target cancer effectively and expands the ability to provide radiation therapy in remote locations. As a result, tens of thousands of patients will have greater access to therapy that is delivered more easily and conveniently.

About Xoft, Inc.

Xoft, founded in 1998, develops Electronic Brachytherapy (eBx) systems based upon miniaturized X-ray tube technology for the practice of radiation oncology in virtually any clinical setting, eliminating the need for heavily shielded environments. Xoft provides a "point of care model" that is patient centric and accessible to a broader spectrum of patients and their physicians. The Axxent treatment platform provides a therapeutic dose of radiation directly to the region at risk with minimal radiation exposure to surrounding healthy tissue and without the complex handling, resource logistics and costs associated with using radioactive isotopes. Xoft aligns with the Nuclear Regulatory Commission's (NRC) directive to seek alternatives for radioactive medical isotopes. Commercially available for treatment of early stage breast cancer, endometrial, skin and surface indications, the Axxent® Electronic Brachytherapy System is also cleared for use in the treatment of other cancers or conditions where radiation therapy is indicated. For more information, visit www.xoftinc.com.

Axxent is a registered trademark of Xoft, Inc.


Source: Xoft

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