KS, I am willing to stick my neck out again, 2025 is just a bridge too far, the PNV product in my opinion may be on the market late FY 2021, which could be after June CY2020 to before before July 2021, this is only my opinion, but the reason why I say this is because even though the product by PNV for the breast augmentation, may be in a different form to BTM (Foam) it will essentially be made of the same polymers, these polymers have already been tested in vivo, so the regulatory process should be quicker one would think on that side?, what may slow it down a tad is that it will be used in conjunction with another product (the breast implant by EL) but even that has been tested in vivo as well, so it may end up being much quicker than your estimate of 2025?
Are you willing to stick your neck out and stay with your original date of 2025?
Recent Bans of Textured Implants & Polynovo to Stop BIA ALCL?, page-26
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