Dune Medical Devices' MarginProbe

Courtesy of Dune Medical Devices

Dune Medical Devices lived out the best-case scenario for devicemakers moving through the FDA process, hitting green lights all the way to a full approval for MarginProbe, a tool that can detect cancer along the edges of excised breast tissue. Since then, the now-Boston-based company has been on the up and up, dismissing buyout rumors and expanding its staff.

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 removed tissue, and a recent study found that it cut the rate of re-excision about 50%. All the positive data was enough to sway the FDA, and Dune CEO Dan Levangie told FierceMedicalDevices that the response from physicians has been just as positive.

With FDA approval in hand, Dune ditched the Boston suburbs for an office in town, hiring sales staff to help make MarginProbe the standard of care in lumpectomy procedures. And while the late-December approval only added fuel to the rumors that Dune was on the block for $200 million or considering an IPO, Levangie said the company is looking to grow organically, expanding MarginProbe and using the revenue to fund its pipeline.

And that pipeline could prove lucrative. Using MarginProbe's cancer-detecting platform technology, Dune has developed a prototype biopsy needle that would provide real-time information to surgeons, and the company is aiming to get it approved in Europe this year and on shelves in the U.S. in 2014. Beyond that, Levangie said MarginProbe's platform could well work for other cancer surgeries, and the company is investigating an application for prostate cancer.

Dune Medical Devices' MarginProbe