Results

Technical feasibility

The pre-clinical proof-of-concept study of the NRI was conducted in September 2018. In this study, designed to optimize the implantation technique and to specify the optimal depth range for device implantation, successful implementation and placement of the NAC implant were demonstrated in excised human breast tissue.

Results

The implantation technique was optimized and the optimal depth range for device implantation was optimized.

In all specimens, device implantation was successful and without any events. The implantation technique according to the suggested IFU was reported to be easy and feasible. In all implantations (n=9) There was no need to fixate the device, and the surgeon reported that the fatty breast tissue comprising the pocket in which the device was implanted was holding the device firmly enough.

Nipple projection and sensation were reported to be optimal at the depth of 0.5cm. Below this depth (at 0.7cm and 1.0cm) the device projection was too low.

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