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FDA Formally Accepts Dune Medical Devices Ltd.'s MarginProbe(TM) System Pre-Market Approval (PMA) Application and Grants Expedited Review Status


5/16/2011 9:14:50 AM

FRAMINGHAM, Mass., May 16, 2011 /PRNewswire/ -- Dune Medical Devices, Inc. today announced that the U.S. Food and Drug Administration (FDA) formally accepted for filing the company's Pre-Market Approval (PMA) application for the MarginProbe System. The FDA's actions mean that the PMA application was sufficiently complete and ready for substantive review. Additionally, the FDA believes MarginProbe represents a breakthrough technology that may offer a clinically meaningful advantage, and, since there is no legally marketed alternative device, confirmed that the PMA application has been granted expedited review.

"We're extremely pleased that the FDA has accepted the MarginProbe System PMA application and granted expedited review," said Dune Medical CEO Bill Densel. "Our mission is to develop a range of applications that allow physicians to detect cancer in targeted tissue in real time, and react immediately. This milestone with MarginProbe brings us one step closer to providing surgeons with an intraoperative technology that detects microscopically positive margins in patients undergoing surgery for breast cancer."

The PMA submission includes data from the pivotal study recently presented Friday, April 29 at the 12th Annual Meeting of the American Society of Breast Surgeons (ASBS) in Washington, DC.

Successful breast conserving surgery requires cancer-free margins at the edges of excised tissue. However, real time, intraoperative methods currently available to surgeons are limited in their ability to identify microscopically-positive margins. Because of this, patients frequently require re-excision procedures, which are reported to take place in up to 30 percent of patients. Readmissions for re-excision to obtain clear margins have been shown to increase cost and emotional distress for patients, as well as have the potential for more scarring and deformation at the surgical site.

About the MarginProbe System

The MarginProbe System provides real time, intraoperative detection of cancerous tissue at the edges of excised breast tissue, thereby enabling surgeons to immediately resect additional tissues. In clinical studies as an adjunct to standard of care, it has been shown to improve a surgeon's ability to achieve a complete resection of the disease, leading to lower rates of re-excision procedures. The MarginProbe System is commercially available in Europe. It is an investigational device in the United States.

About Dune Medical Devices

Dune Medical Devices is a private medical device company developing applications for the real time detection of cancerous tissues during surgical, interventional, and diagnostic procedures. As a stand-alone platform or in combination with imaging modalities, Dune's breakthrough technology will provide physicians with information that has the potential to improve procedure success rates, better outcomes, and lower costs. Founded in 2002 by Dr. Dan Hashimshony and financed by Apax Partners, the Company has offices in the U.S., Europe, and Israel. For more information, please visit www.dunemedical.com.

SOURCE Dune Medical Devices, Inc.



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