Baltimore, MD and Caesarea, Israel - A novel hand-held surgical probe shows promise in clinical studies that it could consistently enable obtaining a clear margin during a single lumpectomy procedure. In real time, the probe detects differences in electrical waveforms reflected from fresh tissue specimens. This and other observations from an ongoing, international multi-center study of the surgical probe, developed by Dune Medical Devices, Ltd., Israel, were reported by researchers at the annual scientific meeting of the American Society of Breast Surgeons (ASBS).

Published reports indicate that anywhere from 20 to 60 percent of the estimated 250,000 breast-conserving lumpectomies performed each year in the US necessitate re-excision because a clear margin was not obtained in the initial procedure. A second surgical procedure can cause emotional distress for the patient, increase the cost of treatment and contribute to poorer cosmetic results.

In the study presented at ASBS, researchers intraoperatively applied the probe to the surface of 41 fresh, lumpectomy specimens. Probe output and pathology data were separately evaluated by two pathologists and recorded as positive or negative for malignancy. To assess potential clinical outcomes, researchers assumed that if the data had been available during the initial surgery, a detected positive margin would have been excised immediately. According to intraoperative data, the probe would have identified positive margins in 9 out of 12 patients, potentially eliminating the need for additional surgery in those cases. This would be equivalent to a 7.3% positive margin rate. Assessing margins without the probe, the positive margin rate was 29.3%.


"We currently have no technology that allows us to determine in the operating room whether we have removed all the tumor from a woman's breast , which is why we sometimes have to take the patient back to remove more," said principal investigator Lorraine Tafra, M.D., director of the Breast Center at Anne Arundel Medical Center, Annapolis, MD. "This innovative device has the potential to decrease the need for re-excisions and significantly contribute to improving the accuracy of breast conserving surgery. Our goal is to remove the entire tumor the first time, while leaving as much normal tissue as possible to retain the original contour and appearance of the breast. This device brings us closer to that goal."

According to Dr. Tamar Karni, Chief Surgeon at The Comprehensive Breast Care Center, Assaf Harofeh Medical Center, Tel Aviv, and a clinical advisor to Dune Medical Devices, "We are extremely encouraged but certainly not surprised by the positive clinical potential demonstrated by the probe in this pilot clinical evaluation. The rapidity, ease of use and reproducible results indicate potential for this probe to become the first truly reliable and practical means for achieving intraoperative margin assessment."

The cancer probe and console system developed by Dune Medical Devices uses patent-protected, proprietary RF spectroscopy that enables the clinical application of this technology to intraoperative, on-contact measurement of suspected tissue surfaces.

According to Dr. Dan Hashimshony, founder and CEO of Dune Medical Devices, Ltd., "Dune Medical is extremely pleased by the emerging clinical validation of our technology platform in breast cancer, We are pursuing a plan of extensive clinical trials to provide the community of surgeons and patients with sufficient clinical data to justify wide spread use of this technology in the future. We will shortly launch pivotal clinical trials in the United States and in Israel. We believe that combining the accuracy of real-time tissue characterization with the practical utility of a small and easy-to-use device has the potential to improve surgical oncology practice and outcomes in a wide range of cancers."

Headquartered in Caesarea, Israel, Dune Medical Devices, Ltd. is a developer of surgical oncology technologies and products.

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