Dune Medical lands FDA approval for breast cancer tissue detector

Dune Medical Devices' MarginProbe system

Framingham, Mass.-based Dune Medical Devices finally got the FDA nod for its MarginProbe breast cancer tissue detection system, a device that can help surgeons determine whether they have excised all the cancerous tissue during early-stage breast cancer surgery.

The approval was based on a 664 patient study evaluating the MarginProbe’s ability to identify cancerous tissue along the edges of removed breast tissue during early lumpectomy procedures.

The device proved to be 3 times more effecting in finding such cancers compared to traditional intra-operative imaging and assessments, according to a press release.

The MarginProbe system uses electromagnetic waves to identify possibly cancerous tissue on the edges of a breast tumor in real time during surgical procedures, and is the company’s 1st commercial product.

Physicians using MarginProbe may be able to better identify lingering cancerous tissue during surgery, reducing the number of repeat procedures needed to remove additional cancerous cells detected at the edge of the removed tissue, according to Dune.

An estimated 30%-60% of women who undergo breast lumpectomies have to return for repeat surgeries, the company reported.

"Following their breast cancer surgery, telling a patient that they need more surgery can be an emotional issue for doctors and patients. This may result in tremendous anxiety and frustration," MarginProbe study investigator and Beth Israel Medical Center chief of breast surgery Dr. Susan Boolbol said in prepared remarks.

The regulatory win marks a major milestone for Dune, and the Israeli company plans to move its U.S. headquarters from Framingham, Mass., to Boston in order to start developing a sales team and commercial strategy, the Boston Globe reported.

The MarginProbe system has been on the European market since 2008, and initially submitted the device for U.S. regulatory approval in April 2011.

In November Dune inched closer to its pre-market approval win with an “approvable letter” from the FDA, with full approval hinging on a final agreement on post-approval study design.

The MarginProbe device will initially be available in select markets, with full U.S. commercial launch planned this year.

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