Xoft to showcase a variety of investigational IORT oncology applications at ACS Annual Congress

Clinical experience with the FDA cleared Axxent® Electronic Brachytherapy, eBx(TM), System from Xoft shows promise for the multi-disciplinary use of the isotope-free cancer treatment platform to deliver intraoperative radiation therapy (IORT). Xoft will showcase a variety of investigational IORT oncology applications at the American College of Surgeons 95th Annual Clinical Congress here in Chicago, October 11-15, 2009.

IORT is a radiation therapy technique where a concentrated dose of radiation is delivered to a cancerous tumor site during surgery after the tumor is removed. Because the target and normal tissues can be clearly identified during surgery, IORT may increase targeting accuracy, thereby increasing dose to the target and reducing dose to critical structures. For breast IORT, the shorter treatment time is generally more convenient for patients than the seven-week course of external beam-therapy, and may increase patient compliance.

"We are very pleased with the strong interest from clinicians around the country to investigate multi-disciplinary approaches for use of Electronic Brachytherapy to deliver IORT for breast and other cancers," said Michael Klein, president and CEO of Xoft. "Currently, we are supporting studies investigating spine, inter-abdominal and breast applications, and as more oncologists and surgeons understand this powerful tool, we expect to see studies investigating treatments for pancreatic and other recurring cancers."

"At Little Company of Mary Hospital, we have treated a number of patients using breast IORT with excellent results. Combined with data from European studies showing comparable results to whole-breast irradiation and other forms of APBI, we believe these preliminary results are very encouraging and deserve the attention of American breast surgeons," said Olga Ivanov, M.D., breast surgeon and medical director for Little Company of Mary's Comprehensive Breast Health Center.

The Xoft eBx System uses a miniature X-ray source instead of a radioactive isotope to deliver radiation to the breast from within a balloon catheter. The low energy and rapid dose fall-off of the electronic source permit treatment in typical operating rooms, with minimal shielding required. Lightweight and mobile, the system can be moved easily between multiple ORs.

"I believe that giving a single fraction of radiation at the time of surgery will be advantageous because it will allow all the radiation to be delivered before any remaining tumor cells have a chance to grow. It also intensifies the dose to the part of the breast at highest risk for recurrence. My hope is that the availability of IORT will decrease the number of patients who decide to be treated with surgery alone despite the fact that radiation has been shown to be an essential component of treatment and increases overall survival," said Adam Dickler, M.D., radiation oncologist at Little Company of Mary Hospital.

Available for treatment of early stage breast cancer, endometrial cancer, and skin cancer, the Axxent eBx System is also FDA-cleared for IORT (intra-operative radiation therapy). As a platform technology, the Axxent System is designed to deliver non-radioactive therapy directly to cancer sites with minimal radiation exposure to surrounding healthy tissue. Utilizing a proprietary miniaturized X-ray source and robotic controller, the system can be used to deliver radiation in minimally shielded therapeutic 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 which minimizes patient anxiety.

"In breast cancer, we know there is a large segment of patients, often the elderly and women who live longer distances from radiation centers, who do not comply with their prescribed radiation treatment after lumpectomy or who choose to have a mastectomy instead of pursuing breast conserving therapy. For these tens of thousands of women, IORT may an important option to improve access to therapy as well as improve outcomes," added Klein. "What will be critical whether it is breast or another oncology application, is that the treatment is directed using a multi-disciplinary approach, involving specialists in radiation oncology, surgery and pathology."