Study Results of Dune Medical's Breast Biopsy System Presented at the Annual Meeting of the Israel Society of Breast Imaging Test Results Demonstrate Excellent Sensitivity and Specificity and 92% Correlation with Final Histopathology
BOSTON, Feb. 14, 2013 /PRNewswire/ -- Dune Medical Devices, Inc., announced today that its breakthrough tissue assessment tool for use with currently available vacuum assisted breast biopsy systems was the subject of a presentation to the Israel Society of Breast Imaging at the annual meeting of the society held in Tel Aviv on Wednesday, February 6, 2013.
During his presentation, Dr. Iddo Geltner, Core Technology Director, described the results of Dune's development effort in differentiating tissue types in real time during vacuum assisted breast biopsy procedures using a prototype of their breast biopsy system. The results, based upon approximately 4,000 histopathologically confirmed samples, demonstrated excellent performance in differentiating 10 breast tissue types in real time. In addition, use of the prototype device to perform biopsies of ex-vivo specimens demonstrated 92% correlation with final histopathology.
"We believe that our tissue characterization technology, developed initially for use in the recently FDA approved MarginProbe System®, has been successfully adapted for use on commercially available vacuum assisted breast biopsy devices and that this real time information will allow more precise identification of the most suspicious breast tissue. This technology holds the promise of improved diagnostic accuracy with improved efficiency during the biopsy procedure itself," said Dr. Geltner.
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.i Over 1.5 million breast biopsies are performed each year to diagnose these women. 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 undergo a lumpectomy procedure as their initial treatment versus mastectomy, which involves the removal of the whole breastii. Lumpectomy in combination with radiation therapy is as effective in combating breast cancer as mastectomy, as long as no cancer cells are present on the rim or edge of the removed tissue, also known as "clean margins." Research shows there is no significant difference in overall survival between the two procedures;iii however, 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.
Dune Medical Devices
i American Cancer Society: http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-030975.pdf
ii Journal of the American Medical Association: http://jama.jamanetwork.com/article.aspx?articleid=1104931#Abstract
iii Fisher B, et al. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002;347(16):1233-1241.
SOURCE Dune Medical Devices, Inc.