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Intraop Medical Corporation Sponsors IORT Symposium for Treating Early Stage Breast Cancer at the American Society of Breast Surgeons Meeting



[April 8, 2005]  Intraop Medical Corporation (OTCBB: IOPM) announced today that it sponsored a special symposium on the use of Intraoperative Radiation Therapy, or “IORT”, in conjunction with the 6th Annual Meeting of the American Society of Breast Surgeons (“ASBS”), which was held in Los Angeles, California from March 16 - 19, 2005. The ASBS is one of the largest meetings of breast surgeons in the U.S. and was attended by more than 700 physicians. The special symposium was entitled: “Electron Intraoperative Radiation Therapy: A Novel Approach to Breast Preserving Therapy”. Three distinguished speakers spoke at the symposium: David Ollila, MD, Associate Professor of Surgery and Surgical Director at the University of North Carolina Multidisciplinary Breast Center; Barbara Pockaj, MD, Chair of Surgical Oncology at the Mayo Clinic in Scottsdale, and Felix Sedlmayer, Professor and Chairman of the Department of Radiology and Radio-Oncology at the University Clinic in Salzburg, Austria.

Dr. Ollila’s presentation was entitled “Breast Preservation with Single Fraction Radiotherapy Delivered Intraoperatively.” Dr. Ollila described the innovative protocol developed at the University of North Carolina in which eligible patients are treated with a single dose of IORT during surgery, prior to tumor removal. After the tumor is removed, assuming the final pathology shows negative margins, the patients receive no further therapy. If the final pathology shows positive margins the tumor is re-excized and the patient receives additional external beam radiation. At the time of the symposium, 24 patients had completed the protocol. The University of North Carolina is only one of two U.S. centers that have been invited to participate in the newly formed European Consortium of Research in IORT Studies (“ECRIS”) which will meet later this month in Novara, Italy. The University of North Carolina uses Intraop Medical’s Mobetron® to deliver IORT treatment.

Dr. Pockaj’s presentation was entitled “Boost IORT: The Mayo Experience”, and discussed the Mayo Clinic’s use of the Mobetron in the treatment of their first fifty breast cancer patients with IORT. In the Mayo protocol, eligible patients receive IORT boost at the time of lumpectomy, in the operating room. Two to eight weeks after surgery, patients receive 48 Gy of external beam radiation in 24 fractions over 5 weeks, consistent with conventional breast conserving therapy treatment protocols. Dr. Pockaj reported that the IORT procedure added only 20 minutes to the surgical procedure and that none of the patients had experienced IORT complications. Furthermore, Dr. Pockaj reported that the IORT procedure with the Mobetron reduced the overall treatment cost by $1,524 per patient. The next 50 patients in the Mayo Clinic study will receive a shorter course of external beam radiation (40 Gy in 16 days), demonstrated in Canada to be equally effective as the U.S. standard, thereby shortening the overall time to provide the treatment even more.

Dr. Sedlmayer’s presentation was entitled “Boost IORT: A European Viewpoint”. At the University of Salzburg, breast IORT is now the standard of care for patients eligible for breast conserving therapy. More than 700 women have been treated with IORT boost at the time of lumpectomy. The symposium talk discussed the 541 patients that had been treated with sufficient follow-up time to evaluate. Of these 541 patients, more than a third were node positive patients, typically at higher risk for recurrence. The University gives the IORT treatment at the time of lumpectomy in the surgical theater, and follows it four to fourteen weeks later with 51 Gy of external beam therapy over a 5-6 week period. Node positive patients receive chemotherapy before the external beam treatment is delivered. Dr. Sedlmayer reported that with a median follow-up time of 3 years, none of the patients had recurred and only 29 patients had developed metastases, and 7 patients had died of disease. Dr. Sedlmayer indicated that they, like Mayo Clinic, were considering shortening the external beam treatment to 40 Gy in 16 days. At the University of Salzburg, the IORT radiation is delivered with a conventional linear accelerator located in a shielded operating room.

“Intraoperative radiation therapy for early stage breast cancer is gaining increasing interest as the results of studies such as these show it can be very effective in the treatment of this disease,” comments Donald A. Goer, President and CEO of Intraop Medical. “We were pleased to support this symposium at the ASBS so that the latest information on this promising application of IORT technology could be made available to its members.”

The Symposium on the use of IORT for breast cancer was supported by an unrestricted educational grant to the ASBS from Intraop Medical Corporation.