|Dune Medical secured FDA approval for MarginProbe--courtesy of Dune Medical Devices|
Dune Medical Devices' headline-grabbing cancer tool has capped its rapid road through the FDA with a full pre-market approval, getting the agency's sign-off for marketing in the U.S.
MarginProbe works by detecting the presence of cancer at or near the surface of excised breast tissue, slashing the need for repeat operations after breast-conservation surgeries. The full approval comes after November's approvable letter, and Dune plans to hit the ground running now that its lead device has a U.S. OK. The Israeli company is looking to amp up its American operations to commercialize MarginProbe; it told The Boston Globe it plans to add 20 to 25 employees to its Massachusetts operation.
Dune supported its FDA app with a pivotal study of 664 patients, finding its device to be three times more effective in finding cancer on the margins than traditional imaging during lumpectomy procedures, and earlier data showed that MarginProbe cut the rates of repeat operations by about 50% in breast cancer patients.
The device serves a huge unmet need in the world of cancer surgery, CEO Daniel Levangie said. "We have received resounding support from clinicians, advocacy organizations and patients alike, who have recognized the value of MarginProbe and intra-operative, real-time detection of cancer on the margin to potentially improve patient outcomes," Levangie said in a statement.
Dune's quick trip to FDA approval has attracted plenty of attention since the company filed in 2011, and with that comes buyout rumors. Back in October, Israel's Ynetnews reported that Japan's Sysmex Corporation was in talks to pick up Dune for $200 million. Nothing has come of that since, and Dune has declined to comment all along, but one would assume getting the FDA's blessing for a buzzed-about device would tick that asking price northward, if Dune is indeed on the market.
- read Dune's announcement
- check out the Globe's story
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