Xoft Reaches Milestone as Axxent® Electronic Brachytherapy System Is Used to Treat Early Stage Breast Cancer Patients


PHOENIX, May 2 - Bringing improved patient access to a new cancer treatment that is delivered more easily and conveniently, Xoft, Inc. announced that the first breast cancer patients have been treated using the Axxent® Electronic Brachytherapy System. Designed to help reduce recurrence of breast cancer, the breakthrough new therapy for early stage breast cancer uses a miniaturized X-ray source that can deliver localized and targeted radiation treatment in virtually any clinical setting under the supervision of a radiation oncologist. The announcement was made here at the 8th Annual Meeting of the American Society of Breast Surgeons (ASBS).

Treatment of the first two patients was directed by Philip Z. Israel, MD, director of The Breast Center in Marietta, and performed at WellStar Kennestone Hospital. Dr. Israel will highlight early clinical results of these patients at a symposium Xoft is hosting at the ASBS meeting. Titled "The Role of the Surgeon in Electronic Brachytherapy of the Breast," the panel of leading breast surgeons will focus on how this new method of delivering localized, non-radioactive radiation treatment directly to cancer sites may significantly increase access to radiation treatment and thus, demand for breast-conserving therapy. Peter Beitsch, MD, director of the Dallas Breast Center, will discuss best practices to implement this technology as well as a planned patient registry, which will be administered by ASBS to track patient data and outcomes.

"I am delighted to be involved in making this important new tool available to patients," said Dr. Israel. "Electronic Brachytherapy will make partial breast irradiation available to patients in rural areas where large radiation centers are not located. This will give more patients access to breast conserving surgery and possibly avoid mastectomy."

According to Sandra Wood of Hiram, Georgia, the first patient treated using the Axxent System: "Once I came to grips with the fact that I had breast cancer for a second time, I wanted to do everything I could to make sure there was no third time. That's why, after discussing the options with Dr. Israel, my surgeon, I decided to go with the new Axxent treatment.

"Radiation has always been a little scary to me, but the fact that the technicians could stay in the room with me during treatments increased my comfort level tremendously. The fact that treatment was generated by a targeted X-ray and would not affect any other areas of my body was also a great relief. Finally, it was an added benefit that the treatments lasted only five days, as opposed to the 33 daily treatments required with my first lumpectomy," added Mrs. Wood.

Cleared by the FDA for the treatment of early stage breast cancer, the Axxent System is designed to deliver 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.

Data from several randomized controlled clinical studies has demonstrated that radiation therapy is an essential component of treatment for breast cancer when the patient wishes to conserve her breast with a lumpectomy as opposed to undergoing a full mastectomy. However, more recent studies have shown that many patients opt out of receiving breast sparing surgery with radiation therapy due to time, distance, or difficulty accessing radiation therapy centers.

Use of Electronic Brachytherapy potentially reduces the time required for radiation therapy for early stage breast cancer 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.

"As Dr. Israel and WellStar KenneStone Hospital have initiated treatment of patients, we expect several of our other clinical sites to begin making this breakthrough new treatment available to breast cancer patients immediately," said Michael Klein, Xoft CEO and president. "We are proud to see the Axxent System begin to be incorporated into practice, and we are convinced that Electronic Brachytherapy provides breast surgeons and radiation oncologists the ability to make breast conserving therapy available to more women with the knowledge that they are providing the best treatment possible."

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® 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.

Source: Xoft, Inc.

CONTACT:

Chris K. Joseph of Xoft, Inc.,

+1-510-339-2293,

or chris@ckjcomm.com, for Xoft, Inc.

Web site: http://www.xoftmicrotube.com/

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