Devices Oncology

 News Release - June 24, 2008

First Breast Cancer Patient Receives Treatment in National Electronic Brachytherapy Registry Launched by Three Physician Societies

Multi-Disciplinary Oversight Panel Includes American Brachytherapy Society, American Society of Breast Surgeons and American College of Radiation Oncology

SUNNYVALE, Calif., June 24 (HSMN NewsFeed) -- Xoft, Inc. today announced the launch and of the EXIBT Study (Electronic Xoft Intersociety Brachytherapy Trial), a national Electronic Brachytherapy patient registry under oversight from three national physician societies, the American Brachytherapy Society (ABS), the American Society of Breast Surgeons (ASBrS), and the American College of Radiation Oncology (ACRO). The first patient was successfully enrolled and treated in the registry by Drs. Peter Beitsch of the Dallas Breast Center and Timothy Nichols of the Northpoint Cancer Center in Dallas, Texas.

With an enrollment goal of 400 patients, the objective of the multi-center study is to assess the long-term safety and efficacy of the Xoft Axxent® Electronic Brachytherapy System for the treatment of early stage breast cancer patients. The primary endpoint is the measurement and quantification of skin and subcutaneous toxicities through five year follow-up. An important additional primary endpoint includes a quality of life questionnaire based on patient experience with this new form of radiation therapy. Secondary endpoints assess local-regional breast failure and patient survival through five years as well as device performance.

"From earlier diagnosis to decreased morbidities and treatment times and ultimately, improved survival, we have made great strides in treating women with breast cancer. For many women, post lumpectomy radiation therapy can now be completed in one week with brachytherapy compared to the 6-7 weeks required for external beam therapy," said Peter Beitsch, MD, co-Principal Investigator of EXIBT and the surgeon for the first patient on the registry. Dr. Beitsch is director of the Dallas Breast Center and a Board Member of the American Society of Breast Surgeons. "With the innovative Electronic Brachytherapy System, physicians now have the ability to move breast brachytherapy out of the radiation bunker, offering women more comfortable, more accessible treatment with one of their caregivers actually present in the treatment room. Electronic brachytherapy allows for a much less anxiety-producing environment for patients who already have so much on their minds.

"The fact that three physician organizations involved in the treatment of breast cancer, ASBrS, ABS, and ACRO, have agreed to jointly provide oversight for the Electronic Brachytherapy patient registry speaks to the multi- disciplinary nature of breast brachytherapy treatment decisions and the potential impact this new method of delivering non-radioactive, non- isotope- based radiation treatment may have on patients," added Dr. Beitsch.

"Used to treat cancer for more than 100 years, radiation therapy is a critical component in the treatment of cancer patients, proven to reduce recurrence and potentially improve survival," said Rakesh Patel, MD, Associate Professor, University of Wisconsin Medical School, Madison WI, co-Principal Investigator of EXIBT, and Director at Large for the American Brachytherapy Society. "Radiation therapy has been increasingly in the news lately, with expanded regulation of radioactive materials announced by the Nuclear Regulatory Commission. Combined with an increasing body of evidence supporting accelerated partial breast irradiation, continued and multi- disciplinary evaluation of Electronic Brachytherapy, a new method of delivering non-isotope-based radiation treatment is timely and extremely relevant.

"The Electronic Brachytherapy patient registry will set new standards for gathering data by carefully correlating specific surgical and radiation dosimetric parameters with patient outcomes. The results should allow both breast surgeons and radiation oncologists to make more informed and collaborative treatment decisions, thereby resulting in better patient care by identifying women who might benefit most from this new technique," added Dr. Patel.

The EXIBT Study oversight committee includes both radiation oncologists and breast surgeons. Members of the oversight committee members representing ABS and ACRO with a focus on radiation oncology are: Douglas Arthur, MD, Virginia Commonwealth University, Frank Vicini, MD, William Beaumont, David Wazer, MD, Tufts New England Medical Center and Brown University, Arve Gillette, MD, US Oncology. Members of the oversight committee members representing ASBrS with a focus on breast surgery are: Michael Kinney, MD, Northwest Breast Care, Henry Kuerer, MD Anderson, Helen Pass, MD, Columbia University, and Pat Whitworth, MD, Nashville Breast Center and Vanderbilt University.

About Electronic Brachytherapy

Cleared for accelerated treatment of early stage breast cancer and endometrial and rectal indications, the Axxent® Electronic Brachytherapy System is now cleared for use in the treatment of other cancers or conditions where radiation therapy is indicated. As a platform technology, the Electronic Brachytherapy System is designed to address a variety of oncological and non-oncological indications. 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.

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.

Axxent is a registered trademark of Xoft, Inc.

Source: Xoft

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