Significant Decreases in Re-Excision Rates Reported in Two Studies Using MarginProbe® Presented at The American Society of Breast Surgeons Annual Meeting

In Parallel, Earlier Multi Center, Study Showing 62 percent Reduction in Re-excisions was Published in Peer Reviewed Publication

Paoli, PA, May 20, 2015 – Results of two studies, Routine use of the MarginProbe in partial mastectomy patients: three centers’ experience, including comparison to historical re-excision rates and A single institution’s randomized double armed prospective study of lumpectomy margins with adjunctive use of the MarginProbe in nonpalpable breast cancers were presented by Dr. Molly L. Sebastian, Associate Medical Director of the Reinsch Pierce Family Center for Breast Health and Dr. Sheldon Feldman, Chief of Breast Surgery at Columbia University Medical Center, respectively, as part of the general poster session at the American Society of Breast Surgeons 2015 Annual Meeting.

The study, Routine use of the MarginProbe in partial mastectomy patients: three centers’ experience, including comparison to historical re-excision rates examines the use of MarginProbe in 290 cases of breast cancer patients. The study shows that a 3.4 percent re-excision rate were due to a failure to detect positive margins on the main specimen, where the MarginProbe was used. Over all, 10.7 percent required a second surgery.

“Using MarginProbe to test lumpectomy specimens in the operating room, I have significantly reduced the need for re-excision in my patients, “ said Dr. Sebastian. “In fact, all four of the surgeons participating in our study have seen the same results. This is a huge benefit to our patients.”

“We are very excited that the data from the first phase of this study, which included 165 patients, was recently published in a peer reviewed publication,” said Dr. Alice Police, Medical Director at the University of California, Irvine, one of the authors of the study. “It is important that patients will be educated on the value of intraoperative margin assessment during breast conserving surgery. It further solidifies the validity of what the device does, giving our patients the best possible care and clinical outcomes, which is our ultimate goal as breast surgeons.”

“While the average re-excision rate of the group was decreased 59 percent with very strong statistical significance, in the era of the new guidelines for positive margins we are encouraged that, two of the four surgeons started with low historical rates: 12 percent and 16 percent, and respectively they reduced their rates to 3.5 percent and 8.8 percent with the MarginProbe,” said Gil Rosen, Chief Commercial Officer for Dune Medical. “These two surgeons have historical data prior to using MarginProbe that is right where many physicians hope the national average is going to be with the new guidelines, yet they were still able to lower them significantly. With more than 60 hospitals using the MarginProbe routinely, we continue to see the same impressive data across the country.”

Another study that was presented at the meeting, A single institution’s randomized double armed prospective study of lumpectomy margins with adjunctive use of the MarginProbe in nonpalpable breast cancers, had 46 patients who elected breast conservation surgery (BCS) enrolled in the study. Of the sample, only four percent of patients underwent a second procedure. After the lumpectomy was performed and margins were clinically assessed, surgeons had the option to obtain additional shavings of the excised tissue where positive margins were reported. Analysis shows that surgeons at Columbia University Medical Center elected to take slightly thicker shavings, which resulted in a lower re-excision rate than previously reported with the MarginProbe device. Despite thicker shavings being examined, when including additional surgeries, the overall volume of tissue removed was not higher.

The results of both studies report noteworthy reductions in re-excision rates for breast cancer patients, proving the significant value of MarginProbe for both patients and surgeons. When MarginProbe is not used, about one in four patients undergoing breast conservation surgery require a second operation for re-excision in order to successfully obtain negative margins.

About Dune Medical Devices

Dune Medical Devices was founded in 2002 by Dr. Dan Hashimshony, CEO, to realize the extraordinary medical potential of its proprietary tissue characterization technology. Offering surgeons and radiologists the real time ability to identify cancerous tissues and react immediately, this technology holds the promise for a broad range of surgical and diagnostic applications.

Dune Medical Devices is a privately held company with offices in the U.S. and Israel. For more information, please visit http://dunemedical.com/.

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