Darrin Uecker
Analyst · Park City Capital. Please proceed
Yeah, thanks. Those are really good questions. So I think, you know, my feeling is that all the interactions we’ve had with FDA up until now benefit us going forward. So I think where we’re at is, you know, kind of coming out of this last 510(k) is that, you know, FDA is you know, we’ve gotten, you know, I think very good signs from FDA, that they believe that, you know, this is a 510(k) device. So I think that is extremely positive. I think that we under – you know, they believe that because of all the data and everything we’ve done in the past 510(k). So I think that, for one is very positive, it shows that they have a, you know, a pretty good understanding of the technology itself and what we’re trying to do with it, you know, where we ended with the last submission as we described on our previous call. And I think in our press release was that, the clinical data that we provided just didn’t give them enough to be able to come to a substantial equivalence conclusion in terms of the benefit risk and largely, you know, where they ended up was that they wanted to see comparative data. And so really, I think all the data we provided has been very informative. It’s helped, you know, FDA understand this technology, which again, is a new technology for them. So, you know, I think it takes time for reviewers to really begin to understand the technology and how it can be used in skin. And now we have, I think, some pretty good clarity on kind of what their expectations will be with regard to specific clinical indications. The idea of a general dermatologic indication came about through conversation with FDA and I think really their desire that, that we introduced this technology through the FDA in kind of a stepwise approach, because it allows them to provide clearances and perform reviews of the technology in a kind of a more digestible form. So when we do the general derm indication, you know, our expectation is, that will be a relatively small amount of data, in addition to data that we provided previously, and then with each new specific indication, it will really be largely based on that clinical data. And so I think, you know, kind of through this, all this work we’ve been doing with FDA. I think what we’ve realized is that, for a new technology like this, it makes, you know, it’s a lot easier for them to kind of do this in a stepwise approach, and for us to provide data in that kind of stepwise approach. And that’s kind of really where we’re at. So I think the last 510(k) we provided a lot of information, two clinical studies worth and a lot of preclinical data. And so now from that we’re kind of going in a more stepwise fashion. And I think, you know, the other thing we’re doing coming out of that is to have these Q-Submission meetings. So I think those are, you know, our ability to sit with FDA to agree on kind of the requirements of the data prior to anything being submitted to FDA. And so I think all those things put us in a very good position going forward. And, you know, I’ve been involved in a number of new technologies, new medical device technologies in my career, I mean most notably in the medical robotics field where, you know, we introduced the first FDA clearance robot to the market. And, you know, it takes time, I think, is the lesson as you’re going with – as you’re introducing these new technologies to reviewers that have never seen it before to work through that process. And I think that’s what we’ve experienced, for sure over the last, you know, 12 months or so. And I think it definitely benefits as going forward. We’re much further along than we were prior. And I think we have a much better understanding of the requirements that FDA is wanting, and I think they have a much better understanding of the technology, you know, today. So hopefully that helps.