Clinical Trial Results for Dune Medical Devices' MarginProbe® System Presented at 66th Annual SSO Cancer Symposium
MarginProbe System significantly reduced pathologically positive margins following initial lumpectomy compared to traditional intra-operative methods
WASHINGTON, March 7, 2013 /PRNewswire/ -- Dune Medical Devices, Inc., announced today that results from the pivotal clinical trial for the MarginProbe System, Dune's breakthrough intra-operative tissue assessment tool for early-stage breast cancer surgery, were presented at the 66th Annual Society of Surgical Oncology (SSO) Cancer Symposium. Dr. Susan K. Boolbol, Chief of Breast Surgery at Beth Israel Medical Center, an investigator for the trial, presented this data for the first time since the MarginProbe System's approval by the United States Food and Drug Administration (FDA) in January 2013. Dr. Boolbol's presentation occurred during a dinner symposium presented by five breast cancer experts titled "Demystifying Margins in Breast Conserving 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 System in identifying cancerous tissue along the margins of removed breast tissue during initial lumpectomy procedures. The MarginProbe System, 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.
"It is important to share this compelling data with our colleagues and thought leaders. Our ability to assess the microscopic margin status in the operating room has been limited. Because early-stage breast cancers are often detected by mammography, the process of achieving negative margins can be challenging," said Dr. Boolbol. "Following their breast cancer surgery, telling a patient that they have positive margins 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. 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.
"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."
About Early-Stage Breast Cancer Treatment Breast cancer is the most common type of cancer affecting women in the U.S., with over 285,000 women diagnosed each year. Increased breast screening awareness and advancements in imaging technology such as mammograms now catch more breast cancer cases in earlier stages, when they are most treatable. In fact, over half of all breast cancer diagnoses are for early-stage cancers. Many of these cases are non-palpable, meaning a tumor cannot be felt during a breast exam.
It is estimated that in 60 to 75 percent of breast cancer cases, patients will opt for a lumpectomy procedure as their initial treatment rather than mastectomy, which involves the removal of the whole breast. Lumpectomy in combination with radiation therapy is as effective in combating breast cancer as mastectomy, provided "clear margins" – meaning cancer cells are not present on the rim or edge of the removed tissue. Research shows that if there is cancer at the edge, or a "positive margin," the risk of recurrence increases significantly.
Following a lumpectomy, surgeons will send the removed tissue to the pathology lab where it is analyzed for cancer on the margin. This is critical information because if there is cancer present on the edges of the removed tissue, there is a possibility that cancer still remains in the breast. Once a tissue sample is sent to pathology for analysis, it can take approximately one week or more to receive the lab results that determine if the patient must undergo a repeat surgery.
Inability to know if all cancerous cells have been removed from the breast during the initial lumpectomy procedure results in repeat surgery rates ranging from 30 to 60%.
About Dune Medical Devices 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.
For more information, please visit www.dunemedical.com.
Dune Medical Devices
SOURCE Dune Medical Devices, Inc.
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