Dune Medical Devices Receives FDA Approval for the MarginProbe System

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Dune Medical Devices, Inc, announced that the FDA has granted Premarket Approval to the MarginProbe System, the company’s breakthrough intraoperative tissue assessment tool for early-stage breast cancer surgery. The technology significantly improves surgeons’ ability to intraoperatively identify “cancer on the margin” and significantly reduce pathologically positive margins following a patient’s initial lumpectomy surgery.

FDA approval of the MarginProbe System was based on a prospective, multicenter, randomized, double-arm study of 664 patients evaluating the effectiveness of MarginProbe in identifying cancerous tissue along the margins of removed breast tissue during initial lumpectomy procedures. MarginProbe, which uses electromagnetic “signatures” to identify healthy and cancerous tissue, was found to be over three times more effective in finding cancer on the margin during lumpectomy, compared to traditional intraoperative imaging and palpation assessment. This enabled surgeons to significantly reduce the number of patients with positive margins following initial surgery.

Reduces Need for Repeat Surgery

“Up to this point our ability to assess the microscopic margin status in the operating room has been limited.  Frequently, early-stage breast cancers are detected by mammography.  This can make the process of achieving negative margins more challenging,” said Susan K. Boolbol, MD, an investigator for the pivotal clinical trial and Chief of Breast Surgery at Beth Israel Medical Center.  “Following their breast cancer surgery, telling a patient that they need more surgery can be an emotional issue for doctors and patients. This may result in tremendous anxiety and frustration. I believe that the MarginProbe System can help advance the field of breast surgery.”

It is estimated that 30% to 60% of patients with early-stage breast cancer who have an initial lumpectomy procedure will undergo a repeat surgery. This is because cancerous cells are found to be present on the rim or edge of the removed tissue, increasing the possibility that cancer still remains in the breast.

Susan Scanlan, breast cancer survivor and Chair of the National Council of Women’s Organizations said, “When I was first diagnosed with breast cancer I decided to undergo a lumpectomy, but like many others, I was told I had cancer on the margin following the procedure. The mental distress of having to go back for a repeat surgery undermined my confidence.  I believe MarginProbe offers women the additional peace of mind that they can move on to the next step in fighting the disease and put breast cancer in their rearview mirror.”

“The MarginProbe System was developed to address one of the longest standing unmet medical needs in the breast cancer surgical community,” said Daniel Levangie, Chief Executive Officer of Dune Medical Devices. “We have received resounding support from clinicians, advocacy organizations and patients alike, who have recognized the value of MarginProbe and intra-operative, real-time detection of cancer on the margin to potentially improve patient outcomes.”

MarginProbe has been available in Europe since 2008 and is now available in select locations throughout the United States with national availability expected in early 2013. ■




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