Dune Medical ticks toward FDA approval for MarginProbe

Dune Medical is creeping closer to FDA approval for MarginProbe--courtesy of Dune Medical Devices

After notching a 10-1 recommendation from an FDA panel over the summer, Dune Medical Devices got an approvable letter from the agency, the last step before a final OK for its MarginProbe device.

The FDA's letter states that MarginProbe is approvable pending a final agreement with the agency on how to conduct a standard post-approval study, and Dune says it will work diligently over the coming weeks to design a study and speed the device's path to the market.

MarginProbe is designed to minimize the need for repeat operations after breast-conservation surgeries by detecting the presence of cancer at or near the surface of excised tissue, and a recent study found that it cut the rate of re-excision by about 50%. The device is already available in Europe, and Dune filed with the FDA in 2011, getting the panel nod in June.

Reportedly, Dune isn't the only company excited about MarginProbe's potential once it gets on the market. Last month, Israel's Ynetnews reported that Japan's Sysmex Corporation is in talks to buy the Israeli devicemaker for $200 million. Dune has declined to comment on the report.

- read Dune's release

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