|Dune's MarginProbe device won a CE marking in the EU.--Courtesy of Dune|
Less then two months after gaining U.S. approval for a cutting-edge breast cancer diagnostic tool, Dune Medical Devices won a CE marking in the European Union for its next-generation model.
Dune, which is based in Israel, Germany, Switzerland and the U.S., now has an overseas regulatory nod for its MarginProbe version 1.2. The company touts the newer version as being smaller, more portable and designed in such a way to lower manufacturing costs and also enable more efficient construction. Similar to the initial device that won FDA approval in January, it is also designed to spot breast cancer tissue at or near the top of already removed tissue, so surgeons and radiologists can make an immediate diagnosis to determine if all cancer tissue has been removed.
That is a crucial ingredient in the bid to boost treatment quality and reduce the cost of care at the same time, and breast cancer diagnosis is a good place to start. The existing standard of care is much more time-consuming, requiring a tissue sample to go to pathology for analysis, which can take a week or more. Dune estimates that between 30% and 60% of all lumpectomy procedures lead to additional surgeries, and a tool that would reduce that number and help preserve breast tissue could help have real value in today's health care marketplace if it works according to expectations. And there is a major need; more than 285,000 women are diagnosed with breast cancer annually.
No word yet as to Dune's U.S. approval plans for the next-generation MarginProbe device. Dune filed for FDA approval for its initial version back in 2001, based on a pivotal study involving 664 patients that showed its device could find breast cancer on the margins three times more effectively than traditional imaging during lumpectomy procedures. And the device, in earlier data, reduced by 50% the rate of repeat operations. The company remains a rumored acquisition target.
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