Enrollment complete in Dune Medical Devices' MarginProbe pivotal clinical trial

Jan 12 2010

Dune Medical Devices today announced the completion of patient enrollment in the MarginProbe™ pivotal clinical trial. The MarginProbe procedure provides surgeons with real-time detection of cancer at the edges of the tissue removed during breast conservation surgery (BCS), which is the only way to ensure the complete removal of the tumor from the breast.  The randomized, controlled trial includes 664 women who underwent BCS at one of 21 leading medical facilities, with 18 in the US and three in Israel.

"This trial is one of the largest randomized, controlled trials for intraoperative margin assessment ever undertaken.  Completing enrollment in only 15 months is a significant accomplishment," said lead investigator Lorraine Tafra, MD, FACS, Medical Director of Anne Arundel Breast Center, Annapolis, MD. "Because of the importance of achieving clear margins in BCS and the potential of MarginProbe to improve upon existing standards, we eagerly anticipate the trial results.  Such a rigorous trial has the potential to help us in the development of better breast surgery techniques."

The main surgical objective of BCS is the removal of the primary tumor with a rim of healthy tissue, known as the margin, preferably in one surgical session.  According to the medical literature, between 20 percent and 40 percent of BCS patients require a second surgery because clear margins were not achieved during the initial procedure.  Dune's real-time, cancer detection procedure is designed to give surgeons a simple, instant indication of the presence of cancer at the margins, allowing for its immediate removal.

"This is a significant milestone in our mission to reduce the need for multiple surgeries to treat breast cancer," said Dr. Dan Hashimshony, founder and CEO of Dune Medical Devices.  "The intent of this trial was to obtain a rigorous and ample body of data that demonstrates the capacity of our technology to improve surgical oncology practice and outcomes.  We are grateful to everybody involved in this significant clinical trial, including physicians, nurses, staff, and especially the patients."