FDA Clears Expanded Use Of Xoft's Axxent(R) Electronic Brachytherapy System For All Radiation Therapy Indications

Main Category: Breast Cancer
Also Included In: Radiology / Nuclear Medicine;  Regulatory Affairs / Drug Approvals;  MRI / PET / Ultrasound
Article Date: 18 Mar 2008 - 0:00 PDT

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Xoft, Inc., announced that it has received expanded clearance from the U.S. Food & Drug Administration (FDA) for the Axxent(R) Electronic Brachytherapy System, a proprietary technology platform designed to deliver localized, non-radioactive, isotope-free radiation treatment in minimally-shielded clinical settings. Previously cleared for accelerated treatment of early stage breast cancer, the Axxent System is now cleared for use in the treatment of other cancers or conditions where radiation therapy is indicated.

As a platform technology, the Axxent Electronic Brachytherapy System is designed to address a variety of oncological and non-oncological indications. Xoft is actively working to extend the use of Electronic Brachytherapy to endometrial and rectal indications, which are pending FDA clearance.

"The prospect of expanding the use of Electronic Brachytherapy beyond our breast cancer patients is very exciting," said Adam Dickler, radiation oncologist at Little Company of Mary Hospital in Chicago. "The ability to deliver electronic X-ray based therapy directly to the cancer site spares healthy tissue and gives us the ability to provide that therapy in a broader spectrum of clinical settings. This tool has been very well received by our breast cancer patients and we would expect it deliver similar benefits across a range of cancer treatments."

Designed to deliver electronic, X-ray-based radiation treatment, the proprietary Axxent treatment platform can be used in virtually any clinical setting under the supervision of a radiation oncologist. The Axxent System is designed to deliver non-radioactive therapy directly to cancer sites with minimal radiation exposure to surrounding healthy tissue. Eliminating the need for heavily shielded environments, it gives radiation oncologists the flexibility to deliver therapy in a broader range of clinical settings. As a result, tens of thousands of patients will have greater access to therapy that is delivered more easily and conveniently.

In its current use for the treatment of early stage breast cancer, the Axxent Electronic Brachytherapy System also provides the opportunity to reduce the therapy time required from seven weeks (for external radiation therapy) down to five days. As a result, tens of thousands of patients will have greater access to therapy that is delivered more easily and conveniently. This may accelerate patient choice of breast sparing lumpectomy surgery with adjuvant radiation therapy over the alternative of a full mastectomy.

"The expanded clearance for the Axxent Controller is very significant in that it validates that the FDA recognizes Electronic Brachytherapy is a platform technology that is viable for treatment of conditions outside of the breast," said Michael Klein, president and CEO of Xoft. "This serves as the foundation for Xoft's expansion into new treatment areas beyond breast cancer and fuels the continued market adoption and expansion of this important technology."

About Xoft, Inc.

Xoft is developing leading-edge new technologies for the practice of radiation oncology through Electronic Brachytherapy, which utilizes proprietary miniaturized X-ray tube technology. The Axxent(R) Electronic Brachytherapy System, Xoft's first treatment system, is currently being used in Accelerated Partial Breast Irradiation (APBI) for the treatment of early-stage breast cancer. This solution provides a therapeutic dose of intracavitary radiation directly to the region at risk without the complex handling and resource logistics necessary when performing brachytherapy using radioactive isotopes.

Axxent is a registered trademark of Xoft, Inc.

Xoft, Inc.
http://www.xoftinc.com

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