FDA Clears New Skin and Surface Treatment Applicator for Use With Xoft’s Axxent(R) Electronic Brachytherapy (eBx) System
Most Recent Indication Expands Treatment Platform to Allow Axxent(R) System to Deliver Surface Brachytherapy, Including Intraoperative Radiation Therapy (IORT)
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
Skin cancer is the most common cancer in
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.
SOURCE Xoft, Inc.