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Dune Medical Devices Ltd. Release: MarginProbe(R) System Shows Substantial Reduction in Need for Repeat Surgeries for Breast Cancer Patients and Cost Effectiveness



3/29/2012 9:21:09 AM

FRAMINGHAM, Mass., March 28, 2012 /PRNewswire/ -- Data from numerous studies of the MarginProbe System were presented Friday, March 23, 2012 during the European Breast Cancer Congress (EBCC) in Vienna. Results across these studies demonstrated a substantial reduction in repeat surgeries needed for breast cancer patients, the ease of integration of the MarginProbe System into routine practice, and a substantial economic benefit to device use.

"We are very excited to see such a significant and growing body of data supporting the use of the MarginProbe System in routine," said Dr. Thill. "These data presented at the EBCC meeting demonstrate the clinical, as well as economic, benefits of the MarginProbe System, while also showing that it is easy to incorporate the device into routine use. I expect that surgeons throughout Europe will be very interested in these data."

Marc Thill, M.D., of the Department of Obstetrics and Gynecology, University Hospital of Schleswig-Holstein, Lubeck, Germany presented a poster showing a significant reduction in repeat surgeries for patients with early stage, in situ lesions in whom clear margin status is a frequent surgical dilemma. In a blinded study on 39 patients with a particularly difficult form of breast cancer, improved detection with the MarginProbe System was associated with a 54% reduction in repeat surgeries from the historical control.

Michael Alvarado, M.D., of the University of California at San Francisco, presented a poster comparing three margin assessment methods including standard of care post surgical pathology (SOC), the MarginProbe System and intraoperative frozen section analysis (FSA). Both the MarginProbe System and FSA were found to significantly reduce repeat surgery rates and therefore highly cost-effective compared to SOC, representing a significant benefit to patients' quality of life, as well as health care systems worldwide. The MarginProbe System, with its real-time results and accuracy, however, could offer significant advantages over FSA's time-consuming and labor-intensive technique.

Mark Gittleman, M.D., Director of Breast Care Specialists in Allentown, PA, presented results from a 596 patient, multi-national, randomized study. Adjunctive use of the MarginProbe System significantly improved surgical outcomes, reducing the number of patients requiring re-excision by 57 percent. There was a significant reduction in the number of patients with positive margins across all commonly used definitions for negative margins.

Boris Yoffe, M.D., of the Department of General and Vascular Surgery, Barzilai Medical Center, Ashkelon, Israel, presented a poster demonstrating that the device was easy to incorporate into routine practice, and successfully reduced the rate of repeat surgeries.

The MarginProbe System enables real-time detection of cancer at or near the surface of excised tissue specimens during surgery for breast cancer. The simple and immediate assessment of the surgical margins allows surgeons to immediately excise additional tissue, potentially saving the need for a second procedure. The MarginProbe System is Dune's first commercial product and is commercially available in Europe. The MarginProbe System is an investigational device in the United States.

For more information, please visit www.dunemedical.com.

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.

Contact:
Michael Graffeo
Dune Medical Devices
Michael.graffeo@dunemedical.com
(508) 620-2782

SOURCE Dune Medical Devices


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