Matt Henriksen
👤 SpeakerAppearances Over Time
Podcast Appearances
And so we have that data, and now you're going through the FDA approval process.
Right.
My first question is, because you were using shockwaves technology as a predicate, does that mean you're going down the 510K pathway?
Okay.
Yeah.
And so what is kind of any...
the, either the strategy or the timing of, with that FDA approval process so far?
Okay.
Okay.
That's good to know.
And so then that means then you're probably starting to prep your...
commercial strategy.
And, you know, the thing that you mentioned earlier that caught my attention was the fact that you did your clinical trial, the enrollment sites were in the U.S.
I'm assuming that that helps create an initial kind of push with these products because you can do your limited launch with hospitals that have already been using the product.
Well, okay.
I was going to talk about the inventory bill, but let's talk about that.
The capital equipment side of it, because that usually is a big component.
And you know, a lot of these companies, not only in IPL, but elsewhere, they'll provide the capital for free.
So that eats up on their cost of goods.
Um, why, why, why does the post tile technology not have that?