Dune Medical Devices has obtained an approvable letter related to its premarket approval application (PMA) for the breast cancer detection system from the US Food and Drug Administration (FDA).
The letter indicates that the system's PMA will be approved, subject to final agreement with the FDA on the post-approval study design.
Using electromagnetic waves, the MarginProbe system detects microscopically positive margins and provides intraoperative information on the malignancy of the surface of the ex-vivo lumpectomy specimen.
Previously early detected breast cancer patients were undergoing a lumpectomy procedure as their initial treatment versus mastectomy, which involves the removal of the whole breast.
Lumpectomy in combination with radiation therapy was also considered as effective in treating breast cancer as mastectomy, where no cancer cells are present on the rim or edge of the removed tissue.
Research studies show that there is no significant difference in overall survival between the two procedures, however, if there is cancer at the edge, or a 'positive margin', the risk of recurrence increases, thus resulting in repeated surgeries, claims the company.
The MarginProbe system, which is intended for use on freshly excised tissue within 20 minutes of tissue excision, is indicated for intraoperative use in conjunction with intraoperative imaging and palpation.
Dune Medical Devices chief executive officer Daniel Levangie said the company will work diligently over the coming weeks to develop the final design of the post approval study.
"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," Levangie added.
