"This is most likely due to the fact that regulatory clearance...

"This is most likely due to the fact that regulatory clearance in Japan is considered as one of the most difficult in the world."

and

"Japan does not accept CE marking and/or an FDA certificate although European and US approval does help to expedite the review process."

Probably 'help' is the key word here. Having a distributor is a given. The issue for PNV then will be the classification. There are 4 classes, and our product will almost certainly be the highest (cat 4) - naturally resulting in more hurdles to jump (ie approval needed for their equivalent authority - the PMDA).

However, assuming the process in underway now, and the suggested timeframe was CY 25, that suggests up to 19 months from this point. My bet is 2026, but hoping for late 2025 at earliest.