The MarginProbe System
Dune Medical Devices announced Monday that the company has received a letter from the Food and Drug Administration indicating that it is close to receiving a pre-market approval from the agency.
The FDA informed Dune Medical, which has filed a PMA for its breast cancer detection device during surgeries, that it will grant the approval once a design of the requisite post approval study has been finalized.
Dune Medical, based in Israel but with U.S. offices in Framingham, Massachusetts, makes the MarginProbe System which can be used following the removal of cancerous tissue to know whether there is cancer in the immediate vicinity of the excised tissue. The company?s randomized clinical trial on 300 breast cancer patients showed that the hand-held probe was able to cut by more than half the rate of re-operation versus the standard care.
The current standard of care involves testing the excised tissue to see whether there is any cancer on the edges, also known as ?positive margin.? That increases the odds that the cancer was not fully removed from the breast, indicating that a repeat surgery is necessary.
However, those tests done at a pathology lab can take one week or more, compared with the MarginProbe which can deliver instant analysis in the operating room, the company said. That reduces any uncertainty and emotional stress over whether a second surgery is required. According to the Journal of the American Medical Association, the lack of knowledge in ascertaining whether all malignantcells have been cut away from the breast during the initial lumpectomy leads to repeat surgery rates ranging from 30 percent to 60 percent.
Founded in 2002 by a physician, Dune Medical intends to apply its tissue characterization technology in which the probe analyzes the electromagentic response of tissue, in a number of medical applications both surgical and diagnostic. Since 2004, the company appears to have raised $35 million in three rounds of funding. The company?s lead investor is Apax Partners, a global private equity firm.
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