"Dion Medical" has completed recruiting patients for a large-scale clinical trial that will be submitted to the FDA

The experiment will test the effectiveness of the MarginProbe technology, which detects cancer cells at the margins of the breast tumor and saves repeated surgeries

The Israeli "Dion Medical" company, which specializes in the development of medical devices for the immediate detection of cancerous tissues in surgeries, reports the completion of the recruitment process of 664 patients in 18 medical centers in the US and 3 in Israel, for clinical trials in order to submit for FDA approval to the system MarginProbe. The system detects in real time, during the first surgery to remove the breast tumor, whether there are cancer cells in the tissue at the margin of the tumor removed from the breast. If so, the surgeon removes it on the spot and the woman is spared a repeat operation, and this is actually the only way to ensure the removal of the cancerous tumor in full, without the need for a repeat operation. The surgeon receives an immediate indication of the cancerous tissue and can thus remove it on the spot.

"This is one of the largest experiments carried out in the field and the completion of patient recruitment in only 15 months is a significant achievement, explained Dr. Lorraine Tapra, medical director of the breast center in Annapolis, Maryland.
According to her, "MarginProbe's potential for a significant improvement in the current treatment standard lies in the possibility of achieving clean margins in breast tumor removal surgeries. The main goal in surgery to preserve the breast is to remove the tumor along with the margin of the healthy tissue and preferably in the first operation."
According to the medical literature, between 20% and 40% of patients who undergo surgery to remove a tumor from the breast (lumpectomy), need a repeat operation, to remove malignant tissues that were not detected in the first operation.

According to Dr. Dan Shamshoni, founder and CEO, "Dion Medical", "We have achieved a significant milestone in the mission to reduce the need for repeated operations to remove a cancerous tumor from the breast in the important American market. The purpose of the experiment was to obtain a lot of well-founded information about the capabilities of the technology to improve oncological surgeries. Within a few months, the results will be submitted to the FDA for product approval."

About MarginProbe

The technology is based on electromagnetic reflection in the RF field, and includes a control unit and a sterile manual test device for single use. During surgery and immediately after the tumor is removed, the tip of the hand-held device is attached to the removed lump and the RF signals are transmitted into the tissues and returned to the control unit. The control unit performs decoding to determine the condition of the tissues and on the spot provides the surgeon with data regarding the presence of cancer cells at the tumor margins.
In October 2008, the American journal "American Journal of Surgery" published the results of an Israeli clinical study that included 300 patients. The test subjects were randomly divided into two groups, in the test group, the surgeons used the MarginProbe. According to the findings, the rate of repeat operations was reduced by 56% in operations where the "Dion Medical" technology was used.
In Europe and Israel the system is approved for marketing. In Israel, the system is in regular use in several centers.