This is a bit of a different species than the NPWT dressing as...

This is a bit of a different species than the NPWT dressing as it is intended for permanent implantation and eventual resorption and elimination from the body through the kidneys (I presume). This process must be explained and documented to the satisfaction of the authorities. Thus it seems natural to me that the approval process might be less straightforward than for the NWPT dressing, perhaps including requests for clarification or additional information. I’d say we must be getting closer, but when the process might be completed is outside the range of my knowledge. I’d advise patience.