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FDA Clears New Applicators for Endometrial Cancer Treatment With Xoft's Axxent(R) Electronic Brachytherapy System
Date:5/21/2008

Second Treatment Indication on Heels of Multi-Use Clearance for Axxent(R) System Strengthens the Creation of a New Platform in Radiation Therapy

SUNNYVALE, Calif., May 21 /PRNewswire/ -- Xoft, Inc., today announced that it has received clearance from the U.S. Food & Drug Administration (FDA) for applicators to be used with the Axxent(R) Electronic Brachytherapy System for the treatment of endometrial cancer. Previously cleared for accelerated treatment of early stage breast cancer, the Axxent System, a proprietary technology platform designed to deliver localized, non-radioactive, isotope-free radiation treatment in minimally-shielded clinical settings, also recently received expanded FDA Clearance for use in the treatment of other cancers or conditions where radiation therapy is indicated.

Endometrial cancer, the most prevalent gynecologic cancer in the United States, is also the fourth most common invasive cancer and represents six percent of all cancer in women. It is a disease where malignant cells form in the tissues of the lining of the uterus, or endometrium. According to the National Cancer Institute, more than 40,000 cases will be diagnosed in 2008 and will result in nearly 7,500 deaths.

While treatment options vary, endometrial cancer is generally treated with surgery, frequently a hysterectomy to remove the uterus, and radiation therapy. Shown to reduce local recurrence, radiation therapy also improves survival in some cases, according to a retrospective study involving more than 21,000 patients published in the Journal of the American Medical Association. The use of brachytherapy for endometrial cancer is well established among radiation oncologists and the trend has been increasing as clinical experience shows benefits. Nearly two-thirds of cases, approximately 25,000, are eligible for treatment with internal brachytherapy exclusively or in combination with external beam therapy. The American Brachytherapy Society (ABS) has endorsed the recommendations made by the National Comprehensive Cancer Network for the use of brachytherapy in the treatment of endometrial cancer and has issued specific guidelines for technique as well as the application of brachytherapy.

"Accelerated treatment of breast cancer using Electronic Brachytherapy has been very well received by our patients and we are very excited to be able to offer the benefits of this non-radioactive treatment for endometrial cancer," said Adam Dickler, MD, radiation oncologist at Little Company of Mary Hospital in Evergreen Park, Illinois. "The ability to deliver electronic X-ray based therapy directly to the tissue at risk, spares surrounding organs and gives us the ability to provide that therapy in a broader spectrum of clinical settings, making it safer and more accessible."

The performance of Electronic Brachytherapy to deliver non-radioactive therapy directly to cancer sites with minimal radiation exposure to surrounding healthy tissue, was the focus of five research studies recently presented at the 2008 World Congress of Brachytherapy hosted by the ABS. The studies bolster a growing body of research supporting use of Electronic Brachytherapy in the treatment of early stage breast cancer and gynecologic applications in which non isotope-based brachytherapy could be used to precisely deliver dose to targeted tissue.

In one study, "A Dosimetric Comparison of Xoft Axxent EB and Ir-192 HDR Brachytherapy in the Treatment of Endometrial Cancer," Dr. Dickler of Little Company of Mary Hospital compared treatment results using iridium-based brachytherapy and Electronic Brachytherapy. Results suggested equivalent target volume coverage for Electronic Brachytherapy while offering increased sparing of healthy bladder and rectum tissue by as much as 54 percent.

As a platform technology, the Axxent Electronic Brachytherapy System is designed to address a variety of oncological and non-oncological indications. Delivering 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. Eliminating the need for heavily shielded environments, it gives radiation oncologists the flexibility to deliver therapy in a broader range of clinical settings. With 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 second FDA clearance we have received in as many months, this indication for the treatment of endometrial cancer firmly establishes the Axxent Electronic Brachytherapy System as a broad based oncology treatment platform with special emphasis on women's health," said Michael Klein, president and CEO of Xoft. "While our first indication for the treatment of breast cancer is steadily gaining momentum in the radiation oncology community, the use of brachytherapy in the treatment of endometrial cancer is already well established and growing in practice. We are proud to expand into new areas and expect that these new indications will continue to improve access to critical cancer treatment."

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 and endometrial and rectal indications. Xoft's 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.


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