Tiger BufordYour Orthopedic Industry Expert (free today)

Advice - get early FIM experiences even if you are in the IDE/PMA pathway - Nanochon discussion

16 Nov 2024 · 1 min

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Tiger Buford advises doing early cartilage-repair implants outside the US to de-risk a first-in-man program before pursuing FDA approval. The Nanocon implant should let patients bear weight within weeks, using an osteochondral allograft protocol that allows immediate weight-bearing with gradual reduction over two weeks.

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The biggest thing you can do to de-risk is just get implantations done outside the US. Yeah. And the other thing, you don't have to tell anybody. I mean, you, you sure your investors are gonna want to know, but it's not for press releases, right? You're just trying to get real experience. Everybody probably need, will need a cartilage repair at some point. The, the market's enormous. I assume the Nanocon implant, you can weight bear you know, pretty early, within a few weeks, I would think.
So, so what we're planning on doing in the, in the first couple cases is recommending an osteochondral allograft recovery, which is immediate weight-bearing but progressive weight-bearing over a 2-week period.