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Intraop Medical Inc. Announces U.S. IORT Lung Study



[October 2004]  Intraop Medical, Inc. announces that Dr. Subir Nag, Director of Intraoperative Radiation Therapy and Brachytherapy at the Arthur James Cancer Hospital at The Ohio State University in Columbus Ohio, has agreed to be the Principal Investigator in a protocol that will use intraoperative radiation therapy (“IORT”) in the treatment of advanced lung cancer.

The protocol is based on a pilot study of about 100 patients treated with IORT at the University of Navarre in Pamplona, Spain. In this pilot study, patients were transported from the surgical theater to the radiation department in the middle of the surgery to give the IORT treatment using a conventional electron linear accelerator. After the IORT treatment, the patients were transported back to the operating room for the completion of the surgery. This pilot study showed significant improvement in both local control and survival (about 40% 5-year survival) compared to conventional treatment for advanced lung cancer (about 15% 5-year survival).

Smaller studies in the U.S. and China showed similar results, but because of the difficulty of delivering IORT for lung cancer patients through patient transportation, it has been difficult to establish IORT as an important component of advanced lung cancer treatment. This new study is designed to determine the role of IORT in advanced lung cancer treatment.

“We are pleased to have Dr. Nag as the Principal Investigator on this study” says Dr. Donald Goer, President and CEO of Intraop Medical, Inc. “Not only is Dr. Nag one of the world’s most prominent IORT practitioners, but at the Arthur James Cancer Hospital, they have experience using IORT to treat lung cancer. Now that there are more hospitals with dedicated IORT treatment units like the Mobetron, it will be possible to test the impressive results of this pilot study in a multi-institutional trial without having to transport the patient out of the operating room. We are very pleased to be able to lend our support for this study.”

“We think this could be a very important study,” says Dr. Subir Nag. “If the multi-institutional results validate the pilot study and our own study, we could demonstrate an improved method of treatment for select lung cancer patients. The more institutions that participate in the study, the more quickly we will learn the answer.”

In addition to The Arthur James Cancer Center in Ohio, several other U.S. centers with dedicated IORT capability are expected to participate in this study. In addition, a similar study has been initiated for European IORT centers. The study will be funded in part by Intraop Medical, Inc.