Framingham, Mass.-based Dune Medical Devices inched closer to premarket approval from the FDA for its MarginProbe breast cancer detection tool, winning an "approvable letter" from the federal watchdog agency.
The company is working together with the FDA on the design of the required post approval study for the MarginProbe system, the final step before Dune can commercialize the product in the U.S., according to the approvable letters.
The MarginProbe system, which uses electromagnetic waves to identify possibly cancerous tissue on the edges of a breast tumor in real time during surgical procedures, is the company’s 1st commercial product.
"We are delighted to have come to this point in the approval process with FDA and will work diligently over the coming weeks to develop the final design of the post approval study,” CEO Daniel Levangie said in prepared remarks. “Having completed our discussions with FDA related to product labeling, the post approval study is the only remaining issue to be resolved prior to final approval.”
Dune Medical submitted a pre-market approval application for the MarginProbe system in April 2011, based on data from a 600-patient pivotal study conducted primarily in the U.S.
Earlier this year the FDA’s general & plastic surgery devices advisory panel voted in favor of approval for MarginProbe, voting 11-0 that the device is safe, 8-1 with 2 abstentions that it is effective and 10-1 that its benefits outweigh its risks.