Dune Medical Devices Gains FDA Nod For Breast Cancer Surgical Device

A U.S. Food and Drug Administration (FDA) advisory panel has approved Dune Medical Devices’ MarginProbe system to be used in breast cancer surgery as a complement to standard methods of intraoperative surgical margin assessment.

The MarginProbe system is designed to detect cancer in real-time at or near the surface of excised tissue specimens during surgery for breast cancer by emitting an electrical signal that bounces back. This read on the cancerous tissue enables surgeons to remove tissue around the cancerous area, reducing the likelihood of positive margins after the lumpectomy. A positive margin is when cancerous cells extend to the edge of the mass of removed tissue, indicating that only part of the cancer was removed.

Historically, 30 to 60 percent of breast cancer patients undergo additional surgery due to positive margins. A clinical trial conducted in 2011 showed that MarginProbe, when used with standard surgical methods, significantly can reduce the rate of positive margins. In the 664-patient trial, there was a three-fold increase in a surgeon’s ability to correctly identify all cancerous tissue and remove it with negative margins, with a 57 percent reduction in candidates for re-excision, according to Dune Medical.

“We are very pleased with the panel’s positive decision on the MarginProbe System for use in the United States,” said Dune’s CEO Dan Levangie. “We believe the MarginProbe System will give surgeons a powerful tool in their fight against breast cancer and provide women a substantially better chance of avoiding additional surgeries. We will work closely with the FDA to complete the approval process and intend to launch the MarginProbe System in the U.S. immediately thereafter.”

Headquartered in Israel, Dune Medical Devices develops proprietary tissue characterization technology. The 10-year-old company provides devices for the surgical and radiological spaces.