James McCullough: Yes. FDA is obviously a major validation, especially coming out of de novo marketing authorization. It is de novo, it’s new. It does allow us to change and simplify the conversation with payers and with physicians. Physicians we can now walk into an office and say, it’s FDA authorized. So, that removes any doubt around is this experimental. And again, the thing that we’re learning more than anything else is the simpler the message, the more effective the sales ramp and the easier time we’re going to have with adoption. And getting to simplicity, as we all know, from experience is difficult. The simplest messages are often difficult, especially in a complex regulatory environment of medical devices and especially with the power of KidneyIntelX coming off of the AI enablement, coming off of the huge clinical data and how does it relate to outcomes, et cetera.
So getting to that very simple message so that a primary care physician who is often overwhelmed, they’re dealing with a complex disease can very simply say, oh, okay, FDA approved. I don’t have to worry about insurance. And boy, here’s the data. If I use this thing, my patient is going to get better. That’s a pretty simple message. Of course, it takes you tens of millions of dollars and multiple years and all this complexity to get to the point where you can legitimately say that. So, I think the setup for the back end of this year is, for us, fascinating, and we are very optimistic because we’re able to carry this incredibly simple but powerful message into the physician office, where there’s a clear unmet need. No one has come back to us to say, ah, you know it’s nice.
I don’t need this. Especially among primary care, everybody needs it. We need a way to be able to identify who’s at high risk in these very large populations. So, we understand who we can treat because you can’t treat them all. There are too many people with diabetes and kidney disease. You need a simple, rapid way to say here’s a patient with kidney disease that really matters, I got to focus on them. And because we have new drugs now that really work, there’s a very simple solution here. So, I am very optimistic about the future to drive growth, which is one of the reasons we got a hold of EVERSANA, who both Tom and I have worked with in the past. And it does give us the resources to deploy with a higher degree of confidence that they’re effective resources and that we can target an ROI, where we can really target an IRR.
And we can make sure that investing in these resources are going to generate return with this simple message. So yes, I am — I’m very confident going into the second half of this year that the seas are going to come a little bit. And we also have, Randy, a ton of experience now. I mean, partnering up with Mount Sinai and getting in early and being able to use KidneyIntelX in the wild was incredibly valuable. And I haven’t done that in previous companies. I’m delighted we did it now because we get a real, in-the-world experience with what happens with KidneyIntelX. So now that gives us the capacity when we move out into other territories, we’ve got a great data set that we can draw from, and the product becomes much more clear in terms of the messaging.
So, I think, having the three legs of the stool, the trifecta has been, as Dan said earlier, a long winding road, but we’re arriving at that station with the trifecta. And I think it’s ours to lose at this point.
Randy Baron: Good luck.
Operator: Thank you. [Operator Instructions] Speakers, I am seeing no further questions in the queue. This means that this will conclude today’s conference call. Thank you all for participating. You may now disconnect. Have a pleasant day. And enjoy your weekend.
