NEWS FROM AFFILIATES
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FDA
CLEARS XOFT’S AXXENT™ ELECTRONIC BRACHYTHERAPY SYSTEM FOR
TREATMENT OF BREAST CANCER
New
Technology Delivers Non-Radioactive, Localized Radiation Therapy Direct to
Cancer Sites in Minimally Shielded Clinical Setting
FREMONT,
Calif., Jan. 4, 2006 – Signaling another advance in the fight against
breast cancer, Xoft, Inc., today announced that it has received clearance from
the U.S. Food & Drug Administration (FDA) for the Axxent™ Electronic
Brachytherapy System for the treatment of breast cancer. Electronic Brachytherapy is a
proprietary technology platform designed to deliver localized, non-radioactive,
isotope-free radiation treatment in a minimally-shielded clinical setting under
the supervision of a radiation oncologist.
“We look forward to being able to
offer this exciting new way to deliver non-radioactive radiation therapy for
the treatment of breast cancer,” said Vivek Mehta, MD, director for the Center of
Advanced Targeted Radiation Therapy at the Swedish Cancer Institute in Seattle.
“Unlike
brachytherapy sources containing radioactive isotopes, the non-radioactive
Electronic Brachytherapy X-ray source can be turned on and off at will,
enabling it to be delivered in virtually any clinical setting rather than in
heavily-shielded environments. The
result is on-demand X-ray treatments that we expect will improve access to
critical radiation therapy.”
Used to treat cancer for more than 100 years,
radiation therapy is administered after breast-sparing surgery to kill any
stray cancer cells that might remain in the breast and is proven to reduce the
rate of local recurrences and improve long-term survival. Ample 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 lumpectomy surgery 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.
“As electronic
brachytherapy now moves into clinical practice, all indications are that this
technology represents a leap
forward in cancer treatment,” said Kambiz Dowlat, MD,
professor of surgery and senior attending, Rush University Medical Center in
Chicago. “However, as
important as the clinical benefits are, the true breakthrough may relate to
easy and convenient access to non-radioactive brachytherapy for women who today
opt for mastectomy or lumpectomy without radiation therapy.”
The Axxent Electronic Brachytherapy System uses disposable micro-miniature X-ray radiation sources to deliver ionizing radiation treatment directly to tumor beds. In its first indication for use, the Axxent System can be used to deliver a course of radiation therapy for early stage breast cancer. It gives radiation oncologists the flexibility to deliver radiation at multiple energy levels, while at the same time eliminating the need for heavily shielded environments so that it can be used in a broader range of clinical settings. This may accelerate patient choice of breast sparing lumpectomy surgery with adjuvant radiation therapy over the alternative of a full mastectomy.
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 on expanding its product offering to include
several complementary oncology indications.
In a survey conducted
at the recent American Society for Therapeutic Radiology
and Oncology (ASTRO) Meeting, 90 percent of radiation oncologists
believe that Electronic Brachytherapy is an exciting new radiation therapy
technology for the treatment of cancer. And, a solid majority said that once
Electronic Brachytherapy received clearance from the FDA they would likely
incorporate the technology into their practice.
"Xoft’s
proprietary Electronic Brachytherapy was designed to leverage the clinical benefits of both traditional brachytherapy
and external beam radiation while
reducing the time required to deliver the therapy,” said Michael Klein,
Xoft CEO and president. “In the
same way that linear accelerators
made cobalt radiation therapy obsolete more than a generation ago, Electronic Brachytherapy has significant
potential to make many isotope based modalities obsolete. The result is a powerful new tool that
will help
breast surgeons and radiation oncologists work together to provide the best
possible therapy with the greatest clinical outcomes for breast cancer
patients.”
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 designed for use in Accelerated Partial Breast Irradiation 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 trademark
of Xoft, Inc.
Media Contact:
Chris K. Joseph
510/339-2293
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Frantz
Medical Group
Frantz Medical Development / Frantz Medical Manufacturing
Frantz Tool & Design / Frantz Medical Ventures / Frantz
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