The pre-clinical proof-of-concept of the NRI was achieved in September 2018. Successful implementation and placement of the NAC implant was demonstrated in excised human breast tissue.
The Ex-Vivo study designed to optimize the implantation technique and to specify the optimal depth range for device implantation, in human ex-vivo tissue.
A single center, single user, prospective, open label, acute ex-vivo study enrolling patients undergoing surgical removal of breast tissue with both skin and subcutaneous components.
freshly excised human breast tissue was used as a model of implantation.
In each specimen, multiple implantations were performed to evaluate the optimal depth-range for proper projection, desired felling (softness/rigidness), required device sizes (diameters) and fixation technique to achieve optimal projection and optimal device positioning.
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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