Jim Clemmer: It’s a good question. As far as the Auryon version for thrombectomy, that’s a 510(k) process. So there won’t be a lot of studies required to get through the 510(k) process that’s built into our development and launch models that we have. And second, if we do a coronary model, there is a pathway that exists today, so we would expect a study there, more of a PMA process. So we’ll highlight and give you guys more guidance as we get closer. It will be more complicated, but there is a pathway that we’ll follow that the FDA kind of has it in place today. And then second back to — you mentioned about AlphaVac. We actually achieved the revenue we gave as guidance last year, 7% to 9%, I think, is what we talked about, so within that range.
But it’s true, we really learned a lot during the course of the year, talked about enhancements we’ll make from some customer feedback. But overall, the product is really safe and effective. People are getting very confident when they use it as to how well it works. We also think the APEX study will open up that large PE market for us. And today we’re in that study phase; more than half enrolled, which is great. But we really want to unlock that — finish the study, unlock that PE market. So until then, we’ll do what you would expect us to do; tread lightly, educate physicians on our product. There’s spot they can use it within the anatomy today to remove clot and that’s what we’ll work on, as well as finishing the study. When that study comes out, Bill, it opens up a large market for us.
And we think we’ll see large growth from there.
Bill Plovanic: Okay. And last question, I promise, just on PRESERVE studies enrolled. Just give us timelines for data submission, approval. I assume this is a 510(k), I believe. How should we think about that? And then, how do you expect the impact on the business? How should we think about the timing for that — the data be seminated into the marketplace and potentially drive that business? Thanks for taking my questions today.
Jim Clemmer: Bill, good question. So, we’re excited that we’ve completely enrolled the study. The study has a 12 month follow-up. So you’d expect us over the course of the year until next July complete the follow-up, compile the data, we’ll submit to the FDA not long after that. And we expect really if the process goes well, to receive an indication by end of calendar year ’24. We hope along the way we can publish some data, make it public. During that process, we think it will be compelling. If it’s based upon other data that you know has been published around the globe by physicians who’ve utilized this unique device to treat these intermediate risk prostate cancer patients, we believe the data is going to be compelling, not only because it reduces the effect of the tumor, but we also give the quality of life benefits back to those patients that they would risk with other procedures.
So we’re excited, Bill. We’re going to again just continue what we’re doing today, support our customers. But we would expect when we receive that indication, you’ll see a different selling and marketing and clinical support approach from our company to maximize the opportunity in this market. That will really kick in more in calendar year ’25 after that indication is received.
Bill Plovanic: Thanks for taking my questions.
Jim Clemmer: Thank you.
Operator: The next question is from the line of Matthew Mishan with KeyBanc Capital Markets. Please proceed with your question.
Matthew Mishan: Thanks. Good morning. Thanks for taking the questions. Hey, Jim, Steve, it seems like you’re taking a little bit of a different approach to guidance this year, especially around some of the individual moving pieces. But could you help us build up to that 20% to 25% Med Tech guidance for FY ’24? What is, what’s above, what’s below, and how you’re accounting for AngioVac in that?
