Medical device maker Dune Medical Devices announced Wednesday that the company has received a pre-market approval from the Food and Drug Administration for its breast cancer detection device.
The MarginProbe System can be used following the removal of cancerous tissue to know whether there is cancer in the immediate vicinity of the excised tissue. It uses electromagnetic technology to distinguish between healthy and cancerous tissue and prevents repeat surgeries to remove cancerous tissue that was not detected following an initial lumpectomy.
The current standard of care involves testing the excised tissue to see whether there is any cancer on the edges, also known as “positive margin.” That increases the odds that the cancer was not fully removed from the breast, indicating that a repeat surgery is necessary.Nearly one in four women get repeat surgeries to ensure that no diseased tissue remains, according to the Journal of the American Medical Association.
In a news release, Dune Medical Devices noted that the nod from the Food and Drug Administration was based on a 664 patient prospective, multi-center, randomized, double arm trial. The product was found to be “over three times more effective in finding cancer on the margin during lumpectomy” compared to traditional methods.
“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. I believe that the MarginProbe System can help advance the field of breast surgery,” said Dr. Susan K. Boolbol, an investigator for the pivotal clinical trial and Chief of Breast Surgery at Beth Israel Medical Center, in the news release.
Founded in 2002 by a physician, Dune Medical intends to apply its tissue characterization technology in which the probe analyzes the electromagentic response of tissue, in a number of medical applications both surgical and diagnostic. The company is based in Israel, but has U.S. offices in Massachusetts, in addition to offices in Germany and Switzerland. Since 2004, the company appears to have raised $35 million in three rounds of funding. The company’s lead investor is Apax Partners, a global private equity firm.