FDA Clears New Skin and Surface Treatment Applicator for Use With Xoft's Axxent(R) Electronic Brachytherapy (eBx) System
Created by News on 3/4/2009 9:35:18 AM

Xoft, Inc., today announced that it has received clearance from the U.S. Food & Drug Administration (FDA) for a skin and surface treatment applicator for use with the Axxent(R) Electronic Brachytherapy (eBx) System to deliver surface brachytherapy, including Intraoperative Radiation Therapy (IORT).


Most Recent Indication Expands Treatment Platform to Allow Axxent(R) System to Deliver Surface Brachytherapy, Including Intraoperative Radiation Therapy (IORT)

SUNNYVALE, Calif., March 4 /PRNewswire/ -- Xoft, Inc., today announced that it has received clearance from the U.S. Food & Drug Administration (FDA) for a skin and surface treatment applicator for use with the Axxent(R) Electronic Brachytherapy (eBx) System to deliver surface brachytherapy, including Intraoperative Radiation Therapy (IORT). This latest FDA Clearance allows the applicator to be used on any external or internal surface of the body where radiation therapy is indicated.

Previously cleared for accelerated treatment of early stage breast cancer and endometrial and rectal cancers, the Axxent System is also cleared for use in the treatment of surface cancers or conditions where radiation therapy is indicated. The proprietary Electronic Brachytherapy treatment platform is designed to deliver localized, non-radioactive, isotope-free radiation treatment in minimally-shielded clinical settings under the supervision of a radiation oncologist.

"As market and clinical adoption for Electronic Brachytherapy grows for our breast and endometrial applications, the FDA Clearance of skin and surface indications completely supports Xoft's mission of expanding the number of patients who can access radiation therapy and can dramatically benefit from it," said Michael Klein, president and CEO of Xoft. "Not only does it create access to a fast, convenient, non-isotope treatment option for millions of skin cancer patients, it continues to expand the clinical utility of the broad based Electronic Brachytherapy treatment platform that is being used at more than 50 radiation oncology centers across the United States."

Skin cancer is the most common cancer in the United States with more than 1 million cases diagnosed annually. If diagnosed and treated early, most cases of skin cancer can be cured; however the National Cancer Institute estimates that skin cancer results in more than 10,000 deaths each year. Radiation therapy is one of several primary treatment options used to treat skin cancers, including surgery and chemotherapy. Designed to kill cancer cells and reduce the spread and local recurrence of cancer, radiation therapy is used alone or in combination with surgery or chemotherapy, depending on the location and stage of the cancer tumor as well as the patient's general health.

In addition to skin indications, the FDA clearance also covers surface indications, which means that many intraoperative radiation therapy procedures can be performed with the Xoft source, while surgery is being performed. Intraoperative treatment potentially reduces the time required for radiation therapy by delivering it immediately during surgery before any remaining cancer cells have a chance to grow. IORT, utilizing the Axxent System's miniaturized X-ray source that can deliver localized and targeted radiation treatment, is designed to minimize radiation exposure to surrounding healthy tissue and enables physicians and treating professionals to remain in the operating room with the patient.

As a platform technology, the Axxent System addresses a variety of oncological and non-oncological indications. The Axxent System is designed to deliver non-radioactive therapy directly to cancer sites with minimal radiation exposure to surrounding healthy tissue. Designed to deliver electronic, X-ray-based radiation treatment, the proprietary Axxent treatment platform can be used in many clinical settings. Treatment can be performed without the need for a shielded room, allowing the radiation oncologist and other medical personnel to be present during treatment delivery and minimizing patient anxiety. As a result, tens of thousands of patients annually will have greater access to therapy that is delivered more easily and conveniently.

About Xoft, Inc.

Xoft, founded in 1998, develops Electronic Brachytherapy (eBx) systems based upon miniaturized X-ray tube technology for the practice of radiation oncology in virtually any clinical setting, eliminating the need for heavily shielded environments. Xoft provides a "point of care model" that is patient centric and accessible to a broader spectrum of patients and their physicians. The Axxent treatment platform provides a therapeutic dose of radiation directly to the region at risk with minimal radiation exposure to surrounding healthy tissue and without the complex handling, resource logistics and costs associated with using radioactive isotopes. Xoft aligns with the Nuclear Regulatory Commission's (NRC) directive to seek alternatives for radioactive medical isotopes. Commercially available for treatment of early stage breast cancer and endometrial and rectal indications, the Axxent(R) Electronic Brachytherapy System is also cleared for use in the treatment of other cancers or conditions where radiation therapy is indicated. For more information, visit www.xoftinc.com.

Axxent is a registered trademark of Xoft, Inc.

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