Dune Medical Gets PMA for Breast Cancer Surgery Probe

Dune Medical Devices, Inc., eceived Premarket Approval (PMA) by the United States Food and Drug Administration for its intra-operative tissue assessment tool for early-stage breast cancer surgery, the MarginProbe System. The technology improves surgeons’ ability to intra-operatively 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 664 patient prospective, multi-center, randomized, double arm study to evaluate 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 intra-operative imaging and palpation assessment. This enabled surgeons to significantly reduce the number of patients with positive margins following initial 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 Dr. Susan K. Boolbol, 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 percent of early-stage breast cancer patients who have an initial lumpectomy procedure will undergo a repeat surgery.i 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 U.S., with national availability expected in early 2013.

Dune Medical Devices was founded in 2002 by Dr. Dan Hashimshony 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 financed by Apax Partners since 2004. It has offices in the U.S., Israel, Germany and Switzerland.

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