Xoft's breast brachytherapy unit gets FDA clearance

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Xoft Inc. yesterday announced that it has received clearance from the FDA for its 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, the company said.
   
"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, in a release. "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."

Radiation therapy is administered after breast-sparing surgery to kill any stray cancer cells and can 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, Xoft said.
   
"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 at 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, Xoft said.

As a platform technology, the Axxent Electronic Brachytherapy System is designed to address a variety of oncological and non-oncological indications. Xoft said it is working on expanding its product offering to include several complementary oncology indications.