Dune Medical Devices has presented positive interim results from a European post-market study of the MarginProbe System, at the German Breast Cancer Society Meeting (DGS 2010) held in Hamburg, Germany. The MarginProbe System is a technology to enable better detection and removal of cancerous tissue during breast-conserving surgery (BCS).
According to Dune, MarginProbe enables intraoperative, real-time detection of ‘positive margins’, or cancer found at the edges of excised breast tissue. Positive margins are an indicator that cancer remains in the breast, and with this information, surgeons can immediately remove it and potentially avoid a second operation.
Dune said that the study, which is currently being conducted at four breast cancer centers in Germany, assesses whether MarginProbe use during surgery for DCIS helps to avoid the need for further surgery to achieve ‘clear margins.’ Earlier this year, the company had completed the MarginProbe pivotal trial to support US market approval.
Marc Thill, head of the Gynecological Cancer Center at University Hospital, Schleswig-Holstein in Luebeck, Germany, said: “DCIS can be a diffuse disease, and reoperation is quite common. The data further demonstrate the benefit of MarginProbe in this setting.
“Given the wide body of data supporting a significant reduction in the number of second surgeries, it is quite conceivable that this technique could be established as the standard of care for invasive cancer as well as for DCIS in surgical therapy.”
Bill Densel, CEO of Dune, said: “The ability to detect DCIS intraoperatively is significant since DCIS is considered a very challenging target. These data support earlier published findings which reported MarginProbe’s capability to detect all types of malignancy found in the breast and to positively impact reoperation rates.
“Dune’s technology creates a novel platform that can probe into the internal structures and properties of human tissues and provide information in real-time. In addition to pursuing MarginProbe approval in the US and commercial roll out in target markets, Dune will continue to advance ongoing development of additional applications for real-time cancer detection in both diagnostic and therapeutic procedures.”