Efficacy of OneMark Device in Identifying Breast Cancer for Surgery and Surveillance

"The OneMark device system consists of a tumor marker preloaded in a delivery system, a handheld probe, and a display console.~The OneMark marker is a metal clip with microparticles embedded in gelatin forming a hydrogel pellet. The pellet is implanted with a preloaded injector percutaneously in soft tissues, such as breast or lymph nodes, to mark a biopsy site or tissue intended for surgical removal. It can be used as a fiducial implant post-biopsy for future identification or monitoring of the tissue, and as an intra-operative localization mark. The microparticles of OneMark marker can be detected by Doppler ultrasound, magnetic resonance imaging (MRI), radiography, and OneMark Detector. During surgery, the OneMark marker may be removed with the target tissue. If patients do not require surgery, the OneMark marker can be left in place."